FOR THE HAZARD CLASSIFICATION AND LABELLING OF FLAVOUR AND
Transcription
FOR THE HAZARD CLASSIFICATION AND LABELLING OF FLAVOUR AND
IFRA-IOFI LABELLING MANUAL 2013 FOR THE HAZARD CLASSIFICATION AND LABELLING OF FLAVOUR AND FRAGRANCE SUBSTANCES ACCORDING TO THE UN GHS, UN TDG and EU DSD. IMPORTANT DISCLAIMER: 1. The IFRA/IOFI Labelling Manual has been carefully prepared by the IFRA/IOFI Secretariats and the IFRA/IOFI GHS TF. The guidelines or recommendations provided by IFRA/IOFI should not be considered or used as a substitute for legal advice. 2. The guidance provided by IFRA/IOFI does not relieve member associations or their members of their obligations under applicable national and regional laws and regulations. 3. While appropriate efforts have been made to insure the accuracy of this document, IFRA/IOFI cannot be held liable for errors or omissions in this document. Member associations and their members should always satisfy themselves in any particular instance that the suggestions made by IFRA/IOFI can be properly followed. 4. Neither IFRA/IOFI nor any individual members or officers, can be held liable for any loss or damage suffered by any member association or its (individual) members as a result of following or relying on the IFRA/IOFI Labelling Manual. BY USING THIS LABELLING MANUAL, YOU WILL BE DEEMED TO HAVE UNDERSTOOD AND ACCEPTED THE CONDITIONS OF THIS DISCLAIMER. Important information in regards to the release of the Labelling Manual 2013 (in the following abbreviated as LM): During 2013 r ca 250 materials have been reviewed. Compared to the 2012 LM the number of substances in Att I has increased from 1522 up to 1597. From the above mentioned number of substances ca 200 substances registered under REACH in 2013 have been reviewed to update the LM accordingly. In some cases expert judgement has been used for the interpretation of some registration dossiers submitted. For example in case of intermediate dossiers (data poor) or where classifications were assigned not in accordance with data given. This is indicated by a separate footnote 12. NCS Att IV and V have been expanded with some 30 NCSs substances with VoU > 1 t. The number of entries has increased from 339 to 366. For some products originating from same family of species the CAS/EINECS numbers could be combined as compositional data were equivalent. Some chemically modified NCSs have been moved to Att I (chemical section); relevant compositions are given, similar NCSs, in Att V. In Att IV the footnotes have been separated from the names and are given in a separate column. Also a Flashpoint which is considered typical for the NCS is now mentioned. It speaks for itself, especially in the band around the classification limits, that the actual value for flammability determination (GHS/transport) shall be used. Last year some materials were no longer maintained and were only mentioned in Att VI- Functionals. Based on feedback received and as some are used as flavour and fragrance ingredient it was concluded that some of these materials ought to come back in Att I, II, and III. - 2 of these materials were deleted as they were no longer reported in the recent global Volume of Use surveys. 84-74-2 Dibutyl phthalate 123-31-9 Hydroquinone Page 1 of 8 - Where route of exposure and/or target organs were missing in case STO endpoints this info has been added as far as available. Access to disseminated REACH registration dossiers can be found by using the following link: http://apps.echa.europa.eu/registered/registered-sub.aspx Quality improvement of the LM is an ongoing activity and we welcome any comment on content or layout; please send your observations/remarks to [email protected]. A. GENERAL CONSIDERATIONS The IFRA/IOFI GHS Task Force, with global representation, including Brazil, Europe, the United States and Japan, will classify fragrance and flavour materials following the criteria laid out in the UN GHS guidance document, which is currently the 5th revised edition (the so-called “Purple Book”, which can be downloaded: http://www.unece.org/trans/danger/publi/ghs/ghs_rev05/05files_e.html It will also assign UN Transport classifications as well as EU DSD classifications, as long as those remain active. EU DSD classifications will be maintained until end of 2014 for LM 2014 and will be deleted with the next LM issue 2015. The Task Force takes into account the physical/chemical, toxicological and eco-toxicological data available for these substances at the time of the publication of this Labelling Manual. Substances that are to be classified as hazardous as well as those which are not classifiable based on current knowledge, are included in the attached lists. Decisions on how to deal with issues in