BPA is currently classified as a category 2 substance, meaning suspected reprotoxicity, but ANSES want this modified to category 1 to change the status of BPA to clearly hazardous.
ANSES said in light of the many studies published since 2002 and its own assessment, it has drafted a proposal for revising the classification of BPA in order to make it more stringent on the EU level with regard to the substance’s reproductive toxicity.
Reprotoxic proposal
The French dossier proposes classifying BPA as reprotoxic for humans based on its observed effects on the fertility and on the male and female reproductive systems of animals, and which have been corroborated by epidemiological studies in humans whose relevance is disputed.
“Classification in category 1 would directly require the application of more stringent regulatory measures, including the obligation to implement reinforced preventive measures for professional uses of bisphenol A (primarily substitution), and a ban on marketing authorisation for mixtures containing bisphenol A intended for use by consumers,” said ANSES.
ANSES published two preliminary reports in September 2011, one on the health effects of this substance and the other on its uses. This highlighted effects that are considered as recognised in animals and suspected in humans, even at low levels of exposure, said the agency.
Classification process
The ECHA committee will examine the proposal with regard to the European criteria for classification and the available scientific proof, in order to collectively rule on the classification to be adopted.
Following the consultation stage, EFSA's Committee for Risk Assessment will deliver a final opinion based on all the available data.
The decision of whether to include the harmonised classification in the labelling and packaging of chemicals (CLP) regulation will be handed down by the European Commission following a vote by the Member States.
The public consultation will be open for 45 days on the ECHA website and will be available during this period on the ANSES website. ANSES said due to the time needed for the compliance phase and possible proposal revisions, the public consultation period probably will not begin before early 2013.
Meanwhile, in mid-October the French Senate is expected to pass the bill banning use of bisphenol A (BPA) in food packages which was approved by the National Assembly in 2011.
The law bans production, import, export, and distribution of any food packaging containing BPA as of 1 January 2014.