Ahead of this week’s meetings of the REACH and CLP Competent Authorities (CARACAL) 24-26 January, the European Commission made available its draft delegated act on the proposed Silver metal classification.
The key elements for us from this proposal on Silver metal are summarized as follows:
- Silver massive: Repro. 2
- Silver powder: Repro. 2
- Silver nano: Repro. 2
This is a positive development, as a classification of Repro. 2, does not trigger the MDR Section 10.4.1-10.4.5 justification procedure.
Next steps:
- 24 January: Commission presents this proposal to CARACAL
- 25-26 January: adoption of the act at the CARACAL plenary
- ~February: public consultation on the draft delegated act and parallel 60-day WTO notification
- ~March: scrutiny by the European Parliament and Council (2 months+ extendable by 2 more) – no amendments possible (only yes/no)
- Q2: Inclusion in Annex VI CLP & publication in the EU Official Journal
- End of 2025: expected entry into force (Q2 2024+ 18-month transitional period)
This information is kindly provided by MedTech Europe.
