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.

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FRANCE: Confirmation of the ban of two neonicotinoid-like active substances

The French government is committed to reducing the impact of plant protection products on pollinators and ecosystems. In this context, the government implements the ban set by the French law EGALim of 30 October 2018 for active substances with a neonicotinoid-like mode of action by publishing on 31 December 2019 a decree that lists the two substances currently meeting this definition:  flupyradifurone and sulfoxaflor.

The decree enters into force on 1st January 2020.

 

To download: 

Government press release  (in French).

Decree No. 2019-1519 of 30 December 2019 listing the active substances used in plant protection products with neonicotinoid-like modes of action (in French).

 

See also our previous articles: 

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

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

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FRANCE – Enforcement of the new system for protecting residents when using plant protection products

The order and the decree regarding the new framework for the use of plant protection products near habitations were published in the French official journal of 29 December 2019.

This system is aimed in particular at strengthening the protection of health of the populations living nearby crop areas treated with plant protection products, as well as that of farmers.

The Order of 27 December 2019 reviews several articles of the Order of 4 May 2017. The existing measures regarding the protection of health and environment are extended to applications other than spraying and powdering and ban applications during heavy rains. The provisions regarding personal protective equipment are updated and minimum distances are set between the spreading zones and both residential areas and places with vulnerable people.

 

The minimum distances to be respected are as follows:

20 m minimum (without reduction possibility) for the treatment of plant aerial part  with plant protection products classified H300, H310, H330, H331, H334, H340, H350, H350i, H360, H360F, H360D, H360FD, H360Fd H360Df, H370, H372 or containing an active substance considered as having endocrine disruptor effects.

For other plant protection products, except biocontrol products as defined by article L. 253-6 of the French Rural Code and products containing only basic or low risk substances:

10 m minimum for orchards, grapes, trees and shrubs, forest, small fruits and ornamentals crops higher than 50 cm, banana and hops,

5 m minimum for other agricultural and non-agricultural uses.

These minimum safety distances do not apply to treatments necessary for the destruction and the prevention of the spread of regulated pests.

Within the framework of charters validated at the department level, these minimum distances can be reduced in accordance with the provisions set by the order further to Anses opinion, in the case of spreading zones closed to residential areas as defined by Article L 253-8 (III) of the French Rural Code, i.e. from 10 m to 5 m for orchards, from 10 m to 5 m or 3 m for grapes and from 5 m to 3 m for other agricultural and non-agricultural uses.

The list of environmentally efficient spraying equipments to be used for reducing minimal distances will be published by the Ministry of agriculture.

 

As for the Decree of 27 December 2019, it sets the procedures of elaboration, consultation and validation as well as the content of the concerted commitment charters.

 

As planned, these texts will entry into force on 1 January 2020.

For fields sown before 1st January 2020, the minimum distances of 5 m and 10 m are applicable from 1 July 2020 but the 20-m buffer zones apply from 1st January 2020.

The same minimum distances are applicable to linear infrastructures if their compliance does not result in the technical impossibility to guarantee operational safety and by 1 July 2021 at the latest.

 

To download:

Arrêté du 27 décembre 2019 relatif aux mesures de protection des personnes lors de l’utilisation de produits phytopharmaceutiques et modifiant l’arrêté du 4 mai 2017 relatif à la mise sur le marché et à l’utilisation des produits phytopharmaceutiques et de leurs adjuvants visés à l’article L. 253-1 du code rural et de la pêche maritime (in French)

Décret n° 2019-1500 du 27 décembre 2019 relatif aux mesures de protection des personnes lors de l’utilisation de produits phytopharmaceutiques à proximité des zones d’habitation (in French)

 

Anses opinion on the a request for scientific and technical support on the efficacy equivalence  of combined drift reduction measures for protecting residents when using plant protection products. Saisine 2019-SA-0173, 17.12.2019   (in French)

 

Our previous articles:

FRANCE – Public consultation: new system for protecting residents when using plant protection products

 

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 2020

The updated list of substances concerned by the French tax on diffuse pollution has been published in the Official Journal of 10 December 2019.  Some modifications have been performed in comparison to the list published in October 2019 for public consultation.

The changes in comparison to the 2018 list correspond to new knowledge on the classification of the substances. The update is based in particular on Regulation (EC) No 790/2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 and on AGRITOX website (ANSES).

The new list applies by 1st January 2020.

 

To download: 

Order of 29 November 2019 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)

 

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.

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FRANCE – ANSES: Withdrawal of 36 glyphosate-based products

ANSES announces the withdrawal of 36 glyphosate-based products out of the 69 products being under renewal. These products will be withdrawn from the market and will no longer be allowed to be used from the end of 2020, due to the lack or insufficient scientific data to rule out any genotoxic risk. In 2018, these products accounted for almost three quarters of the tonnage of glyphosate products sold in France, for agricultural and non-agricultural uses.

Moreover, 4 refusal decisions were notified out of the 11 new applications submitted since January 2018 and under evaluation.

The decisions and conclusions of evaluation are available in the Register of decisions on Anses website.

The comparative evaluation with available non-chemical alternatives continues. The entire evaluation process will be finalised by 31 December 2020.

 

To download: 

List of products based on glyphosate withdrawn on 29 November 2019 (in French)

 

See also our previous articles: 

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

FRANCE: Glyphosate phase-out plan issued

FRANCE: Towards glyphosate phase out

EUROPE: Renewal of glyphosate approval

 

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

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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: 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.

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

 

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/