HSE Biocides ebulletin: EU active substance - open invitation deadline | approval decisions | expiry dates postponed

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Upcoming EU active substance open invitation deadline

Submit a notification by the deadline to keep active substances in the EU Review Programme

The European Chemicals Agency (ECHA) has published an open invitation to provide an opportunity for a person, company or task force/consortium to notify an intention to take up or take over the role of participant in the EU Review Programme for the following active substance. This affects NI.

 

Anyone wishing to support the active substance listed below in the EU will need to submit a notification to ECHA by the following deadline:

  • Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5 (1H,3H)-dione (TMAD) (CAS 5395-50-6 EC 226-408-0) in product type 12
    31 January 2025

If a notification to take over the role of participant is not received, this active substance will be subject to an EU non-approval decision. This means the active substance will no longer be able to be used in biocidal products of the relevant product type in NI.

 

In addition articles treated with such products will no longer be able to be placed on the market in NI. HSE will provide separate updates on these where relevant.

 

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 above, please contact us.


New EU active substance approval decisions

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

Following evaluation under the EU BPR, a decision has been taken to approve the following active substances. This will affect NI:

Action for biocidal product suppliers

If you supply biocidal products containing these active substances in the relevant product types, you must apply for EU BPR product authorisation by 1 July 2025 to keep them on the NI market. New products must not be supplied in NI until product authorisation is granted.

 

Action for active substance suppliers

If you supply these active substances for use in biocidal products of the relevant product types, you may need to apply for technical equivalence. If you haven’t demonstrated technical equivalence for your manufacturing source, EU BPR product authorisation cannot be granted for biocidal products containing your active substance.


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 evaluation to be completed, a decision has been taken to postpone the expiry dates of the following approvals. This affects NI:

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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