Biocides Compliance Services

The Biocidal Product 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.

The new biocides regulation is applicable from 1 September 2013, with a transitional period for certain provisions. It repeals the Biocidal Products Directive (BPD, Directive 98/8/EC).

The BPR introduces exclusion and substitution criteria as new elements

Companies planning to sell their products in one EU Member State must apply for product authorisation in that country. To do so, they submit an application for national authorisation through R4BP v3.

Substances which were on the market before 14 May 2000 and are evaluated under the review programme are referred to as existing active substances.

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All biocidal products must get an authorisation before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it

If a company wishes to extend the national product authorisation to other markets, it can ask other Member States to recognise it. Companies can apply for mutual recognition either in sequence or in parallel.

To apply for mutual recognition in sequence, companies first need to get their product authorised in one Member State. After this, they can request other Member States to recognise this authorisation.

For mutual recognition in parallel, the company can submit an application for product authorisation in one Member State (called the reference Member State) and simultaneously ask other countries to recognise the authorisation as soon as it is granted.

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Entry point for all regulatory services related to: The European Union