HSE Biocides ebulletin: EU active substance - renewal decision | non-approval decisions | expiry dates

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New EU active substance renewal decision

New expiry date

Following evaluation under the EU BPR, a decision has been taken to renew the active substance listed below with the following new expiry date. This affects NI:

Take action to remain on the EU Article 95 List

If you are an EU Article 95 supplier of any of the active substance/product type combinations listed above, you must submit all the data, or a letter of access to all the data, relevant for the renewal by 12 December 2024 to remain on the list.

 

Check the impact on your products

If you supply biocidal products containing this active substance in the relevant product type in NI, you should check the renewal conditions to see how you may be impacted. There may be new conditions that you need to take account of when applying for product authorisation or renewal under EU BPR, or product approval under the Control of Pesticides Regulations (COPR).

 

You may even need to make a change to your existing authorisation or approval to comply with the renewal conditions.

 

Some conditions may mean we need to contact you about cancelling or revoking your product authorisation or approval. In such cases, you will have an opportunity to submit comments or additional information and we will take account of these when finalising our decision.


New EU active substance non-approval decisions

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:

Biocidal products containing this active substance in the relevant product type can no longer be:

  • supplied in NI after 19 December 2024; or
  • used in NI after 19 June 2025

You must manage your stocks of the affected products to ensure they are removed from the NI supply chain by 19 December 2024.

 

New treated articles containing this active substance in the relevant product type cannot enter the supply chain or be imported into NI after 16 June 2024. 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 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 any of the active substance/product type combinations listed above, please contact us.


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 608-042-7) in product types 02, 03 and 11
    30 June 2024

Once the approvals expires, the active substances can no longer be used in biocidal products or treated articles of the relevant product types in NI.

 

If you hold an affected EU BPR product authorisation or 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.

 

 

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