1. 1 PRW Food Contact Plastics 10 & 11 th June 2009 Brussels Peter K.T. Oldring The Valspar Corporation representing CEPE and The FACET Industry Group - FIG

2. 2 2 Why an Industry Code of Practice? - 1  Article 3 of Framework Regulation (EC) No. 1935/2004 - migrants must not endanger human health - is one of the most difficult articles to demonstrate compliance with, as there is no clear guidance on how to do this  Thus the coating’s industry took the initiative and developed a code of practice (CoP) for coated articles where the food contact layer is a coating  This was initiated by light metal packaging JIG – Joint Industry Group and then enlarged to include other coating sectors

3. 3 3  Trade associations and companies representing all in the supply chain have been involved in the discussions from raw material suppliers to the food industry  This code of practice is of voluntary nature, otherwise anti-cartel rules could be infringed. Why an Industry Code of Practice? - 2

4. 4 4 Coatings Covered by CoP  Coated light metal packaging  Coated metal pails and drums  Heavy duty coatings  Coated flexible aluminium packaging  Printing inks for direct food contact

5. 5 5 Lists of Substances - 1  Based on the Council of Europe Resolution AP(2004)1 on coatings intended to come into contact with foodstuffs : technical document n°1  Subdivided into :  Monomers and other starting substances (see Art.4)  Additives (see Art.5)

6. 6 6  The list of monomers and other starting substances listed in Annex II is subdivided into lists A and B.  List A: monomers and other starting substances assessed by SCF/EFSA, classified in list SCF 0-4 and used in compliance with SMLs or other restrictions  List B: temporary appendix to List A (incomplete list of monomers and other starting substances) :List of monomers and other starting substances approved by EU Member states or by FDA. Lists of Substances - 2

7. 7 7  The list of Additives listed in Annex III is sub- divided into lists C and D  List C: additives assessed: substances evaluated by SCF/EFSA, classified in list SCF 0-4 and used in compliance with SMLs or other restrictions  List D : temporary appendix to List C (incomplete list of Additives). List of additives approved by EU Member states or by FDA, Note : the present article does not apply to PPAs, colourants and solvents Lists of Substances - 3

8. 8 8  Total of substances listed ~1100  Substances in lists B & D (over 500 ) are authorised at national level by at least one Member State or by FDA.  We argue that they should continue to be used, provided that they are subjected to additional toxicological information depending on their migration into foodstuffs or the level of exposure to those substances, because they have some form of approval.  Conditions for continued usage follow Lists of Substances - 4

9. 9 9 a)Migration < 10 ppb: no further testing needed provided SAR does not indicate potential for mutagenicity b)Migration < 50 ppb: should have mutagenicity tests according to REACH requirements (timelines) c)Migration > 50 ppb: need to set up common interest group to submit a dossier to EFSA d)Requirements for cases (b) & (c) may be revised by the use of EXPOSURE assessments; i.e. 50 μg/person/day = 50 ppb (due to 1 kg food/person/day). Lists of Substances - 5

10. 10  In addition to those substances in the lists any substances which have an SCF or EFSA opinion (list SCF 0-4) may be used for the manufacture of coatings for direct food contact, subject to any restrictions applicable to them.  Substances authorised as direct food additives, which can also be used in direct food contact coatings are listed in Annex XI.  Authorised monomers and starting substances may be chemically reacted and the resulting product (resin, polymer or pre-polymer) may be used in coatings for direct food contact. Monomers and Additives

11. 11  Additionally, non-listed monomers and other starting substances and additives which are intentionally added may be used provided the following 4 conditions are met: 1. there are no structural alerts AND 2. they do not migrate [With a detection limit of 10  g/kg into food or food simulants][] No Migration Principle - 1

12. 12 AND 3. they are not Class 1 and 2 CMRs as defined by 67/548/EEC and its amendments – the inclusion of Class 3 is still being debated, but informing all in the supply chain ensures all are aware of potential issues – will be changed to incorporate new GHS system – thus CMR 1A & 1B. AND 4. the Declaration of Compliance contains a statement that the no-migration principle is used for compliance. No Migration Principle - 2

13. 13  OMLs:  60 mg/Kg or 60 mg/6dm 2 (preferred)  SMLs:  As specified in the existing EU plastics legislation or the CoE Resolution AP(2004)1  Conditions of testing:  Whenever possible, using conditions specified in the relevant EU Directives,  However there are some exceptions, such as using acetic acid which is unsuitable for testing for OML for coated metal and other test methods specific to heavy duty coatings Migration Limits

14. 14 Declaration of Compliance (DoC)  This will follow the requirements specified in Annex VII of Directive 2007/19/EC:  It will be in 2 parts  Part A – compliance statement which is freely available  Part B – confidential compositional information only available under a secrecy agreement and between named individuals.

