HSE have published their latest bulletins:
Biocides
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Live online workshop: biocides disinfectants efficacy (23 and 24 November 2023)
This workshop will take place over 2 half-days and will develop an understanding of the regulatory approach to efficacy assessment of disinfectant products (Main Group 1) under the GB Biocidal Products Regulations (GB BPR).
It will provide a general overview of the efficacy requirements for this type of product alongside specific advice for the five product types in this group. The workshop will also address common issues related to labelling and efficacy testing for these product types.
The workshop will be delivered by HSE regulatory specialists and will help attendees improve the quality of their submissions and understand how these will be reviewed by the GB regulator.
The workshop is suitable for those involved in the creation and submission of efficacy data packages for disinfectant biocidal product applications, including test houses, applicants, consultants, etc. Although no prior experience is assumed, it will specifically explore efficacy of disinfectants and will not cover other product types or general principles of efficacy assessment.
Topics covered:
- general considerations affecting the labelling, testing and assessment of efficacy for disinfectant products
- specific outlines of the standard testing needed for surface disinfectants in product types 2, 3 and 4
- specific outlines of the standard testing needed for product type 1
- advice for generating adapted or novel methods for less standard products in product types 2, 3 and 4
- advice in testing for product type 5, where limited standard methods are available
- common issues and problems faced in these product types
Registration: Find out more and register for this fee paid workshop. The closing date for registration is 13 November 2023.
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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.
- 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
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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.
- 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)
