Biocidal Products Regulation

The New Biocidal Products Regulation is Now in Force

The EU Biocides Regulation 528/2012 (EU BPR) was published in the Official Journal of the European Union on 27 June 2012 and applies in all EU Member States from 1 September 2013.

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

The new Biocidal Products Regulation reduces financial and administrative burden without compromising the high level of environmental and human health protection, notably through the active involvement of ECHA, the European Chemicals Agency.
It retains the two-step authorisation process brought in by its predecessor, the Biocidal Products Directive, whereby active substances are first tested and approved and included in a Community list (known as the Annex I), with subsequent authorisation of a product containing the active substance. A new element is the ‘Union authorisation’ which allows companies to get an authorisation for their biocidal products that is applicable across the whole EU.

The scope of the Biocidal Products Regulation has been extended to cover articles and materials treated with biocidal products, including furniture and textiles. The regulation also applies to active substances generated in situ, and to biocidal products used in materials that come into contact with food. But other products that are sufficiently covered by existing legislation (including food and feed, food and feed additives and processing aids) are excluded from the scope of the new regulation. Biocidal products approved under the International Convention for the Control and Management of Ships’ Ballast Water and Sediments are considered as authorised.

How does the Directive work and how is it implemented in Europe?

The Directive is implemented by reviewing notified existing active substances that were on the market when the directive came into force, via a 10-year review programme and evaluating new active substances prior to their marketing. This regulatory scheme ultimately requires all biocidal products to be authorised before they can be placed on the EU market and conditions may be applied in order to minimise any risk to people, animals or the environment.

The Directive is implemented in Europe through the Biocidal Products Regulations, and the Health and Safety Executive (HSE) acts as the competent authority to carry out the work under the BPD.

From time to time the Directive is amended, for example when a new or existing active substance is included on to Annex I of the Directive. These amendments are then automatically transposed into all Member Countries.