Download What is FACET? - 1

Assessment of the risk of
consumers exposure
to the substances migrating from
food contact
materials and articles
Cologne 17th October 2011
P.K.T. Oldring
Valspar Corporation
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The Problem / Issue - 1
 Article 3 of the Framework Regulation (EC) No.
1935/2004 effectively states that substances
from FCMs must not migrate in quantities which
could endanger human health.
 It does not tell you how to ensure that human
health is not endangered.
 For plastics there is a Regulation (PIM 10/2011)
which if followed can be used to demonstrate
compliance for plastics with 1935/2004.
 For non-plastics, the restrictions for plastics are
frequently used to demonstrate compliance with
1935/2004.
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The Problem / Issue - 2
 Even plastics have issues as they are not fully
legislated, other than by 1935/2004, e.g PPAs.
 For non-harmonised FCMs (i.e. non-plastics)
national legislation, where it exists applies, and
can be used.
 But national legislation can vary from country to
country.
 For non-plastics without harmonised EU
legislation there can be real issues.
 Without harmonised EU legislation or guidance
on how to assess risks from migrants from FCMs,
different authorities can interpret the same
results differently
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The Problem / Issue - 3
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 NIAS (non-intentionally added substances) and
how to assess any associated risk is becoming
more prominent.
 A new way of realistically assessing risk is
required and this has to be accepted by ALL –
industry and regulators / enforcement
authorities.
 Traditionally risk in EU is driven by hazard rather
than a realistic estimate of exposure.
 Exposure is assessed by assuming that a
consumer weighs 60 kg and eats 1 kg food / day
packaged in the same FCM and that the
substance migrates at its maximum permissible
level (SML).
The Problem / Issue - 4
 Not all substances in FCMs have been fully
assessed by SCF / EFSA.
 This is particularly true for non-plastics.
 Indeed there are more non-plastic FCM
substances than plastic ones.
 NIAS, PPAs etc have definitely not been
assessed.
 EFSA, Member States and DGSanco recognise
these issues.
 EFSA cannot fully evaluate all substance used in
FCMs in a reasonable time frame.
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Latest Developments
The following are the latest developments
1. EFSA/ESCO non-plastic FCM report issued.
2. ILSI TTC paper published
3. EFSA TTC Consultation document published
4. EFSA evaluation of the Cramer Classification
applied to FCS (for which actual tox data exist)
- in press
5. FDA paper on oligomers
All refer to the use of exposure to assess risk!
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Exposure - 1
 Even the most toxic substances cannot endanger
human health if there is no exposure to them.
 Paracelsus – the dose makes the poison.
 Hence having ascertained the hazard it is
necessary to determine the exposure to the
hazard.
 The use of TTC concepts and Cramer Classes
require an estimate of exposure
 Exposure can be estimated either
deterministically or probabilistically.
 Need to ensure high consumers are protected
hence per-capita approach per-se is not
acceptable
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Exposure - 2
 A high consumer cannot be a high consumer of
each and every foodstuff.
 Deterministic approaches use conservative
estimates of both amount of foodstuff consumed
and concentration of migrant(s) in those
foodstuffs.
 More recently there have been a number of
probabilistic approaches to estimate exposure –
e.g. UCD, CSL – and more recently the FACET
project.
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What is FACET? - 1
 FACET = Flavourings, Additives (food), Contact
materials, Exposure Task
 Risk Assessment and hence Risk Management Tool.
 EU Commission funded project ~ €5.9 Mio.
+ some Member State funding (~€1 Mio)
+ some industry funding (~ €400k) - each
association has agreed to contribute €10,000 per
year for 4 years commencing 2008.
+ industry in kind (~ / >(?) €2 Mio)
 Total value of project > €8 Mio.
 Packaging accounts for ~50% of project
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What is FACET? - 2
 There are 20 partners of which FIG (FACET
Industry Group) is one.
 There are 10 work packages and the national
food consumption data from 8 EU countries are
used.
 Modelling to interpolate food consumption from 8
representative EU countries to ALL EU Member
States is the subject of one work package.
