FRANCE: Withdrawal of chloridazon-, imazaquin- and quinoclamine-based products

Further to the expiry of approval of chloridazon, imazaquin and quinoclamine on 31 December 2018, ANSES withdraw 9 authorisations and 1 parallel trade permit for plant protection products containing these active substances.

 

The authorisations are withdrawn on 31.12.2019.

The end of sales and distribution is set on 30.06.2020.

The end of use of the stocks of products is set on 31.12.2020.

 

To download: List of withdrawal of products based on chloridazon, imazaquin and quinoclamine (in French)

 

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

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Keywords: pesticides ban

 

FRANCE: Parliamentary report on the strategy relative to glyphosate phase out

The joint information mission on monitoring the glyphosate phase out strategy provided an information report to the government on 12th November.

The purpose of this mission is to monitor the transition of the French Agriculture towards the ban of the main uses of glyphosate from 1st January 2021 and all its uses on 1st January 2023, in accordance with the commitments of the French Government.

The first part of the report concerns the difficulty of establishing a “T Zero” panorama of the use of glyphosate in France.

The second part of the report deals with the agronomic obstacles that persist. Indeed the authors highlight that two years after the INRA report dated November 2017 “Uses and alternatives to glyphosate in French agriculture” which focused on several technical dead ends, these are still existing and impose crucial choices. They result in serious agronomic dilemmas, especially when the only effective alternative to glyphosate currently available would be to question the “no-till” approach of conservation agriculture developed to fight against soil erosion and depletion. These technical dead ends also give rise to economic, territorial or health difficulties: the ban of glyphosate could lead to the outright cessation of cultivation of certain crops but also to the end of the agricultural exploitation of important parts of our territory, or even the essential fight against plants harmful to human health.

The parliamentary report indicates that this transition will have a high cost, regardless of the sector and whatever alternatives are available. A cost that will weigh heavily on operators whose economic balance is often precarious. So it seems essential to think about a real financial support for farmers.

Facing these concerns, sometimes these hesitations, the mission expects the Government to clarify its message to farmers, namely: what uses will benefit from a derogation on 1st January 2021 and what regulatory or legislative measures will be taken?

 

To download: Information report No.2406 of the joint information mission on the monitoring of the strategy relative to glyphosate phase out (in French)

 

See also our previous articles: 

FRANCE: Glyphosate phase-out plan issued

FRANCE: Towards glyphosate phase out

 

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

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

 

FRANCE: Withdrawal of chlorothalonil-based products

As a result of the entry into force of Regulation (EU) 2019/677 of 29th April 2019 concerning the non-renewal of chlorothalonil approval, ANSES withdraw 25 authorisations and 8 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 20.02.2020.

The end of use of the stocks of products is set on 20.05.2020.

 

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

 

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

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

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

In 2018, the Ministries of Agriculture and Ecological Transition asked Anses to make recommendations aimed at strengthening the regulatory framework for the protection of bees and other pollinators in France. Following this request and the first issued recommendations (Referral No. 2018-SA-0147in French), Anses began working on an update of the risk assessment procedure for bees and other pollinators in the context of Plant Protection Products authorisations (PPPs). On 28 October 2019, Anses published the conclusions of this work and its recommendations (Referral No. 2019-SA-0097in French).

Anses recommends replacing the current bee risk assessment scheme (based on SANCO/10329, 2002 and EPPO, 2010), by an approach based on the current version of the EFSA Bee guidance document (version of 4 July 2014, EFSA Journal 2013;11(7):3295), pending an harmonised approach is validated at European level. It is noted that the EFSA guidance document (2013) has not been adopted at EU level and is currently under revision by EFSA subsequent to a mandate from the European Commission (see our previous articles on this topic).

Anses recommendations concerning the new risk assessment scheme for bees and other pollinators are detailed below.

Effect assessment

Studies conducted with PPPs are recommended regardless of the type of PPP and regardless of the number of active substances they contain. Studies on honey bees and bumble bees are currently recommended.

Recommended laboratory toxicity studies

* on 14 June 2019

** Study required for all PPPs as soon as a chronic exposure to PPP cannot be excluded for any of the EFSA exposure scenario.

