On September 2, 2026, the European Food Safety Authority (EFSA) published a technical report evaluating substances of very high concern (SVHCs) authorized for use in plastic food contact materials (FCMs) in the European Union. Of the 898 substances on the EU’s Union List for plastic FCMs (Annex I, Regulation (EU) No 10/2011), EFSA identified 23 that also appeared on the European Chemicals Agency’s (ECHA) SVHC Candidate List as of April 15, 2026.
Are SVHCs allowed in food contact materials?
SVHCs are included in the EU’s REACH regulation based on their environmental and health hazards such as environmental persistence, bioaccumulation potential, carcinogenicity, reproductive toxicity, and endocrine disruption. However, inclusion on the SVHC Candidate List does not automatically revoke authorization for food contact use (FPF reported). Therefore, despite their hazardous properties, some SVHCs continue to be used in food contact applications.
Assessing the SVHCs allowed in food contact plastics
EFSA developed a screening methodology to reassess approved SVHCs by combining existing safety assessments, toxicological studies, regulatory classifications, and restrictions on chemical migration into food. Sixteen substances were excluded from further prioritization based on criteria including limited relevance to oral exposure, existing migration restrictions, negligible expected exposure, and anticipated regulatory prohibitions.
Of the seven substances assessed in greater detail, six did not have new evidence that challenged their previous safety assessments or existing restrictions. Melamine (CAS 108-78-1) was the only substance identified as potentially requiring reassessment.
More on melamine
Melamine is used to manufacture plastic tableware and other food contact articles and can migrate into food, particularly under certain use conditions (FPF reported). ECHA added melamine to the SVHC Candidate List in 2023 due to concerns about its effects on human health and the environment (FPF reported).
EFSA’s 2010 assessment established a tolerable daily intake (TDI) of 0.2 mg/kg body weight per day, primarily based on urinary tract toxicity. The EU subsequently established a specific migration limit of 2.5 mg/kg food.
In the new evaluation, EFSA identified additional animal studies reporting effects on male reproductive health at doses below the reference point used in its 2010 assessment. While the studies had limitations and uncertainties, EFSA concluded that the evidence could justify a lower TDI and potentially a reduced migration limit.
Is male reproductive health the best measure?
Current regulatory safe limits are generally set based on male reproductive toxicity, assuming that these health effects were the most sensitive. However, a study published in 2021 found that, at least for phthalates, this assumption may not be appropriate. The authors found that some human health effects observed in diverse human populations (children, men and women) occur at levels up to 8000 times below the assumed “safe” exposure limits. Observed health effects below the safe exposure levels were reproductive, neurodevelopmental, behavioral, hormonal, and metabolic (FPF reported).
Moving forward
EFSA recommended that a future reassessment of melamine initially focus on reproductive toxicity. However, they emphasized that identifying a substance for reassessment does not necessarily indicate that its current use poses a risk to human health.
The report also concluded that the screening methodology could be adapted to prioritize other hazardous substances under EU chemicals legislation.
References
EFSA CONTAM and CEF Panels (2010). “Scientific Opinion on Melamine in Food and Feed.” EFSA Journal.
