FRANCE: National memo on sustainable management of fungicides resistance of Sclerotinia sclerotinium in oilseed rape

The national memo on sustainable management of fungicide resistance of Sclerotinia sclerotinium on oilseed rape has been published :

This memo provides an overview of oilseed rape Sclerotinia sclerotinium resistance to the main fungicide families authorised in France and gives recommendations to limit resistance development risks and to maintain the products’ effectiveness.

 

See also our previous articles: 

FRANCE: 2020 National memos on the sustainable management of resistance to fungicides

FRANCE: 2019 National memos on the sustainable management of resistance to fungicides

 

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

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

 

LYNXEE: Appointment of Clément Coin, Efficacy expert

Lynxee consulting’s team is pleased to announce the appointment of Clément Coin.

Graduated with a Master in crop production specialised in plant protection, Clément worked during several years as a field trialist and project manager for different contractors. Then he participated to the drafting of BADs within an agrochemical company.

Thanks to his strong background both in fields and in GEP reports/BAD writing, he has a good vision of the entire data collecting and analysing chain, from the field to the BAD.

Clément joined Lynxee consulting in 2020, where he is in charge of BAD, comparative assessment and labels writing.

 

Lynxee consulting’team now counts three Efficacy Experts. Do not hesitate to contact us for quotes! http://lynxee.consulting/en/contact/

 

FRANCE: 2020 National memos on the sustainable management of resistance to fungicides

Two national memos on the sustainable management of resistance to fungicides were published:

 

  • Management of resistance to fungicides used to control cereals diseases (in French)

This memo provides an overview, by disease and by mode of action, of resistance to fungicides used to control cereal diseases and makes recommendations to limit the risk of resistance development and to maintain a good level of control.

 

  • Management of resistance to fungicides used to control vineyard diseases: downy mildew, powdery mildew, grey mould, black rot (in French)

The aim of this memo is to present the elements of preventive strategy against resistance development, to describe the 2019 general situation for the resistance of downy mildew, powdery mildew, grey mould and black rot of vine to the main families of authorised active substances, and finally to make recommendations for these resistances with the aim of decreasing and optimising fungicide treatments.

 

See also our previous articles: 

FRANCE: 2019 National memos on the sustainable management of resistance to fungicides

 

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

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

LYNXEE: Appointment of Chloé Trinchese as Expert in Physico-chemistry and Analytical methods

Lynxee consulting’s team is pleased to announce the appointment of Chloé Trinchese.

As a Chemical Engineer, Chloé began her career in formulation laboratories and then worked for ANSES (French Agency for food, environmental and occupational health and safety) as a scientific assessor in the Physical-chemistry and Analytical Methods Unit. She was in charge of the assessment of the relevant sections of the dossiers of authorisation for plant protection products and active substances.

With 5 years of experience in scientific assessment, Chloé joined Lynxee consulting, where she is involved, among others, in the drafting of registration dossiers.

Lynxee consulting’s team welcomes Chloé and encourages you to entrust her with the drafting of your dRR (Physico-chemical properties and analytical methods). You will appreciate the quality and rigour of her work.

EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP

European Commission started on 16 January 2020 a public consultation on the draft regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009). The consultation will end on 13 February 2020.

Updated versions of the draft regulation and its annex (including the list of banned co-formulants) can be downloaded via the public consultation website or via the download links below.

The new version of the regulation now specify that the grace period that can be granted by Member States for PPP or adjuvants containing a co-formulant listed in Annex III to Regulation (EC) No 1107/2009 shall expire for the sale and distribution at the latest 3 months and for the disposal, storage and use additional 9 months after the amendment or withdrawal of the authorisations.

In the new version of the annex, the following modifications are found for the entries Aluminium silicate (kaolin), Quartz sand and Silicium dioxide (in yellow) in comparison to the version of July 2019:

To download: 

New Draft Commission Regulation modifying Annex III of Regulation (EC) 1107/2009 and its Annex

 

See also our previous articles: 

EUROPE-COM : draft 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/

 

EUROPE – EFSA: New version of PERSAM tool for PECsoil calculations

EFSA recently released a new version (v3.0.0) of the PERSAM tool to conduct PECsoil calculations in agreement with the new EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (EFSA Journal 2017;15(10):4982).

This new version of PERSAM includes, among other improvements, the updates of the latest version of the EFSA guidance document (2017 release which replaced the initial guidance document published in 2015 – EFSA Journal 2015;13(4):4093).

PERSAM v3.0.0 now covers field crops grown on ridges and permanent crops in addition to the annual field crops. It also allows to conduct initial PECs calculations for microbial active substances.

PERSAM tool will be used directly for Tier 1 (pre-defined scenarios based on total area of annual crops and permanent crops) and Tier 2 calculations (crop specific) to generate PECs. For Tier 3A (more realistic approach), the tool will be used for the generation of a transfer file (initial parametrisation) that will then be used to feed updated versions of PELMO and PEARL. Hence, in Tier 3A, PECs will be generated via PELMO and PEARL models. PERSAM v3.0.0 allows to conduct calculations either at the zonal level or at the country level at Tier 2 and Tier 3A.

As a reminder, a Tier 3B using spatially distributed numerical models was also mentioned in EFSA (2017). PERSAM would not be involved in such cases. However no agreed software tools/guidance are currently available for such refinement.

Complete details of new features of PERSAM v3.0.0 can be found in section 1.2 (p. 7) of the updated PERSAM user manual, that comes with the tool (it can also be downloaded further below). PERSAM 3.0.0 can be downloaded via the ESDAC website (a request form should be fulfilled to receive a download link).

 

To download: 

Update of PERSAM software models for predicting environmental concentrations in soil in permanent crops and annual crops: User manual PERSAM 3.0.0. EFSA Supporting publication 2019:EN-1756.
(The user manual includes the description of input screens and the Tier-1 and Tier-2 calculations of the PERSAM v3.0.0.)

Software tool for calculating the predicted environmental concentrations (PEC) of plant protection products (PPP) in soil: Documented review. EFSA Supporting publication 2019:EN-1763.
(This report describes the validation of the calculation results produced by PERSAM compared to independent results.)

Update of PERSAM software models for predicting environmental concentrations in soil in permanent crops and annual crops: Software architecture. EFSA Supporting publication 2019:EN-1762.
(This report describes the software architecture of the PERsistence in Soil Analytical Model (PERSAM) software tool version 3.0.0.)

Software tool for calculating the predicted environmental concentrations (PEC) of plant protection products (PPP) in soil for permanent and annual crops: External scientific report (Final report). EFSA Supporting publication 2019:EN-1761.
(This report describes the implementation phases of PERSAM version 3.0.0.)

 

See also our previous articles: 

EFSA : Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil

 

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

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

 

Lynxee consulting recruit an Expert in Efficacy and an Expert in Residues in ‘home office’!

With 5 staff, and soon 6 with a new Chemist, our dynamic team grows again! We open a third position for a Registration Specialist in Efficacy (BAD drafting) and are still looking for a Residues Regulatory Expert for project coordination, dossiers drafting, study monitoring etc

Are you interested in this position? Have a look at the job descriptions and submit your application through our website!

 

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/