Chemical Watch: October 2013
The new Biocidal Products Regulation (BPR), which was adopted on 22 May 2012, will come into operation in Europe from 1 September, the European Chemicals Agency (ECHA; Helsinki) says. BPR is aimed at increasing the safety of biocides on the European market and simplifying the procedures for authorization, according to the European Commission. Biocides are chemicals that are used to control harmful organisms, such as molds and bacteria. They include insect repellents, disinfectants, and antifouling paint for ships.
The regulation allows European member states to apply for authorization in a single EU member state, in several states, or for an EU-wide authorization, ECHA says. Industry can apply for approval of an active substance and for authorization of a biocidal product containing an approved active substance through ECHA. The process of authorization has also been simplified for certain types of biocidal products, according to ECHA.
"The regulation is another step towards ensuring that only safe, authorized products are made available throughout the European Union," says Janez Potočnik, European environment commissioner. "The simplification of authorization procedures will bring significant economic benefits to companies while ensuring a high level of environmental protection for citizens," he says.
"ECHA has been working over the last year to get the essential elements in place to allow this important new regulation to enter into operation," says Geert Dancet, executive director at ECHA. "We have been very mindful of the many small and medium-size enterprises in Europe that will need to comply with this new law," he says.
The BPR provides the possibility of requesting an EU-wide authorization for biocides, allowing industry to place such products on the entire EU market. This simplified procedure for authorization will lead to an estimated cost saving of €2.7 billion ($3.6 billion) over 10 years, according to the commission.
One aim of the BPR is to avoid unnecessary testing on animals, ECHA says. Companies should submit an inquiry to ECHA to determine whether the same test or study has been conducted under EU biocides legislation. Companies are required to share such data, says ECHA. Costs of the assessment of active substances to be are equally shared by applicants, the agency says. Companies that place a given active substance on the market but that were not involved in the review program or in the original application for approval of that substance will also have to contribute to the cost, says ECHA. The agency will maintain a list of companies that have contributed to the cost of assessment. Only biocidal products that contain active substances from suppliers on that list will be legally entitled to remain on the market from 1 September 2015, ECHA says.
A completely new version of the Register of Biocidal Products will also be available, ECHA says. The register, currently used for submitting applications and recording decisions, will now also be used for providing information to the public, the commission says. The new version will be the central point through which biocides applications will be made, enabling industry and the authorities to comply with legislative requirements and to exchange information between them, according to ECHA.
The BPR is also the first piece of legislation to incorporate the new commission definition on nanomaterials, the commission says.