What is FACET?

1
What is FACET?

• FACET Flavourings, Additives (food), Contact
  materials, Exposure Task
• EU funded project 5.8 Mio.
• some Member State funding 1 Mio
• some industry funding 520,000
• FACET will be an exposure based, risk management
  tool for
• DGSANCO
• Member States
• EFSA
• Industry

2
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
• List of all substances used in food contact
  materials

3
Outputs of FACET project - 2

• 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

4
FACET

• 4 year project from 1st August 2008
• 20 partners, including an industry consortium
  FIG Facet Industry Group
• FIG currently consists of 14 trade associations
  see later
• Packaging covered
• Paper and board
• Plastics
• Metal

5
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
6
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)

7
Who is involved in WP4?

• Nine partners of packaging part of FACET
• CSL partner 03
• FIG partner 04
• FABES partner 09
• Fraunhofer partner 10
• STFI partner 12
• USC partner 16
• NIRDIM partner 18
• JRC partner 21

8
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

9

10
The role of food packaging in FACET - 1

• Packaging accounts for gt 50 of budget
  significantly more if all of packaging industrys
  in-kind 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

11
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

12
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.

13

Packaging
Usage data Coverage
issues Concentration data Updating
issues Treatment of uncertainty data gaps
Coding issues
Computation User interfaces
Documentation Validation
Consumer buy-in Modelling tools Treatment of high
consumers QSAR Correlation factors
Food consumption database
Flavours
Additives
14

• Examples of data required
• 1. Packaging specific food groups
• 2. Packaging usage data
• 3. Concentration data
• of substance in packaging
• of migrant in food/simulant
• 4. Substance occurrence
• 5. Market shares for
• packaging type
• food type
• substance usage
• 6. Total surface area of packaging produced
• 7. Area / volume (S/V)
• 8. storage conditions
• 9. Pack size(s)

Packaging
QSAR Modelling toxicology Structure of migrant
needed
Usage data Coverage
issues Concentration data Updating
issues Treatment of uncertainty data gaps
Coding issues
Computation User interfaces
Documentation Verifica
tion
Consumer buy-in Modelling tools Treatment of high
consumers, vulnerable groups Correlation factors
Food consumption database
Flavours
Additives
Black box
Exposure estimate FACET Objective
15
Data required - 1

• Lists of substances used in packaging
• Occurrence of substances in those packaging types
• Concentration estimates for each substance in
  that packaging type for modelling
• Packaging estimates (by type) for each foodstuff
  consumed
• Use market share of each packaging type within
  each food group (sum to 100 within food group)
  to give a range

16
Data required - 2

• Consumption estimates for each food group
• Concentration estimates of migrant in each food
  group
• Exposure the sum of (migrant concentration x
  weight foodstuff consumed) for each and every
  individual over the lifetime of the survey
• Packaging loyalty can be modelled in different
  ways and at various levels. Needs further
  discussion and some research

17
Substance Lists

• What substances are used for food contact
  materials?
• Construct Lists from
• Plastics - 2002/72/EC amendments
• Coatings - AP(2004)1 CEPE C-o-P
• Paper board BFR
• Inks non-food contact surface coatings - EUPIA
  inventory list
• Adhesives BFR FDA
• Colorants?

18
Occurrence Data - 1

• Which packaging materials could contain that
  substance?
• Use information about
• Plastic composition
• Paper composition
• Coating composition
• Adhesive composition
• Inks/externals composition
• Nature of packaged foodstuffs (i.e. restrictions
  on use etc)

19
Occurrence Data - 2

• What is the likelihood that the substance is in
  that packaging/coating/adhesive?
• Use market share data for the substance use for
  each application and type of package i.e
  antioxidant A has a 50 M/S for polythene, but
  10 for polypropylene
• NOTE that this is a different market share to the
  amount of a foodstuff packaged in that FCM.

20
Occurrence Data - 3

• Substance occurrence input also needed could
  it be in both fatty and non-fatty food packaging.
• Look at use restrictions

21
Concentration Data

• Concentration of substance in FCM for use in
  modelling migrant concentration. Need
• Typical concentration ranges (expert judgement)
• Layer thickness
• Time / temperature of storage
• Differentiate between food contact layer and
  others.
• Concentration of substance in simulants
• Concentration of substance in real foodstuffs.

22
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?

