EUROPE: News in the Assessment of Metabolites in Groundwaters

The European Commission released a new version (revision 11) of the guidance document SANCO/221/200 as regards the assessment of the relevance of metabolites in groundwater. Previous version (revision 10) dated 2003.

This new version will apply to dossiers submitted from 01.05.2022 but can be applied earlier by applicants.

The main changes concern Stage 2 of Step 3 as regards the assessment of genotoxicity. The section was amended to:

  • Ensure that the evaluation of the genotoxic potential cover all of the following aspects: gene mutation, structural chromosomal alterations (clastogenicity) and numerical chromosomal alterations (aneugenicity);
  • Give an example of a suitable battery of tests: (i) Ames test, (ii) in vitro Mammalian Cell Gene Mutation Test (tk or hprt locus) and (iii) in vitro micronucleus test;
  • Provide instructions for alternative/further studies in case of metabolite specificities and in case of equivocal, inconclusive or positive results.

Other changes were made to reflect the new Regulations and guidance documents that were released since 2003. Clarifications on the scope of the document as regards metabolites formed by microbial pest control agents (micro-organisms) are given.

 

To download: 

Guidance Document On The Assessment Of The Relevance Of Metabolites In Groundwater Of Substances Regulated Under Regulation (EC) No 1107/2009 – Sanco/221/2000, rev.11, 21 October 2021

 

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

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

 

FRANCE – ANSES: Update of the Surface Water Information Notice

Anses updated its Information Notice as regards the Surface Water risk assessment for plant protection products and the use of the FOCUSsw tool.

No significant change was made to the newly released version. The notice was updated as regards the more recent versions of the reference documents for the surface water risk assessment. Rewordings were also performed to adjust the text.

 

To download (in French): 

Information notice as regards the risk of surface water contamination with plant protection products in the framework of Regulation (EC) No. 1107/2009: use of FOCUSsw tool – Revision 2 (18 October 2021)

 

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

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

 

FRANCE – ANSES: Upcoming Evolutions for Bees and Other Pollinators

In a context of evolution of the pollinator protection policy at national level in France and at the European level, Anses published a note summarising the requirements and the reference legal acts currently in force as well as the upcoming developments as regards plant protection products (PPP). The note will be updated on a regular basis.

Changes will take place (i) when the new Order (repealing the 2003 Order) on the protection of bees and other pollinators is adopted in France and (ii) when the new EFSA bee guidance document is adopted (revision of the 2013 version; EFSA Journal 2013;11(7):3295) and when the data requirements and decision-making criteria are updated at European level (update of Regulations (EU) No. 284/2013 and 546/2011, respectively).

As of the entry into force of the new French “Bees” Order, the request for an exemption for PPP application during the flowering period will necessitate, in addition to CEB 230 trials (current requirement), a homing flight test in the case of an insecticide targeting the central nervous system of insects and which may occur during the flowering period. Further studies may be necessary if refinements of the risk assessment are needed.

Then, when adopted, the new EFSA guidance document and the updated European data requirements and decision-making criteria will serve as framework for the pollinator risk assessment. The new French regulation for an exemption for PPP application during the flowering period will continue to apply.

 

To download (in French): 

Anses Note on Current and Future Reference Documents and Requirements as Regards the Risk Assessment of PPP for Bees and Other Pollinators – version 1, 18 October 2021.

 

See also our previous articles: 

FRANCE: Public Consultation on New Measures to Protect Pollinators

EUROPE-EFSA: Latest Progress in the Revision of the 2013 Bee Guidance

 

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

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

 

LYNXEE: Appointment of Tanalou Djae as Expert in Physico-chemistry, Analytical methods and Residues

Lynxee consulting’s team is pleased to announce the appointment of Tanalou Djae.

PhD in environmental geoscience and graduated with a Master 2 in environmental analytical chemistry, Tanalou began her career with various experiences of research on field testing and in chemical analysis laboratories before conducting a PhD co-financed by CIRAD (French agricultural research and cooperation organization working for the sustainable development) and l’ADEME (French Agency for Environmental and Energy Management) on the phytoavailability of copper in soils amended with organic waste products.

Tanalou 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, and then in the Residue Unit where she was in charge of the assessment of active substances and plant protection products dossiers.

With her 6-year experience in field, laboratory and scientific assessment, Tanalou joined Lynxee consulting, where she is involved, among others, in the study monitoring and in the drafting of registration dossiers (Physico-chemical properties, Analytical methods and Residues).

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

 

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

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

EUROPE–EFSA: Public Consultation on Updated Bird and Mammals Risk Assessment

EFSA has launched the public consultation on the draft updated guidance document on Risk Assessment for Birds and Mammals (Access to the consultation). The document is an update of the current EFSA’s guidance document (EFSA Journal 2009; 7(12):1438).

Comments will be welcomed until 10.11.2021.

