Posts

FRANCE – ANSES: Update of the uses of the authorised products on E-Phy following the update of the national catalog

Following the update of the national catalog of plant protection products by order of 12 April 2021 (see our previous article), ANSES has updated the uses of the authorised products on E-Phy website.

The following amendments have been applied:

  • The replacement of the old wordings by the new wordings of the plant protection uses as listed in Annex 2 of the new catalog of uses.

  • Changes to the scopes of uses: for instance, the crops “kumquat” and “pistachio” are now respectively included in the reference crops “Citrus” and “Nuts”, provided that the maximum residue limits are respected. Similarly, the reference crops “Fresh beans without pods” and “Fresh peas without pods” have been replaced by “Fresh beans and peas without pods” and the scope of use has been extended in the absence of restrictions in the conditions of use for the relevant uses.

As a result of these modifications, 45 decisions to amend marketing authorisations were issued.

 

See also our previous articles: 

FRANCE: Update of the national catalog of plant protection uses

 

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

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

 

FRANCE: Public Consultation on New Measures to Protect Pollinators

The Ministries of Agriculture and Environment have launched the public consultation on the draft National Plan for Pollinators (Access to consultation) and the draft “bee” Order to replace the Order of 2003 as regards the Conditions of Use of Insecticides and Acaricides to Protect Bees and Other Pollinating Insects (Access to consultation). The consultation is open until 20 July 2021.

Draft National Plan for Pollinators

The draft National plan contains various actions to be carried out over the period 2021-2026 to “act in favour of pollinating insects, wild and domestic, and of pollination”. It is articulated around six axes:

  1. Improving scientific knowledge (including on wild pollinator populations, and stressors affecting domestic and wild pollinator populations),
  2. Economic levers and supports for farmers, beekeepers and foresters,
  3. Supports for other activity sectors (urban development, linear infrastructure, industrial sites, sites with large land rights, protected areas),
  4. Preservation of bee health (e.g. strengthening of bee health monitoring),
  5. Regulation of plant protection products (PPPs) to protect pollinators (it includes the strengthening of the provisions of the “bee” Order of 2003 – detailed below),
  6. Sharing of pollinator-friendly farming practices.
Draft “Bee” Order

In order to reduce the impact of PPPs on pollinators when applied during flowering, two main evolutions were retained in the draft “Bee” Order on the basis of Anses recommendations (see our previous articles):

  • Extension of the flowering-period specific assessment to all PPPs, i.e., inclusion of fungicides and herbicides:
    PPP applications on attractive flowering crops and on “bee foraging areas” would only be possible “if there is no unacceptable effect on bees (acute or chronic), nor on colony survival and development”. Anses would specify the data required for the evaluation.
  • Limitation of the PPP application period when used on flowering crops and on “bee foraging areas”:
    Applications would have to be carried out within 2 hours before sunset and 3 hours after sunset. This restriction period could be adapted or waived if measures providing an equivalent level of protection to pollinators are implemented (such measures are still to be defined with the support of Anses). Exemptions would also be possible in the case of technical deadlock.

As regards attractive plant covers under perennial crops, covers would have to be rendered unattractive to pollinators prior to any insecticide or acaricide application on crops. The other types of PPPs would not be concerned by this measure.

Transitory measures are planned for the entry into force of the new “bee” Order:

  1. Limitation of the PPP application period when used on flowering crops and on “bee foraging areas” would be immediately applicable to insecticides and acaricides for which an authorisation of application during flowering and/or exudate production period is already granted (current “Bee Claim” procedure), AND for PPPs other than insecticides and fungicides.
  2. For PPPs other than insecticides and fungicides whose authorisation renewal will be in less than 30 months after the entry into force of the new “bee” Order:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses risk assessment conclusions and provided that the required additional data are submitted within 30 months after the entry into force of the “bee” Order.
  3. For PPPs other than insecticides and fungicides whose authorisation renewal will be in more than 30 months after the entry into force of the new “bee” Order AND in the case of major uses in France:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses risk assessment conclusions and provided that the required additional data are submitted within 48 months after the entry into force of the “bee” Order.
  4. If the required additional data are not submitted within the deadlines (30 or 48 months), PPP application on flowering crops and on “foraging bee areas” would no longer be possible.
  5. A notification of the submission of the required additional data and of the uses concerned would have to be made 18 months before the submission.
  6. For PPPs other than insecticides and fungicides whose authorisation renewal will be in more than 30 months after the entry into force of the new “bee” Order AND in the case of minor uses in France:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses conclusions on the renewal dossier. The required additional data would have to be submitted with the renewal dossier with no specific notification needed.

