News Details

On 8 July 2026, the European Commission notified the World Trade Organization (WTO) of two draft implementing decisions under the Biocidal Products Regulation (BPR), which concern the future approval status of two active substances. The proposals would not renew the approval of medetomidine for use in antifouling products, nor would they approve 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH) for use in preservatives for products during storage, or for working or cutting fluid preservatives.

Medetomidine – Renewal Not Proposed

The Commission proposes not to renew the approval of medetomidine (CAS No. 86347-14-0) for use in product type (PT) 21 (antifouling products). According to the European Chemicals Agency (ECHA), the substance has endocrine-disrupting properties that may cause adverse effects in humans and non-target organisms. It is also considered to be very persistent and toxic, meeting the exclusion criterion under Article 5(1)(d) of the BPR.

During the assessment, the Commission also considered comments submitted by industry, including arguments that medetomidine helps to reduce fuel consumption, contributes to the control of marine invasive species, and provides an alternative to copper-based antifouling technologies. However, following discussions with Member States, the Commission concluded that suitable alternative active substances are available, and that none of the criteria for granting a derogation allowing renewal of an excluded substance are met.

If adopted, treated articles incorporating medetomidine for use in product type (PT) 21 may continue to be placed on the market for 180 days after the decision enters into force.

DMDMH – Approval Not Proposed

The Commission also proposes not to approve DMDMH (CAS No. 6440-58-0) as an existing active substance for use in product types 6 (preservatives for products during storage) and 13 (working or cutting fluid preservatives).

According to ECHA's opinion, the efficacy data submitted for the substance were insufficient to demonstrate its effectiveness for any of the proposed uses. In addition, uncertainties in the ecotoxicological data prevented the Agency from concluding that the substance could be used safely in relation to the environment. Although the applicant withdrew its support for DMDMH during the review programme, this occurred after the evaluation had been completed, so the assessment had to be finalised.

If adopted, treated articles containing DMDMH may no longer be placed on the EU market 180 days after the decision enters into force. The non-approval decision would apply 12 months after adoption.

Next Steps

Both draft decisions are expected to be adopted in November 2026. Comments on the proposals may be submitted until 6 September 2026.