Biocidal products are now covered by harmonised legislation across Europe. Within this framework, how should you submit an application for marketing authorisation for a biocidal product? Follow the stages below.
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Updated on 19/09/2014
How biocidal products obtain marketing authorisation
Information for applicants
Keywords : Biocides
Regulation (EU) no. 528/2012 on the marketing and use of biocidal products lays down the rules for assessing authorisation applications for biocidal active substances and for marketing authorisations for biocidal products. This regulation aims to harmonise the marketing and use of these products in Europe and to ensure a unified market.
Before applying for marketing authorisation for biocidal products
Companies wishing to place biocidal products on the market must first make sure that the active substances contained in their products are approved in Europe under Directive 98/8/CE or Regulation (EU) No. 528/2012, or that they are currently being assessed.
The list of banned substances and substances undergoing assessment is available on the website of the French Ministry of Ecology.
Authorised active substances are listed on the website of the European Chemicals Agency (ECHA link to authorised substances page of the ECHA website).
Once an active substance is approved, a marketing authorisation application must be filed in France for the biocidal products containing them.
The list of approved substances, together with the deadlines for submitting applications for biocidal products containing them which are already on the market, can also be accessed through the Biocides Helpdesk, a platform set up by ANSES in support of the Ministry of Ecology, to meet the needs of companies wishing to submit such applications.
Submitting an application for marketing authorisation
Applications for marketing authorisation (MA) of biocidal products are assessed at national level.
Companies wishing to submit an application for an MA in France must do so directly in the "Register For Biocidal Products 3" (R4BP3), accessible through the European Chemicals Agency (ECHA) website. This European platform provides a way for companies and the authorities to exchange the information required for the examination of applications, in compliance with the assessment procedures established by Regulation (EU) no. 528/2012, and implemented in the Member States since 1 September 2013.
Assessment of the application is made by a reference Member State. Following the assessment, if the product is considered sufficiently effective and shows no unacceptable risks for humans and the environment, the Member State issues a marketing authorisation (MA). Based on this, MA applications can be examined in other Member States according to a mutual recognition procedure.
In France, assessments of the risks and efficacy of a product are conducted by ANSES, both for initial assessments and for mutual recognition procedures.
ANSES works closely with the Ministry of Ecology as the primary contact for answering questions from businesses wishing to submit MA applications for their biocidal products. To this end, in April 2010 ANSES set up the Biocides Helpdesk, a bilingual (French/English) website designed to facilitate access to the regulations, to information on the marketing of biocidal products, and to the procedures in force in France.
All questions related to marketing authorisations should be addressed to us by e-mail by clicking here.