New missions for ANSES concerning biocidal products
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News of 01/07/2016
ANSES is today broadening its sphere of competence by taking over management of marketing authorisations (MAs) for biocidal products and responsibility for declarations to the biocidal products inventory (SIMMBAD). The Agency will build on the organisation it set up in July 2015 to issue marketing authorisations for plant protection products, while taking account of the specific features of the European regulation governing biocidal products. This regulation, applicable since 2013, seeks to ensure a high level of protection for humans, animals and the environment. In gaining these new missions, the Agency strengthens the integrative approach it has adopted in the area of chemical risk, with the aim of safeguarding consumers and the environment.
Biocidal products are mixtures or preparations consisting of active substances, to be used for domestic or industrial purposes with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
Biocidal active substances and products are governed by a European regulation (EU No 528/2012), which has been in force since 2013 and aims to harmonise the placing on the market and use of these products in Europe. The main purpose of this regulation is to ensure a high level of protection for humans, animals and the environment by only placing on the market those biocidal products that are effective and do not entail unacceptable risks.
Until now, the Agency had been in charge of assessing biocidal active substances and products. Today, the Ministry of the Environment, which was previously responsible for issuing, withdrawing and amending MAs for these products, is transferring these tasks to the Agency.
Acquiring these new missions complements and strengthens the integrative approach adopted by the Agency in the area of chemical risk, with the aim of safeguarding consumers and the environment.
To carry out its new missions, the Agency will build on the organisation it set up on 1 July 2015 in the framework of the transfer of responsibility for MAs for plant protection products, fertilisers, growing media and adjuvants.
The Agency has also developed guidelines, which were submitted for public consultation in June, describing the criteria enabling it to exercise its power of judgement and thus reach individual decisions, on the basis of the scientific assessment of the MA application dossiers, carried out in compliance with the regulations.
The MA decisions taken will be made public via a registry of decisions (in French only) accessible from the ANSES website. Lastly, the Monitoring Committee (in French only), created in the framework of the transfer of MAs for plant protection products, will have its sphere of competence broadened to include biocidal products. It can thus be consulted on the conditions under which the decisions will be taken, in particular on the management measures associated with the MAs, but also on the health and environmental benefits of the different biocide solutions available and the possible socio-economic impact of restrictions or prohibitions on the use of these products.
For more information
- Read the press kit ‘New missions for ANSES in the area of biocidal products’
- Decree n° 2016-859 of 29 June 2016 relating to regulatory procedures for approval, making products available on the market and declaration of biocidal products and active substances (in French only)
- Read the biocidal guidelines (in French only)
- Consult the register for biocidal decisions (in French only)
- Read our article on biocidal products
- See our ‘ANSES and biocides’ leaflet (in French only)