The EU Biocides Regulation 528/2012 (EU BPR)
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).
Further information on the UK BPR Product Authorisation Process
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.
Further information on the active substance process and the simplified active substance process.
- Review Regulation - This highlights the key aspects of the Review Regulation (Regulation (EU) No 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR).
- Active substance eligible for inclusion in the biocides active substance review programme - This outlines the notification process for an active substance that is eligible for inclusion in the biocides active substance review programme under Article 15 of the Review Regulation (Regulation (EU) No 1062/2014) of the EU Biocides Regulation 528/2012. This process only applies to active substances that weren’t included in the review programme previously for certain specific reasons e.g. due to incorrect advice from the EU Commission or Competent Authority, it benefited from a food and feed derogation in the Fifth Review Regulation and/or due to change of the scope of the product type.
- Nanomaterials - This provides information about the transitional measures for nano active substances that are under the scope of the EU Biocides Regulations 528/2012 (EU BPR).
- In-situ generation - This provides information on the provisions, including transitional measures, for in-situ generated active substances under the EU Biocides Regulation 528/2012 (EU BPR).
- Data Protection – This guidance provides information on the different data protection provisions in the Biocidal Products Directive provides.
- Guidance for data sharing - This guidance document provides suggestions for applicants on some steps they can take to achieve data sharing when submitting information to the HSE in support of active substances or biocidal products applications.
- Alterative suppliers of active substance – This guidance provides information about the impact of Article 95 of the EU Biocides Regulation 528/2012 (EU BPR), alternative suppliers of active substance list, on biocidal products made available on the UK market..