Compound reclassification proposed
7 Apr 2014
A proposal to reclassify plastics chemical Bisphanol A (BPA) as potentially harmful to reproductive systems was last month backed by the European Chemicals Agency (ECHA).
ECHA’s Committee for Risk Assessment (RAC) has adopted the French government’s proposal to strengthen the existing harmonised classification and labelling (CLH) of BPA from a category 2 reproductive toxicant to a category 1B reproductive toxicant regarding the adverse effects on sexual function and fertility.
BPA is a monomer mainly used in the production of polycarbonate plastics and epoxy resins for plastic household items including water and baby bottles.
The RAC opinion covers the adverse effects BPA has on sexual function and fertility as only these types of main reproductive toxic effects were proposed for revision by France.
A statement by the ECHA said its RAC adopted its opinion by consensus after comparing the available evidence with the CLP criteria.
The studies performed according to standard test guidelines were given the most weight.
RAC concluded that there were adverse effects on reproductive capacity following oral exposure to BPA in a multi-generation guideline study in mice and in rats.
Impaired female reproductive capacity was also observed in several supplementary non-guideline studies.
BPA already has a harmonised classification in Annex VI to the CLP Regulation as a substance suspected to damage fertility, that may cause respiratory irritation and allergic skin reaction, and as a substance that causes serious eye damage.
Meanwhile, the European Food Safety Authority’s (EFSA) consultation on its draft opinion on BPA closed last month, with the final version expected later this year.
The consultation includes a re-evaluation of the tolerable daily intake (TDI) for BPA in the light of all available evidence.
It is the EFSAs first evaluation of the health risks for all population groups – including foetuses, infants, young children and adults – resulting from exposure to BPA from both dietary and non-dietary sources.
