National product authorisations (BPR)

The national authorisation of a biocidal product is granted by the competent authority of the Member State (MSCA) where the biocidal product will be made available on the market (receiving MS) and is only valid for the approved terms and conditions stated therein. If a company wishes to place a biocidal product only on a single market, authorisation from that country is sufficient.

To avoid duplication of the evaluation procedure, the product authorisation granted in one MS can be recognised in other MS through the mutual recognition procedure. Therefore, if a company wishes to place the product on the market in several countries, it can apply for mutual recognition. See also information about the peer review process  (reaching agreement among member states).

The Biocidal Products Regulation (BPR) introduces the possibility to have certain biocidal products authorised at Union level. This will allow companies to place their biocidal products on the market throughout the entire Union, without the need to obtain a specific national authorisation. Union authorisation will give the same rights and obligations in all the Members States as those provided by national authorisations.

Specialty: provisional authorisation

According to article 55(2) of the BPR, competent authorities (or the Commission in case of Union authorisations) may authorise, for a period not exceeding three years, a biocidal product containing a new active substance. This is only possible if the evaluating competent authority has submitted a recommendation for approval of the new active substance.

Specialty: treated articles

Treated articles are substances, mixtures or articles that have been treated with a biocide or into which a biocide has been intentionally incorporated (impregnated wood, paint that is formulated with a preservative, anti-odour socks, antibacterial carpet, etc.). Treated articles whose primary function is biocidal are classified as biocidal products.

Treated articles have been regulated since 1 September 2013. A European ‘Note for Guidance’ is available from the ECHA website. It contains a great deal information about how these treated objects will be regulated. Read more about treated articles.
For further information on the national authorisation in relation to other application types, see the ECHA website: National authorisation and mutual recognition