15. 15  Statement then when used under recommended conditions it will comply with Framework Regulation – 1935/2004  Statement of compliance with existing regulations (EU, national) e.g 1985/2005 (epoxies) and with this Code of Practice  Statement that when used under recommended conditions, it will comply with all relevant restrictions (OML, SML, QmA) set out in the Coatings Code of Practice – normally based upon current harmonised plastics rules  Statement defining any limitations on compliance – e.g. food types, process times and temperatures, shelf life, markets, etc. Declaration of Compliance (DoC) – Part A

16. 16  Between named individuals on a business to business basis:  Identity of all constituents with a restriction on use.  Notification or identification of any constituent that is not yet fully evaluated  Identification of the dual use substance(s)– if additive always; if monomer or starting substance, only if it migrates above 10 ppb as agreed with food industry  Identification of the substance subject to the no- migration principle and a suitable analytical method with LOD = 10 ppb. Declaration of Compliance (DoC) – Part B

17. 17 Transfer of information along the supply chain All from named people to named people Raw material supplier to coating manufacturer  Raw material X contains substances a, b, c  Raw material Y contains substances a, d, e NO amounts, no PPAs, no processing information etc transferred. Coating manufacturer to converter Coating Z contains two raw materials X & Y List of substances present in coating a, b, c, d, e no trade names, no amounts transferred Declaration of Compliance (DoC) – Part B

18. 18 Converter to food industry Packaging has two coatings Z & W Coating Z contains a, b, c, d, e Coating W contains b, c g, h List substances present in packaging a, b, c, d, e, g, h, no trade names, no amounts transferred Declaration of Compliance (DoC) – Part B

19. 19 Risk Assessment  Risk assessments, to demonstrate the safety of a product under Article 3 of the Framework Regulation, can use internationally recognised scientific principles including exposure assessments and structural alerts.  These are important tools for handling NIAS (Non Intentionally Added Substances) and the so- called ‘Forest of Peaks’.

20. 20 NIAS  Applicable to the products formed during the manufacture of the resin or during the curing process.  Full characterisation of all individual peaks is not practical  Estimation of a limit of migration equating to a consumer exposure below a scientifically- validated level of concern ( i.e. x µg/person/day) using, for example, probabilistic modelling  If this level of concern is exceeded, other considerations using internationally recognised techniques can be used, such as SAR and Cramer classes for toxicological thresholds

21. 21 Coating’s Code of Practice – Update - 1  Lists of starting substances are the only practical way forward despite counter arguments that we should only look at what migrates.  Need knowledge of starting substances in order to predict potential migrants  Presentation made to DGSANCO & Member States  Joint working group between some Member States and industry held Oct 2008  Code of Practice very well received  A few minor modifications requested and incorporated

22. 22  A meeting is to be arranged to discuss with the Dutch Authorities (G4) as to whether they could adopt the concepts of the Code of Practice into their forthcoming rewrite of their legislation.  Under EU law, this would then result in the Code of Practice being a default legislation for Europe – but not harmonised.  Under the Treaty of Rome the Dutch legislation would apply Europe wide. Coating’s Code of Practice – Update - 2

23. 23  In order to comply with Art. 3 of 1935/2004 we need an accepted (EFSA, DGSANCO, Member States and industry) tool to deal with NIAS  Tool needs to combine different approaches  TTC (Threshold of Toxicological Concern) – ILSI group active  Use of Cramer Classes  Use of QSAR  Use of exposure = FACET risk management tool Coating’s Code of Practice – Update - 3

24. 24 FACET = Flavourings, Additives (food), Contact materials, Exposure Task EU funded project ~ €5.8 Mio. + some Member State funding + some industry funding  ~€0.5 Mio cash + 1-2+ Mio in kind FACET will be an exposure based, risk management tool for  DGSANCO  Member States  EFSA  Industry What is FACET - 1?

