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Proposed EU Chemicals Regulation in Parliament:

This article was originally published in Clinica

Executive Summary

The European Commission's proposal for a Regulation on the Registration, Evaluation and Authorisation of Chemicals is currently being examined by the European Parliament. The final text may impact the medical devices and diagnostics industries' access to materials used in the manufacture and sterilisation of its products. Industry is monitoring closely and developments and amendments to the text. Given that this is an early stage of the EU co-decision process for adopting Regulations, the text is unlikely to be adopted before 2006, and even then, there are likely to be transition periods for the various requirements, which could mean that some may not apply until long after adoption. The aim of the text is to prevent exposure to unsafe chemicals, but the Commission has also stressed the need to safeguard the competitiveness of the European industry as a whole, and SMEs in particular.

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