Karin ASCHBERGER

Nanomaterials in Food
Current and future applications and
regulatory aspects
Karin Aschberger – JRC-IHCP Nanobiosciences Unit
www.jrc.ec.europa.eu
Nanosafe 2014, Grenoble
18-20 November 2014
Serving society
Stimulating innovation
Supporting legislation
The opinions expressed in this presentation are those of the
authors and not necessarily those of the European
Commission.
Nano in agriculture, feed and food
Nanosafe 2014
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To receive more up-to-date information on the state
of the art of nanotechnology applications EFSA
launched a call for tender for an
Inventory of food additives and other food
additives and other food ingredients/food contact
materials/feed additives application in the area
of nanotechnologies.
CFT/EFSA/FEED/2012/01
1 March 2013 – 1 March 2014
Nanosafe 2014
JRC Ispra
IHCP-Nanobiosciences
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Task 1 – Extensive literature search
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1
2
3
Searches in 3 steps:
[Nano*, …]
[Application, …]
[Property, …]
13-04-2013 - 28-08-2013
8968 hits – 662 selected relevant records
EFSA supporting publication 2014:EN-621
Nanosafe 2014
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Application fields
Task 2: Nano Inventory
• Developed in Microsoft Access
environment to facilitate
collection, storage and extraction
of data
• 3 predefined queries to generate
inventory lists
Currently used
Nanosafe 2014
Foreseeable for
future use
EFSA supporting publication 2014:EN-621
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Task 2: Analysis of Nano Inventory
250
AGRI
FEED
FOOD
200
150
100
Unclear status
In development
50
Marketed
0
Peters et al. in preparation
Distribution of NM applications that are already marketed, in development or
with unclear status over the most relevant application fields
Nanosafe 2014
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Task 2: Analysis of Nano Inventory
EFSA supporting publication 2014:EN-621
Peters et al. in preparation
Overview of nanomaterial type mentioned in 633 records of the Nano
Inventory (filtered with the query “current and future applications”)
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Task 2: Analysis of Nano Inventory
available on the market
in development
EFSA supporting publication 2014:EN-621
trend from inorganic materials towards organic materials
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Task 3: Nano-applications in agricultural
production
Increase efficacy of agro-chemicals
Detection and treatment of diseases
- Pesticides - Plant growth promoters - Animal feed additives
- Organic: encapsulations and solid lipid nanoparticles
- Inorganic: titanium dioxide, silver, silica, aluminia
- Commercialised products: Nanocid®(Ag), Chitosan (Chitin
based polymer), PrimoMaxx (plant growth regulator),
- Naturally occurring: ashes, metals, nanoclay (fertilizer)
- Agri-waste management, water, soil cleaning
http://www.nanocid.com
Nanosafe 2014
Task 3: Nano-applications in feed
Limited information identified – most in development
- encapsulation of nutrients
- increased absorption of nanoforms (Fe, Se)
- use a antibiotics (nanosilver)
- absorb bacteria and mycotoxins (montmorillonite based
nanoclays, polystyrene based particles)
- improve digestibility of feed
Nanosafe 2014
Montmorillonite Clay http://www.kalyx.com
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Task 3: Nano-applications in food (1)
Most applications as food additives to improve product quality
(texture, taste), solubility or bioavailability of nutrients
SAS – precipitated or fumed silica; surface coating, clearing of
beverages, anti-caking agent, etc.
Other anti-caking agents: calcium silicate, sodium aluminosilicate,
dicalcium phosphate, sodium ferrocyanide and microcrystalline
cellulose;
nano?
TiO2 as white pigment (parts in nano-size range), nanoform as
antimicrobial
Nickel oxide, cobalt - inactivation of foodborne pathogens
Iron oxide: food colorant
Nanosafe 2014
TEM images of Aerosil 200F (a),Aerosil 380F (b);
Dekkers et al. Nanotoxicology, 2011; 5(3): 393–405,
Task 3: Nano-applications in food (2)
Nano-encapsulations and nanodelivery systems
Incorporation, adsorption or dispersion of bioactive
compounds (vitamins, isoflavones, omegs-3 FA) in nanosized vesicles
Improved stability, and solubility (hydro-lipophilic),
increased bioavailability and delivery to cells/tissues
LycovitTM (Lycopene), LifePak NanoTM (carotenoids, CoQ10),
MicroHydrinTM (antioxidant)
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EFSA supporting publication 2014:EN-621
Task 3: Nano-applications in food
contact materials
Coatings of machinery in food production, surfaces,
kitchenware/equipment, nano-sieves, active and intelligent
food packaging
Improved quality, freshness and storage time of food
UV-protection, anti-microbials, improved gas-exchange
barrier of packaging, contaminant sensors for food monitoring
Improved mechanical and heat resistance (e.g. biodegradable
composites)
Nanoparticles of silver, titanium dioxide, magnesium oxide,
zinc oxide, nanocomposites, chitosan, nisin (polycyclic
antibacterial peptide; 34 amino acid residues)
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Task 4: Review of legislation
Information about relevant regulation gathered from:
• EUR-LEX Europa, EC websites
Recently published reports (OECD 2013, WHO/FAO 2013)
Peer-reviewed publications (literature search performed under task 1 plus
additional peer-reviewed papers)
Websites of national and international institutions, organizations, and
governments
Questionnaire on "Regulation and safety assessment of nanomaterials in
agri/feed/food applications"
Nanosafe 2014
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Task 4: Review of EU legislation
• Pre-market approval required for many agri/feed/food
applications, Risk assessment (implicitly) covers nanomaterials
(food/feed additives, novel food, pesticides, etc.)
