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.

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EUROPE – COM : Update of MRL setting procedure (SANTE/2015/10595 rev. 6.1)

The Commission published an update of Technical Guidelines SANTE/2015/10595 “MRL setting procedure in accordance with articles 6 to 11 of Regulation (EC) No 396/2005 and article 8 of Regulation (EC) No 1107/2009”.

The last version (rev. 5.5) was dated February 2021. The purpose was to detail the new requirements in the pre-submission phase and submission application procedure in relation with the implementation of the Transparency Regulation (EU) 2019/1381.

In this new version 6.1, the conditions that lead to the setting of temporary MRLs have been detailed for the following ‘exceptional cases’:

  • Cases of emergency authorisations notably where pesticide residues arise as a result from uses of plant protection products.
  • Cases of environmental contamination, of cross-contamination from storage facilities and handling circuits and cases of contamination due to the transfer of residues from the treated parts of the plant to food products in relation with the active substance persistence.  
  • Cases of natural occurrence of substances unauthorised use as a pesticide and of substances with multiple uses whose residues are not a consequence of uses in plant protection.

These new provisions apply to all MRL applications submitted as of 27 March 2021. For all applications submitted before 27 March 2021, all procedural steps as described in SANTE/2015/10595 Rev. 5.4 continue to apply. 

 

To download: 

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.4

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.5

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 6.1

 

See also our previous articles: 

EUROPE – COM: Update of MRL setting procedure (SANTE/2015/10595 rev. 5.4)

 

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

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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.

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GB – HSE : GB adoption of EU guidance document SANTE/2020/12830 (analytical methods)

The EU has recently introduced a new technical guidance document for validation requirements and assessment of analytical methods in support of the registration of plant protection products, SANTE/2020/12830.

HSE has undertaken an assessment of the new guidance, considered its implications, and concluded that it is suitable for use under the GB regime. 

The guidance document will apply to all applications made to HSE in support of GB active substance approvals and GB plant protection product authorisations from 1 November 2021.

 

A télécharger : SANTE/2020/12830 rev 1.

 

Nos articles précédents : EUROPE – COM: Publication of a new guidance document on analytical methods

 

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

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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.

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FRANCE – ANSES: Update of the uses of the authorised products on E-Phy following the update of the national catalog

Following the update of the national catalog of plant protection products by order of 12 April 2021 (see our previous article), ANSES has updated the uses of the authorised products on E-Phy website.

The following amendments have been applied:

  • The replacement of the old wordings by the new wordings of the plant protection uses as listed in Annex 2 of the new catalog of uses.

  • Changes to the scopes of uses: for instance, the crops “kumquat” and “pistachio” are now respectively included in the reference crops “Citrus” and “Nuts”, provided that the maximum residue limits are respected. Similarly, the reference crops “Fresh beans without pods” and “Fresh peas without pods” have been replaced by “Fresh beans and peas without pods” and the scope of use has been extended in the absence of restrictions in the conditions of use for the relevant uses.

As a result of these modifications, 45 decisions to amend marketing authorisations were issued.

 

See also our previous articles: 

FRANCE: Update of the national catalog of plant protection uses

 

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

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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, 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.

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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/

 

EUROPE: Update of the guidance document on the scope and borderline issues of Reg. (EC) No 1107/2009

In May 2021, the Commission published a revision of the working guidance document SANCO Doc 6621-99 initiated in 1994 and relating to the scope and limits of application of Regulation (EC) No 1107/2009. A table lists the various cases examined and the conclusions issued by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF).

The guidance document also outlines the criteria to determine whether a product falls in the scope of the Regulation concerning plant protection products and the procedure to present a new request for interpretation for a case not listed in the table.

 

To download: 

SANCO Doc 6621-99 rev 62 – REGULATION (EC) No 1107/2009 – SCOPE AND BORDERLINE ISSUES – May 2021

 

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

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EUROPE: Publication of a new ATP (adaptation to technical progress)

The 17th ATP (adaptation to technical progress) of the CLP (regulation (EC) No 1272/2008) was published on 28 May 2021 in the Official Journal of the European Union. It mainly takes into account the opinions of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) on the proposals issued between March and September 2019 to add, update or delete harmonised classification and labelling of some substances.

Thus, Part 3 of Annex VI of the CLP regulation has been amended with the addition of harmonised classification and labelling for 22 new substances, the modification for 41 substances and the deletion of one substance. Harmonised Acute Toxicity Estimates (ATE) values have also been included in this Annex.

This Regulation shall apply from 17 December 2022.

 

To download: 

COMMISSION DELEGATED REGULATION (EU) 2021/849 of 11 March 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

 

See also our previous articles: 

EUROPE: publication of the 12th ATP to CLP

 

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