The European Food Safety Authority (EFSA) has conducted a re-assessment of the risks to public health of styrene plastic that comes into contact with food.
EFSA’s scientific experts have published a draft scientific opinion where they concluded (1) there is no evidence suggesting styrene damages genetic information following oral exposure; and (2) styrene in food contact materials can be considered safe below the specific migration limit (SML) of 40 parts per billion (ppb).
The preliminary version is available for public consultation until today, Jan. 28, 2025. The EFSA wishes to gather input and feedback from stakeholders interested in the refinement and finalisation of the opinion.
The European Comission requested EFSA to conduct the re-assessment due to evidence brought forward by the International Agency for Research on Cancer (IARC). In 2019, the IARC published a monograph concluding that styrene and its primary metabolite styrene-7,8-oxide (SO) are ‘probably carcinogenic to humans’.
At present, styrene is authorised without a migration limit or other restrictions for the manufacture of plastic food contact materials in accordance with Commission Regulation (EU) No 10/20111. The Commission is now preparing to introduce a migration limit of 40 ppb in foods.
The study assessed whether there is evidence that styrene is genotoxic (damaging to genetic material) following oral exposure and, if not, whether its use is authorised under EU regulations subject to a SML of 40 ppb.
The EFSA team based its research on studies reported in the 2019 IARC monograph, studies provided by the US Styrenic Information and Research Centre, and studies collected through a targeted literature search between 2018 and 2024. It also took into account data provided by third parties during 2022 and 2023.
The studies evaluated whether styrene induces gene mutations, chromosome damage, or DNA damage in live rodents after oral exposure. All results assigned high relevance/reliability were negative, with two positive results being evaluated as low relevance.
In humans, biomonitoring studies were conducted for workers occupationally exposed to styrene in the glass-reinforced plastics industry.
The EFSA team noted several limitations in the biomonitoring studies using genotoxicity biomarkers, such as the large variability and uncertainties in the extent and profile of exposure, the possible co-exposure to other genotoxicants, the lack of consistency across studies, the absence of an exposure response, and the lack of control for relevant confounding factors.
Overall, the team concluded the results of these biomonitoring studies ‘do not provide sufficient evidence to support an association between styrene exposure and genotoxic damage in humans’.
Having concluded that styrene is not genotoxic, the EFSA noted its guidance for food contact materials says a SML up to 50 micrograms per kilogram of food is not of safety concern. Therefore, the report concludes, the use of styrene in the manufacture of food contact materials with a SML of 40 micrograms per kilogram of food is not of safety concern.