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Transitional period PDF Print E-mail
Written by DPR Biocides - Anses   
Friday, 09 April 2010 14:29

During the transitional period of the implementation of the Biocidal Products Directive 98/8/EC, there is no need to have a prior authorisation to place most biocidal products on the French market. Only certain products are currently subject to an authorisation which pre-dates the Directive. This chiefly concerns:

  1. Disinfectants for public swimming pools, drinking water, hot and cold water supplies (mainly PT 2, 4, 5), under marketing authorisation from the French Ministry of Health
  2. Disinfectants used for embalming and taxidermy (PT 22) under marketing authorisation from the French Ministry of Health
  3. Products described in paragraph 9 of law N°2008-757 of 1 August 2008 pdf. Questions about these products should be addressed to This e-mail address is being protected from spambots. You need JavaScript enabled to view it web. These products mainly belong to product types (PTs) 2, 3, 4, 14 and 18 (transitional marketing authorisations formerly granted by the French Ministry of Agriculture):

(a) Rodenticide biocidal products (PT 14)

(b) Products used for decontamination and for pest control treatment of premises, materials, vehicles, locations and outbuildings (PT 3, 4 and 18):

- For transport, reception, cleaning and accommodations of domestic animals or for the preparation and transport of their food, except the disinfectants used either against contagious diseases of livestock which are submit to obligatory declaration, or against diseases which are subject to a collective disease prevention organised by the State

- For harvest, transport, storage, industrial transformation and marketing of products of animal or plant origin

- For collection, transport and treatment of household wastes and waste of animal or plant origin

 

Without authorisation, these products cannot be placed on the French market and must be immediately withdrawn. A table is available summarising the different systems according to product type pdf. Note: this document is for information; only legislative texts and French regulations are authoritative.

Concerning products describe in point 3 above, the content of an application for marketing authorisation is detailed in the French Ministerial Order of 13 July 2010 pdf and a guidance document pdf for the transitional period is available to help applicant companies. An interactive Cerfa pdf application form, as mentioned in the French Ministerial Order, is available. Fees payable to ANSES for evaluating applications are described according to application type in the French Ministerial Order of 26 October 2010 pdf.

Applications have to be submitted, for active substances of same PT, at latest :

  • 8 months before the inscription of the last active substance. It concerns first applications, changes of product use, changes of product composition, changes of use conditions and all noteworthy changes in the application dossier
  • 5 months before the inscription of the last active substance. It concerns changes of classification / packaging / labelling, other trade names and the placing on the market under another brand

Transitional period dossiers which have been submitted after the deadlines shall not be treated.

 

Furthermore, products placed on the French market during this transitional period, must:

  • contain active substances notified for the appropriate use, to wit listed in annex II of EC Regulation 1451/2007 pdf and without any non-inclusion decision following applicant withdrawal. Otherwise, the product will not be placed on the French market. An indicative table for existing substances pdf is available, and gives substances currently under evaluation, the ones which are included or not included in annex I or IA of Directive 98/8/EC.
  • be labelled according to article 10 of French National Order of 19 May 2004. A labelling guide pdf for biocidal products is available.
  • be declared to INRS for monitoring  of possible side-effects: French National Research and Safety Institute web
  • be declared to the ministry  responsible for the environment before their actual placing on the market: Ministry of ecology - Declaration of biocidal products web. For more information on this declaration, please contact: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

Once the active substances contained in the product(s) are included in annex I and/or IA of Directive 98/8/CE, products must be submitted for authorisation to the French ministry responsible for the environment. Companies will have to submit applications, for which the data requirements are set out in the National Order of 19 May 2004 pdf.

Last Updated on Thursday, 19 July 2012 15:40
 

Joint Research Center

Joint Research Center

This European Commission website presents the technical guidance documents currently in force for the preparation and evaluation of biocide dossiers.

Europa, guidance document

EuropaThe European Union offers an EC guidance document for the declaration of biocidal products.