- Regulatory reference texts:

• Articles R522-26 to R522-27 of the French Environmental Code,
• Article 4 of the Ministerial Order of 19 May 2004 .

- Notes:

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.

- Deadlines:

2 months with the possibility of a suspension of the evaluation if additional information is necessary.

- Validity of the authorisation:

10 years.

- Fees payable to ANSES:

€1,800

- Composition of the dossier:

• A certified copy of the first authorisation issued, translated into French,
• Part of the documents listed in the section Dossier Submission - How? (in French): explanatory letter, R4BP form, form specific to France (if applicable), letter(s) of access,
• The classification, packaging and labelling, including a draft label, in French,
• The Safety Data Sheet(s) in French,
• The dossier must comply with Article 3 of the Ministerial Order of 19 May 2004 with the exception of data relating to efficacy for which a summary is enough:

1. Identification of the applicant and manufacturers:

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:

• An explanatory letter (in French) confirming that an application for authorisation has been made in another Member State and that mutual recognition is sought in France,
• Part of the documents listed in the section Dossier Submission - How? (in French), i.e.: letter(s) of access, R4BP form, form specific to France,
• An electronic copy of the dossier summary.

- Subsequently, the following documents must be sent no later than two months after obtaining the first authorisation:

• A certified copy of the first authorisation, translated into French,
• An evaluation report (in electronic format only),
• A summary of the dossier (in electronic format only),
• The labelling, instruction manual(s) and SDS, in French,
• Fees payable to ANSES (fees).