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RAC proposes to strengthen the classification of bisphenol A

ECHA/PR/14/07

The French proposal to classify bisphenol A (BPA) as a presumed human reproductive toxicant which may damage fertility has been unanimously supported by RAC.

Helsinki, 19 March 2014 – The Committee for Risk Assessment (RAC) has adopted an opinion 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 in line with a proposal from the French competent authority.  

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. The RAC opinion solely covers the adverse effects on sexual function and fertility as only these types of main reproductive toxic effects were proposed for revision by France.

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 (functional fertility) 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. In addition, toxic effects in reproductive organs were observed in several of the studies.

Classification focuses on the intrinsic properties of the substance and does not take human exposure levels into account. Relevant adverse effects on reproduction can be sufficient to justify the classification as a reproductive toxicant also at high doses.

BPA is a monomer mainly used in the production of polycarbonate plastics and epoxy resins and is also currently being discussed in the context of other EU processes. ECHA has received a proposal to restrict the use of BPA in thermal paper. In addition, a substance evaluation of BPA was carried out by the German competent authority in 2012 and, as a result of this evaluation, ECHA issued a decision in December 2013 to request further data on BPA in the areas of skin absorption and environmental exposure. At the European Food Safety Authority (EFSA), a public consultation on the draft opinion on bisphenol A (BPA) – Assessment of human health risks ended on 13 March 2014.

Further information

The opinions will be available at the following link in the near future:

Opinions

Background Information

The role of RAC in EU regulatory processes

The Committee is responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions and proposals for harmonised classification and labelling. RAC also prepares opinions on specific questions relating to risks of chemicals to human health or the environment and on any other aspects concerning the safety of substances at the Executive Director's request. The final decision for proposals for harmonised classification and labelling, for proposals for restrictions as well as on applications for authorisation will be taken by the European Commission through a committee procedure.

Further information about RAC