Nick Kernoghan, Smithers Pira Ltd. How to Show that Food Packaging Complies with EU and FDA Regulations My Presentation • What regulations apply and very briefly what they cover • Where to find these regulations • What you need to check and measure to comply with these regulations • What documentation you need to give your customers • What documentation you need to have yourself • EU first then the FDA • Summary 1 EU Food Contact Regulations for Plastics • Regulation 1935/2004 – The Framework Regulation – General regulations applying to all food contact articles and materials – Article 3 – general safety statement – Article 6 – national laws – Articles 8 & 9 – procedure for notifying new substances – Article 15 – labelling – Article 16 – declaration of compliance and supporting documentation – Article 17 – traceability 2 EU Food Contact Regulations for Plastics • Regulation 2023/2006 and its amendment Regulation 282/2008 – The GMP and Plastics Recycling Regulations – Manufacture according to GMP – Documented QA system that says what you do and what you measure – Documented QC system that records what you have done and measured – Rules for transfer of ink components to food either by migration or set off – Rules for manufacture and use of recycled plastics 3 EU Food Contact Regulations for Plastics • Regulation 450/2009 – The Active and Intelligent Packaging Regulation – Active packaging either releases substances into food or absorbs substances to achieve a technical effect e.g. oxygen scavengers – Intelligent packaging displays the history of the pack e.g. time-temperature indicators – Approval process to establish a positive list – Labelling has to meet the requirements of both food packaging and food Regulations (1935/2004, 79/112/EEC and 89/109/EEC) – If the active or intelligent ingredient is in an insert inside the pack then the insert must be labelled DO NOT EAT 4 EU Food Contact Regulations for Plastics • Regulation 10/2011 – The Plastics Regulation – – – – – – – – – – – Repelled Directive 2002/72/EC and its 7 amendments List of approved monomers and additives Provisional positive list, now only 9 silver biocides The overall migration limit (OML) Specific migration limits (SML’s) Residual quantity limits (QM’s) Specifications Rules for measuring overall migration Rules for measuring specific migration Multi-material multi-layer laminates Key dates – 1st January 2013 and 1st January 2016 • Regulation 321/2011 – 1st amendment to 10/20011 - banned the use of Bisphenol A in food contact articles for babies and infants • Regulation 1282/2011 - 2nd amendment to 10/2011 – adds more approved monomers and additives 5 Where to Find the EU Regulations • http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_eu.htm List of all the regulations and pdf’s of them Latest scientific opinions and advice from EFSA News Documents – guidance documents, lists of recycling processes, provisional list of additives – Food contact materials database – – – – 6 What You Need To Check and Measure to Comply with the EU Regulations • Ensure that all your monomers and additives are listed either in Regulation 10/2011 or on the provisional positive list • Show compliance with the overall migration limit by migration testing • Show compliance with specific migration limits, or residual quantity limits, for monomers listed with these restrictions in Regulation 10/2011. This involves experimental testing • Show compliance with specific migration limits for additives either by calculation of 100% migration, or, by diffusion rate calculations, or, by experimental migration measurements • Note that multi-material multi-layer laminates (i.e. laminates containing both plastics and non-plastics) only have to comply with the compositional requirements, not the OML or SML’s. 7 What Documentation You Need to Give Your Customers – Declarations of Compliance • This is covered in Article 16 of Regulation 10/2011. • There is no change from the position in Directive 2002/72/EC. • However, it is important to treat this as the cornerstone of compliance for the whole system. • It’s purpose is to give all the companies downstream of yours a fair chance of complying with what is now quite complicated legislation so it is important that your Declarations of Compliance (DoC’s) contain all the information that is required. This includes sufficient information on substances with restrictions and dual use additives to enable the downstream companies to write their own DoC’s. • What should be on a declaration of compliance is outlined on the next slide. 8 Declarations of Compliance (DoC’s) • • • • • • • • Identity and address of manufacturer or importer Identity of materials, articles or substances Date of declaration For plastics confirm compliance with Regulations 10/2011 and 282/2008 For non-plastics confirm compliance with the relevant harmonised EU legislation or Regulation (EC) No 1935/2004 and national legislation. Adequate information on substances with restrictions and/or specifications Adequate information on any of the 129 substances (dual function additives) with restrictions under food legislation should they be present Specifications on the use Type or types of foods in contact Time and temperature of contact Ratio of food contact surface to volume used to establish compliance • • In presence of functional barrier, need to comply with additional relevant provisions Renewal when substantial changes in manufacture occur. 