FRANCE: Ban of Neonicotinoids – A Derogation for Sugar Beets

The Law establishing a possibility of derogation from the ban on neonicotinoids and other substances having the same mode of action in case of emergency situations for sugar beets was released in mid-December 2020.

The derogations will be set by joint orders of the Ministers of Agriculture and of the Environment after the release of an opinion by a new dedicated Supervisory Board. Derogations will be granted according to the procedures provided for emergency situations in the European regulation by Article 53 of Regulation (EC) No 1107/2009.

Derogations may only be granted in the case of treated seeds (spray treatments are therefore excluded) and only until 1st July 2023, pending alternative solutions are developed.

To limit potential impacts on pollinators, the Law also stipulates that seeding or planting attractive crops in treated fields shall be temporarily banned.

In parallel, the Decree updating the list of banned neonicotinoids and other active substances with an identical mode of action was also released (see our previous article). As a reminder, the three banned substances still authorised at European level are acetamiprid, flupyradifurone and sulfoxaflor.

 

To download (in French): 

Law No. 2020-1578 of 14 December 2020 as regards the conditions of placing on the market of plant protection products in case of emergency situations for sugar beets.

Decree No. 2020-1601 of 16 December 2020 listing the banned active substances from the neonicotinoids family or with a neonicotinoid-like mode of action in accordance with Article L. 253-8 of the French Rural Code.

 

See also our previous articles: 

FRANCE: Update of the list of neonicotinoids substances banned

 

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

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EUROPE – COM: Updated AIR4 and AIR5 work programmes

The AIR4 and AIR5 work programmes for active substances renewal have just been updated by DG SANTE following the recent publication of Regulation (EU) No 2020/1740 repealing Regulation (EU) No 844/2012 as regards the provisions necessary for the implementation of the renewal procedure for active substances under Regulation (EC) No 1107/2009.

Application dates for substances for which the new renewal rules apply according to Reg. (EU) No 2020/1740 have been indicated. The application consists of providing the complete renewal dossier.

The “old renewal rules” of Regulation (EU) No 844/2012 still apply to most of the active substances of the AIR4 programme. Only some active substances from group 4(2) are covered by the “new renewal rules”.

In addition, the “new renewal rules” apply to the majority of the active substances of the AIR5 programme.

 

To download: 

SANTE-2016-10616-rev 13 (December 2020): Draft working document AIR IV renewal programme

SANTE-2018-10048-rev 4 (December 2020): Draft working document establishing the fifth renewal programme

 

See also our previous articles: 

EUROPE – COM: updated AIR4 and AIR5 work programme

EUROPE – COM: New renewal procedure for active substances

 

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

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

 

FRANCE: Withdrawal of 5 active substances-based products

As a result of the entry into force of Regulations (EU) 2020/1280 of 14 September 2020, 2020/892 of 29 June 2020, 2020/1276 of 11 September 2020 and 2020/1498 of 15 October 2020 concerning respectively the non-renewal of benalaxyl, beta-cyfluthrin, bromoxynil and thiophanate-methyl approval, ANSES will withdraw from the first half of 2021, 14 authorisations and 3 parallel trade permits for plant protection products containing these substances.

In the context of the expiry of the approval of the active substance spirodiclofen on 31.07.2020, ANSES has also withdrawn, from 07 December 2020, one authorisation and 3 parallel trade permits for plant protection products containing this substance.

Active substance Benalaxyl Beta-cyfluthrin Bromoxynil Thiophanate-methyl Spirodiclofen
Withdrawal date 05.04.2021 20.01.2021 17.03.2021 19.04.2021 07.12.2020
End of sales and distribution 05.07.2021 20.04.2021 17.03.2021 19.04.2021 31.01.2021
End of use of the stocks of products 05.10.2021 20.07.2021 17.09.2021 19.10.2021 31.07.2021

 

To download: 

List of withdrawal of products based on benalaxyl, beta-cyfluthrin, bromoxynil and thiophanate-methyl (in French)

List of withdrawal of products based on spirodiclofen (in French)

 

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

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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: Brexit impact on parallel trade permits

Following the upcoming end of the transition period set up in the context of the United Kingdom’s exit from the European Union, ANSES published a note to update the procedures relating to the mutual recognitions and parallel trade permits in France.

It should be noted that for parallel trade permits, products from the United Kingdom will no longer be imported in France after 31.12.2020. Thus, all parallel trade permits with UK origine will be withdrawn on 31.12.2020 and those with multiple origins will be amended from 01.01.2021 to remove the UK origin.

Products already on the French market before 31.12.2020 are allowed to be made available to users under the following conditions:

  • A 6-month grace period for sale and distribution is granted (up to 30.06.2021)
  • An additional 12-month grace period is granted for storage and use of products (up to 30.06.2022)

 

To download: 

Anses paper as regards « Brexit » impact on mutual recognitions and parallel trade permits – Version of 26.11.2020 (in French)

 

See also our previous articles: 

France – ANSES: Brexit impact on mutual recognitions and parallel trade permits

 

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

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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.

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EUROPE – COM: New renewal procedure for active substances

Commission Regulation (EU) 2020/1740 of 20 November 2020 repeals Commission Regulation (EU) 844/2012 and sets out the new provisions necessary for the implementation of the renewal procedure for active substances. This follows the adoption of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (EFSA) conducts a scientific risk assessment. Both regulations will apply from 27 March 2021.

The main changes deal with the schedule of the different steps of the renewal procedure, in particular:

  • the provision of pre-submission advice on intended tests and studies for the purposes of a renewal, preceded by a specific notification by the potential applicant and consultation of third parties;
  • the submission of renewal applications on a central online system via the IUCLID software at least three years before the expiry of the approval period of an active substance.

Regulation (EU) 2020/1740 applies for all active substances whose approval period expires on or after 27 March 2024.

In this context, for several active substances, the approval periods have been extended by Regulation (EU) 2020/2007 of 8 December 2020 to allow applicants to prepare and submit their dossiers in the required format.

 

To download: 

Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020

Commission Implementing Regulation (EU) 2020/2007 of 8 December 2020

 

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

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