|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:
(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Without authorisation, these products cannot be placed on the French market and must be immediately withdrawn.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 . 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 and a guidance document for the transitional period is available to help applicant companies. An interactive Cerfa 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 .
Applications have to be submitted, for active substances of same PT, at latest :
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:
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 .
|Last Updated on Thursday, 19 July 2012 15:40|