PRW Food Contact Plastics 10

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PRW Food Contact Plastics10 11th June 2009
BrusselsPeter K.T. OldringThe Valspar
Corporationrepresenting CEPE and The FACET
Industry Group - FIG
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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 coatings 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

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Why an Industry Code of Practice? - 2

• 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.

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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

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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 n1
• Subdivided into
• Monomers and other starting substances (see
  Art.4)
• Additives (see Art.5)

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Lists of Substances - 2

• 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 .

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Lists of Substances - 3

• 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

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Lists of Substances - 4

• 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

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Lists of Substances - 5

1. Migration lt 10 ppb no further testing needed
   provided SAR does not indicate potential for
   mutagenicity
2. Migration lt 50 ppb should have mutagenicity
   tests according to REACH requirements (timelines)
3. Migration gt 50 ppb need to set up common
   interest group to submit a dossier to EFSA
4. 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).

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Monomers and Additives

• 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.

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No Migration Principle - 1

• 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

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No Migration Principle - 2

• 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.

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Migration Limits

• OMLs
• 60 mg/Kg or 60 mg/6dm2 (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

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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.

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Declaration of Compliance (DoC) Part A

• 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.

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Declaration of Compliance (DoC) Part B

• 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.

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Declaration of Compliance (DoC) Part B

• 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

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Declaration of Compliance (DoC) Part B

• 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

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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.

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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

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Coatings 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

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Coatings Code of Practice Update - 2

• 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.

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Coatings Code of Practice Update - 3

• 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

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What is FACET - 1?

• 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

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What is FACET - 2?

• 4 year project from 1st 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

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Partners
Short Name Country
KTL Finland
STFI Sweden
CFRI Hungary
FCNAUP Portugal
USC Spain
IZZ Poland
INCDTIM Romania
Short Name Country
UCD, CREMe Ireland
UU, CSL, FCRA UK
CEPE - FIG, CIAA Belgium
AFSSA France
INRAN, JRC Italy
TUM, FABES, Fraunhofer Germany
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Work - Packages

• 10 Work-packages to address diversity of project
• 1. Management UCD (M. Gibney)
• 2. Flavourings INRAN (C. LeClercq)
• 3. Additives AFSSA (J.L. Volatier)
• 4. Packaging CSL (L. Castle)
• 5. Food Intake UU (A. McKevitt)
• 6. Chemical Occurrence UCD (M. Gibney)
• 7. Regional Modelling FCRA (D. Tennant)
• 8. Databases Modelling CREMe (C. McNamara)
• 9. Concentration Data CIAA (B. Kettlitz)
• 10. Dissemination UCD (M. Gibney)

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Partners in FIG

• Today 12 Associations have signed up to FIG
• APEAL steel
• CEFIC-FCA additives for packaging
• CEPE/EuPIA coatings and inks
• CEPI paper and board
• CIAA food industry
• EAA aluminium
• EMPAC canmakers
• EUPC plastic converters
• EWF wax federation
• FEICA adhesives
• FPE multilayer plastic converters
• Plastics Europe plastic suppliers

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The Role of Food Packaging in FACET - 1

• Packaging accounts for gt 50 of budget
  significantly more if all of packaging industrys
  contributions are taken into account.
• FIGs 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

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The Role of Food Packaging in FACET - 2

• Whilst FIGs 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

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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.

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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?

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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

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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

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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.

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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

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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

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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

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THANK YOU FOR YOUR ATTENTION