HSE Biocides ebulletin: EU active substance - expiry dates | expiry dates postponed

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Upcoming EU active substance expiry dates

Biocidal products must be phased off the NI market

The active substance/product type combinations listed below are due to expire under the EU BPR on the following dates. This affects NI:

  • (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14
    30 June 2024

  • Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8 (PHMB (1600;1.8)) (CAS 27083-27-8 / 32289-58-0 EC n/a) in product types 2, 3 and 11
    30 June 2024

  • 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (Tebuconazole) (CAS 107534-96-3 EC 403-640-2) in product types 7 and 10
    30 June 2025


Once the approvals expire, the active substances will no longer be able to be used in biocidal products of the relevant product types in NI. In addition articles treated with such products will no longer be able to be placed on the market in NI.

 

If you hold an affected EU BPR product authorisation or Control of Pesticides Regulations (COPR) product approval, we will contact you about cancelling or revoking your authorisation or approval. You will have an opportunity to submit comments or additional information and we will take account of these when finalising our decision.

 

If you are aware of any disproportionate negative impacts that are likely to arise from the expiry of any of the active substance/product type combinations listed above, please contact us.


EU active substance expiry dates postponed

Active substance expiry dates postponed whilst the renewal evaluation is completed in the EU

For reasons beyond the control of the applicants, the approvals of the active substance/product type combinations listed below were likely to expire before a decision could be taken on their renewal under the EU BPR. To allow sufficient time for the renewal evaluations to be completed, decisions have been taken to postpone the expiry dates of the following approvals.

 

This affects NI:

The decision on the below 7 substance/product type combinations can be found here.

Expiry date postponement from 30 June 2024 to 31 December 2026:

  1. 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydro-1-napthyl]-4-hydroxycoumarin (Brodifacoum) (CAS 56073-10-0 EC 259-980-5) in product type 14

  2. 3-[3-(4’-bromo[1,1’-biphenyl]-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-1-benzopyran-2-one (Bromadiolone) (CAS 28772-56-7 EC 249-205-9) in product type 14

  3. Chlorophacinone (CAS 3691-35-8 EC 223-003-0) in product type 14

  4. Coumatetralyl (CAS 5836-29-3 EC 227-424-0) in product type 14

  5. 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin (Difenacoum) (CAS 56073-07-5 EC 259-978-4) in product type 14

  6. 3-[3-(4′-bromo[1,1′biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one (Difethialone) (CAS 104653-34-1 EC 600-594-7) in product type 14

  7. 4-hydroxy-3-[(1RS,3RS;1RS,3RS)-1,2,3,4-tetrahydro-3-[4-(4-trifluoromethylbenzyloxy)phenyl]-1-naphthyl]coumarin (Flocoumafen) (CAS 90035-08-8 EC 421-960-0) in product type 14


If you want to supply new biocidal products containing these active substances, you can still apply for EU BPR product authorisation. New products (including new trade names) must not be supplied in NI until product authorisation is granted.

 

HSE will provide separate updates on the renewal decisions when relevant.

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