B thuringiensis ssp aizawai GC-91 final RR 1107 Part B Section 7
Transcription
B thuringiensis ssp aizawai GC-91 final RR 1107 Part B Section 7
Part A National Assessment – Germany Agree 50 WG Page 1 of 30 Registration Report – Central Zone REGISTRATION REPORT Part A Risk Management Product code: Agree 50 WG Active Substance: Bacillus thuringiensis ssp. aizawai GC-91 500 g/kg COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Mitsui AgriScience International SA Date: November 2015 Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Agree 50 WG Page 2 of 30 Registration Report –Central Zone Table of Contents PART A – Risk Management 4 1 Details of the application 4 1.1 Application background 4 1.2 Annex I inclusion 4 1.3 Regulatory approach 5 1.4 Data protection claims 5 1.5 Letters of Access 5 2 Details of the authorisation. 6 2.1 Product identity 6 2.2 Classification and labelling 6 2.2.1 Classification and labelling under Directive 99/45/EC 6 2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 6 2.2.3 R and S phrases under Regulation (EC) No 547/2011 7 2.2.4 Other phrases 7 2.3 Product uses 10 3 Risk management 16 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 16 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 16 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 16 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 16 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 16 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 17 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 17 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 17 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 17 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 18 Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Agree 50 WG Page 3 of 30 Registration Report –Central Zone 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 19 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 19 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 19 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 20 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 21 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 21 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 22 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 23 3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 24 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 25 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 25 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 25 3.1.7 Efficacy (Part B, Section 7, Point 8) 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 29 25 Appendix 1 – Copy of the product authorisation 30 Appendix 2 – Copy of the product label 30 Appendix 3 – Letter of Access 30 Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment – Germany Agree 50 WG Page 4 of 30 Registration Report – Central Zone PART A – Risk Management This document describes the acceptable use conditions required for the registration of Agree 50 WG containing Bacillus thuringiensis ssp. aizawai GC-91 in Germany. This evaluation is required subsequent to the inclusion of Bacillus thuringiensis ssp. aizawai GC-91 on Annex 1. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to Agree 50 WG where that data has not been considered in the EU review. Otherwise assessments for the safe use of Agree 50 WG have been made using endpoints agreed in the EU review of Bacillus thuringiensis ssp. aizawai GC-91. This document describes the specific conditions of use and labelling required for Germany for the registration of Agree 50 WG. Appendix 1 of this document provides a copy of the final product authorisation Germany. Appendix 2: The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions drawn by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again. Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation. Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. 1 Details of the application 1.1 Application background This application was submitted by Mitsui AgriScience International in April 2012. The application was for approval of Agree 50 WG, an insecticide formulated as water dispersible granules containing 500 g/kg of Bacillus thuringiensis ssp. aizawai strain GC-91. Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. 1.2 Annex I inclusion Bacillus thuringiensis ssp. aizawai GC-91 was included on Annex I of the EU Directive 91/414/EEC on 1 May 2009 under Inclusion Directive 2008/113/EC and implemented under Regulation (EU) No 540/2011. The approval of Bacillus thuringiensis ssp. aizawai GC-91 (Inclusion Directive 2008/113/EC from 8 December 2008) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Agree 50 WG Page 5 of 30 Registration Report –Central Zone For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. These concerns were all addressed in the submission. Expiration of approval: 30/04/2019. 1.3 Regulatory approach To obtain approval the product Agree 50 WG must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points. This application was submitted in order to allow the first approval of this product/use in Germany in accordance with the above. 1.4 Data protection claims The applicant, Mitsui AgriScience International S.A./B.V. (Boulevard de la Woluwe 60, Brussels, Belgium), is holder of all proprietary data used in the dossier. The data owner is Certis U.S.A. (9145 Guilford Road, Columbia, USA). The same applies to all studies assessing the physical-chemical properties and the storage stability of Agree 50 WG for which Certis Europe (Safariweg 55, 3605 Maarssen, Netherlands) was the sponsor. Data protection claims are indicated in the reference list included in the Registration Report, Part B section 1-7. 1.5 Letters of Access On behalf of Certis U.S.A., Mitsui AgriScience International S.A./B.V. submitted data for approval of Bacillus thuringiensis ssp. aizawai GC-91 and has full access to the data. The same applies for all data for Agree 50 WG. A Letter of Access from Certis Europe is provided. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Agree 50 WG Page 6 of 30 2 Details of the authorisation. 2.1 Product identity Product Name Authorization Number Function Applicant Composition Formulation type Packaging Registration Report –Central Zone Agree 50 WG 007638-00 Biological insecticide Mitsui AgriScience International SA/BV Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91): 500 g/kg; biopotency: 25,000 IU/mg product; δ-endotoxin: 3.8%; spores: 3 x 1013 CFU/kg Water dispersible granules [Code: WG] 1 kg primary packaging (polyethylene bag), 1 secondary packaging containing 10 pieces of primary packaging 2.2 Classification and labelling 2.2.1 Classification and labelling under Directive 99/45/EC In accordance with Directives 67/548/EEC and 1999/45/EC the following classification / labelling with regard to toxicological data is proposed for the preparation. Hazard Symbol: Indication of danger: Risk Phrases: Safety Phrases: Labelling texts and restrictions: 2.2.2 Xi Irritant 43 2-24-36-37-46 To avoid risks to man and the environment, comply with the instructions for use. Micro-organisms may have the potential to provoke sensitising reaction. Classification and labelling under Regulation (EC) No 1272/2008 According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the following classification for toxicological hazards of the preparation according to GHS is proposed: Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Pictograms, code: Signal word: Hazard code: GHS07 Warning H317 EUH401 Agree 50 WG Page 7 of 30 Registration Report –Central Zone May cause an allergic skin reaction. To avoid risks to human health and the environment, comply with the instructions for use. Micro-organisms may have the potential to provoke sensitising reactions. 18 percent of the mixture consists of ingredients of unknown oral, dermal and inhalation toxicity. 2.2.3 R and S phrases under Regulation (EC) No 547/2011 SF1891 Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. 2.2.4 Other phrases The authorization of the PPP is linked to the following conditions (mandatory labelling): • Operator protection Safety instructions (codes according to BVL 1)) SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB110 The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. SS2101 Wear a protective suit against pesticides Applicant: Mitsui AgriScience International SA Justification Mandatory for plant protection products. Mandatory for plant protection products. Based on BBA-Guideline Part I, 3-3 (1993) with regard to the dangerous substance directive (Biologische Bundesanstalt für Land- und Forstwirtschaft, Richtlinen für die Prüfung von Pflanzenschutzmitteln - Kennzeichnung von Pflanzenschutzmitteln (Gesundheitsschutz) (Federal Biological Research Centre for Agriculture and Forestry, Guidelines for Evaluation of Plant Protection Products – Labelling of Plant Protection Products (Human Health)). Based on BBA-Guideline Part I, 3-3 (1993) with Evaluator: DE Date: November 2015 Part A National Assessment - Germany Agree 50 WG Page 8 of 30 and sturdy shoes (e.g. rubber boots) when handling the undiluted product. SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. VH650 The packaging must be provided with the wording "micro-organisms may have the potential to provoke sensitising reactions". VA269 The product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 %. Registration Report –Central Zone regard to the dangerous substance directive (Biologische Bundesanstalt für Land- und Forstwirtschaft, Richtlinen für die Prüfung von Pflanzenschutzmitteln - Kennzeichnung von Pflanzenschutzmitteln (Gesundheitsschutz) (Federal Biological Research Centre for Agriculture and Forestry, Guidelines for Evaluation of Plant Protection Products – Labelling of Plant Protection Products (Human Health)). With regard to preventive health protection and good agricultural practice. Based on BBA-Guideline Part I, 3-3 (1993) with regard to the dangerous substance directive (Biologische Bundesanstalt für Land- und Forstwirtschaft, Richtlinen für die Prüfung von Pflanzenschutzmitteln - Kennzeichnung von Pflanzenschutzmitteln (Gesundheitsschutz) (Federal Biological Research Centre for Agriculture and Forestry, Guidelines for Evaluation of Plant Protection Products – Labelling of Plant Protection Products (Human Health)). With regard to preventive health protection and good agricultural practice. http://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/eAntrag-CodelistenEN.pdf?__blob=publicationFile&v=6 1) Environment EB001-2 Do not contaminate water with the product or its container (Do not clean application equipment near surface water./Avoid contamination via drains from farmyards and roads). NW642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Agree 50 WG Page 9 of 30 Registration Report –Central Zone Labelling phrases for efficacy and sustainable use WMI11 Mode of action (IRAC-group): 11 (bacillus thuringiensis) NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4) NN1001 The product is classified as not harmful for populations of relevant beneficial insects. NN1002 The product is classified as not harmful for populations of relevant beneficial predatory mites and spiders. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment Germany Registration Report – Central Zone Agree 50 WG Page 10 of 30 2.3 Product uses PPP (product name/code) active substance Agree 50 WG Bacillus thuringiensis ssp. aizawai GC-91 Formulation type: Conc. of as : WG 500 g/kg Applicant: Zone(s): Mitsui AgriSciences International S.A./B.V. central EU professional use non professional use x x Verified by MS: yes 1 UseNo. 001 2 Member state(s) DE 3 4 Crop or 5 6 7 and/ F situation G or (crop destination / I purpose of crop) Pests or Group of pests controlled Method / Kind (additionally: developmental stages of the pest or pest group) Application Timing / Growth stage of crop & season grape vine (VITVI) F (use as table and wine grape) grape berry moth 1.generation (L1-L2) from emergence of first larvae after beginning of infestation or warning service appeal / from BBCH 53 Applicant: Mitsui AgriScience International SA spraying or fine spraying (low volume spraying) 8 Max. number (min. interval between applications) a) per use b) per crop/ season 3 (at least days apart) 10 11 12 13 Application rate PHI Water L/ha (days) g, kg as/ha kg, product / ha a) max. rate per a) max. rate appl. min / max b) max. total rate per appl. b) max. total per crop/season rate per crop/season 7 a) – base dose: a) 0,125 -0,375 – base dose: 0,25 kg/ha b) 1,125 400 l/ha - BBCH 61: - BBCH 61: 0,5 kg/ha 800 l/ha - BBCH 71: - BBCH 71: 0,75 kg/ha 1200 l/ha b) 2,25 Evaluator: DE Date: November 2015 14 Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures NW642-1 Use cannot be authorised due to insufficient number of efficacy trails to allow efficacy assessment (EPPO PP 1/226 (1) and PP 1/225 (1)) Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Part A National Assessment - Germany Product code Page 11 of 30 Registration Report –Central Zone 002 DE grape vine (VITVI) F (use as table and wine grape) grape berry moth spraying or 2. and 3. generation (L1- fine L2) spraying (low volume spraying) from emergence of first larvae after beginning of infestation or warning service appeal / from BBCH53 003 DE berries (NNNOB) except for strawberry F free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 11 004 DE berries (NNNOB) except for strawberry G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 11 Applicant: Mitsui AgriScience International SA 3 (at least 7 a) – base dose: days apart) 0,25 kg/ha - BBCH 61: 0,5 kg/ha - BBCH 71: 0,75 kg/ha -BBCH 75: 1 kg/ha b) 2,25 3 (at least 7 a) 1 days apart) b) 3 a) 0,125 – 0,5 b) 1,5 – base dose: 400 l/ha - BBCH 61: 800 l/ha - BBCH 71: 1200 l/ha - BBCH 75: 1600 l/ha NW642-1 Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. a) 0,5 b) 1,5 max. 1000 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 max. 1000 NW642-1 Use cannot be authorised due to insufficient number of efficacy trails to allow efficacy assessment (EPPO PP 1/226 (1) and PP 1/225 (1)) Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Use cannot be authorised due to insufficient number of efficacy trails to allow efficacy assessment (EPPO PP 1/226 (1) and PP 1/225 (1)) Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 12 of 30 Registration Report –Central Zone 005 DE strawberry (FRAAN) F free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 13 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 1000 - 2000 006 DE strawberry (FRAAN) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 13 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 1000 - 2000 007 DE fruit vegetables (NNNVF) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 09 a) 0,25 – 0,5 b) 3 008 DE leafy and stem vegetables F (NNNVL) except for vegetable cabbage free biting caterpillars after beginning of infestation; from emergence of first larvae / from BBCH 09 a) < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha b) 6 200 - 800 009 DE leafy and stem vegetables G (NNNVL) except for vegetable cabbage free biting caterpillars spraying or fine spraying (low volume spraying) spraying or fine spraying (low 6 (at least 7 a) < 50 cm: days apart) 0,5 kg/ha 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 6 3 (at least 7 a) 1 days apart) b) 3 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 Applicant: Mitsui AgriScience International SA after beginning of infestation; from emergence of first larvae / Evaluator: DE Date: November 2015 a) 0,5 b) 1,5 200 - 1000 NW642-1 Use cannot be authorised due to insufficient number of efficacy trails to allow efficacy assessment (EPPO PP 1/226 (1) and PP 1/225 (1)) Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Use cannot be authorised due to insufficient number of efficacy trails to allow efficacy assessment (EPPO PP 1/226 (1) and PP 1/225 (1)) Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. NW642-1 Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Use cannot be authorised because no final conclusion on possible health risks for consumers through residues Part A National Assessment - Germany Product code Page 13 of 30 010 DE vegetable (BRSOX) cabbage F free biting caterpillars 011 DE vegetable (BRSOX) cabbage G free biting caterpillars 012 DE root and tuber vegetables F (NNNVW) free biting caterpillars 013 DE root and tuber vegetables G (NNNVW) free biting caterpillars 014 DE bulb crops (NNNSZ) F free biting caterpillars 015 DE herbs (NNNKR) F free biting caterpillars 016 DE herbs (NNNKR) G free biting caterpillars Applicant: Mitsui AgriScience International SA volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying Registration Report –Central Zone from BBCH 09 of B. t is possible. after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 1000 after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 1000 after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 days apart) a) 1 b) 3 a) 0,5 b) 1,5 200 - 800 after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 after beginning of infestation; from emergence of first 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 Evaluator: DE Date: November 2015 NW642-1 Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. NW642-1 NW642-1 Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. NW642-1 Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Use cannot be authorised because no final conclusion on possible health risks for Part A National Assessment - Germany Product code Page 14 of 30 Registration Report –Central Zone (low volume spraying) spraying or fine spraying (low volume spraying) larvae / from BBCH 09 consumers through residues of B. t is possible. after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 017 DE pulse crops (NNNLG) except: runner beans F free biting caterpillars 018 DE pulse crops (NNNLG) except: runner beans G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 019 DE ornamentals (NNNZZ) F free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 a) 1 days apart) b) 6 a) 0,5 b) 3,0 min 1000 l/ha Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 NW642-1 Plant height is restricted to max. 50 cm Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. Plant height is restricted to max. 50 cm. Use cannot be authorised because no final conclusion on possible health risks for consumers through residues of B. t is possible. NW642-1 Plant height is restricted to max. 50 cm. Part A National Assessment - Germany 020 DE ornamentals (NNNZZ) 021 DE woody (NNNZG) Remarks: Product code Page 15 of 30 G free biting caterpillars ornamentals G free biting caterpillars spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) Registration Report –Central Zone after beginning of infestation; from emergence of first larvae 6 (at least 7 a) 1 days apart) b) 6 after beginning of infestation; from emergence of first larvae 3 (at least 7 a) < 50 cm: a) 0,25 – 0,5 days apart) 0,5 kg/ha b) 1,5 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 3 (a) In case of group of crops the Codex classification should be used (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil born insects, foliar fungi (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) Use CIPAC/FAO Codes where appropriate (f) All abbreviations used must be explained Applicant: Mitsui AgriScience International SA a) 0,5 b) 3,0 min 1000 l/ha Plant height is restricted to max. 50 cm. a) < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha NW642-1 This use is included in GAP 020. (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants (i) (j) (k) (l) g/kg or g/l Growth stage at last treatment PHI = Pre-harvest interval Remarks may include: Extent of use/economic importance/restrictions (e.g. feeding,grazing)/minimal intervals between applications Evaluator: DE Date: November 2015 Part A National Assessment Germany Product code Page 16 of 30 Registration Report –Central Zone 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a pale brown, water dispersible granules-based formulation with a fish meal odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of 392 °C. In aqueous solution, it has a pH value around 6.4. The stability data indicate a shelf life of 6 month at ambient temperature based on content of cfu, but based on biopotency a shelf life of 24 month is observed. The technical characteristics are acceptable for a water dispersible granules (WG) formulation. Implications for labelling: None Compliance with FAO specifications: There is no FAO specification for bacillus thuringiensis ssp. aizawai GC-91. Compliance with FAO guidelines: The product Agree 50 WG complies with the general requirements according to the FAO/WHO manual (2010). Compatibility of mixtures: There are no tank mixtures recommended for Agree 50 WG. Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable. Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of Agree 50 WG has been provided and is considered to be acceptable. 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) The submitted analytical method is suitable and reliable for the determination of concentration of the number of spores of Bacillus thuringiensis aizawai strain GC-91 in the product Agree WG and in aqueous dilutions. The method was validated by definition of the linearity, the precision and the accuracy according to the criteria set by SANCO/3030/99 rev. 4. 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 17 of 30 Registration Report –Central Zone For the time being, analytical methods for residues of bacillus thuringiensis ssp. aizawai strain GC-91 are not required. 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) Inclusion of Bacillus thuringiensis ssp. aizawai strain GC-91 into Annex I entered into force in May 2009 (Commission Directive 2008/113/EC). The relevant review information are summarized in the review report for the active substance Bacillus thuringiensis ssp. aizawai strain GC-91 (SANCO/1538/2008) and EFSA conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. aizawai (strains ABTS 1857, GC-91) (EFSA Journal 2013, 11(1):3063). If the product is used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected. 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Acute toxicity studies for Agree 50 WG were not evaluated as part of the EU review of Bacillus thuringiensis ssp. aizawai strain GC-91. In the EU review of Bacillus thuringiensis ssp. aizawai strain GC-91 Agree 50 WP was a representative formulation. The acute toxicity studies for the Agree 50 WP were evaluated during the review and were considered adequate. In general, WP formulations are toxicologically considered more critical than WG formulations due to the higher potential risk for dust to be inhaled. Therefore, it is considered acceptable to use the study results on Agree 50 WP for the assessment of Agree 50 WG, too. Agree 50 WG, containing 500 g/L Bacillus thuringiensis ssp. aizawai strain GC-91, has a low potential of toxicity following acute oral, dermal or inhalation exposure. It is not irritating to the rabbit eye or skin. It has been found to be classifiable as a skin sensitiser to the guinea pig. Taking into account all submitted data Agree 50 WG should be labelled as irritating, with phrase R 43 - May cause sensitisation by skin contact. 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) The safety of the application of Agree 50 WG was not evaluated as part of the EU review of Bacillus thuringiensis subspecies aizawai strain GC-91. Therefore, the risk was assessed for all intended uses here and is considered to be adequate. Data on dermal absorption of Agree 50 WG was not provided and considered not relevant for microorganisms. Operator exposure was modelled using the German model and the exposure study by Mich, qualitative considerations as well as weight of evidence. According to the model calculations, it can be concluded that the risk for the operator using Agree 50 WG on the intended uses in greenhouses and outdoor is acceptable with the use of personal protective equipment. Given the sensitising potential of Delfin WG impermeable gloves and a protective suit against pesticides and sturdy shoes should be worn when handling the concentrate. A protective suit against pesticides and sturdy shoes (e.g. rubber boots) should also be used when applying/handling the product ready for application. Hence, phrase S36/37 should be added to the national standard phrases S2, S24 and S46. 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) In the case of greenhouse applications no bystander or resident exposure is expected. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 18 of 30 Registration Report –Central Zone Bystanders of outdoor applications may be potentially exposed towards spray mist during the application of Agree 50 WG, whereas residents could be exposed towards spray deposits on surfaces after application. Since micro-organisms may have the potential for sensitisation, this has to be taken into account in risk assessment for bystanders and residents. But, there is no reference value for this toxicological property. In this particular case the plant protection product is applied at a maximum concentration of 0.5 % (w/v). Therefore, from a formal point of view the spray solution is not considered sensitising (< 1 % w/w) so that most likely there will be no risk for bystanders and residents. But in order to further minimise the potential exposure of bystanders and residents and thus further reduce the probability of sensitisation the use of drift-reducing nozzles (tractor-mounted equipment) or spraying shields (hand-held equipment) is recommended mandatorily. 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) Since workers are normally potentially exposed towards dry foliar residues on plant surfaces, intensive dermal exposure might occur. This might be enhanced by multiple applications. In this case max. 6 applications of Agree 50 WG are intended. Although no systemic effects are to be expected by dermal contact because no penetration of Bacillus thuringiensis through intact skin is considered likely, the use of gloves and protective garment is necessary for workers during re-entry tasks due to the sensitising potential of Agree 50 WG. Implications for labelling resulting from operator, worker, bystander assessments: Hazard Symbol: Indication of danger: Risk Phrases: Safety Phrases: Xi Irritant 43 2-24-36-37-46 R and S phrases under Regulation (EC) No 547/2011: SF1891 Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. Other phrases: Safety instructions SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB110 The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. VH650 The packaging must be provided with the wording "micro-organisms may have the potential to provoke sensitising reactions". VA269 The product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 %. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany 3.1.4 Product code Page 19 of 30 Registration Report –Central Zone Residues and Consumer Exposure (Part B, Section 4, Point 8) No MRLs for Bacillus thuringiensis ssp. aizawai, strain GC-91 are established. Inclusion into Annex IV of Reg. (EC) No 396/2005 is currently discussed but not recommended by Germany due to the following reasons (see below). 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) No supervised residue trials were submitted for the assessment of Bacillus thuringiensis ssp. aizawai, strain GC-91 on any of the crops for which approval is sought. The applicant provided rationales for waiving such studies, noting particularly the ubiquitous occurrence of the strain, its very specific action against lepidoptera larvae and the insignificant amount of toxin production. However, the potential of Bacillus thuringiensis ssp. aizawai, strain GC-91 for the formation of toxins after application is unclear. Bacillus thuringiensis ssp. aizawai, strain GC-91 proved positive for the genetic sequences coding the Bacillus cereus toxins, but the rate of formation is expected to be lower. In a scientific opinion by EFSA (2005, Opinion of the Scientific Panel on Biological Hazards on Bacillus cereus and other Bacillus spp. in foodstuffs, The EFSA Journal 175, 1-48, ASB2012-9549), an amount of 105 CFU/g food was identified as a point of departure for B. cereus, which, in view of the limited information available, seems also sufficiently protective for Bacillus thuringiensis ssp. aizawai, strain GC-91. For estimating the potential amount of CFUs after application of Agree 50 WG, an approach was developed based on harvest yields (Statistisches Bundesamt: Wachstum und Ernte – Fachserie 3, Reihe 3.2.1 – Gemüse 2011) or empirical residues after foliar treatment as described by MacLachlan and Hamilton in 2009 (see Part B, Section 4). From these calculations it is obvious that based on the intended application rates an exceeding of 105 CFU/g food cannot be excluded for the uses on grape vine, berries (except strawberries), strawberries, fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh herbs and legume vegetables. Further information is required to confirm that these uses can be considered safe with respect to consumer health. For root and tuber vegetables only the aerial part is sprayed. A significant contamination of roots and tubers with the microorganism is not expected. Therefore these uses are considered to be safe (uses 12 and 13). 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) The Bacillus thuringiensis ssp. aizawai, strain GC-91 contains the genetic information to produce B. cereus like toxins. Nevertheless, since no further information is available for a quantitative risk assessment, it is proposed to apply the suggested value of 105 CFU/g food (EFSA 2005) also to Bacillus thuringiensis ssp. aizawai, strain GC-91. The data provided for the application of Bacillus thuringiensis ssp. aizawai, strain GC-91 to food crops is insufficient to estimate the amount of CFU per g food. Therefore, the consumer risk assessment for the intended uses on grape vine, berries (except strawberries), strawberries, fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh herbs and legume vegetables can not be finalized at the moment. No dietary risk to consumers is assumed to arise from non-food crops (ornamentals). Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany 3.1.5 Product code Page 20 of 30 Registration Report –Central Zone Environmental fate and behaviour (Part B, Section 5, Point 9) 3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) A natural breakdown of the endospores of Bta in soil begins after application onto the fields and gradually reduces the numbers of spores remaining. Any vegetative cells or crystal proteins are likely to be far more rapidly degraded. This reduction in numbers will be greatly augmented by the photo degradation effects of sunlight. It is very unlikely that Bta endospores will germinate and grow into vegetative cells, unless appropriate conditions exist, meaning favourable soil pH, soil moisture content, sufficient nutrient availability and lack of competition/predation from other soil micro-organisms. The good persistence of Bt spores in soil after the first two weeks seems to be a result of their inability to germinate in soil. Survival and viability of parasporal crystal proteins associated with the application of Agree 50 WG is expected to be short-term as effects of other soil micro-organisms and natural sunlight, in combination with the natural degradation of the proteins, occurs. The survival of Bta in the soil is a dynamic process involving sporostasis, germination and sporulation in specific habitats and will be influenced by changing conditions regarding soil type, native microflora, nutrient availability and fertilization. According to the PEC calculation (in compliance with country specific requirements in Germany), the highest load of Agree 50 WG in soil is expected upon field application in flowers (sun flower as representative crop). The value of 40.0 mg Agree 50 WG/kg dry weight soil corresponds to 20 mg Bta/kg dry weight soil. of CFU and IU, this is equivalent to 1.2 × 109 CFU or 1,000,000 IU/kg dry weight soil, respectively. 3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) Various experiments examining the movement of Bt in soils following spraying of commercial products containing Bt showed little or no movement. Thus movement of Bta through the soil by leaching is unlikely to occur. Additionally, adsorption and binding of protoxins and toxins from Bt have been demonstrated to occur readily, rapidly and strongly onto the clay fraction and clay humic acid complexes of soils. Desorption occurs far less readily. It is thus concluded that no threat of contamination of groundwater exists following applications of Agree 50 WG according to GAP. 3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) Under natural conditions, residues of Bta in water are not considered to be able to persist for very long periods due to a combination of natural physical and chemical degradation factors such as solar radiation and predation from resident bacteriophages, protozoans and other lower animal forms. It may be stated that Bta GC-91 is inactivated under natural conditions, including water. The highest predicted environmental concentration of Agree 50 WG and its active ingredient Bta GC-91 in surface waters is 128.07 µg/L (64.04 µg Bta/L) corresponding to 3.84 × 106 CFU or 3202 IU/L. 3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) Due to solar inactivation Bt spores and δ-endotoxin crystals are rapidly degraded in air. Furthermore, unlike chemical products, evaporation and volatility of bacteria is not expected to be a factor to consider in assessing the fate in air. Hence volatilisation from plant surfaces and from soil can be excluded. Spray drift, however, can occur following an application of Bta which may lead to temporary concentrations in Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 21 of 30 Registration Report –Central Zone the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray droplets settle out. The overall half-life determined during the nine-day monitoring period was 2.4 days. This gives an indication of the rapid disappearance of spray droplets containing Bta and parasporal crystals from air. Implications for labelling resulting from environmental fate assessment: None 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Birds Effects on birds for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity to birds are used and the ingredients in the formulation are not expected to pose a risk to birds. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. • The risk assessment for effects on birds is carried out according to the latest draft of the ‘European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009)1 • The risk of Agree 50 WG to birds was assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with the active substance Bta GC-91 and maximum residues occurring on food items following applications according to the proposed use pattern. Acute risk assessment The TERA values exceed the Annex VI trigger value of 10, indicating that Agree 50 WG poses no risk to birds following application according to the proposed use patterns. Table 3.1.6.1-1 Screening assessment for birds following GAP directed application of Agree 50 WG. Indicator species Crop Small omnivorous bird Vegetables Small insectivorous birds Test item Bta Orchards and GC-91 ornamentals/ nursery Toxicit Application MAF2 y ) rate1) LD50 Short cut value3) DDD TER (10) 0.5 kg/ha 1.9 158.8 150.86 > 22.1 0.5 kg/ha 1.9 46.8 44.46 > 75.0 > 3333 mg/kg b.w. 1) Refers to Bta GC-91 (corresponding to 1 kg Agree 50 WG/ha) MAF according to 6 successive applications at intervals of 7 days provided in EFSA Guidance document 20092 3) Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092 2) 1 European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009; 7(12): 1438. [139 pp.]. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 22 of 30 Registration Report –Central Zone Long-term risk assessment As the acute TER value indicates no risk to birds and no adverse effects were observed in short-term toxicity studies, no long-term effects are to be expected upon field application of Agree 50 WG according to GAP. Terrestrial vertebrates (other than birds) Effects on mammals for Agree 50 Wg were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to mammals. Therefore, all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. • The risk assessment for effects on mammals is carried out according to the latest draft of the ‘European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009)2 • The risk of Agree 50 WG to mammals was assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with CGA-237218 technical and maximum residues occurring on food items following applications according to the proposed use pattern. Acute risk assessment The TERA values exceed the Annex VI trigger value of 10, indicating that Agree 50 WG poses no risk to mammals following application according to the proposed use patterns. Table 3.1.6.1-2 Indicator species Screening assessment for mammals following application of Agree 50 WG. Crop Small herbi- Vegetables/ ornamentals vorous mammals and nursery Test item Toxicity LD50 CGA237218 technical > 5050 mg/kg b.w. Applicatio MAF 2) n rate1) 0.5 kg/ha 1.9 Short cut value3) DDD 136.4 129.58 > 39.0 TER (10) 1) Refers to Bta GC-91 (corresponding to 1 kg Agree 50 WG/ha) MAF according to 6 successive applications provided in EFSA Guidance document 20092 3) Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092 2) Long-term risk assessment Due to the absence of toxicity in the acute study and the highly specific mode of action of Bta GC-91, no adverse effects in mammals are to be expected upon prolonged exposure to Agree 50 WG. 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) Effects on aquatic non-target organisms for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However, further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to aquatic species. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. A new study assessing the acute toxicity of the formulated product Agree 50 WG on daphnids has been performed and as a result there are new end-points which are used in the risk assessment. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 23 of 30 Registration Report –Central Zone For the risk assessment the maximum (initial) PECSW was compared with the acute ecotoxicological endpoints of aquatic organisms. The toxicity exposure ratios (TER) are given only for worst case scenarios, for which the relevant trigger value is passed. Only drift entries were considered in the PECSW calculation since this is the only suitable exposure pathway for the use of Agree 50 WG. Table 3.1.6.2-1 TER values for Agree 50 WG/Bta GC-91 with exposure via spray drift Compound CGA237218a Agree 50 WG CGA237218a CGA237218a) Organism Fish Endpoint Exposure (PECSW) LC50 > 2.0 × 1010 CFU/L 3.84 × 106 CFU/L Daphnids (acute) Daphnids (chronic) LC50 > 100 mg/L 128.07 µg/L NOEC = 1.57 × 108 CFU/L 3.84 × 106 CFU/L Algae EbC50 > 3.6 × 109 CFU/L 3.84 × 106 CFU/L TER (trigger) > 5208 (100) > 781 (100) 40.9 (10) > 938 (10) a) Synonym for Bta GC-91 technical material contained in Agree 50 WG The TER values exceed the trigger values indicating that Agree 50 WG poses no risk to aquatic organisms following application according to the proposed use patterns. Implications for labelling EB001-2 Do not contaminate water with the product or its container (Do not clean application equipment near surface water./Avoid contamination via drains from farmyards and roads). NW642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR. 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees The risks of Agree 50 WG to honey-bees was assessed from hazard quotients between toxicity endpoints, estimated from acute oral and contact studies with active ingredient and formulated product. The recommended use pattern for Agree 50 WG includes application in grape vine, berries, vegetables, herbs, ornamentals and other crops at a maximum application rate of up to 1 kg product/ha. All the hazard quotients are considerably less than 50, indicating that the active ingredient(s) poses a low risk to bees. It is concluded that Agree 50 WG will not adversely affect bees or bee colonies when used as recommended. The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied (B4). Other non-target arthropods Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 24 of 30 Registration Report –Central Zone Studies on the effects of the Bta GC-91-based product TUREX 50 WP (= Agree 50 WP) on non-target arthropods were conducted and evaluated as part of the EU review of Bta GC-91. Due to the absence of toxicity in laboratory glass plate tests with Typhlodromus pyri and Aphidius rhopalosiphi at 4.5-fold the maximum intended application rate of Agree 50 WG in Germany, no unacceptable risk for non-target arthropods is expected upon GAP directed use. The risk for non-target arthropods in off-crop habitats was assessed according to country specific requirements in Germany following the TER (toxicity exposure ratio) approach. From the calculated TER value no unacceptable risk for non-target arthropods in off-field areas is indicated. Table 3.1.6.3-2 Off-field TER values for non-target arthropods Species LR50 (kg/ha) Off-field foliar PER Off-field foliar Trigger value TER (kg/ha) Typhlodromus pyri > 4.5 0.072 > 62.5 Aphidius rhopalosiphi PER: predicted environmental rate depending on application rate and drift TER: toxicity exposure ratio 10 Lepidoptera species in off-crop habitats In this section no new study on the toxicity of Bta on Lepidopteran species is submitted. Additionally, field studies revealed that Macrolepidoptera caterpillars may be affected by the use of Btk products, but severe effects on populations were not recorded because populations recovered after applications. Regarding the the risks to non-target-arthropods, including lepidopteran species, the following is stated in the EFSA Conlusion on Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91): Several laboratory studies on non-target arthropods for both strains were available. These studies indicated a low risk from pathogenicity and infectivity for non-target arthopods following exposure to Bacillus thuringiensis aizawai strain ABTS 1857 and strain CG-91. The only potentially significant area of concern for non-target arthropods is in relation to the specific species showing susceptibility to particular subspecies of Bacillus thuringiensis. In the case of Bacillus thuringiensis aizawai, this relates to a restricted group of Lepidopteran families and it is important that this selectivity is considered within the context of the wide scale impact of broad-spectrum insecticides on non-target arthropods. Clearly for the in-crop area where application occurs there will be an impact on Lepidopteran species i.e. the intended effect on the target pest species. However, the published information shows that recovery occurs within a relatively short period of time (depending on application timing, life history of affected species, dispersal ability etc). Recovery of any affected populations is therefore likely to be rapid. Therefore the risk for non-target arthropods was indicated as low. The risk for non-target arthropods for the strain GC-91 was indicated as low by the HQ calculation. 3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) Earthworms Effects on earthworms for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However, further data on Agree 50 WG are not required as data of Agree 50 WP, containing the same active ingredient as Agree 50 WG, on toxicity are used and the ingredients in Agree 50 WG are not expected to pose a risk to earthworms. The presented risk assessment performed according to country specific requirements in Germany and calculating the relation between the expected environmental concentration of Agree 50 WG in soil and Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 25 of 30 Registration Report –Central Zone the endpoint from the acute study is considered adequate. The obtained TER value indicates no risk for earthworms upon field application of Agree 50 WG. Table 3.1.6.4-1 Acute TER value for earthworms Compound LC50 Maximum PECS for Agree 50 WG TERA Limit Agree 50 WP > 1000 mg/kg d.w. soil 40 mg/kg. d.w. soil > 25 10 Effects on other soil non-target macro-organisms No EU data requirement for MPCP. 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) No EU data requirement for MPCP. 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Effects on the soil microflora for Agree 50 WG were not evaluated as part of the EU review of Bta GC91. However, further data on Agree 50 WG are not required as data of Agree 50 WP, containing the same active ingredient and similar co-formulants as Agree 50 WG, on toxicity are used which have been already evaluated in the EU review. The study demonstrated the absence of adverse effects on nitrogen turnover and dehydrogenase activity at application rates of up to 20 kg/ha. This is 3.3-fold the maximum accumulated application rate intended for Agree 50 WG and it can be concluded that GAP directed use of Agree 50 WG poses no risk for the soil microflora. 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Non-Target Plants Tests on non-target plants are not required. Other non-target species (Flora and Fauna) Tests on other non-target species are not required. Implications for labelling resulting from ecotoxicological assessment: Other phrases: EB001-2 Do not contaminate water with the product or its container (Do not clean application equipment near surface water./Avoid contamination via drains from farmyards and roads). NW642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR. 3.1.7 Efficacy (Part B, Section 7, Point 8) Uses in viticulture (001 and 002): Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 26 of 30 Registration Report –Central Zone From a formal point of view the applicant did not deliver the complete set of data necessary for the registration in viticulture (e.g. trials on the impact of the product on the fermentation and the quality of the wine). The evaluation is based therefore additionally on the long term experience with other products containing the same active ingredient. The trials are exclusively done during the second generation. Consequently risk assessment could be finalised only for the maritime zone and only for the 2nd and 3rd generation (use -002) of Eupoecilia ambiguella and Lobesia botrana and not for their first generation (use -001). Uses in soft-berries (003 and 004): An assessment was not possible, because no data were submitted for this uses (EPPO standard PP 1/226). An extrapolation form other uses is not possible due to the specific conditions in berry crops and the time of pest occurrence during spring time. Uses in strawberries (005 and 006): An assessment was not possible, because no data were submitted for this uses (EPPO standard PP 1/226). An extrapolation form other uses is not possible due to the specific application techniques conditions in strawberry crops. Use in fruit vegetables (007): The application rates used in the presented trials are very different and only little information is given if higher dose rates correspond with crop size (fruit vegetables in the greenhouse can grow up to 5 m). Only in few trials the dose rate corresponds with the proposed GAP for cucurbits and solanaceous fruits. In all trials efficacy was sufficient. The area of use is in the greenhouse. Therefore, results from greenhouse trials conducted the Mediterranean can be included. Furthermore, it is possible to extrapolate from the submitted data to larvae of other Noctuid moths. According to the EPPO extrapolation table 09/15092 efficacy in Solanaceae, data on Autographa gamma and Mamestra oleracea in brassica crops can be used for extrapolation to Solanaceous vegetables. Fruit vegetables are defined in Germany as a grouping of cucurbits, solanaceous fruits and pulse crops. Use 007 includes fruit vegetables, whereas uses 017 and 018 include pulse crops. The target crops in use 007 should be changed to: fruit vegetables (except pulse crops). Uses in leafy and stem vegetables (008 and 009): No data submitted. Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). Uses in vegetable cabbage (010 and 011): The majority of submitted data are not rateable. The efficacy for: • Plutella xylostella is proven for the maritime zone; • Mamestra brassicae is not finally evaluable; • Pieris sp. is not finally evaluable; • Spodoptera littoralis is proven for the Mediterranean zone. Efficacy can be extrapolated from other uses (see report for fruit vegetables) and from experience with respect to the former authorisation. Uses in root and tuber vegetables (012 and 013): No data submitted. Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). Use in allium bulb crops (014): Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 27 of 30 Registration Report –Central Zone No data submitted. Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). Uses in fresh herbs (015 and 016): Fresh herbs are a minor use. This group is consisting of crops from many plant families and susceptible to many different species of lepidopteran larvae. Efficacy for fresh herbs can be extrapolated from other crops. Uses in pulse crops (017 and 018): Pulse crops except from runner beans, build dense crop stands already at lower heights; therefore no vertical separation is necessary. Application rates with vertical separation is only relevant for runner beans, thus uses 017 and 018 are amended to grant authorisation with respect to efficacy: Pulse crops except from runner beans: 1 kg/ha in 200 to 800 l water/ha The plant height is restricted to max. 50 cm. Efficacy can be extrapolated from other uses (see report for fruit vegetables) and from experience with respect to the former authorisation. Uses in (woody) ornamentals (019 - 021): The application rates used in the presented trials are very different and often higher than applied for, just as the number of application was higher. Little information is given if higher dose rates correspond with crop size (ornamentals in the greenhouse can grow up to 2 m for instance). Regarding small crops, in most trials efficacy was sufficient concerning number of attacked leaves, damaged plants, and larvae control and the reference product acted similar or only slightly better. For higher and dense crops the doses applied for may not be sufficient. Efficacy can be extrapolated for small plants, thus uses 019 and 0208 are amended to grant authorisation with respect to efficacy: Ornamentals: 1 kg/ha in at least 1.000 l water/ha The plant height is restricted to max. 50 cm. Use 021 (woody ornamentals) is per definition included in use 020 (ornamentals). In general: Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product is not expected to exhibit herbicidal activity. Agree 50 WG is, therefore, not expected to cause phytotoxic effects. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on yield or transformation processes are known. Agree 50 WG is classified as not harmful for populations of relevant beneficial insects or beneficial predatory mites and spiders. It is concluded that the proposed use of Agree 50 WP will not pose an unacceptable risk to populations of earthworms or other soil macro-organisms, when applied according to the recommended use pattern. There is no indication of any unacceptable adverse effects on soil macro- or soil micro-organisms relevant for the maintenance of soil quality. The application of Bta products is considered to have a low potential of causing resistance or crossresistance within the target pest organism. Decreased sensitivity or resistance has been reported for Bacillus thuringiensis in some countries including France (for Spodoptera littoralis only). Therefore, it is precautionary recommended to alternate with products based on different active substances after three applications outdoors. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany 3.2 Product code Page 28 of 30 Registration Report –Central Zone Conclusions Concerning the physical, chemical and technical properties of the formulation as well as the analytical methods (formulation and residue) an authorisation can be granted. Concerning effects on the environment an authorisation can be granted. Exposure assessment: With respect to mammalian toxicology an authorisation can be granted. The exposure towards Bacillus thuringiensis spp.aizawai strain GC-91 in Agree 50 WG is not considered to give rise to concern for operators, workers, bystanders or residents in the greenhouse or in the case of outdoor applications. Due to potential sensitisation by microorganisms personal protective equipment, i.e. gloves and protective garment for operators and workers is necessary. The exposure will be reduced further due to necessary PPE allocated according to dangerous substances regulations. If the product is used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected. Residues: Authorization of the uses 1 - 11 and 14 - 18 is not possible due to the reasons outlined below. For the time being no final conclusion on possible health risks for consumers through residues of B. t. resulting from applications of Agree 50 WG on grape vine, berries (except strawberries), strawberries, fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh herbs and legume vegetables can be drawn. The genetic potential for enterotoxin formation has been shown for several B. t. strains (Beattie et al., 19992; Damgaard, 19953; Helgason et al., 20004). Even though in lab testing the potential of B. t. to produce enterotoxins was less than e.g. that of Bacillus cereus, enterotoxin formation cannot be excluded based on currently available data, since both species belong to the Bacillus cereus group due to their close genetic match. The concentration of Bacillus thuringiensis ssp. aizawai, strain GC-91 which is required to induce enterotoxin formation is not known yet. On the other hand it is not clear, which B. t. concentrations really have to be envisaged in the varieties of agricultural commodities treated with Agree 50 WG. Based on the available information and the calculations performed so far, an exceeding of 105 CFU/g food cannot be excluded for uses on grape vine, berries (except strawberries), strawberries, fruiting vegetables, leaf, stem and bulb vegetables, brassica vegetables, fresh herbs and legume vegetables (uses 1 – 11 and 14 - 18) and thus the uses can not be considered as safe. For a more realistic estimation of the potential CFUs per g food after treatment with Agree 50 WG and to derive appropriate withholding periods (based on degradation rates/ spore half-lives on the plant surface), supervised residue trials are required on grapes (outdoor), strawberries (outdoor and indoor), tomatoes (indoor), lettuce (open headed varieties, outdoor and indoor), beans with pods (outdoor and indoor) conducted in accordance with the data requirements laid down in Reg. (EC) No 1107/2009 and consecutive regulations. Beattie, S. H. et al. (1999). Detection of toxigenic strains of Bacillus cereus and other Bacillus spp. with an improved cytotoxicity assay. Letters Appl. Microbiol. 28, 221-225. 2 3 Damgaard, P.H. (1995). Diarrhoeal enterotoxin in production by strains of Bacillus thuringiensis isolated from commercial Bacillus thuringiensis-based insecticides. FEMS Immun. Med. Microbiol. 12, 245-250. 4 Helgason, E., Okstad, O.A., Caugant, D.A., Johansen, H.A., Fouet, A., Mock, M., Hegna, I. and Kolsto, A.B. (2000). Bacillus anthracis, Bacillus cereus, and Bacillus thuringiensis - one species on the basis of genetic evidence. Appl Environ Microbiol 66, 2627-2630. