Europe REACHing for Greener Solutions

Closely related to ROHS and WEEE is REACH, the Registration, Evaluation, Authorisation & Restriction of CHemical substances. REACH is a relatively new European regulation, introduced in June 2007 and addresses the management of risks associated with the production and use of chemical substances. The regulation aims to improve protection of human health and the environment against potentially harmful chemicals. REACH is also involved in promoting “green chemicals” and encourages manufacturers to work towards the gradual replacement of unsafe chemicals with safer, greener chemicals

The regulation affects all manufacturers and importers of chemical substances, mixtures of chemical substances or chemical substances that make up an article. Medical devices affected by REACH range from dental filling materials and bone cements to catheters and pace makers. Any chemical substance used in a medical device which is not registered with the EU will need to go through an extensive registration process, requiring detailed technical data and results of testing for the safety of its use.

A number of REACH Annexes, which include technical guidances, are currently being reviewed. More information about REACH can be found on the European Chemicals Agency (ECHA) website.

Worried about compliance with European environmental regulations? Contact us for advice on how these changes may affect your business.