- Regulatory reference texts:

• Articles R522-15 to R522-21 of the French Environmental Code,
• Article 2 of the Ministerial Order of 19 May 2004 ,

- Notes:

The product must contain one or more active substances listed in Annex I of Directive 98/8/EC, and/or substance(s) of concern.

- Deadlines:

15 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:

The amount varies depending on the data required. For each case €2,500 is required to ensure completeness check when submitting the application.

• For the first application for a product: €32,500 + possible extra charges
• For the first application for a product for which a hazard assessment is already available, or for which a product’s nature requires less data: €16,000 + possible extra charges
• For the first application for a product for which an environmental hazard assessment has been conducted by calculation: €25,500 + possible extra charges
• For the first application for a product for which additional data from Annex IIIB are required: €37,000 + possible extra charges

- Composition of the dossier:

• The administrative documents listed in the section Dossier Submission - How?

• The dossier, which must comply with Annexes II, III, IV of the Ministerial Order of 19 May 2004 .

• For each active substance and for the product, a complete dossier or a Letter of Access must be submitted.