Given the current timeline, the new “bee” Order could be released by the end of 2021.

European context

The strengthening projet of the French measures for pollinators happens in a context of evolution of the pollinator protection policy at European level, with the current revision of the EFSA guidance document (EFSA Journal 2013;11(7):3295; see our previous articles) and with the revision of the uniform principles for evaluation and authorisation of PPPs as regards pollinators (Regulation (EU) No. 546/2011).

On 28 June 2021, a majority of Member States voted in favour of the European Commission’s proposal for a protection goal of 10% as a maximum permitted level of honeybee colony size reduction. This threshold will now be integrated into the draft updated EFSA guidance document for finalisation. The final version could be released by the end of 2021.

As regards uniform principles, their revision could take place in the first half of 2022.

 

To download (in French): 

Draft National Plan in Favour of bees and other pollinating insects – Version of 28.06.2021 for Public Consultation.

Draft Order as Regards the Protection of Bees and Other Pollinating Insects and the Maintenance of Pollination Service when Using Plant Protection Products – Version of 28.06.2021 for Public Consultation.

 

See also our previous articles: 

FRANCE – Anses: Recommendations for the Risk Assessment for Bees and Other Pollinators   

FRANCE – ANSES: recommendations to strengthen the protection of bees

EUROPE-EFSA: Latest Progress in the Revision of the 2013 Bee Guidance

 

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

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

 

FRANCE: Update of the list of spray drift reduction equipment

The French list of spray drift reduction equipment was updated by DGAL/SDQSPV/2021-364 note of 17 May 2021. This note repeals the previous one DGAL/SDQSPV/2020-689 of 06 November 2020.

These equipments allow the reduction of the width of unsprayed buffer zones from water bodies, as well as the safety distances nearby residential areas. New equipments were added for vineyards, orchards and low crops. In addition, the conditions of use of  some equipments were specified.

 

To download:

DGAL/SDQSPV/2021-364 Note (in French)

 

Texts of reference:

Arrêté du 4 mai 2017 relatif à la mise sur le marché et à l’utilisation des produits visés à l’article L.253-1 du code rural modifié par l’arrêté du 27 décembre 2019 (in French)

 

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

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

FRANCE: Update of the national catalog of plant protection uses

The Order of 12 April 2021, published in the Official Journal of the French Republic of 21 April 2021, repeals the Order of 26 March 2014 on the implementation of the national catalog of plant protection uses.

This Order takes into account the latest updates of the catalog by providing adaptations of marketing authorisations (Annexes 1 and 2). It also defines the scope of the use and lists the transitional uses (Annex 3). An “Experimentation” section has also been included in the catalog for each use in order to identify the main pests representative of the use and for which biological efficacy data are expected.

 

To be noted:

Annex 2 of the new catalog of uses lists the correspondences between the old and the new wordings of the plant protection uses. If necessary, updates of this annex will be published in the Official Bulletin of the Ministry of Agriculture. ANSES will adapt the marketing authorisations and parallel trade permits within 6 months following the application date of the Order. A 6-month period will also apply following the publication of an amendment of this annex 2. The modifications of authorisation will be made public directly on the Ephy website. The products whose first marketing authorisation is granted within 18 months following the publication of amendment of Annex 2 may still be sold and used until stock depletion and without updating labels. Products firstly authorised after this 18-month period will have to be labelled in accordance with the amendments of Annex 2.

Applications for marketing authorisations and parallel trade permits will have to be in compliance with the new version of the catalog of uses at least 6 months after its publication. Applications submitted before this deadline may refer to the old version.

However, applications for marketing authorisations cannot refer to the transitional uses listed in the Annex 3 of the catalog of uses in force at the time of the submission, except for applications for marketing authorisation for resale products, generic products or parallel trade permits. The corresponding uses listed in this annex should be used.

 

To download: 

Order of 12 April 2021 on the implementation of the national catalog of plant protection uses specified in the marketing authorisation and parallel trade permit decisions of plant protection products and adjuvants (in French)

Technical instruction DGAL/SDQSPV/2021-278 (12.04.2021): National catalog of plant protection products (in French)

 

See also our previous articles: 

FRANCE: National PPP uses catalog – New DGAL memo

FRANCE: Focus on the changes in the catalog of uses

 

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

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

 

FRANCE – ANSES: Implementation of the regulatory provisions on banned co-formulants

Following the publication of the list of co-formulants banned in plant protection products (PPP), adjuvants and mixed products (Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009), ANSES published on 24 March 2021 a note concerning the implementation of these new regulatory provisions.