the area of hazard assessment are documented in a Modus Operandi (MO) justifying the contents of the work product of the group (Labelling Manual and Flavour or Fragrance Ingredient Data Sheets (FFIDSs)). This document will serve as a means to ensure an identical approach within the Fragrance and Flavour Industry during the process and to serve as a reference of supplementary convention and expert interpretation for fragrance and flavour raw materials. The benefit of this activity is to provide a single global classification of all flavour and fragrance materials to avoid regional differences as the GHS standards are rolled out globally over time. Please note that the MO is currently under revision. B. USE OF THE IFRA/IOFI LABELLING MANUAL The information provided in this Labelling Manual is intended to provide direction to companies to assure a consistent hazard classification and labelling for fragrances and flavours and their ingredients. It must be stressed that: Any official regional classification of substances prevails over self-classification of the GHS Task Force. The Attachments to this Manual are not comprehensive and the absence of a substance or a specific classification should not be taken to imply that no classification and/or labelling are required. In order to make the Attachments as comprehensive as possible, the GHS Task Force welcomes for consideration, any proposal for additions or amendments on the basis of the voluntary shared knowledge within the Flavour and Fragrance Industry. The substances examined have been considered for their flammability. Results using the Pensky Martin Closed Cup (PMCC) method were taken as the reference. Due to the variability of flash point determinations (e.g. influenced by minor impurities and variations in the compositions of oils), actual measured flash points are the responsibility of the member companies. Member companies should not rely on the recommendation as contained in the Manual, but rather rely on their own data. The listing of a substance in one of the Attachments does not mean an approval for use in fragrances or flavours. Indeed, some of the substances may be subject to restrictions for specific applications, such as the IFRA Standards, EU Cosmetic Legislation, flavour regulations, etc. The implementation of a new or an amended classification or labelling should be initiated after publication of the updated Labelling Manual (see section C). Page 2 of 8 For some of the substances, individual limit concentrations have been officially assigned in Annex VI of the CLP Regulation (EU DSD). They are mentioned in the Attachments and have to be followed instead of the general so-called administrative limit concentrations when classifying a preparation according to the conventional method of the EU DPD or CLP respectively. Each supplier is reminded that they bear the final responsibility for the appropriate classification and labelling of the products they place on the market, based on the quantity and composition of their product. a) Aspiration hazard (UN GHS: AH Cat1; EU DSD: Xn; R65) Some substances and preparations pose a specific hazard upon ingestion since they can be aspirated into lungs and cause lung damage. The criteria for classification are purely of a physicochemical nature (hydrocarbons or preparations [mixtures] containing >10% hydrocarbons with a kinematic viscosity and/or surface tension below a given value). Based on measured results for a number of Natural Complex Substances (NCS) with hydrocarbon contents between 10 and 90+ %, and on similar measurements of some flavour and fragrance compounds, the Task Force has come to the conclusion that in practice, substances and preparations containing more than 10% of hydrocarbon(s) fall within the criteria for viscosity and/or surface tension, unless the material is a solid or reported to be a viscous liquid. In the absence of data for a specific NCS and based on the above, it is recommended: - to determine the hydrocarbon content of substances (supplier information, analysis) and preparations (calculation) and to classify as AH Cat 1 and Xn; R65 respectively if more than 10% Hydrocarbons are present; - non-classification should only be possible if viscosity measurement results [and/or surface tension measurements (EU DSD)] are available for a specific, not obviously viscous substance preparation. b) Classification of Natural Complex Substances (NCS) NCS (Essential oils and volatile solvent extracts) used in perfume compounds and flavours are known to have variable composition. This variability is well defined by ISO norms and /or by industry statistics. The bridging principle approach, as defined by GHS, CLP and EU DPD, must be utilised to assess