What consequences are to be expected?
The risks to public health associated with the genotoxicity of styrene in plastic food contact materials have been re-evaluated by the EFSA.
✅ Background
Styrene is approved in the EU as a monomer for the production of polystyrenes used in packaging with direct food contact. Following the IARC classification in 2018 as “probably carcinogenic to humans,” EFSA was commissioned in 2020 to re-evaluate the genotoxicity. In the course of the re-evaluation, uncertainties regarding the genotoxicity of styrene after oral intake were identified, meaning that additional data were required for a final assessment. The EU Commission plans a specific migration limit (SML) of 0.04 mg/kg food. In 2023, EFSA was therefore requested to re-evaluate the safety of styrene for use in food packaging materials at a maximum migration of 0.04 mg/kg food.
🔍 Approach & Data Basis
Based on data provided by the US Styrenic Information and Research Center (SIRC), a literature review (period 2018 to 2024), and studies reported in the IARC Monograph 2019, EFSA evaluated the reliability of in vivo studies on genotoxicity and the relevance of the results, toxicokinetic studies (absorption, distribution, metabolism, and excretion), as well as data on human exposure. This resolved the uncertainties from the 2020 assessment.
🧪 Results & Implications
EFSA found no scientific evidence of genotoxicity of styrene after oral exposure in rodents. The results of reliable oral in vivo genotoxicity studies covering various genetic endpoints and target tissues showed that oral administration of styrene to mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight, respectively) did not induce genotoxic effects.
For substances that are demonstrably non-genotoxic, according to EFSA guidelines for food contact materials (FCM), an SML of up to 0.05 mg/kg food would not be safety-relevant. Consequently, the use of styrene in the manufacture of FCM while complying with the SML of 0.04 mg/kg food proposed by the European Commission is not a safety concern.
Currently, styrene is listed in Regulation (EU) No. 10/2011 without a limit value. In our opinion, it is to be expected that a limit value of 0.04 or possibly 0.05 mg/kg food will be included.
📋 Original Texts
EFSA summary in plain language from June 10, 2025:
Re-evaluation of risks to public health related to the genotoxicity of styrene in plastic food contact materials
Related Scientific Publication
DOI: https://doi.org/10.2903/j.efsa.2025.9473
Conclusion: The EFSA re-evaluation shows that styrene does not induce genotoxic effects after oral intake. The uncertainties from the 2020 assessment have been resolved, and the use of styrene in food packaging materials while complying with the proposed specific migration limit (SML) of 0.04 mg/kg food is not a safety concern.
Recommendation: For companies using styrene-containing packaging materials, it is advisable to observe and comply with the SML of 0.04 mg/kg food proposed by the European Commission already now. This ensures the safety of packaging and minimizes potential health risks for consumers. Furthermore, we recommend staying informed about future amendments to Regulation (EU) No. 10/2011, as a limit value of 0.04 or possibly 0.05 mg/kg food could be included.
If you have any questions, please contact fcm@innoform.de. We are happy to provide you with a quote for specific migration of styrene.
