In December 2023, the EC launched with the REACH Committee (comprised of Member States), a written voting procedure on the Commission proposal for a REACH Restriction of D4/5/6.
The outcomes of this voting procedure have been made publicly available, including the revised Commission proposal and annex. The latest version has the following content:
- The new transitional period of 7 years in the October version has been maintained (point 3.c of the proposal)
- The addition of IVDs to the derogations in the October version has been maintained (both medical devices and IVDs are proposed for derogations) (points 4.1; new 5.1.c & 5.1.d- see below)
- The only difference is editorial: the latest version lists derogations under points 5.1.c and 5.1.d, whereas the October version had them under 6.1.c and 6.1.d (the latest version has merged the derogations under the former points 5 & 6, into one current point – 5).
Next steps:
- The REACH Committee’s favourable Opinion on the revised Commission proposal has been sent to the European Parliament and Council for scrutiny lasting from 8 January-8 April. By way of reminder, during this process, the co-legislators cannot make changes to the text, they can only approve/veto.
- Please note this REACH Restriction process is separate from the potential Stockholm Convention nomination of D4/5/6 à on this file.
This information is kindly provided by MedTech Europe.
