EU Food Additives, Food Contact: Regulatory Requirements and Recent Developments 101

1. EU Food Additives, Food Contact:Regulatory Requirements and Recent Developments 101 Craig Simpson, Senior European Legal Advisor, Steptoe & Johnson LLP Food Contact & Additives, Washington DC, September 25, 2013 www.steptoe.com

2. Food Additives www.steptoe.com

3. Food Additives: Outline • Commercial significance? • Basic food additives regulatory framework • New Union lists of additives • Authorization procedure (common) • Implications of re-evaluation of food additives www.steptoe.com

4. Implications of non-compliance • Regulation 178/2002 (Article 17(1)): ‘Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law.’ • Case-315/05 (Lidl Italia): • MS national laws can impose liability on distributors for non-compliant product labeling (of manufacturer) • alcoholic strength of herbal liqueur • Court did not appear to address Lidl’s defense argument that: ‘The distributor cannot know whether or not the label affixed to the packaging by the producer contains true information.’ • Are food additives on permitted lists for food and use? • Use conditions (dosage?) complied with? • Business interruption • EU compliance guarantees and indemnities from manufacturers? www.steptoe.com

5. Food Additives within the EU Regulatory Framework Food Ingredients Food Improvement Agents Other ingredients: positive lists, labeling, etc. in food specific or generic food regulations Common Authorization Procedure (Regulation 1331/2008) www.steptoe.com

6. Regulatory Framework: Basics • What are we talking about?  ‘Additives’: • not normally consumed as food in itself • intentional addition for technological purpose (colors, sweeteners, stabilizers etc.) • not enzymes or flavorings(parallel authorization laws) • overlapping functions? • Regulation 1333/2008 on food additives: • consolidates previous framework and sectoral directives (colors, sweeteners other additives) • new additives uses covered (e.g. in enzymes) • ‘General conditions’ for additives: • no health risk at levels proposed   • technological need unachievable by other means • consumer not misled (‘natural’, freshness) • demonstrated consumer advantage www.steptoe.com

7. Regulatory Framework: Basics • Additive entry on positive list must: • state what foods can be used in • state what conditions under which may be used • any restrictions on sale (e.g. specific labeling) • Lowest use level to achieve effect – consider: • ADI (amount ingestible over life without health risk) • probable intake (from all sources and by special groups (children, diabetics)) • Obligation on food additive producers and users to: • report information suggesting health risk • provide Commission with actual use information (exposure assessment) on request www.steptoe.com

8. Union (Permitted/Positive) Lists • New Union positive lists (Regulation 1333/2008 Annexes) applicable since 1 June 2013! • Review compliance with ‘general conditions’ and drop non-compliant • Significance for industry: • new restrictions on use (foods, amounts) • restriction of food color lycopene (E 160d) • some additives banned • colors Red 2G (E 128) and brown FK (E 154) banned • new additives allowed (marketing opportunities?)   • new glazing agent for food supplements www.steptoe.com

9. Example of List Entry for Specific Food www.steptoe.com

10. Authorization Procedure • New authorization procedures (implementing Regulation 234/2011) • Individual additive case by case, not combined • Procedure: • application (dossier) by ‘interested party’ (supply chain, NGOs, competitors?) to Commission for additive ‘update’ (add, remove or restrict/extend use conditions) containing:  • risk management and risk assessment data • demonstrate satisfaction of general requirements • evidence of efficacy for intended effect • no express requirement to produce unfavorable data • dietary exposure assessment • proposed maximum use levels • Commission requests EFSA risk assessment, except where deems no health risk www.steptoe.com

11. Authorization Procedure/Confidentiality • EFSA opinion in 9 months: • dietary exposure assessment looking at other possible sources and special groups exposure • whether exceeds ADI • overall risk assessment • Commission risk management decision on update in 9 months: EFSA opinion, Community law and ‘other legitimate factors’ (societal, economic, traditional, ethical, precautionary principle and feasibility of controls) • Confidentiality: • Commission decision on application • 3 weeks for applicant to withdraw if refused • confidentiality precluded for use or safety data (valuable toxicological test data?) • full copies of original unpublished studies required • altered balance: transparency trumps confidentiality? • no data protection period compared to other regimes – biocides, REACH, health claims www.steptoe.com

12. New Authorization Case Study: Steviol Glycosides • Paraguayan plant extract 300 times sweeter than sugar (E 960) • EFSA March 2010 opinion: • establishes ADI   • likely exceeded at maximum proposed use levels • Commission Regulation nevertheless allows: • importance of stevia to energy reduced products (sweetness without sugar energy for diabetics) • reduction in proposed use levels in soft drinks as main source of dietary exposure • energy reduced or without added sugar products only • producers and users to provide use information for future refined risk assessment www.steptoe.com

13. Re-evaluation of Food Additives • The unnoticed ‘REACH’ of food law • Concerns: • 1970s evaluations based on assumptions • potential for certain additives to exceed ADI • already re-evaluations on risk basis (tartrazine, allura red) • Regulation 257/2010 programme for re-evaluation • undertaken by EFSA • all additives last evaluated prior to January 20, 2009 • colors: by end 2015, sweeteners: by end 2020, others: by end 2018 • prioritization ad hoc where new risk evidence (for example, aspartame) www.steptoe.com

