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HSE Biocides ebulletin

Issued: 2 November 2023

 

This ebulletin contains information on regulating biocides in Northern Ireland (NI). 

 

The EU Biocidal Products Regulation (EU BPR) operates independently from the GB Biocidal Products Regulation (GB BPR), which applies in Great Britain.

 

Separate ebulletins containing information specific to regulating biocides in Great Britain are issued as appropriate.

New EU active substance approval decision

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 substance/product type combination. This will affect NI:

• Reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate (CAS n/a EC n/a) in product types 2 and 4
  

Action for biocidal product suppliers

If you want to supply biocidal products containing this active substance in the relevant product types, you must apply for EU BPR product authorisation by 1 February 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 this active substance for use in biocidal products of the relevant product type, 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.

New EU redefinition of an active substance

Active substance redefinition for biocidal products on the NI market

The below active substance was approved under EU BPR for product type 8 in 2016. The evaluation of product types 2 and 4 have recently been completed. The evaluation has concluded that, although the composition and reference specification were consistent with the product type 8 assessment and approval, the assigned name was not appropriate.

 

Therefore, a decision was made to redefine the active substance. New approvals were given for product types 2 and 4, product type 10 remains under review and the existing approval for product type 8 has been redefined as follows. This will affect NI:

 

Previous definition of the active substance as identified in Annex II of Delegated Regulation (EU) No. 1062/2014 and approved in Implementing Regulation (EU) No. 2016/1093;

 

• Didecylmethylpoly(oxyethyl)ammonium propionate referred to with its chemical name ‘poly(oxy-1,2-ethanediyl), α-[2-(didecylmethylammonio)ethyl]- ω-hydroxy-, propanoate (salt) (Bardap 26)’ (CAS 94667-33-1 EC n/a) in product type 8 
  Expiry date 31 December 2027
  
  

New active substance identity as redefined in Implementing Regulation (EU) No. 2023/2088;

 

• Reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate (CAS n/a EC n/a) in product type 8 
  Expiry date 31 December 2027
  
  

Implementing Regulation (EU) No. 2016/1093 has been repealed.

 

Action for biocidal product suppliers

If you supply biocidal products containing this active substance for the relevant product type on the NI market, you will need to apply for a change to your authorisation. New products must not be supplied in NI until product authorisation is granted.