Companies placing biocidal products or biocidal active substances on the UK market will have to comply with the UK Biocidal Product Regulation (UK-BPR) regime starting January 1, 2021.
According to the UK authorities the national regime will reflect the current EU framework. Active substance approvals and new biocidal product authorisations will be specific to the United Kingdom. The UK Health and Safety Executive (HSE) will be the national authority on biocides.
The HSE will transfer all existing EU article 95 entries to its own UK Article 95 list. To remain on this list, companies will need to submit supporting information to the HSE. This is the same information submitted to ECHA, for example, an active substance dossier or a letter of access to data held by HSE. To meet these requirements, companies will be provided a two-year phase-in period.
A biocidal product authorisation valid in the United Kingdom, will retain their validity after January 1, 2021 until its normal expiry date. However, the authorisation holder will need to be established in the UK within one year (by January 1, 2022).
If you have an application being processed by another country in the EU, EEA or Switzerland as part of an EU-wide authorisation process (for example, a mutual recognition or union authorisation application), you will need to resubmit your application to HSE if you intend to seek a national authorisation in the United Kingdom.
SCC Regulatory Services in the UK
For the UK market, we can provide you the following regulatory services:
- Developing a regulatory strategy, including a testing strategy for the UK
- Data transfers to UK HSE for existing approvals and authorisations
- Data gap analysis
- Legal services related to Letter of Access (LoA) issues by
- Preparing and submitting active substance approvals and product authorisations under the national regime
- Follow-up and defence
Please do not hesitate to contact our experts if you have questions or want to learn how we can help you ensure the regulatory compliance of your biocidal actives and products on the UK market.