14. Re-evaluation of Food Additives • EFSA ‘open call’ for ‘any interested party’ to submit all relevant data by deadline • failure to submit information within deadlines may result in removal from Union list (‘no data, no market’) • joint submission optional: no REACH SIEF equivalent • reliance on data submission of competitors? • ‘Food color ethyl ester of beta-apo-8’ – carotenic acid (C 30) (E 160f) is not offered any more by the manufacturer and re-evaluation of this substance by the Authority is no longer supported by the business operators. Therefore, this additive should not be included in the Union list.’ (Regulation 1129/2011, Recital 16) • EFSA will consider ‘all relevant data’: • original dossier • original EFSA/SCF Opinion • new data from industry, Commission and MSs • literature search • March 27 call for data: • 15 additives: deadline of July • 36 additives: deadline of November www.steptoe.com

15. Re-evaluation Case Study: Aspartame • 200 times sweeter than sugar, authorized for low calorie foods • EFSA assesses new studies suggesting cancer and preterm birth links: no ADI change • Nevertheless, Commission requests in May 2011 full re-evaluation by July 2012 • Call for data end May 2011 produces 600 studies papers (published and unpublished) • EFSA Opinion now delayed until November • Commission anticipates new maximum levels and mandatory warnings www.steptoe.com

16. Food Contact Materials www.steptoe.com

17. Food Contact Materials: Legislative Framework • Requirements for all food contact materials: ‘Framework’ Regulation 1935/2004 • Legislation on specific groups of materials and articles (glass, paper, etc.) • Legislation on specific substances – Bisphenol A example • National legislation where no EU harmonized legislation • Aims: • free movement of goods (removal of trade barriers within EEA) • consumer health (no migration into foods in unacceptable quantities) • Defines ‘food contact materials’ as: • materials and articles, including active and intelligent food contact materials, which in their finished state • are intended to be brought into contact with food  • are already in contact with food and were intended for that purpose • can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use • ‘in their finished state are intended’ – scope grey area www.steptoe.com

18. Framework Regulation 1935/2004: Scope and Minimum Requirement • Default ‘catch-all’ Article 3: in absence of specific legislation • Food contact materials shall be manufactured in compliance with good manufacturing practice so that under normal or foreseeable conditions of use, they do not transfer constituents to food in quantities which could: • endanger human health; • bring about unacceptable change in composition of food; or • bring about deterioration in the organoleptic characteristics www.steptoe.com

19. Framework Regulation 1935/2004: Specific Measures • List of groups of materials and articles which may be covered by ‘specific measures’ (Annex I) (* = measures already adopted) • Unharmonized national measures (consistent with EU laws) permitted in absence of specific measures www.steptoe.com

20. Framework Regulation 1935/2004: Specific Measures • Specific measures may be adopted, such as: • positivelist of authorized substances for use in manufacturing (specific restrictions) • specific limits on the migration of specific substances into food and overall limits on the migration of substances into food • specific provisions protecting human health • basic rules for checking compliance • rules for sampling and methods of analysis • specific provisions for traceability; publicly available Community Registers • additional labelling provisions (i.e. active and intelligent materials) • adapting general authorization procedure laid down in Framework Regulation (individual/for the world) • Substance authorization conditional on final material or article satisfying catch-all provision www.steptoe.com

21. Framework Regulation 1935/2004: Other Requirements • Materials and articles to be accompanied with written declaration of compliance: • available to enforcement authorities • national laws requiring same outside specific measures? • Traceability system • one up, one down supplier/DU identification system • labeling number system • facilitate recall, attribution of responsibility for non-compliance • Labeling: • ‘for food contact’ • instructions for safe use • in local language www.steptoe.com

22. Specific Legislation Case Study: Plastics -- Overview • Specific plastics legislation: Regulation 10/2011 • Scope: • Bulk plastic, Plastic multi-layer and Plastic layer(s) in multi-material multi-layer articles (also if printed or coated) • Without prejudice to EU and national provisions on printing inks, adhesives or coatings • Union (positive list) of substance categories permitted to be intentionally used in the manufacture of plastic layers in plastic materials and articles, subject to specific derogations, e.g.: • polymer production aids other than those listed, subject to national law • colorants and solvents, subject to national law • polymeric additives and starting substances • non-intentionally added substances • aids to polymerization • additives in the provisional list, subject to national law www.steptoe.com

23. Specific Legislation Case Study: Plastics -- Migration Limits/Functional Barrier • Specific Migration Limits per substance: • specific migration limits (mg/kg) in Annex I • generic specific migration limit of 60 mg/kg • if used also as food additive or flavoring, not in quantities having technological effect and exceeding food additive or flavorings maximum levels • Overall Migration Limit (total constituents limit): • not exceeding 10 mg per dm2 • stricter for foods intended for children • Functional barrier concept for plastic multi-layer material/article: • not in direct contact with food • exempted from Plastics Regulation restrictions (except vinyl chloride monomer) • can use substances not on Union/provisional list, except CMRs/nanoform • but… still specific and overall migration limits for final material or article • Functional barrier concept for multi-material multi-layer material or article: • similar but not subject to migration limits under Regulation (national law?) www.steptoe.com

