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anses

French Agency for Food, Environmental and Occupational Health & Safety

ECHA adopts ANSES's proposal for a tougher classification of bisphenol A as toxic for reproduction

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News of 25/03/2014

Bisphenol A (BPA) is a synthetic chemical which has been in use for over 50 years in the plastics industry. 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 CLP regulation, ANSES proposed in September 2012 a tougher classification for bisphenol A which would list it as toxic for reproduction. The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) has just adopted the French proposal. Therefore, more stringent regulatory measures will be applied.

 

Bisphenol A is a synthetic chemical which has been in use for over 50 years in the plastics industry. Until now, it has been listed in the harmonised classification as a suspected reprotoxic substance. It is also currently classified as an irritant for the respiratory tract which may also cause severe ocular damage and can cause sensitisation by skin contact.

In its work conducted in 2011 and 2013, ANSES recommends a reduction of consumer exposure to bisphenol A through substitution when it is intended for use in food contact materials.

In addition, as of 2012, ANSES - in the framework of the implementation of European regulations on the labelling of chemical substances - submitted to the European Chemicals Agency (ECHA) a proposal for amending the classification of bisphenol A, in order to make it tougher by listing the substance as toxic to reproduction (fertility). For this proposal, ANSES based its conclusions on studies and data published after the European discussions which led to the current classification.

Following the public consultation period, ANSES went on to supplement its proposal with data from recently-published American studies. ECHA's Committee for Risk Assessment (RAC) has issued a favourable opinion of the French proposal based on all the available data.

The immediate consequence of classification in category 1 will be 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.

ECHA's opinion will be sent to the European Commission within 18 months at the latest from the date of publication of the RAC recommendation. The European Commission’s decision whether to include the harmonised classification in the CLP regulation (1) will be based on this opinion.

 

(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.

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