FRANCE: Withdrawal of Diquat-based products

As a result of the entry into force of Regulation (EU) 2018/1532 concerning the non-renewal of diquat approval, ANSES has withdrawn 15 authorisations and 4 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 04.08.2019.

The end of use of the stocks of products is set on 04.11.2019.

 

To download: List of withdrawal of products based on diquat (in French)

 

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FRANCE – ANSES: Epoxiconazole-based products ban

On 28 May 2019, Anses opinion on endocrine-disrupting properties of the active substance epoxiconazole was published and the  withdrawal of marketing authorisations of epoxiconazole-based products was announced.

Epoxiconazole is a fungicide active substance listed as candidate for substitution by Regulation (EU)  2015/408. This substance is persistent and toxic, a suspected carcinogen (C2) and presumed human reproductive toxicant (R1B). The authorisation of epoxiconazole is under evaluation at EU level. A decision should be taken by 30 April 2020.

Further to the adoption of the European legislation on endocrine disruptors in December 2017 and to the implementation of the guidance document on identification published on 5 June 2018, ANSES immediately issued an internal assessment of endocrine-disrupting properties of epoxiconazole.

Based on this evaluation, Anses have concluded that epoxiconazole is an endocrine disruptor for humans and non-target organisms.

For this reason, ANSES has notified the authorisation holders of its intention to withdraw 76 epoxiconazole-based products from the French  market.

To download:

ANSES OPINION on endocrine-disrupting properties of epoxiconazole (in French)

 

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France: Article 43 evaluation grouping for products containing more than one active substance

Anses has published a note detailing the requirements for grouping article 43 renewal applications in accordance with Regulation (EC) No.1107/2009.

It is noted that the applicant shall apply for a renewal of authorisation within 3 months of the renewal of each  active substance contained in the product. When the product contains more than one active substance, evaluations of the renewal dossiers of the product can be grouped, if the approval expiry dates of the substances are spaced by less than 12 months. The decision of grouping is granted by the zonal Rapporteur Member State (zRMS). When evaluations are grouped, only one fee is requested. The fee can also be adjusted  in some cases.

To download:

Gestion d’une demande de renouvellement d’AMM pour un produit phytopharmaceutique comportant au moins deux substances actives dont les dates de fin d’approbation sont espacées de moins d’un an (in French – Version dated  10 April 2019)

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EUROPE-EFSA: Consultative Group for the Review of the Bee Guidance Document 2013

In March 2019, the European Commission (EC) mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295) which has still not been adopted at EU level. The scope of the mandate is to revise several areas of the current guidance document as asked by Member States and stakeholders and by considering new scientific evidence that has become available since its publication in 2013.

In particular, the EC asked for a review focused on:

  • Bee background mortality,
  • Exposure routes,
  • The list of bee-attractive crops,
  • The methodology with regard to higher tier testing.

For the purpose of the revision of the guidance, EFSA is setting up a stakeholder consultative group which will be consulted at various stages during the review and provide input to the EFSA scientific working group charged with revising the document. A call for stakeholder expert representatives was started by EFSA on 8 May 2019 with a deadline for application on 21 May 2019 (Please refer to Call to EFSA stakeholder organisations below). EFSA will select for the consultative group a maximum of 14 stakeholder  expert representatives from the nomination received.

Besides, Member State’ experts will also be consulted during the revision process and a public consultation and workshop will be held once a draft of the revised document is available.

Further details including timelines about how EFSA plans to address the mandate will be published by July 2019. According to EFSA, the revised guidance is to expected in 2021.

 

To download:

Call to EFSA stakeholder organisations for nominating stakeholder experts to the ad hoc EFSA Bee Guidance Stakeholder Consultation Group

 

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