  • For all on going applications for marketing authorisation submitted before 24.03.2021 for products containing a co-formulant listed in Annex III: an application for a non-significant change of composition should be submitted before 24 September 2021 under the form of dossiers of “Application for modification of declared information in a pending application” (PMOI). In the absence of such an application, the marketing authorisation will not be granted.

  • For all marketing authorisations existing on 24.03.2021: all authorisation holders will receive a letter from ANSES asking them to fill in the Table of banned coformulants and to send it back by 31 May 2021 at the latest. Holders of marketing authorisation should indicate whether they will apply for a non-significant change of composition. The compliance with the deadline of 31 May 2021 is a prerequisite for maintaining the authorisations. If an application for a non-significant change of composition is planned, the marketing authorisation holder must submit it before 24 March 2022 or face authorisation withdrawal. A modification of the marketing authorisation will be issued in case of positive conclusions of evaluation of the composition change.

 

Removal procedure

ANSES will proceed quickly to the analysis of all the received answers. In case of withdrawal, a letter of withdrawal intention will be sent to the marketing authorisation holders who will have 10 working days to submit their observations. These will be analysed by ANSES which will decide to maintain the marketing authorisations or to withdraw them by 24 March 2023 at the latest.

Grace periods may not exceed 3 months for sale and distribution and 9 additional months for the disposal, storage and use for the withdrawn products.

 

To download: 

ANSES note – Implementation of the regulatory provisions on banned co-formulants – Version 1 of 24.03.2021 (in French)

Table of banned coformulants to be sent by 31 May 2021

 

See also our previous articles: 

EUROPE – COM: Publication of the list of co-formulants banned in PPP

 

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

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

 

FRANCE – ANSES: Product labelling following PPE updates in marketing authorisations

On 02.03.2021, ANSES published an update of its note on the procedure for updating personal protective equipment (PPE) in marketing authorisations.

As a reminder, all dossiers for which a marketing authorisation was issued after 1 January 2020 required an update of the PPE by the authorisation holders. ANSES has then issued decisions amending the marketing authorisations. The updated note indicates in particular that this PPE review does not require to update the labels, in accordance with Article R253-42-II of the French Rural Code, for the products already labelled before the date of decision amending the marketing authorisations.

 

To download: 

ANSES Note – Updating of personal protective equipments mentioned in the marketing authorisations of plant protection products, in application of article 15 of the Order of 04 May 2017 amended by the Order of  27 December 2019 – Version 2 of 02.03.2021 (in French)

 

See also our previous articles: 

FRANCE – ANSES: Procedures for updating PPE in marketing authorisations

 

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

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

 

FRANCE: Specific provisions for the ban extension of plant protection products in 2022

Since 1 January 2017, the Labbé’s law aims to better regulate the use of plant protection products in France by banning their use for amenity areas, forest and areas accessible or open to the public (excluding biocontrol products officially listed by the Ministry of Agriculture in accordance with articles L.253-5 and L.253-7 of the Rural Code, low-risk products or organic farming products). Since 1 January 2019, this ban has been extended to all non-professional users.

On 21 January 2021, the Order of 15 January 2021 was published in the Official Journal of French Republic as regards measures to protect people when using plant protection products in private properties, places frequented by the public and places for collective use and amending the Order of 4 May 2017 as regards the placing on the market and the use of plant protection products and their adjuvants referred to in Article L. 253-1 of the French Rural Code.

This Order extends the Labbé’s law bans on the use of plant protection products to various places frequented by the public or for collective use as of 1 July 2022, such as:

  • Private residential properties;
  • Hotels, collective inns, campsites and residential leisure parks;
  • Cemeteries and columbariums;
  • Family gardens and amusement parks;
  • Commercial and service areas;
  • Workplaces;
  • Educational institutions;
  • Health facilities;
  • Social and medico-social facilities;
  • Childminder homes;
  • Sport equipments;
  • Aerodromes (excluding areas requiring treatment for safety reasons).

The ban does not apply to treatments and measures necessary for the destruction and prevention of the spread of regulated harmful organisms, or to treatments necessary for the control of significant health hazard threatening the historical or biological legacy.

Regarding sport equipments (large sport grounds, hippodromes, tennis courts, golf courts and practices), an exemption will be granted until 1 January 2025 for uses with no suitable alternative technical solution for achieving the quality required in the context of official competitions.

