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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!

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

FRANCE: Update of the Appendix to the guidelines for the delivery of approvals by ANSES

ANSES has published an update of the risk-mitigation measures that appear the most frequently and that are described in the Annex to the Guidelines for the delivery of approvals of plant protection products and adjuvants on 02/04/2018. This update follows, inter alia, the publication of the Order of 4 May 2017 on the use of plant protection products and their adjuvants, repealing the Order of 12 September 2016.

The main changes are as follows:

  • Measures concerning residues and consumer exposure: two new measures to manage the risk of MRL exceedance for perennial crops
  • Measures concerning risks to the environment:
    • Aquatic organisms:
      • New SPe 2 phrases relating to soil types, products to be incorporated into the soil, depth of sowing and wastewater discharges from off-ground greenhouses
      • New SPe 3 phrases for unsprayed buffer zone to water surface bodies for uses on potato
      • Unsprayed buffer zone to water surface bodies up to more than 100 meters
    • Birds and mammals: new SPe 5 and SPe 6 phrases relative to treated seeds

To download: Annexe aux lignes directrices pour la délivrance des décisions relatives à la mise sur le marché des produits phytopharmaceutiques et adjuvants (in French)

See also our previous articles:

FRANCE: The new Order on the Use of PPPs and adjuvants is finally published!

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

Amenity areas: French regulatory differences between professional and amateur products

Ecophyto II, laws for the future of agriculture,  and for the energetic transition and for biodiversity regrowth, placing on the market of PPPs, products used in amenity areas, separation of professional and amateur ranges of products, biocontrol… the regulatory framework is changing fast. How does it translate concretely in France for plant protection products for professional use but also for amateur use in terms of restriction of use, mode of application, packaging, labelling…?

Lynxee consulting has summarised in a poster the key elements to better understand the current regulations and their declination as two ranges of uses. The poster was presented during the 4th Conference on amenity uses and home & garden products organised by the French association for plant protection (AFPP) on 19-20 octobre 2016 in Toulouse.

To download the poster (in French): Lynxee Poster Amenity 2016

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

TRAINING: EU Regulation and French requirements

We propose a new training course on EU Regulation (Regulation 1107/2009) and French requirements.
Duration: 1 day. Languages: English or French.
We can customise this training course according to your needs. Please feel free to let us know your specific expectations!