{"id":2873,"date":"2018-08-16T09:47:22","date_gmt":"2018-08-16T09:47:22","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=2873\/"},"modified":"2025-07-21T12:40:16","modified_gmt":"2025-07-21T12:40:16","slug":"france-update-of-the-explanatory-note-and-of-the-application-cerfa-form","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-update-of-the-explanatory-note-and-of-the-application-cerfa-form\/","title":{"rendered":"FRANCE: Update of the explanatory note and of the application cerfa form!"},"content":{"rendered":"

ANSES has updated the general note for the submission of applications. <\/b>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.<\/span><\/p>\n

Note that a special version of the cerfa has been created to easily fill in the PDF form.<\/span><\/p>\n

 <\/p>\n

The main changes of this second version of the explanatory note No. 52173 are as follows:<\/b><\/p>\n

– In the GAP table, new concept for greenhouse uses:<\/span><\/p>\n

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 (<\/span>EFSA Guidance Document for protected crops – <\/span><\/i>EFSA Journal 2014;12(3):3615<\/span><\/i><\/a>)<\/span><\/p>\n

– The term \u201cMention Abeille\u201d (“Bee Claim”) disappears in favor of “exemption under the <\/span>Order of November 28, 2003<\/span><\/a>” (in French)<\/span><\/p>\n

– 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)<\/span><\/p>\n

– The intracommunity VAT number is requested for companies with headquarters in the European Union<\/span><\/p>\n

– The case of dose split and how to indicate it in the cerfa form is described<\/span><\/p>\n

– CDs and DVDs containing the application sent to ANSES must <\/span>not<\/span> be re-writable<\/span><\/p>\n

– <\/span>IMPORTANT<\/b>: 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<\/span><\/p>\n

– It is made clear that when the product is intended for amateur use, the draft label must be provided with the artwork<\/span><\/p>\n

– Regarding the electronic format, all study reports must be provided.<\/span><\/p>\n

– The numbering of the documents to be used in the application has been modified (Appendix IV of the notice)<\/span><\/p>\n

– 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)<\/span><\/p>\n

 <\/p>\n

The main changes of this second version of cerfa form No. 15722 are as follows:<\/b><\/p>\n

– Point 1.3.4: The term \u201cMention Abeille\u201d (“Bee Claim”) disappears in favor of “exemption under the Order of November 28, 2003”<\/span><\/p>\n

– Point 1.3.6: introduction of the notion of “significant composition change”. vs “non-significant change”<\/span><\/p>\n

– 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<\/span><\/p>\n

– Point 9.2: addition of the box “Without classification”<\/span><\/p>\n

 <\/p>\n

To download: <\/b><\/p>\n

Note g\u00e9n\u00e9rale pour le d\u00e9p\u00f4t des dossiers (formulaires Cerfa et notices \u00e0 utiliser)<\/span><\/a> (23\/07\/2018) (in French)<\/span><\/p>\n

Notice explicative pour remplir le formulaire relatif \u00e0 une autorisation de mise sur le march\u00e9 <\/span>Cerfa N\u00b052173#02<\/span><\/a> (pdf) (in French)<\/span><\/p>\n

Formulaire relatif \u00e0 une autorisation de mise sur le march\u00e9 <\/span>Cerfa N\u00b0 15722*02<\/span><\/a> (word) Cerfa N\u00b0 <\/span>15722*02<\/span><\/a> (pdf) <\/span>Cerfa N\u00b015722*02<\/span><\/a> (pdf \u00e0 remplir) (in French)<\/span><\/p>\n

 <\/p>\n

See also our previous article: <\/b><\/p>\n

FRANCE \u2013 ANSES: Procedures for applications for approval and new cerfa forms!<\/span><\/a><\/p>\n

 <\/p>\n

Lynxee consulting<\/b>\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n

Contact us!<\/b> https:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n

 <\/p>\n

 <\/p>\n

<\/h6>\n
Photo credit: ulleo\/pixabay<\/h6>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

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 [\u2026]<\/span><\/p>\n","protected":false},"author":4,"featured_media":8398,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[64,53],"class_list":["post-2873","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-anses-en","tag-french-requirements"],"yoast_head":"\nFRANCE: Update of the explanatory note and of the application cerfa form! - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"ANSES has updated the general note for the submission of applications. 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