The new Biocidal Products Regulation enters into operation on 1 September 2013. It concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials, or articles against harmful organisms. The regulation introduces new ways to authorise the biocidal products.
One aim is to avoid unnecessary testing on animals. Therefore, before carrying out any tests on animals, companies need to send an inquiry to ECHA to find out whether the same test or study has already been conducted and submitted under EU biocides legislation. If such information exists, companies are required to share the data. The costs of the assessment of active biocidal substances are equally shared by applicants.
Only biocidal products which contain active substances from suppliers on that list will be legally entitled to remain on the market from 1 September 2015. The list of recognised suppliers will be available on ECHA’s website.
In addition to applying for authorisation in a single Member State, companies can apply for authorisation in several Member States simultaneously or for an EU-wide authorisation. The authorisation process is simplified for certain types of biocidal products.
A new version of the Register for Biocidal Products (R4BP 3) will be available from 1 September at 09:00 (Helsinki time). It is the central hub through which all biocides applications will be made. It provides functions which enable the industry and the authorities to comply with the legislative requirements and exchange information between them.
Companies have to use IUCLID 5 to collect, organise, and store the technical and scientific data on active substances and biocidal products. For an application, companies can create an IUCLID 5 dossier and submit it to ECHA and the national authorities through R4BP 3.
- European Chemicals Agency (ECHA), Helsinki, Finland
Also of Interes
- New Biocides Legislation – Interview with Jukka Malm,
Vera Köster,
ChemViews Mag. 2012.
DOI: 10.1002/chemv.201200033
Jukka Malm, European Chemicals Agency (ECHA), talks about the upcoming changes to the biocides legislation
