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Come 1 September, the new Biocidal Products Regulation will become applicable for companies, and all active substances on their own or in biocidal products must be associated with a dossier or a letter of access submitted to the European Chemicals Agency, with certain exceptions. After a two year transition period, no biocidal product will be allowed to be made available on the EU market unless the manufacturer or importer is approved by the Agency.
The new Regulation means that any person manufacturing or importing an active substance on its own or in biocidal products after 1 September must submit a dossier or a letter of access to the European Chemicals Agency before it can be placed on the market, with certain exceptions. The first list of approved suppliers will also be published on this date. As of 1 September 2015, no biocidal product will be allowed to be made available on the EU market unless the manufacturer or importer is included in the list.
The new Regulation includes an option for ‘Union authorization’ for certain products, which would provide an applicant access to the entire EU market with one application. All product types will be eligible by 2020 for Union authorization. Other authorization options are the ‘simple authorization procedure’ for certain product types, ‘national authorization’ for authorization in one EU country, ‘mutual recognition in sequence,’ and ‘mutual recognition in parallel’, which gives a company access to specific national markets. There is a possibility of a new ‘product authorization’ in the future.
In preparation for the applicable date, ECHA is currently finalizing the Register for Biocidal Products (R4BP 3) that will operate as the central hub for all biocides applications that are submitted. Applicants will provide the required information to the authorities, who will then validate the applications and maintain lists of active substance suppliers.
The new Regulation includes mandatory data sharing, which is a principle with which manufacturers and suppliers may already be familiar through REACh regulation. The goal of this principle is to reduce the amount of testing on animals by avoiding the duplication of studies. The scope of the Regulation has also been extended from the Biocidal Products Directive, which will be repealed on 1 September 2013, and will now cover furniture, textiles and other articles treated with biocidal products.
Every manufacturer or importer of the active substance(s) contained in a product, or the importer of a biocidal product, will now have to contribute to the costs of the application for that active substance; if you are not on the list of approved active substance suppliers by 1 September 2015 then you will no longer be allowed on the market. A formulator who is not a manufacturer or importer will therefore need to be sure that its suppliers of active substances are on the list; regulatory consequences will begin to apply after 1 September 2015.
Another change from the Biocidal Products Directive is that applications will now be submitted completely online (via IUCLID 5.5). ECHA’s help desk is prepared to answer questions, and each member state has their own helpdesk for biocides questions in their national languages.
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