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. 2025 Jun 10;23(6):e9473.
doi: 10.2903/j.efsa.2025.9473. eCollection 2025 Jun.

Re-assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials

EFSA Panel on Food Contact Materials (FCM); Lambré Claude, Riccardo Crebelli, Maria Da Silva, Konrad Grob, Evgenia Lampi, Maria Rosaria Milana, Marja Pronk, Mario Ščetar, Georgios Theodoridis, Els Van Hoeck, Nadia Waegeneers, Claudia Bolognesi, Emma Di Consiglio, Marcel Mengelers, Zainab Al Harraq, Irene Muñoz Pilar, Sandra Rainieri, Gilles Rivière

Re-assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials

EFSA Panel on Food Contact Materials (FCM) et al. EFSA J. .

Abstract

The EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re-evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food. A rigorous assessment of the in vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search and (iii) reported in the 2019 IARC Monograph was performed. All studies were assessed for reliability and relevance and the results integrated in the weight of evidence. The results provided by reliable in vivo oral genotoxicity studies, covering different genetic endpoints and target tissues, including liver, the primary site of metabolism, demonstrated that the oral administration of styrene in mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight (bw), respectively) did not induce genotoxic effects. The Panel concluded that there was no evidence that styrene is genotoxic following oral exposure. For substances demonstrated to be non-genotoxic, according to the EFSA Note for Guidance for FCM, an SML up to 50 μg/kg food would not be of safety concern. Consequently, the use of styrene in the manufacture of FCM respecting the SML of 40 μg/kg food proposed by the European Commission is not of safety concern.

Keywords: CAS No 100‐42‐5; food contact materials; genotoxicity; oral exposure; safety assessment; styrene.

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Figures

FLOW CHART 1
FLOW CHART 1
Summary of in vivo studies on gene mutations. According to the EFSA Technical Report (EFSA, 2023), the reliability of the studies is scored as: 1. Reliable without restriction; 2. Reliable with restrictions; 3. Not reliable; 4. Not assignable. The relevance is referred to the results of the individual genotoxicity studies.
FLOW CHART 2
FLOW CHART 2
Summary of in vivo studies on chromosomal damage. According to the EFSA Technical Report (EFSA, 2023), the reliability of the studies is scored as: 1. Reliable without restriction; 2. reliable with restrictions; 3. not reliable; 4. not assignable. The relevance is referred to the results of the individual genotoxicity studies.
FLOW CHART 3
FLOW CHART 3
Summary of in vivo studies on comet assay. According to the EFSA Technical Report (EFSA, 2023), the reliability of the studies is scored as: 1. Reliable without restriction; 2. Reliable with restrictions; 3. Not reliable; 4. Not assignable. The relevance is referred to the results of the individual genotoxicity studies.
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