France has proposed amending the harmonised CLH of BPA from reproductive toxicity category 2 (hazard statement code H361f) to reproductive toxicity Category 1B (hazard statement code H360F).
A chemical is placed in hazard statement code H361f if it is “suspected of damaging fertility”. It is placed in the code H360F if it “may damage fertility”, according to ECHA.
ECHA stressed that the public consultation is targeted at the adverse effects on sexual function and fertility only, not on developmental toxicity or other hazard classes than reproductive toxicity.
CLH regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union.
ANSES (the French Agency for food, environmental and occupational health and safety) considers that the classification for fertility within reprotoxicity needs to be revised on the basis of available studies, such as one published by the agency in 2011.
“Depending on the effect defined as the leading effect for classification, human data corroborate or validate the finding[s] on animal, when others are more debatable,” according to an ANSES dossier.
“We therefore propose that a classification Repr. 1B–H360Fis warranted (Repr. Cat. 2; R60 according to Directive 67/548/EEC) but welcome a discussion regarding a classification in Repr. 1A; H360F.
“Depending on how the uncertainties on human data are considered, we suggest that a classification of BPA in Repr. 1A; H360F is discussed.”
After the consultation period the Risk Assessment Committee (RAC) will prepare a scientific opinion taking into account the received comments. RAC will adopt an opinion on any CLH proposal within 18 months of receipt of the proposal.
BPA is a monomer mainly used in the production of polycarbonate plastics and epoxy resins.
‘No need for BPA re-classification’ – trade body
Jasmin Bird, communications manager from the Polycarbonate/BPA-Group of PlasticsEurope, said they will evaluate the French dossier and provide comments during the consultation phase.
"Industry remains convinced that there is no need for a re-classification of Bisphenol A, and that when the robust science and the available data on BPA have been considered thoroughly, the conclusion will be that a re-classification of BPA is unwarranted,” she told FoodQualityNews.com.
"The members of the PC/BPA and epoxy resin groups believe that the proposed classification of BPA as a Category 1B Reproductive Toxicant is not supported by the criteria for classification according to Global-Harmonized-System (GHS) or by the available scientific evidence.
“Industry is convinced that the current GHS classification as Category 2 Reproductive Toxicant reflects adequately any risks associated with BPA."
ECHA has invited comments on a proposal which will be open until 11 October 2013.
Meanwhile, the Danish EPA, Chemicals Division is evaluating bisphenol-A-(epichlorhydrin); epoxy resin under the community rolling action plan (CoRAP) scheduled by 2015.