the impact of this variability on the classification. If robust test data are available, a specific quality of a NCS must be classified on the basis of the result as indicated in GHS (cf. 1.3.2.3). This classification, however, is only applicable to the material and thus, its composition tested and other NCSs where the chemical composition has been demonstrated to be equivalent. For other grades of NCS’s, and for endpoints for which reliable test data are lacking, the UN GHS guidance document, as well as the EU DSD regulations, incorporate requirements whereby the hazard classification of complex substances shall be evaluated on the basis of levels of their known chemical constituents. Where knowledge about hazardous constituents exists, e.g. on substances with sensitizing, toxic, harmful, corrosive, environmentally hazardous properties, the classification and subsequent labelling of these NCSs should follow the additivity rules for mixtures (GHS) and conventional method (EU CLP/DPD) respectively. Guidance for the typical abundance of the hazardous constituents occurring in the NCSs is provided in Attachment V. These values are a result of the shared knowledge of the Industry at the time of the publication of this LM. The hazard classifications based on these values, derived following the approaches indicated above, are located in Attachment IV of this Manual. Uncertainty may exist over whether any particular quality of a NCS corresponds to the quality on which the tests and/or calculations were carried out. Attachment V, footnote 3 a-d, covers cases where the classification was obtained by reliable test data for a particular endpoint, as opposed to calculation. c) Classification of Fragrance and Flavour compounds containing Natural Complex Substances (NCS) Flavour and Fragrance compounds are mixtures according to the UN GHS guidance document. In practice, test data on the flavour or fragrance compounds are often not available or collected. Therefore, the classification of these products should be based on the chemical composition and Page 3 of 8 should include the contributions of hazardous substances present as constituents in the NCSs present in the formulation. Available robust test data on specific NCS’s should take precedence. This implies that the hazardous substances present in a NCS should be known and it is recommended to request that this information be included in the Safety Data Sheet of that NCS (section 3: Composition/information on ingredients, according to the UN GHS guidance document). In case of absence of this information, Attachment V can be used. However, it should be realized that when a NCS is mentioned in an official inventory (e.g. Annex VI of the European CLP regulation) this classification must be used and not the classification resulting from the constituents. d) Transport classification The assignment of UN numbers, packing group and hazard class is based on the criteria as laid down in the Recommendations on the Transport of Dangerous Goods Model regulations as published by the United Nations, 17th edition (so-called Orange Book ST/SG/AC.10/1/Rev.17). The assigned UN-number is a recommendation, which should be used to verify detailed differences between the various modes of transport, such as: air, sea and land (land transport can be separated into road, rail and in-land water ways). Where needed, the EU hazard classification of the substance is supplemented with the ADR-rules, including the links to the EU-DSD and DPD. Also, for transport, due account should be given to any national deviations from the rules applied here. C. IMPLEMENTATION AND OTHER INFORMATION The time for implementing new or modified classifications with regard to, UN Transport and EU DSD regulations as indicated in attachments I to VI, as approved by the GHS Task Force should not exceed a period of six months following the publication of the Labelling Manual. Other regional requirements must be observed. Regarding the implementation of GHS classifications it is up to the individual companies to decide at what time - and depending on the respective regulations in the country or region considered – these shall be applied. Please note that the legal requirements regarding compliance dates of any new officially classified substances prevail over the above mentioned six months period as agreed by our industry. The GHS Task Force adds the following clarification regarding compliance: New or modified classifications apply to the substances defined by the indicated Chemical Abstracts Service Registry numbers (CAS numbers) regardless of whether alternative CAS numbers exist. New additions to the lists are marked with “ + “ Corrections and modifications are indicated with “ x “ For those substances, for which classification and labelling was not considered necessary “Not Classified”, based on the data available to the Group and the shared knowledge of the flavour and fragrance industry brought to their attention, be aware that classification might arise when considering the presence of classified constituents, as outlined above. UN GHS Following the UN GHS guidance document, the GHS Task Force applies the criteria for all hazard classes and categories (except for some physico-chemical hazards not encountered in F&F ingredients, see Appendix 1) as mentioned in the so-called “Purple Book” aiming at harmonized UN GHS classifications of substances. The results comprise the indication of Flash Point and Acute Toxicity Estimate (ATE). Further M-factor of 1 has to be considered for the Environmental Hazard categories A1/C1 unless otherwise indicated. The labelling elements (Pictogram, Signal Word, Hazard statements, Precautionary statements) that have to be used for a given hazard classification are spelled out in Annexes 1, 2 and 3 to the UN GHS. The table of UN GHS hazard classifications for chemically defined substances can be found in attachment I of the LM. Please note that this table includes substances which have been identified by the group of having L (E) C50 values of less than or equal to 0.1mg/l and larger than 0.01mg/l for acute aquatic toxicity. Following UN GHS for these substances M-factors of 10 have been assigned. UN TDG: Page 4 of 8 The assignment of UN numbers, packing group and hazard class is based on the criteria as laid down in the Recommendations on the Transport of Dangerous Goods Model regulations as published by the United Nations 17th edition (so-called “Orange Book”). The assigned UN-number is a recommendation that should be used to verify detailed differences between the various modes of transport, such as: air, sea and land (land transport can be separated into road, rail and in-land water ways). Also, for transport, consideration should be given to any national deviations from the rules applied here. The table of UN Transport classifications for chemically defined substances can be found in attachment III of the LM. EU DSD: The classification and labelling of substances is either prescribed in Annex VI to the CLP Regulation (EC) No 1272/2008, or has to be done by the supplier using the criteria of Annex VI of the Dangerous Substances Directive 67/548/EEC (EU DSD). For preparations, like flavour and fragrance compounds, the rules of the Dangerous Preparations Directive 1999/45/EC (EU DPD) have to be followed. Although the CLP regulation has entered into force on 20 January 2009 - which has introduced the GHS into the European Union - a staggered approach for that implementation has been foreseen. During the transition periods, ending on 1 June 2015, the indication of the classification following the DSD and DPD Directives is still mandatory in the respective Safety Data Sheets. Note that Annex I to the DSD and its adaptations to technical progress have been transferred to the CLP Regulation EC (No) 1272/2008, Annex VI; the Annex I to the DSD has been repealed. Several substances of interest to the fragrance and flavour industry with their official classifications are mentioned in Annex VI to the CLP Regulation. They are included in the respective attachments to this Labelling Manual with their Annex number next to their CAS and EU number. The table of EU DSD hazard classifications for chemically defined substances can be found in attachment III of the LM. Please note that this table includes substances which have been identified by the group of having L(E)C50 values of less than or equal to 0.1mg/l and larger than 0.01mg/l for acute aquatic toxicity. Following Directive 2006/8/EC for these substances specific concentration limits are applied. EU CLP: The difference in classification between UN-GHS and EU-CLP is caused by the difference of implementation of the building blocks.In Appendix II the difference in building blocks between the two classification schemes is given. For the blue coloured fields the schemes are identical, the yellow colour indicates a difference. To derive from UN-GHS to EU-CLP is the substraction of the EU-non applicable building blocks from UN-GHS classification. For example a substance with ATO 5(3700),FL 4,SCI 3, will become “Not classified” under EU-CLP. Natural Complex Substances: a) Classifications provided in this annex are examples only provided as guidance based on available data and representative constituent information only. They do not represent appropriate classifications for all qualities of an NCS as these may vary substantially. It is incumbent on the supplier and/or