25. 25 What is FACET - 2?  4 year project from 1 st September 2008  20 partners, including an industry consortium – FIG – Facet Industry Group  FIG currently consists of 12 trade associations – see later  Packaging covered  Paper and board  Plastics – rigid and flexible  Metal – rigid and flexible

26. 26 Partners Short NameCountry KTLFinland STFISweden CFRIHungary FCNAUPPortugal USCSpain IZZPoland INCDTIMRomania Short NameCountry UCD, CREMeIreland UU, CSL, FCRA UK CEPE - FIG, CIAA Belgium AFSSAFrance INRAN, JRCItaly TUM, FABES, Fraunhofer Germany

27. 27 Work - Packages 10 Work-packages to address diversity of project 1. ManagementUCD (M. Gibney) 2. FlavouringsINRAN (C. LeClercq) 3. AdditivesAFSSA (J.L. Volatier) 4. PackagingCSL (L. Castle) 5. Food IntakeUU (A. McKevitt) 6. Chemical OccurrenceUCD (M. Gibney) 7. Regional ModellingFCRA (D. Tennant) 8. Databases & Modelling CREMe (C. McNamara) 9. Concentration DataCIAA (B. Kettlitz) 10. Dissemination UCD (M. Gibney)

28. 28 Partners in FIG Today 12 Associations have signed up to FIG:  APEALsteel  CEFIC-FCAadditives for packaging  CEPE/EuPIAcoatings and inks  CEPIpaper and board  CIAAfood industry  EAAaluminium  EMPAC canmakers  EUPCplastic converters  EWF wax federation  FEICAadhesives  FPEmultilayer plastic converters  Plastics Europe plastic suppliers

29. 29 The Role of Food Packaging in FACET - 1  Packaging accounts for > 50% of budget – significantly more if all of packaging industry’s contributions are taken into account.  FIG’s main focus is WP4.1 - split into 5  WP4.1.1 Compile an inventory list  WP4.1.2 Occurrence / concentration  WP 4.1.3 Linking packaging to foodstuffs  WP 4.1.4 Linking substances to foodstuffs  WP 4.1.5 Filling data gaps

30. 30 The Role of Food Packaging in FACET - 2  Whilst FIG’s main focus is WP4.1, FIG also has expertise in QSAR, stochastic modelling and exposure assessments.  FIG will also be involved in:  WP4.2 migration modelling  WP4.3 QSAR  WP5 food intake (coding issues)  WP6 chemical occurrence  WP7 regional modelling  WP8 databases and exposure modelling  WP10 dissemination (?) certainly to industry

31. 31 WP4. Food Packaging Objectives  To obtain information on the chemical composition of food packaging materials  To link foods consumed with concentration of migrants from its packaging  To establish a migration modelling framework to deliver realistic estimates of exposure for subsequent use in risk assessment.

32. 32 Packaging Usage Data - 1  Define food groups relevant for packaging  Link with WP5 (food intake)  Link with HUB Codes  Identification of types of packaging materials used for each food group  MATRIX project –may need to further subdivide paper & board and coatings  STFI project – inks and coatings  PITJIF for inks  CSL pan-European model (for some?)  Migresives project for adhesives?

33. 33 Packaging Usage Data - 2  Estimation of market statistics for each FCM for each food group  Will need wherever possible to sub-divide to avoid worst case assumptions – i.e. split fish into ‘oily (fatty)’ and aqueous – otherwise will have to assume migrant concentration levels in simulant D or D/X rather than A

34. 34 Outputs of FACET Project - 1 Databases/Lists  Harmonised database on nationally available food intake data (8 EU countries)  Database on occurrence of substances in food packaging  Extended harmonised food consumption database for regional modelling and risk assessment – for filling data gaps

35. 35 Outputs of FACET Project - 2 Databases/Lists (Cont.)  List of all substances used in food contact materials which will eventually replace the Synoptic Document  FACET (FIG) will be working with DGSANCO to ensure that their proposed database and that for FACET communicate and are integrally linked.  DGSANCO will update the fields relevant to their operations.

36. 36 Outputs of FACET Project - 3 Models/Tools  Migration model for multi-layer and multi-material packaging  QSAR tool to estimate toxicity of food contact substances  Free, publicly available PC software for estimating exposure to target food chemicals and food migrants  Sustainability and acceptability ensured  Filling data gaps by modelling

37. 37 What will FACET do - 1  Estimate EU consumer exposure to:  Migrants from food contact materials, including those from non-direct food contact layer  Also applicable to Food Additives and Flavourings  Offer a risk management tool for migrants from food packaging, through the use of:  Exposure estimates  QSAR  Other exposure toxicological tools – e.g. Cramer classes

38. 38 What will FACET do - 2  It will give everyone access to a list of substances used in all food contact materials with appropriate restrictions.  It will engage all stakeholders to maximise the acceptability.  It will deliver a risk management tool for migrants from food packaging acceptable to all  Offer a way forward for regulators for exposure driven legislation  Minimise issues surrounding ‘chemical of the month’. FACET web site www.ucd.ie/facet www.ucd.ie/facet

39. 39 THANK YOU FOR YOUR ATTENTION