9 Declarations of Compliance – Adequate Information • Identity of substances that have specific migration limits, residual quantity limits and/or specifications. May need non-disclosure agreements and/or help from us • Your DoC’s should enable your customers to show that they comply with the limits – Concentration of the substance in the plastic – can be over-stated, or, – Statement of the maximum thickness of the plastic that can be used without breaching the limits. This has to be based on either experimental migration results, diffusion calculations or 100% migration calculation • Identity of dual use additives that are present • Your DoC’s should enable your customers to show that the dual use additives that are present will not result in any limits in food legislation being breached – Concentration of the dual use additive in the plastic – can be over-stated, or, – Statement of the maximum amount that can migrate to food from a particular thickness of plastic, or, – Statement that there is not migration with a reason why e.g. inorganic additive insoluble in food • Please do not keep non-proprietary information secret 10 What Documentation you Need to Have Yourself • Information that enables you to trace your products one step up and down the supply chain and a procedure for product withdrawal • Declarations of compliance from your suppliers of plastics, additives, masterbatches, colorants etc. including: – Details of substances listed in Regulation 10/2011 with restrictions or specifications and sufficient information on the amounts present or migrating to enable you to show you comply. – Details of dual use additives used and sufficient information on the amounts present to enable you to pass useful information onto your customers in your Declarations of Compliance • A documented QA system saying how your manufacture your products and what you measure during that process (e.g. weights of masterbatch added, thickness, melting point, burst strength, tensile strength etc. – any physical testing you use to control your product quantity during manufacturing) 11 What Documentation You Have to Keep Yourself • A documented QC system that shows you have measured the things required by your QA system including any physical properties you measure to show that you manufacture a consistent product • Formulation details and manufacturing records covering substances you add • Records of annual overall migration measurements • Records of annual specific migration or residual quantity measurements on monomers • Records showing how you know that specific migration limits are complied with for additives – your 100% migration calculations, diffusion calculations or migration measurements • Correspondence with your suppliers and customers 12 FDA Food Contact Regulations • Code of Federal Regulations (CFR) Chapter 21 Parts 170 to 190: – – – – – – – – – – – – – – – – • 170 Food additives 171 Food additive petitions 172 Food additives permitted for direct addition to food for human consumption 173 Secondary direct food additives permitted for direct addition to food for human consumption 174 Indirect food additives: General 175 Adhesives and components of coatings 176 Indirect food additives: Paper and paperboard components 177 Indirect food additives: Polymers 178 Indirect food additives: Adjuvants, production aids and sanitizers 180 Food additives permitted in food or in contact with food on an interim basis pending further study 181 Prior-sanctioned food ingredients 182 Substances generally recognized as safe 184 Direct food substances affirmed as generally recognised as safe 186 Indirect food substances affirmed as generally recognised as safe 189 Substances prohibited from use in human food 190 Dietary supplements Can buy the book or look at http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=201121 13 FDA 21 CFR Section 177: Indirect Food Additives Polymers • • • • • • • • • • • • • • • 177.1500 Nylon resins 177.1520 Olefin polymers 177.1550 Perfluorocarbon resins 177.1555 Polyacrylate resins 177.1556 Polyaryletherketone resins 177.1560 Polyarylsulfone resins 177.1570 Poly-1-butene resins and butene/ethylene copolymers 177.1580 Polycarbonate resins 177.1585 Polyestercarbonate resins 177.1590 Polyester elastomers 177.1595 Polyetherimide resins 177.1600 Polyethylene resins, carboxyl modified 177.1610 Polyethylene, chlorinated 177.1620 Polyethylene, oxidized 177.1630 Polyethylene phthalate polymers 14 FDA 21 CFR Types of Regulations • 3 general types of Regulations: – Those covering specific polymers, e.g. 177.1520 on polyolefins, 177.1630 on PET. These contain: • List of permitted additives and maximum levels of use where not covered by general lists • Specifications such as density and melting point • End-test extractable limits and sometimes test methods for these • Resin needs to comply, not the finished article. – Those covering substances by use e.g. 178.2010 on antioxidants/stabilizers for polymers. These contain lists of permitted substances and max. levels of use – Those listing substances used in specific types of packaging e.g. 175.105 on adhesives, 177.300 on can coatings. These contain: • Lists of starting components and intermediates that react together in the curing reaction • Permitted curing reactions for can coatings • Restriction on adhesives such that they can only be used when a functional barrier is present or for very low exposure at seems and edges 15 FDA End Test Extractable Limits • These are applied to resins, or sometimes finished products, to show that your product is similar to that which was initially approved by the FDA • They are a little bit like the EU’s overall migration tests, except they use quick extractions into solvents rather slower, more complex migration measurements • Typical solvents are heptane, 95% ethanol and water • Either done by resin producer when the testing the resin is the key stage or the converter when testing the finished product is the key stage • These tests sometimes specify testing the resin without any additives present, but not often practical so the fully formulated resin is normally tested instead. 