New Biocidal Products Regulation enters into operation on 1 September 2013
The new Biocidal Products Regulation 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 aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for human health and the environment. ECHA is the focal point for all processes under the new regulation.
Helsinki, 30 August 2013 – From 1 September onwards, industry can apply for the approval of an active biocidal substance as well as authorisation for a biocidal product containing an approved active substance through ECHA.
The regulation introduces new ways to authorise the biocidal products. 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.
One aim of the regulation 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 regulation also ensures that the costs of the assessment of active biocidal substances are equally shared by applicants. Consequently, active substance manufacturers and importers that were not involved in the review programme or in the original application of an approved active substance, but have nevertheless placed that active substance on the market, will have to contribute to the costs. ECHA will maintain a list of suppliers of the active substances which have contributed to the costs of assessment and 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.
ECHA's Executive Director Geert Dancet says: "ECHA has been working hard over the last year to get the essential elements in place to allow this important new regulation to enter into operation. In preparing, we have been very mindful of the many small and medium-sized enterprises in Europe who will need to apply this new law. We are and will continue to provide material that will help all companies to comply - guidance documents, webinars, video tutorials, manuals, frequently asked questions and Biocides Stakeholders' Days. Finally, our helpdesk and the Member States' authorities are ready to answer industry's questions."
A totally new version of the Register for Biocidal Products (R4BP 3) will also be available. 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. The system will be officially opened on 1 September at 09:00 (Helsinki time). Companies can electronically submit authorisation applications from that time. ECHA also provides manuals and templates for companies to use R4BP 3 in order to successfully complete their applications. SMEs can benefit from lower fees.
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.
Guidance and IT-tools