• NMs explicitly addressed by some Regulations e.g.: plastic
FCM, Novel Food revision, Food Information to Consumer,
Biocides, Active and intelligent materials and articles
• NM Definition: 1169/2011 (FIC*); EC Recommendation
2011/696/EU
Nanosafe 2014
*Food Information to Consumer Regulation
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EU: Definition of Nanomaterial
Commission Recommendation
Regulation (EU) No 1169/2011 on the
(2011/696/EU)
provision of food information to
"Nanomaterial" means a natural,
consumers (FIC)
incidental or manufactured material
"Engineered nanomaterial" means any
containing particles, in an unbound state or
intentionally produced material that has
as an aggregate or as an agglomerate and
one or more dimensions of the order of 100
where, for 50 % or more of the particles in
nm or less or that is composed of discrete
the number size distribution, one or more
functional parts, either internally or at the
external dimensions is in the size range 1
surface, many of which have one or more
nm-100 nm. In specific cases and where
dimensions of the order of 100 nm or less,
warranted by concerns for the environment,
including structures, agglomerates or
health, safety or competitiveness the number
aggregates, which may have a size above the
size distribution threshold of 50 % may be
order of 100 nm but retain properties that are
replaced by a threshold between 1 and 50
characteristic of the nanoscale.
%.
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Task 4: Review of EU legislation
• Need to label NM in food applications (from Dec 2014)
Ingredients:
…, anticaking agent E551 (nano), …
• EFSA: Re-evaluation of all food additives approved before 2009
(e.g. CaCO3, SAS)
• EFSA guidance on risk assessment of nano-applications
available:
http://www.efsa.europa.eu/en/efsajournal/pub/2140.htm
• NM as chemical substance regulated by REACH*, Classification
& Labelling; ECHA guidance available
Nanosafe 2014
*EU Chemicals Regulation: Registration, Evaluation,
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Authorisation of Chemicals
Task 4: Review of non-EU legislation
Main findings
•
Many activities ongoing in several countries: mainly USA, Canada,
Australia/New Zealand (FSANZ), China, Japan, Malaysia, Korea,
Switzerland
•
EU candidate states (e.g. Turkey) – similar approaches as EU
•
Nanomaterials definitions – not legally binding recommendations/
guidance; beside size other specific properties considered (e.g US)
•
Nano-specific legislation for agri/feed/food not available, case-bycase approach for risk assessment often recommended (e.g. USA)
•
System for certifying products in Taiwan, Iran, Thailand
Nanosafe 2014
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Conclusions
• nano-encapsulates, silver and titanium dioxide are the most often
mentioned nanomaterials
• food additives and food contact materials are the most often
mentioned current applications
• future developments are expected for nano-encapsulates and nanocomposites in applications such as novel food, food/feed additives,
biocides, pesticides and food contact materials.
• most toxicological data was found for silica, titanium dioxide and
silver
• EU: binding NM definitions and specific provision for some
applications
• non-EU countries: broader approach to regulate NM, mainly built on
guidance
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http://www.efsa.europa.eu/en/supporting/pub/621e.htm?utm_source=newsletter&utm_medium=email&utm_
content=pub&utm_campaign=20140724
Nanosafe 2014
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Thanks to all colleagues
RIKILT
Ruud Peters
Puck Brandhoff
Stefan Weigel
Hans Marvin
Hans Bouwmeester
EFSA
Reinhilde Schoonjans
M.Vittoria Vettori
Nanosafe 2014
JRC-Ispra
Hubert Rauscher
Valeria Amenta
Maria Arena
Filipa Botelho Moniz
Stefania Gottardo
Agnieszka Mech
Laia Quiros Pesudo
Teodor Ivanov
Aris Tsois
silver nanoparticles radiolabelled with Ag-105.
Copyright EU 2013
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Joint Research Centre (JRC)
www.jrc.ec.europa.eu
Contact: [email protected]
[email protected]
Thank you for your attention!
Questions?
Serving society
Stimulating innovation
Supporting legislation
NIVA Safety and Risk of ENM
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