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What is FACET? - 3
 FIG (FACET Industry Group) consists of 12 trade
associations covering metal, plastics, paper and
board, adhesives, inks, waxes, European food
industry.
 Glass industry decided not to participate!
 FIG is mainly concerned with the packaging part
of FACET, but there have been, and are ongoing,
interactions with other partners.
Migration modelling
Food coding
Food consumption
Regional modelling of exposure
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Schematics of how FACET
model will work
particularly for packaging
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HOW MODEL IS RUN
Substance of
interest
How much of
each food is
eaten?
Exposure =
concentration x
weight of food
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Where is
substance
used? In
what FCMs.
How much
can
migrate?
Repeat for all
consumers
How
much is
in FCM?
What foods
are packed in
these FCMs
HOW MODEL IS RUN – INPUTS
FROM INDUSTRY AND OTHERS
Substance
from list
Where is
substance
used?
How
much is
in FCM?
How much of
this food is
eaten?
What foods
eaten contain
substance?
How much
can
migrate?
Exposure =
concentration x
weight of food
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Repeat for all
consumers
industry
others
WP4. Food Packaging - 1
Objectives of WP 4
 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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WP4. Food Packaging - 2
 Packaging is WP4 which is split into 3 subsections
 WP 4.1 Packaging usage and substance
occurrence data
 WP 4.2 Modelling migration of substances
from FCMs.
 WP 4.3 Use of QSAR for assessing
toxicology of migrants
 Packaging industry consortium involved as a
partner in WP4 as the FIG (FACET Industry
Group)
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WP 4.1
Packaging usage and
substance occurrence data
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Summary of progress made - 1
 6475 substances in FCM (direct or indirect)
compiled – some may not be used
 Many substances are used by two or more
packaging sectors.
 Some substances are also either direct food
Additives or Flavour substances.
 FACET database indirectly links with the new
DG-SANCO database covering EU-regulated
FC-substances
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Summary of progress made - 2
 252 material codes plus 179 which are ink related
(i.e. different inks, ink for different substrates and
ways of printing substrate e.g. reverse or surface)
 Most sectors will use migration modelling, hence
concentration range in material needed.
 Others will use analytical data
 FIG (FACET Industry Group) purchased additional
EuroMonitor (EM) data to cover 20 Member States
 Linked with food item descriptions - 18 food
packaging categories with common tier 0 and
lower tiers of 56 and 172 categories
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Supporting migration modelling
 FIG clustered 431 material codes to 26
representative materials for which modelling
parameters exist or will be obtained to for
diffusion and partition coefficients.
 FIG (including FDE (ex CIAA) clustered 172
packaging food groups to 31 representative foods
where parameters exist.
 Ready Meals most challenging and solutions
proposed.
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WP 4.2
Migration Modelling of
substances from FCMs.
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Migration Modelling
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 Test materials for migration studies were selected
to ensure all packaging sectors to be modelled are
covered
 Experimental studies to derive missing data for
representatives material nearly complete.
 Data collated for:
31 representative foods
3 temperatures
20 model substances (migrants)
 Representative material groups
Non polar e.g. Polyolefin
Medium polar e.g PET
Polar e.g. polyamide
WP 4.3
Use of QSAR for assessing
toxicology of migrants
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(Q)SAR modelling of Hazard
Manual link to OECD Toolbox
Need SMILES structure for substance
Existing published tox data retrieved
Possible for Cramer Class evaluations
About 150 substances of differing complexity have
been run with various degrees of success by Fera
Staff.
 For some substances Cramer Class approach is not
suitable
 More sophisticated modules also incorporated – but
need tox knowledge for interpreting
 Oligomers present an issue – see later - FDA paper

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Latest developments from
EFSA, EFSA/ESCO, ILSI and
FDA
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Latest Developments - 1
 EFSA/ESCO report endorses the use of thresholds
of toxicological concern (TTC) to set levels of
tolerable exposure for different chemical classes.