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 29 of 30 Registration Report –Central Zone The use of Bacillus thuringiensis ssp. aizawai, strain GC-91 on ornamentals (uses 19 - 21) is not considered relevant in terms of consumer health protection. For root and tuber vegetables (uses 12 and 13) only the aerial part is sprayed. A significant contamination of roots and tubers with the microorganism is not expected. Therefore, as far as consumer health protection is concerned, the intended uses 12 and 13 and 19 - 21 can be authorized. Efficacy: The following uses are duly substantiated and can be authorised from the perspective of the efficacy assessment: -002, -007, -008, -009, -010, -011, -012, -013, -014, -015 and -016 Pulse crops except from runner beans, build dense crop stands already at lower heights; therefore no vertical separation is necessary. Application rates with vertical separation is only relevant for runner beans, thus uses 017 and 018 are amended to grant authorisation with respect to efficacy: Pulse crops except from runner beans: 1 kg/ha in 200 to 800 l water/ha The plant height is restricted to max. 50 cm. Uses 019 and 020 are amended to grant authorisation with respect to efficacy: Ornamentals: 1 kg/ha in at least 1.000 l water/ha The plant height is restricted to max. 50 cm. Use 021 (woody ornamentals) is per definition included in use 020 (ornamentals). The following uses can not be authorised: 001: trials were presented exclusively for the second generation of the pest insects. There are no conclusive test results for the control of the first generation of pest insects. According to the assessment authority an extrapolation is not possible. An efficacy assessment of the product against the applied organisms is therefore not possible. 003/004/005/006: According to EPPO standard PP 1/226 (1) and the EPPO standard PP 1/225 (1), 6-15 efficacy trails including minimum effective dose trails shall be provided over at least 2 years. No efficacy results according to EPPO Standard PP were submitted. An efficacy assessment of the product against the applied organisms is therefore not possible. Beneficials: The product is classified as not harmful for populations of relevant beneficial insects, predatory mites and spiders. An authorisation can only be granted for the uses -012, -013, -019 and -020. 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation No further information is required. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part A National Assessment - Germany Product code Page 30 of 30 Registration Report –Central Zone Appendix 1 – Copy of the product authorisation • See below. Appendix 2 – Copy of the product label The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions drawn by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again. Appendix 3 – Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Applicant: Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Dr. Susanne Luttmann Referentin TELEFON +49 (0)531 299-3612 TELEFAX +49 (0)531 299-3002 E-MAIL [email protected] Mitsui AgriScience International S.A./B.V. Bouleward de la Woluwe 1200 Brussels BELGIEN IHR ZEICHEN IHRE NACHRICHT VOM AKTENZEICHEN 200.22100.007638-00/00.66658 (bitte bei Antwort angeben) DATUM 11. November 2015 ZV1 007638-00/00 Agree 50 WG Zulassungsverfahren für Pflanzenschutzmittel Bescheid Das oben genannte Pflanzenschutzmittel mit dem Wirkstoff: 500 g/kg Bacillus thuringiensis subspecies aizawai Stamm GC-91 (25000 IU/mg) Zulassungsnummer: 007638-00 Versuchsbezeichnungen: MTA-11111-I-0-WG Antrag vom: 30. April 2012 wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen: Zulassungsende BVL_FO_05_2437_200_V1.7 Die Zulassung endet am 30. April 2020. Festgesetzte Anwendungsgebiete bzw. Anwendungen Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1): Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de SEITE 2 VON 35 Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 007638-00/00-012, Freifressende Wurzel- und Knollenge- 007638-00/00-013 Schmetterlingsrau- müse pen 007638-00/00-019, Freifressende Zierpflanzen 007638-00/00-020 Schmetterlingsraupen Festgesetzte Anwendungsbestimmungen Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 375 der Verordnung vom 31. August 2015 (BGBl. I S. 1474), festgesetzt: Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. Verpackungen Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen: Verpackungs- Verpackungs- Anzahl art material von Beutel HDPE 1 Inhalt bis von bis 1,00 Einheit kg Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen: Anwendung nur durch berufliche Anwender zulässig. Auflagen Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden: Kennzeichnungsauflagen: (EB001-2) SP 1: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsgeräte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen./Indirekte Einträge über BVL_FO_05_2437_200_V1.7 Hof- und Straßenabläufe verhindern.) (SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschäden führen. SEITE 3 VON 35 (SB012) Mikroorganismen können ein Potential zur Auslösung von Sensibilisierungsreaktionen haben. (SB110) Die Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflanzenschutz "Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit ist zu beachten. (SF1891) Das Wiederbetreten der behandelten Flächen/Kulturen ist am Tage der Applikation nur mit der persönlichen Schutzausrüstung möglich, die für das Ausbringen des Mittels vorgegeben ist. Nachfolgearbeiten auf/in behandelten Flächen/Kulturen dürfen grundsätzlich erst 24 Stunden nach der Ausbringung des Mittels durchgeführt werden. Innerhalb 48 Stunden sind dabei der Schutzanzug gegen Pflanzenschutzmittel und Universal-Schutzhandschuhe (Pflanzenschutz) zu tragen. (SS110) Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten Mittel. (SS2101) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen beim Umgang mit dem unverdünnten Mittel. (SS2202) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung des anwendungsfertigen Mittels. (VA269) Die Anwendung des Mittels muss mit einem verlustmindernden Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 75 % BVL_FO_05_2437_200_V1.7 eingetragen ist. (WMI11) Wirkungsmechanismus (IRAC-Gruppe): 11 SEITE 4 VON 35 Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2. Sonstige Auflagen: (VH650) Die Verpackung ist mit der Aufschrift "Mikroorganismen können ein Potential zur Auslösung von Sensibilisierungsreaktionen enthalten" zu versehen. Vorbehalt Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden. Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/2008 Signalwort: (S1) Achtung Gefahrenpiktogramme: (GHS07) Ausrufezeichen Gefahrenhinweise (H-Sätze): (EUH 401) Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten. (H317) Kann allergische Hautreaktionen verursachen. Sicherheitshinweise (P-Sätze): BVL_FO_05_2437_200_V1.7 - keine - SEITE 5 VON 35 Abgelehnte Anwendungsgebiete bzw. Anwendungen Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 007638-00/00-001 Einbindiger Trauben- Weinrebe wickler (Heuwurm), Bekreuzter Traubenwickler (Heuwurm) 007638-00/00-002 Einbindiger Trauben- Weinrebe wickler (Sauerwurm), Bekreuzter Traubenwickler (Sauerwurm) 007638-00/00-003, Freifressende Beerenobst (ausgenom- 007638-00/00-004 Schmetterlingsrau- men: Erdbeere) pen 007638-00/00-008, Freifressende Blatt- und Stielgemüse 007638-00/00-009 Schmetterlingsrau- (ausgenommen: Kohl- pen 007638-00/00-005, Freifressende gemüse) Erdbeere 007638-00/00-006 Schmetterlingsraupen 007638-00/00-007 Freifressende Fruchtgemüse Schmetterlingsraupen 007638-00/00-017, Freifressende Hülsengemüse (ausge- 007638-00/00-018 Schmetterlingsrau- nommen: Stangen- pen 007638-00/00-010, Freifressende bohne) Kohlgemüse 007638-00/00-011 Schmetterlingsraupen 007638-00/00-015, Freifressende Kräuter (trocken) 007638-00/00-016 Schmetterlingsraupen BVL_FO_05_2437_200_V1.7 007638-00/00-021 Freifressende Schmetterlingsraupen Ziergehölze SEITE 6 VON 35 Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 007638-00/00-014 Freifressende Zwiebelgemüse Schmetterlingsraupen Hinweise Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB6641) Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienengefährlich eingestuft (B4). (NN1001) Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft. (NN1002) Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen eingestuft. Weitere Hinweise und Bemerkungen Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben, soweit sie noch nicht erfüllt sind. Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulassungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen. BVL_FO_05_2437_200_V1.7 Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. SEITE 7 VON 35 Rechtsbehelfsbelehrung Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur Niederschrift einzulegen. Mit freundlichen Grüßen im Auftrag gez. Dr. Martin Streloke Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. BVL_FO_05_2437_200_V1.7 Anlage SEITE 8 VON 35 Anlage 1 zugelassene Anwendung: 007638-00/00-012 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Wurzel- und Knollengemüse Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: 2.2 1 kg/ha in 200 bis 800 l Wasser/ha Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstengewässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorgegebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden. 2.3 BVL_FO_05_2437_200_V1.7 (F) Wartezeiten Freiland: Wurzel- und Knollengemüse Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich. 3 Anwendungsbezogene Anwendungsbestimmungen - keine - SEITE 9 VON 35 Anlage 1 zugelassene Anwendung: 007638-00/00-013 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Wurzel- und Knollengemüse Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - 1 kg/ha in 200 bis 1000 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine 2.3 (F) Wartezeiten Gewächshaus: Wurzel- und Knollengemüse Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich. BVL_FO_05_2437_200_V1.7 3 Anwendungsbezogene Anwendungsbestimmungen - keine - SEITE 10 VON 35 Anlage 1 zugelassene Anwendung: 007638-00/00-019 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 6 - für die Kultur bzw. je Jahr: 6 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Pflanzengröße bis 50 cm 2.2 1 kg/ha in mindestens 1000 l Wasser/ha Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstengewässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorgegebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden. (WH915) In die Gebrauchsanleitung ist eine Arten- und/oder Sortenliste der Kulturpflanzen aufzunehmen, für die der vorgesehene Mittelaufwand verträglich ist (Positivliste). 2.3 BVL_FO_05_2437_200_V1.7 (N) Wartezeiten Freiland: Zierpflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung. 3 Anwendungsbezogene Anwendungsbestimmungen - keine - SEITE 11 VON 35 Anlage 1 zugelassene Anwendung: 007638-00/00-020 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 6 - für die Kultur bzw. je Jahr: 6 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Pflanzengröße bis 50 cm 2.2 1 kg/ha in mindestens 1000 l Wasser/ha Sonstige Kennzeichnungsauflagen (WH915) In die Gebrauchsanleitung ist eine Arten- und/oder Sortenliste der Kulturpflanzen aufzunehmen, für die der vorgesehene Mittelaufwand verträglich ist (Positivliste). 2.3 (N) Wartezeiten Gewächshaus: Zierpflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung. BVL_FO_05_2437_200_V1.7 3 Anwendungsbezogene Anwendungsbestimmungen - keine - SEITE 12 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Einbindiger Traubenwickler (Heuwurm), Bekreuzter Traubenwickler (Heuwurm) Pflanzen/-erzeugnisse/Objekte: Weinrebe Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Weinbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Erläuterung zum Schadorganismus: 1. Generation Stadium des Schadorganismus: Larvenstadium L1 bis Larvenstadium L2 Erläuterung zur Kultur: Nutzung als Tafel- und Keltertraube Stadium der Kultur: ab 53 Anwendungszeitpunkt: Ab Schlüpfen der ersten Larven nach Befallsbeginn oder ab Warndienstaufruf Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Basisaufwand: 0,25 kg/ha in 400 l Wasser/ha - ES 61: 0,5 kg/ha in 800 l Wasser/ha - ES 71: 0,75 kg/ha in 1200 l Wasser/ha BVL_FO_05_2437_200_V1.7 3 Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom der- SEITE 13 VON 35 BVL_FO_05_2437_200_V1.7 zeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. Wirksamkeit Die vorgelegten Versuche wurden ausschließlich zum Zeitpunkt der 2. Generation der Schadinsekten durchgeführt. Es fehlen aussagekräftige Versuchsergebnisse zur Bekämpfung der 1. Schädlingsgeneration. Ein Extrapolation ist nach Aussage der Bewertungsbehörde nicht möglich. SEITE 14 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Einbindiger Traubenwickler (Sauerwurm), Bekreuzter Traubenwickler (Sauerwurm) Pflanzen/-erzeugnisse/Objekte: Weinrebe Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Weinbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Erläuterung zum Schadorganismus: 2. und 3. Generation Stadium des Schadorganismus: Larvenstadium L1 bis Larvenstadium L2 Erläuterung zur Kultur: Nutzung als Tafel- und Keltertraube Stadium der Kultur: ab 53 Anwendungszeitpunkt: Ab Schlüpfen der ersten Larven nach Befallsbeginn oder ab Warndienstaufruf Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 Anwendungstechnik: spritzen oder sprühen Aufwand: - Basisaufwand: 0,25 kg/ha in 400 l Wasser/ha - ES 61: 0,5 kg/ha in 800 l Wasser/ha - ES 71: 0,75 kg/ha in 1200 l Wasser/ha - ES 75: 1 kg/ha in 1600 l Wasser/ha BVL_FO_05_2437_200_V1.7 3 Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei SEITE 15 VON 35 BVL_FO_05_2437_200_V1.7 der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 16 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-003 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Beerenobst (ausgenommen: Erdbeere) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 11 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in maximal 1000 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. Wirksamkeit Nach EPPO PP 1 /226 (1) und der EPPO PP 1/225 (1) sind 6 - 15 Wirkungsversuche inkl. Grenzaufwandversuche aus möglichst 2 Versuchsjahren vorzulegen. Es wurde keine ausrei- SEITE 17 VON 35 BVL_FO_05_2437_200_V1.7 chende Anzahl an Wirksamkeitsergebnissen gemäß EPPO Standard PP 1/226 "Number of efficacy trials" eingereicht. Die Wirksamkeit des Mittels gegenüber den beantragten Schadorganismen ist somit nicht belegt. SEITE 18 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-004 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Beerenobst (ausgenommen: Erdbeere) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 11 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in maximal 1000 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. Wirksamkeit Nach EPPO PP 1 /226 (1) und der EPPO PP 1/225 (1) sind 6 - 15 Wirkungsversuche inkl. Grenzaufwandversuche aus möglichst 2 Versuchsjahren vorzulegen. Es wurde keine ausrei- SEITE 19 VON 35 BVL_FO_05_2437_200_V1.7 chende Anzahl an Wirksamkeitsergebnissen gemäß EPPO Standard PP 1/226 "Number of efficacy trials" eingereicht. Die Wirksamkeit des Mittels gegenüber den beantragten Schadorganismen ist somit nicht belegt. SEITE 20 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-005 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Erdbeere Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 13 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 1000 bis 2000 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. Wirksamkeit Nach EPPO PP 1 /226 (1) und der EPPO PP 1/225 (1) sind 6 - 15 Wirkungsversuche inkl. Grenzaufwandversuche aus möglichst 2 Versuchsjahren vorzulegen. Es wurde keine ausrei- SEITE 21 VON 35 BVL_FO_05_2437_200_V1.7 chende Anzahl an Wirksamkeitsergebnissen gemäß EPPO Standard PP 1/226 "Number of efficacy trials" eingereicht. Die Wirksamkeit des Mittels gegenüber den beantragten Schadorganismen ist somit nicht belegt. SEITE 22 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-006 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Erdbeere Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 13 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 1000 bis 2000 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. Wirksamkeit Nach EPPO PP 1 /226 (1) und der EPPO PP 1/225 (1) sind 6 - 15 Wirkungsversuche inkl. Grenzaufwandversuche aus möglichst 2 Versuchsjahren vorzulegen. Es wurde keine ausrei- SEITE 23 VON 35 BVL_FO_05_2437_200_V1.7 chende Anzahl an Wirksamkeitsergebnissen gemäß EPPO Standard PP 1/226 "Number of efficacy trials" eingereicht. Die Wirksamkeit des Mittels gegenüber den beantragten Schadorganismen ist somit nicht belegt. SEITE 24 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-007 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Fruchtgemüse Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 6 - für die Kultur bzw. je Jahr: 6 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Pflanzengröße bis 50 cm 0,5 kg/ha in mindestens 600 l Wasser/ha - Pflanzengröße 50 bis 125 cm 0,75 kg/ha in mindestens 900 l Wasser/ha - Pflanzengröße über 125 cm 1 kg/ha in mindestens 1200 l Wasser/ha BVL_FO_05_2437_200_V1.7 3 Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. BVL_FO_05_2437_200_V1.7 SEITE 25 VON 35 SEITE 26 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-008 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Blatt- und Stielgemüse (ausgenommen: Kohlgemüse) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 27 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-009 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Blatt- und Stielgemüse (ausgenommen: Kohlgemüse) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab dem Auflaufen Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 1000 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 28 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-010 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Kohlgemüse Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 29 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-011 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Kohlgemüse Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 1000 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 30 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-014 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Zwiebelgemüse Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 31 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-015 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Kräuter (trocken) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 32 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-016 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Kräuter (trocken) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 33 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-017 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Hülsengemüse (ausgenommen: Stangenbohne) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Pflanzengröße bis 50 cm BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 34 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-018 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Hülsengemüse (ausgenommen: Stangenbohne) Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 09 Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Pflanzengröße bis 50 cm BVL_FO_05_2437_200_V1.7 3 1 kg/ha in 200 bis 800 l Wasser/ha Begründung Zum gegenwärtigen Zeitpunkt kann nicht ausgeschlossen werden, dass Stämme des Bacillus thuringiensis Enterotoxine produzieren und diese bei einer Lebensmittelkontamination zu Erkrankungen beim Menschen führen können, wie es auch für Stämme des Bacillus cereus bekannt ist. Beide Spezies gehören auf Grund der hohen genetischen Übereinstimmung der Bacillus cereus-Gruppe an. Für Bacillus cereus gilt, dass mindestens 100000 CFU/g Lebensmittel notwendig sind, bevor Toxine gebildet werden können (EFSA, 2005). Daher werden für Bacillus thuringiensis Konzentrationen größer/gleich 100000 CFU/g Lebensmittel als gesundheitlich nicht akzeptabel bewertet. Für die beantragte Anwendung kann ausgehend vom derzeitigen Kenntnisstand nicht geschlussfolgert werden, dass auf den für den Verzehr vorgesehenen Produkten die Anzahl von 100000 Kolonie bildenden Einheiten pro g Lebensmittel bei der Ernte unterschritten wird. Die Anwendung wird somit nicht positiv beurteilt, da ein gesundheitliches Risiko für Verbraucher auch bei sachgerechter und bestimmungsgemäßer Anwendung des Mittels nicht ausgeschlossen werden kann. SEITE 35 VON 35 Anlage 2 nicht zugelassene Anwendung: 007638-00/00-021 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Freifressende Schmetterlingsraupen Pflanzen/-erzeugnisse/Objekte: Ziergehölze Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Anwendungszeitpunkt: Nach Befallsbeginn; ab Schlüpfen der ersten Larven Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 3 - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: zeitlicher Abstand der Behandlungen mindestens 7 Tage spritzen oder sprühen Aufwand: - Pflanzengröße bis 50 cm 0,5 kg/ha in mindestens 600 l Wasser/ha - Pflanzengröße 50 bis 125 cm 0,75 kg/ha in mindestens 900 l Wasser/ha - Pflanzengröße über 125 cm 1 kg/ha in mindestens 1200 l Wasser/ha 3 Begründung BVL_FO_05_2437_200_V1.7 Wirksamkeit Die Ziergehölze stellen eine Untergruppe der Kulturgruppe "Zierpflanzen" dar. Die Anwendung 021 wird negativ bewertet, da sie als solche bereits in den Anwendungen 019 bzw. 020 miterfasst und mitbewertet ist. Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 1 of 26 REGISTRATION REPORT Part B Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment Product code: Agree 50 WG Active Substance: Bacillus thuringiensis ssp. aizawai GC-91 500 g/kg Central Zone Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Mitsui AgriScience International SA Date: November 2015 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Agree 50 WG Registration Report – Central Zone Page 2 of 26 Table of Contents IIIM1 1 IDENTITY OF THE PLANT PROTECTION PRODUCT .............................. 6 IIIM1 1.1 Applicant ................................................................................................................ 6 IIIM1 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation.......... 6 IIIM1 1.5 Type of Preparation and Code ............................................................................. 6 IIIM1 1.6 Function.................................................................................................................. 6 IIIM1 1.6.1 Biological sphere of action and arear of application ............................................. 6 IIIM1 1.7 Other/Special Studies ............................................................................................ 6 IIIM 1.7.4 Quality control data from 3-5 production batches, including product stored for duration of shelf life if it is metabolically active ........................................... 6 IIIM 1.7.5 The formation, presence and/or impact of unintentional ingredients ................... 6 IIIM1 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT ................................................................... 7 IIIM1 2.7 Summary and evaluation of of data on properties of MPCP presented under points 2.1 to 2.6 ......................................................................................... 15 IIIM1 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT ........................................................................................................... 15 IIIM1 3.1 Field of Use ........................................................................................................... 15 IIIM1 3.2 Nature of the Effects on Harmful Organisms ................................................... 15 IIIM1 3.3 Details of Intended Use ....................................................................................... 15 IIIM1 3.3.1 Details of existing and intended uses ................................................................. 15 IIIM1 3.3.2 Details of harmful organisms against which protection is afforded ............... 15 IIIM1 3.3.3 Effects achieved ................................................................................................... 15 IIIM1 3.4 Proposed Application Rates (Active Substance and Preparation) ................. 16 IIIM1 3.5 Concentration of the Active Substance in the Material Used ......................... 16 IIIM1 3.6 Method of Application, Type of Equipment Used and Volume of Diluent .... 16 IIIM1 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection ...................................... 16 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Agree 50 WG Registration Report – Central Zone Page 3 of 26 IIIM1 3.7.1 Maximum number of applications and their timings ...................................... 16 IIIM1 3.7.2 Growth stages of crops or plants to be protected ............................................. 16 IIIM1 3.7.3 Development stages of the harmful organism concerned ................................ 16 IIIM1 3.7.4 Duration of protection afforded by each application ....................................... 16 IIIM1 3.7.5 Duration of protection afforded by the maximum number of applications .. 16 IIIM1 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops .............................................................................. 16 IIIM1 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops .......................................................... 16 IIIM1 3.8.2 Limitations on choice of succeeding crops ........................................................ 16 IIIM1 3.8.3 Description of damage to rotational crops ........................................................ 16 IIIM1 4 FURTHER INFORMATION ON THE MPCP................................................ 17 IIIM1 4.1 Packaging: description ........................................................................................ 17 IIIM1 4.2 Specifications of the packaging and mesasures of its suitability..................... 17 IIIM1 4.3 Label instructions regarding cleaning equipment and protective clothing ... 17 IIIM1 4.4 Procedures for cleaning application equipment and protective clothing; measures of their effectiveness ........................................................................... 17 IIIM1 4.5 Nessessary waiting period (in days) for re-entry; recommended protective measures to reduce occupational exposure ..................................... 18 IIIM1 4.6 Label instructions (safe handling and storage)................................................. 18 IIIM1 4.7 Recommendations (handlimg, storage, transport, fire: specific risks, specify procedures to minimise hazards and the generation of waste............ 18 IIIM1 4.8 Label instructions (clean up of spills) ................................................................ 19 IIIM1 4.9 Detailed procedures in case of accident to: contain a spillag, decontaminate an area or vehicle, disposal of packaging and adsorbents, protect workers and bystanders, first aid. ........................................................ 19 IIIM1 4.10 Procedures for destruction/ disposal of MPCP and its package ..................... 20 IIIM1 4.10.1 Controlled incineration ....................................................................................... 20 IIIM1 4.10.2 Methods other than controlled incineration ..................................................... 20 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany IIIM1 11 Agree 50 WG Registration Report – Central Zone Page 4 of 26 SUMMARY AND ASSESSMENT OF IMPACT ON THE ENVIRONMENT AND THE ENVIRONMENTAL RISK............................. 21 Appendix 1: List of data used in support of the evaluation .................................................... 22 Appendix 2: Critical Uses – justification and GAP tables ....................................................... 25 Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: ..................................................................................................... 26 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Agree 50 WG Registration Report – Central Zone Page 5 of 26 Introduction This document summarises the information related to the identity, the physical and chemical properties, the data on application, further information and the classification for the product Agree 50 WG containing the active substance Bacillus thuringiensis subspecies aizawai strain GC-91 which was approved according to Regulation (EC) No 1107/2009. Agree 50 WG was not the representative formulation. Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Appendix 1 of this document is the table of intended uses for Agree 50 WG. Information on the detailed composition of Agree 50 WG can be found in the confidential dossier of this submission (Registration Report - Part C). Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Agree 50 WG Registration Report – Central Zone Page 6 of 26 IIIM1 1 IDENTITY OF THE PLANT PROTECTION PRODUCT IIIM1 1.1 Applicant Mitsui AgriScience International SA Boulevard de la Woluwe, 60 Woluwedal 60 1200 Brussels, Belgium IIIM1 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation Trade name: Agree 50 WG, Agree WG, Turex 50 WG, Turex WG Company code number: None IIIM1 1.5 Type of Preparation and Code Type : Water dispersible granules IIIM1 1.6 Code : WG Function The product will be used as a biological insecticide. IIIM1 1.6.1 Biological sphere of action and arear of application Function: Agree 50 WG acts as insecticide, for biological control of the species of the order Lepidoptera. Field of use: Agriculture, viniculture, horticulture, orcharding, forestry and amenity areas (grass land), professional use. IIIM1 1.7 Other/Special Studies Confidential information - data provided separately (Part C). IIIM 1.7.4 Quality control data from 3-5 production batches, including product stored for duration of shelf life if it is metabolically active No EC data requirement. IIIM 1.7.5 The formation, presence and/or impact of unintentional ingredients No EC data requirement. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany IIIM1 2 Registration Report – Central Zone Agree 50 WG Page 7 of 26 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT Agree 50 WG was not the representative formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a pale brown, water dispersible granules-based formulation with a fish meal odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of 392 °C. In aqueous solution, it has a pH value around 6.4. The stability data indicate a shelf life of 24 month at ambient temperature. The technical characteristics are acceptable for a water dispersible granules (WG) formulation. Tabelle 1: Summary of the physical, chemical and technical properties of the plant protection product Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Y/N Colour, odour and physical state (IIIM1 2.1) Visual assessment and organoleptic determination Batch no. 4093650 The preparation consists of small granules with a pale brown color (RAL 8025) and a fish meal like odour. Y Aversa, S., 2011a, BT066/11 acceptable Storage stability after 18 weeks at 30 °C (IIIM1 2.2.1) Visual control of the test item container. Batch no. 4093650 Storage material: aluminium sachet. Y Aversa, S., 2011a, BT066/11 acceptable Weight change of the test item container. Control of activity by bioassay. Method no. R&D 0011; Validation Applicant Mitsui AgriScience International SA No damage of the test item containers was observed. No loss in weight was found after storage. The activity of the test item was not significantly changed after the storage. The changes of the physical and Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 8 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Aversa, S., 2013, BT067/11 acceptable Y/N according to SANCO/3030/99 rev. 4 (11/07/00) chemical properties are negligible. Content of Bta GC-91: Before storage: 2.80 x 1010 CFU/g After storage: 2.38 x 1010 CFU/g degradation: 15 % Agree 50 WG is stable when stored at 30 °C for 18 weeks. Storage stability after 24 months at 20 °C (IIIM1 2.2.1) Visual control of the test item container. Weight change of the test item container. Control of activity by bioassay. Method no. R&D 0011; Validation according to SANCO/3030/99 rev. 4 (11/07/00) Applicant Mitsui AgriScience International SA Batch no. 4093650 Storage material: aluminium sachet. No damage of the test item containers was observed. No loss in weight was found after storage. The changes of the physical and chemical properties are negligible. Content of Bta GC-91: before storage: 2.80 x 1010 CFU/g after 6 month: 2.74 x 1010 CFU/g after 12 month: 1.26 x 109 CFU/g Evaluator: DE Date: November 2015 Y The formulation is stable for 6 month at 20 °C (with respect to content of CFU) According to the instruction for use the product should be stored in a cool and dry place, but no data were submitted for storage stability at temperatures < 20 °C. Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 9 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Aversa, S., 2013, BT067/11 acceptable Chen, C.-Y. (2012) acceptable, based on biopotency formulation is stable for 24 month at 20 °C. Y/N After 24 month: 1.16 x 10 9 CFU/g degradation: 95.9 % after 24 month applicant: The decrease in CFU counts is likely due to a loss in culturability and is not expected to have any negative influence on the efficacy of the product. Microbial conaminants methods: MFLP-44 April 1998, NF EN ISO 4832:2006, NF EN ISO 68883:2003, NF EN ISO 21567:2005, Nf EN ISO 6579:2002, NF EN ISO 112901/A1:2005 Applicant Mitsui AgriScience International SA Batch no. 4093650 After storage: Anaerobic spore formers: <10 CFU/g, Coliforms: <10 CFU/g, Staphylococcus aureus: absent in 1g, Shigella sp.: absent in 25 g, Salmonella sp.: absent in 25 g, Listeria monocytogenes: absent in 10 g Lot # 99-98 Potencies at 20 ° C after storage: t=0 15.0 BIU/LB 3 month: 16.1 BIU/LB 6 month: 12.6 BIU/LB 12 month: 14.7 BIU/LB Evaluator: DE Date: November 2015 Y Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 10 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Ahrens, A., 2011a, acceptable. Y/N 24 month: 11.2 BIU/LB Degradation after 24 month: 25 % Explosive properties (IIIM1 2.3.1) EEC A.14, OECD 113 (1981), OPPTS 830.6316 (1995) Batch no. 4093650 Oxidizing properties (IIIM1 2.3.1) EEC A.17 Batch no. 4093650 Flammability (IIIM1 2.3.2) EEC A 10 Auto-flammability (IIIM1 2.3.2) EEC A 16 Acidity or alkalinity and pH (IIIM1 2.3.3) - - Since the pH was < 10 and > 4, the acidity/alkalinity test was not performed - - acceptable pH of a 1% aqueous dilution, emulsion or dispersion (IIIM1 2.3.3) CIPAC MT 75.3 Batch no. 4093650 Before storage: 6.40 Y Aversa, S., 2011a, BT066/11 acceptable. After 18 weeks, 30°C: 6.28 After 2 years, 20°C: 6.33 Batch no. 4093650 The test item has no explosive properties. Y The test item has no oxidizing properties. Y no ignition during preliminary test Y 20110112.02 Ahrens, A., 2011b, acceptable. 20110112.04 Ahrens, A., 2011c, acceptable 20110112.01 Batch no. 4093650 Auto-ignition at 392 °C. Y Ahrens, A., 2011d, acceptable. 20110112.03 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Aversa, S., 2013, BT067/11 Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 11 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Y/N (demineralised water, 20°C) Viscosity (IIIM1 2.3.4) - - not required for solid formulations - - acceptable Surface tension (IIIM1 2.3.4) - - not required for solid formulations - - acceptable Wettability (IIIM1 2.4.1) CIPAC MT 53.3.1 Batch no. 4093650 Before storage: Static: 2s Dynamic: 1 s Y Aversa, S., 2011a, BT066/11 acceptable. MT 53.3.2 Aversa, S., 2013, BT067/11 After 18 weeks, 30°C: Static: 2s Dynamic: 1 s After storage: Static: 2s Dynamic: 1 s Persistence of foaming (IIIM1 2.4.2) CIPAC MT 47.2 Applicant Mitsui AgriScience International SA Batch no. 4093650 CIPAC water D, 0.05 %: 10 s: 49 mL 1 min: 11 mL 3 min: 5 mL 12 min: 2 mL Evaluator: DE Date: November 2015 Y Aversa, S., 2011c, BT065/11 acceptable. highest use concentration is 0.5 %, but based on results at 0.05 % and 0.2 % no problems are expected Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 12 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Y/N Suspensibility (IIIM1 2.4.3) CIPAC MT 47.2 TUREX WP CIPAC water D, 0.2 %: 10 s: 31 mL 1 min: 23 mL 3 min: 20 mL 12 min: 15 mL Y Fifi, 2006 additional information (Turex 50 WP and Agree 50 WG differ slightly in composition) CIPAC MT 184 Batch no. 4093650 CIPAC water D, 0.07 %: Before storage: 82 % After 18 weeks, 30 °C: 84 % After 2 years, 20 °C: 78 % Y Aversa, S., 2011a, BT066/11 acceptable. Aversa, S., 2013, BT067/11 CIPAC water D, 0.4 %: Before storage: 75 % After 18 weeks, 30 °C: 68 % After 2 years, 20 °C: 93 % Spontaneity and degree of dispersion (IIIM1 2.4.3) Dry and wet sieve test (IIIM1 2.4.4) CIPAC MT 174 CIPAC MT 185 Batch no. 4093650 Batch no. 4093650 CIPAC water D, 1 %: Before storage: After 18 weeks, 30 °C: After 2 years, 20 °C: Y 93 % 101 % 94 % Before storage: 1.97 % on 75 µm sieve After 18 weeks, 30 °C: 1.95 % on 75 µm sieve Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Aversa, S., 2011a, BT066/11 acceptable. Aversa, S., 2013, BT067/11 Y Aversa, S., 2011a, BT066/11 Aversa, S., 2013, BT067/11 acceptable. Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 13 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Aversa, S., 2011a, BT066/11 acceptable. Y/N After 2 years, 20 °C: 1.35 % on 75 µm sieve Particle size distribution (IIIM1 2.4.5) CIPAC MT 170 Batch no. 4093650 Before storage: < 10 %: 500 µm > 90 %: 125 µm Y Aversa, S., 2013, BT067/11 After 18 weeks, 30 °C: < 10 %: 500 µm > 90 %: 125 µm After 2 years, 20 °C: < 10 %: 500 µm > 90 %: 125 µm Dust content (IIIM1 2.4.5) Friability and attrition (IIIM1 2.4.5) CIPAC MT 171 CIPAC MT 178.2 Applicant Mitsui AgriScience International SA Batch no. 4093650 Batch no. 4093650 nearly dust free Y Before storage: 2.99 mg After 18 weeks, 30 °C: 3.71 mg After 2 years, 20 °C: 3.60 mg Before storage: 99.96 % After 18 weeks, 30°C: 99.92 % After 2 years, 20°C: 99.84 % Evaluator: DE Date: November 2015 Aversa, S., 2011a, BT066/11 acceptable. Aversa, S., 2013, BT067/11 Y Aversa, S., 2011a, BT066/11 Aversa, S., 2013, BT067/11 acceptable. Part B – Section 1 Core Assessment – Germany Test or study & Annex point Registration Report – Central Zone Agree 50 WG Page 14 of 26 Method used / deviations Test material purity and specification Findings GLP Reference Acceptability / comments Y/N Emulsifiability, emulsion stability and re-emulsifiability (IIIM1 2.4.6) - - not required for WG formulations - - acceptable Flowability, pourability (rinsability) and dustability (IIIM1 2.4.7) CIPAC MT 172 Batch no. 4093650 Spontanious flow without any residue. Y Aversa, S., 2011c, BT065/11 acceptable. Density (IIIM1 2.5) CIPAC MT 186 Batch no. 4093650 pour density: 0.477 g/mL Y Aversa, S., 2011c, BT065/11 acceptable. tap density: 0.526 g/mL - - acceptable Adherence and distribution to seeds, for seed treatment products (IIIM1 2.6) - Applicant Mitsui AgriScience International SA - not intended for seed treatment Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany IIIM1 2.7 Registration Report – Central Zone Page 15 of 26 Summary and evaluation of of data on properties of MPCP presented under points 2.1 to 2.6 All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a pale brown, water dispersible granules-based formulation with a fish meal odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of 392 °C. In aqueous solution, it has a pH value around 6.4. The stability data indicate a shelf life of 6 month at ambient temperature based on the content of cfu/g, based on biopotency a shelf life of 24 month is observed. The technical characteristics are acceptable for a water dispersible granules (WG) formulation. Experimental testing of the product's physico-chemical and technical characteristics: See Appendix 3 Implications for labelling: None IIIM1 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT IIIM1 3.1 Field of Use Agree 50 WG is a biological insecticide formulated as a water dispersible granule, containing 3 × 1013 colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product.. IIIM1 3.2 Nature of the Effects on Harmful Organisms Agree 50 WG is non-systemic and poisons the caterpillars. Therefore, it is used to control leaf consuming caterpillars on various crops. Upon ingestion, the crystal proteins dissolve in the stomach and damage the tissue. The caterpillars stop eating and die after a few days. Mostly young caterpillars are more sensitive than old ones. For an adequate effectiveness all plant parts should be sufficiently sprayed. Applications are performed at pest occurrence, independ-ently from the crop growth stage. IIIM1 3.3 Details of Intended Use IIIM1 3.3.1 Details of existing and intended uses Please refer Part B Section 7. IIIM1 3.3.2 Details of harmful organisms against which protection is afforded Please refer Part B Section 7. IIIM1 3.3.3 Effects achieved Please refer to Part B Section 7. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany IIIM1 3.4 Registration Report – Central Zone Page 16 of 26 Proposed Application Rates (Active Substance and Preparation) Please refer to Part B Section 7. IIIM1 3.5 Concentration of the Active Substance in the Material Used Please refer to Part B Section 7. IIIM1 3.6 Method of Application, Type of Equipment Used and Volume of Diluent Please refer to Part B Section 7. IIIM1 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection IIIM1 3.7.1 Maximum number of applications and their timings Please refer to Part B Section 7. IIIM1 3.7.2 Growth stages of crops or plants to be protected Please refer to Part B Section 7. IIIM1 3.7.3 Development stages of the harmful organism concerned Please refer to Part B Section 7. IIIM1 3.7.4 Duration of protection afforded by each application Please refer to Part B Section 7. IIIM1 3.7.5 Duration of protection afforded by the maximum number of applications Please refer to Part B Section 7. IIIM1 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops IIIM1 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops Please refer to Part B Section 7. IIIM1 3.8.2 Limitations on choice of succeeding crops Please refer to Part B Section 7. IIIM1 3.8.3 Description of damage to rotational crops Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 17 of 26 Please refer to Part B Section 7. IIIM1 4 FURTHER INFORMATION ON THE MPCP IIIM1 4.1 Packaging: description Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable. IIIM1 4.2 Specifications of the packaging and mesasures of its suitability Taking into account the composition of the product and its anticipated physical properties, Agree 50 WG is characterized as non-reactive and non-hazardous; no further investigations and tests were conducted. The chemically inert product does not require special stability or resistance properties of the packaging or the material used in packaging. Professional use: Primary packaging: 1.0 kg bag: material: 48 gauge polyester/0.003 PE laminated shape/size: approx. 16.5 cm x 7.6 cm x 33.0 cm material: 28 gauge solid unbleached sulphate (SUS) shape/size: approx. 16.8 cm x 7.6 cm x 26.0 cm Secondary packaging: 1.0 kg box: Master shipping package: 10.0 kg box: IIIM1 4.3 material: ECT (edge crush test) 48 double wall fibreboard shape/size: approx. 38.9 cm x 34.4 cm x 26.8 cm Label instructions regarding cleaning equipment and protective clothing Please refer to Point IIIM 4.4. IIIM1 4.4 Procedures for cleaning application equipment and protective clothing; measures of their effectiveness Equipment cleaning procedure: Rinse the application equipment thoroughly with water. Distribute the cleaning water on the treated area. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 18 of 26 Protective clothing cleaning procedure: Protective clothing shall be washed according to manufacturer’s instruction. If no such instructions for washables exist, use detergent and hot water. Keep and wash protective clothing separately from other laundry. IIIM1 4.5 Nessessary waiting period (in days) for re-entry; recommended protective measures to reduce occupational exposure Pre-harvest interval for each relevant crop: Agree 50 WG is not supposed to produce any relevant residues on the crop. B. thuringiensis ssp. aizawai does not produce toxins or secondary metabolites of toxic concern to non-arthropods, including man and domestic animals. Fixing a pre-harvest interval is therefore not relevant. Re-entry period for livestock, to areas to be grazed: Not relevant (see above). Agree 50 WG is not intended for use on pastures. Re-entry period for man to crops, buildings or spaces treated: Not relevant (see above). Withholding periods for animal feeding stuffs: Not relevant (see above). Waiting period between application and handling treated products: Not relevant (see above). Waiting period between last application and sowing or planting succeeding crops: B. thuringiensis ssp. aizawai does not cause injuries to plants. Due to restricted field persistence and absence of toxicity, waiting periods for planting or sowing of succeeding crops are not required. IIIM1 4.6 Label instructions (safe handling and storage) Please refer to Point IIIM 4.7. IIIM1 4.7 Recommendations (handlimg, storage, transport, fire: specific risks, specify procedures to minimise hazards and the generation of waste Handling and storage precautions: Keep away from food, drink and animal feeding stuffs. When using, do not eat, drink or smoke. Wash hands and face before eating, drinking or smoking. Do not breathe dust or spray. Avoid contact with skin Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 19 of 26 and eyes. Wear suitable protective clothing, gloves, eye/face protection and respiratory protection. (minimal A2, P3 filter). Store in a cool, dry and a well-ventilated place, secure area out of the reach of children and domestic animals. Do not store food, beverages or tobacco products in the storage area. Prevent eating, drinking, tobacco usage, and cosmetic application in areas where there is a potential for exposure to the material. Always wash thoroughly after handling, high humidity and temperatures over 30ºC decrease the activity of the product. Do not contaminate waters with this product or its container. Transport: Transport of Agree 50 WG does not require special precautions. Procedures to minimize the generation of waste: Remainder of spray shall be diluted and sprayed over already treated areas. Totally cleaned packages can be given to the waste disposal or recycling system. Hazardous combustion products: Not known at the indicated conditions of use. Please, for any further information refer to the Material Safety Data Sheet submitted in KIIIM 4.7/01 IIIM1 4.8 Label instructions (clean up of spills) Please refer to Point IIIM 4.9. IIIM1 4.9 Detailed procedures in case of accident to: contain a spillag, decontaminate an area or vehicle, disposal of packaging and adsorbents, protect workers and bystanders, first aid. Containment of spillages: Wear chemical safety glasses with side shields or chemical goggles, rubber gloves, rubber boots, longsleeved shirt, long pants, head covering, and a NIOSH-approved dust or pesticide respirator with dust prefilters. For small spills, sweep up, keeping dust to a minimum and place in an approved chemical container. Wash the spill with water containing a strong detergent, absorb with pet litter or other absorbent material, sweep up and place in a chemical container. Seal the container and handle in a approved manner. Flush the area with water to remove any residue. Do not allow wash water to decontaminate water supplies. Decontamination of areas, vehicles and buildings: Refer to the above statement on spillages. Disposal of damaged packaging, adsorbents and other materials: Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 20 of 26 Refer to the above statement on spillages. Protection of emergency workers: Refer to the above statement on spillages. First aid measures: Eye contact: Immediately wash eyes with a large amount of running water. Hold eyelids apart to rinse the entire surface of the eyes and lids. Do not apply any medicating agent except on the advice of a physician. Skin contact: Wash with plenty of soap and water, including hair and under fingernails. Do not apply any medicating agent except on the advice of a physician. Remove contaminated clothing and decontaminate prior to use. Inhalation: necessary. Move victim from contaminated area to fresh air. Apply artificial respiration if Ingestion: If victim is fully conscious, immediately give large amounts of water to drink and induce vomiting. Never give anything by mouth to a unconscious person. Please, for any further information refer to the Material Safety Data Sheet submitted in KIIIM 4.9/01. IIIM1 4.10 Procedures for destruction/ disposal of MPCP and its package The disposal of product has to be performed in accordance with all applicable federal, state and local environmental regulations. Wastes resulting from the use of Agree 50 WG, i.e. residual water dispersions can be disposed of at an approved waste disposal facility. Remainder of spray can also be diluted and sprayed over already treated areas. The same procedure is applicable to larger quantities, which may occur very rarely only. Totally cleaned packages can be given to the regular waste disposal. Please, for any further information refer to the Material Safety Data Sheet submitted in KIIIM 4.10/01. IIIM1 4.10.1 Controlled incineration Incineration should be made in authorized and specialized plant. IIIM1 4.10.2 Methods other than controlled incineration Not applicable. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany IIIM1 11 Registration Report – Central Zone Page 21 of 26 SUMMARY AND ASSESSMENT OF IMPACT ON THE ENVIRONMENT AND THE ENVIRONMENTAL RISK See Part B, Section 6. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 22 of 26 Appendix 1: List of data used in support of the evaluation Annex point/ Author(s) Year reference No Owner How considered in Title Data Source (where different from protection dRR company) claimed Study-Status / Usage* Report-No. GLP or GEP status (where relevant), Published or not KIIIM1 2.1 2.2 2.3.3 2.4.1 2.4.3.1 2.4.3.2 2.4.4 2.4.5.1 2.4.5.2 2.4.5.3 KIIIM1 2.2.1 KIIIM1 2.1 Aversa, S. 2011 Physical-chemical properties of product Agree WG before and after accelerated storage at 30 ± 2 ºC for 18 weeks BT066/11 GLP: Y, published: N Y Mitsui 1 Chen, C.Y. Anonymo us Storage stability of Agree WG Material safety data sheet Agree 50 WP Certis, USA GLP: N, published: N Interim report of study BT067/10 6 months check point. Physical-chemical properties of product Agree WG after 2 years shelf life BT067/11 GLP: Y, published: N Physical, chemical, technical properties and accelerated storage of TUREX WP 50 (Bacillus thuringiensis). BT033/05 GLP: Y, published: N 2294298 / Physical, chemical,technical properties and shelf life of Turex WP 50 (Bacillus thuringiensis) at room temperature for two years BT034/05 GLP: Y, published: N Y Mitsui 1 Y Mitsui 3 Y Mitsui 3 Y Mitsui 5 Y Mitsui 5 2012 2001 KIIIM1 2.2 Aversa, S. 2011 KIIIM1 2.2 Fifi, A.P. 2006 KIIIM1 2.2 Fifi, A.P. 2008 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Annex point/ Registration Report – Central Zone Page 23 of 26 Author(s) Year reference No Title Data Source (where different from protection dRR company) claimed Study-Status / Owner How considered in Usage* Report-No. GLP or GEP status (where relevant), Published or not KIIIM1 2.2 2.3.3 2.4.1 2.4.3.1 2.4.3.2 2.4.4 2.4.5.1 2.4.5.2 2.4.5.3 KIIIM1 2.2 Aversa, S. 2013 Physical-chemical properties of product Agree WG after 2 years shelf life BT067/11 GLP: Y, published: N Y Mitsui 1 Coranelli, S. Analytical method validation Y for the determination of the active ingredient content in the formulated product Agree WG and in aqueous dilutions Mitsui 1 Y Mitsui 1 Y Mitsui 1 Y Mitsui 1 Y Mitsui 1 Y Mitsui 3 2011 BT064/11 KIIIM1 2.3.1.1 KIIIM1 2.3.1.2 KIIIM1 2.3.2 KIIIM1 2.3.2 KIIIM1 2.3.2 GLP: Y, published: N Ahrens, A. 2011a Agree WG Explosive properties A.14 20110112.02 GLP: Y, published: N Ahrens, A. 2011b Agree WG Oxidizing Properties A.17 20110112.04 GLP: Y, published: N Ahrens, A. 2011 Agree WG Flammability (solids) A.10 20110112.01 GLP: Y, published: N Ahrens, A. 2011 Agree WG Auto-flammability (solids-determination of relative self-ignition temperature) A.16 20110112.03 GLP: Y, published: N Smeykal, 2006 Turex 50 WP - AutoH. flammability (BowesCameron-Cage test) 20060301.01 GLP: Y, published: N Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Annex point/ Registration Report – Central Zone Page 24 of 26 Author(s) Year reference No Title Data Source (where different from protection dRR company) claimed Study-Status / Owner How considered in Usage* Report-No. GLP or GEP status (where relevant), Published or not KIIIM1 2.4.2 2.4.3 2.4.7 2.5 KIIIM1 4.7 4.9 KIIIM1 4.7 KIIIM1 4.10 * 1 2 3 4 5 Aversa, S. 2011c Physical-chemical properties: flowability, bulk density and persistent foaming of product Agree WG BT065/11 GLP: Y, published: N Anonymo 2012 Safety data sheet Agree WG us GLP: N, published: N Anonymo 2001 Safety data sheet - Agree 50 us WP GLP: N, published: N Anonymo 2012 Safety data sheet Agree WG us 2012 GLP: N, published: N Y Mitsui 1 Y Mitsui 1 Y Mitsui 3 Y Mitsui 1 accepted (study valid and considered for evaluation) not accepted (study not valid and not considered for evaluation) not considered (study not relevant for evaluation) not submitted but necessary (study not submitted by applicant but necessary for evaluation) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation) Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Agree 50 WG Registration Report – Central Zone Page 25 of 26 APPENDIX 2: CRITICAL USES – JUSTIFICATION AND GAP TABLES Product use for professional Please refer to Appendix 2 of Part B Section 7 Product use for amateur Please refer to Appendix 2 of Part B Section 7 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Agree 50 WG Registration Report – Central Zone Page 26 of 26 Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: The following physical, chemical and technical properties of the plant protection product were experimentally tested: pour and tap density, colour, pH, storage stability at high temperatures (18 weeks at 30 °C), wettability, persistent foaming, suspensibility, particle size distribution (laser diffraction), content of dust/fines, attrition and flowability. A significant higher attrition was detected compared to the data submitted by the applicant. The formulation complies with the chemical, physical and technical criteria which are stated for this type of formulation in the FAO/WHO manual (2010). Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 1 of 10 REGISTRATION REPORT Part B Section 2: Analytical Methods Detailed summary of the risk assessment Product code: Agree 50 WG Active Substance: Bacillus thuringiensis ssp. aizawai GC-91 500 g/kg Central Zone Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Date: Applicant Mitsui AgriScience International SA Mitsui AgriScience International SA November 2015 Evaluator: DE Date: November 2015 Part B – Section 1 Core Assessment – Germany Applicant Mitsui AgriScience International SA Agree 50 WG Registration Report – Central Zone Page 2 of 10 Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 3 of 10 III 5 Methods for Analysis, Manufacturing, Quality Control and Postregistration Monitoring of MPCP ..................................................................... 4 IIIA 5.1 Quality control and post-registration monitoring methods .............................. 4 IIIA 5.1.1 Methods to differentiate a mutant or genetically-modified microorganism from the parent strain .......................................................................... 4 IIIA 5.1.2 Methods to detect spontaneous change in major characteristics of micro- organism.................................................................................................... 4 IIIA 5.1.3 Methods to define contents of micro-organism in appropriate terms .............. 4 IIIA 5.1.4 Methods to identify contaminant micro-organisms in MPCP .......................... 5 IIIA 5.1.5 Methods to show control to a specified and acceptable level, of microbial impurities and of any other impurities of toxicological concern ................................................................................................................... 5 IIIA 5.2 Storage stability test and determination of shelf life (methods of analysis) .................................................................................................................. 6 IIIA 5.3 Production process for MPCP, describing techniques used to ensure a uniform product .................................................................................................... 6 IIIA 5.4 Description of Analytical Methods for the Determination of Residues............ 6 Appendix 1 – List of data submitted in support of the evaluation ........................................... 