Food safety linked to chemical contamination through packaging materials: EFSA s guidelines for active and intelligent packaging & Migresives EU research program Alexandre Feigenbaum, Dimitrios Spyropoulos, Catherine Joly European Food Safety Authority, Parma - INRA Reims
Food safety: Risk & Risk perceptions PESTICIDES: Greece, Italy, Hungary, France, Portugal, Slovenia, Germany, Spain, Finland NEW VIRUSES LIKE AVIAN INFLUENZA: Malta, Latvia, The Netherlands RESIDUES IN MEAT: Cyprus, Greece, Belgium FOOD HYGIENE OUTSIDE HOME: Poland, United Kingdom, Denmark, Ireland, Spain FOOD CONTACT MATERIALS: United Kingdom, Denmark, Germany CONTAMINATION BY BACTERIA: Czech Republic, Luxembourg, Slovakia POLLUTANTS LIKE MERCURY OR DIOXINS: Belgium GMOs: Austria ADDITIVES: Lithuania, Estonia WELFARE OF FARMED ANIMALS: Denmark, Sweden
Food contact materials are often perceived as a source of danger. CCM Conference, Bonn 3 June 2008
Food contact materials are often perceived as a source of danger. http://www.environmentcaliforni a.org/uploads/wm/hh/wmhhmjk T2OLz4Nc4kXzynQ/Toxic-Baby- Bottles.pdf CCM Conference, Bonn 3 June 2008
Basic principles EFSA to provide high quality scientific advice on risk assessment issues Organisation of / support to Scientific Panels and working groups of first rank experts Risk assessment separated from risk management EFSA s independency ensured by independent Management Board (not part of EC) Close co-operation with national authorities.
A & I materials EFSA s guidelines
Active packaging An active packaging improves or enhances quality, practicity and/or shelf life. Scavengers (O 2, H 2 O, C 2 H 4, CO 2, off-flavours, CH 3 CHO) Emitters and releasers (antimicrobials, Ag +, EtOH ) Grafted, acting on the surface of the food An intelligent packaging provides relevant information to consumers (eg about cold chain) Acting by physical, chemical or microbiological processes (De Kruijf 2002 + other references in abstract)
Active packaging Active and intelligent packaging challenges the current regulation on FCMs, since these have to be as inert as possible Official test methods were not suitable for A&I In order to render legally possible the use of A & I packaging, the EU regulation on FCM had to be modified in depth (2004-2008). A & I substances and/or systems will be evaluated and there will be a Community list of active substances / systems
The EC Regulation on A & I (end 2008) 1/2 It will explain why and how A&I shall be authorised: -provisions will ensure that the transition to a Community authorisation procedure is smooth and does not disturb the market. -Passive parts are regulated by usual legislation (2002/72 for plastics) -Active and intelligent components: active substances intentionally released must comply with food legislation: they have to be authorised food additives or flavourings constituents of the active component of an A&I material and article shall be included in a Community list of substances that can be used to manufacture components.
The EC Regulation (end 2008) Active components 2/2 In order to ensure harmonisation, safety assessment of the substances which constitute the components should be carried out by EFSA, after submission of a valid application the applicant should also propose appropriate specific testing to be used for control of compliance How will authorisations be obtained: -Following publication of the Regulation, ESFA will publish on its web site guidelines for applications (which are of course highly dependent on the regulation). -Before adoption, there will be 2 months for public consultation -Applications must be submitted within 18 months following adoption of EFSA s guidelines -EFSA should answer within 6 months following reception of a valid application
Why is there always the need of risk assessment? example of an O2 adsorber Active polymer (absorbing system) The polymer reacts with residual O2 present in the package The degradation products of the polymer can migrate into food
Why is there always the need of risk assessment? example of an O2 adsorber Whether absorbers, releasers or even grafted, active packaging systems may release chemicals into food. Hence the need of a risk assessment requested by the regulation. The risk assessment approach is documented in EFSA s guidelines. The degradation products of the polymer can migrate into food CCM Conference, Bonn 3 June 2008
The polymer design can be improved so that the degradation compounds remain chemically bonded to the polymer backbone (cf Chevron OSP patent) The degradation products of the polymer can migrate into food
Principles of risk assessment according to EFSA guidelines (currently only available as a draft) 1/3 The safety assessment focuses on: the migration of the active and/or intelligent substance(s) the migration of their possible degradation and/or reaction products the toxicological properties of constituents The objective fixed by the regulation is a list of authorised constituents rather than of authorised finished systems. Therefore the efficacy will not be evaluated.
Principles of risk assessment according to EFSA guidelines 2/3 Information to be provided: principle and target function of the A&I material or article, identity and main characteristics of the A&I substance: composition, impurities. Physical and chemical properties (physical state, decomposition temperature, solubility, octanol/water partition, stability, reactivity, hydrolysis ) types of materials in which the substance is incorporated Recommended conditions of use. Recommended restrictions of use: types of foods, time and temperature of use, maximum % of the A&I substance(s) in the final food contact material.