 

To download: 

Draft EFSA guidance-document – Risk assessment for birds and mammals – Version of 29.09.2021 for Public Consultation.

Draft Annex B – Deposition values – Version of 29.09.2021 for Public Consultation.

Draft Annex C – HTET Residue Studies – Version of 29.09.2021 for Public Consultation.

Draft Annex D – HTET Ecological Field Studies – Version of 29.09.2021 for Public Consultation.

Draft Annex E – HTET Field Effect Studies – Version of 29.09.2021 for Public Consultation.

Draft Appendix F – Summary of Generic Model Species Parameters – Version of 29.09.2021 for Public Consultation.

 

See also our previous articles: 

EUROPE – EFSA: Database of Ecological and Residue Data Used in Assessments for Birds and Mammals

 

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

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

 

EUROPE: New Schedule for Southern Zone Guidelines for Protected Crops

The Southern Member States Steering Committee (SMS SC) has released an updated version of the decision table as regards the assessments and tools that will be requested for protected crops (initial version dated May 2021).

In addition to minor wording adjustments, the September 2021 version postpones the implementation date initially set on 01.12.2021 to a provisional date to be confirmed: 01.06.2022.

 

To download: 

SMS SC – Decision table for protected crops (September 2021)

 

See also our previous articles: 

EUROPE: New Guidelines for Southern Zone Member States

 

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

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

 

EUROPE: New Guidelines for Southern Zone Member States

The Southern Member States Steering Committee (SMS SC) has released two guidelines as regards the risk assessment for Plant Protection Products.

One document is a decision table as regards protected crops. It allows the determination of requested assessments and tools for the toxicology, efficacy, residues, environmental fate and ecotoxicology sections depending on the intended protection structures. The guidelines will apply to zonal applications submitted from 01.12.2021.

The other document deals with the possibility to use the ‘VFSMOD’ tool for runoff mitigation determination for surface water (i.e. vegetative filter strips). The SMS SC concluded that mitigations determined with VFSMOD can be presented in zonal applications. However, presenting mitigations determined according to the FOCUS Landscape Guidance (current validated approach) remains mandatory. The acceptance of the proposed mitigations will be decided at national level by each Member State.

 

To download: 

SMS SC – Decision table for protected crops (May 2021)

SMS SC – Quantitative Mitigation of Surface Runoff Pesticides with Vegetative Filter Strips using VFSMOD (May 2021)

 

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

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

 

FRANCE: Public Consultation on New Measures to Protect Pollinators

The Ministries of Agriculture and Environment have launched the public consultation on the draft National Plan for Pollinators (Access to consultation) and the draft “bee” Order to replace the Order of 2003 as regards the Conditions of Use of Insecticides and Acaricides to Protect Bees and Other Pollinating Insects (Access to consultation). The consultation is open until 20 July 2021.

Draft National Plan for Pollinators

The draft National plan contains various actions to be carried out over the period 2021-2026 to “act in favour of pollinating insects, wild and domestic, and of pollination”. It is articulated around six axes:

  1. Improving scientific knowledge (including on wild pollinator populations, and stressors affecting domestic and wild pollinator populations),
  2. Economic levers and supports for farmers, beekeepers and foresters,
  3. Supports for other activity sectors (urban development, linear infrastructure, industrial sites, sites with large land rights, protected areas),
  4. Preservation of bee health (e.g. strengthening of bee health monitoring),
  5. Regulation of plant protection products (PPPs) to protect pollinators (it includes the strengthening of the provisions of the “bee” Order of 2003 – detailed below),
  6. Sharing of pollinator-friendly farming practices.
Draft “Bee” Order

In order to reduce the impact of PPPs on pollinators when applied during flowering, two main evolutions were retained in the draft “Bee” Order on the basis of Anses recommendations (see our previous articles):

  • Extension of the flowering-period specific assessment to all PPPs (except thinning products), i.e., inclusion of fungicides and herbicides:
    PPP applications on attractive flowering crops and on “bee foraging areas” would only be possible “if there is no unacceptable effect on bees (acute or chronic), nor on colony survival and development”. Anses would specify the data required for the evaluation.
  • Limitation of the PPP application period when used on flowering crops and on “bee foraging areas”:
    Applications would have to be carried out within 2 hours before sunset and 3 hours after sunset. This restriction period could be adapted or waived if measures providing an equivalent level of protection to pollinators are implemented (such measures are still to be defined with the support of Anses). Exemptions would also be possible in the case of technical deadlock.

As regards attractive plant covers under perennial crops, covers would have to be rendered unattractive to pollinators prior to any insecticide or acaricide application on crops. The other types of PPPs would not be concerned by this measure.

