On January 28, 2016 the European Food Safety Authority (EFSA) published a scientific opinion on “Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials.” EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) recommends refining the safety assessment of substances used in food contact materials (FCMs) and concludes on the following key findings:
1) Chemical migration testing should focus more on finished materials and articles, including manufacturing processes, rather than on the single substances used in FCMs;
2) the approach to estimating consumer exposure should be revisited. The CEF Panel proposes setting four default food categories based on infants’ and toddlers’ food consumption. To ensure a higher level of protection, the assumed consumption levels for each of the categories shall be higher than the current default level of 17 g/kg body weight/day (i.e. 1 kg food in contact with 6 dm2 of the relevant FCM consumed by an adult weighing 60 kg);
3) the required toxicity data for substances in FCMs should be related to the expected human exposure. The CEF Panel proposes three threshold levels of human exposure as triggers for requiring additional toxicity data: 1.5, 30, and 80 µg/kg body weight/day. This shall apply to both intentionally and non-intentionally added substances (NIAS); and
4) genotoxicity testing should be mandatory for all substances used in FCMs, even if their migration into food is low. For NIAS, non-animal testing methods could be explored.
EFSA notes that this scientific opinion is not intended as a guidance document. “The opinion will provide the European Commission (EC) with the scientific basis for a discussion among risk managers on possible implications for risk management,” EFSA states. Thereafter, EFSA will consult with the EC and then develop guidance on data requirements for the safety assessment of substances in FCMs.
The preceding draft opinion was subject to a public consultation from July 7 to October 7, 2015 (FPF reported). The Food Packaging Forum and the non-profit organization CHEM Trust had submitted detailed responses to the public consultation (FPF reported). In total, EFSA received 205 comments and four data sets from 21 interested parties, including governmental and non-governmental organizations, industry, and consultants. The outcome of the public consultation was considered in the preparation of the final scientific opinion and is compiled in a technical report.
EFSA (January 28, 2016). “Food contact materials: building on scientific developments.”
EFSA (January 28, 2016). “Report on the public consultation on the EFSA draft Scientific Opinion on Recent developments in the risk assessment of chemicals in food and their potential impact on the safety as-sessment of substances used in food contact materials.”