- Regulatory reference texts:

• Articles R522-40 to R522-43 of the French Environmental Code,
• Article 6 of the Ministerial Order of 19 May 2004 .

- Notes:

• Packaging or containers of biocidal products receiving authorisation must display, in clearly visible, legible and indelible characters, the following information:

- The name of the product,

- The research and development authorisation number,

- The name, address and telephone number of the authorisation holder,

- The labelling in accordance with the Ministerial Order of 20 April 1994,

- Any other precautions of use or contraindications, if relevant, appearing on the authorisation decision,

- The claimed product type,

- The specific statement "product for experimental use only".

• Any publicity concerning biocidal products with authorisation for distribution for experimentation is prohibited.

- Deadlines:

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

- Validity of the authorisation:

2 years renewable, for limited quantities.

- Fees payable to ANSES:

€1,800

- Composition of the dossier:

• Part of the documents listed in the section Dossier submission - How? (in French): explanatory letter, R4BP form, letter(s) of access
• The dossier is defined in Annex VII of the Ministerial Order of 19 May 2004 including:

- Contact details of the applicant and the manufacturer/ importer of the active substances and biocidal products.

- Manufacturing site.

- Contact details of the user(s).

- Quantities required for production research and development operations and justification of these quantities.

- The research and development programme. If relevant, surface of the area to be treated.

- Undertaking that the biocidal substance or product will only be handled by personnel of the users and will not be available to the public.

- Identity of the active substance (Annex IIA, II) and the biocidal product (Annex IIB, II).

- Spectral and analytical data.

- Available information on the physico-chemical, toxicological and ecotoxicological properties.

- Proposal for classification and labelling with, if necessary, the notice "Caution: substance not yet fully tested".

If no physico-chemical, toxicological or ecotoxicological data is available in the dossier from the applicant, the Minister shall determine, on a case-by-case basis, the information to be provided taking into account the following points:

• chemical nature of the active substance;
• estimates of the quantities necessary for the research and development operations;
• anticipated use of the substance and product.