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Transitional period PDF Print E-mail
Written by DPR Biocides - Anses   

The transitional regime is defined by Article 89 of Regulation ( EU) No 528/2012: it is the period of time during which the making available on the market and use of biocidal products are governed by the national provisions in force in each Member State, pending approval of all the active substances they contain at European level. When all of a product's active substances have been approved, the transitional regime no longer applies and this product must be authorised in accordance with the BPR. The status of the biocidal active substances, and in particular the approval date of the approved active substances, can be consulted on the website of the European Chemicals Agency (ECHA) web.

In France, the placing on the market and use of certain biocidal products previously required national marketing authorisation to be obtained in the transitional period ("transitional" MA). Act No. 2015-1567 of 2 December 2015 has removed this obligation, for products that were subject to this requirement.

The effect of this is not to absolve biocidal product manufacturers and marketing managers from their responsibility with regard to risks to the environment or to human or animal health, related to the placing of their products on the market. Nevertheless, specific provisions remain in force for certain product types including:

  1. Biocidal products used against notifiable contagious livestock diseases or diseases that are subject to State-organised collective prophylaxis. The Ministry of Agriculture is the competent authority during the transitional period.
  2. Disinfectant products for domestic hot water circuits, thermal waters and public swimming pools, as well as disinfectant products for water intended for human consumption and production and distribution facilities for water intended for human consumption (predominantly PT2, PT4 and PT5). The Directorate General for Health is the competent authority during the transitional period.
  3. Products used in embalming for the preservation of bodies (PT22). The Directorate General for Health is the competent authority during the transitional period.

 

In addition, biocidal products  must also be brought into compliance with Article 95 of the BPR, with effect from 1 September 2015. Furthermore, products in the transitional regime remain subject to national requirements. They must:

  • contain active substances that have been notified in the review programme for appropriate use, i.e. listed in Annex II of Regulation (EU) No 1062/2014 pdf and not been subject to non-approval decisions further to withdrawal. Otherwise, the product cannot be placed on the market.
  • be labelled in accordance with the provisions of Article 10 of the Ministerial Order of 19 May 2004. A guide to labelling pdf of biocidal products intended for those responsible for placing them on the market is available.
  • be declared to the INRS for the purposes of toxicovigilance: French National Research and Safety Institute web
  • be declared to Simmbad before their actual placing on the market: Simmbad - Declaration of biocidal products web. For further information on the declaration of products, send an email to the following address: This e-mail address is being protected from spambots. You need JavaScript enabled to view it web

Once the active substances in the product are approved on the EU list of active substances of Regulation (EU) No 528/2012, the products will be subject to the authorisation of ANSES. Companies must submit dossiers in accordance with Decree 2014-1175 of 13 October 2014 pdf.

Last Updated on Monday, 11 July 2016 14:14