Transitory measures are planned for the entry into force of the new “bee” Order:

  1. Limitation of the PPP application period when used on flowering crops and on “bee foraging areas” would be immediately applicable to insecticides and acaricides for which an authorisation of application during flowering and/or exudate production period is already granted (current “Bee Claim” procedure), AND for PPPs other than insecticides and fungicides.
  2. For PPPs other than insecticides and fungicides whose authorisation renewal will be in less than 30 months after the entry into force of the new “bee” Order:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses risk assessment conclusions and provided that the required additional data are submitted within 30 months after the entry into force of the “bee” Order.
  3. For PPPs other than insecticides and fungicides whose authorisation renewal will be in more than 30 months after the entry into force of the new “bee” Order AND in the case of major uses in France:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses risk assessment conclusions and provided that the required additional data are submitted within 48 months after the entry into force of the “bee” Order.
  4. If the required additional data are not submitted within the deadlines (30 or 48 months), PPP application on flowering crops and on “foraging bee areas” would no longer be possible.
  5. A notification of the submission of the required additional data and of the uses concerned would have to be made 18 months before the submission.
  6. For PPPs other than insecticides and fungicides whose authorisation renewal will be in more than 30 months after the entry into force of the new “bee” Order AND in the case of minor uses in France:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses conclusions on the renewal dossier. The required additional data would have to be submitted with the renewal dossier with no specific notification needed.

Given the current timeline, the new “bee” Order could be released by the end of 2021.

European context

The strengthening projet of the French measures for pollinators happens in a context of evolution of the pollinator protection policy at European level, with the current revision of the EFSA guidance document (EFSA Journal 2013;11(7):3295; see our previous articles) and with the revision of the uniform principles for evaluation and authorisation of PPPs as regards pollinators (Regulation (EU) No. 546/2011).

On 28 June 2021, a majority of Member States voted in favour of the European Commission’s proposal for a protection goal of 10% as a maximum permitted level of honeybee colony size reduction. This threshold will now be integrated into the draft updated EFSA guidance document for finalisation. The final version could be released by the end of 2021.

As regards uniform principles, their revision could take place in the first half of 2022.

 

To download (in French): 

Draft National Plan in Favour of bees and other pollinating insects – Version of 28.06.2021 for Public Consultation.

Draft Order as Regards the Protection of Bees and Other Pollinating Insects and the Maintenance of Pollination Service when Using Plant Protection Products – Version of 28.06.2021 for Public Consultation.

 

See also our previous articles: 

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

FRANCE – ANSES: recommendations to strengthen the protection of bees

EUROPE-EFSA: Latest Progress in the Revision of the 2013 Bee Guidance

 

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

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

 

EUROPE: New PELMO and PEARL Versions Released

New versions of the models PELMO (i.e. v.6.6.4) and PEARL (i.e. v.5.5.5) used for Predicted Environmental Concentrations in Groundwater (PECgw) calculations, accompanied by a new version of the Generic Guidance for Tier 1 FOCUS GroundWater Assessments (i.e. v.2.3) were released by the FOrum for Co-ordination of pesticide fate models and their USe (FOCUS DG SANTE).

The FOCUS DG SANTE recommends that the previous versions of the generic guidance (v.2.2), of PELMO (v.5.5.3) and of PEARL (v.4.4.4) should no longer be used in submissions made after 1 January 2022.

Updates of version 2.3 of the generic guidance are:

  • Update of the equations for converting pH measured in CaCl2 and KCl to pH measured in H2O, and,
  • Irrigation water in PELMO and PEARL is now applied at the soil surface for the crops apples, citrus and vines,

both to reflect the EFSA guidance on PECsoil calculation (EFSA Journal 2017;15(10):4982);

  • Update on guidance on pesticide property parameter derivation in case of pH dependence, to reflect the EFSA report on the ‘repair action’ on the FOCUS surface water scenarios (EFSA Journal 2020;18(5):6119);
  • Reference to the OECD 106 evaluators checklist in relation to equilibrium sorption parameters added (EFSA supporting publication 2017:EN-1326);
  • New options for defining transformation product formation fractions in PELMO;
  • Correction to periods to crop factors (Kc) for the crop onions at the Porto and Thiva scenarios;
  • Reference added to the new endorsed guidance determining aged (non equilibrium) sorption parameters (SANTE/12586/2020-REV 0).

The new versions of PELMO and PEARL were also developed to work in combination with the new PERSAM tool for PECsoil calculations. They will be used to generate higher tier (‘Tier 3A’) PECsoil (reference to our previous post on PERSAM).

 

To download: 

Generic Guidance for Tier 1 FOCUS GroundWater Assessments (version 2.3) (June 2021)

FOCUS PELMO 6.6.4 (GW) 6.6.1 (soil)

FOCUS PEARL 5.5.5

 

See also our previous articles: 

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

EUROPE – EFSA: Revision of Surface Water FOCUS Scenarios

EUROPE: Guidance on Aged Sorption Studies Adopted

 

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

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