This page provides background information about the Biocidal Products Directive (BPD) and how it is implemented in the UK through the Biocidal Products Regulations (BPR) and the Biocidal Products Regulations (Northern Ireland) (BPR NI)
The Biocidal Products Directive (BPD) is a European directive which introduces a common authorisation scheme covering the placing on the market of biocidal products and their subsequent use.
The BPD has three main aims;
Under the BPD each Member State is required to establish a Competent Authority (CA) to carry out the work of the BPD. In the UK the Health and Safety Executive (HSE) acts as the CA on behalf of Ministers.
The BPD is implemented in each Member State according to their own legislative system. In the UK the BPD is implemented through the Biocidal Products Regulations (BPR) and the Biocidal Products Regulations (Northern Ireland) (BPR NI). There have been a number of amendments to the BPR/BPR NI since the original legislation was published. These are outlined in the Law section of our resource page.
When the BPD is amended, for example when a new or existing active substance is included onto Annex I/IA of the BPD, these amendments are automatically transposed/implemented into UK law.
The scope of the BPD is very wide, covering 23 different product types. This covers non-agricultural pesticides that are currently covered by the existing UK Control of Pesticides Regulations (COPR), such as wood preservatives, public hygiene insecticides, rodenticides, surface biocides and antifouling paints, as well as a wide range of biocidal products not currently covered by any specific legislation, such as disinfectants and preservatives. Any biocidal products that fall into these 23 product types are within the scope of BPD.
If you are unsure whether the product or active substance is regulated under BPR/D, you should read more about the law.
To achieve its aims the BPD implements a positive authorisation system for active substances and biocidal products. To assess the risks and efficacy of an active substance the industry is required to submit data that is evaluated at European level by Member States. Those active substances considered acceptable for use in biocidal products are entered into Annex I/IA of BPD. Industry is charged a fee for this process, which varies depending on the Member State that leads the assessment.
Once an active substance has been included on to Annex I/IA, Member States can authorise products containing it in their country (providing any necessary data has been supplied and any conditions put on Annex I/A inclusion are met).
The Member State will assess the data submitted by the industry on the biocidal product to determine if it can be used effectively without posing unacceptable risks. Only authorised biocidal products can be placed on the market. The authorisation granted/issued will detail conditions and restrictions relating to the marketing and use of the product.
If the product is to be placed on the market in more than one Member State there are Mutual Recognition procedures in place to facilitate the acceptance of an authorisation issued in one Member State in other Member States where the product is also marketed (providing relevant conditions are similar). However, an application still has to be made to other Member States to initiate this process, and processing fees will be incurred.
Biocidal active substances on the market when the BPD came into force (14 May 2000) need to be reviewed to ensure they can be used without unacceptable effects to people, animals or the environment. To assess these biocidal active substances (referred to as ‘existing’ active substance) a review programme was established. This review programme is controlled by a series of EU Commission Regulations call the Review Regulations.
Further information on the review regulations can be found on the EU Commissions website.
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