23
Packaging Usage Data - 2

• Estimation of market shares 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
• Calculation of rigid packaging surface area to
  volume (S/V) ratio range
• Flexibles still unclear on S/V ratio but could do
  average surface area vs weight packed

24
Data required depends on final use - 1

• If the ideal objective is that user could enter
  only substance name and get an exposure
  assessment, then
• Need to provide either data or default fallback
  assumption for every type of input
• Need to inform user what defaults are being used
  and then they have the option to reject or modify
  them

25
Data required depends on final use - 2

• Realistically data cannot be provided for every
  combination so need a wizard in software that
  identifies essential gaps and requests user to
  fill them in before completing assessment
• Alternative would be for user to complete
  assessment excluding affected food groups or
  packaging types
• In this case it should be made clear that the
  exposure assessment is an under-estimate

26
Exposure Model Outputs

• FIG to indicate options they want for migrants
  from FCMs e.g.
• Which percentile (s)
• Age and gender groups
• Vulnerable groups
• Europe or regional
• mg/kg body weight/day
• mg/person/day
• Exposure drivers (food groups)
• However outputs will depend on consumption data
  available and its suitability for these needs.

27
What will FACET do?

• Estimate EU consumer exposure to
• Food Additives
• Food Flavourings
• Migrants from food contact materials, including
  those from non-direct food contact layer
• 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

28
Structure of FIG - 1

• Paper board (PB)
• Laminated
• Non-laminated
• Plastics (P)
• Monolayer
• Multilayer
• Metal (M)
• Coated
• Uncoated
• Externals (E)
• Adhesives (A)
• Glass (?)

29
Structure of FIG - 2

• FIG consists of
• Admin - FIG
• Steering FIG
• FIG task forces
• Sector groups
• All of which need to interact with each other
  and other partners to ensure consistency of
  approach

30
Steering - FIG Structure

• Work Package Leader non-industry project
  manager
• Laurence Castle (CSL) Aine Hearty (UCD)
• Chair and deputy chairs
• Chair Peter Oldring (PO)
• Deputy chairs - Nigel Barnwell (NB), Bart Brands
  (BB), Fred Savrij Droste (FD)
• Sector groups
• Paper and board NB, John Swift ?
• Plastics BB, Dario Dainelli, Mark Vints
• Metal FD, Ron Colwell, Thomas Dirnberger
• Externals Sandro Leuenberger ?
• Business Martin Reynolds Ralf Eisert ?
• Secretariat Anne Marie Hamelton, Christian
  Jassogne, Jacques Warnon

31
Responsibilities of Steering FIG

• To manage overall technical activities of FIG
• Co-ordinate activities of the different sectors
• Set up ad hoc-task forces, as necessary
• Liaise with other project partners, including the
  non-packaging partners
• To ensure full integration with existing projects
  Matrix, CSL, STFI.
• Co-opt experts as and when appropriate
• Disseminate information to FIG membership
• Prepare reports etc, as required by DGRESEARCH,
  in a timely manner
• Ensure that submissions for milestones and
  deliverables are prepared and submitted on time

32
FIG Task Forces

• FIG task forces
• Will be set up to achieve specific tasks
• Not a purely technical exercise market data
  needed
• Some task forces will be specific to a sector
  group
• Others across all packaging sectors

33
Rigid Metal Sector Group - TSC 30

• Joint Industry Group for light metal packaging
  (JIG) has fully supported the use of exposure to
  derive realistic risk estimates (TSC 4)
• The participation of JIG in FIG will be through
  TSC 30 chaired by Ron Colwell.
• TSC 30 group being formed

34
Position of DGSANCO

• DGSANCO were involved in the call for FP7 and
  suggested appropriate wording for FCMs
• At last Member State meeting DGSANCO stated that
  they would consider exposure driven legislation
  when a suitable tool was available

35
Potential Consequences of FACET

• Exposure driven legislation will bring EU closer
  to FDA approach with end uses rather than
  substances being approved.
• Exposure rather than substance driven approach
• Reduced dossiers could be accepted when migration
  exceeds 50 ppb, provided that exposure doesnt
  exceed 50 µg/person/day.
• Reduction in (management of) scares relating to
  substance of the month
• A standardised risk measurement tool which will
  give same answer to industry and regulators

36
Coatings Code of Practice FACET

• 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