On 23 April, the European Parliament voted on two files relevant to MedTech Europe from a chemicals angle: the CLP Regulation core revision and the Commission proposal for a Regulation on Microplastic Pellet Losses.
1. CLP Core Revision
- This is a file MedTech Europe engaged in over the last few years via public consultations and interviews with Commission consultants, with a view to maintain the partial scope exemptions for MD/IVD uses.
- The Commission proposal published at the end of 2022 maintained our partial scope exemptions.
- The European Parliament adopted its position in the 23 April 2024 Plenary, whereby our partial scope exemptions are maintained (link).
- The final step is for the Council to endorse its position (which does not foresee changes to our partial scope exemptions). The timeline for this is yet to be confirmed- likely in the next few months.
- After the Council vote, the text will be published in the EU Official Journal and the revision process will be completed.
2. Commission proposal for a Regulation on preventing Microplastic Pellet Losses
- The proposal mainly focuses on requirements for handlers of microplastic pellets above a certain tonnage, including risk assessment measures, to prevent spillage of these pellets. In the event of spillage, the proposal also lays down requirements for remedies, including sanctions and clean-up measures.
- This is a file that MedTech Europe has not engaged in directly, as members did not indicate an impact for our uses. Our uses of Microplastics are already regulated in the EU REACH Restriction on Microplastics.
- However, the Secretariat has been monitoring the file and the European Parliament adopted its report at its 23 April 2024 Plenary (link).
- The next steps after the Parliament elections will be for the co-legislators- Council and Parliament- to start agreeing on their negotiating mandates on the file and begin trilogues. The timelines for this are not yet confirmed and we will continue to monitor how the file evolves.
Note: This information is kindly provided by MedTech Europe.
