Dear Members, please see below update from MedTech Europe on the EU situation regarding the proposal to include MCCP (Medium Chain Chlorinated Paraffins), used as a flame retardant, in the EU POP (Persistent Organic Pollutants) regulation. This will impact devices placed on the NI market as well as the UK market, but as MCCP would be added under the Stockholm convention, we will also see similar action taken under UK POPs. This means that companies with MCCP present in products they manufacture or import, need to supply information and evidence to support any requests for derogations and longer transition times both in the EU context, but also in terms of NI and GB. DHSC and DEFRA will be interested in understanding the UK context regarding any potential GB derogations and impact on supply of devices.
Companies need to identify the presence of the substances in their devices and any associated spare parts and accessories. As below, note that it’s mainly present in electronic and electrical equipment. You will need to provide data on how much MCCP is being placed on the market, what plans and progress is being made to substitute MCCP, the timelines to complete substitution. The number of devices on the market, what disease states are they used to test for, so how many tests per year and numbers of patient potentially impacted. Are MCCP free alternatives available on the market (if know)?
Please note that the attached document is confidential, and not to be shared outside of BIVDA members.
If you have any feedback either in the GB / NI context or the EU context please send it to me at regulatory@bivda.org.uk
Dear members,
I hope you are well.
As agreed in our 24 June Chemicals Working Group meeting, the MedTech Europe Secretariat would contact the European Commission to better understand the timelines for the EU implementation of the Stockholm Convention Annex A listing of MCCP.
We have had contact and understood the following:
- The Commission is already working on a draft delegated act,
- There will be a public consultation on the draft delegated act in the autumn of 2025,
- The adoption of the delegated act is planned for 1H of 2026,
- The legal deadline for the ban will be communicated by the Stockholm Convention Secretariat by the end of this year too,
- The threshold will be the REACH approach of 0.1% w/w.
We took the opportunity to recall that 1) MCCP is used in medical technologies MD/IVD/RUO/spare parts (mainly EEE as it is a flame retardant and we have engaged on the use of MCCP under RoHS in 2022) and that 2) the exemptions and transitional periods adopted under the Stockholm Convention, should also be implemented in the EU POPs delegated act.
Please note that we understood the Commission has already started contacting Member State authorities on the draft EU implementation, with a commenting period until 11 August. In light of this, and to avoid a situation as we experienced with the last round of POPs (UV-328 and Dechlorane Plus deviations), we strongly invite members to:
- Inform the Secretariat if you are approached/have an opportunity to contact a Member State local authority to share the aligned position – highlighted in bold above.
- If you have additional information, beyond what we had previously prepared for the Stockholm Convention April 2025 meeting, now is the opportunity to add more input that can be shared with Member States (Attached).
We also understood the Commission is looking at the input from the REACH Restriction of MCCP and that under this mechanism, there is little industry feedback. Hence why requesting the Stockholm Convention decision to be implemented in the EU as is, and the fact we engaged under RoHS due to its use in EEE, should be communicated to local authorities and if possible already now, before the draft delegated act goes to public consultation in the autumn.
