|Written by DPR Biocides - Anses|
|Friday, 09 April 2010 14:55|
A frame formulation must contain the same active substances having the same characteristics, and their composition can only have variations from a previously authorised product, that do not affect the level of risk with which they are associated, or their efficacy.
- Regulatory reference texts: Articles R522-24 to R522-25 of the French Environmental Code
- Fees payable to ANSES: €2,000
- Regulatory reference texts:
- Deadlines :
5 months with the possibility of a suspension of the evaluation if additional information is necessary
- Validity of the authorisation:
- Fees payable to ANSES:
- Composition of the dossier:
The dossier must comply with Article 3 of the Ministerial Order of 19 May 2004 i.e.:
1.1. Name and address of the applicant.
1.2 Names and addresses of the manufacturers of the biocidal product and active substances, including the address of the production facility.
1.3. Where appropriate, a letter of access to the relevant necessary data.
2. Identity of the biocidal product:
2.1. Commercial name.
2.2. Full composition of the biocidal product.
2.3. Physical and chemical properties ensuring proper use, storage and transport of the product.
3. Intended uses:
3.1. Product type and field of use.
3.2. Category of users.
3.3. Method of use.
4. Data on efficacy.
5. Analytical methods.
6. Classification, packaging and labelling, including a draft label, in accordance with the provisions of Article 20 of the abovementioned Decree of 26 February 2004 and Article 10 of the present Ministerial Order.
7. Safety Data Sheet. ( SDS)
|Last Updated on Friday, 25 March 2011 16:12|