16 Checking Legal Status of Polymers and Additives • The FDA have produced a list of all indirect food additives approved in their regulations searchable by name or CAS No. You can find it at www.fda.gov/Food/FoodIngredientsPackaging/ucm115326 • Where a Regulation states that an additive is approved for use up to a certain level round applies. If the Regulation states 1% as the limit you can go to 1.5%, but if it states 1.0% you can only go to 1.05% • Additives and resins listed in 21 CFR can be used by anyone provided any specifications and restrictions are met. However, there are some 800 substances approved by Food Contact notifications (FCN’s) which you can only use if you either get permission from the notifying company or you submit your own FCN. You can find these at www.fda.gov/Food/FoodIngredientspackaging/FoodContactSubstance sFCS/ucm116567.htm 17 Things Not Covered by FDA Regulations and Exemptions • Prior Sanctions - PVC, RCF, PS, BHT and BPA-Epichlorohydrin Esters • GRAS – whether as a result of an FDA or self determination e.g. zinc oxide and zinc stearate • Basic Resin Doctrine excluding need to regulate substances used in trace quantities during polymerisation such as catalysts, chain regulators, chain transfer agents etc. • Housewares exemption excluding repeat use eating and cooking utensils in most situations • No migration exemption – 50 ppb for most substances provided not CMT, 10 ppb for milk bottles, carbonated drinks bottles and biologically active molecules • Threshold of regulation (TOR) – substances where exposure is less than 0.5 ppb in the diet. TOR approvals are non-propriety and a list is available at www.fda.gov/Food/FoodIngredientspackaging/FoodContactSubstance sFCS/ucm09685.htm 18 Summary of How to Show FDA Compliance • Code of Federal Regulations Chapter 21 Sections 170 to 190 – end tests, maximum use levels and some specifications apply • List of effective TOR approvals • The Lehman List of Prior Sanctions • The list of effective FCN’s (propriety) • Self determination of GRAS • Self determination of no migration • The first 2 are generic, as are some of the 3rd, and all can rely on them to establish that substances are listed and any specifications, restrictions and compositional limits complied with. Note substances must be listed or covered by an exclusion. • FCN’s are propriety so need permission of notifier or your own duplicate FCN • The last 2 can be used with self determination and self certification or with the help of expert advisors such as Smithers Pira 19 What Documentation You Need To Give Your Customers – Compliance Statements • • • • • • • • • • Identity and address of manufacturer or importer Identity of materials, articles or substances Date of compliance statement Where applicable confirm compliance with specific sections of Chapter 21 of CRF, e.g. 177.1520 for polyolefins, 177.1630 for PET, 175.105 for adhesives, 178.XXXX for additives which are only listed under the general requirements for polymers and sections 182, 184 and 186 for FDA certified GRAS List applicable FCN’s and ToR approvals. Need notifier’s consent to use FCN. Restrictions on the use such as exclusions for certain types of food or certain times and temperatures of contact Any exemptions from regulation claimed with an explanation of why they are valid (self certified GRAS, Prior Sanctions, no migration, housewares) Presence of functional barrier where it is necessary for no migration or adhesives compliance No need to mention specific substances unless covered by an FCN or TOR approval big difference from EU Renewal when substantial changes in manufacture occur. 20 What Documentation You Need To Keep Yourself Correspondence with your suppliers and customers Compliance Statements from your suppliers Results of any end-tests you carry out Any compositional information you have Any experimental details on specifications you check Results of any physical testing you carry out to show that you manufacture a consistent product • Your manufacturing records to show that you manufacture a consistent product. • • • • • • 21 Summary on EU and FDA Compliance • There is a lot of complicated legislation with a lot of requirements • Good communications along the supply chain is vital to help everyone show they comply • Your compliance documentation needs to tell your customers what they need to know to enable them to show their customers that food contact articles comply • You need good documented QA and QC systems • You need to keep a lot of supporting documentation and records • Most important of all……………DON’T PANIC!! 22 Help Available From Pira • We can help you: Understand and interpret these Regulations Decide what measurements you need to make Make these measurements for you Help you write your declarations of compliance Help you get the information you need from your suppliers Help you produce your QA, QC and supporting documentation systems – Notify new substances for food contact uses to EFSA and/or the FDA – Notify recycling processes to EFSA and/or prove their effectiveness according to FDA protocols – – – – – – 23 My Contact Details • Nick Kernoghan • Smithers Pira Ltd • Cleeve Road, Leatherhead, Surrey, KT22 7RU, United Kingdom • +44 13 72 80 21 73 • [email protected] • www.pira-international.com/Testing 24
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