ANSES's proposed guidelines on issuing marketing authorisations for biocidal products are submitted for public consultation
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News of 06/06/2016
On 1 July 2016, ANSES will be given a new mission, currently the responsibility of the Ministry of the Environment: issuing marketing authorisations (MAs) for biocidal products. The Agency has prepared some proposed guidelines on reaching decisions relating to marketing authorisations for these products. It is today submitting its proposals for public consultation, due to run until 20 June, in order to collect comments from the public, which will then be examined before validation and publication of the final guidelines.
Since 2006, ANSES has been responsible for assessing biocidal products in accordance with the criteria defined by the European regulations. The Ministry of the Environment currently issues marketing authorisations (MAs) on the basis of this scientific assessment of the risks associated with the use of these products and their effectiveness.
In application of Article L.1313-1 of the French Public Health Code, as amended by Act No. 2015-1567 of 2 December 2015 concerning various provisions for adapting to European Union law in the field of risk prevention, ANSES will also be responsible for issuing marketing authorisations for biocidal products, from the date of publication of the implementing decree, planned for 1 July 2016.
For several months now, the Agency has been working on the conditions under which this new mission will be implemented, based on the organisation set up to issue decisions relating to plant protection products, for which it has been responsible since July 2015, and taking into account the specific features of the European regulations governing biocidal products.
ANSES has developed guidelines specifying the principles to be applied for issuing MA decisions. These guidelines describe the criteria enabling the Agency to exercise its power of judgement and thus reach individual decisions, on the basis of the scientific assessment of the marketing authorisation application dossiers carried out in compliance with the regulations.
In accordance with Articles L. 120-1 and L. 120-2 of the French Environmental Code, the Agency's proposed guidelines are today being submitted for public consultation until 20 June.
These proposals will be adopted after the contributions received from the public consultation have been analysed and published, before the actual transfer to the Agency of the mandate to issue marketing authorisations for biocidal products.