 ILSI proposed a step-wise approach
 By following this step-wise approach, it may be
possible to apply a TTC threshold of 90
µg/person/day for an unknown substance
 The EFSA TTC approach propose that the following
human exposure threshold values are sufficiently
robust and conservative to be used in EFSA’s work;
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Latest Developments - 2
0.15 µg/person per day for substances with a
structural alert for genotoxicity
This TTC also applies to substances for which
the structure is totally unknown.
18 µg/person per day for organophosphate
and carbamate substances with anticholinesterase activity
90 µg/person per day for Cramer Class II &
III substances
1800 µg/person per day for Cramer Class I
substances,
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Latest Developments - 3
BUT for application to ALL groups in the
population, these values should be expressed
in terms of body weight, i.e. 0.0025, 0.3, 1.5
and 30 µg/kg body weight per day,
respectively.
Use of the TTC approach for infants under
the age of 6 months, with immature
metabolic and excretory systems, should be
considered on a case-by-case basis.
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Latest Developments - 4
 EFSA Evaluation of Cramer Classes concluded that:
 The TTC approach, as proposed by Munro et al. in
1996, appears to be more conservative (more
protective for consumers) than the complete
individual risk assessment for 95.9 % of the 845
compounds included in the extended (Munro and
FCM for which EFSA had full tox dossiers)
substances dataset.
 These figures suggest that the TTC approach can
be a useful tool for prioritisation of evaluations of
lists of substances for which no toxicity data are
available.
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FDA paper on Oligomers - 1
“Based on an analysis of the available data, accepting
toxicity data of monomers as a component of a
weight-of-evidence safety decision on polymeric foodcontact materials, in general, does appear to be a
conservative approach for assessing genetic toxicity
and potential carcinogenicity for dietary exposures
≤150 µg/person/day. Such an analysis is assisted by
also including a discussion of where the reactive
groups on genotoxic or carcinogenic monomeric
components may have been altered or eliminated in
the polymeric material and SAR analysis of
representative structures of the oligomers.”
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FDA paper on Oligomers - 2
“Clearly, consideration of the LMWOs is an
important component of evaluating the safety of
polymers used in food contact materials. When
concerns exist regarding reactivity or SAR, further
testing may be required; however, the use of the
approaches described herein can, in general, be
used to make a safety determination.”
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References
1. EFSA/ESCO - 2011:EN-139. Report of ESCO WG on non-plastic Food
Contact Materials. European Food Safety Authority, Parma, Italy. 25
July 2011.
2. ILSI TTC - Application of the TTC concept to unknown substances found
in analysis of foods. S. Koster, A. R. Boobis, R. Cubberley, H. M.
Hollnagel, E. Richling, T. Wildemann, G. Würtzen and C. L. Gall. Food
and Chemical Toxicology 2011, 49, 1643–1660.
3. EFSA TTC - Draft Scientific Opinion on Exploring options for providing
preliminary advice about possible human health risks based on the
concept of Threshold of Toxicological Concern (TTC). Public
consultation, July 2011.
4. EFSA Cramer Class - Threshold of Toxicological Concern approach for
the risk assessment of substances used for the manufacture of plastic
Food Contact Materials. R. Pinalli, C. Croera, A. Theobald and A.
Feigenbaum. Trends in Food Science and Technology, 2011, in press.
5. FDA - Assessing the toxicity of polymeric food contact substances. Chad
P. Nelson, Geoffrey W. Patton, Kirk Arvidson, Helen Lee, Michelle L.
Twaroski. Food & Chemical Toxicology 49 (2011) 1877 – 1897
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Summary
These TTC concepts coupled with the advances in
estimating migration and exposure that FACET will
bring, will be significant developments in our
capabilities to make better scientifically-based risk
assessment of migration from FCMs.
For an overview of the FACET project consult the
September (2011) publication:
A. Hearty et al: Food Science & Technology (2011),
Vol, 25 (2), 26-29.
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THANK YOU FOR YOUR
ATTENTION
FACET WEB SITE
www.ucd.ie/facet
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