manufacturer to ensure their NCS is appropriately classified based on test data or on constituent information for their supplied material. IFRA/IOFI does not warrant the accuracy of this information that is provided only to help companies identify possible classification considerations for their materials. The table of UN TDG, EU DSD and UN GHS hazard classifications/hazard statements for Natural Complex Substances (NCS) can be found in attachment IV of the LM. b) As explained in sections b) and c), in the case of absence of information about actual levels of hazardous substances present in natural complex substances, this list should be taken into account for the hazard classification of NCS and for their contributions to the hazard classification of flavour and fragrance compounds. NCS constituent information provided in this annex are examples only provided as guidance based on representative constituent information only. They do not represent Page 5 of 8 constituent composition for all qualities of an NCS as these may vary substantially. It is incumbent on the supplier and/or manufacturer to ensure their NCS is appropriately classified based on test data or on constituent information for their supplied material. IFRA/IOFI does not warrant the accuracy of this information that is provided only to help companies identify possible classification considerations for their materials. The table on the potential presence of hazardous constituents in natural complex substances (NCS), containing percentage information, UN GHS and EU DSD classification can be found in attachment V of the LM. Functional components: The IFRA/IOFI GHS TF decided to no longer maintain in the LM those ingredients that are not typical flavour or fragrance materials, but are considered to be “functional ingredients, e.g., solvents. The materials from the LM2010 that will no longer be maintained and therefore, will drop out of the LM in the following editions can be found in attachment VI of the LM. Appendix I Overview of GHS hazard classes considered and the abbreviations used. Appendix II Overview of UN-GHS and EU-CLP building blocks Page 6 of 8 Appendix 1: GHS Hazard classes and its related abbreviations. The table below reflects the 4 physical, 11 health and 1 environmental hazard classes as well as their abbreviations that have been considered for classification. Flammable gas GHS Class abbreviation FG Pressurised gas PG Flammable liquid FL 1,2,3,4 Flammable solid FS 1,2 Acute toxicity, oral ATO 1,2,3,4,5 Acute toxicity, dermal ATD 1,2,3,4,5 Acute toxicity, inhalation ATI 1,2,3,4,5 Skin corrosion/irritation 1A,1B,1C,2,3 Serious eye damage/eye irritation SCI EDI Respiratory sensitization RS 1 Skin sensitization SS 1, 1A,1B Germ cell mutagenicity MUT 1A,1B,2 Carcinogenicty CAR 1A,1B,2 Reproductive Toxicity Specific Target Organ toxicity – Single exposure Specific Target Organ toxicity – Single exposure REP 1A,1B,2 STO-SE 1, 2 GHS Hazard Class Specific Target Organ toxicity – Single exposure STO-SE (NE) STO-SE (RI) Specific Target Organ toxicity – Repeated STO-RE exposure Aspiration hazard AH Hazardous to aquatic environment Repeated exposure may cause skin dryness or cracking. Corrosive to the respiratory tract. EH GHS Hazard Categories 1,2A,2B 3 (Transient target organ effects: narcotic effects) 3 (Transient target organ effects: respiratory tract irritation) 1, 2 1, 2 A1,A2,A3,C1,C2,C3,C4 EUH 66 EUH 71 Page 7 of 8 Appendix II Difference of building blocks between UN-GHS and EU-CLP. GHS Hazard Class GHS Class Abbreviation GHS Hazard Categories EU Flammable liquid FL 1,2,3,4 1,2,3 Flammable solid FS 1,2 1,2 Acute toxicity, oral ATO 1,2,3,4,5 1,2,3,4 Acute toxicity, dermal Acute toxicity, inhalation Skin corrosion/irritation ATD ATI SCI 1,2,3,4,5 1,2,3,4,5 1A,1B,1C,2,3 1,2,3,4 1,2,3,4 1A,1B,1C,2 Serious eye damage/eye irritation EDI 1,2A,2B Respiratory sensitization RS 1(A,B) 1,2 1(A,B) Skin sensitization SS 1(A,B) 1(A,B) Germ cell mutagenicity MUT 1A,1B,2 1A,1B,2 Carcinogenicty CAR 1A,1B,2 1A,1B,2 Reproductive Toxicity Reprotox: Effects on or via lactation Specific Target Organ systemic toxicity - Single exposure REP 1A,1B,2 1A,1B,2 yes yes 1, 2 1, 2 STO-SE Specific Target Organ systemic toxicity - Single exposure STO-SE 3 (Transient target organ effects: narcotic effects) 3 (Transient target organ effects: respiratory tract irritation) Specific Target Organ systemic toxicity - Single exposure STO-SE Specific Target Organ systemic toxicity - Repeated exposure STO-RE 1, 2 1, 2 Aspiration hazard AH 1, 2 Acute aquatic toxicity EH A1,A2,A3 1 A1 Chronic aquatic toxicity EH C1,C2,C3,C4 C1,C2,C3,C4 3-NE 3-RI Legend: blue=identical; yellow=different. 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