24. Specific Legislation Case Study: Plastics -- Declaration of Compliance • Expanded declaration of compliance requirement: • not only for materials or articles… • products from intermediate stages of manufacturing • substances ‘intended for manufacturing’ (how far back in supply chain?) • Renewable if substantial composition or production changes resulting in migration changes or new scientific data • Documents supporting compliance to be available to authorities (testing, calculations including modeling, evidence on safety) www.steptoe.com

25. Recent Court Judgment on Rights of Non-Applicants • European General Court judgment Case T-262/10: • http://www.steptoe.com/publications-7881.html • inclusion of substances in positive list of additives for use in food contact materials • rights of third parties where authorisation benefits not only applicant • annuls Commission Decision to ban additive on sole basis of applicant withdrawal • must  decide on authorisation if no procedural option for others to take over, or make new, application www.steptoe.com

26. Legislation on specific substances • EU temporary Bisphenol A ban in polycarbonate plastic infant feeding bottles (Directive 321/2011) • leaching of BPA when bottle heated • national French and Danish bans (despite EU limits not exceeded) • EFSA Opinion that TDI still safe but some scientific uncertainty (precautionary principle – controversial) • stricter national bans in France (all food contact applications), Sweden and Belgium (food packaging marketed to under 3 yrs.) • Next EFSA opinion expected November – ban lifted, or permanent? www.steptoe.com

27. Legislation on specific substances • Control of imports of polyamide and melamine plastic kitchenware from China and Hong Kong • exceed permitted Plastics Regulation migration limits of primary aromatic amines (‘PAA’) and formaldehyde • followed several alerts no Rapid Alert System for Food and Feed • requirement for importers to: • have declaration of compliance and test results that meet migration limits • give prior notice of arrival of imports • Member States to designate points of first introduction through which imports may enter EU • documentary, identity (visual inspection) and physical checks (sampling) www.steptoe.com

28. Nanomaterials www.steptoe.com

29. Nanomaterials: Food Additives • Former EU institutional debate about whether existing legal framework addressed nanomaterials • Emergence of EU food law provisions specifically requiring separate risk assessment and labeling of nanomaterials  • Food Additives (Regulation 1333/2008): • additives already on positive list require new entry/change in specifications (considered new additive) where change in particle size • additive producers to inform Commission of new scientific and technical information affecting safety • Food Information Regulation (1169/2011): • labeling of engineered nanomaterial ingredients (‘nano’) (including food additives) from December 2014 • first definition of engineered nanomaterials in EU food law: • ‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. • Properties that are characteristic of the nanoscale include: • (i) those related to the large specific surface area of the materials considered; and/or • (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material; • ….but different to Commission recommendation on the definition of a nanomaterial (2011/696/EU) weeks before: •  ‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. • In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. • By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions • Commission anticipates aligning with recommendation (common legislative basis) www.steptoe.com

30. Nanomaterials: Food Contact • No specific provisions in Framework Regulation (although covered equally) • general obligation to inform the Commission of new scientific or technological information ‘which might affect’ authorized substance safety assessment - ‘if necessary’ EFSA to review safety (Article 11(5)) • covers nanomaterials? • relies on judgment of business operator to inform and of EFSA whether to review • Specific provisions in Plastics Regulation: • ‘substances in nanoform shall only be used if explicitly authorized and mentioned in the specifications in Annex I’ (Article 9(2)) • nano titanium nitride only additive specifically authorized in nanoform • carbon black and amorphous silica on Union list with nanoscale specifications • also applies to substances derogated from Union list? • non Union/provisional listed substances cannot be used even if behind a functional barrier if nanoform (Articles 13 and 14) • no definition of nanomaterials www.steptoe.com

31. Nanomaterials: Food Contact Additives www.steptoe.com

32. Conclusion • EU based distributors, retailers in supply chain liable for non-compliance of food additives/food contact regulations • business interruption consequences • compliance guarantees • Overhaul of food additives legislation • new positive lists and authorization procedure for updating • new opportunity or potentially more restrictive regime? • strategic commercial use? • dossier requirements favor transparency over confidentiality – protection of valuable test data? • Ensure that your key additives are supported through additives re-evaluation process (‘no data, no market’) • Compliance with general food contact requirements, those established for specific types of material, plus national requirements • interpretational gray areas remain • Protection of companies relying on food additive authorization applications of others? • Temporary substance bans for food contact use – precautionary principle justified? • Emergence of separate risk assessment/authorization requirements for nanomaterials in additives and contact materials legislation www.steptoe.com

33. Steptoe Food Practice For additional information about compliance with European Union food laws, please contact csimpson@steptoe.comor visit our website. http://www.steptoe.com/practices-332.html www.steptoe.com