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.

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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.

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EUROPE: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012/11284 – Rev. 21  – June 2018 – Draft working document – AIR III Renewal programme

This 21th revision contains new expiry dates set by Regulation (EU) 2018/524 of 28 March 2018 (Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram) and Regulation (EU) 2018/917 of 27 June 2018 (alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor). It also contains the renewal of active substances (Ampelomyces quisqualis strain AQ10, carfentrazone-ethyl and trifloxystrobin).

 

AIR 4 programme

SANTE-2016-10616-rev 9 – June 2018 – AIR IV Renewal programme

SANTE-2016-11734-rev.10 –  June 2018 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

These new versions update revision 8 of October 2017 and 9 of February 2018 of guidance documents SANTE-2016-10616 (AIR IV Renewal programme) and SANTE-2016-11734 (application overview for AIR IV substances).

 

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

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EUROPE: AIR5 work programme

Further to the publication in January of Regulation (EU) 2018/155 allocating the MS for the renewal of AIR5 active substances, the Commission has released a work programme:

  • the decision of 06 June 2018 gives priority to the evaluation of active substances that may fail the approval criteria (= that meet the “cut-off” criteria) and of candidates for substitution, and groups the evaluation of active substances with similar properties
  • the draft working document SANTE/2018/10048 provides an overview of indicative dates for application and dossier submission of 66 active substances. They are divided into 2 groups: no change in expiry date, a.s. to be potentially extended.

 

To download:

Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council

SANTE-2018-10048–rev 1 (June 2018): Draft working document establishing the fifth renewal programme

 

See also our previous article:

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

 

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

Contact us! http://lynxee.consulting/en/contact/30

 

EUROPE: Adoption of the new EFSA guidance document for dermal absorption

Nearly one year ago, the European Food Safety Agency (EFSA) published a revised version of its guidance document on dermal absorption (EFSA Journal 2017;15(6):4873) which defines new default values to be used in absence of experimental data.

The new guidance document was adopted at the Standing Committee on Plants, Animals, Food and Feed of 25 May 2018. This document will start to be used for any active substance or plant protection product applications submitted after 25 August 2018.

For the purpose of this guidance document, a plant protection product is considered:

  • as a concentrate, when the amount of active substance is ⩾50 g/L or g/kg, i.e. ⩾5%, or
  • as a dilution, when the amount of active substance is <50 g/L or g/kg, i.e. <5%.

Member States may decide in the future to carry out a further more precise analysis in order to refine the trigger value of 5%.

 

To download:

Guidance on dermal absorption (SANTE/2018/10591)

 

See also our previous articles:

EUROPE: New EFSA GD on Dermal absorption

 

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

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FRANCE: Publication of lists of resistance cases identified in France

A series of documents concerning the resistance of fungi, insects, mites and weeds in France has been published on the R4P website on 18/06/2018:

  • Lists of cases of resistance to active substances currently or previously approved, built from experimental data or from literature gathered by French laboratories (INRA and ANSES) and with the assistance of researchers and experts recognised  in each discipline. For each category of pests, two lists are proposed:
    • List I: proven cases of resistance to active substances currently approved in France
    • List II: proven cases of resistance to active substances no longer approved in France
  • Overview of 17 weeds officially resistant in France
  • Maps showing the extent of resistance to herbicides in France, by weed species

 

To download (in French):

  • Lists I (cases of resistance to substances currently approved):

 

See also our previous articles:

FRANCE: New website of a French think tank about resistance to Plant Protection Products (R4P)

 

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

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EUROPE: Publication of the guidance document EFSA/ECHA on identifying endocrine disruptors

The European Food Safety Authority (EFSA) and the European CHemicals Agency (ECHA) published on 7 June 2018 the first version of the common guidance document on how to identify endocrine disruptors (EDs) contained in plant protection products and biocides.

Started in 2017, the drafting of the document was finalised with the integration of the scientific criteria to identify active substances used in plant protection and having ED properties (adopted in April with Regulation (EU) 2018/605), and the consideration of all comments received during the public consultations held in December 2017 and January 2018.

The guidance document immediately applies to biocides. For active substances used in plant protection, the document will apply to those substances for which a decision is scheduled on or after 10 November 2018.

 

To download (pre-publication version):

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

 

See also our previous article:

EUROPE: Publication of Endocrine disruptors criteria

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

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

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FRANCE: Usable in Organic farming (UAB) claim granted to more than 50 new products

The French National Institute of Origin and Quality (INAO) has decided to include PPP registered for amateur uses and products authorised for use after harvest, according to their criteria, in the register of inputs which can be used in organic farming.

This decision is issued in the context of the implementation of significant restrictions on the sales of products for amateur use pursuant to Labbé’s law (February 2014) and modified by the Energetic transition law (August 2015) as of 1 January 2019: products with the UAB claim will remain on the market and will continue to be used by amateurs.

Thus, more than 50 products are awarded UAB claim.


As a reminder, on the E-phy website and in the open data file of the catalogue of PPPs, products with the mention UAB can be easily found by applying a filter on searches.

See also our previous articles:

FRANCE: Focus on the bans of Amenity uses and Home & Garden products

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

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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.

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