FRANCE: Update of the explanatory note and of the application cerfa form!

ANSES has updated the general note for the submission of applications. It introduces the second version of the explanatory note No. 52173 and of the application cerfa form No. 15722. The previous version was dated from July 2017.

Note that a special version of the cerfa has been created to easily fill in the PDF form.

The main changes of this second version of the explanatory note No. 52173 are as follows:

– In the GAP table, new concept for greenhouse uses:

G = Greenhouse (greenhouse / tunnel) to decline according to G1: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, soil-bound crops; G2: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, above soil-less crops (EFSA Guidance Document for protected crops – EFSA Journal 2014;12(3):3615)

– The term “Mention Abeille” (“Bee Claim”) disappears in favor of “exemption under the Order of November 28, 2003” (in French)

– The notion of “significant composition change” is introduced. It is assimilated to a new application for approval by the standard procedure (Article 33 of Regulation (EC) No. 1107/2009) or by the mutual recognition procedure (Article 40 of Regulation (EC) No. 1107/2009)

– The intracommunity VAT number is requested for companies with headquarters in the European Union

– The case of dose split and how to indicate it in the cerfa form is described

– CDs and DVDs containing the application sent to ANSES must not be re-writable

– IMPORTANT: With regard to dRR parts A and B, the applicant must now highlight in grey the information presented in the draft part A and part B which must, pursuant to article 63, remain confidential

– It is made clear that when the product is intended for amateur use, the draft label must be provided with the artwork

– Regarding the electronic format, all study reports must be provided.

– The numbering of the documents to be used in the application has been modified (Appendix IV of the notice)

– The format of the list of studies for data protection in France to be provided in Excel format or in a format compatible with Excel has been modified (Appendix V of the notice)

The main changes of this second version of cerfa form No. 15722 are as follows:

– Point 1.3.4: The term “Mention Abeille” (“Bee Claim”) disappears in favor of “exemption under the Order of November 28, 2003”

– Point 1.3.6: introduction of the notion of “significant composition change”. vs “non-significant change”

– Point 8: new concept for greenhouse uses: G = Greenhouse (greenhouse / tunnel) to decline according to G1: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, soil-bound crops; G2: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, above soil-less crops

– Point 9.2: addition of the box “Without classification”

To download:

Note générale pour le dépôt des dossiers (formulaires Cerfa et notices à utiliser) (23/07/2018) (in French)

Notice explicative pour remplir le formulaire relatif à une autorisation de mise sur le marché Cerfa N°52173#02 (pdf) (in French)

Formulaire relatif à une autorisation de mise sur le marché Cerfa N° 15722*02 (word) Cerfa N° 15722*02 (pdf) Cerfa N°15722*02 (pdf à remplir) (in French)

See also our previous article:

FRANCE – ANSES: Procedures for applications for approval and new cerfa forms!

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