|"Low risk" product|
|Written by DPR Biocides - Anses|
|Friday, 09 April 2010 15:00|
- Regulatory reference texts:
The first authorisation must be granted by and for another Member State. The product must contain one or more active substances listed in Annex IA of Directive 98/8/EC.
2 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:
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 (to be provided in French).
7. Safety Data Sheet (to be provided in French).
Concerning the mutual recognition of products already on the French market (“existing” products), the procedure is carried out in two phases:
- Initially, the following documents must be sent before the application submission deadline, when submitting the first application for authorisation:
- Subsequently, the following documents must be sent no later than two months after obtaining the first authorisation:
|Last Updated on Friday, 25 March 2011 16:12|