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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

 

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EUROPE – COM : Update of guidance documents physical, chemical and technical properties of plant protection products (SANCO/10473/2003– rev 5)

The Commission published an update of guidance documents SANCO/10473/2003 ‘for generation and evaluation of data on the physical, chemical and technical properties of plant protection products under regulation (EC) N° 1107/2009’. The intention of this guidance document is to describe the physical, chemical and technical data required to support the registration and/or authorisation of a formulation as set out in Regulation (EU) No. 284/2013.

This latest version 5 describes the relevant physical, chemical and technical properties to plant protection products and the appropriate analytical methods for their measurements. It also details the requirements for the technical characteristics and the means of generating data by type of formulation. The currently used liquid, solid, seed treatment and miscellaneous preparations are mentioned.

This 5th version applies to submissions made from 01.11.2021.

 

To download: SANCO/10473/2003 –rev.5

 

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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: 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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EUROPE – EFSA: Public consultation: Updated guidance on the assessment of human exposure in risk assessment for plant protection products

EFSA has launched a public consultation on a draft updated guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products.

The draft updated guidance now includes the greenhouse uses. The default values for crop parameters and for human parameters have been revised. The calculator for exposure assessment has also been revised as an online tool (available on the R4EU platform) including new scenarios, updated default values, revised crop groupings, as well as improved functionalities such as exposure estimates for several active substances in a product, calculation of safe re-entry interval and generation of a report.

The public consultation is opened until 09 May 2021.

 

To download: 

Draft updated EFSA Guidance and its annexes

 

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

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EUROPE – EFSA: Guidance document on active substance applications for approval and renewal and on MRL applications

EFSA published on 03 March 2021 a technical report describing the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment or the renewal of approval of an active substance, and for applications for setting of maximum residue levels (MRLs). This guidance document is applicable for all applications submitted as of 27 March 2021.

This document describes the procedures and the timelines for handling these applications and also includes the new requirements related to the implementation of the Transparency Regulation (Regulation (EU) 2019/1381). The different support initiatives available and the interaction between the applicant, EFSA members and RMS/Co-RMS from the preparation of the application (pre-submission phase) to the adoption and publication of the EFSA’s conclusions or reasoned opinions are presented.

Eventually, a practical guidance for applicants and Member States also describes the key technical points for preparing dossiers and assessment reports under Regulation (EC) No 1107/2009 with the aim to enhance their quality.

 

To download: 

EFSA Supporting publication 2021:EN-6464: Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure

 

See also our previous articles: 

EUROPE-EFSA: Guidance on active substance applications for approbation and renewal

 

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

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

On 24 February 2021, the European Commission has published a new guidance document (SANTE/2020/12830, Rev.1) on pesticide analytical methods for risk assessment and post-approval control and monitoring control.

This document has been finalised in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF – section Phytopharmaceuticals – Pesticides Residues) on 22-23 February 2021. It supersedes guidance documents SANCO/3029/99 (requirements for analytical methods used in pre-registration for risk assessment) and SANCO/825/00 (requirements for analytical methods for post-approval control and monitoring purposes) and is applicable since 01 March 2021.

The main directives of these two previous documents are restated, but further details and explanations have been included. New points are also developed:

  • Possible use of isotopically labelled internal standard for methods using mass spectrometry as detection system.
  • If a hydrolysis step is necessary (if esters, amides and/or conjugates are included in the residue definition and that the structures of the conjugates are unknown or no conjugate standard is available), the efficiency of hydrolysis step must be demonstrated.
  • Individual recovery data must be detailed in addition to mean recoveries for each matrix and each fortification level.
  • Further explanations on matrix effects and mathematical formula to calculate them.
  • For the analytical calibration, the suitability of the chosen function should preferably be demonstrated by a residual analysis rather than reporting the coefficient of correlation (r) or determination (R²).
  • The limit of detection (LOD) must be determined and correspond to the lowest calibration standard (preferably in matrix) rather than calculated from the signal-to-noise ratio in control samples.
  • Examples for acceptable/non-acceptable deviations of an independent laboratory validation (ILV) from the primary method.
  • Stability of the extracts and standards must be demonstrated.
  • Extraction efficiency must be demonstrated in accordance with the guidance document SANTE 2017/10632 Rev. 3.
  • For the post-approval control and monitoring methods, the following are now required:
    • the determination of the residues in honey (primary method + confirmatory method + ILV);
    • an ILV for the determination of residues in drinking water or groundwater; 
    • an analytical method for the determination of residues in body fluids and tissues, regardless the toxicological classification of the active substance and/or metabolites (primary method + confirmatory method).

Appendix 1 lists all foodstuffs of plant origin and processed commodities and the group of matrices associated with them (high-water, high-acid, high-oil, dry or difficult to analyse commodities) and Appendix 2 gives an overview of methods required.

 

To download: 

SANTE/2020/12830, Rev.1 (24.02.2021) – Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes

 

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

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EUROPE: Update of guidance document on zonal evaluation, mutual recognition, withdrawal and amendment of authorisations

The European Commission has published an update of the guidance document SANCO/13169/2010 Rev. 11 on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009. This version updates the revision of July 2014. It has been finalised in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) on 25 January 2021 and applies to all applications submitted from 01 March 2021.

This new revision now includes the procedures to be followed for applications of plant protection products authorisation according to Article 34 of Regulation (EC) No 1107/2009 (exemption from the submission of studies), withdrawals or amendments of an authorisation (Articles 44 and 45) and grace periods under Article 46. The procedures for placing on the market of low-risk plant protection products according to Article 47 are also described and appendices have been added.

The guidance document also highlights the importance of the zonal evaluation procedure for any application for new authorisations, which will then be subject to commenting from other Member States in the zone. Appendix 1 on the commenting requirements for each type of application has thus been updated.

Also note the ongoing implementation of the Plant Protection Products Application Management System (PPPAMS) on which the applicants are encouraged to use to submit their application (already suitable for Art. 33, Art. 40-42 and Art. 53).

 

To download: 

SANCO/13169/2010 Rev. 11 – Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009

 

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