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anses

French Agency for Food, Environmental and Occupational Health & Safety

ECHA puts ANSES's proposal for tougher bisphenol A classification up for public consultation

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News of 19/09/2013

Bisphenol A is a synthetic chemical which has been in use for over 50 years. Since last year, it has been the subject of a law which aims to ban its use in food containers.  The studies conducted by ANSES on the uses and health effects of bisphenol A led to recommendations, issued in September 2011 and in April 2013, to reduce population exposure to it through substitution in materials in contact with foodstuffs. On the European level in the context of the REACh regulation, ANSES proposed in September 2012 a tougher classification for bisphenol A which would list it as toxic for reproduction. The European Chemicals Agency has just put the French proposal up for consultation with the other Member States.

 

In conjunction with its expert assessment of endocrine disruptors, including bisphenol A, ANSES published two initial reports on bisphenol A in September 2011, one on the health effects of the 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. In April 2013, several studies confirmed these results with regard to pregnant women and the potential risks for unborn children in particular. 

In 2012, French legislation banned bisphenol A in food containers. The ban on this substance in containers used by children under 3 years of age came into force as if 2013, and a ban for the entire population is set for 2015. Within the EU regulatory framework, bisphenol A is currently listed in the harmonised classification system as a suspected reprotoxic substance. It is also currently classified as an irritant for the respiratory tract which may cause severe ocular damage and can cause sensitisation by skin contact.

As of 2012, ANSES - in its role as an organisation in charge of providing support to the French authorities for the implementation of European regulations on the labelling of chemical substances - submitted to the European Chemicals Agency (ECHA) a proposal for amending this classification, in order to make it tougher by listing bisphenol A as a substance toxic to reproduction.

Classification in this category (category 1) would directly require the application of more stringent regulatory measures, with the obligation to implement strengthened preventive measures for professional uses of bisphenol A (primarily its substitution), and a ban on marketing authorisation for mixtures containing bisphenol A intended for use by consumers.

This proposal is the subject of a public consultation on the ECHA website.The consultation for bisphenol A opened on 27/08/2013 and will close on 11/10/2013. Comments can be submitted using the form specifically designed for this purpose

Following the consultation stage, EFSA's Committee for Risk Assessment will deliver a final opinion based on all the available data, which will be sent to the European Commission no later than 18 months after the proposal's publication date. The decision, based on this opinion, whether to include the harmonised classification in the CLP regulation(1) will be handed down by the European Commission.

 

(1) CLP: Classification, Labelling, Packaging; Regulation (EC) no. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) no. 1907/2006.