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


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4357 [28 pp.].
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Kettil Svensson and Detlef Wölfe. The CEF Panel also wishes to thank the former members of the CEF Panel, Ricardo Crebelli, Jean Claude Lhuguenot, Catherine Leclercq and Iona Pratt, and EFSA staff, Eric Barthélémy and Dimitrios Spyropoulos, for the preparatory work on this scientific opinion.
Opinion of the Scientific Committee/Scientific Panel
On request from
Question Number
2 December 2015
Published in the EFSA Journal
28 January 2016
European Food Safety Authority (EFSA), Parma, Italy
This Opinion describes recent developments in the safety assessment of chemicals in food and explores their potential impact on EFSA evaluation of food contact materials (FCM). It is not intended to be a guidance document. The draft opinion was subject to a public consultation and this final Opinion takes into account the scientific comments received. The Opinion will provide the European Commission with the scientific basis for a discussion among risk managers on possible implications for risk management. One major area to revisit is the estimation of consumer exposure. Four food consumption categories could be set. They are approximately 9, 5, 3 and 1.2 times higher than the current SCF default scenario, i.e. 17 g/kg bw per day, and so using them would afford a higher level of protection, particularly for infants and toddlers. Special exposure scenarios might be used if consumption were lower. The amount of toxicity data needed should be related to the expected human exposure. The tiered approach of the SCF is updated. For substances used in FCM, genotoxicity testing is always required, even if their migration leads to a low exposure. Beyond this, three threshold levels of human exposure, namely 1.5, 30 and 80 μg/kg bw per day, are proposed as triggers for the requirement for additional toxicity data. Regarding the identification and evaluation of migrating substances, experience has shown that more focus is needed on the finished materials and articles. Considering the non-intentionally added substances (NIAS), such as impurities of the substance along with reaction and degradation products including oligomers, the same approach as is used for authorised substances could, in principle, be applied for their toxicological assessment, as the same degree of safety should be warranted for all migrating substances. However, non-testing methods could have increased importance for the assessment of genotoxicity of NIAS. 
food contact materials, plastics, substances, safety assessment, migration, exposure, toxicological evaluation
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