The European Union's new Biocidal Products Regulation (BPR) will enter into force on 1 September 2013. After 3 years of deliberation, the EU Parliament put its stamp of approval on the proposal in January 2012, and by the middle of May the EU Council is expected to formally pass it.

Function decides whether biocide or not
Previous drafts for the BPR text introduced treated articles as biocidal products. The EU Commission showed examples of this as a carpet impregnated with an anti-moth compound and a sleeping back with insect repellent. Reportedly, the Swedish biocides authority, however, was able to modify the definition so it only refers to the primary function of a treated article. Now, neither the carpet nor the sleeping bag are biocidal products because those articles' primary functions are as floor cover and a warming cover for sleeping, respectively. On the other hand, the regulation expressly puts biocides for incorporating into disinfectant towellettes as product type 2 (PT 2) and biocides to hamper sweat odour in clothes as PT 9.

Families of biocidal products
The final draft of the BPR treats similarly biocidal products and the former grouping frame formulations. The BPR has renamed these latter as biocidal product families. Another new concept to the BPR is nanomaterials as potential biocidal products. A product that contains any form of nanomaterial is excluded from the so-called simple authorization procedure and must be subjected to close scrutiny.

... "biocidal product family" means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products; [EU Parliament P7_TA-PROV(2012)01-19. Article 3 (1)(s)].

EU-wide authorization
The BPR will introduce new procedures for authorization. For instance, it will be possible to achieve union-wide approval as a biocidal product; the authorization will be valid in all EU countries. The application for approval is to be sent to EU's chemicals authority ECHA (European Chemicals Agency). The BPR determines when ECHA may grant the first union authorizations. For instance, hand hygiene disinfectants (PT1), disinfectants for the production of food and feed, and insecticides and repellants ECHA may as the first be granted on 1 September 2013. Disinfectants for home and hospital use may first be granted on 1 January 2017.

Earliest possible dates for EU authority to grant approvals for biocidals:

The Regulation lays down the dates for ECHA to start granting union-wide approval of biocidal products. DHI presumes that applications for approval of products as of 1 September 2013 can already now be submitted to ECHA.

Products precluded from union authorization
Union-wide authorization is, however, not possible for biocides to control animals, such as birds, fish, and rats, and antifoulants, presumably due to geographic and ecological considerations.

Product-types for which union approval is not allowed:

Be prepared for approval
The "old" biocidal products directive (the BPD) determined that, given time, all biocidal products in the EU must have pre-market approval. This has not been changed. These applications for approval are very extensive and demand a lot of work and time to compile and write. For instance, for disinfectants for union authorization as of 1 September 2013, we recommend that companies finish testing as soon as possible and start compiling data for the dossier.