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/

 

FRANCE: Public consultation – two neonicotinoid-like active substances to be banned

The French law EGAlim of 30 October 2018 (law for achieving a balance in trade relations in the agricultural sector and for healthy, sustainable and affordable food), modified Article L253-8 of the French Rural Code to extend the ban of neonicotinoids to all active substances with a similar mode of action.

As the modalities of implementation remained to be set, the government started on 11 September 2019 a public consultation on the draft Decree listing the active substances used in plant protection products with a neonicotinoid-like mode of action. This draft Decree includes two active substances: flupyradifurone and sulfoxaflor. The ban of neonicotinoid based-products in France would therefore be extended to the products containing these substances by the end of the year.

The public consultation will be closed on 4 October 2019.

 

To download: 

Government press release as regards the draft French Decree to ban the use of two active substances with a neonicotinoid-like mode of action (in French).

The draft French Decree listing the active substances used in plant protection products with neonicotinoid-like mode of action (in French).

 

See also our previous articles: 

FRANCE: New Agriculture and Food law published

FRANCE: Withdrawal and restrictions on the use of neonicotinoid-based PPPs

 

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

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

 

FRANCE-ANSES: Update on the SDHI issue

Following an opinion published on 16/04/2018 by a group of scientists alerting on the risks related to the use of SDHI in agriculture, ANSES organised an expertise of the available scientific data and published their findings on 14/01/2019, concluding that there was no Human health alert that could lead to the withdrawal of approvals for these fungicides.

Since then, ANSES has further investigated in three directions: drawing up and financing specific research projects, detecting possible health effects that can be observed in the field via existing monitoring systems, and finally exchanging with research organisations and Human health agencies responsible for the evaluation of these substances, including the European Food Safety Authority (EFSA).

ANSES informed the European authorities, the Member States and the North American agencies of the alert about SDHI fungicides and their work on the subject in 2018, and forwarded their conclusions to EFSA, ECHA and the Member States in January 2018, so that they pay particular attention to any new data during the ongoing evaluation and renewal processes.

So far, no new information has arised to confirm the existence of a Human health alert that would lead to the withdrawal of existing approvals, in accordance with National and European regulations relating to plant protection products.

ANSES has also indicated that they are continuously improving  their plant protection products risk assessment methods. Besides the work in progress on the SDHI issue, ANSES has voluntarily decided to investigate the issue of cumulative food exposures to different SDHI in 2019. This work will be completed in the first half of 2020.

 

To learn more:

SDHI: ANSES updates on the work launched following the opinion of January 2019 (in French)

See also our previous articles: 

FRANCE: ANSES conclusions on the assessment of SDHI are available

 

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

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

EUROPE-EFSA: Recurring Issues in Ecotoxicology

EFSA published a technical report on the outcome of expert’s discussions in Ecotoxicology that took place during Pesticide Peer Review Meeting 185 in October 2018.

Numerous general and specific issues are addressed. The specific issues discussed are related to risk assessment for terrestrial vertebrates, aquatic organisms, non-target arthropods, soil organisms and non-target terrestrial plants.

 

To download: 

Outcome of the Pesticides Peer Review Meeting on general recurring issues in ecotoxicology – EFSA Supporting publication 2019:EN-1673.

 

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

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

 

LYNXEE: Appointment of Claire Vannier as Expert in Efficacy

Lynxee consulting’s team is pleased to announce the appointment of Claire Vannier.

With a Master 2 in Biology, Bioprotection and Biotechnology in Environment, Claire began her career as a field trialist in different agrochemical companies (Dow AgroSciences, BASF, DuPont Solution).

She was then in charge of drafting biological assessment dossiers (BAD), activity that she has been practicing since more than 7 years.

Thanks to these complementary experiences, she joined Lynxee consulting to reinforce the Efficacy Team. She is involved, among others, in the drafting of BAD, comparative assessment, labels and in field trials project management.

Lynxee consulting’s team welcomes Claire and encourages you to entrust her with the preparation of your BADs. You will appreciate her excellent knowledge of field testing and her rigour in trial compilation.

 

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

In March 2019, the European Commission mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295). In this context, EFSA just released the timelines for the guidance review (available to download below).

The first consultation will begin in a few weeks. Stakeholder and Member State representatives will be invited to give their views on the current guidance document. As announced in May 2019, the stakeholder feedback will be provided by a consultation group which has been selected by EFSA. The details of the consultation group members has also been released by EFSA (available to download below).

After a full public consultation to be held during summer 2020, the publication of the final revised guidance should be published in March 2021.

