As Great Britain is no longer part of the EU scheme for regulating biocides following the UK’s withdrawal from the EU, organisations are faced with two sets of regulations with which to comply. Many of the rules in the EU Biocidal Products Regulation (BPR) are included in the GB version, but the two regulations now operate independently.
Organisations that manufacture or import biocidal products must have a valid biocidal product authorisation before placing the product on the market. This needs to be done through the European Chemicals Agency (ECHA) for products placed on the EU market and the Health and Safety Executive (HSE) for products being placed on the GB market.
Although the EU BPR has been copied over into GB law, there are some transitional measures and additional steps that businesses need to take to ensure that they can continue to place their biocidal products or active substances on the market in GB. Organisations that place products on the EU and GB markets need to have separate approvals and authorisations for each region.
BPR in action
HSE has decided not to extend the special permits for biocidal hand sanitisers that were set up at the start of the COVID-19 outbreak to enable short-term derogations from GB BPR. Organisations wishing to place hand sanitisers on the UK market must meet the normal requirements of BPR.
In the EU, some Member States had also enabled derogations for companies placing hand sanitisers on the market due to the COVID-19 outbreak. Since the derogations are not uniform throughout the EU, organisations need to contact the relevant national authority to understand their current position.
To apply for a biocidal products authorisation, the active substance (the substance in the biocidal product that is intended to destroy, deter and prevent the action of harmful or undesired organisms) must first be approved, and the supplier of the active substance must be listed on the Article 95 List of Approved Suppliers.
To help businesses navigate the requirements for biocidal products authorisation in the EU and GB, NCEC has created a comprehensive Biocidal Product Regulation Compliance Report.
The report has been authored by NCEC’s regulatory experts and explains the practical steps that companies need to take to meet the requirements for biocidal product authorisation, and active substance approval. Our experts have carried out extensive review of the applicable regulations and guidance documents, seeking clarification from the HSE and ECHA as required. The report outlines the key requirements of both biocidal product regimes and what this practically means for businesses.
NCEC’s report includes:
- Overview of EU and GB BPR.
- Active substance approval process, including scope, exclusions and renewal requirements.
- Biocidal product approval process, including information requirements and different approval pathways.
- Analysis of the key differences between GB BPR and EU BPR and the approval pathways.
- Details on product labelling.
- Consolidation of each EU Member State BPR provision and competent authorities.
General report (£2,495+VAT) – A comprehensive summary of the current BPR requirements and explanations of the different authorisation pathways.
Our biocidal product regulation compliance report is driven by our experts’ regulatory knowledge and close links with regulatory bodies such as ECHA, the HSE and EU Member State competent authorities. The report includes thousands of hours of review, extensive discussions with each regulatory body and the compilation of comprehensive processes for biocide approval in both regions.
If you require help with your biocidal authorisation process, need assistance in understanding this change, want to register your interest in this report or discuss your requirements for a bespoke report, please complete the adjacent form or contact us at [email protected].