Letter to REACH Committee on carcinogenic, mutagenic or reproductive toxicant substances in medical devices

Dear members of the REACH Committee,

We are writing to you regarding the REACH Committee meeting that will take place on 13 May. At this meeting, a discussion is planned on the Draft Commission Regulation(EU) amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants.

The undersigned NGOs would like to comment on the proposed exemption to devices within the scope of Regulation (EU) 2017/745 [Medical Device Regulation (MDR)] from the restrictions laid down in entries 28-30 of Annex XVII to Regulation (EC) No 1907/2006 as regards the use of CMRs in medical devices for supply to the general public.

We would like to comment on the two following issues…