Biocides: EU approves use of two additional active substances
Two additional active substances will be approved for use in biocidal products in Product Type (PT) 1 (human hygiene) on 1 July 2021. Commission Implementing Regulation (EU) 2021/365 approves the use of active chlorine released from hypochlorous acid and Commission Implementing Regulation (EU) 2021/364 approves the use of active chlorine generated from sodium chloride by electrolysis. Whilst the timeline is short, it presents an opportunity for companies wanting to offer an alternative to hand sanitisers based on alcohol or quaternary ammonium.
In addition, on 1 July 2022 these two active substances will be approved for use in PTs 2 (disinfectants and algaecides not intended for direct application to humans or animals), 3 (veterinary hygiene), 4 (disinfectants for food and feed areas) and 5 (drinking water) (Commission Implementing Regulations (EU) No 2021/345 and 2021/347 of 25 February 2021). Companies intending to submit an application for product authorisation for these PTs need to start taking action now to allow sufficient time for efficacy testing and undertaking other required studies.
Confusing situation for human hygiene use
Active chlorine released from hypochlorous acid and active chlorine generated from sodium chloride by electrolysis were listed for Product Types 2, 3, 4 and 5 on the consolidated version of regulation EC No 1062/2014, the work programme for the systematic examination of all existing active substances referred to in the EU Biocidal Product Regulation (BPR) No 528/2012.
The two substances were therefore part of the review programme for PTs 2, 3, 4, 5 but not for PT 1. Whilst the PT 1/active substance combinations were added later, biocidal products based on either of the two actives cannot currently be placed on the market for human hygiene use unless they are authorised under an Article 55 derogation.
What about approval for the Great Britain (GB) market?
With the UK’s withdrawal from the EU and the end of the Brexit transitional period, a separate GB BPR regime was introduced on 1 January 2021. This new GB BPR regulation (which covers England, Scotland, Wales and associated islands) mostly mirrors the EU BPR regulation. Biocidal products placed on the market in Northern Ireland (NI) are still covered by the EU BPR under the Northern Ireland protocol.
As a consequence, GB now has its own active substance review programme. HSE has confirmed that the GB BPR assessment programme will be established once the dossiers have been submitted to HSE for the active substances (before 29 June 2021). There is therefore no deadline for approval of the two active chlorine substances at this time. However, biocidal products in PTs 2, 3, 4 and 5 can be placed on the GB market under transitional measures. An application for a critical situation permit may be submitted for PT1 use.
How TSG can help
If you need guidance on submitting dossiers, TSG can help.
Our team of experienced consultants has many years’ experience assisting clients in navigating the BPR from active substance approval applications to gaining product authorisations/registrations across Europe for a wide range of products and use areas. We are very familiar with the requirements for disinfectants covering both active substances and biocidal products.
We can help you with:
- Strategic guidance
- Biocidal product dossier preparation and submission
- Article 55 derogation applications
- Efficacy testing
To learn more about our services, please contact us at [email protected]