Styrene in FCM Not a Safety Concern Reports EFSA Panel

In a re-assessment of the risks to public health from styrene used in plastic food-contact materials, the European Food Safety Authority (EFSA) Panel on Food Contact Materials (FCM) concluded that “the use of styrene in the manufacture of FCM respecting the SML [specific migration limit] of 40 μg/kg food proposed by the European Commission is not of safety concern.”

By way of background, following the publication of a monograph in 2019 by the International Agency for Research on Cancer (IARC), which concluded that styrene was “probably carcinogenic to humans” (Group 2A), the European Commission asked EFSA to re-evaluate the safety of styrene for use in plastic FCM. In 2020, EFSA published an assessment in which it stated 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.” As a result, the Authority recommended 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.” 

The EFSA Panel on Food Contact Materials re-assessment included a review of vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search, and (iii) reported in the 2019 IARC Monograph. The full article, titled, Re-assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials, was published in the EFSA Journal on June 10, 2025.

We understand that the European Commission intends to introduce a specific migration limit (SML) for styrene in the Plastics Regulation (EU) No. 10/2011 taking into consideration the EFSA’s opinion.