November 30, 2020

Volume X, Number 335

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EFSA Updates Opinion on Styrene in FCMs

The European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) published an assessment  of the impact of IARC Monograph Vol. 121 on the safety of styrene for use in plastic food contact materials (FCMs). In September 2019, IARC updated its evaluation of styrene to classify the substance as “probably carcinogenic to humans” (Group 2A). Based on that classification, the European Commission asked EFSA to re-evaluate the safety of styrene for use in in plastic FCMs.

The EFSA’s evaluation notes that the migration of styrene into foods packed in styrenic plastics is below 10 µg/kg for the majority of foods but has been reported at levels up to 230 µg/kg. EFSA estimates that consumer dietary exposure to styrene is approximately 0.1 µg/kg body weight per day.

EFSA states that IARC’s conclusion, which is based on high-dose occupational exposures by inhalation and animal studies, “cannot be directly applied to the evaluation of risks for consumers from the oral exposure to styrene” The Authority concludes “based on the data provided in the IARC Monograph and by the industry, a concern for genotoxicity associated with oral exposure to styrene cannot be excluded”, adding that “a systematic review of genotoxicity and mechanistic data, comparative toxicokinetics and analysis of species differences is required for assessing the safety of styrene for its use in FCM.”

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 297
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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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