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: List of neonicotinoids substances banned

The list of substances from the neonicotinoids family banned from 1st September 2018 in plant protection products and seed treatments was published on 1st August. This ban is planned by the law for biodiversity regrowth, nature and landscapes published in 2016, exemptions being possible on a case by case basis until 1st July 2020.

According to Decree 2018-675 of 30 July issued under article L.253-8 of the French Rural Code, five substances are concerned: acetamiprid, clothianidin, imidacloprid, thiacloprid and thiametoxam. European restrictions are already in place since 2013 for three of them (clothianidin, imidacloprid and thiametoxam) (see Regulation (EU) No.485/2013). These restrictions have just been extended so as to only allow  the use of these three active substances in permanent greenhouses where no contact with bees is expected (Regulations (EU) No. 2018/783, No .2018/784 and No. 2018/785 of 29 May 2018).

 

To download: Décret n° 2018-675 du 30 juillet 2018 relatif à la définition des substances actives de la famille des néonicotinoïdes présentes dans les produits phytopharmaceutiques (in French)

See also our previous articles:

EUROPE: Neonicotinoids ban for outdoor uses

FRANCE: Risks/Benefits of neonicotinoids compared to their alternatives

 

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

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

 

FRANCE: Ecophyto II+, update and improvement of Ecophyto II

Version II+ of Ecophyto plan, updating and improving Ecophyto II, was examined during the Strategic Orientation Committee (COS) of 27 July 2018. This new version features the actions planned in the French action plan of 25 April 2018 on plant protection products and on a less pesticide-dependent agriculture  and in the French action plan of 22 June 2018 for a ban of glyphosate within three years .

Among the issues, the ministers notably announced that, in a first step, renewals of authorisations of glyphosate-based products will only be obtained for a maximum period of three years. Besides, the uses for which comparative assessments will underline that non-chemical alternative solutions are available and are commonly used, will be banned progressively.

With regard to neonicotinoids, ministers indicated that only few exemptions to the ban are envisaged. Those exemptions will only concern acetamiprid-based products, for low volumes and after a comprehensive risk assessment.

The public consultation for Ecophyto II+, initially announced for July 2018, will be held in Autumn 2018. The plan is expected to be published by the end of 2018.

 

To download:

Press release of 27 July 2018 – Strategic orientation committee of Ecophyto plan (in French)

 

See also our previous articles:

FRANCE: Action plan for plant protection products

 

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

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