9 Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany III 5 Registration Report – Central Zone Page 4 of 10 Methods for Analysis, Manufacturing, Quality Control and Post-registration Monitoring of MPCP This document reviews the analytical methods for the product Agree 50 WG containing the Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91) which was included into Annex I of Directive 91/414 EC by directive 2008/113/EC. It is approved under Regulation (EC) 1107/2009 as listed in implementing Regulation (EU) 540/2011 of 25 May 2011 Agree 50 WG was not the representative formulation. IIIA 5.1 Quality control and post-registration monitoring methods IIIA 5.1.1 Methods to differentiate a mutant or genetically-modified micro-organism from the parent strain Not required, because the strain Bacillus thuringiensis ssp. aizawai GC-91 is of natural origin, not a mutant and or genetically modified. IIIA 5.1.2 Methods to detect spontaneous change in major characteristics of microorganism Confidential information, please refer to Part C. IIIA 5.1.3 Methods to define contents of micro-organism in appropriate terms An analytical method has been developed and validated for the determination of the content of active ingredient Bacillus thuringiensis ssp. aizawai CG-91 in the formulated product Agree 50 WG and in aqueous dilutions obtained after suspensibility and dispersibility tests. The following analytical method for the determination of the active substance has not previously been reviewed and is provided in support of this assessment. Report: Title: Document No: Guidelines: GLP KIIIM 5.1.3/01, Coranelli, S. (2011) Analytical method for the determination of the active ingredient content in the formulated product Agree WG and in aqueous dilutions Study BT064/11 SANCO/3030/99 rev.4. Yes Material: Agree WG, Batch No. 4093650, containing Bacillus thuringiensis aizawai strain GC-91, content: 11 BIU/lb, 2.75 × 1010 CFU/g Reference item: Agree technical powder, Batch No. 041211, containing Bacillus thuringiensis aizawai strain GC-91, content: 22 BIU/lb, 5.6 × 1010 CFU/g Blank Formulation: Agree WG inert, Batch No. 106-48 Demineralized water and Standard Water D. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 5 of 10 Principle of the method The active ingredient content was determined by colonies counting and reported as spore concentration. After a first dilution of the sample (100 times) the suspension was heat shocked for 45 min at 65 °C for killing of vegetative cells. Then sufficient dilutions were prepared to obtain 30 - 300 colonies. Namely, 0.1 mL of the already diluted dispersions were plated on nutrient agar (15 - 20 mL of agar were added). Finally, the Petri dishes were incubated at 30 ± 1°C for 24 hours and the colonies were counted. The calculation of spore/g was performed according to the following formula: [spore] = (dilution) × (mean number of colonies counted)/(weight or volume of sample) The method was validated with regard to specificity, linearity, precision and accuracy. For the validation of the method in aqueous dilutions (dispersions), the samples were prepared using Standard Water D. Validation Table 5.1.3-1: Summary of validation of the method for the determination of Bacillus thuringiensis aizawai strain CG-91. Reference Linearity Accuracy Repeatability n=5 (Recoveries) (Precision) n=5 KIIIA 5.1.3/01 concentration 0.1 - 4 g/L: formulated product: r = 0.9945 aqueous dilutions: r = 0.9965 The accuracy was evaluated by a recovery determination on two fortification levels. formulated product: 100.11 % aqueous dilutions: 101.76 % formulated product: RSD = 2.28 % aqueous dilutions: RSD = 2.13 % acceptable according modified Horwitz eqn.: 2.68 % (for 1 %) Conclusion: The analytical method is suitable and reliable for the determination of concentration of the number of spores of Bacillus thuringiensis aizawai strain GC-91 in the product Agree WG and in aqueous dilutions. The method was validated by definition of the linearity, the precision and the accuracy according to the criteria set by SANCO/3030/99 rev. 4. IIIA 5.1.4 Methods to identify contaminant micro-organisms in MPCP Please refer to dRR Part C. IIIA 5.1.5 Methods to show control to a specified and acceptable level, of microbial impurities and of any other impurities of toxicological concern Please refer to Part C. IIIA 5.1.6 Methods to show presence of any human and mammalian pathogens Confidential information, please refer to Part C. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany IIIA 5.2 Registration Report – Central Zone Page 6 of 10 Storage stability test and determination of shelf life (methods of analysis) The analytical method described under IIIA 5.1.3 has been used in the storage stability tests to determine the content of Bacillus thuringiensis aizawai strain GC-91. IIIA 5.3 Production process for MPCP, describing techniques used to ensure a uniform product No EC data requirement. IIIA 5.4 Description of Analytical Methods for the Determination of Residues IIIA 5.4.1 Evaluation of Bacillus thuringiensis ssp. aizawai GC-91 The conclusions regarding the peer review of the analytical methods for residues of Bacillus thuringiensis ssp. aizawai GC-91 are summarized in SANCO/1538/08 – rev. 4. An EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. aizawai (strains ABTS 1857, GC-91) is available (EFSA 2012, ASB2013-1005). IIIA 5.4.1.1 Overview of residue definitions and levels for which compliance is required In Regulation (EC) No 396/2005 no MRLs and thus no residue definition are regulated for B. thuringiensis ssp. aizawai GC-91. The active components of commercial B. thuringiensis ssp. aizawai preparations, spores and crystal proteins, are not toxic or pathogenic to humans, plants, and most animals. The remaining issue for consumer exposure is that B. thuringiensis ssp. carries the genetic material that encodes for the Bacillus cereus enterotoxin, however at a lower level. It is proposed to apply the suggested value of 105 CFU/g food as a trigger for safe uses (EFSA 2005, ASB2012-9549). Consequently, the level of 105 CFU/g food is considered here as the maximum acceptable level for B. thuringiensis ssp. aizawai GC-91 in food. A residue definition for soil and water was not defined in the Draft Assessment Report (ASB2010-10682) and was not considered necessary because of low risks for terrestrial vertebrates, aquatic organisms or bees. IIIA 5.4.1.2 Description of Analytical Methods for the Determination of Residues of Bacillus thuringiensis ssp. aizawai GC-91 in Plant Matrices (OECD KIII A 5.3.1) EFSA concluded that validated analytical methods for all representative uses have to be generated. However, due to several data gaps, the risk assessment could not be finalized (EFSA 2012, ASB20131005) and a residue definition for monitoring was not proposed. It is not clear if MRLs and a corresponding residue definition will be established in future or if B. thuringiensis ssp. aizawai GC-91 will be included in Annex IV (meaning that no MRLs are required). For the time being it is therefore not feasible to develop or evaluate appropriate analytical methods. Only such intended uses are currently foreseen for authorization, which result in < 105 CFU/g food. In that case the risk to consumers is low and analytical methods for the determination of residues in plant matrices are not required. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany IIIA 5.4.1.3 Registration Report – Central Zone Page 7 of 10 Description of Analytical Methods for the Determination of Residues of Bacillus thuringiensis ssp. aizawai GC-91 in Animal Matrices (OECD KIII A 5.3.1) EFSA concluded that validated analytical methods for all representative uses have to be generated. However, due to several data gaps, the risk assessment could not be finalized (EFSA 2012, ASB20131005) and a residue definition for monitoring was not proposed. It is not clear if MRLs and a corresponding residue definition will be established in future or if B. thuringiensis ssp. aizawai GC-91 will be included in Annex IV (meaning that no MRLs are required). For the time being it is therefore not feasible to develop or evaluate appropriate analytical methods. Only such intended uses are currently foreseen for authorization, which result in < 105 CFU/g food. In that case the risk to consumers is low and analytical methods for the determination of residues in animal matrices are not required. IIIA 5.4.1.4 Description of Methods for the Analysis of Bacillus thuringiensis ssp. aizawai GC-91 in Soil (OECD KIII A 5.4) B. thuringiensis ssp. aizawai GC-91 is an ubiquitously occurring microorganism with low risk for soil microflora, earthworms and other non-target organisms. Due to its ubiquitous occurrence, a detection of B. thuringiensis ssp. aizawai GC-91 cannot be directly traced back to the application of a plant protection product. Analytical methods for the determination of residues of B. thuringiensis ssp. aizawai GC-91 in soil are not feasible and therefore not required. IIIA 5.4.1.5 Description of Methods for the Analysis of Bacillus thuringiensis ssp. aizawai GC-91 in Water (OECD KIII A 5.6) Bacterial cells and especially spores may survive in water, but are not expected to cause any environmental impact and are not expected to occur in concentrations which could be potentially harmful to humans. Therefore, analytical methods for the determination of residues of B. thuringiensis ssp. aizawai GC-91 in water are not required. IIIA 5.4.1.6 Description of Methods for the Analysis of Bacillus thuringiensis ssp. aizawai GC-91 in Air (OECD KIII A 5.7) B. thuringiensis ssp. aizawai GC-91 is not expected to occur in concentrations in air which could be potentially harmful to humans. Analytical methods for the determination of residues in air are therefore not required. IIIA 5.4.1.7 Description of Methods for the Analysis of Bacillus thuringiensis ssp. aizawai GC-91 in Body Fluids and Tissues (OECD KIII A 5.8) The registration of plant protection products which contain microorganisms is not allowed, if these microorganisms or their toxins are harmful to humans. Therefore, it is concluded that analytical methods for body fluids and tissues are generally not required. IIIA 5.4.1.8 Other Studies/ Information Other studies are not required. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany IIIA 5.4.2 Registration Report – Central Zone Page 8 of 10 Conclusion on the availability of analytical methods for the determination of residues For the time being, analytical methods for residues of B. thuringiensis ssp. aizawai GC-91 are not required. Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 9 of 10 Appendix 1 – List of data submitted in support of the evaluation Annex point/ Author(s) Year reference No Data Title Source (where different Owner How considered in dRR from protection Study-Status claimed company) / Usage* Report-No. GLP or GEP status (where relevant), Published or not KIIIM1 5.1.3 * 1 2 3 4 5 Coranelli, S. 2011 Analytical method for the Y determination of the active ingredient content in the formulated product Agree 50 WG and in aqueous dilutions, Biotecnologie BT Srl, Fraz. Pantalla, Italy, Certis Europe B.V., NL, BT064/11, GLP: yes, Published: no MTA 1 accepted (study valid and considered for evaluation) not accepted (study not valid and not considered for evaluation) not considered (study not relevant for evaluation) not submitted but necessary (study not submitted by applicant but necessary for evaluation) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation) Annex point/ reference No Author(s) Year Italy 2007 EFSA 2005 EFSA 2012 Applicant Mitsui AgriScience International SA Title Report-No. Authority registration No Bacillus thuringiensis subspecies aizawai strain GC-91 (Draft Assessment Report) GLP: Open Published: Yes ASB2010-10682 Opinion of the scientific panel of biological hazards on Bacillus cereus and other Bacillus spp in foodstuffs EFSA Journal (2005) 175, 1-48 ! EFSAQ-2004-010 The EFSA Journal, 175, 1-48 GLP: No Published: Yes BVL-2294154, ASB2012-9549 Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91) EFSA Journal 2013;11(1):3063 ! EFSAQ-2009-00247 EFSA Journal (2013) 11 (1), 3063 ASB2013-1005 Data protection claimed Open No Owner LIT How considered in dRR * Add Y Add Evaluator: DE Date: November 2015 Agree 50 WG Part B – Section 1 Core Assessment – Germany Registration Report – Central Zone Page 10 of 10 Annex point/ reference No Author(s) Year KIIM 4.3.1, KIIM 4.5, KIIM 4.5.1, KIIM 4.5.3, KIIM 4.5.4, KIIM 4.5.5, KIIM 4.5.6 Hill, K. K.; Ticknor, L. O.; Okinaka, R. T. et al. 2003 KIIM 4.5.1 Kim, Y.-R.; Czajka, J.; Batt, C. A. 2000 KIIM 4.5.1, KIIM 4.5.4 Bernhard, K.; Jarrett, P.; Meadows, M. et al. 1997 KIIM 4.5.3, KIIM 5.3.7.1 Hadley, W. H.; Burchiel, S. W.; McDowell, Th. D. et al. 1987 KIIM 4.5.5, KIIM 4.5.6 Valadares de Amorim, G.; Whittome, B.; Shore, B. et al. 2001 Title Report-No. Authority registration No Fluorescent amplified fragment length polymorphism analysis of Bacillus anthracis, Bacillus cereus, and Bacillus thuringiensis isolates 0099-2240/04 ! 10.1128/AEM.70.2.1068-1080.2004 Appl Environ Microbiol, 70 (2), 10681080 GLP: No Published: Yes BVL-2294132, BVL-2294140, BVL2294143, BVL-2294145, BVL2294147, BVL-2294149, BVL2294151, ASB2012-9391 Development of a fluorogenic probebased PCR assay for detection of Bacillus cereus in nonfat dry milk 0099-2240/00 Appl Environ Microbiol, 66 (4), 14531459 GLP: No Published: Yes BVL-2294142, ASB2012-9394 Natural isolates of Bacillus thuringiensis: Worldwide distribution, characterization, and activity against insect pests IN974669 ! 0022-2011/97 J Invertebr Pathol, 70, 59-68 GLP: No Published: Yes BVL-2294141, BVL-2294146, ASB2012-9393 Five-month oral (diet) toxicity/infectivity study of Bacillus thuringiensis insecticides in sheep 0272-0590/87 Fundam Appl Toxicol, 8, 236-242 GLP: No Published: Yes BVL-2294144, BVL-2294192, BVL2294204, TOX2006-1566 Identification of Bacillus thuringiensis subsp. kurstaki strain HD1-like bacteria from environmental and human samples after aerial spraying of Victoria, British Columbia, Canada, with Foray 48B LIT How considered in dRR * N No LIT N No LIT N No LIT N No LIT N Data protection claimed No Owner Appl Environ Microbiol, 67 (3), 10351043 GLP: No Published: Yes BVL-2294148, BVL-2294150, TOX2006-1561 * Y: N: Add: Yes, relied on No, not relied on Relied on, study not submitted by applicant but necessary for evaluation Applicant Mitsui AgriScience International SA Evaluator: DE Date: November 2015 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version REGISTRATION REPORT Part B Section 3: Mammalian Toxicology Detailed summary of the risk assessment Product code: Agree 50 WG Active Substance: 500 g/kg Bacillus thuringiensis ssp. Aizawai GC-91 (3 x 1013 CFU/kg) Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Mitsui AgriScience International S.A./B.V Date: November 2015 Page 1 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Table of Contents 3 Mammalian Toxicology ...................................................................................................... 3 3.1 Toxicological Evaluation of Active Substance.................................................................... 3 3.1.1 Bacillus thuringiensis subspecies aizawai strain GC-91...................................................... 3 3.2 Toxicological Evaluation of Pesticide ................................................................................. 3 3.3 Dermal Absorption .............................................................................................................. 5 3.4 Safety Assessment of Pesticide Application........................................................................ 6 3.4.1 Selection of critical uses and justification ........................................................................... 6 3.4.2 Evaluation of the Active Substance Bacillus thuringiensis ssp. aizawai strain GC91 ....................................................................................................................................... 10 3.4.2.1 Operator exposure and risk assessment ............................................................................. 10 3.4.2.2 Worker exposure and risk assessment ............................................................................... 12 3.4.2.3 Bystander and resident exposure and risk assessment ....................................................... 12 3.4.3 Conclusion of Exposure Estimation and Risk Assessment ............................................... 13 3.5 Justified Proposals for Classification and Labelling and Safety Instructions ................... 13 Appendix 1 List of Data Submitted in Support of the Evaluation......................................................... 15 Appendix 2 Exposure Calculations ....................................................................................................... 17 A 2.1 Exposure Calculations for Bacillus thuringiensis ssp. aizawai strain GC-91 ................... 17 A 2.1.1 Operator exposure calculations.......................................................................................... 17 Appendix 3 Detailed Evaluation of the Exposure Studies Relied upon ................................................ 22 Page 2 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version 3 Mammalian Toxicology 3.1 Toxicological Evaluation of Active Substance 3.1.1 Bacillus thuringiensis subspecies aizawai strain GC-91 Table 3.1-1: General information on Bacillus thuringiensis subspecies aizawai strain GC-91 Common Name Bacillus thuringiensis ssp. aizawai CAS-No. Not applicable Chemical substance class Not applicable Table 3.1-2: Agreed EU endpoints Value Reference ADI Not applicable based on the lack of pathogenicity and infectivity in the available data. EFSA Conclusion 2013 (ASB2013-1005) AOEL systemic Not applicable based on the lack of pathogenicity and infectivity in the available data. EFSA Conclusion 2013 (ASB2013-1005) ARfD (acute reference dose) Not applicable based on the lack of pathogenicity and infectivity in the available data. Table 3.1-3: Classification and proposed labelling for Bacillus thuringiensis subspecies aizawai strain GC-91 with regard to toxicological data (according to the criteria in Dir. 67/548/EEC) with regard to toxicological data (according to the criteria in Reg. (EC) No 1272/2008) 3.2 Not applicable Not applicable Toxicological Evaluation of Pesticide Table 3.2-1: General information on Agree 50 WG Product name and code Agree 50 WS (MRA-11111-I-0-WG) Formulation type Water dispersible granules Active substance (incl. content) Bacillus thuringiensis subspecies aizawai strain GC-91; 500 g/kg, 25000 IU/mg, 3 x 1013 CFU/kg Category Insecticide Statement as to whether the product was already evaluated as the ‘representative formulation’ during the Annex I inclusion or has been previously evaluated in an other MS according to Uniform Principles No, but the previous formulation Agree 50 WP containing also 500 g/kg Bacillus thuringiensis subspecies aizawai strain GC-91 was the representative formulations during Annex I inclusion, Rapporteur MS: IT (May 2007). For the detailed composition of Agree 50 Page 3 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version WP it is referred to Vol. 4 of the DAR. In general, WP formulations are toxicologically considered more critical than WG formulations due to the higher potential risk for dust to be inhaled. Moreover, Xxx in all) of Agree 50 WP were replaced by one Xxx .Taken all together, it is considered acceptable to use the study results on Agree 50 WP for this evaluation.of Agree 50 WG. Information on the detailed composition of Agree 50 WG can be found in the confidential dossier of this submission (Registration Report - Part C). A summary of the toxicological evaluation for Agree 50 WG on the basis of studies conducted using Agree 50 WP is given in Table 3.2-2. For full summaries of studies on the product Agree 50 WP it is referred to the DAR by IT (May 2007). Table 3.2-2: Type of test, species (Guideline) Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for Agree 50 WP Result Acceptability Classification (acc. to the criteria in Dir. 67/548/EEC) Classification (acc. to the criteria in Reg. (EC) No 1272/2008) Reference LD50 oral, rat (EPA FIFRA 81-1) > 5050 mg/kg bw corresponding to 3.23 × 1010 CFU Bta/kg bw 1), 2) Yes None None Xxx 1991 LD50 oral, rat (EPA FIFRA 81-1) > 5050 mg/kg bw corresponding to 1.2 × 1011 CFU Bta/kg bw 1), 3) Yes None None Xxx 1992 LD50 dermal, rabbit (EPA 152A-11) > 2020 mg/kg bw corresponding to 2.85 × 109 CFU Bta/kg bw 1) Yes None None Xxx 1991 LC50 inhalation, rat (EPA 81-3) > 5.78 mg/L air corresponding to 1.8 × 108 CFU Bta/L air 1), 4) Yes None None Xxx 1991 LC50 inhalation, rat (EPA 81-3) > 0.651 mg/L air corresponding to 3.4 × 108 CFU Bta/L air 1), 5) Yes None None Xxx 1993 Skin irritation, rabbit (EPA 152A-11) Non-irritant 1) Yes None None Xxx 1991 Eye irritation, rabbit (EPA 152A-14) Non-irritant 1) Yes None None Xxx 1991 Skin sensitisation, Sensitising 6) Yes 7) R43 H317 Xxx Page 4 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version 1999 guinea pig (design comparable to M&K; no statement, but OECD 406 mentioned in the bibliography) Supplementary studies No data – not required for combinations of plant protection products 1) 2) 3) 4) 5) 6) 7) test using ‘technical material’ 2/5 females but 0/5 males died 1/5 females but 0/5 males died no mortality at this powder concentration containing an average of 14.8 % of particles < 1 µm; study with shortcomings in generation of test atmosphere: substantial fluctuations of MMAD during 4h-test period (3.911 µm – 11.332 µm) no mortality at this powder concentration containing an average of 10.8 % of particles < 1 µm; MMAD constant during 4htest period (3.228 µm – 3.612 µm) test on formulated product no GLP statement, no positive controls even though not compulsory from a scientific point of view in this case Table 3.2-3: Additional relevant toxicological information Type of test, species (Guideline) Classification of the Substance substance (Concentration (acc. to the criteria in Dir. in product, 67/548/EEC and/or in % w/w) Reg. (EC) No 1272/2008) Short-term toxicity studies No data – not required Toxicological data on active substance (not tested with the preparation) Bacillus thuringiensis subspecies aizawai strain GC-91 (50 % (w/w)) Toxicological data on non-active substances (not tested with the preparation) Reference Classification of Agree 50 WG (acc. to the criteria in Dir. 67/548/EEC, in Dir. 1999/45/EC and/or in Reg. (EC) No 1272/2008) Considering that all microbials should be regarded as potential sensitizers, the agreed warning phrase is “Micro-organisms may have the potential to provoke sensitising reactions”. 1) Considering that all microbials should be regarded as potential sensitizers, the agreed warning phrase is “Micro-organisms may have the potential to provoke sensitising reactions”. 1) None None Further relevant No data – not toxicological required information 1) In accordance with EFSA Conclusion 2013 Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91) (ASB2013-1005) An overview on the classification and labelling of the preparation is given in paragraph 3.5. 3.3 Dermal Absorption Not applicable. Page 5 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version 3.4 Safety Assessment of Pesticide Application Table 3.4-1: Product information and toxicological reference values used for safety assessment of pesticide application Product name and code Agree 50 WS (MRA-11111-I-0-WG) Formulation type Water dispersible granules Active substance (incl. content) Bacillus thuringiensis subspecies aizawai strain GC-91; 500 g/kg, 25000 IU/mg, 3 x 1013 CFU/kg Category Insecticide Container size, short description Bags, composite material, 1 kg Statement as to whether the The safety of the application of Agree 50 WG was not evaluated as part of the EU product was already review of Bacillus thuringiensis subspecies aizawai strain GC-91. evaluated as the ‘representative formulation’ during the Annex I inclusion AOEL systemic Not derived Oral absorption 100 % Inhalative absorption Considered non-relevant for micro-organisms Dermal absorption Considered non-relevant for micro-organisms 3.4.1 Selection of critical uses and justification The critical GAPs used for the safety assessment of pesticide application are presented in Table 3.4-2. A list of all intended uses within the zone is given in Appendix 2 of Part B, Section 1. Page 6 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Table 3.4-2: 1 UseNo. 2 Zone Critical uses according to Reg. 1107/2009 (worst case) for safety assessment of pesticide application (Agree 50 WG, 500 g a.s./kg, 3 x 1013 CFU/kg) 3 Crop and/ or situation (crop destination / purpose of crop) 1* 2 */# 3 ** 4 **/° 5**/° 6**/° 4 F G or I 5 Pests or Group of pests controlled 6 Method / Kind (additionally: developmental stages of the pest or pest group) (a) Central Grape vine (VITVI) (use as table and wine grape) (b) F (c) Grape berry moth 2nd and 3rd generation (L1-L2) (d-f) Spraying or fine spraying (low volume spraying) Central Berries (NNNOB) except for strawberries F Free biting caterpillars Spraying or fine spraying (low volume spraying) Central Strawberries (FRAAN) F Central Leafy and stem vegetables (/NNNVL) except for vegetable cabage F Central Vegetable cabage (BRSOX) F Central Root and tuber vegetables F Free biting caterpillars Free biting caterpillars Free biting caterpillars Free biting caterpillars Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) 7 Application Timing / Growth stage of crop & season 8 Max. number (min. interval between applications) a) per use b) per crop/ season (h) (g) From emergence of 3;3 first larvae after beginning of (at least 7 days) infestation or warning service appeal / from BBCH 53 After beginning of 3;3 infestation; from emergence of first (at least 7 days) larvae / from BBCH 11 3;3 After beginning of infestation; from emergence of first (at least 7 days) larvae / from BBCH 13 After beginning of 3;3 infestation; from emergence of first (at least 7 days) larvae / from BBCH 09 After beginning of 3;3 infestation; from emergence of first (at least 7 days) larvae / from BBCH 09 After beginning of 3;3 infestation; from emergence of first (at least 7 days) larvae / from BBCH 09 Page 7 / 23 10 11 12 Application rate Water L/ha kg product / ha kg as/ha a) max. rate min / max a) max. rate per appl. per appl. b) max. total b) max. total rate per rate per crop/season crop/season a) 0.125 – 0.5 a) - base dose: 0.25 - BBCH 61: 0.5 - BBCH 71: 0.75 - BBCH75: 1 b) 3 a) 1 b) 1.5 a) 0.5 b) 3 b) 1.5 a) 1 a) 0.5 b) 3 b) 1.5 a) 1 a) 0.5 b) 3 b) 1.5 a) 1 a) 0.5 b) 3 b) 1.5 a) 1 a) 0.5 b) 3 b) 1.5 - base dose: 400 - BBCH 61: 800 - BBCH 71: 1200 - BBCH 75: 1600 max. 1000 1000 - 2000 200 - 800 200 - 800 200 - 800 13 PHI (days) (i) 14 Remarks: safener/synergist per ha recommended or mandatory tank mixtures (j) Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version 7**/° 8**/° 9* 10 * Central Bulb crops (NNNSZ) Central Herbs (NNNKR) Central Pulse crops (NNNLG) Central Ornamentals (NNNZZ) F F F F Free biting caterpillars Free biting caterpillars Free biting caterpillars Free biting caterpillars Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) After beginning of infestation; from emergence of first larvae / from BBCH 09 After beginning of infestation; from emergence of first larvae / from BBCH 09 After beginning of infestation; from emergence of first larvae / from BBCH 09 After beginning of infestation; from emergence of first larvae 3;3 a) 1 a) 0.5 (at least 7 days) b) 3 b) 1.5 3;3 a) 1 a) 0.5 (at least 7 days) b) 3 b) 1.5 3;3 a) < 50 cm: 0.5 a) 0.25 – 0.5 (at least 7 days) 50-125 cm: 0.75 > 125 cm: 1 6;6 b) 3 a) < 50 cm: 0.5 b) 1.5 a) 0.25 – 0.5 (at least 7 days) 50-125 cm: 0.75 > 125 cm: 1 11**** Central Berries (NNNOB) except for strawberries 12**** Central Fruit vegetables 13**** Central Pulse crops (NNNLG) 14**** Central Ornamentals (NNNZZ) G G G G Free biting caterpillars Free biting caterpillars Free biting caterpillars Free biting caterpillars Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) Spraying or fine spraying (low volume spraying) After beginning of infestation; from emergence of first larvae / from BBCH 11 After beginning of infestation; from emergence of first larvae / from BBCH 09 After beginning of infestation; from emergence of first larvae / from BBCH 09 After beginning of infestation; from emergence of first larvae Page 8 / 23 3;3 b) 6 a) 1 b) 3 a) 0.5 (at least 7 days) b) 3 b) 1.5 6;6 a) < 50 cm: 0.5 a) 0.25 – 0.5 (at least 7 days) 50-125 cm: 0.75 > 125 cm: 1 3;3 b) 6 a) < 50 cm: 0.5 b) 3 a) 0.25 – 0.5 (at least 7 days) 50-125 cm: 0.75 > 125 cm: 1 6;6 b) 3 a) < 50 cm: 0.5 (at least 7 days) 50-125 cm: 0.75 b) 1.5 a) 0.25 – 0.5 200 - 800 200 - 800 < 50 cm: min 600 50-125 cm: min 900 > 125 cm: min 1200 < 50 cm: min 600 50-125 cm: min 900 > 125 cm: min 1200 max. 1000 < 50 cm: min 600 50-125 cm: min 900 > 125 cm: min 1200 < 50 cm: min 600 50-125 cm: min 900 > 125 cm: min 1200 < 50 cm: min 600 50-125 cm: min 900 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version > 125 cm: min 1200 > 125 cm: 1 b) 6 * ** *** **** b) 3 Critical GAPs for operators in high crops outdoors, German model Critical GAPs for operators in low crops outdoors, German model has to be clarified Critical GAPs for operators in high crops in the greenhouse, German model and exposure data by Mich (1996); all intended uses on low crops in the greenhouse are covered by these critical GAPs on high crops # Critical GAPs for operators in high crops outdoors, UK POEM ° Critical GAPs for operators in low crops outdoors, UK POEM (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, the use situation should be described (e.g. fumigation of a structure) information on season at time of application (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (h) The minimum and maximum number of application possible under practical (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds conditions of use must be provided (d) All abbreviations used must be explained (i) PHI - minimum pre-harvest interval (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, (j) Remarks may include: Extent of use/economic importance/restrictions drench (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated Page 9 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version 3.4.2 Evaluation of the Active Substance Bacillus thuringiensis ssp. GC-91 3.4.2.1 Operator exposure and risk assessment aizawai strain Estimation of operator exposure and risk assessment Even if this approach using the below mentioned German model is not suitable for exposure estimation in the case of micro-organisms (cf. EFSA conclusion on B.thuringiensis ssp. kurstaki), it may provide a rough overview of operator exposure. Estimations according to the UK POEM are not deemed necessary. Table 3.4-3: Critical uses Models Table 3.4-4: Model data Exposure models for intended uses Ornamentals, grape vine, strawberries and various others (max. 6 x 1 kg Agree 50 WG/ha) German model (available on http://www.bfr.bund.de/cm/343/anwendersicherheit_deutsches_modell_v1.xls) [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277, 1992] Estimated operator exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 External exposure (mg/kg bw/day) Level of PPE Total external exposure (mg/kg bw/day) Tractor mounted boom spray application outdoors to low crops Application rate: 0.5 kg a.s./ha German Model Body weight: 70 kg no PPE 1) inhalative: 0.001286 dermal: 0.577143 0.57843 with PPE 2) inhalative: 0.001286 dermal: 0.294286 0.29557 no PPE 1) inhalative: 0.001486 dermal: 0.771426 0.77291 with PPE 2) inhalative: 0.001486 dermal: 0.658286 0.65977 no PPE 1) inhalative: 0.002286 3) dermal: 0.438571 0.44086 with PPE 2) inhalative: 0.002286 3) dermal: 0.290071 0.29236 Air assisted spray application outdoors to high crops Application rate: 0.5 kg a.s./ha German Model Body weight: 70 kg Hand-held spray application outdoors to high crops Application rate: 0.5 kg a.s./ha German Model Body weight: 70 kg 1) 2) no PPE: Operator wearing T-shirt and shorts with PPE: gloves during mixing/loading (PPE acc. to the Federal Office of Consumer Protection and Food Safety (BVL); 2006; Personal protective equipment for handling plant protection products - Guidelines for requirements concerning personal protective equipment in plant protection) Page 10 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version 3) scenario resulting in the worst predicted exposure via inhalation For the detailed calculations it is referred to Appendix 2. Estimation of operator exposure based on measured values and risk assessment Operator exposure was estimated using a GLP study performed for the generic assessment of products applied in greenhouses. Even if this approach is not suitable for exposure estimation in the case of microorganisms (cf. EFSA conclusion on B.thuringiensis ssp. kurstaki), it may provide a rough overview of operator exposure. Detailed considerations and calculations as well as a summary of the greenhouse study it is referred to Appendices 3. Estimation of operator exposure based on measured values after greenhouse applications and risk assessment Table 3.4-5: Exposure models for intended uses Critical uses Fruit vegetables, ornamentals and others (max. 6 x 1 kg Agree 50 WG/ha) Model German model (available on http://www.bfr.bund.de/cm/343/anwendersicherheit_deutsches_modell_v1.xls) [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277, 1992] and Exposure study according to Mich (1996) Table 3.4-6: Model data Estimated operator exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 External exposure (mg/kg bw/day) Level of PPE Total external exposure (mg/kg bw/day) Knapsack spray applications in greenhouses to high crops Application rate: 0.5 kg a.s./ha German Model and Exposure study Body weight: 70 kg 1) 2) no PPE 1) inhalative: 0.000917 dermal: 0.844467 0.84538 with PPE 2) inhalative: 0.000917 dermal: 0.695967 0.69688 no PPE: Operator wearing T-shirt and shorts with PPE: gloves during mixing/loading (PPE acc. to the Federal Office of Consumer Protection and Food Safety (BVL); 2006; Personal protective equipment for handling plant protection products - Guidelines for requirements concerning personal protective equipment in plant protection For the detailed calculations it is referred to Appendix 2. Up to now (cf. DAR by Italy, LoEP 2007) no dose-effect relationship, no specific target organ or NOAEL could be determined for Bacillus thuringiensis ssp.aizawai strain GC-91. Since no dermal uptake of micro-organisms is anticipated through the intact skin, no systemic exposure will result from this path of entry. Page 11 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Exposure towards Bacillus thuringiensis ssp.aizawai strain GC-91 via inhalation will normally be cleared by mucociliary clearance mechanisms. Even if this clearance is delayed and/or slow, as was figured out during the EU review process for Bacillus thuringiensis ssp. kurstaki strain SA-11, it can be assumed that at least part of the primarily inhaled micro-organisms can be ingested. As a worst case assumption all inhaled bacilli might be ingested. In order to address that Bacillus species (other than B. cereus) might cause food poisoning the following considerations are taken as a basis: The minimum dose reported for potentially pathogenic microorganisms involved in foodborne illness is 106 CFU/g food according to the opinion of the EFSA Panel on Biological Hazards on Bacillus cereus and other Bacillus ssp in food stuffs (EFSA Journal 2005, 175). If ingestion of 100 g contaminated food is assumed, 108 CFU of such pathogenic Bacillus species could cause diarrhea. Although Bacillus thuringiensis ssp. aizawai GC-91 is not pathogenic, the respective estimated inhalation exposure is compared with this reference value of 108 CFU/day. On the basis of 70 kg body weight for operators this corresponds to 1.43 x 106 CFU/kg bw/day. According to the German model (‘worst case’: hand-held equipment, outdoor application on high crops) 2.286 µg/kg bw/day of bacilli are inhaled during application of Agree 50 WG without RPE (see above). This corresponds to 1.37 x 105 CFU/mg bw/day. Thus, there is a margin of safety of 10.4 between the estimated operator exposure via inhalation and the assumed reference value (1.43 x 106 CFU/kg bw/day / 1.37 x 105 CFU/mg bw/day). Therefore and probably due to the sensitising potential of micro-organisms, the applicant recommends the use of adequate PPE (including RPE) during mixing/loading and application by the operator. Since the above mentioned assumptions seem to overestimate exposure significantly and hence represent unrealistic worst case conditions, the use of RPE by the operator is not deemed required for the use of Agree 50 WG in the greenhouse or outdoor under the actual described conditions of use (e.g. handling of nearly dustfree WG (approximately 0.01% w/w, attrition resistance approximately 99.96 %, cf. dRR Part B – section 1 by the applicant, ASB2012-9812) during mixing/loading and 0.5 % (w/v) Agree 50 WG in the spray dilution at the most). 3.4.2.2 Worker exposure and risk assessment Estimation of worker exposure and risk assessment Since workers are normally potentially exposed towards dry foliar residues on plant surfaces, intensive dermally exposure might occur. This might be enhanced by multiple applications. In this case max. 6 applications of Agree 50 WG are intended. Although no systemic effects are to be expected by dermal contact because no penetration of Bacillus thuringiensis through intact skin is considered likely, the use of gloves and protective garment is necessary for workers during re-entry tasks due to the sensitising potential of Agree 50 WG. 3.4.2.3 Bystander and resident exposure and risk assessment In the case of greenhouse applications no bystander or resident exposure is expected. Bystanders of outdoor applications may be potentially exposed towards spray mist during the application of Agree 50 WG, whereas residents could be exposed towards spray deposits on surfaces after application. Since micro-organisms may have the potential for sensitisation, this has to be taken into account in risk assessment for bystanders and residents. But, there is no reference value for this toxicological property. In this particular case the plant protection product is applied at a maximum concentration of 0.5 % (w/v). Therefore, from a formal point of view the spray solution is not considered sensitising (< 1 % w/w) so Page 12 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version that most likely there will be no risk for bystanders and residents. But, in order to further minimise the potential exposure of bystanders and residents and thus further reduce the probability of sensitisation the use of drift-reducing nozzles (tractor-mounted equipment) or spraying shields (hand-held equipment) is recommended mandatorily. 3.4.3 Conclusion of Exposure Estimation and Risk Assessment The risk assessment according to the German model and the exposure study by Mich as well as qualitative considerations have shown that exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 in Agree 50 WG is not considered to give rise to concern for operators, workers, bystanders or residents in the greenhouse or in the case of outdoor applications. Due to potential sensitisation by micro-organisms the need of personal protective equipment, i.e. gloves and protective garment is highlighted for operators and workers. Notwithstanding the recommendation by the applicant, where respiratory protection is explicitly included into the protection equipment for operators, this is not deemed necessary in this particular case due to intended uses and the formulation of the product. Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous substances regulations. If the product is used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected. 3.5 Justified Proposals for Classification and Labelling and Safety Instructions Justified proposals for classification and labelling In accordance with Directives 67/548/EEC and 1999/45/EC the following classification and labelling with regard to toxicological data is proposed for the preparation: Table 3.5-1: Classification and labelling according to Directives 67/548/EEC and 1999/45/EC Hazard symbol: Xi Indication of danger: Irritating Risk phrases: R43 Safety phrases: 2-24-36-37-46 Labelling texts and restrictions: To avoid risks to man and the environment, comply with the instructions for use. ‘Micro-organisms may have the potential to provoke sensitising reactions.’ According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the following classification for toxicological hazards of the preparation according to GHS would be proposed: Table 3.5-2: Hazard class, category: Classification and labelling according to Regulation (EC) No 1272/2008 Skin Sens. 1 Page 13 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Signal word: Warning Hazard statement: H317 Labelling texts and restrictions: To avoid risks to man and the environment, comply with the instructions for use. ‘Micro-organisms may have the potential to provoke sensitising reactions.’ '30 to 50 percent of the mixture consist of ingredients of unknown oral, dermal and inhalation toxicity.' 1) 1) Depending on individual composition of test substance which is not exactly known in every particular case. Safety instructions Table 3.5-3: Safety phrases for instructions for use Safety instructions (codes according to BVL 1)) 1) 2) 1 2 3 4 Justification 2) SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. 1 SB110 The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. 1 SF1891 Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. 2 SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. 3 SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. 3 SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. 2 VH650 The packaging must be provided with the wording "micro-organisms may have the potential to provoke sensitising reactions". 3 The product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 %. 2 http://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/eAntrag-CodelistenEN.pdf?__blob=publicationFile&v=6 Justification: Mandatory for plant protection products With regard to preventive health protection and good agricultural practice Based on BBA-Guideline Part I, 3-3 (1993) with regard to the dangerous substance directive (Biologische Bundesanstalt für Land- und Forstwirtschaft, Richtlinen für die Prüfung von Pflanzenschutzmitteln – Kennzeichnung von Pflanzenschutzmitteln (Gesundheitsschutz) (Federal Biological Research Centre for Agriculture and Forestry, Guidelines for Evaluation of Plant Protection Products – Labelling of Plant Protection Products (Human Health)) Based on the exposure estimation according to the German model and exposure data by Mich (1996) for the operator and the uniform principles for the protection of workers: None Page 14 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Appendix 1 List of Data Submitted in Support of the Evaluation Table A 1: List of data submitted in support of the evaluatio Annex point/ reference No Author Year All EFSA 2013 Mich, G. 1996 OECD: KIIIM1 7.1.1 Xxx 1991 OECD: KIIIM1 7.1.1 Xxx 1992 OECD: KIIIM1 7.1.2, OECD: KIIIM1 7.1.4 Xxx 1991 OECD: KIIIM1 7.1.3 Xxx 1991 OECD: KIIIM1 7.1.3 Xxx 1993 OECD: KIIIM1 7.1.5 Xxx 1991 OECD: KIIIM1 7.1.6 Xxx 1999 Title Report-No. Authority registration No Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. Aizawai (strains ABTS 1857, GC-91) EFSA Journal 2013;aa(1):3063 ASB2013-1005 Operator exposure in greenhouses during practical use of plant protection products EF 94-02-03 ! MO-00-002686 ! M024096-01-1 BVL-1752398, BVL-1760625, BVL1771380, BVL-1771381, BVL1937458, TOX2000-2081 CGA-237218 WP FL-910959: Acute oral toxicity study in rats with a microbial pest control agent (MPCA) 8188-91 BVL-2294311, ASB2012-9779 Agree FL-920303 (CGA-237218 WP): Acute oral toxicity study in rats with a microbial pest control agent (MCPA) 8938-92 BVL-2294312, Z48651 Agree (CGA-237218 WP) FL-911716: Acute dermal toxicity/irritation study in rabbits with a microbial pest control agent (MPCA) 8373-91 BVL-2294313, BVL-2294316, ASB2012-9780 CGA-237218 WP FL-910986: Acute inhalation toxicity study in rats with a microbial pest control agent (MPCA) 8200-91 BVL-2294314, Z48652 Agree FL-921616: Acute inhalation toxicity study in rats with a microbial pest control agent 9398-92 BVL-2294315, ASB2012-9781 CGA-237218 WP FL-910959: Primary eye irritation study in rabbits with a microbial pest control agent (MPCA) 8189-91, BVL-2294317, ASB2012-9782 AGREE 50WP: Skin sensitization test 99/1054-1A ! B99/0036.A, BVL-2294318, ASB2012-9783 Page 15 / 23 Data protection claimed Owner How considered in dRR * Add Add CEU Y CEU Y CEU Y CEU Y CEU Y CEU Y CEU Y Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Annex point/ reference No Author Year OECD: MIIIM1 Sec 1 Applicant 2012 * Y: N: Add: Data Title protection Report-No. claimed Authority registration No Bacillus thuringiensis ssp. aizawai GC91 / Agree 50 WG: Identity, physical, chemical and technical properties, data on application, further information, classification and labelling on the plant protection product - Tier 2, IIIA-1,2,3,4 - Draft registration report - Part B - Core assessment MIII / Sec. 1, BVL-2288427, BVL-2298152, ASB2012-9812 Yes, relied on No, not relied on Relied on, study not submitted by applicant but necessary for evaluation Page 16 / 23 Owner How considered in dRR * Y Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Appendix 2 Exposure Calculations A 2.1 Exposure Calculations for Bacillus thuringiensis ssp. aizawai strain GC-91 A 2.1.1 Operator exposure calculations Table A 2: Formulation type: Application rate (AR): Area treated per day (A): Dermal absorption (DA): Inhalation absorption (IA): Body weight (BW): AOEL Estimation of operator exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 using the German model (FCTM) WG 0.5 20 0 0 100 70 Not derived Application technique: kg a.s./ha ha % (concentr.) % (dilution) % kg/person mg/kg bw/d Dermal hands m/l (DM(H)): Dermal hands appl. (DA(H)): Dermal body appl. (DA(B)): Dermal head appl. (DA(C)): Inhalation m/l (IM): Inhalation appl. (IA): Field crop tractor mounted 2 0.38 1.6 0.06 0.008 0.001 mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. Operator exposure towards Bacillus thuringiensis ssp. aizawai strain GC-91 Without PPE Operators: External dermal exposure after application in strawberries, cabbage Dermal exposure during mixing/loading Hands EDEOM(H) = (DM(H) x AR x A) / BW (2 x 0.5 x 20) / 70 External dermal exposure 20 mg/person External dermal exposure 0.285714 mg/kg bw/d Dermal exposure during application Hands EDEOA(H) = (DA(H) x AR x A) / BW (0.38 x 0.5 x 20) / 70 External dermal exposure 3.8 mg/person External dermal exposure 0.054286 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A) / BW (1.6 x 0.5 x 20) / 70 External dermal exposure 16 mg/person External dermal exposure 0.228571 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A) / BW (0.06 x 0.5 x 20) / 70 External dermal exposure 0.6 mg/person External dermal exposure 0.008571 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 40.4 mg/person Total external dermal exposure 0.577143 mg/kg bw/d Operators: External inhalation exposure after application in strawberries, cabbage Inhalation exposure during mixing/loading EIEOM = (IM x AR x A) / BW (0.008 x 0.5 x 20) / 70 External inhalation exposure 0.08 mg/person External inhalation exposure 0.001143 mg/kg bw/d Inhalation exposure during application EIEOA = (IA x AR x A) / BW (0.001 x 0.5 x 20) / 70 With PPE Hands EDEOM(H) = (DM(H) x AR x A x PPE 1)) / BW (2 x 0.5 x 20 x 0.01) / 70 External dermal exposure 0.2 mg/person External dermal exposure 0.002857 mg/kg bw/d Hands EDEOA(H) = (DA(H) x AR x A x PPE) / BW (0.38 x 0.5 x 20 x 1) / 70 External dermal exposure 3.8 mg/person External dermal exposure 0.054286 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A x PPE) / BW (1.6 x 0.5 x 20 x 1) / 70 External dermal exposure 16 mg/person External dermal exposure 0.228571 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A x PPE) / BW (0.06 x 0.5 x 20 x 1) / 70 External dermal exposure 0.6 mg/person External dermal exposure 0.008571 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 20.6 mg/person Total external dermal exposure 0.294286 mg/kg bw/d EIEOM = (IM x AR x A x PPE) / BW (0.008 x 0.5 x 20 x 1) / 70 External inhalation exposure External inhalation exposure EIEOA = (IA x AR x A x PPE) / BW (0.001 x 0.5 x 20 x 1) / 70 Page 17 / 23 0.08 mg/person 0.001143 mg/kg bw/d Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version External inhalation exposure 0.01 mg/person External inhalation exposure 0.000143 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.09 mg/person Total external inhalation exposure 0.0012857 mg/kg bw/d External inhalation exposure 0.01 mg/person External inhalation exposure 0.000143 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.09 mg/person Total external inhalation exposure 0.0012857 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.57843 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.29557 mg/kg bw/d 1) reduction factor for gloves is 0.01 (professional appl.) Table A 3: Formulation type: Application rate (AR): Area treated per day (A): Dermal absorption (DA): Inhalation absorption (IA): Body weight (BW): AOEL Estimation of operator exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 using the German model (HCTM) WG 0.5 20 0 0 100 70 Not derived Application technique: kg a.s./ha ha % (concentr.) % (dilution) % kg/person mg/kg bw/d Dermal hands m/l (DM(H)): Dermal hands appl. (DA(H)): Dermal body appl. (DA(B)): Dermal head appl. (DA(C)): Inhalation m/l (IM): Inhalation appl. (IA): High crop tractor mounted 2 0.7 9.6 1.2 0.008 0.018 mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. Operator exposure towards Bacillus thuringiensis ssp. aizawai strain GC-91 Without PPE Operators: External dermal exposure after application in ornamentals Dermal exposure during mixing/loading Hands EDEOM(H) = (DM(H) x AR x A) / BW (2 x 0.5 x 8) / 70 External dermal exposure 8 mg/person External dermal exposure 0.114286 mg/kg bw/d Dermal exposure during application Hands EDEOA(H) = (DA(H) x AR x A) / BW (0.7 x 0.5 x 8) / 70 External dermal exposure 2.8 mg/person External dermal exposure 0.04 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A) / BW (9.6 x 0.5 x 8) / 70 External dermal exposure 38.4 mg/person External dermal exposure 0.548571 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A) / BW (1.2 x 0.5 x 8) / 70 External dermal exposure 4.8 mg/person External dermal exposure 0.068571 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 54 mg/person Total external dermal exposure 0.771429 mg/kg bw/d Operators: External inhalation exposure after application in ornamentals Inhalation exposure during mixing/loading EIEOM = (IM x AR x A) / BW (0.008 x 0.5 x 8) / 70 External inhalation exposure 0.032 mg/person External inhalation exposure 0.000457 mg/kg bw/d With PPE Hands EDEOM(H) = (DM(H) x AR x A x PPE 1)) / BW (2 x 0.5 x 8 x 0.01) / 70 External dermal exposure 0.08 mg/person External dermal exposure 0.001143 mg/kg bw/d Hands EDEOA(H) = (DA(H) x AR x A x PPE) / BW (0.7 x 0.5 x 8 x 1) / 70 External dermal exposure 2.8 mg/person External dermal exposure 0.04 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A x PPE) / BW (9.6 x 0.5 x 8 x 1) / 70 External dermal exposure 38.4 mg/person External dermal exposure 0.548571 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A x PPE) / BW (1.2 x 0.5 x 8 x 1) / 70 External dermal exposure 4.8 mg/person External dermal exposure 0.068571 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 46.08 mg/person Total external dermal exposure 0.658286 mg/kg bw/d EIEOM = (IM x AR x A x PPE) / BW (0.008 x 0.5 x 8 x 1) / 70 External inhalation exposure External inhalation exposure Page 18 / 23 0.032 mg/person 0.000457 mg/kg bw/d Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Inhalation exposure during application EIEOA = (IA x AR x A) / BW (0.018 x 0.5 x 8) / 70 External inhalation exposure 0.072 mg/person External inhalation exposure 0.001029 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.104 mg/person Total external inhalation exposure 0.001486 mg/kg bw/d EIEOA = (IA x AR x A x PPE) / BW (0.018 x 0.5 x 8 x 1) / 70 External inhalation exposure 0.072 mg/person External inhalation exposure 0.001029 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.104 mg/person Total external inhalation exposure 0.001486 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.77291 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.65977 mg/kg bw/d 1) reduction factor for gloves is 0.01 (professional appl.) Table A 4: Formulation type: Application rate (AR): Area treated per day (A): Dermal absorption (DA): Inhalation absorption (IA): Body weight (BW): AOEL Estimation of operator exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 using the German model (HCHH) WG 0.5 1 0 0 100 70 Not derived Application technique: kg a.s./ha ha % (concentr.) % (dilution) % kg/person mg/kg bw/d Dermal hands m/l (DM(H)): Dermal hands appl. (DA(H)): Dermal body appl. (DA(B)): Dermal head appl. (DA(C)): Inhalation m/l (IM): Inhalation appl. (IA): High crop hand held 21 10.6 25 4.8 0.02 0.3 mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. Operator exposure towards Bacillus thuringiensis ssp. aizawai strain GC-91 Without PPE Operators: External dermal exposure after application in ornamentals Dermal exposure during mixing/loading Hands EDEOM(H) = (DM(H) x AR x A) / BW (21 x 0.5 x 1) / 70 External dermal exposure 10.5 mg/person External dermal exposure 0.15 mg/kg bw/d Dermal exposure during application Hands EDEOA(H) = (DA(H) x AR x A) / BW (10.6 x 0.5 x 1) / 70 External dermal exposure 5.3 mg/person External dermal exposure 0.075714 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A) / BW (25 x 0.5 x 1) / 70 External dermal exposure 12.5 mg/person External dermal exposure 0.178571 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A) / BW (4.8 x 0.5 x 1) / 70 External dermal exposure 2.4 mg/person External dermal exposure 0.034286 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 30.7 mg/person Total external dermal exposure 0.438571 mg/kg bw/d Operators: External inhalation exposure after application in ornamentals Inhalation exposure during mixing/loading EIEOM = (IM x AR x A) / BW With PPE Hands EDEOM(H) = (DM(H) x AR x A x PPE 1)) / BW (21 x 0.5 x 1 x 0.01) / 70 External dermal exposure 0.105 mg/person External dermal exposure 0.0015 mg/kg bw/d Hands EDEOA(H) = (DA(H) x AR x A x PPE) / BW (10.6 x 0.5 x 1 x 1) / 70 External dermal exposure 5.3 mg/person External dermal exposure 0.075714 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A x PPE) / BW (25 x 0.5 x 1 x 1) / 70 External dermal exposure 12.5 mg/person External dermal exposure 0.178571 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A x PPE) / BW (4.8 x 0.5 x 1 x 1) / 70 External dermal exposure 2.4 mg/person External dermal exposure 0.034286 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 20.305 mg/person Total external dermal exposure 0.290071 mg/kg bw/d EIEOM = (IM x AR x A x PPE) / BW Page 19 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version (0.02 x 0.5 x 1) / 70 External inhalation exposure 0.01 mg/person External inhalation exposure 0.000143 mg/kg bw/d Inhalation exposure during application EIEOA = (IA x AR x A) / BW (0.3 x 0.5 x 1) / 70 External inhalation exposure 0.15 mg/person External inhalation exposure 0.002143 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.16 mg/person Total external inhalation exposure 0.002286 mg/kg bw/d EIEOA = (IA x AR x A x PPE) / BW (0.3 x 0.5 x 1 x 1) / 70 External inhalation exposure 0.15 mg/person External inhalation exposure 0.002143 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.16 mg/person Total external inhalation exposure 0.002286 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.44086 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.29236 mg/kg bw/d 1) (0.02 x 0.5 x 1 x 1) / 70 External inhalation exposure External inhalation exposure 0.01 mg/person 0.000143 mg/kg bw/d reduction factor for gloves is 0.01 (professional appl.) Table A 5: Formulation type: Application rate (AR): Area treated per day (A): Dermal absorption (DA): Inhalation absorption (IA): Body weight (BW): AOEL Estimation of operator exposure towards Bacillus thuringiensis subspecies aizawai strain GC-91 using the German model and the exposure data by Mich (1996) WG 0.5 1 0 0 100 70 Not derived Application technique: kg a.s./ha ha % (concentr.) % (dilution) % kg/person mg/kg bw/d Dermal hands m/l (DM(H)): Dermal hands appl. (DA(H)): Dermal body appl. (DA(B)): Dermal head appl. (DA(C)): Inhalation m/l (IM): Inhalation appl. (IA): High crops hand held, greenhouse 21 13.1884 82.47509 1.56194 0.02 0.10841 mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. mg/person/kg a.s. Operator exposure towards Bacillus thuringiensis ssp. aizawai strain GC-91 Without PPE Operators: External dermal exposure after application in fruit vegetables Dermal exposure during mixing/loading Hands EDEOM(H) = (DM(H) x AR x A) / BW (21 x 0.5 x 1) / 70 External dermal exposure 10.5 mg/person External dermal exposure 0.15 mg/kg bw/d Dermal exposure during application Hands EDEOA(H) = (DA(H) x AR x A) / BW (13.1884 x 0.5 x 1) / 70 External dermal exposure 6.5942 mg/person External dermal exposure 0.094203 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A) / BW (82.47509 x 0.5 x 1) / 70 External dermal exposure 41.237545 mg/person External dermal exposure 0.589108 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A) / BW (1.56194 x 0.5 x 1) / 70 External dermal exposure 0.78097 mg/person External dermal exposure 0.011157 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 59.112715 mg/person Total external dermal exposure 0.844467 mg/kg bw/d With PPE Hands EDEOM(H) = (DM(H) x AR x A x PPE 1)) / BW (21 x 0.5 x 1 x 0.01) / 70 External dermal exposure 0.105 mg/person External dermal exposure 0.0015 mg/kg bw/d Hands EDEOA(H) = (DA(H) x AR x A x PPE) / BW (13.1884 x 0.5 x 1 x 1) / 70 External dermal exposure 6.5942 mg/person External dermal exposure 0.094203 mg/kg bw/d Body EDEOA(B) = (DA(B) x AR x A x PPE) / BW (82.47509 x 0.5 x 1 x 1) / 70 External dermal exposure 41.237545 mg/person External dermal exposure 0.589108 mg/kg bw/d Head EDEOA(C) = (DA(C) x AR x A x PPE) / BW (1.56194 x 0.5 x 1 x 1) / 70 External dermal exposure 0.78097 mg/person External dermal exposure 0.011157 mg/kg bw/d Total external dermal exposure: EDEO = EDEOM(H) + EDEOA(H) + EDEOA(B) + EDEOA(C) Total external dermal exposure 48.717715 mg/person Total external dermal exposure 0.695967 mg/kg bw/d Page 20 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Operators: External inhalation exposure after application in fruit vegetables Inhalation exposure during mixing/loading EIEOM = (IM x AR x A) / BW (0.02 x 0.5 x 1) / 70 External inhalation exposure 0.01 mg/person External inhalation exposure 0.000143 mg/kg bw/d Inhalation exposure during application EIEOA = (IA x AR x A) / BW (0.10841 x 0.5 x 1) / 70 External inhalation exposure 0.054205 mg/person External inhalation exposure 0.000774 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.064205 mg/person Total external inhalation exposure 0.000917 mg/kg bw/d EIEOA = (IA x AR x A x PPE) / BW (0.10841 x 0.5 x 1 x 1) / 70 External inhalation exposure 0.054205 mg/person External inhalation exposure 0.000774 mg/kg bw/d Total external inhalation exposure: EIEO = EIEOM + EIEOA Total external inhalation exposure 0.064205 mg/person Total external inhalation exposure 0.000917 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.84538 mg/kg bw/d Total external exposure: EEO = EDEO + EIEO Total external exposure 0.69688 mg/kg bw/d 1) EIEOM = (IM x AR x A x PPE) / BW (0.02 x 0.5 x 1 x 1) / 70 External inhalation exposure External inhalation exposure reduction factor for gloves is 0.01 (professional appl.) Page 21 / 23 0.01 mg/person 0.000143 mg/kg bw/d Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Appendix 3 Detailed Evaluation of the Exposure Studies Relied upon Reference: KIIIM1 7.3.3, Measurement of operator exposure Report Mich, G.; 1996; Operator exposure in greenhouses during practical use of plant protection products. Report No. EF 94-02-03, Doc. No. M-02409601, June 6, 1996; ECON GmbH Ingelheim, conducted in Germany, Dates of work July, 1994 – June, 1996, TOX2000-2081 Guideline(s): Following the OECD guidance document for the conduct of studies of occupational exposure to pesticides during agricultural application, Series on Testing and Assessment No. 9, 1997 GLP: Yes (certified laboratory) Acceptability: The study is considered to be acceptable. Materials and methods To elucidate the potential of operator’s exposure by application of plant protection products in greenhouses an exposure study was performed. Dermal and inhalation exposure were measured using the patch technique (passive dosimetry technique), by analysis of whole body underwear, glove and hand rinsing and absorbent air filters during mixing/loading. The following plant protection products were applied on ornamentals at 2 sites in Germany: the wettable powder fungicide Euparen WP 50 (a.s. dichlofluanid), the insecticide Rody (a.s. fenpropathrin) and the fungicide Saprol Neu (a.s. triforine) (both emulsifiable concentrates). Twelve experienced operators were monitored. The products were applied with conventionally used knapsack sprayers at recommended rates. All analytical methods were validated for the various matrixes in a wide range of concentrations. Samples were extracted for analysis followed by gas chromatographic determination. The results of the measurements are reported as determined (i.e. µg active substance per sample) and as specific exposure values, i.e. as mg of exposure per kg of active substance handled. The latter facilitates the use of the data for generic purposes. Samples were analysed for each of the 3 active substances. The following scenarios were investigated: a) mixing and loading Euparen WP 50 for hydraulic knapsack sprayers, b) application using knapsack sprayers to low cultures on tables, c) application using knapsack sprayers to high cultures, d) airborne concentrations after application. The test substances Euparen WP 50, Rody and Saprol Neu were applied in 4 greenhouses in the low crop scenario. 