• Establishment of a frame formulation ( FF)

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

• Authorisation of a product covered by a frame formulation

- Regulatory reference texts:

• Articles R522-24 to R522-25 of the French Environmental Code,

• Article 4 of the Ministerial Order of 19 May 2004 .

- Notes:

A frame formulation must be established in advance and it is necessary to be the holder of this frame formulation or holder of a letter of access to the FF.

- Deadlines :

5 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:

• Provide a letter of access to the FF or be the holder.

• Provide letters of access to the active substances included in the product.

The dossier must comply with Article 3 of the Ministerial Order of 19 May 2004 i.e.:

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.

7. Safety Data Sheet. ( SDS)