Based on current available information, EU legislation will no longer apply in the United Kingdom after January 1, 2021. This means that any company placing biocidal products or biocidal active substances on the UK market will have to comply with the UK Biocidal Product Regulation (UK-BPR) regime.
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.
Based on current available information, 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. A two-year phase-in period will be provided to ensure companies have time to meet these requirements.
If you hold a biocidal product authorisation that is valid in the United Kingdom, it will remain valid 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
- Preparing and submitting active substance approvals and product authorisations under the national regime, including follow-up and defence
- Support with data transfer to UK HSE for existing approvals and authorisations
- Data gap analysis