Recommended semi-field (tunnel) and field studies

Honey bees

When an acceptable risk cannot be demonstrated with laboratory studies, the recommended higher tier studies are those referred to in the European Commission documents in relation to Regulations (EU) No. 283/2013 and 284/2013:

Anses also refers to recommendations for tunnel and field studies from the EPPO Standard PP1/170 (4) (EPPO, 2010).

Tunnel and field studies are assessed in light of the protection goal for bees: it must be demonstrated that “under  field conditions  there are no unacceptable  effects on honeybee larvae,  honeybee behaviour, or colony  survival and development after use  of the plant protection product in accordance  with the proposed conditions of use” (Reg. (EU) No. 546/2011).

Other pollinators

Given the lack of validated standard protocol, no particular test is recommended by Anses. Anses however indicates that the studies should allow the assessment of an expected effect on the colony survival and on the colony ability to produce new fertile individuals that will perpetuate the cycle the following year.

Considered routes of exposure and risk assessments

With some exceptions, Anses recommends that exposure assessments be based on the EFSA Guidance Document (2013) for sprayed PPPs or for PPPs used for granular application or for seed treatment.

Initial risk assessments

For honey bees, it is noted that the scenario of oral exposure via guttation water is currently not recommended by Anses because the EFSA’s assessment method is deemed to be affected by too important uncertainties. In addition, guttation water is not regarded as a major exposure route. Exposure via guttation water may be considered once the methodology has been updated by EFSA.

A risk assessment for effects on the hypopharyngeal glands or for cumulative effects is also not recommended at this time due to the lack of validated experimental protocols available.

For bumble bees, only the acute risk for adults is considered. No further evaluation is recommended at this time due to the lack of validated experimental protocols available.

Regarding solitary bees, no assessment is recommended at this time due to the lack of validated experimental protocols available.

Risk quotients (“HQ”, “ETR”) should be compared to the threshold values as defined in the revision SANTE/10094/2015 (in the course of adoption) of the Regulation (EU) No. 546/2011. This revision will update the threshold values for the honey bee acute risk assessments on the basis of the threshold values defined in the current EFSA guidance document (2013). It is noted that document SANTE/10094/2015 does not mention threshold values for the honey bee chronic and larvae risk assessments, and for the bumble bee acute risk assessments. Nevertheless, in the absence of established threshold values, Anses recommends the use of the threshold values defined in EFSA (2013).

Refined risk assessments

When an acceptable risk cannot be demonstrated with laboratory studies, several options may be proposed:

  • Mitigation measures for problematic scenario (i.e. different variants of the SPe 8 phrase and mitigation measures as reported in EFSA guidance document (2013)).
  • Specific studies supporting the non relevance of certain exposure scenario or studies allowing to refine default exposure levels (residue studies conducted in pollen/nectar, residue dissipation studies, determination of the nectar sugar content of crops, etc.).
  • Higher tier studies (e.g. tunnel or field studies, studies assessing the ability of foragers to return to the hive).
Assessments for microorganism-based PPPs

For microorganism-based PPPs, the same methodology as for chemical-based PPPs is recommended. Adaptations of available experimental protocols are however recommended to justify the lack of pathogenicity/infectivity of microorganisms.

Perspective of the recommended risk assessment scheme

Anses indicates that the recommendations are made on the basis of the current version of the EFSA guidance document (2013) and on the basis of validated experimental guidelines currently available. Therefore, Anses call for:

  • An update of these recommendations after the revision of the EFSA guidance document (expected for March 2021).
  • An update of these recommendations as soon as a new experimental protocol is validated (e.g. acute toxicity assay on adults – solitary bees, chronic toxicity assay on adults and toxicity assay on larvae – bumble and solitary bees).
  • The development of new standardised assays for assessing the effects of microorganism-based PPPs.
  • The determination of regulatory threshold values for the chronic risk assessment for adults and for the risk assessment for larvae.

 

To download (in French): 

AVIS de l’Anses relatif à l’Evolution de la méthodologie d’évaluation du risque vis-à-vis des abeilles domestiques et des insectes pollinisateurs sauvages dans le cadre des dossiers de demande d’AMM des produits phytopharmaceutiques (Saisine n° 2019-SA-0097)

 

See also our previous articles: 

EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published

FRANCE – ANSES: recommendations to strengthen the protection of bees

 

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

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