4 trials were performed in each house. The treated plants (hibiscus, cyclamen, anturium and scutelarium) had a height of 10-25 cm (+ 1.15 m table height). In the high crop scenario the test substances Euparen WP 50, Rody and Saprol Neu were applied in 3 greenhouses. Again 4 trials were performed in each house. In this scenario roses were treated. They covered a height from 1.2-1.75 metres. Results and discussion All data were evaluated according to Lundehn et al., 1992 (TOX2003-430, German Model). For the calculation of exposure recorded values below limit of quantification were calculated as half the limit of quantification. Results of geometric mean exposure during application for the three scenarios are given below. Page 22 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 3 - Core Assessment zRMS version Table 3.5-4: Specific exposure during knapsack application in greenhouse low crops Route of exposure during application in low crops Exposure [mg/kg a.s. handled] Actual Potential 0.43926 0.43926 0.00894 0.7357 0.22265 6.31994 0.39849 0.39849 Dermal (head) Dermal (hands) Dermal (body) Inhalation Table 3.5-5: Specific exposure during knapsack application in greenhouse high crops Route of exposure during application in high crops Exposure (mg/kg a.s. handled) Actual Potential 1.56194 1.56194 0.00746 13.1884 0.22789 82.47509 0.10841 0.10841 Dermal (head) Dermal (hands) Dermal (body) Inhalation Conclusions The study provides appropriate data for hand held scenarios in greenhouses. Application data may be used for generic purposes. Mixing/loading data are available for one wettable powder preparation (WP) only. However, it should be considered that the process of mixing/loading for both indoor and outdoor applications is comparable. Therefore, generic exposure estimates for mixing/loading can be taken from other models. Page 23 / 23 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Agree 50 WG Active Substance: 500 g/kg Bacillus thuringiensis ssp. Aizawai GC-91 (3 x 1013 CFU/kg) Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Mitsui AgriScience International S.A./B.V. Date: November 2015 Page 1 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Table of Contents 4 METABOLISM AND RESIDUES DATA ......................................................................... 3 4.1 Evaluation of the active substances ..................................................................................... 3 4.1.1 Bacillus thuringiensis aizawai strain GC-91 ....................................................................... 3 4.1.1.1 Storage stability ................................................................................................................... 3 4.1.1.2 Metabolism in plants and plant residue definition(s)........................................................... 3 4.1.1.3 Metabolism in livestock and animal residue definition(s) ................................................... 3 4.1.1.4 Residues in rotational crops ................................................................................................. 4 4.1.1.5 Residues in livestock ........................................................................................................... 4 4.2 Evaluation of the intended uses ........................................................................................... 4 4.2.1 Selection of critical use and justification ............................................................................. 4 4.2.2 Fruit and vegetables as compiled in table 8.2-1 (uses 1-18) ................................................ 9 4.2.2.1 Residues in primary crops ................................................................................................... 9 4.2.2.2 Distribution of the residue in peel/pulp ............................................................................. 11 4.2.2.3 Residues in processed commodities .................................................................................. 11 4.2.2.4 Proposed pre-harvest intervals, withholding periods......................................................... 11 4.2.3 Ornamentals (uses 19-21) .................................................................................................. 11 4.2.3.1 Residues in primary crops ................................................................................................. 11 4.2.3.2 Distribution of the residue in peel/pulp ............................................................................. 11 4.2.3.3 Residues in processed commodities .................................................................................. 11 4.2.3.4 Proposed pre-harvest intervals, withholding periods......................................................... 12 4.3 Consumer intake and risk assessment................................................................................ 12 4.3.1 Bacillus thuringiensis ssp. aizawai, strain GC-91 ............................................................. 12 4.4 Proposed maximum residue levels (MRLs) ...................................................................... 12 4.5 Conclusion ......................................................................................................................... 12 Appendix 1 List of data submitted in support of the evaluation ........................................................... 13 Appendix 2 Detailed evaluation of the additional studies relied upon .................................................. 15 Appendix 3 Pesticide Residue Intake Model (PRIMo) ......................................................................... 15 Page 2 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances 4.1.1 Bacillus thuringiensis aizawai strain GC-91 Table 4.1-1: Identity of the active substance Structural formula not applicable Common Name Bacillus thuringiensis aizawai strain GC-91 CAS number not applicable 4.1.1.1 Storage stability Table 4.1-2: Stability of residues (Annex IIA, point 6.1) Stability of Bacillus thuringiensis aizawai strain GC-91 4.1.1.2 not applicable Metabolism in plants and plant residue definition(s) Metabolism studies were not considered of relevance for viable residues (DAR, IT 2007; ASB201010682). Table 4.1-3: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, 6.6.2 and 6.7.1) Plant groups covered none Rotational crops none Metabolism in rotational crops similar to metabolism not applicable in primary crops? (yes/no) Distribution of the residue in peel/ pulp not applicable Processed commodities (nature of residue) not necessary Residue pattern in raw and processed commodities similar? (yes/no) not applicable Plant residue definition for monitoring None discussed candidate for Annex IV of Reg. (EC) No 396/2005 (which is currently not supported by DE) Plant residue definition for risk assessment none Conversion factor(s) (monitoring to risk assessment) not applicable 4.1.1.3 Metabolism in livestock and animal residue definition(s) Metabolism studies in livestock animals were not considered of relevance (DAR, IT 2007; ASB201010682). Page 3 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Table 4.1-4: Metabolism in livestock (Annex IIA, point 6.2.2 to 6.2.5 and 6.7.1) Animals covered none Time needed to reach a plateau concentration in milk not applicable and eggs Animal residue definition for monitoring None discussed candidate for Annex IV of Reg. (EC) No 396/2005 (which is currently not supported by DE) Animal residue definition for risk assessment not applicable Conversion factor(s) (monitoring to risk assessment) not applicable Metabolism in rat and ruminant similar (yes/no) not applicable Fat soluble residue: (yes/no) not applicable 4.1.1.4 Residues in rotational crops No field residue studies in rotational crops were conducted, nor were they deemed necessary due to the ubiquitous occurrence of Bacillus thuringiensis aizawai strain GC-91 in agricultural environments. However, in soil the spores of Bacillus thuringiensis spp. are relatively persistent, showing half-live times above 100 days. 4.1.1.5 Residues in livestock No calculation of the dietary burden is necessary and livestock feeding studies are not required. 4.2 Evaluation of the intended uses 4.2.1 Selection of critical use and justification The critical GAPs used for consumer intake and risk assessment are presented in Table 4.2-1. Page 4 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Table 4.2-1: 1 2 Critical Use (worst case) used for consumer intake and risk assessment 3 4 5 6 7 8 9 Application Crop and/ or situation UseNo. Member state(s) (crop destination / purpose of crop) (a) F G or I 12 13 Remarks: Method / Kind (d-f) (b) 11 Application rate Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 10 (c) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) kg product / ha a) max. rate per appl. b) max. total rate per crop/season kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha PHI (days) (i) e.g. recommended or mandatory tank mixtures min / max (j) 1 grape vine (use as table and wine grape) F Grape berry moth, European grape vine moth spraying or fine spraying (low volume spraying) from BBCH 53; From emergence of first larvae after beginning of infestation or warning service appeal a) b) 3 3 a) b) 0.75 2.3 a) b) 0.38 1.1 400 / 1200 F 2 grape vine (use as table and wine grape) F Grape berry moth, European grape vine moth spraying or fine spraying (low volume spraying) from BBCH 53; From emergence of first larvae after beginning of infestation or warning service appeal a) b) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 400 / 1600 F 3 berries (except strawberry) F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 11; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 1000 F 4 berries (except strawberry) G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 11; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 1000 F 5 strawberry F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 13; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 1000 / 2000 F Page 5 / 15 e.g. safener/synergist per ha Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version 1 2 3 4 5 6 7 8 9 Application Crop and/ or situation UseNo. Member state(s) (crop destination / purpose of crop) (a) F G or I 12 13 Remarks: Method / Kind (d-f) (b) 11 Application rate Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 10 (c) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) kg product / ha a) max. rate per appl. b) max. total rate per crop/season kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha PHI (days) (i) e.g. recommended or mandatory tank mixtures min / max (j) 6 strawberry G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 13; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 1000 / 2000 F 7 fruiting vegetables G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 6 6 a) b) 1.0 6.0 a) b) 0.50 3.0 600 / 1200 F 8 Leaf, stem and bulb vegetables F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 800 F 9 Leaf, stem and bulb vegetables G Free biting caterpillars spraying or fine spraying (low volume spraying) After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 1000 F 10 Brassica vegetables F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 800 F 11 Brassica vegetables G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 1000 F Page 6 / 15 e.g. safener/synergist per ha Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version 1 2 3 4 5 6 7 8 9 Application Crop and/ or situation UseNo. Member state(s) (crop destination / purpose of crop) (a) F G or I 12 13 Remarks: Method / Kind (d-f) (b) 11 Application rate Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 10 (c) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) kg product / ha a) max. rate per appl. b) max. total rate per crop/season kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha PHI (days) (i) e.g. recommended or mandatory tank mixtures min / max (j) 12 root and tuber vegetables F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 800 F 13 root and tuber vegetables G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 1000 F 14 bulb vegetables F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 800 F 15 Fresh herbs F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 800 F 16 Fresh herbs G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 200 / 800 F 17 Legume vegetables F Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 600 / 1200 F Page 7 / 15 e.g. safener/synergist per ha Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version 1 2 3 4 5 6 7 8 9 Application Crop and/ or situation UseNo. Member state(s) (crop destination / purpose of crop) (a) F G or I 12 Method / Kind (c) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) kg product / ha a) max. rate per appl. b) max. total rate per crop/season kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha PHI (days) (i) G Free biting caterpillars spraying or fine spraying (low volume spraying) from BBCH 09; After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 600 / 1200 F 19 ornamentals F Free biting caterpillars spraying or fine spraying (low volume spraying) After beginning of infestation; from emergence of first larvae a) b) (7 days) 6 6 a) b) 1.0 6.0 a) b) 0.50 3.0 600 / 1200 N 20 ornamentals G Free biting caterpillars spraying or fine spraying (low volume spraying) After beginning of infestation; from emergence of first larvae a) b) (7 days) 6 6 a) b) 1.0 6.0 a) b) 0.50 3.0 600 / 1200 N 21 ornamentals F Free biting caterpillars spraying or fine spraying (low volume spraying) After beginning of infestation; from emergence of first larvae a) b) (7 days) 3 3 a) b) 1.0 3.0 a) b) 0.50 1.5 600 / 1200 N (b) (c) (d) (e) (f) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) Outdoor or field use (F), glasshouse application (G) or indoor application (I) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds All abbreviations used must be explained Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated Page 8 / 15 (g) (h) (i) (j) e.g. recommended or mandatory tank mixtures (j) Legume vegetables (a) e.g. safener/synergist per ha min / max 18 Remarks: 13 Remarks: (d-f) (b) 11 Application rate Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 10 Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application The minimum and maximum number of application possible under practical conditions of use must be provided PHI - minimum pre-harvest interval Remarks may include: Extent of use/economic importance/restrictions Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version 4.2.2 Fruit and vegetables as compiled in table 8.2-1 (uses 1-18) 4.2.2.1 Residues in primary crops No supervised residue trials were submitted for the assessment of Bacillus thuringiensis ssp. aizawai, strain GC-91 on any of the crops for which approval is sought. The applicant provided rationales for waiving such studies, noting particularly the ubiquitous occurrence of the strain, its very specific action against lepidoptera larvae and the insignificant amount of toxin production. However, the potential of Bacillus thuringiensis ssp. aizawai, strain GC-91 for the formation of toxins after application is unclear. Bacillus thuringiensis ssp. aizawai, strain GC-91 proved positive for the genetic sequences coding the Bacillus cereus toxins, but the rate of formation is expected to be lower. In a scientific opinion by EFSA (2005, Opinion of the Scientific Panel on Biological Hazards on Bacillus cereus and other Bacillus spp. in foodstuffs, The EFSA Journal 175, 1-48, ASB2012-9549), an amount of 105 CFU/g food was identified as a point of departure for B. cereus, which, in view of the limited information available, seems also sufficiently protective for Bacillus thuringiensis ssp. aizawai, strain GC-91. For estimating the potential amount of CFUs after application of “Agree 50 WG”, an approach was developed based on harvest yields (Statistisches Bundesamt: Wachstum und Ernte – Fachserie 3, Reihe 3.2.1 – Gemüse 2011) or empirical residues after foliar treatment as described by MacLachlan and Hamilton in 2009. The approach is as follows: − For all commodities, which are harvested once a year and where the harvested commodity represents the major part of the whole plant (e.g. brassica vegetables, leafy vegetables), maximum residues are estimated by correlating the total amount of CFUs applied per hectare to the yield of the crop per hectare. In case of crop groups, the span between the highest and lowest yield is taken into account. The degradation rate of Bacillus thuringiensis ssp. aizawai, strain GC-91 is unknown and therefore not considered. − For other plants, which contain large percentages of inedible parts (fruit trees, berry bushes etc.) or which may be harvested continuously (e.g. fruiting vegetables in glasshouse), potential residue levels can not be calculated in the same way. In these cases the empirical residue values derived by MacLachlan and Hamilton are used. These values describe typical residue concentrations directly after application of 1 kg active substance per hectare or within one hectoliter. Based on these values, the amount of active substance remaining on crops after treatment according to the intended uses can be estimated and translated into the maximum amount of CFU per g food. Amount of CFU in the active substance: 3 x 1013 CFU/kg Use No. 1: Grape vine Maximum rate per season: 1.1 kg as/ha Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 1.5 mg as/kg, P95 = 6.6 mg as/kg Calculation according to current GAP: Median residue: 0.0000015 kg as/kg food × 1.1 kg as/ha → 0.00000165 kg as/kg food = 4.95 x 104 CFU/g food (0.00000165 kg as/kg food × 3 x 1013 CFU/kg = 4.95 x 107 CFU/kg food = 4.95 x 104 CFU/g food) P95 residue: 0.0000066 kg as/kg food × 1.1 kg as/ha → 0.0000073 kg as/kg food = 2.2 x 105 CFU/g food (0.0000073 kg as/kg food × 3 x 1013 CFU/kg = 2.2 x 108 CFU/kg food = 2.2 x 105 CFU/g food) Page 9 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Use No. 2: Grape vine (calculation see use no. 1) Maximum rate per season: 1.5 kg as/ha Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 1.5 mg as/kg, P95 = 6.6 mg as/kg Calculation according to current GAP: Median residue: 6.8 x 104 CFU/g food P95 residue: 3.3 x 105 CFU/g food Uses No. 3 & 4: Berries, except strawberries (calculation see use no. 1) Maximum rate per season: 1.5 kg as/ha Median residues according to MacLachlan & Hamilton after application of 1 kg as/ha: 2.7 mg as/kg (based on currants) Calculation according to current GAP: Median residue: 1.2 x 105 CFU/g food (P95 not sufficiently reported) Uses No. 5 & 6: Strawberries (calculation see use no. 1) Maximum rate per season: 1.5 kg as/ha Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 1.5 mg as/kg, P95 = 24 mg as/kg Calculation according to current GAP: Median residue: 6.8 x 104 CFU/g food P95 residue: 1.1 x 106 CFU/g food Use No. 7: Fruiting vegetables (calculation see use no. 1) Maximum rate per season: 3 kg as/ha Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 1.3 mg as/kg, P95 = 4.3 mg as/kg (based on peppers) Calculation according to current GAP: Median residue: 1.2 x 105 CFU/g food P95 residue: 4 x 105 CFU/g food Uses No. 8, 9 & 14: Leaf, stem and bulb vegetables Maximum rate per season: 1.5 kg as/ha Minimum and maximum yield for leafy vegetables per season: 76.4 dT/ha (Lamb´s lettuce) – 277.4 dT/ha (head lettuce) Calculation based on total annual yield: Minimum residue: 1.5 kg as/ha ÷ 227400 kg yield/ha = 0.0000066 kg as/kg food = 2 x 105 CFU/g food (0.0000066 kg/kg food × 3 x 1013 CFU/kg = 2 x 108 CFU/kg food = 2 x 105 CFU/g food) Maximum residue: 1.5 kg as/ha ÷ 76400 kg yield/ha = 0.00002 kg as/kg food = 6 x 105 CFU/g food (0.00002 kg/kg food × 3 x 1013 CFU/kg = 6 x 108 CFU/kg food = 6 x 105 CFU/g food) Minimum and maximum yield for stem vegetables per season: 201.8 dT/ha (rhubarb) – 430.3 dT/ha (celery) Calculation based on total annual yield (method see use on leafy vegetables): Minimum residue: 1.1 x 105 CFU/g food Maximum residue: 2.3 x 105 CFU/g food Minimum and maximum yield for bulb vegetables per season: 388.5 dT/ha (green onions) – 535.4 dT/ha (bulb onions) Calculation based on total annual yield (method see use on leafy vegetables): Minimum residue: 8.5 x 104 CFU/g food Maximum residue: 1.2 x 105 CFU/g food Page 10 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Uses No. 10 & 11: Brassica vegetables Maximum rate per season: 1.5 kg as/ha Minimum and maximum yield for brassica vegetables per season: 122.2 dT/ha (broccoli) – 772.3 dT/ha (head cabbage) Calculation based on total annual yield (method see use on leafy vegetables): Minimum residue: 5.9 x 104 CFU/g food Maximum residue: 3.7 x 105 CFU/g food Uses No. 12 & 13: Root and tuber vegetables Maximum rate per season: 1.5 kg as/ha For root and tuber vegetables only the aerial part is sprayed. A significant contamination of roots and tubers with Bacillus thuringiensis ssp. aizawai, strain GC-91 is not expected. Uses No. 15 & 16: Fresh herbs (calculation see use no. 1) Maximum rate per season: 1.5 kg as/ha Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 19 mg as/kg, P95 = 104 mg as/kg (based on lettuce) Calculation according to current GAP: Median residue: 8.6 x 105 CFU/g food P95 residue: 4.7 x 106 CFU/g food Uses No. 15 & 16: Legume vegetables (calculation see use no. 1) Maximum rate per season: 1.5 kg as/ha Residues according to MacLachlan & Hamilton after application of 1 kg as/ha: Median = 1.8 mg as/kg, P95 = 8.5 mg as/kg (based on beans with pods) Calculation according to current GAP: Median residue: 8.1 x 104 CFU/g food P95 residue: 3.8 x 105 CFU/g food From these calculations it is obvious that based on the intended application rates an exceedance of 105 CFU/g food can not be excluded. Further information is required to confirm that the uses applied for can be considered as safe uses with respect to consumer health (data gap, see Conclusions). 4.2.2.2 Distribution of the residue in peel/pulp Not applicable. 4.2.2.3 Residues in processed commodities No data available. 4.2.2.4 Proposed pre-harvest intervals, withholding periods Currently no proposal for a withholding period is possible, because no residue studies are available. 4.2.3 Ornamentals (uses 19-21) 4.2.3.1 Residues in primary crops The intended uses are not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. 4.2.3.2 Distribution of the residue in peel/pulp Not applicable. 4.2.3.3 Residues in processed commodities Not applicable. Page 11 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version 4.2.3.4 Proposed pre-harvest intervals, withholding periods Not applicable. 4.3 Consumer intake and risk assessment 4.3.1 Bacillus thuringiensis ssp. aizawai, strain GC-91 The Bacillus thuringiensis ssp. aizawai, strain GC-91 contains the genetic information to produce B.cereus like toxins, however at a lower level. Nevertheless, since no further information is available for a quantitative risk assessment, it is proposed to apply the suggest value of 105 CFU/g food (EFSA 2005) also to Bacillus thuringiensis ssp. aizawai, strain GC-91. The data provided for the application of Bacillus thuringiensis ssp. aizawai, strain GC-91 to food crops is insufficient to estimate the amount of CFU per g food. The consumer risk assessment for the intended uses 1-11 and 14-18 can not be finalized at the moment. The uses 19-21 involve treatment of non-food crops. No dietary risk to consumers is assumed to arise from these uses. 4.4 Proposed maximum residue levels (MRLs) No MRLs for Bacillus thuringiensis ssp. aizawai, strain GC-91 are established. Inclusion into Annex IV of Reg. (EC) No 396/2005 is currently discussed. For the time being Germany is not in favour of this proposal. 4.5 Conclusion The available data are considered insufficient for an evaluation of the intended uses on food crops (apart from root and tuber vegetables, in which no residues are expected). Based on the available information and the calculations performed so far, an exceedance of 105 CFU/g food can not be excluded for uses 1-11 and 14-18 and thus the uses cannot be considered safe. For a more realistic estimation of the potential CFUs per g food after treatment with “Agree 50 WG” and in order to derive appropriate withholding periods (based on degradation rates/ spore half-lives on the plant surface), supervised residue trials are required. They should be conducted in accordance with the data requirements laid down in Reg. (EC) No 1107/2009 and consecutive regulations. The following studies should be provided to fill the data gaps: − Grapes: 8 trials on grapes are required (outdoor treatment under conditions of the critical GAP with at least 4 trials conducted as decline trials). Extrapolation to other small fruit and berries grown outdoors is considered appropriate, though this is not in full compliance with the data requirements. It is noted, that berries except strawberries are also intended to be treated in glasshouse. However, since this is not an important use in Germany and both outdoor trials on grapes and indoor trials on strawberries are required, the overall data package is considered sufficient. − Strawberries: 8 trials on strawberries are required each for the outdoor and the glasshouse situation (treatment under conditions of the critical GAP with at least 4 trials each conducted as decline trials) − Fruiting vegetables: 8 trials on tomatoes are required (indoor treatment under conditions of the critical GAP with at least 4 trials conducted as decline trials). Extrapolation to other fruiting vegetables grown indoors is considered appropriate, though this is not in full compliance with the data requirements. − Brassica, leafy, bulb and stem vegetables: 8 trials on lettuce (open headed varieties) are required each for the outdoor and the glasshouse situation (treatment under conditions of the critical GAP with at least 4 trials each conducted as decline trials). Extrapolation to brassica vegetables, other leafy Page 12 / 15 Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version vegetables (including fresh herbs), stem and bulb vegetables is considered appropriate, though this is not in full compliance with the data requirements. − Legume vegetables: 4 trials on beans with pods are required each for the outdoor and the glasshouse situation (treatment under conditions of the critical GAP with at least 2 trials each conducted as decline trials). Extrapolation to other legume vegetables is possible. The use of Bacillus thuringiensis ssp. aizawai, strain GC-91 on ornamentals is not considered relevant in terms of consumer health protection. The chronic and the short-term intake is unlikely to present a public health concern. As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended uses 12-13 and 19-21. It does not agree with the authorization of uses 1-11 and 14-18 for the reasons outlined above. Appendix 1 Annex point/ reference No KIIA 6.3 List of data submitted in support of the evaluation Author(s) Year Italy 2007 EFSA 2005 EFSA 2012 Akiba, Y. 1985 KIIA 6.3 Bae, S.; Fleet, G. H.; Heard, G. M. 2004 KIIA 6.3 Beegle, C. C.; Dulmage, H. T.; Wolfenbarger, D. A. et al. 1981 Title Report-No. Authority registration No Bacillus thuringiensis subspecies aizawai strain GC-91 (Draft Assessment Report) GLP: Open Published: Yes ASB2010-10682 Opinion of the scientific panel of biological hazards on Bacillus cereus and other Bacillus spp in foodstuffs EFSA Journal (2005) 175, 1-48 ! EFSAQ-2004-010 The EFSA Journal, 175, 1-48 GLP: No Published: Yes BVL-2294154, ASB2012-9549 Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91) EFSA Journal 2013;11(1):3063 ! EFSAQ-2009-00247 EFSA Journal (2013) 11 (1), 3063 ASB2013-1005 Microbial ecology of Bacillus thuringiensis - VI. Germination of Bacillus thuringiensis spores in the soil Jpn J Appl Entomol Zool, 21, 76-80 GLP: No Published: Yes BVL-2294216, ASB2012-9598 Occurrence and significance of Bacillus thuringiensis on wine grapes 0168-1605 ! 10.1016/j.ijfoodmicro.2004.01.013 Int J Food Microbiol, 94, 301-312 GLP: No Published: Yes BVL-2294218, ASB2012-9600 Persistence of Bacillus thuringiensis Berliner insecticidal activity on cotton foliage Environ Entomol, 10, 400-401 GLP: No Published: Yes BVL-2294224, ASB2012-9603 Page 13 / 15 Data protection claimed Open No Owner LIT How considered in dRR * Add Y Add No LIT Y No LIT Y No LIT Y Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Annex point/ reference No Author(s) Year KIIA 6.3 Benoit, T. G .; Wilson, G. R.; Bull, D. L. et al. 1990 KIIA 6.3 Damgaard, P. H.; Hansen, B. M.; Pedersen, J. C. et al. 1996 KIIA 6.3 Hendriksen, N. B.; Hansen, B. M. KIIA 6.3 Hostetter, D. L.; Ignoffo, C. 1975 M.; Kearby, W. H. KIIA 6.3 Ignoffo, C. M.; Hostetter, D. L.; Pinnell, R. E. 2002 1974 KIIA 6.3 MacLachlan D.J. and Hamilton, D. 2009 KIIA 6.3 Martin, Ph. A. W. 1994 KIIA 6.3 Pedersen, J. C.; Damgaard, P. H.; Eilenberg, J. et al. 1994 KIIA 6.3 Pinnock, D. E.; Brand, R. J.; Jackson, K. L. et al. 1973 KIIA 6.3 Pusztai, M.; Fast, P.; Gringorten, L. et al. 1991 Title Report-No. Authority registration No Plasmid-associated sensitivity of Bacillus thuringiensis to UV light 0099-2240/90/082282-05 Appl Environ Microbiol, 56 (8), 22822286 GLP: No Published: Yes BVL-2294220, RIP9300149 Natural occurrence of Bacillus thuringiensis on cabbage foliage and in insects associated with cabbage crops J Appl Microbiol, 82, 253-258 GLP: No Published: Yes BVL-2294222, ASB2012-9602 Long-term survival and germination of Bacillus thuringiensis var. kurstaki in a field trial 10.1139/W02-009 Can J Microbiol, 48, 256-261 GLP: No Published: Yes BVL-2294217, ASB2012-9599 Persistence of formulations of Bacillus thuringiensis spores and crystals on eastern red cedar foliage in Missouri J Kansas Entomol Soc, 48, 189-193 GLP: No Published: Yes BVL-2294213, ASB2012-9595 Stability of Bacillus thuringiensis and Baculovirus heliothis on soybean foliage Environ Entomol, 3 (4), 117-119 GLP: No Published: Yes BVL-2294211, ASB2012-9593 A new tool for the evaluation of crop residue trial data (day-zero-plus decline), Food Additives and Contaminants 2009, 1-18 An iconoclastic view of Bacillus thuringiensis ecology Am Entomol, Sommer 1994, 85-90 GLP: No Published: Yes BVL-2294214, ASB2012-9596 Dispersal of Bacillus thuringiensis var. kurstaki in an experimental cabbage field 07019901 Can J Microbiol, 41, 118-125 GLP: No Published: Yes BVL-2294212, ASB2012-9594 The field persistence of Bacillus thuringiensis spores on cercis occidentalis leaves J Invertebr Pathol, 23, 341-346 GLP: No Published: Yes BVL-2294210, ASB2012-9592 The mechanism of sunlight-mediated inactivation of Bacillus thuringiensis crystals Biochem J, 273, 43-47 GLP: No Published: Yes BVL-2294209, BVL-2294225, RIP9300151 Page 14 / 15 LIT How considered in dRR * Y No LIT Y No LIT Y No LIT Y No LIT Y no publ Add No LIT Y No LIT Y No LIT Y No LIT Y Data protection claimed No Owner Agree 50 WG – ZV1 007638-00/00 Part B – Section 4 - Core Assessment zRMS version Annex point/ reference No Author(s) Year KIIA 6.3 Rosenquist, H.; Smidt, L.; Andersen, S. R. et al. 2005 KIIA 6.3 Sánchez-Yánez, J. M.; Pena-Cabriales, J. J. 2000 KIIA 6.3 Smith, R. A.; Barry, J. W. 1997 KIIA 6.3 Smith, R. A.; Couche, G. A. 1990 KIIA 6.3 Statistisches Bundesamt 2011 * Y: N: Add: Title Report-No. Authority registration No Occurrence and significance of Bacillus cereus and Bacillus thuringiensis in ready-to-eat food page 129-136 ! 0378-1097 ! 10.1016/j.femsle.2005.06.054 FEMS Microbiol Lett, 250, 129-136 GLP: No Published: Yes BVL-2294223, ASB2011-60 Persistencia de esporas de Bacillus thuringiensis en hojas de maiz, de frijol y en suelo - Persistence of Bacillus thuringiensis spores on soil and maize and bean leaves (in Spanish with English abstract) LIT How considered in dRR * Y No LIT Y No LIT Y No LIT Y no publ. Add Data protection claimed No Terra, 18 (4), 325-331 GLP: No Published: Yes BVL-2294219, ASB2012-9601 Environmental persistence of Bacillus thuringiensis spores following aerial application IN974738 ! 0022-2011/98 J Invertebr Pathol, 71, 263-267 GLP: No Published: Yes BVL-2294215, ASB2012-9597 The phylloplane as a source of Bacillus thuringiensis variants 0099-2240/91/010311-05 Appl Environ Microbiol, 57 (1), 311315 GLP: No Published: Yes BVL-2294221, Z39235 Wachstum und Ernte – Fachserie 3, Reihe 3.2.1 – Gemüse 2011 Owner Yes, relied on No, not relied on Relied on, study not submitted by applicant but necessary for evaluation Appendix 2 Detailed evaluation of the additional studies relied upon Not applicable. Appendix 3 Pesticide Residue Intake Model (PRIMo) Not applicable. Page 15 / 15 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 1 of 12 REGISTRATION REPORT Part B Section 5: Fate and Behavior in the environment Detailed summary of the risk assessment Product code: Agree 50 WG Active Substance: 50% Bacillus thuringiensis ssp. aizawai GC-91 Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Mitsui AgriScience International S.A./B.V. Date: November 2015 Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 2 of 12 Table of Contents IIIM 9 Fate and behaviour in the environment for the Microbial Pest Control Product (Rationale to waive testing, based on adequacy of information provided for MPCA, to permit an assessment of the fate and behaviour of MPCP in the environment) .............................................................................. 3 General note 3 Summary on environmental behaviour of Bta GC-91 ............................................................... 4 Fate and behaviour in soil ............................................................................................................ 4 Fate and behaviour in water ........................................................................................................ 4 Fate and behaviour in air ............................................................................................................. 5 Predicted Environmental Concentration in Soil (PECS) .......................................................... 7 Predicted Environmental Concentration in Surface Water (PECSW) .................................... 7 Appendix 1: List of data submitted in support of the evaluation ........................................... 8 Appendix 2: Table of Intended Uses justification and GAP tables ........................................ 9 Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 3 of 12 IIIM 9 Fate and behaviour in the environment for the Microbial Pest Control Product (Rationale to waive testing, based on adequacy of information provided for MPCA, to permit an assessment of the fate and behaviour of MPCP in the environment) General note This document reviews data on the environmental behaviour of the microbial plant protection product Agree 50 WG containing Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91). Inclusion of Bta GC-91 into Annex I entered into force in May 2009 (Commission Directive 2008/113/EC1). Bta GC-91 was notified and defended by Mitsui AgriScience International S.A./B.V. Agree 50 WG was not the representative formulation, and has not been previously evaluated in the EU according to Uniform Principles. Nonetheless, Agree 50 WG contains the same active substance (Bta GC-91), in the same proportions, which can be found in the representative formulation Agree 50 WP. It appears therefore feasible to lean on the data of Agree 50 WP for the evaluation of Agree 50 WG. This document refers to the conclusions of the EU review of Bta GC-91. The active substance data is relied upon in the risk assessment of the formulation Agree 50 WG. Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has not previously been considered within the EU review process, as part of the Annex I inclusion decision. The review report for Bta GC-91 (SANCO/1538/08 - rev. 3 final – 06/05/2008) is considered to provide the relevant review information or a reference to where such information can be found. The data presented in the present dossier comply with the agreed end points in the Review Report. The Annex I Inclusion Directive for Bta GC-91 (Commission Directive 2008/113/EC1) provides specific provisions under Part B, which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation: - For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the active substance Bta GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Appendix 1 of this document would contain the list of references included in this document for support of the evaluation. However, no references are submitted. Appendix 2 of this document presents the uses of Agree 50 WG. Information on the detailed composition of Agree 50 WG can be found in the confidential dossier of this submission (Registration Report - Part C). Agree 50 WG is a biological insecticide formulated as water dispersible granules, containing 3 x 1013 colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product. The potency of Agree 50 WG is 25,000 IU/mg. With regard to safety issues, it is important to note that Bta and all other members of the species of Bacillus thuringiensis are naturally present in our environment. Therefore, their application in pest control means only a fluctuation of the bacterium population in the biotope of the pest insect. The experience that Bta presents no risk for the environment has been confirmed by numerous studies. The inclusion of results of other subspecies of Bacillus thuringiensis or products containing them is justifiable due to close family relationship resulting in much conformity. 1 OJ L 330, 09.12.2008, p.6 Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 4 of 12 Summary on environmental behaviour of Bta GC-91 Fate and behaviour in soil Based on available information derived from studies and published literature on Bacillus thuringiensis bacteria, the environmental fate and population dynamics of Bta upon field application of Agree 50 WG can be summarized as follows: A natural breakdown of the endospores of Bta in soil begins after application onto the fields and gradually reduces the numbers of spores remaining. Any vegetative cells or crystal proteins are likely to be far more rapidly degraded. This reduction in numbers will be greatly augmented by the photo degradation effects of sunlight. It is very unlikely that Bta endospores will germinate and grow into vegetative cells, unless encouraging conditions exist, meaning favourable soil pH, soil moisture content, sufficient nutrient availability and lack of competition / predation from other soil microorganisms. The good persistence of Bt spores in soil after the first two weeks seems to be a result of their inability to germinate in soil. Survival and viability of parasporal crystal proteins associated with the application of Agree 50 WG is expected to be short-term as effects of other soil micro-organisms and natural sunlight, in combination with the natural degradation of the proteins, occurs. The survival of Bta in the soil is a dynamic process involving sporostasis, germination and sporulation in specific habitats and will be influenced by changing conditions regarding soil type, native micro flora, nutrient availability and fertilization. Fate and behaviour in water Surface water Under natural conditions, residues of Bta in water are not considered to be able to persist for very long periods due to a combination of natural physical and chemical degradation factors such as solar radiation and predation from resident bacteriophages, protozoans and other lower animal forms. It may be stated that Bta GC-91 is inactivated under natural conditions, including water. Ground water Various experiments examining the movement of Bt in soils following spraying of commercial products containing Bt showed little or no movement. Even 1 year following an application onto a sandy clay loam soil in a cabbage field in Denmark, 77% of recovered Btk remained in the 0 to 2 cm topsoil layer (Pedersen et al., 1995, please refer to DAR, B.8.1.2, 2007). In experiments in Japan, Akiba (1991) (please refer to DAR, B.8.1.2, 2007) found that under artificially and naturally irrigated conditions, there was no translocation of sprayed Bt into the soil down to a depth of 10 cm. Artificial irrigation with 450 mm simulated rainfall in a soil column showed no movement through 6 cm of volcanic ash and only a few bacteria were detected in the flow through water from movement through a 6 cm column of alluvium sand. Under natural rainfall conditions, a reduction of Bt numbers in the top 0 to 1 cm of surface soil of 71 to 99% occurred in the first week of a 34-day post-application observation period. No dispersion of Bt was detected in the field soils below 1 cm to investigated depths of 9-10, 19-20 and 29-30 cm. It can thus be concluded that movement of Bta through the soil by leaching is unlikely to occur. Additionally, adsorption and binding of protoxins and toxins from Btk have been demonstrated to occur readily, rapidly and strongly onto the clay fraction and clay humic acid complexes of soils. Desorption occurs far less readily (Venkateswerlu & Stotzky, 1992; Tapp & Stotzky, 1995; Crecchio & Stotzky, 1998; Crecchio & Stotzky, 2001, please refer to DAR, B.8.1.2, 2007). It is thus concluded that no threat of contamination of groundwater exists following applications of Agree 50 WG according to GAP. Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 5 of 12 Fate and behaviour in air A rapid degradation of Bta in air is assumed since inactivation by solar radiation is a very important factor causing loss of activity and degradation of bacteria spores and δ-endotoxin crystals in the field environment. Furthermore, unlike chemical products, evaporation and volatility of bacteria is not expected to be a factor to consider in assessing the fate in air. Hence volatilisation from plant surfaces and from soil can be excluded. An investigation of photochemical-oxidative degradation in air is of no relevance in view of the volatility characteristics of the bacteria. Spray drift, however, can occur following an application of Bta which may lead to temporary concentrations in the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray droplets settle out. Following an aerial spray program at 4 L product/ha (2.1% Btk concentration), measurements of Btk concentrations in the air demonstrated an initial half-life (10-hour period from start of spraying) of 3.3 hours. The overall half-life determined during the nine-day monitoring period was 2.4 days, (Teschke et al., 2001, please refer to DAR, B.8.1.3, 2007). This gives an indication of the rapid disappearance of spray droplets containing Bta and parasporal crystals from air. Concentrations of Agree 50 WG in various environmental compartments are predicted following the proposed use pattern. The predicted environmental concentrations (PEC values) in soil and surface water are provided. Full details of all proposed uses pattern that will be assessed is included in Appendix 2. A summary is provided in Table 9-1. Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 6 of 12 Table 9-1 Summary of critical Good Agricultural Practice for Agree 50 WG (50% Bta GC-91), Professional use, Central Europe F, Application Application rate per treatment G, Growth stage Number Interval kg MPCA./hL water kg or (k) between (g MPCP/hL) MPCA./ha L/ha I applications (MPCP (a) kg/ha) (b) min...max (min.) (j) min...max min...max min...max Grapes F BBCH 53-89 1-3 7 days 0.025 2000 0.5 (0.05) (1.0) G BBCH 00-99 Red, black/white currant, blueberry, F BBCH 00-79 1-3 7 days 0.025 2000 0.5 goosberry, blackberry, raspberry (0.05) (1.0) G BBCH 00-99 Strawberry F BBCH 13-89 1-3 7 days 0.083 - 0.167 300 - 600 0.5 (0.167 – 0.333) (1.0) G BBCH 13-89 0.025 2000 (0.05) Tomato, pepper (sweet and chilli), G BBCH 09-89 1-6 7 days 0.025 2000 0.5 eggplant (0.05) (1.0) Cucumber, gherkin, courgette, F/ BBCH 09-89 1-6 7 days 0.025 2000 0.5 melon, patisson G (0.05) (1.0) Lettuce, endive, curled endive, F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 lamb´s lettuce, spinach (0.125 – 0.5) (1.0) G BBCH 09-99 0.05 – 0.25 200 - 1000 (0.1 – 0.5) Red cabbage, savoy cabbage, F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 pointed head cabbage, white (0.125 – 0.5) (1.0) cabbage, Brussel sprouts, kale Chinese cabbage, choi cabbage, F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 cauliflower, broccoli, Indian (0.125 – 0.5) (1.0) mustard, kohlrabi 0.05 – 0.25 200 - 1000 G BBCH 09-99 (0.1 – 0.5) Swede F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (0.125 – 0.5) (1.0) F BBCH 09-99 Beetroot, raddish, black raddish, 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 carrot, celery, celery leaves, (0.125 – 0.5) (1.0) celeriac, parsley G BBCH 09-99 0.05 – 0.25 200 - 1000 (0.1 – 0.5) Onions, shallots, pickles, garlic, leek F BBCH 07-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (0.125 – 0.5) (1.0) Witloof, Chicory F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (0.125 – 0.5) (1.0) Herbs F/ BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 G (0.125 – 0.5) (1.0) F/ BBCH 09-99 Dwarf snap and slicing bean, pole 1-3 7 days 0.025 2000 0.5 G snap and slicing bean, yard long (0.05) (1.0) bean Ornamentals and flowers F/ BBCH 09-99 1-6 7 days 0.025 2000 0.5 G (0.05) (1.0) Nursery crops and perennials F/ BBCH 09-99 1-6 7 days 0.025 2000 0.5 G (0.05) (1.0) Forestry F BBCH 09-99 1-3 7 days 0.025 2000 0.5 (0.05) (1.0) Public green F BBCH 09-99 1-3 7 days 0.025 2000 0.5 (0.05) (1.0) n.r.: not relevant Crop and/or situation Applicant Mitsui AgriScience International S.A./B.V. PHI (days) (l) n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 7 of 12 Predicted Environmental Concentration in Soil (PECS) In order to perform a risk assessment for non-target organisms, the actual concentration of Agree 50 WG upon six applications in ornamentals and flowers (sunflower as representative crop) is calculated as here the highest exposure is expected according to the intended uses. The calculation bases on a maximum application rate of 1 kg Agree 50 WG/ha, assuming as a worst case that no degradation occurs between applications. For the risk assessment the resultant load of Agree 50 WG will be related to the top 5 cm of soil to achieve the highest theoretical soil concentration. Assumptions: Accumulated dose rate, considering 6 applications in vegetables: 6 kg Agree 50 WG /ha (= 3 kg Bta/ha = 1.8 x 1014 CFU/ha) Incorporation into the top 5 cm layer (= 50 L soil/m2) Soil density of 1.5 g/ cm³ (= 75 kg soil/ m2) Plant interception was not considered for the PEC calculation, as this is the worst case and covers all uses. According to the PEC calculation the expected initial concentration is 8.0 mg Agree 50 WG/kg dry weight soil (4 mg Bta/kg dry weight soil). In terms of CFU, this is equivalent to 2.4 × 108 CFU or 200,000 IU/kg dry weight soil. Predicted Environmental Concentration in Surface Water (PECSW) Aquatic organisms may be exposed to Agree 50 WG through spray drift from the application site into adjacent water bodies. The present PEC calculation was performed on the basis of six applications in flowers and ornamentals, as here the highest exposure of aquatic non-target organisms is to be expected. Following the Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001), the maximum drift rate is 6.41% (considering six applications) of the applied amount at a distance of 3 m to surface waters. As a worst case, no degradation between the applications is assumed. Drift was considered according to Rautmann et al.2, 2001. Table 9-1 Calculation of the predicted environmental concentration of Agree 50 WG in lentic water bodies (PECsw) Applic. rate kg/ha Rate mg/m2 Distance (m) Drift (%)2) Amount of drift g/ha mg/m2 Initial PECSW (µg/L) 1m 30 cm 6.01) 600.0 3 6.41 384.6 38.46 38.46 128.073) 1) accumulated application rate of Agree 50 WG for GAP directed use in flowers (6 x 1 kg/ha) according to Rautmann et al. 2001 (flowers/ornamentals > 50 cm) 3) equivalent to 3.84 x 106 CFU/L or 3202 IU/L 2) Due to the PECSW calculation, the initial concentration of Agree 50 WG in 30 cm depth in surface waters is 128.07 µg/L (64.04 µg Bta/L) corresponding to 3.84 × 106 CFU or 3202 IU/L. 2 Rautmann et al. (2001), New basic drift values in the authorisation procedure for plant protection. In Forster, R. & Streloke, M. Workshop on Risk Assessment and Risk Mitigation Measures in the Context of the Authorisation of Plant Protection Products (WORMM). Mitt. Biol. Bundesanst. Land-Forstwirtsch. Berlin-Dahlem, Heft 381. Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 8 of 12 Appendix 1: List of data submitted in support of the evaluation No references are submitted in this section. Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 9 of 12 Appendix 2: Table of Intended Uses justification and GAP tables Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δ-endotoxins). Application rates are the same throughout the Central zone. Crop and/or Member- Product F, state or situation name G, country or I (a) (b) Pests or Groups of pests controlled (c) Formulation Type Conc. of MPCA Application rate per treatment PHI Remarks kg MPCA./hL water L/ha kg MPCA./ha (days) Interval (kg MPCP/ha) between (kg MPCP/hL) applications (l) (m) min-max min-max min-max min-max (min.) Application Method Growth stage Number (k) kind (f - h) (j) Grapes Central Europe Agree 50 WG F Tortricidae (Lobesia botrana, Eupoecilia ambiguella) WG 50% Foliar spraying BBCH 53-89 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - Red, black and white currant, blueberry, goosberry, blackberry, raspberry Strawberry Central Europe Agree 50 WG F Geometridae (Operophtera brumata) WG 50% Foliar spraying April - May BBCH 00-79 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-3 7 days 0.083 - 0.167 (0.167 – 0.333) 300 - 600 0.5 (1.0) Not relevant - 0.025 (0.05) 2000 Tomato, pepper (sweet and chilli), eggplant Cucumber, gherkin, courgette, melon, patisson (d - f) G Central Europe Agree 50 WG F Plutellidae (Plutella xylostella), WG Noctuidae (Autographa gamma, Plusia spp.) G 50% Foliar spraying Central Europe Agree 50 G Noctuidae (Chrysodeixis WG chalcites, Autographa gamma, Polia oleracea, Plusia spp.) WG 50% Foliar spraying Central Europe Agree 50 G Noctuidae (Chrysodeixis WG chalcites, Autographa gamma, Polia oleracea, Plusia spp.) WG 50% Foliar spraying Applicant Mitsui AgriScience International S.A./B.V. January – December BBCH 00-99 April – September BBCH 13-89 January – December BBCH 13-89 January December BBCH 09-89 January – December BBCH 09-89 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 10 of 12 Crop and/or Member- Product F, state or situation name G, or country I (b) (a) Pests or Groups of pests controlled (c) Formulation Type Conc. of MPCA (d - f) Application rate per treatment PHI Remarks Interval kg MPCA./hL water L/ha kg MPCA./ha (days) between (kg MPCP/hL) (kg MPCP/ha) applications (l) (m) min-max min-max min-max min-max (min.) Application Method Growth stage Number kind (k) (f - h) (j) High volume spraying April – September BBCH 09-99 F Plutellidae (Plutella xylostella), WG Pieridae (Pieris spp.), Noctuidae (Polia oleracea, Autographa gamma, Plusia spp.) G 50% Agree 50 WG F Plutellidae (Plutella xylostella), Crambidae (Evergestis forficalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) WG 50% Foliar spraying Agree 50 WG F Plutellidae (Plutella xylostella), Crambidae (Evergestis forficalis), Pieridae (Pieris spp.), Noctuidae (Autographa G gamma, Mamestra brassicae, Plusia spp.) WG 50% Foliar spraying F Plutellidae (Plutella xylostella), Crambidae (Evergestis forvicalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) F Plutellidae (Plutella xylostella) WG 50% Foliar spraying AprilSeptember BBCH 09-99 1-3 WG 50% Foliar spraying April – September BBCH 09-99 January – December BBCH 09-99 1-3 Lettuce, endive, curled endive, lamb´s lettuce, spinach Central Europe Red cabbage, savoy cabbage, pointed head cabbage, white cabbage, Brussel sprouts, kale Chinese cabbage, choi cabbage, cauliflower, broccoli, Indian mustard, kohlrabi Swede Central Europe Central Europe Central Europe Agree 50 WG Beetroot, raddish, black raddish, carrot, celery, celery leaves, celeriac, parsley Central Europe Agree 50 WG Agree 50 WG G Applicant Mitsui AgriScience International S.A./B.V. January – December BBCH 09-99 April – September BBCH 09-99 April – September BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 0.5 (1.0) Not relevant 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 January – December BBCH 09-99 Evaluator: Germany Date: November 2015 - - Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 11 of 12 Crop and/or Member- Product F, state or situation name G, or country I (b) (a) Pests or Groups of pests controlled (c) Formulation Type Conc. of MPCA Application rate per treatment PHI Remarks Interval kg MPCA./hL water L/ha kg MPCA./ha (days) between (kg MPCP/hL) (kg MPCP/ha) applications (l) (m) min-max min-max min-max min-max (min.) Application Method Growth stage Number kind (k) (f - h) (j) Onions, shallots, pickles, garlic, leek Witloof, Chicory Central Europe Agree 50 WG F Plutellidae (Acrolepiopsis assectella) WG 50% Foliar spraying April – September BBCH 07-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - Central Europe Agree 50 WG F Noctuidae (Autographa gamma, WG Plusia spp.) 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - Herbs Central Europe Agree 50 WG F Plutellidae (Plutella xylostella) WG 50% Foliar spraying April – September BBCH 09-99 January – December BBCH 09-99 April – September BBCH 09-99 January – December BBCH 09-99 April – September BBCH 09-99 January – December BBCH 09-99 April – September BBCH 09-99 January – December BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - (d - f) G Dwarf snap and slicing bean, pole snap and slicing bean, yard long bean Ornamentals and flowers Central Europe Agree 50 WG F Noctuidae (Polia oleracea, Autographa gamma, Plusia spp.) G WG 50% Foliar spraying Central Europe Agree 50 WG F Pieridae (Pieris spp.), Noctuidae WG (Plusia spp., Mamestra spp.) 50% Foliar spraying 50% Foliar spraying G Nursery crops and perennials Central Europe Agree 50 WG F Pieridae (Pieris spp.), Noctuidae WG (Plusia spp., Mamestra spp.), Lymantriidae (Euproctis G chrysorrhoea, Leucoma salicis, Lymantria dispar), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 Core Assessment Agree 50 WG Registration Report – Central Zone Page 12 of 12 Crop and/or Member- Product F, state or situation name G, or country I (b) (a) Forestry Central Europe Agree 50 WG Public green Central Europe Agree 50 WG Pests or Groups of pests controlled (c) F Pieridae (Pieris spp.), Geometridae (Operopthera brumata), Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) F Pieridae (Pieris spp.), Geometridae (Operophtera brumata), Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) Formulation Type Conc. of MPCA (f - h) (j) WG 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) not relevant (yes) WG 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) not relevant - (d - f) Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (latin names pests) (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Applicant Mitsui AgriScience International S.A./B.V. Application rate per treatment PHI Remarks Interval kg MPCA./hL water L/ha kg MPCA./ha (days) between (kg MPCP/hL) (kg MPCP/ha) applications (l) (m) min-max min-max min-max min-max (min.) Application Method Growth stage Number kind (k) (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used must be indicated (i) g/kg or g/l (or potency, or % Cry-toxins) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (k) Indicate the minimum and maximum number of application possible under practical conditions of use (l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions (relative importance crop and pest) Evaluator: Germany Date: November 2015 Part B – Section 5 National addendum - Germany Registration Report – Central Zone Agree 50 WG Page 1 of 11 REGISTRATION REPORT Part B Section 5: Fate and Behavior in the environment Detailed summary and risk assessment Product code: Agree 50 WG Active Substance: 50% Bacillus thuringiensis ssp. aizawai GC-91 Central Zone Zonal Rapporteur Member State: Germany National addendum for Germany Applicant: Mitsui AgriScience International S.A./B.V. Date: November 2015 Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 2 of 11 Table of Contents IIIM 9 Fate and behaviour in the environment for the Microbial Pest Control Product (Rationale to waive testing, based on adequacy of information provided for MPCA, to permit an assessment of the fate and behaviour of MPCP in the environment) .............................................................................. 3 Appendix 1: List of data submitted in support of the evaluation ........................................... 4 Appendix 2: Table of Intended Uses justification and GAP tables ........................................ 5 Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 3 of 11 IIIM 9 Fate and behaviour in the environment for the Microbial Pest Control Product (Rationale to waive testing, based on adequacy of information provided for MPCA, to permit an assessment of the fate and behaviour of MPCP in the environment) This document usually describes only those chapters where national exposure assessment approaches differ from those given in the core assessment due to specific national assessment requirements. In the present case, no specific national assessment requirements are identified and accordingly, additional calculations are not necessary for the exposure assessment (reference should be made to the core assessment for more information). Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 4 of 11 Appendix 1: List of data submitted in support of the evaluation No references are submitted in this section. Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 5 of 11 Appendix 2: Table of Intended Uses justification and GAP tables Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δ-endotoxins) in Germany. Date: PPP (product name/code) active substance Applicant: Zone(s): Verified by MS: 1 UseNo. 2 Member state(s) 2012-06-12 Agree 50 WG Bacillus thuringiensis subsecies aizawai strain GC- 91 Mitsui AgriSciences International S.A./B.V. central EU yes 3 Crop and/ or situation (crop destination / purpose of crop) 4 F G or I 5 Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 6 7 Formulation type: Conc. of as : professional use: non professional use: 8 Application Method / Kind Timing / Growth stage of crop & season DE grape vine (VITVI) F 002 DE grape vine (VITVI) (use as table and wine grape) grape berry moth 1.generation (L1-L2) (use as table and wine grape) F grape berry moth 2. and 3. generation (L1L2) Applicant: Mitsui AgriScience International S.A./B.V. spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) from emergence of first larvae after beginning of infestation or warning service appeal / from BBCH 53 from emergence of first larvae after beginning of infestation or warning service 11 12 Application rate Max. number (min. interval between applications) a) per use b) per crop/ season 001 10 WG 500 g/kg x 3 (at least 7 days apart) 3 (at least 7 days apart) kg, product / ha g, kg as/ha a) max. rate per appl. a) max. rate b) max. total rate per appl. per crop/season b) max. total rate per crop/season a) – base dose: a) 0,125 -0,375 0,25 kg/ha b) 1,125 Water L/ha min / max – base dose: - BBCH 61: 400 l/ha 0,5 kg/ha - BBCH 61: - BBCH 71: 800 l/ha 0,75 kg/ha - BBCH 71: b) 2,25 1200 l/ha a) – base dose: a) 0,125 – 0,5 – base dose: 0,25 kg/ha b) 1,5 400 l/ha - BBCH 61: - BBCH 61: 0,5 kg/ha 800 l/ha - BBCH 71: - BBCH 71: Evaluator: Germany Date: November 2015 13 14 Remarks: PHI (days) e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 6 of 11 appeal / from BBCH53 0,75 kg/ha 1200 l/ha -BBCH 75: - BBCH 75: 1 kg/ha 1600 l/ha b) 2,25 003 DE berries (NNNOB) F free biting caterpillars except for strawberry 004 DE berries (NNNOB) G free biting caterpillars except for strawberry 005 006 DE DE strawberry (FRAAN) strawberry (FRAAN) F G free biting caterpillars free biting caterpillars Applicant: Mitsui AgriScience International S.A./B.V. spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 max. 1000 from BBCH 11 max. 1000 from BBCH 11 1000 - 2000 from BBCH 13 from BBCH 13 Evaluator: Germany Date: November 2015 1000 - 2000 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 7 of 11 007 008 DE DE fruit vegetables (NNNVF) G leafy and stem vegetables (NNNVL) F free biting caterpillars free biting caterpillars except for vegetable cabbage 009 DE leafy and stem vegetables (NNNVL) G free biting caterpillars except for vegetable cabbage 010 011 012 013 DE DE DE DE vegetable cabbage (BRSOX) vegetable cabbage (BRSOX) root and tuber vegetables (NNNVW) root and tuber vegetables (NNNVW) F G F G free biting caterpillars free biting caterpillars free biting caterpillars free biting caterpillars Applicant: Mitsui AgriScience International S.A./B.V. spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 6 (at least 7 days apart) from BBCH 09 spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine after beginning of infestation; from a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 3 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 6 b) 6 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 200 - 800 from BBCH 09 200 - 1000 from BBCH 09 200 - 800 from BBCH 09 200 - 1000 from BBCH 09 200 - 800 from BBCH 09 Evaluator: Germany Date: November 2015 200 - 1000 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 8 of 11 spraying (low volume spraying) 014 015 016 017 DE DE DE DE bulb crops (NNNSZ) herbs (NNNKR) herbs (NNNKR) pulse crops (NNNLG) F F G F free biting caterpillars free biting caterpillars free biting caterpillars free biting caterpillars emergence of first larvae / after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 < 50 cm: 0,5 kg/ha b) 1,5 min 600 l/ha from BBCH 09 spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) b) 3 from BBCH 09 200 - 800 from BBCH 09 after beginning of infestation; from emergence of first larvae / 200 - 800 from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 3 Applicant: Mitsui AgriScience International S.A./B.V. 200 - 800 Evaluator: Germany Date: November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 9 of 11 018 DE pulse crops (NNNLG) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 3 (at least 7 days apart) from BBCH 09 a) < 50 cm: a) 0,25 – 0,5 < 50 cm: 0,5 kg/ha b) 1,5 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 3 019 DE ornamentals (NNNZZ) F free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 3 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 6 020 DE ornamentals (NNNZZ) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 3 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 6 Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Registration Report – Central Zone Page 10 of 11 021 DE woody ornamentals (NNNZG) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 3 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 1,5 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 3 Applicant: Mitsui AgriScience International S.A./B.V. Evaluator: Germany Date: November 2015 Part B – Section 5 National addendum - Germany Agree 50 WG Applicant: Mitsui AgriScience International S.A./B.V. Germany Evaluator: Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 1 of 37 REGISTRATION REPORT Part B Section 6 Impact on Non-Target Organisms Detailed summary and risk assessment Product code: Agree 50 WG Active Substance: 50% Bacillus thuringiensis ssp. aizawai GC-91 Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Mitsui AgriScience International S.A./B.V. Date: Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß November 2015 Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 2 of 37 Table of Contents IIIM 10 Rationale to waive additional testing, based on adequacy of information provided for MPCA, to permit an assessment of the impact of the MPCP on non-target organisms. ....................................................... 3 IIIM 10.1 Effects on Birds........................................................................................................... 6 IIIM 10.2 Effects on Aquatic Organisms ................................................................................. 10 IIIM 10.3 Effects on Bees .......................................................................................................... 17 IIIM 10.4 Effects on Arthropods Other Than Bees ................................................................ 19 IIIM 10.5 Effects on Earthworms ............................................................................................ 24 IIIM 10.6 Effects on Soil Micro-organisms ............................................................................. 25 IIIM 10.7 Additional Studies .................................................................................................... 27 IIIM 11 Summary and evaluation of environmental impact .............................................. 27 IIIM 11.1 Distribution and fate of the MPCA ........................................................................ 27 IIIM 11.2 Identification of non-target species at risk and extent of their exposure..................................................................................................................... 28 IIIM 11.3 Precautions necessary to minimise environmental contamination and to protect non-target species.................................................................................... 29 Appendix 1a: List of data submitted in support of the evaluation .............................................. 30 Appendix 1b: References cited but not included ........................................................................... 31 Appendix 2: Table of Intended Uses justification and GAP tables ........................................... 34 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment IIIM 10 Agree 50 WG Registration Report – Central Zone Page 3 of 37 Rationale to waive additional testing, based on adequacy of information provided for MPCA, to permit an assessment of the impact of the MPCP on non-target organisms. General note This document reviews data of ecotoxicological studies for the microbial plant protection product Agree 50 WG containing Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91). Inclusion of Bta GC-91 into Annex I entered into force in May 2009 (Commission Directive 2008/113/EC1). Bta GC-91 was notified and defended by Mitsui AgriScience International S.A./B.V. Agree 50 WG was not the representative formulation, and has not been previously evaluated in the EU according to Uniform Principles. Nonetheless, Agree 50 WG contains the same active substance (Bta GC-91), in the same proportions, which can be found in the representative formulation Agree 50 WP. It appears therefore feasible to lean on the data of Agree 50 WP for the evaluation of Agree 50 WG. This document refers to the conclusions of the EU review of Bta GC-91. The active substance data is relied upon in the risk assessment of the formulation Agree 50 WG. Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has not previously been considered within the EU review process, as part of the Annex I inclusion decision. The review report for Bta GC-91 (SANCO/1538/08 - rev. 3 final – 06/05/2008) is considered to provide the relevant review information or a reference to where such information can be found. The data presented in this dRR dossier comply with the agreed end points in the Review Report. The Annex I Inclusion Directive for Bta GC-91 (Commission Directive 2008/113/EC1) provides specific provisions under Part B, which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation: - For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the active substance Bta GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Appendix 2 of this document presents the uses of Agree 50 WG. Information on the detailed composition of Agree 50 WG can be found in the confidential dossier of this submission (Registration Report - Part C). Agree 50 WG is a biological insecticide formulated as water dispersible granules, containing 3 x 1013 colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product. The potency of Agree 50 WG is 25,000 IU/mg. 1 OJ L 330, 09.12.2008, p.6 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 4 of 37 With regard to safety issues, it is important to note that Bta and all other members of the species of Bacillus thuringiensis are naturally present in our environment. Therefore, their application in pest control means only a fluctuation of the bacterium population in the biotope of the pest insect. The experience that Bta presents no risk for the environment has been confirmed by numerous studies. The inclusion of results of other subspecies of Bacillus thuringiensis or products containing them is justifiable due to close family relationship resulting in much conformity. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 5 of 37 Introduction This section of the submission summarises the ecotoxicological effects of the formulation Agree 50 WG and evaluates the potential risk to various representatives of terrestrial, aquatic and soil organisms. Full details or the proposed use pattern that will be assessed are shown in Appendix 2. A summary is presented in Table 10-1. Table 10-1: Proposed use pattern of Agree 50 WG in Central Europe (professional use) F, Application Application rate per treatment G, Growth stage Number Interval kg MPCA./hL water kg or (k) L/ha between (g MPCP/hL) MPCA./ha I applications (MPCP (a) kg/ha) (b) min...max (j) min...max min...max min...max (min.) Grapes F BBCH 53-89 1-3 7 days 0.025 2000 0.5 (0.05) (1.0) G BBCH 00-99 Red, black/white currant, blueberry, F BBCH 00-79 1-3 7 days 0.025 2000 0.5 goosberry, blackberry, raspberry (0.05) (1.0) G BBCH 00-99 Strawberry F BBCH 13-89 1-3 7 days 0.083 - 0.167 300 - 600 0.5 (0.167 – 0.333) (1.0) G BBCH 13-89 0.025 2000 (0.05) Tomato, pepper (sweet and chilli), G BBCH 09-89 1-6 7 days 0.025 2000 0.5 eggplant (0.05) (1.0) Cucumber, gherkin, courgette, F/ BBCH 09-89 1-6 7 days 0.025 2000 0.5 melon, patisson G (0.05) (1.0) Lettuce, endive, curled endive, F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 lamb´s lettuce, spinach (1.0) (0.125 – 0.5) G BBCH 09-99 0.05 – 0.25 200 - 1000 (0.1 – 0.5) F BBCH 09-99 Red cabbage, savoy cabbage, 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 pointed head cabbage, white (1.0) (0.125 – 0.5) cabbage, Brussel sprouts, kale F BBCH 09-99 Chinese cabbage, choi cabbage, 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 cauliflower, broccoli, Indian (1.0) (0.125 – 0.5) mustard, kohlrabi G BBCH 09-99 0.05 – 0.25 200 - 1000 (0.1 – 0.5) Swede F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (1.0) (0.125 – 0.5) F BBCH 09-99 Beetroot, raddish, black raddish, 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (0.125 – 0.5) carrot, celery, celery leaves, (1.0) celeriac, parsley G BBCH 09-99 0.05 – 0.25 200 - 1000 (0.1 – 0.5) Onions, shallots, pickles, garlic, leek F BBCH 07-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (0.125 – 0.5) (1.0) Witloof, Chicory F BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 (1.0) (0.125 – 0.5) Herbs F/ BBCH 09-99 1-3 7 days 0.0625 – 0.25 200 - 800 0.5 G (1.0) (0.125 – 0.5) Dwarf snap and slicing bean, pole F/ BBCH 09-99 1-3 7 days 0.025 2000 0.5 snap and slicing bean, yard long G (0.05) (1.0) bean Ornamentals and flowers F/ BBCH 09-99 1-6 7 days 0.025 2000 0.5 G (0.05) (1.0) Nursery crops and perennials F/ BBCH 09-99 1-6 7 days 0.025 2000 0.5 G (0.05) (1.0) Forestry F BBCH 09-99 1-3 7 days 0.025 2000 0.5 (0.05) (1.0) Public green F BBCH 09-99 1-3 7 days 0.025 2000 0.5 (0.05) (1.0) n.r.: not relevant Crop and/or situation Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß PHI (days) Evaluator: Germany Date: November 2015 (l) n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. n.r. Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 6 of 37 Please note: As worst case, the maximum number of applications were considered for the risk assessment within the frame of the risk envelope approach. IIIM 10.1 Effects on Birds In this section, no new studies are submitted assessing the effect of Agree 50 WG. Instead data from the assessment with the active ingredient Bta GC-91 are presented. Overview and summary Table 10.1-1 Study Short-term dietary toxicity EU Endpoints: Toxicity of Bta GC-91 to birds EU agreed endpoints Test substance Test species Bta GC-91 Colinus virginianus / Anas platyrhynchos (SANCO/1538/08 - rev. 3 final – 06/05/2008) LD50 > 3333 mg/kg b.w. Endpoints used in risk assessment LD50 > 3333 mg/kg b.w. Effects on birds for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on the toxicity to birds are used and the ingredients in the formulation Agree 50 WG are not expected to pose a risk to birds. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Risk Assessment Toxicity The short-term toxicity of Bta GC-91 to Colinus virginianus and Anas platyrhynchos was evaluated (refer to Annex IIM, Section 6, Point IIM 8.1/01 and 02). The test substance was administered at a daily dose of 3333 mg/kg b.w./day for five days in both studies. No treatment related mortalities or effects of Bta occurred in both test organisms. The acute LD50 can be determined to lie above the tested concentration of 3333 mg/kg b.w./day. Table 10.1-2 Summary of avian toxicity endpoint for Bta GC-91 Study type Short-term dietary toxicity Test substance Bta GC-91 Species Colinus virginianus (Northern bobwhite) Anas platyrhynchos (mallard) Endpoint Reference XXXXX, 1990a LD50 > 3333 mg/kg b.w. XXXXX, 1990b Exposure Birds are typically exposed to dry residues on their food items following the dilution and spraying of the formulated product. During these processes, much of the formulation constituents are likely to be lost by volatilisation. Therefore, where oral exposure is the main route of exposure, toxicity data for the active substance are used in preference to data from tests with the formulated material. Exposure to Agree 50 WG via dermal and Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 7 of 37 inhalation routes is considered unlikely, since at the time of application and for a short period thereafter, most wild mammals will leave the immediate vicinity of spray operations in response to the human disturbance. The potential exposure of birds to Agree 50 WG was estimated following GAP directed applications of the product in the different uses at maximum application rates. The risk assessment for effects on birds is carried out according to the latest draft of the ‘European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals’ (EFSA Journal 2009)2. Toxicity exposure ratios Acute toxicity exposure ratio (TERA) Birds may be exposed to Agree 50 WG as a result of feeding on contaminated vegetation, seeds or insects. Standard exposure scenarios for the intended uses are described in the EFSA Journal2 (please refer to Table 10.1-3 for details). The risk for indicator species of each scenario was assessed in a screening assessment. Data on short-term toxicity are used as they cover acute toxicity to birds. According to the EFSA Journal (2009)2 the daily dietary dose (DDD) was calculated for the active substance with the following formulae: DDD (multiple) = application rate (kg/ha) × shortcut value × MAF With: Shortcut value = default parameter combining food intake rate, body weight, concentration of the substance in the diet (based on the 90th percentile residues) and the fraction of diet obtained in the treated area for the bird indicator species/crop combination in question. In case of multiple applications a corresponding MAF (multiple application factor) is considered. The TER value was calculated by dividing the acute endpoint by the daily dietary dose (DDD) for each application rate. The screening assessment was performed for the uses with the maximum number of applications (6) which are vegetables, flowers and ornamentals and nursery crops and perennials. As here the highest exposure is expected all other uses should be covered by the assessment. The screening assessment is shown in Table 10.1-3. Table 10.1-3 Screening assessment for birds following GAP directed application of Agree 50 WG. Indicator species Crop Small omnivorous bird Vegetables Small insectivorous birds Orchards and ornamentals/ nursery Test item Bta GC-91 Toxicity Application Short cut MAF2) value3) rate1) LD50 > 3333 mg/kg b.w. DDD TER (10) 0.5 kg/ha 1.9 158.8 150.86 > 22.1 0.5 kg/ha 1.9 46.8 44.46 > 75.0 1) Refers to Bta GC-91 (corresponding to 1 kg Agree 50 WG/ha) MAF according to 6 successive applications at intervals of 7 days provided in EFSA Guidance document 20092 3) Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092 2) The TERA value exceeds the Annex VI trigger value of 10, indicating that Agree 50 WG poses no risk to birds following application according to the proposed use patterns. 2 European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009; 7(12): 1438. [139 pp.]. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 8 of 37 Risk mitigation No risk mitigation measures are required. Review Comments: IIIM 10.1 Birds None Agreed endpoints: IIIM 10.1. Birds LD50 > 3333 mg MPCA/kg bw (Colinus virginianus / Anas platyrhynchos) Short-term and long-term toxicity exposure ratio (TERST/LT) As the acute TER value indicates no risk to birds and no adverse effects were observed in short-term toxicity studies, no long-term effects are to be expected upon field application of Agree 50 WG according to GAP. Effects on Terrestrial Vertebrates Other Than Birds In this section, no new studies are submitted assessing the effect of Agree 50 WG. Instead data from the assessment with the active ingredient Bta GC-91 are presented. Table 10.1-4 a) Ecotoxicological endpoints of Bta GC-91 for mammals Test substance Test species EU agreed endpoints (SANCO/1538/08 - rev. 3 final – 06/05/2008) Endpoints used in risk assessment CGA-237218 technical material a) Rat LD50 > 5050 mg/kg b.w. LD50 > 5050 mg/kg b.w. Synonym for Bta GC-91 technical material contained in Agree 50 WG Effects on mammals for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to mammals. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Toxicity An acute oral toxicity study has been conducted with CGA-237218 technical on rats (refer to Annex IIM, Sec. 3, P. IIM 5.3.2/01). No test substance related signs of infectivity were observed in the study, so that the acute oral LD50 was estimated to be > 5050 mg/kg b.w. Table 10.1-5: Acute oral toxicity to mammals Substance Species Endpoint CGA-237218 technical material Rat LD50 Value (mg/kg bodyweight) > 5050 mg/kg b.w. a) b) Report XXXXX, 1991 (please refer to Point IIIM 7.1.1) Synonym for Bta GC-91 technical material contained in Agree 50 WG Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 9 of 37 Exposure Mammals are typically exposed to dry residues on their food items following the dilution and spraying of the formulated product. During these processes, much of the formulation constituents are likely to be lost by volatilisation. Therefore, where oral exposure is the main route of exposure, toxicity data for the active substance are used in preference to data from tests with the formulated material. Exposure to Agree 50 WG via dermal and inhalation routes is considered unlikely, since at the time of application and for a short period thereafter, most wild mammals will leave the immediate vicinity of spray operations in response to the human disturbance. The potential exposure of mammals to Agree 50 WG was estimated following GAP directed applications of the product in the different uses at maximum application rates. The risk assessment for effects on mammals is carried out according to the latest draft of the ‘European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals’ (EFSA Journal 2009)2. Toxicity exposure ratios Acute toxicity exposure ratio (TERA) Mammals may be exposed to Agree 50 WG as a result of feeding on contaminated vegetation, seeds or insects. Standard exposure scenarios for the intended uses are described in the EFSA Journal2 (please refer to Table 10.1-3 for details). The risk for indicator species of each scenario was assessed in a screening assessment. According to the (EFSA Journal 2009)2 the daily dietary dose (DDD) was calculated for the active substance with the following formulae: DDD (multiple) = application rate (kg/ha) × shortcut value × MAF With: Shortcut value = default parameter combining food intake rate, body weight, concentration of the substance in the diet (based on the 90th percentile residues) and the fraction of diet obtained in the treated area for the mammal indicator species/crop combination in question. In case of multiple applications a corresponding MAF (multiple application factor) is considered. The TER value was calculated by dividing the acute endpoint by the daily dietary dose (DDD) for each application rate. The screening assessment was performed for use in vegetables, ornamentals and flowers and nursery crops/ and perennials. As here the highest exposure is expected due to the highest number of successive treatments all other uses are covered by the presented risk assessment. Details are shown in Table 10.1-6. Table 10.1-6 Screening assessment for mammals following application of Agree 50 WG. Indicator species Crop Test item Toxicity LD50 Application rate1) MAF2) Short cut value3) DDD TER (10) Small herbivorous mammals Vegetables/ ornamentals and nursery CGA237218 technical > 5050 mg/kg b.w. 0.5 kg/ha 1.9 136.4 129.58 > 39.0 1) Refers to Bta GC-91 (corresponding to 1 kg Agree 50 WG/ha) MAF according to 6 successive applications provided in EFSA Guidance document 20092 3) Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092 2) 2 European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009; 7(12): 1438. [139 pp.]. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 10 of 37 The TERA values exceed the Annex VI trigger of 10, indicating that Agree 50 WG poses no acute risk to mammals following application according to the proposed use patterns. Risk mitigation No risk mitigation measures are required. Review Comments: IIIM 10.3 None Agreed endpoints: IIIM 10.3 LD50 >5050 mg CGA-237218 (GC-91)/kg bw (rat) Short-term and long-term toxicity exposure ratio (TERST/LT) No data on the short- or long-term toxicity of Bta GC-91 or Agree 50 WG are presented here. Due to the absence of toxicity in the acute study and the highly specific mode of action of Bta GC-91, no adverse effects in mammals are to be expected upon prolonged exposure to Agree 50 WG. IIIM 10.2 Effects on Aquatic Organisms In this section, one new study is submitted assessing the effect of Agree 50 WG on the aquatic invertebrate Daphnia magna. For all other aquatic non-target species assessment data the active ingredient Bta GC-91 or products containing it are presented. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Table 10.2-1 Test item Agree 50 WG Page 11 of 37 Ecotoxicological endpoints for aquatic organisms Test species Fish CGAOncorhynchus 237218a) mykiss CGACyprinodon 237218a) variegatus Aquatic invertebrates CGA237218a) Daphnia magna CGA237218a) Daphnia magna CGA237218a) Palaemonetes vulgaris Agree 50 WG Registration Report – Central Zone Daphnia magna Single cell algae Desmodesmus CGAsubspicatus 237218a) (=Scenedesmus subspicatus) EU agreed endpoints (SANCO/1538/08 - rev. 3 final – 06/05/2008) Endpoints used in risk assessment 32-day (static renewal) LC50 > 2.0 × 1010 CFU/L 30-day (static renewal) LC50 > 2.1 × 109 CFU/L LC50 > 2.0 × 1010 CFU/L 21-day (static renewal) EC50 > 3.24 × 108 CFU/L NOEC = 1.57 × 108 CFU/L 21-day (static renewal) EC50 > 6.2 × 108 CFU/L NOEC ≥ 6.2 × 108 CFU/L 30-day (static renewal) EC50 > 1.9 × 109 CFU/g food Reference XXXXX, 1991a XXXXX, 1991b Christensen, 1991c Long term toxicity: NOEC = 1.57 × 108 CFU/L Collins, 1993 Christensen, 1991d (study was not submitted in the EU dossier) Acute toxicity: EC50 (48 hours) > 100 mg Agree 50 WG/L (nominal)c) > 25 mgb) Agree 50 WG/L (actual) Dengler, 2010 (please refer to point IIIM 10.2 Acute toxicity of the formulation) 72-hour EbC50 > 56.5 mg/L corresponding to 3.6 × 109 CFU/L EbC50 > 3.6 × 109 CFU/L Grade, 1993 a) Synonym for Bta GC-91 technical material contained in Agree 50 WG b) Actual content based on CFU counts c) A new study on the formulated product Agree 50 WG has been performed and as a result there are new end-points which are used in the risk assessment. Effects on aquatic non-target organisms for Agree 50 WG were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to aquatic species. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Toxicity Fish Static renewal tests on rainbow trout and sheephead minnow were conducted with the technical material CGA237218 over a period of 32 days and 30 days, respectively (XXXXX, 1991a and b). Exposure through aqueous and dietary routes caused no adverse effects to both fish species based on parameters of survival, infectivity and/or pathogenicity. The LC50 value was estimated to be > 2.0 x 1010 CFU/L as worst-case scenario. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 12 of 37 Daphnia Three studies on the effect of the technical material CGA-237218 on aquatic invertebrates were conducted (refer to Table 10.2-2). As a conclusion, a CGA-237218 content of 6.2 x 108 CFU/L was regarded as threshold value for toxicity of Bta GC-91 to daphnids (Daphnia magna). The lowest no-observed-effect-concentration (NOEC) was determined to be 1.57 x 108 CFU/L (Christensen, 1991c). In addition, an aquatic invertebrate toxicity study performed on Agree 50 WG is provided in support of the assessment (please refer to Point “Toxicity of the preparation” below) Algae An acute toxicity study on Scenedesmus subspicatus was conducted with the technical material CGA-237218 (refer to Annex IIM, Sec. 6, P. IIM 8.4/01). No significant effects were detected at any concentration. Therefore, the EbC50 was estimated to be > 56.5 mg CGA 237218 technical/L (equivalent to 3.6 x 109 CFU/L). Exposure Aquatic organisms may be exposed to Agree 50 WG and Bta GC-91 through spray drift. Exposure of aquatic organisms from this route was estimated by calculating Predicted Environmental Concentration in surface water (PECSW) (see Part B, Section 5). For 6 applications in flowers and vegetables (drift value of 6.41% for plant heights > 50 cm) assuming worst case conditions of no degradation of Bta GC-91 between the spraying resulting in an accumulated application rate of 6 kg Agree 50 WG/ha, the initial concentration of Agree 50 WG and Bta GC-91 in 30 cm depth in surface waters is as follows: Table 10.2-2 PECSW values for Agree 50 WG Test substance PECSW Agree 50 WG 128.07 µg/L Bta GC-91 64.04 µg/L or 3.84 x 106 CFU/L Toxicity exposure ratios The initial risk assessments were carried out by comparing the PECSW values with the acute and long-term toxicity endpoints. Acute toxicity exposure ratios (TERA) were calculated using the following equations: TER = LC50 or EC50 [CFU/L] PECSW [CFU/L] TERA for fish The highest short-term toxicity endpoint for rainbow trout was used as it covers the acute risk assessment. The resulting acute TER value for Bta GC-91, based on the maximum PECSW value following six applications in flowers and vegetables x 3 m from the application site is shown below. Table 10.2-3 Test organism Fish acute TER value for Agree 50 WG (Bta GC-91) Test substance Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß 32-day LC50 (static renewal) PECSW TERA Trigger value Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 13 of 37 CGA-237218a) Oncorhynchus mykiss > 2.0 CFU/L × 1010 3.84 x 106 CFU/L > 5208 100 d) Synonym for Bta GC-91 technical material contained in Agree 50 WG The TER for Bta GC-91 is above the Annex VI trigger value of 100, indicating that GAP directed use of Agree 50 WG poses no risk to fish. Review Comments: IIIM 10.2 TERA for fish None. Agreed endpoints: 32-day LC50 > 2.0 x 1010 CFU/L IIIM 10.2 TERA for fish TERLT for fish Due to the absence of toxicity in the semi static studies conducted over a period of 30 and 32 days, respectively, no risk for fish is expected even upon prolonged exposure to Agree 50 WG. TERA for Daphnia The acute Agree 50 WG TER for Daphnia magna was calculated using the calculated PECSW at 3 m from the application site following based on the maximum PECSW value following six applications in flowers x 3 m from the application site. The resulting TERA is presented below: Table 10.2-4 Acute TER value for D. magna for Agree 50 WG Test organism Test substance Daphnia magna Agree 50 WGa) 48-hour LC50 (static) PECSW TERA Trigger value > 100 mg/L (nominal) 128.07 µg/L > 781 100 > 25 mg/L (actual) 128.07 µg/L > 195 100 The TERA values calculated with the nominal concentration as well as with the mean measured (actual) concentration are above the Annex VI trigger of 100, indicating a low acute risk to D. magna following GAP directed application of Agree 50 WG. TERLT for Daphnia The TERLT of Agree 50 WG for Daphnia magna was calculated using the calculated PECSW at 3 m from the application site following based on the maximum PECSW value following 3 applications in orchards x 3 m from the application site and the lowest NOEC obtained in the 21-day static renewal tests with the active ingredient (1.57 × 108 CFU/L). The resulting TERLT is presented below: Table 10.2-5 a) Daphnia TERLT value for Agree 50 WG Test organism Test substance 21- day NOEC (static renewal) PECSW TERLT Trigger value Daphnia magna CGA-237218a) 1.57 × 108 CFU/L 3.84 × 106 CFU/L 40.9 10 Synonym for Bta GC-91 technical material contained in Agree 50 WG From the TERLT value exceeding the trigger of 10 no long-term risk for daphnids is indicated. Prolonged exposure, however, is not likely to occur due to the restricted persistence of Bta in water. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 14 of 37 Risk mitigation No risk mitigation measures are required. Review Comments: IIIM 10.2 TERLT for Daphnia During the peer review process it was noted that data on growth and reproduction had not been presented in the original DAR, for no apparent reason. Indeed, sublethal endpoints have been investigated in the chronic daphnid study by Christensen (1991c) and the results can be summarised as follows: Survival: At test termination, survival in the control group was 100%, which exceeded the minimum standard criterion (≥70% survival) established by the U.S. EPA in 1985. Survival in the test concentrations ranged from 0% in the highest concentration tested (5.71 x 109 CFU/L) to 90% in the 1.57 x 108 CFU/L test concentration. Statistical analysis indicated that the survival rate among daphnids in the three highest mean measured concentrations (5.71 x 109, 1.77 x 109 and 6.24 x 108 CFU/L) was significantly different (α=0.05) when compared to control survival. Growth: Daphnid growth, as determined by body length, in the control group averaged 4.6 mm. The average length of daphnids in the test concentrations ranged from 4.7 mm in the highest concentration in which growth was evaluated (1.57 x 108 CFU/L) to 4.8 mm in the 4.86 x 107 CFU/L test concentration. Daphnid growth was not significantly decreased in the two concentrations evaluated when compared to the control. Reproduction: Reproduction in the control group averaged 107 offspring/female which exceeded the minimum standard criterion established by the U.S. EPA (≥40 offspring/female). Reproductive capacity among daphnids in the test concentrations ranged from 0 offspring/female in the two highest concentrations tested (5.71x109 and 1.77 x 109 CFU/L) to 163 offspring/female in the 6.24 x 108 CFU/L test concentration; however, this last group exhibited significant mortality from the control and so was excluded from reproductive analysis. Statsitical analysis of reproduction revealed no difference between the number of offspring produced by the treatment groups in which survival was not affected (1.57 x 108 and 4.86 x 107 CFU/L) and the control daphnids. Agreed endpoints: IIIM 10.2 TERLT for Daphnia Based on the results given above, survival of daphnids (Daphnia magna) represents the most sensitive endpoint. Therefore, the 21-day NOEC was determined to be 1.57 x 108 CFU/L (mean measured concentration). TERLT for algae The long-term risk for algae from exposure to Agree 50 WG was assessed using the EbC50value for Bta GC-91 (Table 10.2-2). The resulting TER, calculated on the basis of the PECSW value for six applications in flowers at 3 m from the application site, is given in the Table 10.2-6. Table 10.2-5 Algae TERLT value for Agree 50 WG Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 15 of 37 Test organism Test substance 72-hour EbC50 (static) PECSW TERLT Trigger value Desmodesmus subspicatus (=Scenedesmus subspicatus) CGA-237218a) > 3.6 x 109 CFU/L 3.84 x 106 CFU/L > 938 10 e) Synonym for Bta GC-91 technical material contained in Agree 50 WG The TER value is above the Annex VI trigger value of 10, indicating that application of Agree 50 WG according to the proposed label uses poses no risk to algae. Risk mitigation No risk mitigation measures are required. Review Comments: IIIM 10.2 TERLT for algae None. Agreed endpoints: IIIM 10.2 TERLT for algae 72-hours EC50 > 3.6 x 109 CFU/L (Desmodesmus subspicatus) Acute toxicity of the formulation For an overview on toxicity of Bta GC-91 and Agree 50 WG to aquatic non-target species please refer to Table 10.2-2. The following Daphnia acute toxicity study performed on Agree 50 WG is provided in support of the assessment and has not been previously evaluated. Report: KIIIM 10.2/01, Dengler, 2010 Title: Assessment of toxic effects of Agree WG on Daphnia magna using the 48 h acute immobilisation test Document No: S10-02545 Guidelines: OECD 202 (2004) GLP Yes Executive Summary Under the conditions of the study, Agree WG was found to be not toxic to Daphnia magna. The EC50 (48h) of the test item was determined to be > 100 mg/L (nominal) or > 25 mg/L (actual). I. MATERIALS AND METHODS Test Item Designation Characteristics Batch no. Agree WG Granular, light brown 1000990 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Active ingredient(s)/Content Storage conditions Stability (expiry date) Agree 50 WG Registration Report – Central Zone Page 16 of 37 Bta CG-91, conc. of a.i.: 8.5 x 1012 CFU/kg (nominal), 1.02 x 1012 CFU/kg (actual) Max 40°C Not available Test System Species Age Weight Supplier Acclimatisation period Diet Daphnia magna 6 - 24 hours (at start of treatment) Not provided Certis USA, Colombia Not provided Single cell green algae Test Conditions Housing Temperature Oxygen concentration Photoperiod pH value Hardness (CaCO3) The daphnids were held in 100 mL glass beakers filled with 50 mL test solution (loading: 10 mL/animal) 21.0 ± 0.1°C 97 ± 0.5%. 16 hours daily (~1250 lux) 8.16 ± 0.21 10°dH Study Design and Methods Conducted at In-life dates Treatment Observations Statistics Eurofins Agroscience Services GmbH, Eutinger Straße 24, NiefernÖschelbronn, Germany 07.07.2010 to 12.10.2010 During the 48-hour static limit tests the daphnids were exposed to Agree 50 WG at a nominal concentration of 100 mg/L. Test media were prepared by dilution of the test item in test water and application of defined volumes of the stock solutions to the test vessels. Two concentrations of the reference item potassium dichromate (1.0 mg/L and 2.0 mg/L) were tested in addition. Each test item and an untreated control (test water) were set up in four replicates with 5 individuals each. Assessment of immobilisation of the daphnids was carried out after 24 and 48 hours. Temperature and pH as well as oxygen saturation were measured at test start, after 24 and after 48 hours. Hardness of the test water was measured at test start only. To determine the content of viable spores of Bta CG-91 in the test item, CFU counts were performed at the start of the test The data did not warrant statistical analysis. II. RESULTS AND DISCUSSION CFU counts The content of CFU in the test item was 12% of the nominal, corresponding to 1.02 x 109 CFU/g. Therefore, the average content of Agree WG in the sample at test start was considered to be 25% of the nominal. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 17 of 37 Mortality After 24 and 48 hours no immobilisation was observed in the test groups exposed to Agree WG, in the untreated control and in the group exposed to 1.0 mg/L of the toxic reference. Immobilisation in the second control group exposed to 2.0 mg/L potassium dichromate was 50% after 24 hours and 95% upon 48 hour exposure. These data fell well within the range previously obtained with the toxic reference in the laboratory indicating a suitable sensitivity of the test animals. III. CONCLUSIONS. The EC50 (48h) of the test item was determined to be > 25 mg/L (actual content based on CFU counts) (Dengler, 2010) Implications for labelling The product has to be labelled according to the following: • Do not contaminate water with the product or its container (EB001-2) • The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR (NW 642-1). IIIM 10.3 Effects on Bees Effects on bees for Agree 50 WG were not evaluated as part of the EU review of Bt aizawai GC-91. However, the comparable formulation CGD 97220 I and the active substance were tested. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Toxicity Table 10.3-1 presents the results of laboratory bee toxicity studies with the active substance and the formulation. Further details regarding the tests with the formulation are provided in section 10.3.2. Table 10.3 - 1: Results of laboratory bee toxicity studies Test substance Exposure route LD50 Reference CGD 97220 I (= Agree 50 WG) oral, 48 h > 197 µg product/bee * Kleiner, 1992; con, 72 h > 77 µg product/bee ** oral, 10 days = 91 µg/bee * CGA-237218 technical (=Bt aizawai GC91) 92 10 48 068 Parrish and Yeager, 1994 * EU agreed endpoint (SANCO/1538/08 - rev. 3 final – 06/05/2008) ** no EU agreed endpoint (see remark below) Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 18 of 37 Remark on the contact endpoint with CGD 97220 I (Kleiner, 1992): According to the test guideline (BBA-Guideline VI, 23-1) in the contact toxicity test 1 mL test solution has to be applied to ten bees through the gauze of each test cage by a hand sprayer. Mortality is compared to a water control. However, no LD50 calculation is required. In this test 1 mL test solution containing 0.4 % CGD 97220 I was applied on an area of 8 x 6.5 cm (backside of test cages), corresponding to a dose of 77 µg CGD 97220 I/cm2. Taking into account that a bee has a surface of approximately 1 cm2, the applied dose is equivalent to 77 µg CGD 97220 I/bee. Exposure The recommended use pattern for Agree 50 WG includes application in grape vine, berries, vegetables, herbs, ornamentals and other crops at a maximum application rate of up to 1 kg product/ha. Bees may be exposed to Agree 50 WG by direct spraying while bees are foraging on flowers and weeds, through contact with fresh or dried residues or by oral uptake of contaminated pollen, nectar and honey dew. Hazard quotients for bees Hazard quotients for oral and contact exposure according to EPPO (2003) Environmental risk assessment scheme for plant protection products (Chapter 10: Honeybees (PP 3/10(2)). Bulletin OEPP/EPPO Bulletin 33: 141-145) were calculated as follows: Hazard Quotient = Maximum application rate (g formulation/ha) Acute LD50 (µg formulation/bee) Table 10.3 - 2 Hazard quotients for honeybees Test substance Max. single application rate Exposure route [µg product/ha] oral Agree 50 WG Bt aizawai GC-91 technical LD50 [µg product/Biene] > 197 Hazard quotient (HQ) <6 1000 500 HQ trigger 50 con > 77 < 13 oral = 91 <6 50 Risk assessment Due to the results of laboratory tests Agree 50 WG is considered to be practically non-toxic to bees. All hazard quotients are clearly below the trigger of 50, indicating that the intended use poses a low risk to bees in the field. Due to the findings of the EU review of Bacillus thuringien-sis ssp. aizawai strain GC-91 no signs of infectiveness or pathogenicity have been observed in laboratory chronic toxicity feeding tests. Bee brood testing is not required since the test item is not an IGR. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 19 of 37 Overall conclusion: It is concluded that Agree 50 WG will not adversely affect bees or bee colonies when used as recommended. Risk mitigation: NB6641: The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4) IIIM 10.4 Effects on Arthropods Other Than Bees In this section, no new studies are submitted assessing the effect of Agree 50 WG. Instead data from the assessment with another Bta-GC-91 product are presented. Table 10.4-1 Ecotoxicological endpoints for arthropods other than bees Test item EU agreed endpoints (SANCO/1538/08 - rev. 3 final – 06/05/2008) TUREX 50 WPa) LR50 > 4.5 kg/ha Test species Endpoints used in risk assessment Aphidius rhopalosiphi LR50 > 4.5 kg/ha Typhlodromus pyri a) Other trade name of Agree 50 WP, contains the same content of Bta-GC-91 as Agree 50 WG Effects of Agree 50 WG on arthropods were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to arthropods. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Toxicity The toxicity of the Bta GC-91-based product TUREX 50 WP (= Agree 50 WP) to non-target arthropods has been investigated. The testing and risk assessment strategy used here follow the approach recommended in the ESCORT 2 guidance document (Candolfi et al. 2001)3 and the EC Guidance Document on Terrestrial Ecotoxicology4. The toxicity of the formulation to non-target arthropods has been investigated by carrying out Tier I test on Aphidius rhopalosiphi and Typhlodromus pyri. These two species are tested, in accordance with ESCORT 2, as representative non-target arthropods since they have been found to be particularly sensitive species, and therefore can be considered as indicators of potential effects to the most sensitive arthropods in the field. Both studies confirmed the absence of toxicity of the test item to non-target arthropods. The results of the studies were submitted with the EU dossier in Annex IIIM, Section 6, Point 10.4/01-02). An overview on the obtained data is provided in Table 10.4-2. The data can be directly used for the risk assessment of Agree 50 WG as both products contain the same content of Bta GC-91. 3 Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt H (2000) ‘Guidance Document on regulatory testing procedures for plant protection products with non-target arthropods’ From the workshop, European Standard Characteristics of Non-target Arthropod Regulatory Testing (ESCORT 2) 21-23 March 2000. 4 EC Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329, 17 October 2002. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Page 20 of 37 Table 10.4-2 Agree 50 WG- Toxicity to non-target arthropods Test substance TUREX 50 WPa) a) Registration Report – Central Zone Species Exposed life stage Study type LR50 (kg product/ha) Reference Aphidius rhopalosiphi Typhlodromus pyri Adult Acute laboratory (glass plate) > 4.5 Warmers, 2005a Adult Acute laboratory (glass plate) > 4.5 Warmers, 2005a Containing the same content of Bta GC-91 as Agree 50 WG Exposure In-field Non-target arthropods living in the crop can be exposed to residues from Agree 50 WG by direct contact either as a result of overspray or through contact with residues on plants and soil or in food items. The maximum number of successive treatments for Agree 50 WG is 6 and the maximum application rate are 1.0 kg/ha. The infield exposure is calculated according to ESCORT 2 (2000)4 using the following equation: PERIn-field = Maximum application rate [g product/ha] × MAF Due to six applications a default MAF (leaf) of 3.2 was adopted. Table 10.4-3 In-field PER values for application of Agree 50 WG Compound referred to Application rate MAF PER (foliar) Agree 50 WG 1000 g/ha 3.2 3200 g/ha Off-field Risk assessment of areas immediately surrounding the crop is considered important since these areas represent a natural reservoir for immigration, emigration and reproduction of arthropod populations and provide increased species diversity. Exposure of non-target arthropods living in off-field areas to Agree 50 WG will mainly be due to spray drift. Off-field areas are assumed to be densely vegetated and thus spray drift is unlikely to reach bare ground. Therefore, evaluation of exposure via soil residues in off-field areas was not considered. The off-field exposure value was calculated from in-field exposure in conjunction with drift values published by the JKI (2006)5 as shown in the following equation: PEROff-field = 5 Maximum in-field exposure × (% drift/100) Vegetation distribution factor Julius Kühn Institute spray drift data from 27. March 2006, http://www.jki.bund.de/fileadmin/dam_uploads/_AT/abdrifteckwerte/Abdrifteckwerte.xls Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 21 of 37 Vegetation distribution factor: The model used to estimate spray drift was developed for drift onto a twodimensional water surface and, as such, does not account for interception and dilution by three-dimensional vegetation in off-crop areas. Therefore, a vegetation distribution or dilution factor is incorporated into the equation when calculating off-field exposure, to be used in conjunction with toxicity endpoints derived from two-dimensional (glass plate or leaf disc) studies. A dilution factor of 10 is recommended by ESCORT 2. The PERoff-field was calculated for use of Agree 50 WG in flowers/ornamentals and vegetables because here the highest exposure is expected due to the highest number of successive treatments. For six applications the drift value at 1 m distance is 6.41% of the application rate (90th percentile drift). The drift factor (% drift/100) is therefore 6.41/100 = 0.06. The resulting PERoff-field value is shown in Table 10.4-4. Table 10.4-4 Off-field foliar Predicted Environmental Rates (PER) for Agree 50 WG Study type Maximum in-field foliar PER a Drift factor (% drift/100) a Vegetation distribution factor Off-field foliar PER 10 19.2 (g formulation/ha) (g formulation/ha) Glass plate a 3200 0.06 for flowers/vegetables, plant height > 50 cm Risk assessment The risk to non-target arthropods is assessed using the approach recommended in the published ESCORT 2 document (Candolfi et al. 2001) 4 and the EC Guidance Document on Terrestrial Ecotoxicology5. In-field The potential risk of Agree 50 WG to in-field non-target arthropods was assessed by calculation of the hazard quotient (HQ = exposure/toxicity) with the predicted environmental rate (PER) and the lowest lethal rate (LR50) values according to the following formula: In field HQ = In - field PER LR 50 The HQ trigger for Tier I laboratory is 2. The resulting HQin-field values are presented in Table 10.4-5. Table 10.4-5 In-field HQs for non-target arthropods Species Typhlodromus pyri Aphidius rhopalosiphi LR50 (g/ha) > 4500 In-field foliar PER (g/ha) HQ 3200 < 0.71 Trigger value 2 4 Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt H (2000) ‘Guidance Document on regulatory testing procedures for plant protection products with non-target arthropods’ From the workshop, European Standard Characteristics of Non-target Arthropod Regulatory Testing (ESCORT 2) 21-23 March 2000. 5 EC Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329, 17 October 2002. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 22 of 37 The in-field HQ values indicate that GAP directed application of Agree 50 WG poses no risk to in-field nontarget arthropods. Off-field In order to assess the potential risk of Agree 50 WG to off-field non-target arthropods, the predicted environmental rate (Table 10.4-4) is compared with the toxicity endpoints according to the following formula: Off - field HQ = PER off −field (g/ha) × Correction factor LR 50 (g/ha) The HQ trigger for Tier I laboratory studies is 2. Correction factor: ESCORT 2 recommends that a correction factor of 5 is used when assessing Tier II data, or 10 for Tier I data, to account for extrapolation from testing just 2 representative species, to the species diversity expected in off-crop areas. HQoff-field values are given in Table 10.4-6. Table 10.4-6 Off-field HQ values for non-target arthropods Species LR50 (g product/ha) Off-field foliar PER Correction factor Off-field foliar HQ Trigger value 10 < 0.004 2 (g product/ha) Typhlodromus pyri Aphidius rhopalosiphi > 4500 19.2 The off-field HQ value for the tested non-target arthropods fall below the trigger value of 2, indicating that GAP directed application of Agree 50 WG does not pose an unacceptable risk to non-target arthropods in off-field areas. In the following paragraphs, a quantitative risk assessment is presented using the toxicity/exposure ratio (TER) approach: The PERoff-field was calculated for use of Agree 50 WG in flowers/ornamentals and vegetables , as here the highest exposure is expected. For six successive treatments the drift value at 1 m distance is 6.41% of the application rate (90th percentile drift). The drift factor (% drift/100) is therefore 6.41/100 = 0.06. The maximum in-field exposure is calculated as the maximum application rate x the maximum number of treatments. The resulting PERoff-field value is shown in the following Table. Off-field foliar Predicted Environmental Rates (PER) for Agree 50 WG a Maximum application rate (kg/ha) Maximum number of treatments 1.0 6 Drift factor Off-field foliar PER (% drift/100) Vegetation distribution factor 0.06 5 0.072 (kg/ha) For flowers/ornamentals and vegetables Risk assessment Off-field Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 23 of 37 In order to assess the potential risk of Agree 50 WG to off-field non-target arthropods, the predicted environmental rate (Table 10.4-4) is compared with the toxicity endpoints according to the following formula: LR50 PERoff-field TERoff-field = The TER trigger for Tier I laboratory studies is 10. The calculated TER value for non-target arthropods in offfield areas is given in following table: Off-field TER values for non-target arthropods Species Typhlodromus pyri Aphidius rhopalosiphi LR50 Off-field foliar PER Off-field foliar (kg/ha) (kg/ha) TER > 4.5 0.072 > 62.5 Trigger value 10 The off-field TER value for the tested non-target arthropods exceeds the trigger value of 10, indicating that GAP directed application of Agree 50 WG does not pose an unacceptable risk to non-target arthropods in off-field areas. Risk mitigation measures Not required. Comments: IIIM 10.4 Agreed endpoint/s: IIIM 10.4 a) In general, the test method used is not considered suitable for testing MPCAs because test organisms were only exposed to fresh dry product residues on glass plates (contact exposure). However, Bacillus thuringiensis is basically a proteinaceous insecticide that must be ingested by susceptible species to be effective. Nevertheless, on the basis of available information submitted in the EU review of Bt subspecies aizawai, the use of Agree 50 WG is considered unlikely to cause any adverse effects on predatory mites and predatory wasps. For the non-target arthropod risk assessment, more attention should be paid to the effects of Btk on non-target lepidopteran species. It should be noted that expected concentrations are likely to be below the levels calculated in the worst case scenario in Tier I since the MPCA is very susceptible to UV light and rainfall. Therefore, a qualitative risk assessment based on an overall view of all available information is regarded as the most relevant evaluation. In the case of large-scale (aerial) applications of Bta in forestry, further risk mitigation measures should be considered at Member States level. LR50 > 4.5 kg TUREX 50 WPa)/ha Other trade name of Agree 50 WP, contains the same content of Bta-GC-91 as Agree 50 WG Effects of Bta on Lepidoptera species in off-crop habitats In this section no new study on the toxicity of Bta on Lepidopteran species is submitted. Additionally, field studies revealed that Macrolepidoptera caterpillars may be affected by the use of Btk products, but severe effects on populations were not recorded. Populations recovered after applications (Glare & O’Callaghan, 2000). Regarding the the risks to non-target-arthropods, including lepidopteran species, the following is stated in the EFSA Conlusion on Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91): Several laboratory studies on non-target arthropods for both strains were available. These studies indicated a low risk from pathogenicity and infectivity for non-target arthopods following exposure to Bacillus thuringiensis Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 24 of 37 aizawai strain ABTS 1857 and strain CG-91. The only potentially significant area of concern for non-target arthropods is in relation to the specific species showing susceptibility to particular subspecies of Bacillus thuringiensis. In the case of Bacillus thuringiensis aizawai, this relates to a restricted group of Lepidopteran families and it is important that this selectivity is considered within the context of the wide scale impact of broad-spectrum insecticides on non-target arthropods. Clearly for the in-crop area where application occurs there will be an impact on Lepidopteran species i.e. the intended effect on the target pest species. However, the published information shows that recovery occurs within a relatively short period of time (depending on application timing, life history of affected species, dispersal ability etc). Recovery of any affected populations is therefore likely to be rapid. Therefore the risk for non-target arthropods was indicated as low. The risk for nontarget arthropods for the strain GC-91 was indicated as low by the HQ calculation. IIIM 10.5 Effects on Earthworms In this section, no new studies are submitted assessing the effect of Agree 50 WG. Instead data from the assessment with another Bta GC-91-based product are presented. Table 10.5-1 Test item CGD 97220 Ia) a) Ecotoxicological endpoints for earthworms EU agreed endpoints (SANCO/1538/08 - rev. 3 final – 06/05/2008) Endpoints used in risk assessment LC50 > 1000 mg/kg artificial soil LC50 > 1000 mg/kg artificial soil Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG Effects of Agree 50 WG on earthworms were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to earthworms. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Toxicity The acute toxicity of the formulation CGD 97220 I (equivalent to Agree 50 WP) to the earthworm Eisenia foetida was determined in a laboratory study (refer to Annex IIIM, Sec. 6, P. IIIM 10.5). The median lethal concentration LC50 of the test item to Eisenia foetida determined after 14 days exposure was shown to be greater than 1000 mg/kg artificial soil. As the content of Bta GC-91 in Agree 50 WP and Agree 50 WG is the same the obtained data can be directly used to assess the risk of Agree 50 WG. Earthworm toxicity endpoints are summarised in Table 10.5-2. Table 10.5-2 a) Acute earthworm toxicity endpoint for Agree 50 WG Test substance Endpoint Value Reference CGD 97220 Ia) LC50 > 1000 mg/kg artificial soil Winkler, 1992a Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG Exposure The exposure to soil organisms was estimated by calculating the maximum predicted environmental concentrations in soil (PECS) (please refer to Part B, Section 5). The PECS value was calculated for 6 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 25 of 37 applications of 1.0 kg Agree 50 WG/ha in vegetables assuming as a worst case that no degradation of the product and the active ingredient occurs between the treatments. Under these conditions and based on standard assumptions for the soil density and the incorporation depth, the PECS was determined to be 8 mg Agree 50 WG/kg dry weight soil. Toxicity exposure ratios: TERA and TERLT Acute risk The potential acute risk of Agree 50 WG to earthworms was assessed by comparing the maximum instantaneous PECS with the 14-day LC50 value to generate the acute TER value. The TERA was calculated as follows: TER A = LC 50 (mg/kg) PEC S (mg/kg) The resulting TERA value is shown in Table 10.5-3. Table 10.5-3 Acute TER value for earthworms Compound referred to LC50 Maximum PECS for Agree 50 WG TERA Limit Agree 50 WG > 1000 mg/kg d.w. soil 8.0 mg/kg. d.w. soil > 125 10 The acute TER value is much higher than the Annex VI acute trigger value of 10, indicating that GAP directed application of Agree 50 WG poses no acute risk to earthworms. Long-tern risk Due to the absence of acute toxicity no adverse effects on earthworms are to be expected even upon prolonged exposure to Agree 50 WG or Bta GC-91. Risk mitigation No risk mitigation measures are considered necessary. Comments: IIIM 10.5 None. Agreed endpoint/s: IIIM 10.5 LC50 > 1000 mg/kg d.w. soil IIIM 10.6 Effects on Soil Micro-organisms In this section, no new studies are submitted assessing the effect of Agree 50 WG. Instead data from the assessment with another Bta GC-91-based product are presented. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Table 10.6-1 Agree 50 WG Page 26 of 37 Ecotoxicological endpoints for soil micro-organisms Test substance Test design b) EU agreed endpoints (SANCO/1538/08 - rev. 3 final – 06/05/2008) Endpoints used in risk assessment NOEC = 20 kg/ha NOEC = 20 kg/ha C N CGD 97220 Ia) a) b) Registration Report – Central Zone Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG C:carbon transformation, N: nitrogen turnover Effects of Agree 50 WG on the activity of the soil microflora were not evaluated as part of the EU review of Bta GC-91. However further data on Agree 50 WG are not relevant as active substance data on toxicity are used and the ingredients in the formulation do not pose a risk to soil microorganisms. Therefore all relevant data were assessed in the EU review. Risk assessments for Agree 50 WG with the proposed use pattern are provided here and are considered adequate. Toxicity Side effects of CGD 97220 I (synonym for Agree 50 WP) on the activity of the soil microflora were assessed in two soils over a period of 28 days at 2.0 L/ha and 20.0 L/ha (corresponding to 2 and 20 kg/ha; refer to Annex IIIM, Sec. 6, P. IIIM 10.6). Even at the higher concentration, the test item had no negative influence on the nitrogen turnover or the dehydrogenase activity in the two test soils. In conclusion, the test substance represents no hazard to soil microflora at a concentration of 20.0 kg/ha. Table 10.6-2 a) Toxicity of Agree 50 WG to soil micro-organisms Test substance Endpoint Reference CGD 97220 Ia) NOEC = 20 kg/ha Winkler, 1992b Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG Exposure The maximum predicted environmental concentrations of Agree 50 WG in soil (PECS) was calculated for use in vegetables (6 x 1 kg/ha) as here the highest exposure is to be expected. For details please refer to Part B, Section 5. Table 10.6-3 Predicted Environmental Concentrations in soil (PECS) of Agree 50 WG Compound referred to Maximum accumulated application rate Maximum PECS Agree 50 WG 6.0 kg/ha 8.0 mg/kg dry weight soil Risk assessment CGD 97220 I had no significant effect on soil micro-organisms at 20 kg/ha. This value is more than 3-fold the maximum accumulated application rate intended for Agree 50 WG. Due to the assumption of the worst case that no degradation of Agree 50 WG occurs between the treatments and the absence of adverse effects observed in the laboratory study with CGD 97220 I containing the same amount of Bta GC-91 as Agree 50 WG, it can be concluded that GAP directed use of Agree 50 WG poses no risk for the soil microflora. Risk mitigation No risk mitigation measures are considered necessary. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Page 27 of 37 Study Comments: IIIM 10.6 None. Agreed endpoint/s: IIIM 10.6 NOEC = 20 kg/ha IIIM 10.7 Registration Report – Central Zone Additional Studies No additional studies are required IIIM 11 Summary and evaluation of environmental impact IIIM 11.1 Distribution and fate of the MPCA Fate and behaviour in soil Based on available information derived from studies and published literature on Bacillus thuringiensis bacteria, the environmental fate and population dynamics of Bta upon field application of Agree 50 WG can be summarized as follows: A natural breakdown of the endospores of Bta in soil begins after application onto the fields and gradually reduces the numbers of spores remaining. Any vegetative cells or crystal proteins are likely to be far more rapidly degraded by the photo degradation effects of sunlight. The better persistence of Bt spores in soil after the first two weeks seems to be a result of their inability to germinate in soil. Survival and viability of parasporal crystal proteins associated with the application of Agree 50 WG is expected to be short-term as effects of other soil micro-organisms and natural sunlight, in combination with the natural degradation of the proteins, occurs. The highest predicted environmental concentration of Agree 50 WG and its active ingredient Bta GC-91 in soil was calculated as 8 mg/kg dry weight soil (4 mg Bta/kg dry weight soil). In terms of CFU, this is equivalent to 2.4 × 108 CFU or 200,000 IU/kg dry weight soil. Fate and behaviour in water Surface water Under natural conditions, residues of Bta in water are not considered to be able to persist for very long periods due to a combination of natural physical and chemical degradation factors such as solar radiation and predation from resident bacteriophages, protozoans and other lower animal forms. It may be stated that Bta GC-91 is inactivated under natural conditions, including water. The highest predicted environmental concentration of Agree 50 WG and its active ingredient Bta GC-91 in surface waters is 128.07 µg/L (64.04 µg Bta/L) corresponding to 3.84 × 106 CFU or 3202 IU/L. Ground water Various experiments examining the movement of Bt in soils following spraying of commercial products containing Bt showed little or no movement neither in laboratory columns nor in the field under natural irrigation conditions. Additionally, adsorption and binding of protoxins and toxins from Btk have been demonstrated to occur readily, rapidly and strongly onto the clay fraction and clay humic acid complexes of soils while Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 28 of 37 desorption occurs far less readily. It is thus concluded that no threat of contamination of groundwater exists following applications of Agree 50 WG according to GAP. Fate and behaviour in air Unlike chemical products, evaporation and volatility of bacteria is not expected to be a factor to consider in assessing the fate in air. Hence volatilisation from plant surfaces and from soil can be excluded. An investigation of photochemical-oxidative degradation in air is of no relevance in view of the volatility characteristics of the bacteria. Spray drift, however, can occur following an application of Bta which may lead to temporary concentrations in the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray droplets settle out. However, rapid degradation of Bta in air or in these droplets mainly due to inactivation by solar radiation is assumed and confirmed by literature reports. IIIM 11.2 Identification of non-target species at risk and extent of their exposure According to the presented risk assessment, the use of Agree 50 WG at the proposed label rates according to good agricultural practice poses no risk to any of the non-target species. Terrestrial vertebrates Birds and mammals Due to the highly specific mode of action of Bta and its low field persistence birds and mammals are not considered to be at risk upon application of Agree 50 WG. This was confirmed by the absence of toxicity upon oral administration in birds and rats and TER values exceeding the Annex IV trigger of 10 for all indicator species considered in screening assessments for these two vertebrate groups, respectively. Aquatic organisms Fish The acute TER value of fish for Agree 50 WG exceeds the Annex VI trigger value of 100 indicating that no adverse effects are to be expected upon field application at recommended use levels. Due to the absence of toxicity in the semi static studies conducted over a period of 30 and 32 days, respectively, no risk for fish is expected even upon prolonged exposure to Agree 50 WG. Furthermore, prolonged exposure is not likely to occur due to the restricted persistence of Bta in water. Daphnids The acute TER value of aquatic invertebrates for Agree 50 WG is above the Annex VI trigger value of 10. Therefore, no risk is expected for aquatic invertebrates following GAP directed use. Considering the absence of acute toxicity and the NOEC obtained in the 21-day static renewal tests (1.57 × 108 CFU/L) that is more than 10fold higher than the PECSW (1.44 × 107 CFU/L) no adverse effects on daphnids are to be expected even upon prolonged exposure to Agree 50 WG. Prolonged exposure, however, is not likely to occur due to the restricted persistence of Bta in water. Algae Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 29 of 37 The long-term TER value of algae for Agree 50 WG strongly exceeds the Annex VI trigger value of 10 suggesting that no negative side effect is expected following field application according to GAP. Bees Application of Agree 50 WG at intended use levels represents no risk for honey bees as the calculated Hazardous Quotient is far below the trigger value of 50. Other arthropods Following the result of the non-target arthropod risk assessment the HQ values are below the trigger value of 2 indicating that no unacceptable risk is to be expected upon field application of Agree 50 WG according to GAP. The risk for non-target Lepidopteran species in off-crop habitats was assessed using data from open peer reviewed literature. Following the results the HQ values for 4 out of 5 species (Vanessa cardui, Manduca sexta, Pieris rapae and Heliothis virescens) are below the trigger of 2, although the worst case was assumed. Hence, no negative side effects are expected following field application according to GAP. Assuming the same conditions, the HQ value for Lymantria dispar exceeds the trigger of two. However, due to the fast inactivation of Bta spores and the behaviour of L. dispar to feed in crowns of broadleaf trees, where a lower exposure rate is expected, no unacceptable risk is expected upon field application of Agree 50 WG. Earthworms The acute TER value of earthworms for Agree 50 WG exceeds the Annex VI trigger value of 10 indicating that no adverse effects are to be expected upon field application at recommended use levels. Soil microbial activity No effects > 25% on short-term respiration and nitrogen turnover were observed at the tested rates with other Bta GC-91 containing products. Therefore, no unacceptable risk to the soil microflora and their activity is expected at recommended application rates of Agree 50 WG. IIIM 11.3 Precautions necessary to minimise environmental contamination and to protect non-target species The above risk assessment proves that Agree 50 WG is not toxic to the tested aquatic and terrestrial species, and considering the expected environmental concentration will not be hazardous to natural populations upon applications according to Good Agricultural Practice. No hazard classification or specific labelling according to EC Directive 67/548/EEC is required for Agree 50 WG. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Appendix 1a: Agree 50 WG Registration Report – Central Zone Page 30 of 37 List of data submitted in support of the evaluation Annex point/ reference number Author(s) Year KIIIM 10.2/01 Dengler, D. 2010 KIIIM 10.4/01 Broderick, N.A., 2006 Raffa, K.F., Handelsman,J. KIIIM 10.4/02 Broderick, N.A., 2009 Robinson, C.J., McMahon, M.D., Holt, J., Handelsman, J., Raffa, K.F. Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Title Testing Facility Owner / Source (where different from owner) Report No GLP or GEP status (where relevant) Published or not ASSESSMENT OF TOXIC EFFECTS OF AGREE WG ON DAPHNIA MAGNA USING 48H ACUTE IMMOBILISATION TEST Eurofins Agroscience Service GmbH Certis USA LLC Report-no. S10-02545 GLP: yes Published: no MIDGUT BACTERIA REQUIRED FOR BACILLUS THURINGIENSIS INSECTICIDAL ACTIVITY Proc Natl Acad Sci USA, 103, 15196-15199 Report-no. not applicable GLP/GEP: no Published: yes CONTRIBUTIONS OF GUT BACTERIA TO BACILLUS THURINGIENSIS-INDUCED MORTALITY VARY ACROSS A RANGE OF LEPIDOPTERA BMC Biology, 7, 1-9 Report-no. not applicable GLP/GEP: no Published: yes Data protection claimed Owner yes/no yes CEB no LIT no LIT Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Appendix 1b: Agree 50 WG Registration Report – Central Zone Page 31 of 37 References cited but not included Author(s) Annex point XXXXX IIIM 10.2 XXXXX IIIM 10.2 Christensen, K.P. IIIM 10.2 Christensen, K.P. IIIM 10.2 Collins, M.K. IIIM 10.2 Glare, T.R., O'Callaghan, M. IIIM 10.4 Title Testing Facility Owner / Source (where different from owner) Report No GLP or GEP status (where relevant) Published or not 1991a (CGA-237218 TECHNICAL MATERIAL) INFECTIVITY AN PATHOGENICITY TO RAINBOW TROUT (ONCORHYNCHUS MYKISS) DURING A 32-DAY STATIC RENEWAL TEST Springborn Laboratories Inc., Massachusetts, USA Certis USA LLC Report-no. 90-6-3363 GLP: yes Published: no 1991b (CGA-237218) - INFECTIVITY AND PATHOGENICITY TO SHEEPSHEAD MINNOW (CYPRINODON VARIEGATUS) DURING A 30-DAY STATIC RENEWAL TEST Spingborn Lab. Inc., Wareham, Massachusetts 02571, USA Certis Europe B.V., NL Report-no. 1781.0889.6230.160, 154-21 GLP: yes Published: no 1991c CGA-237218 CHRONIC TOXICITY TO DAPHNIDS (DAPHNIA MAGNA) UNDER STATIC RENEWAL CONDITIONS Springborn Laboratories Inc., Massachusetts, USA Certis USA LLC Report-no. 1781.0889.6229.130, 90-7-3385 GLP: yes Published: no 1991d CGA-237218 TECHNICAL MATERIAL INFECTIVITY AND PATHOGENICITY TO GRASS SHRIMP (PALAEMONETES VULGARIS) DURING A 30-DAY STATIC RENEWAL TEST Springborn Laboratories Inc., Massachusetts, USA Certis USA LLC Report-no. 90-6-3445 GLP: yes Published: no 1993 INFECTIVITY AND PATHOGENICITY TO DAPHNIDS (DAPHNIA MAGNA) DURING A 21-DAY STATIC RENEWAL TEST Springborn Laboratories Inc., Massachusetts, USA Certis USA LLC Report-no. 93-10-4968 GLP: yes Published: no 2000 BACILLUS THURINGIENSIS: BIOLOGY, ECOLOGY AND SAFETY not applicable John Wiley and Sons Inc New York Year Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Data protec- Owner tion claimed yes/no yes CEB yes CEB yes CEB yes CEB yes CEB no LIT Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Author(s) Agree 50 WG Registration Report – Central Zone Page 32 of 37 Annex point Grade, R. IIIM 10.2 Kleiner, R. IIIM 10.3 XXXXX IIIM 10.1 XXXXX IIIM 10.1 Parrish, J.R, Yeager, B. IIIM 10.3 Warmers, C. IIIM 10.4 Title Testing Facility Owner / Source (where different from owner) Report No GLP or GEP status (where relevant) Published or not Report-no. not applicable GLP/GEP: no Published: yes 1993 REPORT ON THE GROWTH INHIBITATION TEST OF CGA 237218 TECH. TO GREEN ALGAE (SCENEDESMUS SUBSPICATUS) CIBA-GEIGY Ltd., CH-4002 Basel, Switzerland Certis USA LLC Report-no. 938007 GLP: yes Published: no 1992 TESTING TOXICITY TO HONEYBEE - APIS MELLIFERA L. (LABORATORY) ACCORDING TO BBA GUIDELINE VI, 23-1 (1991) BioChem Agrar, Cunnersdorf, Germany Certis USA LLC Report-no. 92 10 48 068 GLP: yes Published: no 1990a CGA-237218 TECHNICAL (GC-91) - AN AVIAN ORAL PATHOGENICITY AND TOXICITY STUDY IN THE BOBWHITE Wildlife International, Ltd., Easton, Maryland, USA Certis USA LLC Report-no. 108-308 GLP: yes Published: no 1990b CGA-237218 TECHNICAL (GC-91) - AN AVIAN ORAL PATHOGENICITY AND TOXICITY STUDY IN THE MALLARD Wildlife International, Ltd., Easton, Maryland, USA Certis USA LLC Report-no. 108-309 GLP: yes Published: no 1994 HONEY BEE TOXICITY FEEDING TEST/CHRONIC- CGA-237218 BIO/WEST, INC., Utah 84321, USA Certis USA LLC Report-no. HB419 GLP: yes Published: no 2005a TUREX 50 WP: ACUTE TOXICITY TO THE APHID PARASITOID, APHIDIUS RHOPALOSIPHI DE STEFANI PEREZ (HYMENOPTERA, BRACONIDAE) IN THE LABORATORY (LIMIT TEST) GAB Biotechn. GmbH & GAB Analytik GmbH, Niefern-Öschelbronn Certis USA LLC Year Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Data protec- Owner tion claimed yes/no yes CEB yes CEB yes CEB yes CEB yes CEB yes CEB Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Author(s) Agree 50 WG Registration Report – Central Zone Page 33 of 37 Annex point Warmers, C. IIIM 10.4 Winkler, J. IIIM 10.5 Winkler, J. IIIM 10.6 Title Testing Facility Owner / Source (where different from owner) Report No GLP or GEP status (where relevant) Published or not Report-no. 20051317/01-NLAp GLP: yes Published: no 2005b TUREX 50 WP: TOXICITY TO THE PREDATORY MITE, TYPHLODROMUS PYRI SCHEUTEN (ACARI, PHYTOSEIIDAE) IN THE LABORATORY (LIMIT TEST) GAB Biotechn. GmbH & GAB Analytik GmbH, Niefern-Öschelbronn Certis USA LLC Report-no. 20051317/01-NLTp GLP: yes Published: no 1992a ACUTE TOXICITY EARTHWORM TEST EISENIA FOETIDA ACCORDING TO THE OECD GUIDELINE 207 BioChem GmbH, Cunnersdorf, Germany Certis USA LLC Report-no. 921049014 GLP: yes Published: no 1992b EFFECTS ON THE ACTIVITY OF SOIL MICROFLORA ACCORDING TO THE BBA GUIDELINE VI, 1-1 (1990) BioChem GmbH, Cunnersdorf, Germany Certis USA LLC Report-no. 921049013 GLP: yes Published: no Year Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Data protec- Owner tion claimed yes/no yes CEB yes CEB yes CEB Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 34 of 37 Appendix 2: Table of Intended Uses justification and GAP tables Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δendotoxins). Application rates are the same throughout the Central zone. Crop and/or Member- Product F, state or name G, situation country or I (a) (b) Pests or Groups of pests controlled (c) Formulation Type Conc. of MPCA Application Method Growth stage Number kind (k) Application rate per treatment kg MPCA./hL water L/ha kg MPCA./ha Interval between (kg MPCP/hL) (kg MPCP/ha) applications min-max min-max min-max min-max (min.) PHI Remarks (days) (f - h) (j) (l) (m) Grapes Central Europe Agree 50 WG F Tortricidae (Lobesia botrana, Eupoecilia ambiguella) WG 50% Foliar spraying BBCH 53-89 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - Red, black and white currant, blueberry, goosberry, blackberry, raspberry Strawberry Central Europe Agree 50 WG F Geometridae (Operophtera brumata) WG 50% Foliar spraying April - May BBCH 00-79 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-3 7 days 0.083 - 0.167 (0.167 – 0.333) 300 - 600 0.5 (1.0) Not relevant - 0.025 (0.05) 2000 Tomato, pepper (sweet and chilli), eggplant Cucumber, gherkin, courgette, melon, patisson (d - f) G Central Europe Agree 50 WG F Plutellidae (Plutella xylostella), WG Noctuidae (Autographa gamma, Plusia spp.) G 50% Foliar spraying Central Europe Agree 50 G Noctuidae (Chrysodeixis WG chalcites, Autographa gamma, Polia oleracea, Plusia spp.) WG 50% Foliar spraying Central Europe Agree 50 G Noctuidae (Chrysodeixis chalcites, Autographa gamma, WG Polia oleracea, Plusia spp.) WG 50% Foliar spraying Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß January – December BBCH 00-99 April – September BBCH 13-89 January – December BBCH 13-89 January December BBCH 09-89 January – December BBCH 09-89 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Page 35 of 37 Crop and/or Member- Product F, state or situation name G, country or I (a) (b) Lettuce, endive, curled endive, lamb´s lettuce, spinach Central Europe Red cabbage, savoy cabbage, pointed head cabbage, white cabbage, Brussel sprouts, kale Chinese cabbage, choi cabbage, cauliflower, broccoli, Indian mustard, kohlrabi Swede Central Europe Central Europe Beetroot, raddish, black raddish, carrot, celery, celery leaves, celeriac, parsley Registration Report – Central Zone Pests or Groups of pests controlled (c) Formulation Type Conc. of MPCA (d - f) Application Method Growth stage Number (k) kind (f - h) (j) High volume spraying April – September BBCH 09-99 Application rate per treatment kg MPCA./hL water L/ha kg MPCA./ha Interval (kg MPCP/ha) between (kg MPCP/hL) applications min-max min-max min-max min-max (min.) F Plutellidae (Plutella xylostella), WG Pieridae (Pieris spp.), Noctuidae (Polia oleracea, Autographa gamma, Plusia spp.) G 50% Agree 50 WG F Plutellidae (Plutella xylostella), Crambidae (Evergestis forficalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) WG 50% Foliar spraying Agree 50 WG F Plutellidae (Plutella xylostella), Crambidae (Evergestis forficalis), Pieridae (Pieris spp.), Noctuidae (Autographa G gamma, Mamestra brassicae, Plusia spp.) WG 50% Foliar spraying F Plutellidae (Plutella xylostella), Crambidae (Evergestis forvicalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) F Plutellidae (Plutella xylostella) WG 50% Foliar spraying AprilSeptember BBCH 09-99 1-3 WG 50% Foliar spraying April – September BBCH 09-99 January – December BBCH 09-99 1-3 Agree 50 WG Central Europe Agree 50 WG Central Europe Agree 50 WG G Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß January – December BBCH 09-99 April – September BBCH 09-99 April – September BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 PHI Remarks (days) (l) (m) 0.5 (1.0) Not relevant - 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 January – December BBCH 09-99 - Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 36 of 37 Crop and/or Member- Product F, state or situation name G, country or I (a) (b) Pests or Groups of pests controlled Formulation Type Conc. of MPCA Application Method Growth stage Number (k) kind Application rate per treatment kg MPCA./hL water L/ha kg MPCA./ha Interval (kg MPCP/ha) between (kg MPCP/hL) applications min-max min-max min-max min-max (min.) PHI Remarks (days) (f - h) (j) (l) (m) Onions, shallots, pickles, garlic, leek Witloof, Chicory Central Europe Agree 50 WG F Plutellidae (Acrolepiopsis assectella) WG 50% Foliar spraying April – September BBCH 07-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - Central Europe Agree 50 WG F Noctuidae (Autographa gamma, WG Plusia spp.) 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - Herbs Central Europe Agree 50 WG F Plutellidae (Plutella xylostella) WG 50% Foliar spraying April – September BBCH 09-99 January – December BBCH 09-99 April – September BBCH 09-99 January – December BBCH 09-99 April – September BBCH 09-99 January – December BBCH 09-99 April – September BBCH 09-99 January – December BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - (c) (d - f) G Dwarf snap and slicing bean, pole snap and slicing bean, yard long bean Ornamentals and flowers Central Europe Agree 50 WG F Noctuidae (Polia oleracea, Autographa gamma, Plusia spp.) G WG 50% Foliar spraying Central Europe Agree 50 WG F Pieridae (Pieris spp.), Noctuidae WG (Plusia spp., Mamestra spp.) 50% Foliar spraying 50% Foliar spraying G Nursery crops and perennials Central Europe Agree 50 WG F Pieridae (Pieris spp.), Noctuidae WG (Plusia spp., Mamestra spp.), Lymantriidae (Euproctis G chrysorrhoea, Leucoma salicis, Lymantria dispar), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Evaluator: Germany Date: November 2015 Part B – Section 6 Core Assessment Agree 50 WG Registration Report – Central Zone Page 37 of 37 Crop and/or Member- Product F, state or situation name G, country or I (a) (b) Forestry Central Europe Agree 50 WG Public green Central Europe Agree 50 WG Pests or Groups of pests controlled (c) F Pieridae (Pieris spp.), Geometridae (Operopthera brumata), Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) F Pieridae (Pieris spp.), Geometridae (Operophtera brumata), Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) Formulation Type Conc. of MPCA Application Method Growth stage Number (k) kind PHI Remarks (days) (f - h) (j) (l) (m) WG 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) not relevant (yes) WG 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) not relevant - (d - f) Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (latin names pests) (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6 Applicant Author Dr. Jacqueline Süß Application rate per treatment kg MPCA./hL water L/ha kg MPCA./ha Interval (kg MPCP/ha) between (kg MPCP/hL) applications min-max min-max min-max min-max (min.) (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used must be indicated (i) g/kg or g/l (or potency, or % Cry-toxins) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (k) Indicate the minimum and maximum number of application possible under practical conditions of use (l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions (relative importance crop and pest) Evaluator: Germany Date: November 2015 Part B – Section 6 National addendum Germany Delfin WG Registration Report – Central Zone Page 1 of 9 REGISTRATION REPORT Part B Section 6: Impact on Non-Target Organisms Detailed summary and risk assessment Product code: Agree 50 WG Active Substance: 50% Bacillus thuringiensis ssp. aizawai GC-91 Central Zone Zonal Rapporteur Member State: Germany National addendum for Germany Applicant: Mitsui AgriScience International S.A./B.V. Date: November 2015 Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Part B – Section 6 National addendum Germany Delfin WG Registration Report – Central Zone Page 1 of 9 Table of Contents IIIM 10 Rationale to waive additional testing, based on adequacy of information provided for MPCA, to permit an assessment of the impact of the MPCP on non-target organisms.................................................................. 2 IIIM 10.4 Effects on Arthropods Other Than Bees ............... Fehler! Textmarke nicht definiert. IIIM 10.5 Effects on Earthworms ........................... Fehler! Textmarke nicht definiert. IIIM 10.6 Effects on Soil Micro-organisms ............ Fehler! Textmarke nicht definiert. IIIM 11 Summary and evaluation of environmental impact ...... Fehler! Textmarke nicht definiert. IIIM 11.1 Distribution and fate of the MPCA ....... Fehler! Textmarke nicht definiert. IIIM 11.2 Identification of non-target species at risk and extent of their exposure.................................................... Fehler! Textmarke nicht definiert. Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Part B – Section 6 National addendum Germany IIIM 10 Delfin WG Registration Report – Central Zone Page 2 of 9 Rationale to waive additional testing, based on adequacy of information provided for MPCA, to permit an assessment of the impact of the MPCP on non-target organisms. This document usually describes only those chapters in which national exposure assessment approaches differ from those given in the core assessment due to specific national assessment requirements. In the present case, no specific national assessment requirements are identified and accordingly, additional calculations are not necessary for the risk assessment (reference should be made to the core assessment for more information) Applicant Mitsui AgriScience International S.A./B.V. Evaluator: Germany Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Part B – Section 6 National addendum Germany 2.3 Registration Report – Central Zone Page 3 of 9 Delfin WG Product uses GAP rev. PPP (product name/code) Agree 50 WG Formulation type: WG active substance Bacillus thuringiensis subsecies aizawai Conc. of as : 500 g/kg professional use x , date: 2012-06-12 Stamm GC- 91 Applicant: Mitsui AgriSciences International S.A./B.V. Zone(s): central EU non professional use Verified by MS: yes 1 UseNo. 2 Member state(s) 3 Crop and/ or situation (crop destination / purpose of crop) 4 F G or I 5 Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 6 7 8 Application Method / Kind Timing / Growth stage of crop & season DE grape vine (VITVI) (use as table and wine grape) F grape berry moth 1.generation (L1-L2) spraying or fine spraying (low volume spraying) from emergence of first larvae after beginning of infestation or warning service appeal / from BBCH 53 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser 11 12 Application rate Max. number (min. interval between applications) a) per use b) per crop/ season 001 10 3 (at least 7 days apart) kg, product / ha g, kg as/ha a) max. rate per appl. a) max. rate b) max. total rate per appl. per crop/season b) max. total rate per crop/season a) – base dose: a) 0,125 -0,375 0,25 kg/ha b) 1,125 Water L/ha min / max – base dose: - BBCH 61: 400 l/ha 0,5 kg/ha - BBCH 61: - BBCH 71: 800 l/ha 0,75 kg/ha - BBCH 71: b) 2,25 1200 l/ha Evaluator: Germany 13 14 Remarks: PHI (days) e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Part B – Section 6 National addendum Germany 002 DE grape vine (VITVI) F grape berry moth 2. and 3. generation (L1L2) (use as table and wine grape) Registration Report – Central Zone Page 4 of 9 Delfin WG spraying or fine spraying (low volume spraying) from emergence of first larvae after beginning of infestation or warning service appeal / from BBCH53 3 (at least 7 days apart) a) – base dose: a) 0,125 – 0,5 – base dose: 0,25 kg/ha b) 1,5 400 l/ha - BBCH 61: - BBCH 61: 0,5 kg/ha 800 l/ha - BBCH 71: - BBCH 71: 0,75 kg/ha 1200 l/ha -BBCH 75: - BBCH 75: 1 kg/ha 1600 l/ha b) 2,25 003 DE berries (NNNOB) F free biting caterpillars except for strawberry 004 DE berries (NNNOB) G free biting caterpillars except for strawberry 005 006 DE DE strawberry (FRAAN) strawberry (FRAAN) F G free biting caterpillars free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 max. 1000 from BBCH 11 max. 1000 from BBCH 11 1000 - 2000 from BBCH 13 from BBCH 13 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Evaluator: Germany 1000 - 2000 Part B – Section 6 National addendum Germany 007 008 DE DE fruit vegetables (NNNVF) G leafy and stem vegetables (NNNVL) F free biting caterpillars free biting caterpillars except for vegetable cabbage 009 DE leafy and stem vegetables (NNNVL) G free biting caterpillars except for vegetable cabbage 010 011 012 DE DE DE vegetable cabbage (BRSOX) vegetable cabbage (BRSOX) root and tuber vegetables (NNNVW) F G F free biting caterpillars free biting caterpillars free biting caterpillars Registration Report – Central Zone Page 5 of 9 Delfin WG spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 6 (at least 7 days apart) from BBCH 09 spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 3 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 6 b) 6 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 200 - 800 from BBCH 09 200 - 1000 from BBCH 09 200 - 800 from BBCH 09 200 - 1000 from BBCH 09 from BBCH 09 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Evaluator: Germany 200 - 800 Part B – Section 6 National addendum Germany 013 014 015 016 017 DE DE DE DE DE root and tuber vegetables (NNNVW) bulb crops (NNNSZ) herbs (NNNKR) herbs (NNNKR) pulse crops (NNNLG) G F F G F free biting caterpillars free biting caterpillars free biting caterpillars free biting caterpillars free biting caterpillars Registration Report – Central Zone Page 6 of 9 Delfin WG spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 200 - 1000 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) 1 a) 0,5 b) 3 b) 1,5 3 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 < 50 cm: 0,5 kg/ha b) 1,5 min 600 l/ha from BBCH 09 200 - 800 from BBCH 09 200 - 800 from BBCH 09 200 - 800 from BBCH 09 from BBCH 09 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 3 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Evaluator: Germany Part B – Section 6 National addendum Germany 018 DE pulse crops (NNNLG) G free biting caterpillars Registration Report – Central Zone Page 7 of 9 Delfin WG spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / 3 (at least 7 days apart) from BBCH 09 a) < 50 cm: a) 0,25 – 0,5 < 50 cm: 0,5 kg/ha b) 1,5 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 3 019 DE ornamentals (NNNZZ) F free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 3 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 6 020 DE ornamentals (NNNZZ) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 3 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 6 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Evaluator: Germany Part B – Section 6 National addendum Germany 021 DE woody ornamentals (NNNZG) G free biting caterpillars Registration Report – Central Zone Page 8 of 9 Delfin WG spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 3 (at least 7 days apart) a) < 50 cm: a) 0,25 – 0,5 a) < 50 cm: 0,5 kg/ha b) 1,5 min 600 l/ha 50 – 125 cm: 50 – 125cm: 0,75 kg/ha min 900 l/ha > 125 cm: > 125 cm: 1 kg/ha min 1200 l/ha b) 3 Applicant Mitsui AgriScience International S.A./B.V. Applicant Document ID dRR Part B Section 6Date: November 2015 Applicant Author Dr. Sabine Asser-Kaiser Evaluator: Germany Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 1 of 55 REGISTRATION REPORT Part B Section 7: Efficacy Data and Information Detailed Summary Product Code: Agree 50 WG Reg. No.: ZV1 007638-00-00 Active Substance: Bacillus thuringiensis ssp.aizawai GC-91 500g/kg Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Mitsui AgriScience International S.A./B.V Date: 2012-04-27 Evaluator: Julius Kühn-Institut Date: 2015-11-12 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 2 of 55 Table of Contents IIIA1 6 Efficacy Data and Information on the Plant Protection Product ............................ 4 General information ............................................................................................. 4 Recent registration situation/history of the PPP ................................................... 4 Information on the active ingredients (Uptake and mode of action) ..................... 5 Information on crops and pests ........................................................................... 5 Information on the intended uses ........................................................................ 6 Further Information .............................................................................................. 6 IIIA1 6.1 Efficacy data........................................................................................................ 8 IIIA1 6.1.1 Preliminary range-finding tests ............................................................................ 8 IIIA1 6.1 Efficacy data for caterpillars infesting grape vine ................................................. 8 IIIA1 6.1.2 Minimum effective dose tests .............................................................................. 8 IIIA1 6.1.3 Efficacy tests ....................................................................................................... 9 IIIA1 6.1.4 Effects on yield and quality ................................................................................ 10 IIIA1 6.1.4.1 Impact on the quality of plants and plant products ............................................. 10 IIIA1 6.1.4.2 Effects on the processing procedure ................................................................. 10 IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products .................................... 10 IIIA1 6.1 Efficacy data for free biting caterpillars infesting soft berries ............................. 10 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 11 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 11 IIIA1 6.1 Efficacy data for free biting caterpillars infesting strawberries ............................ 11 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 12 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 12 IIIA1 6.1 Efficacy data for free biting caterpillars infesting fruit vegetables ....................... 12 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 12 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 13 IIIA1 6.1.4 Effects on yield and quality ................................................................................ 16 IIIA1 6.1 Efficacy data for free biting caterpillars infesting leafy and stem vegetables ...... 17 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 17 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 17 IIIA1 6.1 Efficacy data for free biting caterpillars infesting vegetable cabbage ................. 17 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 18 IIIA IIIA1 6.1.3 Efficacy tests ..................................................................................................... 18 1 6.1.4 Effects on yield and quality ................................................................................ 21 IIIA1 6.1 Efficacy data for free biting caterpillars infesting root and tuber vegetables ....... 22 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 22 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 22 Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 3 of 55 IIIA1 6.1 Efficacy data for free biting caterpillars infesting allium bulb crops .................... 23 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 23 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 23 IIIA1 6.1 Efficacy data for free biting caterpillars infesting fresh herbs ............................. 23 IIIA1 6.1 Efficacy data for free biting caterpillars infesting pulse crops ............................. 24 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 24 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 24 IIIA1 6.1 Efficacy data for free biting caterpillars infesting ornamentals ........................... 26 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 26 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 26 IIIA1 6.1 Efficacy data for free biting caterpillars infesting forests .................................... 27 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 27 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 27 IIIA1 6.1 Efficacy data for free biting caterpillars in the public green ................................ 28 IIIA1 6.1.2 Minimum effective dose tests ............................................................................ 28 IIIA1 6.1.3 Efficacy tests ..................................................................................................... 28 IIIA1 6.1.4 Effects on yield and quality for all crops............................................................. 28 IIIA1 6.2 Adverse effects ................................................................................................. 29 IIIA1 6.2.1 Phytotoxicity to host crop................................................................................... 29 IIIA1 6.2.2 Adverse effects on health of host animals ......................................................... 29 IIIA1 6.2.3 Adverse effects on site of application ................................................................ 29 IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees)................................ 29 IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...................... 33 IIIA1 6.2.6 Impact on succeeding crops .............................................................................. 33 IIIA1 6.2.7 Impact on other plants including adjacent crops ................................................ 33 IIIA1 6.2.8 Possible development of resistance or cross-resistance ................................... 33 IIIA1 6.3 Economics ........................................................................................................ 34 IIIA1 6.4 Benefits ............................................................................................................. 34 IIIA1 6.4.1 Survey of alternative pest control measures ...................................................... 34 IIIA1 6.4.2 Compatibility with current management practices including IPM........................ 34 IIIA1 6.4.3 Contribution to risk reduction ............................................................................. 34 IIIA1 6.5 Other/special studies ......................................................................................... 34 IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...................... 34 IIIA1 6.7 List of test facilities including the corresponding certificates .............................. 38 Appendix 1: List of data submitted in support of the evaluation ............................................. 39 Appendix 2: GAP tables ........................................................................................................ 47 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment IIIA1 6 Registration Report Central Zone Page 4 of 55 Efficacy Data and Information on the Plant Protection Product General information This document reviews efficacy data for the microbial plant protection product Agree 50 WG (also called Turex WG or Turex 50 WG) containing Bacillus thuringiensis ssp. aizawai strain GC-91 (Bta GC-91). Inclusion of Bta GC-91 into Annex I entered into force in May 2009 (Commission Directive 2008/113/EC). Bta GC-91 was notified and defended by Mitsui AgriScience International S.A./B.V. Agree 50 WG was not the representative formulation, and has not been previously evaluated in the EU according to Uniform Principles. Nonetheless, Agree 50 WG contains the same active substance (Bta GC-91), in the same proportions, which can be found in the representative formulation Agree 50 WP. Agree 50 WG consists of spores and crystal proteins (δ-endotoxins) from the bacteria B. thuringiensis subsp. aizawai GC-91 and contains 25,000 i.u./mg. It is a biological insecticide formulated as a water dispersible granule, containing 3 × 1013 colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product. Agree 50 WG is to be applied at a dose rate of 0.05-0.1% up to 1 kg/ha. Agree 50 WG is non-systemic and poisons the caterpillars. Therefore, it is used to control leaf consuming caterpillars on various crops. Upon ingestion, the crystal proteins dissolve in the stomach and damage the tissue. The caterpillars stop eating and die after a few days. Mostly young caterpillars are more sensitive than old ones. For an adequate effectiveness all plant parts should be sufficiently sprayed. Applications are performed at pest occurrence, independently from the crop growth stage. This document refers to the conclusions of the EU review of Bta GC-91. The active substance data is relied upon in the risk assessment of the formulation Agree 50 WG. The representative formulation in the EU review was Agree 50 WP. The Annex I Inclusion Directive for Bta GC-91 (Commission Directive 2008/113/EC) provides specific provisions under Part B, which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation: For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the active substance Bta GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Recent registration situation/history of the PPP Some Bacillus thuringiensis subsp. aizawai containing products are registered in Europe for the control of lepidopteran larvae in various crops such as vegetables, ornamentals, fruits, grape vine, other arable crops and forests, in greenhouses and in the field. Some of these products contain combinations of B. thuringiensis subsp. aizawai and B. thuringiensis subsp. kurstaki. Table 6-1: A list of countries and products can be found in the following Country products Belgium XenTari WG (15,000 IU/mg) Finland Turex 50 WP (500 g/kg) Germany Turex (500 g/kg); XenTari (540 g/kg) Greece Italy Xentari WG (3%) Flobac (100 g/kg); Xentari (100 g/kg); Turex (500 g/kg Bt kurstaki & aizawai); Agree (500 g/kg Bt kurstaki & aizawai) Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Luxembourg The Netherlands Portugal Spain Sweden France Registration Report Central Zone Page 5 of 55 XenTari WG (3%) Turex 50 WP (50%); XenTari WG (15,000 IU/mg) Turex (380 g/kg) XenTari GD (150 g/kg); Turex (250 g/kg) Turex 50 WP (50% Bt kurstaki & aizawai strain GC 91) Turex 50 WP (50% Bt kurstaki & aizawai strain GC 91) Table 6-2: Existing approval of products containing Bta GC-91 in the European zone Country Registration number Country Registration number Italy 9477 Netherlands 11702 N Spain 19430/13 Germany 04143-00 (until 2005) Portugal 3234 Switzerland W-6882 Greece 1661 Sweden 4492 Cyprus 2189 Finland 1735 Information on the active ingredients (Uptake and mode of action) Bacillus thuringiensis (Bt) is an ubiquitous bacterium occurring worldwide, mainly in soils as well as on insects and on plant surfaces. B. thuringiensis belongs to the spore forming bacteria of the family Bacilliacea. Dormant spores of B. thuringiensis can persist for long in the environment and contribute to the transmission of the species in the environment, but are metabolically inactive. During sporulation B. thuringiensis produces inclusion bodies which are composed of insecticidal crystal proteins (ICP, also called Cry proteins or δ-endotoxins). These Cry toxins are highly toxic to a wide variety of important agricultural and health related insect pests of the order Lepidoptera. The crystal proteins of B. thuringiensis must be ingested to be effective against the target insect. Upon ingestion of B. thuringiensis by the larvae, the crystalline inclusions dissolve in the larval midgut, releasing the insecticidal crystal proteins (δ-endotoxins). Most of the crystal proteins are protoxins, converted proteolytically into smaller toxic polypeptides under the alkaline conditions in the insect midgut. The activated Cry toxins interact with the midgut epithelium cells of susceptible insects. After binding to specific midgut receptors, they insert into the apical membrane to create ion channels, or pores, disturbing the osmotic balance, permeability and the regulation of the transmembrane electric potential. This can result in colloid-osmotic lysis of the cells, which is the main cytotytic mechanism common to all ICPs. Spore germination and proliferation of the cells into the haemocoel may result in septicaemia, contributing to mortality of the insect larvae. Each B. thuringiensis strain has a unique Cry protoxin pattern varying in number and amount of the single proteins produced. Each type of Cry toxins has a unique spectrum of activity and targets only a small range of Lepidopteran species. Within the small target ranges there are dramatic differences in potency in species that are often closely related. Information on crops and pests Lepidoptera (moths and butterflies) are the second most diverse pest insect order outnumbered only by the beetles. There is hardly any cultivated plant that is not attacked by at least one lepidopteron pest. As pollinators of many plants, adult moths and butterflies are usually beneficial insects that feed on nectar using their siphoning proboscis. The larvae (caterpillars) however almost always have chewing mouthparts that are suitable for feeding on various parts of a plant. Most caterpillars are defoliators or miners of succulent plant tissues. Tomato looper The tomato looper (Chrysodeixis chalcites) is a moth of the family Noctuidae. It is endemic to southern Europe, the Levant and tropical Africa, but can be found in great parts of Europe as a migratory species. The tomato lopper feeds on different herbaceous plants including tomato, strawberries or tobacco and can cause damages in greenhouse crops. Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 6 of 55 Cabbage moth The Cabbage Moth (Mamestra brassicae) is a common European moth of the family Noctuidae. The larvae of the cabbage moth damage many different cabbage species. Winter moth Winter moth (Operophtera brumata) larvae hatch and feed ravenously on leaves and fruit beginning in early spring. Larvae feed on the inside of buds and leaf clusters during the day, inching their way to the outside of leaves at night. In June, larvae drop to the ground under the trees where they bury themselves in the soil until fall. November through January, adults come out and mate. Having no wings, females have a gruelling climb up tree trunks where they lay eggs. Information on the intended uses The intended dose rate for all uses is 1 kg/ha. Use of Agree 50 WG is applied for different pests in soft berry fruits, grapes, fruit and other vegetables including fresh herbs and ornamentals. Table 6-3: Overview of included pests species Pests Acrolepiopsis assectella ACROAS Autographa gamma PHYTOGA Chrysodeixis chalcites PLUSCH Eupoecilia ambiguella CLYSAM Euproctis chrysorrhoea EUPRCH Evergestis forficalis EVERFO Leucoma salicis LEUOSA Lymantria dispar LYMADI Lobesia botrana POLIBO Malacosoma neustria MALANE Mamestra sp. 1MAMEG Mamestra brassicae BARABR Operophtera brumata CHEIBR Pieris sp. PIERSP Plusia sp. PLUSSP Plutella xylostella PLUTMA Polia oleracea Thaumetopoea processionea Yponomeura sp., HYPNSP leek moth silver Y moth tomato looper European grape berry moth brown-tail moth garden pebble moth white satin moth gypsy moth grape berry moth European lackey moth e.g. glasshouse tomato moth cabbage moth common winter moth e.g. small white e.g. silver Y moth or tomato looper cabbage moth glasshouse tomato moth oak processionary caterpillar e.g. spindle ermine moth Apart from Germany, authorisation is applied for different uses in the European central zone (Austria, Belgium, Czech Republic, Hungary, Ireland, Luxembourg, the Netherlands, Poland, Romania, Slovenia, Slovak Republic, and the United Kingdom). Further Information Another WP formulation of Turex is already authorised in the Netherlands (trade name: Turex Spuitpoeder). In this document and trials it is abbreviated to Turex SP, but the formulation is WP. Besides the new WP formulation (Agree 50 WP/Turex WP) also a WG formulation of Turex (Agree 50 WG) has been developed to be marketed in Europe. The bridging trials presented here, were undertaken by the applicant to demonstrate that all three products (Turex SP, Turex/Agree WP and Turex/Agree 50 WG) are similarly effective in pest control when applied in the same crops against the same pests to justify registration of Agree 50 WG in the Central European zone. Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 7 of 55 Data to support the label claims dossier were generated in a total of 53 trials. The majority of these trials (48) were carried out in testing facilities officially recognized in accordance with the Principles of Good Experimental Practice (GEP). Of these trials only a minority was conducted in one of the three concerned EPPO zones (maritime, north-east, south-east), mainly in the maritime zone. Many of the submitted trials were conducted in the Mediterranean zone. The applicant claims that inclusion of data obtained in the Mediterranean EPPO zone for the evaluation of Agree 50 WG in the Central European zone would be justified as under the conditions occurring in the South, pest pressure is usually higher than under the temperate climate occurring in great parts of Central Europe and are thus, at least or even more challenging than in the Central European zone (Bouma, 2005). Conditions in the Mediterranean EPPO zone might be comparable to those occurring in the South-East EPPO zone, at least with regard to temperatures during the time period which is of relevance for cropping. Moreover, available trials in vegetables from the Netherlands and Switzerland, in grapes conducted in the Northern Part of France and in Switzerland and the orchard trials from Poland confirm the efficacy of Agree 50 WG also under the conditions in the Central European zone. A serious problem which appeared during the evaluation process was that the product Agree WG used in some trials was not the one applied for. The content of the test product Agree 50 WG applied for is 25,000 i.u./mg Bt aizawai but in these trials it was a combination of Bt kurstaki & aizawai (Turex 50 WP). In table 6-1 it is described that products named Turex 50 WP and Agree can have different active ingredients. Information for the use of products containing such combinations is given for some trials with Chrysodeixis chalcites and Mamestra brassicae. Therefore these results are not rateable. Information about the de facto content is not given for all trails as in some report the test product is only declared as Bacillus thuringiensis; this is particularly true for non GEP trials. Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment IIIA1 6.1 Efficacy data IIIA1 6.1.1 Preliminary range-finding tests Registration Report Central Zone Page 8 of 55 Data was not included by the applicant due to a large number of GEP trials for registration. IIIA1 6.1 Efficacy data for caterpillars infesting grape vine Authorization is applied for DE. See use-no. 001 and 002 in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Notes on crop Pest(s)/target(s)/aim(s) Pest stage(s) (BBCH) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Use-No. Pest(s)/target(s)/aim(s) Pest stage(s) (BBCH) Dose rate(s) in amount of water to be used 007638-00/00-001 Viticulture grape vine (VITVI) from 53 use as table and wine grape grape berry moth (CLYSAM_2), European grape vine moth (POLYBO_2) 1st generation (Larval stage L1 to L2) Outdoors After beginning of infestation or warning service appeal; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) basic application rate: 0.25 kg/ha in 400 l water/ha growth stage (BBCH scale) 61: 0.5 kg/ha in 800 l water/ha growth stage (BBCH scale) 71: 0.75 kg/ha in 1200 l water/ha 007638-00/00-002 grape berry moth (CLYSAM_3), European grape vine moth (POLYBO_3) 2nd and 3rd generation (Larval stage L1 to L2) basic application rate: 0.25 kg/ha in 400 l water/ha growth stage (BBCH scale) 61: 0.5 kg/ha in 800 l water/ha growth stage (BBCH scale) 71: 0.75 kg/ha in 1200 l water/ha growth stage (BBCH scale) 75: 1 kg/ha in 1600 l water/ha Authorization is applied for the central zone also. See use-no. 001 in appendix 2, table 2. Crop and/or situation (a) Grapes F, Pests or Groups of pests G, controlled or I (c) (b) F Tortricidae (Lobesia botrana, Eupoecilia ambiguella) Application* Growth stage (j) BBCH 53-89 Application rate per treatment kg MPCA./hL water (kg MPCP/hL) L/ha min-max min-max 0.025 (0.05) kg MPCA./ha (kg MPCP/ha) min-max 2000 0.5 (1.0) Foliar application with 1-3 applications and an interval of 7 days between applications. From a formal point of view the applicant did not deliver the complete set of data necessary for the registration in viticulture (e.g. trials on the impact of the product on the fermentation and the quality of the wine). The evaluation based therefore additionally on the long term experience we have with this and with other products containing the same active ingredient. IIIA1 6.1.2 Minimum effective dose tests No information delivered for viticulture. Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment IIIA1 6.1.3 Registration Report Central Zone Page 9 of 55 Efficacy tests The effectiveness trials testing the efficacy against vine moth were carried out in 1999, 2007, 2010 and 2012 in France (Northern and Southern part), Italy and Spain. The trials were conducted in compliance with the CEB guideline 100 or 222: Vine tortrix as well as EPPO guideline PP 1/11(3) Eupoecilia ambiguella and Lobesia botrana. The target pests were Eupoecilia ambiguella (9 trials) and Lobesia botrana (10 trials). All trials were set up in a randomised complete block design with 4 replicates. The plots contained between 5 and 30 plants with plot sizes between 8 and 46 m². The grapevine varieties ‘Chardonnay’, ‘Gamay’ and ‘Pinot noir’, ‘Melon de Bourgogne’, ‘Muscated’, ‘Carignan’ (Noir), ‘Syrah’, ‘Bobal’, ‘Fridularo’, ‘Trebbiano’, and ‘Montepulciano’ were used in the trials. Normal crop maintenance applications were applied. No insecticides with the same spectrum of activity were applied during the trial. Additional non GEP-trials (see table W-1) were not considered for the efficacy evaluation as they are badly documented and cryptic. They deliver no information about the design of the trials and about the circumstances under which they took place. Tabel W-1 shows a summary and overview of the trials delivered for the registration of Agree against Eupoecilia ambiguella and Lobesia botrana. Table W-2 gives information about the efficacy against Eupoecilia and Lobesia of the product Agree within the efficacy trials conducted in the maritime and in the Mediterranean zone. Table W-1: Summary of the efficacy trials delivered by the applicant for the registration of Agree against the first to third generation of Lobesia botrana and Eupoecilia ambiguella Trial code FAGS 99 4094 FAGS 99 4299 FAGS 99 4327 FAGS 99 5987 FAGS 99 6006 FAGS 99 6026 FCER129901 FCER102102 S10-2129-01 FCER127062 FCER128065 FCER103660 Bari 2. Generation Bari 3. Generation AOOSVIRIS 3409 01992EIVI CAI 14010 SRS10-045-10IE SRS10-044-10IE *Trial No. 219 *Trial No. 212 *Trial No. 130 *Trial No. 301 *Trial No. 131 *93502 *Trial No. 134 *Trial No. 131.2 *Trial No. 133 Location Civray Cars St. Paul Athée Cercié Villé sur Jarnioux Maisdon sur Sevre Maisdon sur Sevre St. Georges sur Layon Redessan Toulouges Bages Bari Bari Calosso Tribano Ravenna Valencia Valencia country France France France France France France France France France France France France Italy Italy Italy Italy Italy Spain Spain climatic zone Eppo PP 1/241(1) maritim maritim maritim maritim maritim maritim maritim maritim maritim mediterranean mediterranean mediterranean mediterranean mediterranean mediterranean mediterranean mediterranean mediterranean mediterranean Yvorne Yvorne Saillon Mont sur Rolle Leytron Leytron Leytron Leytron Saillon Switzerland Switzerland Switzerland Switzerland Switzerland Switzerland Switzerland Switzerland Switzerland maritim maritim maritim maritim maritim maritim maritim maritim maritim year 1999 1999 1999 1999 1999 1999 2012 2010 2010 2012 2012 2010 2007 2007 2010 1999 2010 2010 2010 Eppo guideline no no no no no no PP 1/11(3) CEB No 222 PP 1/11(3) PP 1/11(3) PP 1/11(3) PP 1/11(3) no no PP 1/11(3) PP 1/11(3) PP 1/11(3) PP 1/11(3) PP 1/11(3) BBCH 79 75-77 77 79 79 79 77-79 79 75 75-79 75-79 75 ? ? 75-79 77 77 79-81 73-81 Pest species Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Eupoecilia ambiguella Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana No. of applications 1 1 1 1 1 1 3 2 2 3 2 2 2 2 2 2 2 3 4 1993 1993 1993 1993 1993 1994 1994 1993 1994 ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Eupoecilia ambiguella Eupoecilia ambiguella Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana Lobesia botrana 3 2 4 3 4 1 4 4 4 infestation untreated [%, no. of perforations/100 bunches] 13 20,5 7,3 40,5 44,8 20,3 171 44,6 328 29,25 203 395 26,7 11,4 239 477 446 67,5 85 2,1 63 and 115 107 0,5 64 27 6,5 64 8 *: Trial not considered as the applying company only delivered a result overview and no trial protocol. Material and Methods of these trials are not clear. Table W-2: Mean efficacy (Abbot) of Agree in the efficacy trials against Lobesia botrana and Eupoecilia ambiguella mean efficacy [%] (Abbot) 75.3 SD 20.4 Min efficacy Max efficacy [%] (Abbot) [%] (Abbot) 17.9 97.87 Conclusion: Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 10 of 55 Viticulture in Germany is a major use (100,000 ha). 9 trials together with the additional information from the Mediterranean area are enough for a registration within the maritime climate zone of the central registration zone. We do not recommend the registration within the south east EPPO-zone as no trials have been conducted there at all. • Not all considered trials where conducted according to an EPPO-guideline. We do not know the French guideline they used, but apparently both guidelines are comparable. We would expect to get trial results according to the EPPO guideline which was first approved in 1977. • The trials are exclusively done during the second generation. As we expect a higher UVdegradation of the Bt-product during the first generation of both moth species than during the second generation, when pea-shaped berries are shadowed by the canopy, we expect a lower efficacy in the first generation than in the second. No trials show the contrary. Consequently we recommend the registration only for the maritime zone and only for the 2nd and 3rd generation of Eupoecilia ambiguella and Lobesia botrana and not for their first generation. • IIIA1 6.1.4 Effects on yield and quality IIIA1 6.1.4.1 Impact on the quality of plants and plant products The applicant delivered only little information on this topic for viticulture. The product had been registered in many European countries until now. During all those years there were no reports about phytotoxicity on grape of this product and we do not expect any. IIIA1 6.1.4.2 Effects on the processing procedure The applicant delivered no information on this topic for viticulture for viticulture except a publication about the effect of Bt.-toxin on yeasts (There was no yeast inhibiting effect). The product had been registered in many European countries until now. During all those years there were no reports about an effect of this product on the fermentation kinetics or the quality of the wine. With regard to the practical experience we have with this product for a lot of years, we do not request more fermentation trials. IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products The applicant delivered no information on this topic for viticulture. The product had been registered in many European countries until now. During all those years there were no reports of negative effects on the yield and quality of the grapes harvested. IIIA1 6.1 Efficacy data for free biting caterpillars infesting soft berries Authorization is applied for DE. See use-no. 003 (field) and 004 (greenhouse) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used 007638-00/00-003 Fruit growing Berries (NNNOB) (except: strawberry (FRAAN)) from 11 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in max. 1000 l water/ha Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Rate App. comment Registration Report Central Zone Page 11 of 55 treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 002-003 in appendix 2, table 2. Crop and/or situation (a) Red, black and white currant, blueberry, goosberry, blackberry, raspberry F, Pests or Groups of pests G, controlled or I (b) (c) Application* Growth stage F Geometridae (Operophtera brumata) April - May BBCH 00-79 (j) G January – December BBCH 00-99 Application rate per treatment kg MPCA./hL water kg MPCA./ha (kg MPCP/hL) (kg L/ha MPCP/ha) min-max min-max min-max 0.025 (0.05) 0.5 (1.0) 2000 Foliar application with 1-3 applications and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests No data submitted for this use. IIIA1 6.1.3 Efficacy tests No data was submitted for the control of winter moth (Operophtera brumata) in red, black and white currant, blueberry, gooseberry, blackberry or raspberry. Due to the specific conditions in berry crops and the time of pest occurrence in spring an extrapolation form other uses is not possible. Conclusion: The registration of the use against winter moth (Operophtera brumata) in red, black and white currant, blueberry, gooseberry, blackberry or raspberry will not be supported because no data were submitted for this use (EPPO standard PP 1/226). An extrapolation form other uses is not possible due to the specific conditions in berry crops and the time of pest occurrence during spring time. IIIA1 6.1 Efficacy data for free biting caterpillars infesting strawberries Authorization is applied for DE. See use-no. 005 (field) and 006 (greenhouse) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-005 Fruit growing Strawberry (FRAAN) from 13 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in 1000 to 2000 l water/ha treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 004-005 in appendix 2, table 2. Crop and/or situation (a) Strawberry F, Pests or Groups of pests G, controlled or I (b) (c) F Plutellidae (Plutella xylostella), Noctuidae (Autographa gamG ma, Plusia spp.) Application* Growth stage (j) April – September BBCH 13-89 January – December BBCH 13-89 Application rate per treatment water kg MPCA./ha kg MPCA./hL L/ha (kg MPCP/hL) (kg MPCP/ha) min-max min-max min-max 0.083 - 0.167 (0.167 – 0.333) 0.025 (0.05) 300 - 600 2000 0.5 (1.0) Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 12 of 55 Foliar application with 1-3 applications and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests No data submitted for this use. IIIA1 6.1.3 Efficacy tests No data was submitted for the control of lepidopteran pests in strawberry. Due to the specific application techniques in strawberry crops a minimum of GEP trails are necessary for a regular registration. Furthermore Plutella xylostella is not a pest of strawberries. Conclusion: The registration of the use against lepidopteran pests in strawberry will not be supported because no data were submitted for this use (EPPO standard PP 1/226). An extrapolation form other uses is not possible due to the specific application techniques conditions in strawberry crops. IIIA1 6.1 Efficacy data for free biting caterpillars infesting fruit vegetables Authorization is applied for DE. See use-no. 007 in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-007 Vegetable growing fruit vegetables (NNNVF) from 09 free biting caterpillars (LEPISF) Greenhouse After beginning of infestation; from emergence of first larvae 6 6 spraying or fine spraying (low volume spraying) plant height up to 50 cm 0.5 kg/ha in at least 600 l water/ha plant height 50 up to 125 cm 0.75 kg/ha in at least 900 l water/ha plant height more than 125 cm 1 kg/ha in at least 1200 l water/ha treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 005 in appendix 2, table 2. Crop and/or situation (a) Tomato, pepper (sweet and chilli), eggplant Cucumber, gherkin, courgette, melon, patisson F, Pests or Groups of pests G, controlled or I (b) (c) G Noctuidae (Chrysodeixis chalcites, Autographa gamma, Polia oleracea, Plusia spp.) G Noctuidae (Chrysodeixis chalcites, Autographa gamma, Polia oleracea, Plusia spp.) Application* Growth stage (j) Application rate per treatment water kg MPCA./ha kg MPCA./hL L/ha (kg (kg MPCP/hL) MPCP/ha) min-max min-max min-max January - December BBCH 09-89 0.025 (0.05) 2000 0.5 (1.0) January – December BBCH 09-89 0.025 (0.05) 2000 0.5 (1.0) *Foliar application with 6 applications at most and an interval between applications of 7 days. IIIA1 6.1.2 Minimum effective dose tests Beet armyworm and silver Y moth:In all trials the intended does rate of 1 kg/ha or higher doses were tested. A clear dose response with the higher rate being more effective was not observed. Tomato looper: In all trials the intended dose (1.0 kg/ha) and a reduced dose (0.5 kg/ha) was tested. In most cases Turex WG (similar to Agree 50 WG) was used, in two trials a product a Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 13 of 55 WP formulation was used. Not in all trials a clear and significant dose response of Turex WG applications with 1 and 0.5 kg/ha was found. Nevertheless, the number of living larvae, the leaf area damaged and the number of damaged leaves was nearly always higher with 0.5 kg/ha than with 1.0 kg/ha proving that 1 kg/ha gives better control than 0.5 kg/ha. Therefore and because of the long history of use of BT products, it seems not to be advisable to reduce the intended dose of 1.0 kg/ha. In all trials evaluated for this use, a dose of 1 kg/ha was applied at crops not higher than 50 cm, and thereby a double dose of the intended one (for Germany). For higher crops (sweet pepper) a higher dose (2 kg/ha) was used by keeping a concentration of 0.1%. For fruit vegetables the intended dose in this use may be sufficient, because fruit vegetables have only little leaf area at a height beneath 125 cm in contrast to other crops such as pulse crops or ornamentals which build dense crop stands even below 50 cm. Regarding these results, it seems not advisable to reduce the intended dose of 1 kg/ha. IIIA1 6.1.3 Efficacy tests Data available to evaluate this use are (a) Tomato looper(Chrysodeixis chalcites): (b) Beet armyworm (Spodoptera littoralis): (c) Silver Y moth (Autographa gamma): 8 trials conducted in the greenhouse, maritime zone; 1 fruit vegetable, 7 ornamental trials 7 additional trials, Mediterranean zone; 2 greenhouse, 5 field trials; 3 fruit vegetable, 4 vegetables trials 1 additional field trial, Mediterranean zone; (a) Tomato looper (Chrysodeixis chalcites, Noctuidae) Material and methods: Eight efficacy trials against tomato looper were carried out in 2003 to 2011 in The Netherlands (Table 1). The trials from 2010 and 2011 were conducted in compliance with the EPPO guidelines pp 1/150(2): ‘Spodoptera exigua on cotton’. All trials were set up in a randomised complete block design with 3 or 4 replicates. In 8 trials the WG and WP formulations were used, in 2 trials the WP formulation only. Agree 50 WG (in the following Agree) was tested at dose rates of 0.05 and 0.1%, resulting in 0.5 and 1 kg/ha, in two trials of 1.5 and 2 kg/ha. The product and the reference products are listed in table 3. Assessments were carried out just before each application and one and two weeks after the last application. The number of living and dead caterpillars was counted per plot. Furthermore, the percentage of leaf surface damaged by C. chalcites was assessed and the number of damaged leaves was counted. The control of larvae of C. chalcites was calculated according to the Henderson & Tilton formula. Results: Treatments with Agree (1% or 1 kg/ha) gave high, increasing levels of control until 14 days after the 2nd applications (85-100%). The levels of control were slow in the beginning but in the comparable for all Bta containing products not depending on the formulation. Similarly comparable were the reference products Xentari and Nomolt, whereas the efficacy of Nomolt was slightly weaker. The percentage of leaf area damaged decreased and was in most trials significantly lower than that recorded for the untreated control at the last assessment. Results were comparable to those found for the reference treatments. Additionally, the number of damaged leaves was significantly lower than those recorded for the untreated control at the last two assessments. The number of damaged leaves found was comparable to those found for the reference treatments. Phytotoxic symptoms were not found. Table F-1: Efficacy trials submitted for Agree 50 WG evaluated against tomato looper Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment No. Year 1 crop g/f 2003 sweet pepper greenhouse ‘express’ 4 m high 2005 pot gerbera greenhouse no. appl. dose 32) Registration Report Central Zone Page 14 of 55 L/ha water GEP Products1) 0.1 % = 2000 l/ha Yes 3/4/7/8/9 2 kg /ha 2 22) 0.1 % = 1000 l/ha Yes 3/4/7/8/9/10 1 kg /ha 3 2008 pot gerbera greenhouse 2 0.1 % = 1500 l/ha Yes 35 cm high 1/3/7/8 1.5 kg /ha 4 2010 hibiscus ‘Sunny greenhouse 2 0.1 % = 1000 l/ha Yes; Red’ 1/2/4/5/7 1 kg /ha 5 2010 hibiscus ‘Athe- greenhouse 2 0.1 % = 1000 l/ha Yes; na’ 1/2/4/5/6/7 1 kg /ha 6 2010 hibiscus greenhouse 2 0.1 % = 1000 l/ha Yes; ‘S. Zaragoza’ 1/2/4/5/6/7 1 kg /ha 7 2011 hibiscus ‘Bor- greenhouse 2 0.1 % = 1000 l/ha Yes deaux’ 1/2/3/4/5/6/7 1 kg /ha 8 2011 hibiscus ‘Can- greenhouse 2 0.1 % = 1000 l/ha Yes cun’ 1/2/3/4/5/6/7 1 kg /ha 1) For a description of the reference products see table 3 2) Turex WP as a combination of BT subsp. kurstaki and BT subsp. aizawai 3) 0 = not sufficiently effective (up to about 70 %); + = sufficiently effective (70 to 90%); ++ = good efficacy (> 90%) Efficacy 3) + not specified + ++ ++ + ++ ++ (b) Beet armyworm (Spodoptera littoralis, Noctuidae) Material and methods: Seven efficacy trials against beet armyworm were carried out in the Mediterranean zone (Table 2). The trials were conducted in compliance with the EPPO guidelines pp 1/150(2): ‘Spodoptera exigua on cotton’. All trials were set up in a randomised complete block design with 4 replicates. Agree 50 WG (in the following Agree) was tested at dose rates of 1, 1.2, 1.5 and 2 kg/ha. The test and the reference products are listed in table 4. In some trials the number of living and dead caterpillars was counted per plot. Furthermore, the percentage of leaf surface damaged was assessed and the number of damaged leaves was counted. The efficacy was calculated according to the Henderson & Tilton formula. Results: In all but one trials a sufficient (+) or good (++, > 90%) efficacy of the test product was shown. Treatments with Agree gave high, increasing levels of control until to 7 days after the last applications (70-96%). The levels of control were slow in the beginning but in the comparable for all Bta containing products not depending on the formulation. Also, there was no difference in efficacy between the different doses. In mean, the reference products Xentari, Delfin, Laser, and Steward were similarly comparable. The percentage of leaf area damaged decreased and the number of damaged leaves was significantly lower than those recorded for the untreated control at the last assessments. Results were comparable to those found for the reference treatments. In the last trial the number of damaged fruits (F) was recorded. All BT products reduced the number of damaged fruits to about 60-75%. Only Redan performed better with 90% sound fruits (trial 15). Phytotoxic symptoms were not found. Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 15 of 55 Table F-2: Efficacy trials submitted for Agree 50 WG evaluated against Beet armyworm No. Year Crop & cultivar F/G no. dose rate ProdGEP country appl. L/ha water ucts1) 9 1999, IT pepper ‘Soldi‘ G 3 1.5 & 2 kg/ha in 13 No 900 L/ha 10 2005, ES* brokkoli ** F 2 1.5 & 2 kg/ha 7, 9, 12 Yes 11 2006, IT* cauliflower ‘PaF 6 1.2 kg/ha in 900 - 1,7 miros‘ 1200 l/ha 12 2008, IT pepper ‘Quadrato F 3 1 & 1.5 kg/ha in 9, 7, 15 rosso‘ 1000 L/ha 13 2010, IT lettuce ‘Mafalda‘ F 3 1.5 kg/ha in 1000 13, 14 L/ha 14 2010, IT lettuce ‘Ballerina’ G 4 1, 1.5 & 2 kg/ha in 9, 13, 15 800 L/ha 15 2010, IT pepper ‘Corino‘ F 4 1.5 kg/ha in 1000 9, 13, 16 L/ha * low infestation level in untreated; ** original trial document not submitted (AS 6204 I 03) **) 0 = not sufficiently effective (up to about 70 %); + = sufficiently effective (70 to 90%); ++ = good efficacy (> 90%) F) In this trail, the number of damaged fruits (F) was recorded. EF **) ++ ++ + ++ 0 + +F) (c) Silver Y moth (Autographa gamma, Noctuidae) Material and methods: See table 3. Three different formulations of Agree were tested: Agree WP (new), Agree WP (old) and Agree WG. Results: The degree in pest incidence increased throughout the trial with 70% of fruits infested at the last assessment. Under the conditions of the study, efficacy with regard to the reduction in fruit damage was generally low for all Bt products. Best results were obtained with the chemical standard treatment. Efficacy with regard to the reduction of leaf damage was very similar for all products with best results achieved with the highest rate of Agree WP and the chemical treatment; however, not significant. Applied at the same rate, the results for the Agree formulations were very similar confirming that data on Agree WP (old or new formulation) can be used to support the label claims of Agree 50 WG. There was no clear dose-response observed for Agree WP. Table F-3: Efficacy trials submitted for Agree 50 WG evaluated against silver Y moth No. Year Crop & cultivar F/G no. dose rate ProdGEP country appl. L/ha water ucts1) 16 2010, water melon ‘Pata F 3 1.0, 1.5 and 2.0 9, 13, 17 Yes ES negra’ kg/ha in 1000 L/ha *) + = sufficiently effective (70 to 90%) Table F-4: Reference products used in the efficacy trials Product active substance content 1 Turex SP (WP) B. t. subsp. aizawai 25.000 i.u./mg 2 Turex SP (WP) B. t. Subsp. aizawai 25.000 i.u./mg 3 Turex WP B. t. subsp. aizawai 25.000 i.u./mg 4 Turex WP B. t. subsp. aizawai 25.000 i.u./mg 5 Turex WG B. t. subsp. aizawai 25.000 i.u./mg EF *) + application rate per ha 1.0 kg/ha 25x109 i.u./ha 0.5 kg/ha 12.5x109 i.u./ha 1.0 kg/ha 25x109 i.u./ha 0.5 kg/ha 12.5x109 i.u./ha 1.0 kg/ha 25x109 i.u./ha Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 16 of 55 6 Turex WG 7 XenTari WG 8 Nomolt Product B. t. subsp. aizawai B. t. subsp. aizawai teflubenzuron active substance 25.000 i.u./mg 15.000 i.u./mg 150 g/L content 0.5 kg/ha 12.5x109 i.u./ha 1 kg/ha 15x109 i.u./ha 0.4 L/ha application rate per ha 9 10 11 12 13 14 15 16 17 B. t. subsp. aizawai diflubenzuon B. t. subsp. aizawai tebufenozid B. t. subsp. kurstaki indoxacarb spinosad clorpirifos methyl cypermethrin 25.000 i.u./mg 25 g/kg 25.000 i.u./mg 240 g/L 32.000 i.u./mg 300 g/kg 42 g/L 220 g/L no information 1.5 kg/ha 0.5 kg/ha 2 kg/ha 0.75 L/ha 1 kg/ha 0.125 kg/ha 0.2-0.25 L/ha 1.5 L/ha 1.0 L/ha Turex WP Dimilin Turex WP Mimic Delfin WG Steward Laser SC Reldan 22 Cipert IIIA1 6.1.4 37x109 i.u./ha 50x109 i.u./ha 32x109 i.u./ha Effects on yield and quality In only one efficacy trial (15) effects on the yield were recorded, resulting in a reduced the number of damaged fruits of about 60-75%. In all other efficacy trials the percentage of leaf area damaged and the number of leaves damaged was recorded. Both parameters are relevant to the plant quality of ornamentals. In the trials 1-7 the leaf area consumed by lepidopteran larvae in hibiscus and gerbera was significantly reduced. Hence, the quality and depending on the severity of the damage, the number of marketable plants and yield resp. was improved. The yield has been recorded quantitatively in 4 phytotoxicity trials in cucumber (see IIIA1 6.2.1.). The number of fruits was counted after 4 applications with Agree/Turex WG at the proposed dose rate of 0.1% and the double dose rate. No negative influences of Agree/Turex WG on the yield were observed. No tests on transformation processes have been submitted. However, Agree is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product it is not expected to exhibit herbicidal activity. Agree is therefore not expected to cause adverse effects on the yield of treated plants or plant products. In contrary, the protection given by Agree against the various caterpillars will prevent the crops from feeding damages and consequential yield loss. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on yield or transformation processes are known or expected. Conclusion: In all trials besides one a sufficient (+) or good (++) efficacy of the test product was shown. The trials cover a wide range of different crop morphologies, botanical families and cropping systems. Therefore, it can be concluded that the effectiveness of Agree 50 WG is independent of the crop. The application rates used in the presented trials are very different and only little information is given if higher dose rates correspond with crop size (fruit vegetables in the greenhouse can grow up to 5 m). Only in few trials the dose rate corresponds with the proposed GAP for cucurbits and Solanaceous fruits. In all trials efficacy was sufficient concerning number of attacked leaves, living larvae and damaged fruits. In all trials the reference product acted similar or slightly better. The area of use is in the greenhouse. Therefore, results from greenhouse trials conducted the Mediterranean can be included. In 4 additionally submitted trials cucurbits and Solanaceous fruits were included. In the other 11 trails relevant pest species were included. Furthermore, it is possible to extrapolate from the submitted data to larvae of other Noctuid moths. According to the EPPO extrapolation table 09/15092 efficacy in Solanaceae, data on Autographa gamma and Mamestra oleracea in brassica crops can be used for extrapolation to Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 17 of 55 Solanaceous vegetables. Thus, together with data on other pests (Mamestra brassicae, Plutella xylostella, Spodoptera spp., and Pieris sp.) in brassica crops, the claim is support for lepidopteran larvae in Solanaceous fruits and cucurbits. Therefore, authorization is supported. IIIA1 6.1 Efficacy data for free biting caterpillars infesting leafy and stem vegetables Authorization is applied for DE. See use-no. 008 (field) and 009 (greenhouse) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-008 Vegetable growing leafy and stem vegetables (NNNVL) (except: vegetable cabbage (BRSOX)) from 09 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in 200 to 800 l water/ha treatments must be at least 7 days apart Use-No. Area of use Dose rate(s) in amount of water to be used 007638-00/00-009 Greenhouse 1 kg/ha in 200 to 1000 l water/ha Authorization is applied for the central zone also. See uses-no. 008 and 9 in appendix 2, table 2. Crop and/or situation (a) F, Pests or Groups of pests G, controlled or I (b) (c) Application* Growth stage (j) Lettuce, endive, curled F Plutellidae (Plutella xylostella), Pieridae (Pieris spp.), Noctuendive, lamb´s lettuce, idae (Polia oleracea, Autograspinach G pha gamma, Plusia spp.) Application rate per treatment water kg MPCA./ha kg MPCA./hL L/ha (kg MPCP/hL) (kg MPCP/ha) min-max min-max min-max April – September BBCH 09-99 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 January – December BBCH 09-99 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 0.5 (1.0) *Foliar application with 3 applications at most and an interval between applications of 7 days. IIIA1 6.1.2 Minimum effective dose tests No data submitted, see the uses for fruit vegetables and vegetable cabbages. IIIA1 6.1.3 Efficacy tests No data submitted. Conclusion: Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). IIIA1 6.1 Efficacy data for free biting caterpillars infesting vegetable cabbage Authorization is applied for DE. See use-no. 010 (field) and 011 (greenhouse) in appendix 2, table 1. Use-No. 007638-00/00-010 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 18 of 55 Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment Vegetable growing vegetable cabbage (BRSOX) from 09 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in 200 to 800 l water/ha treatments must be at least 7 days apart Use-No. Area of use Dose rate(s) in amount of water to be used 007638-00/00-011 Greenhouse 1 kg/ha in 200 to 1000 l water/ha Authorization is applied for the central zone also. See uses-no. 010, 011 and 012 in appendix 2, table 2. Crop and/or situation F, Pests or Groups of pests G, controlled or I (b) (c) (a) Application* Growth stage (j) Red cabbage, savoy F Plutellidae (Plutella xylostella), cabbage, pointed head Crambidae (Evergestis forficalApril – September cabbage, white is), Pieridae (Pieris spp.), BBCH 09-99 cabbage, Brussel Noctuidae (Autographa gamsprouts, kale ma, Mamestra brassicae, Plusia spp.) Chinese cabbage, choi F Plutellidae (Plutella xylostella), April – September BBCH Crambidae (Evergestis forficalcabbage, cauliflower, 09-99 is), Pieridae (Pieris spp.), broccoli, Indian mustard, kohlrabi G Noctuidae (Autographa gamJanuary – December ma, Mamestra brassicae, BBCH 09-99 Plusia spp.) Application rate per treatment kg MPCA./hL water kg MPCA./ha (kg MPCP/hL) (kg L/ha MPCP/ha) min-max min-max min-max 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 0.5 (1.0) 0.5 (1.0) Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests Data available to evaluate this use are (a) Diamondback moth: 2 trails with only a minor dose (0.5 kg/ha) and sufficient efficacy; (b) Cabbage moth: a minor doses was included in 1 trial (2004 BE) without a clear dose response; in 2 trials higher doses (1.5 & 2 kg/ha) were used with a clear dose response in 1 trial; (c) Cabbage white: minor doses not included but in both trials higher doses (1.5 & 2 kg/ha) with a clear doses response in both trials; Regarding these results, it seems not advisable to reduce the intended dose of 1 kg/ha. IIIA IIIA1 6.1.3 Efficacy tests Data available to evaluate this use are (a) Diamondback moth: 6 trials conducted in the maritime zone; (b) Cabbage moth: 1 trails maritime zone, 4 additional trials, Mediterranean zone; (c) Cabbage white: 2 additional field trial, Mediterranean zone. (a) The diamondback moth Plutella xylostella (Plutellidae) Material and methods: Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 19 of 55 The Diamondback Moth Plutella xylostella is a common European moth. Six trials testing the efficacy of Agree/Turex WG against P. xylostella were carried out in 2002 and 2010 in the Netherlands. The trials 1-3 from 2010 were conducted in compliance with the EPPO guideline PP 1/83(2): Caterpillars on leaf brassicas. While counting the caterpillars a division was made between live caterpillars and pupae. Before the applications as well as one, two and about three weeks after the last application the number of caterpillars per plant was counted. Additionally, at each sampling date the percentage infested plants was determined. The percentage of caterpillar control compared with the untreated treatment was calculated according to Henderson & Tilton. In the trials 3 and 4 only the percentage of damaged sprouts/cabbages was calculated. Results: In the mean of the 2010 trials the efficacy of all Bta containing products was similar and good (Table 1). The feeding damage by the caterpillars was significantly reduced compared to the untreated control. Treated plants showed better plant vigour. In trials 2 and 3 the infestation level was low, but still sufficient for evaluation. In all trials infestation with the cabbage white (Pieris rapae) occurred although infestation level was very low. Larvae of P. rapae were controlled with the Bta product likewise. In trial 3, the percentage of damaged sprouts in the untreated control was 17%. After the application of Turex WP it was significantly lower (8%). This was comparable to the reference product (3%). In trial 4 the number of damaged sprouts and in the trials 5 and 6 the number of damaged heads was significantly reduced (The latter are trial reports of Dutch research stations with unclear intention). Conclusion: Efficacy to control Plutella xylostella is proven for the maritime zone. Table C-1: Efficacy trials submitted for Agree 50 WG evaluated against diamondback moths Year crop g/f no. dose/ for- L/ha waGEP Efficacy 3) Country ap. mulation ter Products1) 2010, NL cauliflower field 3 1 kg/ha, WG 400 l/ha Yes; 1/2/3/5 + ‘Fremont’ 2010, NL cauliflower ‘Cleobis’ field 3 1 kg/ha, WG 400 l/ha Yes; 1/2/3/5 ++ 2010, NL cauliflower ‘Kornalu’ field 3 1 kg/ha, WG 400 l/ha Yes; 1/2/3/5 ++ 2002, NL Brussels sprouts field 5 1 kg/ha, WP not specino; 2/6 + ‘Cyrus’ fied field 5 0.5 kg/ha 2002, NL white cabbage ‘Li500 L/ha no; 7 2) ++ 3) not specified 500 L/ha 2002, NL on’ field 4 no; 4, 5 + 1) For a description of the products see the table 4 2) Turex + adjuvant Designer or Silwet; 3) low infestation level 3) 0 = not sufficiently effective (up to about 70 %); + = sufficiently effective (70 to 90%); ++ = good efficacy (> 90%) (b) The cabbage moth Mamestra brassicae (Noctuidae) Material and methods: The Cabbage Moth Mamestra brassicae is a common European moth of the family Noctuidae. All trials were set up in a randomised complete block design with 4 replicates. Normal crop maintenance applications were applied. No insecticides with the same spectrum of activity were applied during the trial. Results: In Trial 1 the dose per ha of all products is not mentioned and the evaluation method is unclear; therefore the trial is not rateable. In trial 2, the percentage of damaged cabbage heads and the damaged leaf area were significantly reduced after application of Turex WP. This was comparaJulius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 20 of 55 ble to the reference products. No phytotoxic symptoms occurred. In trial 3-5 the test product Agree WG is described as a combination of BT aizawai and kurstaki. Therefore the product applied for is not included and these trials are not rateable. Conclusion: The efficacy is not finally evaluable. TableC- 2: Efficacy trials submitted for Agree 50 WG evaluated against cabbage moths Year crop g/f no. dose L/ha waGEP Country ap. ter Products1) 1993, CH Brussels sprouts field 3 200 g/hL ai no 2004, BE cauliflower field 6 0.5 & 1 kg/ha 600 l/ha not specified; ‘Amerigo’ 2/4/5 2010, IT cauliflower field 5 1, 1.5 & 2 not Yes; 8, 9, 11 ‘Freedom’ kg/ha specified 2010, IT broccoli ‘Switch’ field 4 1.5 kg/ha 800 l/ha Yes; 8, 10, 12 2010, IT broccoli ‘Marafield 5 1, 1.5 & 2 700 l/ha Yes; 8, 10, 12 thon’ kg/ha 1) For a description of the products see the table 4 2) 0 = not sufficiently effective (up to about 70 %); + = sufficiently effective (70 to 90%); ++ = good efficacy (> 90%) Efficacy 2) 0 + + ++ ++ (c) The cabbage white Pieris sp. (Pieridae) Both trials were set up in a randomised complete block design with 4 replicates. Normal crop maintenance applications were applied. No insecticides with the same spectrum of activity were applied during the trial. In both trials a higher as applied dose rate was used. Given that infestation occurred at the end of the trial period, only the last three applications were responsible for control. The efficacy in controlling larvae was sufficient. There was a clear dose response in both trials (1: 94% vs. 100% and 2: 84% vs. 97% efficacy). Conclusion: The efficacy is not finally evaluable. Table C-3: Efficacy trials submitted for Agree 50 WG evaluated against cabbage white Year crop g/f no. Dose L/ha waGEP Efficacy **) Country ap. ter Products* 2005, ES savoy cabbage field 8 1.5 & 2 kg/ha 250 L/ha Yes / 5, 8, 9 ++ ‘Hercules’ (0.75 kg), 14 2005, ES cauliflower ‘Casfield 8 1.5 & 2 kg/ha 600 l/ha Yes / 5, 8, 9 + per’ (0.75 kg), 14 * For a description of the products see the table 4 **) + = sufficiently effective (70 to 90%); ++ = good efficacy (> 90%) Table C-4: Reference products used in efficacy trials Product active substance content 1 Turex SP (WP) B. t. subsp. aizawai 25.000 i.u./mg 2 Turex WP B. t. subsp. aizawai 25.000 i.u./mg 3 Turex WG B. t. subsp. aizawai 25.000 i.u./mg 4 Delfin B. t. subsp. kurstaki 32.000 i.u./mg 5 XenTari WG B. t. subsp. aizawai 15.000 i.u./mg 6 Nomolt teflubenzuron 150 g/L 7 Decis deltamethrin 25 g/L application rate per ha 1.0 kg/ha 25x109 i.u./ha 1.0 kg/ha 25x109 i.u./ha 1.0 kg/ha 25x109 i.u./ha 0.5 kg/ha 16x109 i.u./ha 1 kg/ha 15x109 i.u./ha 0.4 L/ha 0.3 L/ha Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment 8 9 10 11 12 13 14 Turex WP Delfin Delfin Steward Reldan 22 Karate Zeon Mimic B. t. subsp. aizawai B. t. subsp. kurstaki B. t. subsp. kurstaki indoxacarb clorpirifos methyl lambda-cyhalothrin tebufenozid 25.000 i.u./mg 32.000 i.u./mg 32.000 i.u./mg 300 g/kg 220 g/L 100 g/L Registration Report Central Zone Page 21 of 55 1.5 kg/ha 1 kg/ha 1.5 kg/ha 0.125 kg/ha 1.5 L/ha 20 g/L 0.75 kg/ha 37.5x109 i.u./ha 32x109 i.u./ha 48x109 i.u./ha (d) Beet armyworm Spodoptera littoralis (Noctuidae) Efficacy was tested in altogether 7 trails in the Mediterranean; in 2 trials cauliflower and broccoli were included with 1.2 and 1.5 kg/ha and sufficient efficacy (see chapter fruit vegetables). (e) Additional data In four field experiments set up in 1995 at ADAS, United Kingdom, the effectiveness of Agree, Bactospein and two chemical standards was tested against Plutella xylostella, Pieris rapae, Evergestis forficalis and Mamestra brassicae in Brussels sprouts. Spray treatments were applied with 1.125 kg/ha in a water volume of 1000 L/ha. Efficacy for reducing infestation with larvae was sufficient. Within the frame of product development several effectiveness trials were carried out in the USA in 1998, 1999 and 2002. All experiments were set up in complete randomised block design with four replicates. Rated was either the damage score or the number of dead/living larvae or both. The applicant submitted six trials to support the Northern GAP for use in brassica crops although they were conducted in southern states of the USA (Florida, South Carolina). Additionally, it needs to be noted that the number of applications, ranging between three and seven, was in most cases higher than the number of treatments intended for the Central European zone. The dose was approx. 1.1 to 1.4 kg/ha. The obtained results confirm the good effectiveness of Turex WG against Plutella xylostella, Pieris rapae and Evergestis sp. 1 6.1.4 Effects on yield and quality In some trials the percentage of damaged cabbage heads (2002 NL, 2004 BE) or sprouts (2002 NL) was counted. In all trials these parameter were significantly improved compared to the untreated control. Overall conclusion: Drawing a resilient conclusion is difficult. Of all 13 trials only 3 trials were conducted in the central (maritime) zone including GEP and EPPO guidelines proving sufficient efficacy. 4 trials of the maritime zone were unspecified trial records showing sufficient efficacy as well. One old trial was not rateable (1993 CH). For the south east zone 5 trials from the Mediterranean zone were submitted instead with two trials including higher doses only and 3 trails using a product with another formulation (containing a combination of BT aizawa and kurstaki). Concerning the efficacy on different lepidopteran species efficacy for: • Plutella xylostella is proven for the maritime zone; • Mamestra brassicae is not finally evaluable; • Pieris sp. is not finally evaluable; • Spodoptera littoralis is proven for the Mediterranean zone. Note: Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 22 of 55 In existing and former authorisations of Turex or products containing a similar a.s. in Germany, a minor dose rate of 500 and 600 g/ha, respectively, was sufficient to control lepidopteran larvae (e.g. pierid moth or Evergestis sp.) in cabbage except from noctuids. Such a differentiation is not possible considering the submitted results. Hence, the applied amount of product in practice may in some cases and regions be higher than needed. Conclusion: Efficacy can be extrapolated from other uses (see report for fruit vegetables) and from experience with respect to the former authorisation. IIIA1 6.1 Efficacy data for free biting caterpillars infesting root and tuber vegetables Authorization is applied for DE. See use-no. 012 (field) and 013 (greenhouse) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-012 Vegetable growing root and tuber vegetables (NNNVW) from 09 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in 200 to 800 l water/ha treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 013-015 and 017 in appendix 2, table 2. F, Pests or Groups of pests G, controlled or I (b) (c) Crop and/or situation (a) Swede Beetroot, raddish, black raddish, carrot, celery, celery leaves, celeriac, parsley Witloof, Chicory F Plutellidae (Plutella xylostella), Crambidae (Evergestis forvicalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) F Plutellidae (Plutella xylostella) G F Noctuidae (Autographa gamma, Plusia spp.) Application* Growth stage (j) Application rate per treatment kg MPCA./hL water kg MPCA./ha (kg MPCP/hL) L/ha (kg MPCP/ha) min-max min-max min-max April-September BBCH 09-99 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 April – September BBCH 09-99 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 January – December BBCH 09-99 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 April – September BBCH 09-99 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) 0.5 (1.0) 0.5 (1.0) Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests No data submitted, see the uses for fruit vegetables and vegetable cabbages. IIIA1 6.1.3 Efficacy tests No data submitted. Conclusion: Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 23 of 55 Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). IIIA1 6.1 Efficacy data for free biting caterpillars infesting allium bulb crops Authorization is applied for DE. See use-no. 014 in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-014 Vegetable growing bulb crops (NNNSZ) from 09 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in 200 to 800 l water/ha treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 016 in appendix 2, table 2. Crop and/or situation (a) Onions, shallots, pickles, garlic, leek F, Pests or Groups of pests G, controlled or I (b) (c) F Plutellidae (Acrolepiopsis assectella) Application* Growth stage (j) April – September BBCH 07-99 Application rate per treatment kg MPCA./hL water kg MPCA./ha (kg MPCP/hL) L/ha (kg MPCP/ha) min-max min-max min-max 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests No data submitted, see the uses for fruit vegetables and vegetable cabbages. IIIA1 6.1.3 Efficacy tests No data submitted. Conclusion: Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). IIIA1 6.1 Efficacy data for free biting caterpillars infesting fresh herbs Authorization is applied for DE. See use-no. 015 (field) and 016 (greenhouse) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-015 Vegetable growing Herbs (NNNKR) from 09 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) 1 kg/ha in 200 to 800 l water/ha treatments must be at least 7 days apart Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 24 of 55 Authorization is applied for the central zone also. See uses-no. 018-019 in appendix 2, table 2. F, Pests or Groups of pests G, controlled or I (b) (c) Crop and/or situation (a) Herbs Application* Growth stage (j) F Plutellidae (Plutella xylostella) G April – September BBCH 09-99 January – December BBCH 09-99 Application rate per treatment water kg MPCA./ha kg MPCA./hL L/ha (kg (kg MPCP/hL) MPCP/ha) min-max min-max min-max 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Foliar application with 1-3 applications and an interval of 7 days between applications. Conclusion: Fresh herbs are a minor use. This group is consisting of crops from many plant families and susceptible to many different species of lepidopteran larvae. Efficacy for fresh herbs can be extrapolated from other crops. For authorisation in the central zone: It should be taken into account that Plutella xylostella only plays a minor role in a very limited number of herb species. IIIA1 6.1 Efficacy data for free biting caterpillars infesting pulse crops Authorization is applied for DE. See use-no. 017 (field) and 018 (greenhouse) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Crop stage(s) (BBCH) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-017 Vegetable growing pulse crops (NNNLG) from 09 free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 3 3 spraying or fine spraying (low volume spraying) plant height up to 50 cm 0.5 kg/ha in at least 600 l water/ha plant height 50 up to 125 cm 0.75 kg/ha in at least 900 l water/ha plant height more than 125 cm 1 kg/ha in at least 1200 l water/ha treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 020-021 in appendix 2, table 2. Crop and/or situation (a) F, Pests or Groups of pests G, controlled or I (b) (c) Dwarf snap and slicing F Noctuidae (Polia oleracea, Autographa gamma, Plusia bean, pole snap and spp.) slicing bean, yard long bean Application* Growth stage (j) April – September BBCH 09-99 Application rate per treatment kg MPCA./hL water kg MPCA./ha (kg MPCP/hL) L/ha (kg MPCP/ha) min-max min-max min-max 0.025 (0.05) 2000 0.5 (1.0) Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests No data submitted, see the uses for fruit vegetables and vegetable cabbages. IIIA1 6.1.3 Efficacy tests No data submitted. Conclusion: Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 25 of 55 (a) For Germany: The use in this version is only suitable for runner beans. For pulse crops except from runner beans, which build dense crop stands already at lower heights, no vertical separation is necessary. The use should therefore be separated and the application rate for pulse crops apart from runner beans should be: Dose rate(s) in amount of water to be used: 1 kg/ha in 200 to 800 l water/ha (b) For the central zone: Efficacy can be extrapolated from other uses (see reports for fruit vegetables and vegetable cabbages). Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment IIIA1 6.1 Registration Report Central Zone Page 26 of 55 Efficacy data for free biting caterpillars infesting ornamentals Authorization is applied for DE. See use-no. 019 (field) and 020 (greenhouse) for ornamentals and use 021 for woody ornamentals in the greenhouse (3 applications) in appendix 2, table 1. Use-No. Area of application Crop(s)/object(s) Pest(s)/target(s)/aim(s) Area of use Time of treatment Max. number of treatments for the use Max. number of treatments per crop or season Application technique/type of treatment Dose rate(s) in amount of water to be used Rate App. comment 007638-00/00-019 Ornamental growing Ornamentals (NNNZZ) free biting caterpillars (LEPISF) Outdoors After beginning of infestation; from emergence of first larvae 6 6 spraying or fine spraying (low volume spraying) plant height up to 50 cm 0.5 kg/ha in at least 600 l water/ha plant height 50 up to 125 cm 0.75 kg/ha in at least 900 l water/ha plant height more than 125 cm 1 kg/ha in at least 1200 l water/ha treatments must be at least 7 days apart Authorization is applied for the central zone also. See uses-no. 022-025 in appendix 2, table 2. Crop and/or situation (a) F, Pests or Groups of pests G, controlled or I (b) (c) Ornamentals and flowers F Pieridae (Pieris spp.), Noctuidae (Plusia spp., Mamestra spp.) G Nursery crops and perennials F Pieridae (Pieris spp.), Noctuidae (Plusia spp., Mamestra spp.), Lymantriidae (Euproctis G chrysorrhoea, Leucoma salicis, Lymantria dispar), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) Application* Growth stage (j) April – September BBCH 09-99 January – December BBCH 09-99 Application rate per treatment water kg MPCA./ha kg MPCA./hL (kg MPCP/hL) L/ha (kg MPCP/ha) min-max min-max min-max 0.025 (0.05) 2000 0.5 (1.0) 0.025 (0.05) 2000 0.5 (1.0) April – September BBCH 09-99 January – December BBCH 09-99 Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests No data submitted, see the uses for fruit vegetables and vegetable cabbages. IIIA1 6.1.3 Efficacy tests For this application a total of 53 trial reports have been submitted. In these trials a wide range of caterpillar species and their respective families were included in. In most trials a sufficient (+) or good (++, > 90%) efficacy of the test product was shown. The following species were included: • Noctuidae: Chrysodeixis chalcites (tomato looper), Spodoptera littoralis (Beet armyworm), Autographa gamma (Silver Y moth), Mamestra brassicae (Cabbage Moth), • Plutellidae: Plutella xylostella (Diamondback Moth), • Pieridae: Pieris sp. (cabbage white), • Tortricidae: Pandemis cerasana (barred fruit-tree tortrix), Cydia pomonella (codling moth), Adoxophyes orana (summer fruit tortrix), Eupoecilia ambiguella (vine moth) Lobesia botrana (European grapevine moth) Seven of these trials have been conducted with the ornamentals hibiscus (5) and gerbera (2) in the greenhouse to test the efficacy against the tomato looper (Chrysodeixis chalcites) (see use for fruit vegetables). Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 27 of 55 Though most of the included species does not occur or play a minor role in ornamentals, efficacy can be extensively extrapolated. Nevertheless, in many of the submitted trials a higher dose than intended was used (1.5 to 2 kg/ha). It is therefore not clear if a maximum amount of 1 kg/ha is adequate for a sufficient control particularly for high and dense crop stands. Typical species damaging woody ornamentals in Germany for instance would include also members of the family Yponomeutidae (e.g. Yponomeuta cagnella, Y. malinellus.) and other members of the tortrix and the geometridae family. Conclusion: Considering all trials submitted for this application a wide range of different crop morphologies, botanical families and cropping systems is covered. In most of these trials a sufficient (+) or good (++) efficacy of the test product was shown. Therefore, it can be concluded that the effectiveness of Agree is independent of the crop. Hence, results from other crops are included in this evaluation. If the area of use is in the greenhouse, results from greenhouse trials conducted the Mediterranean can also be included. However, the application rates used in the presented trials are very different and often higher than applied for, just as the number of application was higher. Little information is given if higher dose rates correspond with crop size (ornamentals in the greenhouse can grow up to 2 m for instance). Regarding small crops, in most trials efficacy was sufficient concerning number of attacked leaves, damaged plants, and larvae control and the reference product acted similar or only slightly better. For higher and dense crops the doses applied for may not be sufficient. This agrees with the former authorisation in Germany with dose rates from 1 to 2 kg/ha depending on the crop height. (a) For Germany: Efficacy cannot be supported with the recommended dose rate. (b) For the central European zone: Efficacy can be extrapolated from other uses; dose rates have to be evaluated according to the local production systems. IIIA1 6.1 Efficacy data for free biting caterpillars infesting forests Authorisation is applied for the central zone. See use-no. 026 and 027 in appendix 2, table 2. Crop and/ or situation Country/ F Member G or state I Pests or Group of pests controlled (c) (a) Forestry (b) Central Europe F Pieridae (Pieris spp.); Geometridae (Operophtera brumata); Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis); Lasiocampidae (Malacosoma neustria); Yponomeutidae (Yponomeuta spp.) Application* Application rate per treatment Growth stage & season (j) kg MPCA/hL (MPCP/hL) min max BBCH 09-99 (April - September) 0.025 (0.05) Water kg MPCA/ha (MPCP/ha) L/ha min max min max 2,000 0.5 (1.0) Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests The applicant did not present any tests which were created in accordance with the EPPO guideline PP1/225 (2) “Minimum effective dose”. IIIA1 6.1.3 Efficacy tests The applicant did not present any tests which were created in accordance with the EPPO guideline PP1/210 (1) “Defoliators of forest trees” and the EPPO guideline PP1/226 (1) “Number of efficacy trials”. For Germany, the presented examinations were not made with the relevant harmful organisms and the application technology appropriate for forests. The amount of water Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 28 of 55 applied for the application with aircraft (helicopter) is too high in the GAP-table. The water effort varies between 30 and 150 L/ha depending on aircraft type. Studies of plant damages are missing with the less middle amount of 30-150 L/ha. Conclusion: Authorisation cannot be supported. IIIA1 6.1 Efficacy data for free biting caterpillars in the public green Authorisation is applied for the central zone. See use-no. 026 and 027 in appendix 2, table 2. Crop and/ or situation Country/ F Member G or I state Pests or Group of pests controlled (c) (b) (a) Public Green Central Europe F Pieridae (Pieris spp.); Geometridae (Operophtera brumata); Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis); Lasiocampidae (Malacosoma neustria); Yponomeutidae (Yponomeuta spp.) Application* Application rate per treatment Growth stage & season (j) kg MPCA/hL (MPCP/hL) min ax BBCH 09-99 (April - September) 0.025 (0.05) Water kg MPCA/ha (MPCP/ha) L/ha min max min max 2,000 0.5 (1.0) Foliar application with 3 applications at most and an interval of 7 days between applications. IIIA1 6.1.2 Minimum effective dose tests The applicant did not present any tests which were created in accordance with the EPPO guideline PP1/225 (2) “Minimum effective dose”. IIIA1 6.1.3 Efficacy tests For more detailed information to harmful organisms in the urban green: See use no. 019 and 021. For the EU zone B the applicant derives the adequate effectiveness of his means from the submission of studies to the following harmful organisms: gypsy moth (Lymantria dispar), winter moth (Operopthera brumata), brown-tail moth (Euproctis chrysorrhoea), Satin moth (Leucoma salicis), lackey moth (Malacosoma neustria) and spindle ermine moth (Yponomeura sp.). Conclusion: According to the use in ornamentals, efficacy is extrapolated and authorisation supported. IIIA1 6.1.4 Effects on yield and quality for all crops Information or trial results on the effect on yield and quality were only delivered in some trail results on fruit crops, ornamentals, and vegetable cabbages. In these cases results are located at the corresponding uses. In none of the effectiveness trials and selectivity trials unacceptable phytotoxicity or other adverse effects were observed. Agree WG is not expected to cause adverse effects. In contrary, the protection given by Agree WG against the various caterpillars will prevent the crop from eating damage and consequential yield loss. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on yield or transformation processes are known. Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment IIIA1 6.2 Adverse effects IIIA1 6.2.1 Phytotoxicity to host crop Registration Report Central Zone Page 29 of 55 (a) Grapes No phytotoxicity was observed during the trials mentioned. (b) Vegetables and ornamentals In all effectiveness trials in hibiscus (5 trials), gerbera (2 trials), sweet pepper (1 trial), Brussels sprouts (1 trial) and cauliflower (4 trials) assessments were conducted on phytotoxicity, crop vigour and/or visible residue. In none of the effectiveness trials phytotoxic effects were observed. In 2 trials with hibiscus some visible residue was recorded shortly after the first application but this always disappeared at the end of the trial period. Specific phytotoxicity trials have been performed in 2010 in the floriculture crops cyclamen (1 trial), Saintpaulia (1 trial), begonia (1 trial) and Ficus (1 trial) and 2011 in cucumber (4 trials). Trials were conducted according to the EPPO guideline PP 1/135(3): Phytotoxicity assessment. In these trials Turex was applied 4 times at the proposed dose rate of 1.0 kg/ha or 0.1% and the double dose rate. Assessments were made on phytotoxicity, crop vigour, leaf deformation, necrosis and visible residue. In none of these trials unacceptable permanent phytotoxic symptoms were observed. Residue was visible in the trials on the floriculture crops. However, these were only slight and were also seen at the treatments with the reference product. Conclusion: Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product is not expected to exhibit herbicidal activity. Agree 50 WG is, therefore, not expected to cause phytotoxic effects. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on yield or transformation processes are known. IIIA1 6.2.2 Adverse effects on health of host animals This is not an EU requirement. IIIA1 6.2.3 Adverse effects on site of application This is not an EU requirement. IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) Effects on relevant beneficial organisms The toxicity of Agree 50 WG (also labeled Turex 50 WP) on beneficial organisms has been investigated by carrying out tests under laboratory conditions on Aphidius rhopalosiphi and Typhlodromus pyri. With Aphidius rhopalosiphi, unacceptable effects (≥ 30%) on survival were not observed, when Turex 50 WP was applied at 4.5 times the maximal recommended field rate/ha and application (Table 6.2.4-1). However, the parasitation rate of the exposed test animals was reduced by 55.1%. The indicator test species Aphidius rhopalosiphi is not relevant antagonist in vineyards, fields with soft fruits, vegetables and ornamentals. In greenhouses Aphidius rhopalosiphi is not a relevant beneficial insect too. But, the results for Aphidius rhopalosiphi indicate that applications of Agree 50 WG to vineyards, fields with soft fruits, vegetables and ornamentals might reduce the population of relevant parasitoids > 25%. In Table 6.2.4-2.the results of the test on the predatory mite Typhlodromus pyri are shown. An application rate of 4.5 kg/ha (corresponding to 4.5 times the maximal recommended rate/ha and application) is not harmful (effects < 8%) for these beneficial arthropod species. On the basis of these results no effects ≥ 25% are expected for populations of Typhlodromus pyri, when Agree Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 30 of 55 50 WG is applied according to the recommended use pattern, i.e. 3 applications of maximal 1.0 kg/ha to vineyards and fields with soft fruits. Table 6.2.4-1: Effects of Turex 50 WP on Aphidius rhopalosiphi (exposed stage: male and female) in a laboratory test (substrate: glass) Application rate Corrected mortality Effect on parasitisation rate Reference [kg/ha] [%] [%] 4.5 7.5 55.1 Warmers, C., 2005a 20051317/01-NLAp Table 6.2.4-2: Effects of Turex 50 WP on Typhlodromus pyri (exposed stage: protonym) in a laboratory test (substrate: glass) Application rate Corrected mortality Effect on reproduction Reference [kg/ha] [%] [%] 4.5 7.1 -33.9 Warmers, C., 2005b 20051317/01-NLAp Conclusions: Agree 50 WG is classified as not harmful for populations of Typhlodromus pyri. Effects on soil quality Effects on soil macro-organisms being used as indicators of soil quality Effects on earthworms Active substances No data available. Metabolites No data available. Products In this section, no new studies are submitted assessing the effect of Agree 50 WG. Agree 50 WG was not the representative formulation, and has not been previously evaluated in the EU according to Uniform Principles. Instead data from the assessment with another Bta GC-91-based product are presented by the applicant. Nonetheless, the applicant declares that Agree 50 WG (synomym for CGD 97220 I) contains the same active substance (Bta GC-91), in the same proportions, which can be found in the representative formulation Agree 50 WP. It appears therefore feasible to lean on the data of Agree 50 WP for the evaluation of Agree 50 WG Table 6.2.4-3: Ecotoxicological endpoints for earthworms EU agreed endpoints Test item (SANCO/1538/08 - rev. 3 final – 06/05/2008) CGD 97220 LC50 > 1000 mg/kg artificial soil Ia) Endpoints used in risk assessment LC50 > 1000 mg/kg artificial soil a) Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 31 of 55 As the content of Bta GC-91 in Agree 50 WP and Agree 50 WG is the same the obtained data can be directly used to assess the risk of Agree 50 WG. Table 6.2.4-4: Acute earthworm toxicity endpoint for Agree 50 WG Duration, Test product Endpoint Value Dimension organism 14 d, mortality 1000 LC50 Eisenia fetida mg/kg soil CGD 97220 Ia) 56 d, reproducNOEC _ tion Reference Winkler, 1992a a) Synonym for Agree 50 WP containing the same content of Bta GC-91 as Agree 50 WG Proposed use pattern See GAP table – list of intended uses for the central zone, Part A Exposure The exposure to soil organisms was estimated by calculating the maximum predicted environmental concentrations in soil (PECS) (please refer to Part B, Section 5). The PECS value was calculated for 6 applications of 1.0 kg Agree 50 WG/ha in vegetables assuming as a worst case that no degradation of the product and the active ingredient occurs between the treatments. Under these conditions and based on standard assumptions for the soil density and the incorporation depth, the PECS was determined to be 8 mg Agree 50 WG/kg dry weight soil. The PECs for Agree 50 WP (used in the DAR, Vol 3, Annex B, Part 7, B9., Aug. 2009) was calculated as 2.56 Agree 50 WP mg/kg dry weight soil (1.28 mg Bta/ kg dry weight soil) for multiple applications and worst case situation. Table 6.2.4-5: Maximum soil PEC values for Agree 50 WP and Agree 50 WG Test substance Maximum PECsoil [mg/kg] Agree 50 WP Agree 50 WG 2.56 8 Risk assessment (Toxicity exposure ratios, TERA and TERLT) Acute risk The potential acute risk TERA of Agree 50 WG to earthworms was assessed by comparing the maximum instantaneous PECS with the 14-day LC50 value to generate the acute TER value. The TERA was calculated as follows: TER A = LC50 (mg/kg) PECS (mg/kg) Table 6.2.4-6: Acute TER value for earthworms Compound referred LC50 to Maximum PECS TERA Trigger Agree 50 WP > 1000 mg/kg d.w. soil 2.56 mg/ kg. d.w. soil > 390 10 Agree 50 WG > 1000 mg/kg d.w. soil 8.0 mg/ kg. d.w. soil > 125 10 The acute TER value is much higher than the Annex VI acute trigger value of 10, indicating that GAP directed application of Agree 50 WG poses no acute risk to earthworms. Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 32 of 55 Long-term risk Due to the absence of acute toxicity no adverse effects on earthworms are to be expected due to the recommended application of Agree 50 WG or Bta GC-91. Bacillus thuringiensis subsp. aizawai (Bta GC 91) and its ∂–endotoxins are rapidly degraded by UV light and the activities of other microorganisms. The persistence of active vegetative cells is short, but spores are viable for longer periods. Thus, all TER are above the relevant trigger value of 10 indicating a low and acceptable acute risk to earthworms of the plant protection products following treatment with Agree 50 WP in accordance with the intended worst-case use pattern. Conclusion: Thus, the TERA is above the relevant trigger value of 10 indicating a low and acceptable chronic risk for earthworms to the active substance Bta GC 91 as well as to Agree 50 WP, following treatment with the product in accordance with the intended worst-case use pattern and good agricultural practice. Field tests Not required as an acceptable risk to earthworms was identified, based on the laboratory studies available. Effects on other non-target macro-organisms Tests on other soil non-target organisms are triggered by breaching the soil persistence criteria (DT90 > 365 days). For Bta GC 91 and Agree 50 WP no field DT90 values are available, but both were considered not to be persistent and to bio-accumulate in the field (EU DAR). Effects on organic matter breakdown No data required. Overall conclusion with respect to effects on soil macro-organisms It is concluded that the proposed use of Agree 50 WP will not pose an unacceptable risk to populations of earthworms or other soil macro-organisms, when applied according to the recommended use pattern. Instructions and information: None Overall conclusion with respect to effects on soil quality There is no indication of any unacceptable adverse effects on soil macro- or soil microorganisms relevant for the maintenance of soil quality. Effects on soil non-target micro-organisms exposed to Agree 50 WP Table 6.2.4-7: Ecotoxicological endpoints for soil micro-organisms Test item EU agreed endpoints No significant effect > 25% at day 28 at 2.0 L or 20 L product/ha No significant effect > 25% at day 28 at N 2.0 L or 20 L product/ha DHA = Dehydrogenase activity, N = Nitrogen transformation. CGD 97220 I (3 + 1013 CFU/kg) 1 Test design1 DHA Reference Winkler, J. (1992) Report No. 921049013 Risk assessment for soil microflora functions Based on the results of these studies, Agree 50 WP showed no effects of > ± 25% compared to the control on soil microbial activity up to a maximum tested concentration of 20.0 L product/ha, Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 33 of 55 after 28 days. As the proposed use of Agree 50 WP an acceptable risk to soil microbial activity can be concluded. IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes Impact on propagation of plants is not expected. Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product is not expected to exhibit herbicidal activity. Agree is therefore not expected to cause adverse effects. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on yield or propagation processes are known. IIIA1 6.2.6 Impact on succeeding crops No assessments on following crops were made in any of the trials. Besides, an impact on succeeding crops is not expected. Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product it is not expected to exhibit herbicidal activity. Agree 50 WG is therefore not expected to cause adverse effects. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no unacceptable effects on succeeding crops are known. IIIA1 6.2.7 Impact on other plants including adjacent crops Agree 50 WG is based on naturally occurring bacteria and has highly specific insecticidal efficacy. The product it is not expected to exhibit herbicidal activity. In the effectiveness and phytotoxicity trials crop safety has been demonstrated in both protected floriculture crops and protected cucumber; cultivations known to be very sensitive. Agree is therefore not expected to cause adverse effects. In addition, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no unacceptable effects on adjacent crops are known. IIIA1 6.2.8 Possible development of resistance or cross-resistance Active ingredients based on Bacillus thuringiensis subspecies belong to the IRAC main group 11: Microbial disruptors of insect midgut membranes. To control lepidopteran larvae, the subspecies aizawai and kurstaki are used. Resistance to Bacillus thuringiensis subspecies aizawai is reported from different species belonging to the noctuidae, pyralidae and plutelidae family, such as Plodia interpunctella, Plutella xylostella, and Spodoptera littoralis (for further information see: Arthropod Pesticide Resistance Database (APRD)). Resistance to B. thuringiensis can be associated with reduced binding of ICP to the brush border membranes of midgut epithelium. In addition, selection pressure can lead to changes in the mean population response levels. The complex mode of action of B. thuringiensis, involving multiple toxins and B. thuringiensis spores, is supposed to provide protection against resistance because a single mutation in the insect would be unlikely to affect susceptibility. It was, however, suggested that at high levels of selection, the multi-component-toxicity pathway merely expands behavioural and /or physiological opportunities for adaptation to B. thuringiensis. The general lack of cross resistance between conventional insecticides and B. thuringiensis is not surprising because these two types of pesticides have different modes of action and they engender different mechanisms of resistance. The application of Bta products is not considered to have a high potential of causing resistance or cross-resistance within the target pest organism. Hence, only one of report of resistance (Spodoptera littoralis in France) is related to European populations, the applicant therefore recommends alternating with products based on different active substances after three applications as a contribution to risk reduction and integrated pest Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 34 of 55 management strategies. Additionally, the intended number of application is limited to three in most uses or in special cases to six (ornamentals and fruit vegetables). IIIA1 6.3 Economics This is not an EU requirement. IIIA1 6.4 Benefits This is not an EU requirement. IIIA1 6.4.1 Survey of alternative pest control measures This is not an EU requirement. IIIA1 6.4.2 Compatibility with current management practices including IPM This is not an EU requirement. IIIA1 6.4.3 Contribution to risk reduction Decreased sensitivity or resistance has been reported. It is therefore recommended to alternate with another product based on a different active substance after three applications (see 6.2.8). IIIA1 6.5 Other/special studies No additional studies are included to support this application. IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 Agree 50 WG (also called Turex WG or Turex 50 WG) consists of spores and crystal proteins (δ-endotoxins) from the bacteria B. thuringiensis subsp. aizawai GC-91 and contains 25,000 i.u./mg. It is a biological insecticide formulated as a water dispersible granule, containing 3 × 1013 colony forming units (CFU) or 500 g of Bta GC-91 in 1 kg product. Agree 50 WG is to be applied at a dose rate of 0.05-0.1% up to 1 kg/ha. Agree 50 WG is non-systemic and poisons the caterpillars. Therefore, it is used for the control of leaf consuming caterpillars on various crops. Upon ingestion the crystal proteins dissolve in the stomach and damage the tissue. The caterpillars stop eating and die after a few days. Mostly young caterpillars are more sensitive than old ones. For an adequate effectiveness all plant parts should be sufficiently sprayed. Agree 50 WG is intended to control pests in soft fruits, grape vines and vegetables, as well as ornamentals. Agree 50 WG and other products containing B. thuringiensis subsp. aizawai are registered in a large number of European countries. Due to the applicant, data for preliminary range finding tests were not included because of a sufficient number of GEP trials for registration. Because of the long period of registered products in Europe, a dose rate of 0.05-0.1% and 1.0 kg/ha has turned out to be suitable. However, in many trials the tested rates ranged between 1.0 and 2.0 kg/ha. The inclusion of trials with higher dose rates is partly justified as available trial data suggest that the differences between 1.0 and 1.5 kg/ha are usually not significant and often no clear dose-response correlation can be observed when different rates of Turex WG are tested simultaneously. However, the application rates used in the presented trials are very different and often higher than applied for, Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 35 of 55 just as the number of application was higher. Little information is given if higher dose rates correspond with crop size (ornamentals in the greenhouse can grow up to 2 m for instance, fruit vegetable considerably higher even if not so dense). Regarding all results a dose rates of 2 kg/ha seem to provide better control for higher and dense crops On the other hand: In existing and former authorisations of Turex or products containing a similar a.s. in Germany, a minor dose rate of 500 and 600 g/ha, respectively, was sufficient to control lepidopteran larvae (e.g. pierid moth or Evergestis sp.) in cabbage except from noctuids. Such a differentiation is not possible considering the submitted results and the lack of trials for the evaluation of the minimum effective dose. Hence, the applied amount of product in practice may in some cases and regions be higher than needed. This report presents a summary of the trials performed in The Netherlands, Belgium, France, Poland, Italy and Spain. Data to support the label claims were generated in a total of 48 GEP trials which have been carried out in vegetables or assessing the effect against typical vegetable moths (24 GEP trials), in grapes (16 GEP trials) and orchards (8 GEP trials). In addition, data from 28 non-GEP trials are presented which have been carried out in vegetables (18 trials) and grapes (10 trials). The trials were carried out between 1993 and 2012 in the Maritime EPPO zone, the North-East EPPO zone and the Mediterranean EPPO zone. The applicant describes that data obtained in the Mediterranean EPPO zone should be used for extrapolation to the South-East EPPO zone assuming that temperature regimes and the resulting pest pressure are comparable and considering that several countries of the Central European zone belong to the Mediterranean EPPO zone, e.g. all Adriatic states. In addition, data from six trials carried out in the USA are presented. The pests considered in the trials were Chrysodeixis chalcites (8 GEP trials), Plutella xylostella (3 GEP trials, 3 non-GEP trials, 8 other reports), Spodoptera littoralis (6 GEP trials, 1 non GEP trial), Mamestra brassicae (3 GEP trials, 2 non-GEP trials; GEP trials not rateable ), Autographa sp. (1 GEP trial), Pieris sp. (2 GEP trials, 4 other reports) all representing typical vegetables moths which also occur in ornamentals and flowers, herbs, berries etc. In addition, data on Evergestis forficalis are presented (2 non-GEP trials). In some trials mixed populations of different pests occurred. However, the results always refer only to the main target pest. In grapes, the efficacy of Turex WG against Eupoecilia ambiguella (7 GEP trials, 2 non-GEP trials) and Lobesia botrana (9 GEP trials, 8 non-GEP trials) was tested and in orchards control of Cydia pomonella (2 GEP trials), Adoxophyes orana (2 GEP trials) and Pandemis cerasana (4 GEP trials). In the GAP table for the central zone (appendix 2, table 2) individual pest species are mentioned for the respective uses. An evaluation regarding these species is difficult as the applicant has for instance listed pest species which does not occur in or which cover only a small part of the crops within a crop group. This involves for instance the Pieridae in ornamentals or the species Plutella xylostella (Plutellidae) in the uses 004, 005, 008, 009, 014, 015, 018 and 019. However, this species does not occur in strawberries (uses 004, 005) or lettuce (008, 009) and infests only some members in the groups root and tuber vegetables or herbs. A serious problem which appeared during the evaluation process was that in some trials Agree containing a combination of Bt kurstaki & aizawai (Turex 50 WP) was used (see also table 6-1), in some trials with Chrysodeixis chalcites and Mamestra brassicae for instance. Therefore, these results are not rateable. Information about the de facto content is not given in many trials as in some report the a.i. of the test product is only declared as Bacillus thuringiensis. This is particularly true for non GEP trials. The trials performed in Europe on a wide range of different crops species and plant families showed that Agree 50 WG is selective towards most crops. Moreover, products based on Bacillus thuringiensis have already been authorised for a considerable time in many countries within Europe. From these years of experience no negative influences on plants are known. Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 36 of 55 The application of Bta products is considered to have a low potential of causing resistance or cross-resistance within the target pest organism. Decreased sensitivity or resistance has been reported for Bacillus thuringiensis in some countries including France (for Spodoptera littoralis only). Therefore, it is precautionary recommended to alternate with products based on different active substances after three applications outdoors. Under these conditions, the applicant proposes the authorisation of Agree 50 WG to control lepidopteran larvae in soft fruits, grapes, vegetables and ornamentals at a dose rate of 0.050.1% but not more than 1.0 kg/ha by foliar application at a maximum number of three and six applications in ornamentals resp., at an interval of seven days. Applications are performed at pest occurrence, independently from the crop growth stage. In the following table the recommended evaluations are listed. Table S-1: Efficacy evaluation for the applied uses of Agree 50 WG in Germany: Crops Pest Evaluation DE grape berry moth, European authorisation is not supported grape vine grape vine moth (1. generation) grape berry moth, European authorisation is supported for grape vine grape vine moth (2.and 3. the maritime zone only generation) soft berries free feeding caterpillars authorisation is not supported strawberries free feeding caterpillars fruit vegetables free feeding caterpillars leaf and stem vegetables free feeding caterpillars vegetable cabbage root and tuber vegetables allium bulb crops fresh herbs pulse crops free feeding caterpillars free feeding caterpillars free feeding caterpillars free feeding caterpillars ornamentals free feeding caterpillars woody ornamentals free feeding caterpillars free feeding caterpillars authorisation is not supported efficacy is proven, authorisation is supported extrapolation of efficacy is possible; authorisation is supported authorisation is supported extrapolation of efficacy is possible; authorisation is supported authorisation is not supported, a final evaluation is not possible; the dose rate has to be adapted Table S-2: Efficacy evaluation for the applied uses of Agree 50 WG in the central European zone (except Germany): Uses / Crops Pest* Evaluation Central European zone except for DE 001; Tortricidae (Lobesia botrana, authorisation is supported for grape vine Eupoecilia ambiguella) the maritime zone only 002 & 003; Geometridae (Operophtera authorisation is not supported soft berries brumata) 004 & 005; free feeding caterpillars authorisation is not supported strawberries 006 & 007; Solanaceae and free feeding caterpillars authorisation can be supported cucurbitaceae Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Uses / Crops Pest* Central European zone except for DE 008 & 009; leaf and stem free feeding caterpillars vegetables 010, 011 & 012; free feeding caterpillars vegetable cabbage 0013, 014, 015 & 017; root and tuber free feeding caterpillars vegetables 016; free feeding caterpillars allium bulb crops 018 & 019; free feeding caterpillars fresh herbs 020 & 021; free feeding caterpillars pulse crops 022 & 023; ornamentals Registration Report Central Zone Page 37 of 55 Evaluation extrapolation of efficacy is possible; authorisation can be supported authorisation can be supported extrapolation of efficacy is possible; authorisation can be supported free feeding caterpillars extrapolation of efficacy is possible; the dose rates has to be checked particularly for greenhouse use free feeding caterpillars extrapolation of efficacy might be possible 024 & 025; nursery crops and perennials 026; forestry free feeding caterpillars 027; public green free feeding caterpillars authorisation is not supported extrapolation of efficacy might be possible Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment IIIA1 6.7 Country NL NL NL BE FR FR FR FR FR CH ES ES IT IT IT IT IT IT IT IT IT IT IT PO Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 38 of 55 List of test facilities including the corresponding certificates Facility De Bredelaar B.V. Proeftuin Zwaagdijk PPO, Westmaas PCBT, Rumbeke Prestagro Anadiag Eurofins Agroscience Services Agrolis Consulting Novex Ciba Plant Protection AgroSoler C.I.F. Recerca Agricola/ SynTech Research Spain Centro di Saggio Metaponum Agrobios Centro di Saggio CAA Giorgio Nicoli S.r.l. A.S.T.R.A - Innovazione e sviluppo Consiglio per la Ricerca e la Sperimentazione in Agricoltura CORAGRO S.r.l. DST ARA Spermentazioni i Agricoltura Vit. En. Sperimentazione fitofarmaci S.P.F. S.n.c. Consorcio Agrario di Ravenna Regional Plant Health Monitoring Centre Plugia Region in cooperation with AGROLAB s.r.l. Fertico Sp. z o.o., Agricultural Research Service GEP yes yes no no Yes yes yes yes yes no yes yes yes yes yes yes yes yes no Yes yes yes yes yes Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 39 of 55 Appendix 1: List of data submitted in support of the evaluation Annex Point Author Title Year Document C Anonymous Draft label Agree 50 WG Central zone 2011 2011 KIIIM1 6.2 Rinsma, S. Ref. App. Ref. JKI 268413 Biological Assessment Dossier of Turex WG 2012 268427 KIIIM1 6.2 Jansen, E. Control of Chrysodeixis chalcites in glasshouse grown Hibiscus 2011 I-10-3215 268430 KIIIM1 6.2 De Lange, J. Control of Plutella xylostella with Turex in cauliflower 2011 I10.468.VE G-1.ZWA 268433 KIIIM1 6.2 Jansen, E. Control of Chrysodeixis chalcites in glasshouse grown Hibiscus 2012 I-11-3214 268436 KIIIM1 6.2 Oostingh, C. Control of Chrysodeixis chalcites in ornamentals 2011 I11.468.OR N-2.ZWA 268439 KIIIM1 6.2 Temmerma n, F., Rapol, J., Delanote, L. Rupsenbestrijding in de najaarsteelt van bloemkool 2004 PCBT BT04BLK_I NS01 268442 KIIIM1 6.2 Vlaswinkel, M., Kruistum, G. Beheersing koolmotje in spuitkool 2003 PPO 12 35330 268445 KIIIM1 6.2 Waalkens, W. Control of Chrysodeixis chalcites in sweet pepper 2004 I-03-321 268448 KIIIM1 6.2 Rinsma, S. Control of Chrysodeixis chalcites in ornamentals 2008 I08.468.OR N-1.401 268451 KIIIM1 6.2 Waalkens, W. Control of Chrysodeixis chalcites in pot gerbera. 2005 I-04-320-1 268454 KIIIM1 6.2 Prevotat, M. Final report of field study Biocillis Vine Tortrix 2000 PRE99102 268458 KIIIM1 6.7 Jansen, E. Crop safety of PAF97 001, PAI 08 002 and PAI 10 009 in protected fruiting vegetables 2012 F-11-3202 268461 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 40 of 55 Annex Point Author Title Year Ref. App. Ref. JKI KIIIM1 6.7 Jansen, E. Crop safety of PAF97 001, PAI 08 002, PAI 10 008 and PAI 10 009 in protected fruiting vegetables 2012 F-11-3201 268466 KIIIM1 6.7 Jansen, E. Crop safety of Turex SP in ornamentals 2012 I-10-3225 268469 MIIIM1 Sec 6 MTA Draft Registration Report - Part B - Agree 50 WG DE -Section 6 - Ecotoxicology -- Core assessment 2012 MIIIM1 Sec 6 268503 MIIIM1 Sec 6 MTA Draft Registration Report - Part B - Agree 50 WG DE -Section 6 - Ecotoxicology -- Core assessment 2012 MIIIM1 Sec 6 268506 MIIIM1 Sec 7 MTA Draft Registration Report - Part B - Agree 50 WG DE -Section 7 - Efficacy Data an information -- Core assessment 2012 MIIIM1 Sec 7 268508 Document C Anonymous Document C 2005 k.A. 268523 MIIM Sec 6 BarlettaBergman Document MIIM Sec. 6 2006 k.A. 269332 KIIIM1 10.5 Winkler, J. Acute toxicity earthworm test - Eisenia foetida according to the OECD Guideline 207 1992 92 10 49 014 269360 KIIIM1 10.6 Winkler, J. Effects on the activity of soil microflora according to the BBA Guideline VI, 1-1 (1990) 1992 92 10 49 013 269362 MIIIM1 Sec 6 BarlettaBergan, A. Document MIIIM1 Sec. 6 2006 k.A. 269370 MIIM Sec 6 BarlettaBergman, A. Document MIIM Sec. 6 1900 k.A. 269405 MIIIM1 Sec 6 Süß, J. Document MIIIM1 Sec. 6 2009 k.A. 269407 MIIIA1 Sec 6 MTA Draft Registration Report - Part B - Agree 50 WG DE - Section 6 ¿ Ecotoxicology - Core assessment (word) 2012 MIIIA1 Sec 7 MTA Draft Registration Report - Part B - Agree 50 WG DE - Section 7 ¿ Efficacy Data and Information Core assessment (word) 2012 270449 270450 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 41 of 55 Annex Point Author Title Year Ref. App. Ref. JKI KIIIM1 6.1 Nolting, H.G. Zulassung des Pflanzenschuzmittels "Turex" 2000 AP-ZA 004143-00 316614 KIIIM1 6.1 Kohsiek, H. Zulassung des Pflanzenschutzmittels Turex mit dem Wirkstoff: 500 g/kg Bacillus thuringiensis 2000 AP-ZA 004143-00 316615 KIIIM1 6.1 Nolting, H.G. Genehmigungsverfahren für Pflanzenschutzmittel "Turex", Zul.Nr.: 4143-00 das 2002 APG1800414 300/02WR/V d 316616 KIIIM1 6.1 Stridh, H. Supportive letter for Turex 50 WP from orchard grower 2013 Rosenberg, O. Supportive letter for Turex 50 WP from Skogforsk 1900 KIIIM1 6.1 Anonymous Adaptive sampling and control of caterpillar pests of horticultural brassica crops 1997 BtAGR 1997 Brussels UK 316619 KIIIM1 6.1 Anonymous Effectiveness of various insecticides in controlling Diamondback moth, cabbage looper and striped armyworm on cabbage, Spring 1998 1998 TTC-1998001 316620 KIIIM1 6.1 Anonymous Control of diamondback moth with biological pesticides in Homestead, FL, Spring 1999 1999 TTC-1999018 316621 KIIIM1 6.1 Anonymous Control of insect pests of collard with biological pesticides in charleston, SC, spring 1999 1999 TTC-1999021 316622 KIIIM1 6.1 Anonymous Control of diamondback moth with biological pesticides in Homestead, FL, Spring 1999 1999 TTc-1999023 316623 KIIIM1 6.1 Anonymous Effectiveness of Bioinsecticides for control of collard insect pests in Clemson, SC, Spring 1999 1999 TTC-1999031 316624 KIIIM1 6.1 Anonymous Efficacy of Evaluation of Bioinsecticide formulations for control of the insect pests on Cole crops 2002 CER-2002016 316625 KIIIA1 6.1 316617 316618 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 42 of 55 Annex Point Author Title Year Ref. App. Ref. JKI KIIIM1 6.1 Anonymous Ciba Crop protection Trial Report 1993 93420Atrial212 316626 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93781trial219 316627 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93682trial3 01 316628 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93859trial93502 316629 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93417trial131 316630 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93679trial131 316631 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93680trial1 30 316632 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1993 93418trial1 30 316633 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1994 94578 316634 KIIIM1 6.1 Anonymous Ciba Plant Protection Trial Report 1994 94579trial134 316635 KIIIM1 6.2.1 Anonymous Control of Cabbage moth by Turex 2002 Bt TUR2002 Cabbage NL 316636 KIIIM1 6.2.1 Leocata, S. Experimental field evaluation of agree and TTC 1502 against noctuids lepidoptera on protected peppers in Italy 1999 99SL05 316637 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 43 of 55 Annex Point Author Title Year Ref. App. Ref. JKI KIIIM1 6.2.1 Bouma, E. Development of comparable agro-climatic zones for the international exchange of data on the efficacy and crop safety of plant protection products 2005 KIIIM1 6.2.1 Lacertosa, G. Efficacy evaluation of Bacillus thuringiensis subsp. Kurstaki and aizawai (Agree) against Spodoptera littoralis Koch on cauliflower in Basilicata (Southern Italy) 2006 019_MA_0 6 316639 KIIIM1 6.2.1 Sánchez Rosales, J.L. Activity of Turex (B. thuringiensis) for caterpillars control by foliar application at prefixed intervals on lettuces 2005 AS610410 3 316640 KIIIM1 6.2.1 Gengotti, S. Experimental field evaluation of Costar (Bacillus thuringiensis) against Spodoptera spp. in open field lettuce 2010 PCE10CE RLACSAP HYTOGA 316641 KIIIM1 6.2.1 Sannino, L. Efficacia di Bacillus thuringiensis ssp. kurstaki contro Spodoptera littoralis su lattuga in serra -Experimental field trial to evaluate the efficacy of Bacillus thuringiensis ssp. kurstaki against Spodoptera littoralis on lettuce (green ho 2010 CRA-CdSBt-SI-1-272010-Ce 316642 KIIIM1 6.2.1 Tornello, G. Experimental field trial evaluation of BT against Spodoptera sp on open field Peppers - Italy - Sicily Year 2010 2010 ICO10CE4 -CO1 316643 KIIIM1 6.2.1 Biffara, G. Studio sperimentale per la valutazione dell 2008 E02PH08 316644 KIIIM1 6.2.1 Gengotti, S. Experimental field evaluation of Costar (Bacillus thuringiensis) against Mamestra spp. on cabbage 2010 PCE10CE RBRSOXB ARBR 316645 KIIIM1 6.2.1 Tornello, G. Experimental field evaluation of Bt against Mamestra brassica on open field cabbage Italy-Sicily-Year 2010 2010 ICO10CE3 -CO1 316646 KIIIM1 6.2.1 Tornello, G. Experimental field evaluation of Bt against Mamestra brassicae on open field cabbage - italy - sicily - year 2010 2010 ICO10CE3 -CO1 316647 KIIIM1 6.2.1 Anonymous Ciba Plant Protection Trial Report 1993 CIB1993137 316648 KIIIM1 6.2.1 Torres, I. Efficacy and selectivity of TUREX against Plusia sp on WATERMELON in Spain 2010 2011 SRS10041-10IE 316649 316638 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 44 of 55 Annex Point Author Title Year Ref. App. Ref. JKI KIIIM1 6.2.1 Sánchez Rosales, J.L. Determine the activity of TUREX (B. thuringiensis) against caterpillars in Brassicae through prefixed interval of foliar applications 2005 AS6204I02 316650 KIIIM1 6.2.1 Sánchez Rosales, J.L. Determine the activity of TUREX (B. thuringiensis) against caterpillars in Brassicae through prefixed interval of foliar applications 2005 AS6204I01 316651 KIIIM1 6.2.1 Guario, A. Strategie di contenimento della tignoletta a della vite (Lobesia botrana) con formulati a base di Bacillus thuringiensis su vite da vino - Control of Lobesia botrana in grape (Original report and translation) 2007 KIIIM1 6.2.1/7/01 316652 KIIIM1 6.2.1 Bouma, E. Development of comparable agro-climatic zones for the international exchange of data on the efficacy and crop safety of plant protection products 2005 KIIIM1 6.2.1 Bersegeay, A. Insecticide - Vine Grape berry moth - Efficacy 2013 EFF01 316654 KIIIM1 6.2.1 Chatelier, B. Campagne 2010, Insecticide - Vigne Efficacité Eupocilia ambiguella 2010 S10CE113 8BC73 316655 KIIIM1 6.2.1 Imbert, C. Study the efficacy of CER.I1003 at 0,75 - 1 and 1,5 Kg/ha on the second generation of grape berry moth (Lobesia botrana) - Comparison with different standards 2012 EFF01 316656 KIIIM1 6.2.1 Novoa, D. To assess CER.I10003 efficacy in grape for Lobesia botrana control 2012 dn12-43Cer-LB2Ba1 316657 KIIIM1 6.2.1 Nova, D. Efficay test against grape berry moth, lobesia botrana, in grape vines in France with ACETAMIPRIDE and CER.I 1003 2010 dn10-68ce-Lb3-Pr5 316658 KIIIM1 6.2.1 Lopez, F. Efficacy and selectivity of TUREX for the control of Lobesia botrana on GRAPEVINES 2010 SRS10045-10IE 316659 KIIIM1 6.2.1 Lopez, F. Efficacy and selectivity of TUREX for the control of Lobesia botrana on GRAPEVINES 2010 SRS10044-10IE 316660 KIIIM1 6.2.1 Morando, A. Moths control with indecticides application 2010 053/10_Ce rtis 316661 KIIIM1 6.2.1 Chianella, M. Determination of efficacy for control of grape moth (Lobesia botrana) on grapevine in Italy 1999 01992EIVI 316662 J.- 316653 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 45 of 55 Annex Point Author Title Year Ref. App. Ref. JKI KIIIM1 6.2.1 Allegri, A. Efficacy of COSTAR WG to control Lobesia botrana 2010 CAI14010 316663 KIIIM1 6.2.1 Dimon, C. Determination of efficacy of acetamipride against Eupoecilia ambiguella and Lobesia botrana in vine, 2 sites in France 2010 2011 S1002129-01 316664 KIIIM1 6.2.1 Gajek, D. Efficacy of Delfin WG and Agree WG in the control of codling moth Cydia pomonella in apple, Poland 2012 2012 78_PROT_ F12 316665 KIIIM1 6.2.1 Gajek, D. Efficacy of Delfin WG and Agree WG in the control of colding moth Cydia pomonella in apple, Poland 2012 2012 78_PROT_ F12 316666 KIIIM1 6.2.1 Gajek, D. Efficacy of Delfin WG and Agree WG in the control of summer fruit tortrix moth Adoxophyes orana in apple, Poland 2012 2012 79_PROT_ F12 316667 KIIIM1 6.2.1 Gajek, D. Efficacy of Delfin WG and Agree WG in the control of summer fruit tortrix moth Adoxophyes orana in apple, Poland 2012 2012 79_PROT_ F12 316668 KIIIM1 6.2.1 Ferrari, R. Efficacia di formulati a base di Bacillus thuringiensis nei confronti di Pandemis cerasana Hübner (Tortricide ricamatore)- Control of Pandemis cerasana on apple 2010 6_1_3_1_2 _B.doc 316669 KIIIM1 6.2.1 Ferrari, R. Efficacy evaluation of formulations based on Bacillus thuringiensis against Pandemis cerasana Hübner on pear fruit 2010 6_1_3_1_2 _C.doc 316670 KIIIM1 6.2.1 Ferrari, R. Efficacy evaluation of formulated products based on Bacillus thuringiensis against Pandemis cerasana Hübner on pear 2011 6_1_3_1_2 _E.doc 316671 KIIIM1 6.2.1 Chianella, M. Determination of efficacy for control of leaflorells (Pandemis spp.) in apples in Italy 1999 01991E1A P 316672 KIIIM1 6.6.2 Bae, S., Fleet, G.H., Heard, G.M. Occurrence and significance of Bacillus thuringiensis on wine grapes 2004 MIIIM1 Sec 7 MTA Registration Report - Part B - Agree 50 WG - DE Section 7 - Efficacy Data and Information - Core assessment 2013 KIIIM1 6 Rinsma, S., Süß, J. Biological Assessment Dossier 2013 316673 MIIIM1 Sec 7 316674 316676 Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 46 of 55 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 47 of 55 Appendix 2: GAP tables Table 1: List of intended uses for Germany AGAP rev. SUMMARY OF GOOD AGRICULTURAL PRACTICES FOR PESTICIDE USES PPP (product name/code) active substance Applicant: Zone(s): Verified by MS: 1 UseNo. 2 Member state(s) 3 Agree 50 WG Bacillus thuringiensis subsecies aizawai Stamm GC- 91 Mitsui AgriSciences International S.A./B.V. central EU yes 4 Crop or 5 6 Formulation type: Conc. of as : WG 500 g/kg professional use non professional use x 7 and/ F situation G or (crop destination / pur- I pose of crop) Pests or Group of pests controlled Method / Kind (additionally: developmental stages of the pest or pest group) Application Timing / Growth stage of crop & season from emergence of first larvae after beginning of infestation or warning service appeal / from BBCH 53 from emergence of first larvae after beginning of infestation or warning service appeal / from 001 DE F grape vine (VITVI) (use as table and wine grape) grape berry moth 1.generation (L1-L2) 002 DE grape vine (VITVI) F (use as table and wine grape) spraying or grape berry moth 2. and 3. generation (L1- fine sprayL2) ing (low volume spraying) spraying or fine spraying (low volume spraying) , date: 2012-06-12 8 Max. number (min. interval between applications) a) per use b) per crop/ season 3 (at least 7 days apart) 10 kg, product / ha a) max. rate per appl. b) max. total rate per crop/season a) – base dose: 0,25 kg/ha - BBCH 61: 0,5 kg/ha - BBCH 71: 0,75 kg/ha b) 2,25 3 (at least 7 a) – base dose: days apart) 0,25 kg/ha - BBCH 61: 0,5 kg/ha - BBCH 71: 0,75 kg/ha 11 12 Application rate g, kg as/ha Water 13 PHI Remarks: L/ha (days) e.g. safener/synergist per ha min / max a) max. rate per appl. b) max. total rate per crop/season a) 0,125 -0,375 – base dose: b) 1,125 400 l/ha - BBCH 61: 800 l/ha - BBCH 71: 1200 l/ha a) 0,125 – 0,5 b) 1,5 14 e.g. recommended or mandatory tank mixtures – base dose: 400 l/ha - BBCH 61: 800 l/ha - BBCH 71: 1200 l/ha Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment BBCH53 003 DE berries (NNNOB) except for strawberry F free biting caterpillars 004 DE berries (NNNOB) except for strawberry G free biting caterpillars 005 DE strawberry (FRAAN) F free biting caterpillars 006 DE strawberry (FRAAN) G free biting caterpillars 007 DE fruit vegetables (NNNVF) G free biting caterpillars 008 DE leafy and stem vegetables F (NNNVL) except for vegetable cabbage free biting caterpillars 009 DE leafy and stem vegetables G (NNNVL) except for vegetable cabbage free biting caterpillars spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 11 after beginning of infestation; from emergence of first larvae / from BBCH 11 after beginning of infestation; from emergence of first larvae / from BBCH 13 after beginning of infestation; from emergence of first larvae / from BBCH 13 after beginning of infestation; from emergence of first larvae / from BBCH 09 spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / Registration Report Central Zone Page 48 of 55 - BBCH 75: 1600 l/ha -BBCH 75: 1 kg/ha b) 2,25 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 max. 1000 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 max. 1000 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 1000 - 2000 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 1000 - 2000 6 (at least 7 a) < 50 cm: days apart) 0,5 kg/ha 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 6 3 (at least 7 a) 1 days apart) b) 3 a) 0,25 – 0,5 b) 3 a) < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha b) 6 200 - 800 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 a) 0,5 b) 1,5 200 - 1000 Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment 010 DE vegetable (BRSOX) cabbage F free biting caterpillars 011 DE vegetable (BRSOX) cabbage G free biting caterpillars 012 DE root and tuber vegetables F (NNNVW) free biting caterpillars 013 DE root and tuber vegetables G (NNNVW) free biting caterpillars 014 DE bulb crops (NNNSZ) F free biting caterpillars 015 DE herbs (NNNKR) F free biting caterpillars 016 DE herbs (NNNKR) G free biting caterpillars 017 DE pulse crops (NNNLG) F free biting caterpillars spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low volume spraying) spraying or fine spraying (low from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first larvae / from BBCH 09 after beginning of infestation; from emergence of first Registration Report Central Zone Page 49 of 55 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 3 (at least 7 a) 1 b) 3 days apart) a) 0,5 b) 1,5 200 - 1000 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 1000 3 (at least 7 a) 1 b) 3 days apart) a) 0,5 b) 1,5 200 - 800 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 3 (at least 7 a) 1 days apart) b) 3 a) 0,5 b) 1,5 200 - 800 3 (at least 7 a) < 50 cm: 0,5 kg/ha days apart) 50 – 125 cm: a) 0,25 – 0,5 b) 1,5 < 50 cm: min 600 l/ha 50 – 125cm: Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment volume spraying) larvae / from BBCH 09 Registration Report Central Zone Page 50 of 55 018 DE pulse crops (NNNLG) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae / from BBCH 09 3 (at least 7 days apart) 019 DE ornamentals (NNNZZ) F free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 days apart) 020 DE ornamentals (NNNZZ) G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 6 (at least 7 days apart) 021 DE woody (NNNZG) ornamentals G free biting caterpillars spraying or fine spraying (low volume spraying) after beginning of infestation; from emergence of first larvae 3 (at least 7 days apart) Remarks: (a) In case of group of crops the Codex classification should be used (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil born insects, foliar fungi (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) Use CIPAC/FAO Codes where appropriate (f) All abbreviations used must be explained 0,75 kg/ha > 125 cm: 1 kg/ha b) 3 a) < 50 cm: 0,5 kg/ha 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 3 a) < 50 cm: 0,5 kg/ha 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 6 a) < 50 cm: 0,5 kg/ha 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 6 a) < 50 cm: 0,5 kg/ha 50 – 125 cm: 0,75 kg/ha > 125 cm: 1 kg/ha b) 3 a) 0,25 – 0,5 b) 1,5 a) 0,25 – 0,5 b) 3 a) 0,25 – 0,5 b) 3 a) 0,25 – 0,5 b) 1,5 min 900 l/ha > 125 cm: min 1200 l/ha < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha a) < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha a) < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha a) < 50 cm: min 600 l/ha 50 – 125cm: min 900 l/ha > 125 cm: min 1200 l/ha (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants (i) g/kg or g/l (j) Growth stage at last treatment (k) PHI = Pre-harvest interval (l) Remarks may include: Extent of use/economic importance/restrictions (e.g. feeding,grazing)/minimal intervals between applications Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Registration Report Central Zone Page 51 of 55 Table 2: List of intended uses for other Member States of Central Zone except for Germany * (not verified) Table of Good Agricultural Practice for Agree 50 WG (also called Turex WG) containing Bacillus thuringiensis ssp. aizawai GC-91 (50%, 25,000 IU/mg, 3.8% δ-endotoxins). Application rates are the same throughout the Central zone. Member- Product F, Pests or Groups of Formulation pests controlled state or name G, Type Conc. of Method country or MPCA kind I (c) (b) (d - f) (f - h) Application Growth Number (k) stage (j) 0001 Grapes 002 003 004 005 Central Europe Red, black and Central white currant, Europe blueberry, goosberry, blackberry, raspberry Strawberry Central Europe 006 Tomato, pepper Central (sweet and Europe chilli), eggplant 007 Cucumber, Central gherkin, cour- Europe gette, melon, patisson Agree 50 F Tortricidae (Lobesia WG botrana, Eupoecilia ambiguella) Agree 50 F Geometridae (OperWG ophtera brumata) WG 50% Foliar BBCH 53-89 spraying 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - WG 50% Foliar April - May spraying BBCH 00-79 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-3 7 days 0.5 (1.0) Not relevant - G Agree 50 F Plutellidae (Plutella WG xylostella), Noctuidae (Autographa gamma, G Plusia spp.) minmax Application rate per treatment PHI Remark s Interval kg MPCA./hL water kg MPCA./ha (days) between L/ha (kg (kg MPCP/ha) applications MPCP/hL) (l) (min.) (m) min-max min-max min-max WG Agree 50 G Noctuidae (Chrysodeix- WG is chalcites, AutograWG pha gamma, Polia oleracea, Plusia spp.) Agree 50 G Noctuidae (Chrysodeix- WG is chalcites, AutograWG pha gamma, Polia oleracea, Plusia spp.) 50% 50% 50% January – December BBCH 00-99 Foliar April – spraying September BBCH 13-89 January – December BBCH 13-89 Foliar January spraying December BBCH 09-89 Foliar spraying January – December BBCH 09-89 0.083 - 0.167 300 - 600 (0.167 – 0.333) 0.025 (0.05) 2000 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Member- Product F, Pests or Groups of Formulation pests controlled state or name G, Type Conc. of Method or country kind MPCA I (b) (c) (f - h) (d - f) Registration Report Central Zone Page 52 of 55 Application Growth Number stage (k) (j) April – High September volume spraying BBCH 09-99 minmax Lettuce, endive, Central curled endive, Europe lamb´s lettuce, spinach WG Agree 50 F Plutellidae (Plutella WG xylostella), Pieridae (Pieris spp.), Noctuidae (Polia oleracea, AutogG rapha gamma, Plusia spp.) 50% Red cabbage, savoy cabbage, pointed head cabbage, white cabbage, Brussel sprouts, kale Chinese cabbage, choi cabbage, cauliflower, broccoli, Indian mustard, kohlrabi Central Europe Agree 50 F Plutellidae (Plutella WG WG xylostella), Crambidae (Evergestis forficalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) Agree 50 F Plutellidae (Plutella WG WG xylostella), Crambidae (Evergestis forficalis), Pieridae (Pieris spp.), G Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) 50% 013 Swede Central Europe 50% Foliar spraying AprilSeptember BBCH 09-99 1-3 014 015 Beetroot, rad- Central dish, black Europe raddish, carrot, celery, celery leaves, celeriac, parsley Agree 50 F Plutellidae (Plutella WG WG xylostella), Crambidae (Evergestis forvicalis), Pieridae (Pieris spp.), Noctuidae (Autographa gamma, Mamestra brassicae, Plusia spp.) Agree 50 F Plutellidae (Plutella WG WG xylostella) 50% Foliar spraying April – September BBCH 09-99 January – December BBCH 09-99 1-3 008 009 010 011 012 Central Europe G 50% January – December BBCH 09-99 Foliar April – spraying September BBCH 09-99 Foliar spraying April – September BBCH 09-99 1-3 Application rate per treatment PHI Remark s Interval kg MPCA./hL water kg MPCA./ha (days) between L/ha (kg (kg MPCP/ha) applications MPCP/hL) (l) (min.) (m) min-max min-max min-max 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 0.5 (1.0) Not relevant 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant 0.05 – 0.25 (0.1 – 0.5) 200 - 1000 January – December BBCH 09-99 - - Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Member- Product F, Pests or Groups of Formulation pests controlled state or name G, Type Conc. of Method or country kind MPCA I (b) (c) (f - h) (d - f) Registration Report Central Zone Page 53 of 55 Application Growth Number stage (k) (j) minmax Application rate per treatment PHI Remark s Interval kg MPCA./hL water kg MPCA./ha (days) between L/ha (kg (kg MPCP/ha) applications MPCP/hL) (l) (min.) (m) min-max min-max min-max 016 Onions, shal- Central lots, pickles, Europe garlic, leek Agree 50 F Plutellidae (AcrolepiWG opsis assectella) WG 50% Foliar spraying April – September BBCH 07-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - 017 Witloof, Chicory Central Europe Agree 50 F Noctuidae (Autographa WG WG gamma, Plusia spp.) 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - 018 019 Herbs Central Europe Agree 50 F Plutellidae (Plutella WG xylostella) WG 50% Foliar spraying April – September BBCH 09-99 January – December BBCH 09-99 Foliar April – spraying September BBCH 09-99 January – December BBCH 09-99 Foliar April – spraying September BBCH 09-99 January – December BBCH 09-99 Foliar April – spraying September BBCH 09-99 January – December BBCH 09-99 1-3 7 days 0.0625 – 0.25 (0.125 – 0.5) 200 - 800 0.5 (1.0) Not relevant - 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - 1-6 7 days 0.025 (0.05) 2000 0.5 (1.0) Not relevant - G 020 021 Dwarf snap and Central slicing bean, Europe pole snap and slicing bean, yard long bean Agree 50 F Noctuidae (Polia WG oleracea, Autographa gamma, Plusia spp.) G WG 50% 022 023 Ornamentals and flowers Central Europe WG Agree 50 F Pieridae (Pieris spp.), WG Noctuidae (Plusia spp., Mamestra spp.) G 50% 024 025 Nursery crops Central and perennials Europe Agree 50 F Pieridae (Pieris spp.), WG WG Noctuidae (Plusia spp., Mamestra spp.), G Lymantriidae (Euproctis chrysorrhoea, Leucoma salicis, Lymantria dispar), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) 50% Julius Kühn-Institut 2015-11-12 Agree 50 WG ZV1 007638-00-00 Part B – Section 7 Core Assessment Member- Product F, Pests or Groups of Formulation pests controlled state or name G, Type Conc. of Method or country kind MPCA I (b) (c) (f - h) (d - f) Registration Report Central Zone Page 54 of 55 Application Growth Number stage (k) (j) 026 Forestry Central Europe 027 Public green Central Europe Agree 50 F Pieridae (Pieris spp.), WG Geometridae (Operopthera brumata), Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) Agree 50 F Pieridae (Pieris spp.), WG Geometridae (Operophtera brumata), Lymantriidae (Euproctis chrysorrhoea, Lymantria dispar, Leucoma salicis), Lasiocampidae (Malacosoma neustria), Yponomeutidae (Yponomeuta spp.) minmax Application rate per treatment PHI Remark s Interval kg MPCA./hL water kg MPCA./ha (days) between L/ha (kg (kg MPCP/ha) applications MPCP/hL) (l) (min.) (m) min-max min-max min-max WG 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) not relevant (yes) WG 50% Foliar spraying April – September BBCH 09-99 1-3 7 days 0.025 (0.05) 2000 0.5 (1.0) not relevant - Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of relevant, the use situation should be described (e.g. fumigation of a structure) equipment used must be indicated (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (i) g/kg or g/l (or potency, or % Cry-toxins) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (latin names pests) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) ISBN 3-8263-3152-4), including where relevant, information on season at time of application (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (k) Indicate the minimum and maximum number of application possible under practical conditions of use (f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (relative importance crop and pest) * Austria, Belgium, Czech Republic, Hungary, Ireland, Luxembourg, Netherlands, Poland, Romania, Slovenia, Slovak Republic, United Kingdom Julius Kühn-Institut 2015-11-12 Part B – Section 7 Core Assessment Agree 50 WG ZV1 007638-00-00 Registration Report Central Zone Page 55 of 55 Julius Kühn-Institut 2015-11-12