 

To download: 

Order of 15 January 2021 as regards measures to protect people when using plant protection products in private properties, places frequented by the public and places for collective use and amending the Order of 4 May 2017 as regards the placing on the market and the use of plant protection products and their adjuvants referred to in Article L. 253-1 of the French Rural Code (in French)

 

See also our previous articles: 

FRANCE – Public consultation: Extension of the ban of plant protection products in 2022

 

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

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

 

FRANCE: List of substances concerned by the Tax on Diffuse Pollution for 2021

The updated list of substances concerned by the French Tax on Diffuse Pollution has been published in the Official Journal of 13 December 2020. Some modifications have been performed in comparison to the list published in October 2020 for public consultation.

The changes in comparison to the 2019 list correspond to new knowledge on the classification of the substances. The update is based in particular on Regulation (EC) No 1272/2008 as amended by the 14th ATP for the purposes of its adaptation to technical and scientific progress, on opinions on non-harmonised substances published by ANSES, on opinions published by EFSA or on the RAC of ECHA (Risk Assessment Committee of the European Chemicals Agency). On the basis of the information collected, the highest mention attributed to the substance is used to define the tax category.

The new list applies by 1st January 2021.

 

To download: 

Order of 07 December 2020 establishing the list of substances defined by Article L. 213-10-8 of the Environment code as regards the tax on diffuse pollution (in French)

 

See also our previous articles: 

FRANCE: Updated list of substances concerned by the Tax on Diffuse Pollution for public consultation

 

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

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

 

FRANCE – ANSES: Procedures for updating PPE in marketing authorisations

Following the entry into force on 1 January 2020 of the Order of 27 December 2019 on measures for the protection of persons using plant protection products, users should replace the personal protective equipment (PPE) currently mentioned in the marketing authorisations by equipment complying with the new requirements.

On 26 November 2020, ANSES published a note on procedures for updating PPE:

  • For marketing authorisations issued before 1 January 2020, the user will have to replace the PPE, but without notifying it to ANSES.
  • For marketing authorisations issued after 1 January 2020, a request to update PPE is sent to the authorisation holder, who will have to reply within 2 months by email.
  • For all new marketing authorisation applications submitted from 26 November 2020, PPE proposed by the applicant must comply with the new requirements.
  • For the applications currently under instruction, applicants are encouraged to send a single letter to ANSES to update the PPE in all applications under examination. For each application (including the type of application, the brand name of the product and ANSES reference number), a table of equivalence between the PPE initially proposed and the updated PPE must be provided. If no letter is provided, a request to update PPE will be sent directly to the applicants by ANSES departments.

 

The PPE updates concern in particular clothing and gloves:

PPE type Old requirements New requirements
Clothing Water-repellent working coveralls (polyester 65% / cotton 35% – minimum weight 230 g/m²) Clothing PPE certified NF EN ISO 27065/A1
Reusable gloves Nitrile gloves certified EN 374-3 Nitrile gloves certified NF EN ISO 374-1/A1 and NF EN 16523-1+A1 (type A)
Single use gloves Single use nitrile gloves certified EN 374-2 Single use nitrile gloves certified NF EN ISO 374-1/A1 and NF EN ISO 374-2 (types A, B or C)

 

To download: 

ANSES Note – Updating of personal protective equipments mentioned in the marketing authorisations of plant protection products, in application of article 15 of the Order of 04 May 2017 amended by the Order of  27 December 2019 – Version 1 of 26.11.2020 (in French)

Order of 27 December 2019 relating to measures for the protection of persons using plant protection products (in French)

 

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

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

 

FRANCE: Implementation of the national biocontrol strategy for 2020-2025

The “EGAlim” law of 30 October 2018 planned the implementation of a national strategy for biocontrol products in order to reduce the risks and the effects of the use of plant protection products on human health and the environment.

On 10 November 2020, the Government published its national strategy with the main priorities in progress or to be developed in order to promote the development and the use of biocontrol products as an alternative to conventional plant protection products.

4 main priorities have been defined:

– Innovation: accelerate research, industrialisation and development of new biocontrol solutions

→ Improve knowledge, foster and support companies in the development and industrialisation of new products…

– Regulation: Simplify the procedures for the authorisation and the use of biocontrol solutions

→ Strengthen the definition of biocontrol, simplify the submission of applications for authorisation/renewal of macro-organisms, reduce delays for decisions, grant the logo “Usable in Organic Farming (UAB)” faster…

– Ensure the implementation of biocontrol in France

→ Develop trial sites, inform the public to promote biocontrol, develop and strengthen the training of professional users, provide appropriate and independent advice, support farmers…

– Promote biocontrol at European level

→ Achieve a target of 50% reduction of the use of plant protection products by 2025 as set by the European Green Pact and the European Commission’s “farm to fork” strategy.

 

To download: 

National implementation strategy for biocontrol (in French)

 

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

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