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French Agency for Food, Environmental and Occupational Health & Safety

REACH: France proposes restrictions on the use of dimethylfumarate and of lead and its compounds

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News of 23/07/2010

23 July 2010

The REACH Regulation came into force on 1 June 2007, with the aim of improving the protection of human health and the environment, while maintaining the competitiveness and enhancing the innovative capability of the European chemicals industry. It is designed to improve knowledge of the effects of chemical substances on human health and the environment for safer management of the risks related to the use of these products.

One aspect of the Regulation concerns a Restriction procedure, which allows Member States or the European Commission to intervene and propose measures for managing risks concerning any substance, irrespective of tonnage, whenever it is considered that its marketing or use would result in unacceptable risks to health or the environment. The Member State or the Commission proposes the measures in question, which can go as far as suggesting complete prohibition of the production and use of the substance, via a prohibition proposal, which must take into account the possibilities of substitutions, currently available or under development, as well as the socio-economic impact of the suggested measures.

The first two European restriction proposals under the terms of the REACH Regulation were submitted by France, on 15 April of this year, to the European Chemicals Agency (ECHA), which has now ruled them admissible. They concern certain uses of lead and of dimethylfumarate.

The proposal concerning lead aims to prohibit its use and that of its compounds in jewellery, as well as the marketing of all jewellery containing them. Several cases have been notified of poisoning with lead or its compounds in children, resulting from the ingestion or sucking of small items of jewellery.

The proposal concerning dimethylfumarate aims to prohibit the use and marketing of all items containing this substance. Numerous cases of severe skin disorders (severe dermatitis), occurring after contact with items containing this substance, have been notified in France, particularly by poison control centres. A temporary ban on marketing within the Community had been adopted after problems had been observed in certain European countries. The current proposal under the REACH Regulation aims to make this ban permanent throughout the European Union.

It was AFSSET, henceforth incorporated into ANSES, which undertook the necessary technical expert assessment for compiling the dossiers, at the request of the Ministries for Sustainable Development, Health and Employment.

The European Chemicals Agency (ECHA) has published these two proposals for restriction on its web site and is inviting interested parties to comment.

Find out more

(1) EC Regulation no 1907/2006 concerning the registration, evaluation and authorisation of chemical substances (Registration, Evaluation and Authorisation of CHemicals, REACH)