We are reaching out to inform you that yesterday the Commission adopted the delegated regulation amending Annex I to the Regulation on persistent organic pollutants (POPs) for polybrominated diphenyl ethers (PBDEs).
Background:
- PBDEs are already listed in Annex I to Regulation (EU) 2019/1021 on POPs. Following Article 4(1)(b) of the POPs Regulation, each entry on a polybrominated diphenyl ether in Annex I includes an Unintentional Trace Contaminant (UTC) limit in substances and one for mixtures or articles. Following point 2 of the fourth column of each entry on a PBDE, the UTC limit for the presence of the listed PBDEs in mixtures and articles is subject to review.
- Given that the concentration limit for PBDEs in waste (Annex IV) will decrease over time and there are no major analytical barriers to stricter controls, the Commission proposed setting different UTC limit values for mixtures and articles made from or containing listed PBDE-containing recovered material and other mixtures and articles.
- A public consultation was carried out on the draft delegated act from 18 February to 18 March 2025; members were informed about the consultation in our weekly ECHA substance evaluations dated 20 February 2025. MedTech Europe did not engage in the consultation as the substance and its UTC limit update was not flagged by any member as impacting them.
Next steps:
- Yesterday, the Commission adopted the final delegated regulation amending Annex I to POPs Regulation and setting the updated UTC limits at 10 mg/kg where these chemicals are present in mixtures or articles, and, by way of derogation, at 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE.
- This Regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union, meaning on the 13 August 2025.
As this matter was not identified as relevant by the members, this email is provided for your information and awareness.
