26/09/2012 3 min

ANSES proposes a more stringent EU level classification for bisphenol A as a substance toxic to reproduction

ANSES is in charge of providing support to the French authorities for the implementation of the European regulation concerning the classification and labelling of chemicals. In keeping with the work the Agency has conducted on bisphenol A, it has filed a proposal with the European Chemicals Agency (ECHA) to revise the classification of this substance in order to make it more stringent on the EU level with regard to reproductive toxicity.

In response to formal requests by the Ministries of Health (2009) and Ecology (2010) regarding endocrine disruptors, including bisphenol A, ANSES published two preliminary reports in September 2011, one on the health effects of this substance and the other on its uses. This work made it possible to highlight effects that are considered as recognised in animals and suspected in humans, even at low levels of exposure.

As a logical follow-up to this work, and considering the effects observed on the male and female reproductive systems as well as the criteria set down in the regulation on the classification of chemicals substances (known as the CLP Regulation) (1), ANSES has examined the consequences of the above on the classification of BPA as a reprotoxic substance.

Since 2002, bisphenol A is listed within the harmonised EU classification as a suspected reprotoxic substance (2).

In light of the many studies published on the topic since 2002 and of the expert assessment conducted by ANSES, the Agency has drafted on the behalf of the French authorities a proposal for revising the classification of bisphenol A in order to make it more stringent on the EU level with regard to this substance’s reproductive toxicity.

The French dossier proposes classifying bisphenol A as reprotoxic for humans (3) 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. For this reason ANSES also proposes to consider a classification in category 1A, based on the way in which the uncertainties regarding the human data are interpreted.

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.

The next step

As provided for in the EU regulation on the classification, labelling and packaging of chemicals (CLP), this proposal for revision has been submitted to the Committee for Risk Assessment of the European Chemicals Agency (ECHA). The Committee's experts 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.

First, this proposal (drafted in English) will undergo an admissibility procedure by ECHA. Then it will be published on the ECHA website for public consultation, in order to enable all the stakeholders to present their positions, scientific arguments and any additional information in their possession.

This public consultation will be open for 45 days on the ECHA website. The information will also be available during this period on the ANSES website. Due to the time needed for the compliance phase and any possible revisions of the proposal, the public consultation period probably will not begin before early 2013.

Following the consultation stage, EFSA's Committee for Risk Assessment will deliver a final opinion based on all the available data. This opinion will be sent to the European Commission no more than 18 months after the date of publication of the proposal. The decision, based on this opinion, of whether to include the harmonised classification in the CLP regulation will be handed down by the European Commission following a vote by the Member States.

(1) Regulation (EC) CE 1272\2008
(2) Repr. 2 – H361 according to the CLP regulation criteria
(3) Repr. Cat.1B – H360