Of interest specifically, the non-approval of ETO under the biocides regulation, ECHA and DG SANTE have acknowledged the continued need to use ETO for sterilization of medical devices, and therefore the continued use of ETO may continue with ETO instead being classified as a Medical Device under the EU MDR instead. However that means that a full MDR technical file is required.

Apply for product authorisation by the deadline to keep your products on the NI market.

Following evaluation under the EU Biocidal Products Regulation (EU BPR), a decision has been taken to approve these active substance/product type combinations with the following approval dates. This will affect NI:

1 October 2026

• 1,2-benzisothiazol-3(2H)-one (BIT) (CAS 2634-33-5 EC 220-120-9) in product types 6 and 13
• Formic acid (CAS 64-18-6 EC 200-579-1) in product type 6

1 November 2026

• 2,2-dibromo-2-cyanoacetamide (DBNPA) (CAS 10222-01-2 EC 233-539-7) in product type 6

New EU active substance non-approval decision

Biocidal products must be phased off the NI market.

Following evaluation under the EU BPR, a decision has been taken not to approve the following active substance/product type combination. This will affect NI:

• Ethylene oxide (CAS 75-21-8 EC 200-849-9) in product type 2

Biocidal products within the scope of EU BPR containing this active substance in the relevant product type can no longer be:

• supplied in NI after 23 June 2026; or
• used in NI after 23 December 2026

You must manage your stocks of the affected products to ensure they are removed from the NI supply chain by 23 June 2026.

New treated articles containing this active substance in the relevant product type cannot enter the supply chain or be imported into NI after 20 December 2025. Treated articles that have entered NI supply chains before this date can continue to be supplied and used.

Find out more about treated articles.

Any affected NI product approvals under the Control of Pesticides Regulations (COPR) will be revoked in line with the above dates.

If you are aware of any disproportionate negative impacts that are likely to arise from the non-approval of the active substance/product type combination listed, please contact us