Principles of risk assessment according to EFSA guidelines 3/3 Information to be provided (cntd): existing authorizations of the substance in EU Member States and other countries decomposition products: intended or potential unintended during the manufacturing process, the storage or the use of active and intelligent substance(s) migration data of active and/or intelligent substances, impurities, breakdown and reaction products toxicological data: Toxicological data on each substance, including degradation products. As a general principle, the extent of toxicological data needed depends on the level of migration OR use a functional barrier (see Migresives )
EFSA CEF Unit Workload expected 2009-2011: 2-3 opinions /week (1 opinion = 30-100 pages dossiers) - Flavouring substances & smoke flavourings - Food contact materials - Substances for positive list for plastics - Plastics recycling - A&I dossiers - Food enzymes applications If you intend to submit applications, do not wait for the last moment. If an application deviates from guidelines, explain with sufficient detail the scientific reasons
MIGRESIVES (migration from adhesives)
To regulate food contact materials, the European Commission needs scientific knowledge. Research themes to support risk assessment & regulation: analytical methods mathematical modelling of migration and parameters to feed the models, which requires knowledge of physico-chemistry of food and packaging interaction (plasticisation, swelling ) levels of exposure of consumers degradation products of substances used to manufacture the materials recycling: what is the fate of contaminants in recycled containers? active and intelligent packaging adhesives.
Research programme on MIGRation from adhesives in food packaging materials in support of European legislation and standardisation EU Project FP 6 Collective Research COLL-CT-2006-030309 Project co-ordination: Fraunhofer Institut Verfahrenstechnik und Verpackung, Freising, Germany, Dr A. Störmer Dr. Catherine Joly, INRA, University of Reims IVV Fraunhofer Institut Verfahrenstechnik
Duration: 3 years Feb. 2007-Jan. 2010 Project volume: 3,09 Mio Euro EU contribution: 1,94 Mio Euro Partners: 7 associations 7 core SME partner 7 RTD partner 6 European countries www.migresives.com IVV Fraunhofer Institut Verfahrenstechnik
Current regulatory situation of adhesives for food contact materials Adhesives in food contact materials have to be compliant to Article 3 of EU Regulation 1935/2004: No transfer of substances on/into the food in amounts which could endanger human health. But no specific regulation in EU or member states how to implement this requirement. For formulation of adhesives approx. 4000 substances are used. Only a small part of the substances (ca. 10 %) is already evaluated on EU level (e.g. Plastics Directive 2002/72/EC) or on national level (e.g. German BfR Recommendation XIV plastics dispersions) Approx. 80 90 % of the used raw materials are not yet toxicologically evaluated on EU level. IVV Fraunhofer Institut Verfahrenstechnik
1)Classification of adhesives on basis of chemical groups, structure, end use (type of material, of food, temperature ) Will be the basis of assessment: of likely chemistry in adhesives and prediction of possible neo-formed products of likely exposure of consumers to migrants (depending on structure & end-use) of parameters to feed the models EU
2) Modelling of diffusion and migration of adhesive constituents This will allow to decide and demonstrate - whether there is a functional barrier - what is the possible migration level A freeware will be provided to predict migration and functional barriers properties EU An on line version of the software is available on INRA web site: http://h29.univ-reims.fr/ (request password) The freeware is now being made user friendly
Tools to predict migration Polymer 2 Adhesive Polymer 1 Food Diffusion into polymer 1 & migration into food
Polymer 2 Adhesive Polymer 2 Food Is there a functional barrier? A functional barrier reduces migration (defined in EC 2002/72) -Absolute barrier -Diffusion barrier -Partition barrier -Evaporation barrier
Adhesive / polymer 1 partition effect Kadhes/polym Polymer 2 Adhesive Polymer 1 Food Is polymer 1 a functional barrier? A functional barrier reduces migration (defined in EC 2002/72) -Absolute barrier -Diffusion barrier -Partition barrier -Evaporation barrier
Polymer 1 / food partition effect Kpolymer1/food Polymer 2 Adhesive Food
Current achievements There are various types of functional barriers (eg label/glass bottle - adhesive/paper). If there is a FB, less toxicological information is needed. Determination of sets of parameters describing the usual situations by diffusion & partition coefficients for classes or material - adhesive couples. These parameters are used to feed the freeware
Overall conclusions Research in Migresives and Actipack (2000) does not aim to improve functionalities of Food Contact Materials It characterises possible risks associated to the use of the products. Without such work, the regulation would not be practicable. Functional barriers may reduce migration down to levels where pulic health is not endangered, both for A&I packaging and for adhesive systems. Predictive tools predict the efficacy of functional barriers The main difficulty nowadays is not to develop these models, but to feed them with relevant parameters describing typical situations Risk assessors, risk managers (including industry) should have the same tools available.
Thank you for your attention Thanks to the organisers who have given me the opportunity to present these results
Oxygen scavengers: The OSP TM Concept (Chevron) O O O 2 O O R O O O O O O OH Active packaging: O 2 absorbers O H R O O O O HO O 21% O 2 OH ~ 2.0 mole O 2 uptake OH O O OH ~ 1.0 mole O 2 uptake 25 o C 1% O 2 4 o C - H O O OH Packaging reacts with residual O2 present in headspace. The reaction products remain grafted to the polymer. (Chevron)