 

To download: 

Outline of the revision of the guidance on the risk assessment of plant protection products and bees

Meeting of the Selection Board for EFSA’s Stakeholder Consultation Group for the review of the Bee Guidance Document

 

See also our previous articles:

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

 

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

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

 

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

 

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

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

 

EUROPE – EFSA: Issues in Physical and Chemical Properties and Analytical Methods

EFSA published a technical report on the outcome of expert’s discussions in the area of physical and chemical properties and analytical methods that took place during a Pesticide Peer Review Meeting in November 2018.

The main issues identified are related to (i) the quality and level of details of the renewal assessment reports and (ii) the adherence to the new data requirements, in particular regarding analytical methods and general issues regarding the assessment of the impurity profiles and specifications of the technical material. Discussions which focused mainly on national authorisation of Plant Protection Products (PPP) were not included in this EFSA technical report.

The main topics addressed are:

  • CRD guidance on physical and chemical properties
  • Physical-chemical properties of active substances and PPP
  • Revision of some guidance documents
  • Methods used for the generation of pre-approval data
  • Monitoring methods for body fluids and tissues
  • Evaluation of extraction efficiency in residue analytical methods
  • Guidance of isomers
  • Impurities
  • Five representative batches
  • Confirmation of analyte identification (active substance, relevant and significant impurities)
  • LOQ for relevant and significant impurities (5 batch analysis)
  • Detected but not quantified impurities (5 batch analysis)
  • Specifications
  • Microorganisms
  • Equivalence assessment issues for PPP authorisation at MS level

For each issue addressed in the document, a background is presented followed by the outcome of discussions reflecting the opinion of the majority of the participating experts and the associated EFSA proposals.

 

To download:

Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods – EFSA Supporting publication 2019:EN-1623

 

See also our previous articles:

EFSA: Issues in physical-chemical properties and analytical methods

 

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

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

 

FRANCE – ANSES: recommendations to strengthen the protection of bees

As part of the French action plan on plant protection products (PPP) and on a less pesticide-dependent agriculture, ANSES was seized mid-2018 by the Ministries of Agriculture and Ecological Transition to make recommendations aimed at strengthening the regulatory framework for the protection of bees and other pollinating insects.

ANSES was notably asked to review the requirements to obtain an exemption like a “Bee claim”, as defined by the French decree of 28 November 2003. As a reminder, this national measure supplements and strengthens the European legislation as regards the use of insecticides and acaricides. It bans the spray application of these PPP during flowering and/or honeydew production periods, except in the case of a justified exemption and the attribution of a “Bee claim”.

After an analysis of all available data (in particular those coming from national monitoring networks), ANSES issued the following recommendations:

  • Extend the ban of spraying insecticides and acaricides during flowering and/or honeydew production periods:  
    • to all PPP sprayed during these periods,
    • to all PPP containing systemic active substances and sprayed before flowering of the crop or used as seed treatments,
    • including, microbial-based PPP.
  • Require new types of studies to obtain the exemption “Bee claim” (including for products already authorised) or for the use of systemic active substances via spray application before flowering of the crop or via seed treatments:
    • Honeybees (A. mellifera)
      • Larval toxicity test following repeated exposure (OECD GD 239),
      • Study of effects other than brood development following a chronic exposure (laboratory test on adult bees, 20-30 days exposure) – after validation of the test,
      • Study of long-term effects following an acute exposure (hypopharyngeal gland development) – after validation of the test, and
      • Study of behavioral effects (homing capacity of forager bees) – after validation of the test – in the case of insecticides targeting the central nervous system.
    • Bumblebees (B. terrestris)
      • Acute oral and contact toxicity tests, and
      • Toxicity tests under more realistic conditions (e.g. tunnel) – after validation of the tests

ANSES also reiterates its previous recommendations made to protect bees in the context of the French decree of 28 November 2003 (2013-SA-0234 – in French): irrespective of the crop concerned, PPP with an exemption “Bee claim” should only be applied after sunset and within the next three hours, with measures to ensure operator safety.

Finally, while the “new” EFSA Guidance on Bees (EFSA Journal 2013;11(7):3295) has still not been implemented at EU level, ANSES will start an update of the risk assessment approach for bees and other pollinators. This work will be based on the methodology proposed by EFSA, in particular for the chronic risk assessment for bees (adults and larvae), and by taking into account different exposure scenarios.

To download (in French):

AVIS de l’Anses relatif à l’évolution des dispositions réglementaires visant à protéger les abeilles et les insectes pollinisateurs sauvages (Saisine 2018-SA-0147)

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

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