EFSA Review on DOTL and DOTE

EFSA Review Does Not Prioritise DOTL and DOTE for Re-assessment in Plastic Food Contact Materials

In a technical report issued on 2 September 2026, the European Food Safety Authority (EFSA) reviewed substances of very high concern (SVHC) included in the Union List of substances authorised for use in plastic food contact materials. The review identified 23 substances, of which seven underwent detailed consideration to determine whether additional toxicological information challenges their existing assessments.

Of relevance to the GOSC (Global Organotin Stewardship Council), EFSA concluded that dioctyltin dilaurate (DOTL) and di-n-octyltin bis(2-ethylhexyl)mercaptoacetate (DOTE) should not be prioritised for re-assessment. EFSA examined additional developmental and reproductive toxicity studies, including information from REACH registration dossiers, and found no evidence challenging the existing group tolerable daily intake of 0.1µg tin/kg body weight per day, established based on immunological effects.

Source:

EFSA Supporting publication 2026: EN-10321. doi:10.2903/sp.efsa.2026.EN-10321.

• Substances of Very High Concern (SVHC) present in the Union List of substances authorised to manufacture plastic food contact materials and articles: methodology to evaluate whether their hazardous properties challenge their current assessment 2026 – EFSA Supporting Publications (Wiley Online Library)