FOOD CONTACT ADDITIVES PANEL

Conference FoodMigrosure
Date: September 27-28
VENUE: Baveno, Italy
By: Bart Brands, Dow Europe, Switzerland

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 FoodMigrosure, a perspective
from a producer and user
of additives in FCM’s

• Role of CEFIC-FCA during the 3 years research

• FCA position regarding research on FCM’s
• Positive findings from the conducted research
• A few critical remarks
• A few suggestions
• Conclusions

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 Role of CEFIC-FCA

• Mainly an observer
• Having a strong interest in the scientific developments
related to the safety of FCM’s
• A more scientific understanding of the migration
behavior of substances from a FCM to a food simulant or
even better food, is essential knowledge to producers of
such substances
• Provide samples of additives or FCM’s during the
research
• Provide expert information in relation to the FCM’s and
market applications, when possible

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 FCA position on scientific research
• FCA represents approx 70 companies producing, and frequently also using,
additives in FCM’s
• FCA strongly supports new scientific developments on FCM’s as defined in
the Food Law and the Frame Work Regulation
• FCA as well as many of their members regularly conduct their own
scientific investigations (migration studies, toxicological studies,
development of data in support of exposure assessments
• FCA, as well as all other associations involved with FCM’s, strongly support
research towards exposure based legislation and risk assessment of new
substances.
• This research includes the support for a Tiered Threshold of Toxicological
Concern (ILSI Europe), as well as applying well established tools to
estimate toxicological critical endpoint (QSAR, Topcat, Derek)
• Most essential aspect is the inclusion of the recent scientific research in the
legislation on FCM’s as well Note for Guidance on new substances

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 Positive findings
• Scientific evidence that the already existing migration
modeling to food simulants can be extended to the
prediction of the concentration in food
• Extensive new data generated on the partitioning to food
• Already existing data on dietary intake (UK, Italy, etc.)
and Packaging Use Data, has been used (FDA, M.
Palmer)
• A workable mathematical model has been designed
• Results already being used to make adjustments for
some of the prescribed food simulants for actual
migration testing (milk products), which changes can
effectively prevent too high migration to milk, resulting
in media covered issues (ITX)

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 A few critical remarks

• Is sufficient validation created, to have the scientific

findings accepted by EFSA and Commission to be
included in the applicable Commission documents, as an
extension to migration modeling (food simulants) and in
support of exposure assessment ?
• The migration prediction to food simulants is rather
conservative to ensure that no inappropriate estimations
are being calculated, as the food simulant is a surrogate
for food. Is the model now developed, using the same
conservative mathematical model ? Many uncertainties
seen with food simulants are now over come.
• Can the model be adjusted when PlasticsEurope, FCA,
EuPC come with a more detailed packaging use data
base ? (Matrix > Correlation Factors, instead of FDA)

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 A few critical remarks

• What is the application area of the model ? Food types or

applications / conditions where the model can not be applied ?
• e.g. deep frozen food ?
• How can the model be used in the current petition concept of new
substances ?
• Example: Current petitions are based on the highest found
migration in food simulants (mostly with simulant D). The market
requires that FCM’s can be used for “all food types”. One single
migration result above 5 mg/kg leads to tremendous costs / time
problems. Mostly the FCM shows lower migration in actual foods,
especial aqueous foods.
– Can, with the new scientific evidence predicting concentrations in food,
the toxicological data package be adjusted, to the levels predicted in
food ?
– Can the new scientific evidence be used to modify the current food
simulants for certain food types, in a way to use less aggressive food
simulants ?

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 A few suggestions

• Publication of the FoodMigrosure work in a scientific

magazine
• Ensure that the missing modules are being completed,
and finalyze the report.
• Carefully review and assess the module on “consumer
acceptance” of compliance verification by modeling to
simulants / food. What is the conclusion ? Many
consumer have a mistrust to science they may not fully
understand.
• Ask EFSA AFC for their opinion on the completed work,
including their suggestions for inclusion of this new
science in the respective EFSA (Note for Guidance) and
Commission documents (Directive 2002/72/EC,
85/572/EEC, Practical Guide)
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 Conclusions
• Excellent scientific work
• Will further support the safety of FCM’s
• Can lead to reduced data packages for petitions
of new substances
• Can demonstrate that concentrations in actual
food (t/T depending) can be lower as well higher
than seen with food simulants
• Work accomplished should be made available to
a broad audience.
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