The EU Biocides Regulation 528/2012 (EU BPR)
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
The EU Biocides Regulation 528/2012 (EU BPR) covers a very diverse group of products, including disinfectants, pest control products and preservatives.
This section outlines the process you must follow to gain authorisation for a biocidal product/biocidal product family or approval of an active substance under EU BPR.
It also provides links to the EU BPR data protection, data sharing provisions and alterative suppliers of active substance.
If you are unsure whether the product or active substance is regulated under EU BPR, you should read more about the law.
UK Product Authorisation Process
Once an active substance has been approved for a Product Type (included in the Union List of active substance), products containing it must be authorised in each Member State if they are to be made available on the market in that individual Member State (providing that any necessary data has been supplied and any conditions of the active substance approval are met).
If your biocidal product is already on the UK market when the active substance(s) is approved (included in the Union List of active substance) you may find the information on our Transfer from UK National Law page helpful.
Once your product is authorised under the BPR before you can place it on the market you should be aware of other obligations imposed by EU BPR, which include:
It is important that you are familiar with the requirements of the EU BPR as failure to comply with them and the conditions of authorisation may be an offence under the Health and Safety at Work etc. Act 1974 or under the Regulations.
Submission of Active Substance Dossiers to the UK
Only active substances Included onto the EU BPR approved list (Union list) of active substances or in Annex I of EU BPR (or that are in the active substance review programme to be included on the Approved list / Annex I) can be used in biocidal products placed on the EU market. If the active substance has not been supported under the EU BPR Active Substance Review Programme (existing active substance) or is a New Active Substance, it needs to be evaluated to ensure that it poses no unacceptable risk to people, animals or the environment before products containing it can be authorised and made available on the market.