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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.

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

 

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

 

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

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EUROPE: Guidance on Aged Sorption Studies Adopted

The final version of the guidance document on aged sorption studies of plant protection products in soil was endorsed at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF meeting) of 25-26 January 2021.

The final version integrates the revisions suggested by the EFSA PPR panel (EFSA Journal 2015;13(7):4175 and EFSA Journal 2018; 16(8);5382). Additional comments from Member States made at SCoPAFF meetings between May 2019 and January 2021 will be considered in a later revision of the document.

The guidance document was drafted in order to provide a framework on how to conduct and interpret experimental studies aiming to demonstrate an increase in pesticide sorption with time and how to integrate the results in regulatory higher tier risk assessments. This framework was built on the basis of a literature review, experimental work and extensive modelling.

Only aged sorption as investigated in laboratory studies is under the scope of this document. Field studies being much more complex, further development and tests with real world data would be needed.

The guidance document addresses the following topics:

  • Modelling of aged sorption and conceptual definition of equilibrium sorption;
  • Experiments to derive aged sorption parameters;
  • Fitting of kinetic models to data from aged sorption studies;
  • Aged sorption in the tiered pesticide leaching assessment;
  • Special consideration for metabolite.

This new guidance document will apply from 1 April 2021 (date of dossier submission).

 

To download: 

Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments – SANTE/12586/2020–REV 0 – 26 January 2021

 

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

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EUROPE – COM / Guidance: Assessment of metabolites produced by microorganisms

The European Commission has published a new guidance document that aims to provide a practical approach on how the data requirements on metabolites can be applied in the approval of microorganisms as active substances at EU-level and the authorisation of plant protection products at MS level. This guidance document addresses metabolites present in the active substance and the plant protection product and also those produced by the microorganism after application (in situ production).

To determine whether the microorganism is producing a metabolite of concern, the guidance document is organised according to a “step-by-step” procedure. The described approach implies that the assessment of all metabolites produced by a microorganism through an evaluation as performed for chemical active substances is not required, not feasible and unnecessary from a risk perspective, however parts of such assessment are needed under certain circumstances described in this document. The approach ensures that applicants provide all available data on metabolites including any indication of hazardous effects of any of these metabolites. For those metabolites for which a hazard is identified, this identified hazard is followed-up on by generating additional data where needed for a focused risk assessment for those particular metabolites.

This document has been finalised in the Standing Committee on Plants, Animals, Food and Feed on 23/10/2020. It will apply to applications submitted from 01/11/2021 onwards.

To download:

SANCO/2020/12258 of 23/10/2020 – Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances in accordance with Regulation (EC) No 1107/2009

 

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

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EUROPE – COM / Guidance: Assessment of antimicrobial resistance of microorganisms

Applying microorganisms in the environment by spreading them as plant protection products may potentially contribute to the antimicrobial resistance (AMR) concern, through the spread of resistance genes which can be horizontally transmitted from the microbial pest control agent to pathogenic bacteria.

This new guidance document published by the European Commission explains how to assess antimicrobial resistance of microorganism, as well as the risk of increasing the spread of antimicrobial resistance of human and veterinary concern, in relation to the approval criteria and the low risk criteria set under Regulation (EC) No 1107/2009.

It addresses mainly bacteria via a stepwise approach. The case of viruses and fungi is not addressed extensively since:

– Viruses excluding bacteriophages have not been reported in the scientific literature as contributor to the AMR concern.

– The acquisition of antimicrobial resistance in fungi is multifactorial.

For viruses and fungi there is no need to assess the potential transfer of genes for resistance to antimicrobials. However, some information regarding the antimicrobial susceptibility of fungi still needs to be provided because it has to be demonstrated that there are sufficient treatment options in case infections with the fungal microorganism may occur.

The case of bacteriophages (viruses that infect bacteria) is not currently addressed by this guidance document. The interest in the use of bacteriophages as plant protection products might be reason to develop a specific guidance in the future.

This document, finalised in the Standing Committee on Plants, Animals, Food and Feed on 23/10/2020, will apply to applications submitted from 01/05/2021 onwards.

To download:

SANTE/2020/12260 of 23/10/2020 – Guidance on the approval and low-risk criteria linked to “antimicrobial resistance” applicable to microorganisms used for plant protection in accordance with Regulation (EC) No 1107/2009

 

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

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EUROPE: Update of analytical guidance document for residues

Guidance document SANTE/12682/2019 “Analytical quality control and method validation procedures for pesticide residues analysis in food and feed” supersedes guidance document SANTE/11813/2017 from 01 January 2020. It describes the method validation and analytical quality control requirements to support the validity of data used for checking compliance with maximum residue limits, enforcement actions, or assessment of consumer exposure to pesticides in the EU.

Main changes with respect to the previous version are:

  • a clarification about the non-inclusion of the contribution of sampling to measurement uncertainty in the document, as sampling is not part of the measurement.
  • the use of representative analytes for calibration is no longer relevant: all analytes must now be calibrated in every batch of samples.
  • the need to use calibration standards at the beginning and at the end of the sample sequence to ensure the detectability of the analytes.
  • an explanation of the different approaches to correct the residues when the mean recovery is outside of 80-120 %.
  • the addition of an appendix to clarify the rounding rules of the results and the interpretation of the compliance of these results with respect to measurement uncertainty.

 

To download: 

SANTE/12682/2019 – Analytical quality control and method validation procedures for pesticide residues analysis in food and feed

 

See also our previous articles: 

EUROPE: Update of analytical guidance documents

 

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

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

 

FRANCE: Update of the French GEP reference document

The reference document of Good Experimental Practice (GEP) related to the accreditation to conduct officially recognised efficacy trials (Revision of 2 February 2020) supersedes the same guidance document (Revision of 1 November 2013) from 1st June 2020. This document is the French Reference document on Good Experimental Practice according to EPPO Standard PP 1/181 in accordance with Section 6 of the annex to regulation (EU) No. 284/2013 of 1 March 2013.

Main changes with respect to the previous version are:

– Update of the method to register officially recognised efficacy trials using SIDEP system (‘Système d’Information pour la Déclaration des Essais de Produits’) on ANSES website instead of COLEOR website. Also, this declaration (or other elements transmitted to allow this declaration) must be kept for at least 5 years.

– Deletion of the term “trials series” in the guidance document.

– Regarding staff monitoring, authorisation and aptitude must be reviewed periodically and their skills confirmed. Also, company must ensure of the homogeneity of practices between operators (observations and assessments).

– The map for access to the  trial and trial map must be precise enough to know exactly the trial location. 

– More details relating to crop destruction are awaited (such as, the name of the responsible person , the estimated quantity, the date and the method of destruction ). In addition, the destruction method must be defined in the trial protocol.

– All information related to subcontracted services (trial and data phases ) and subcontractor legal name must be clearly indicated in the trial dossier and trial report.

– When a material or an equipment is defective and out of order, it must be identified as such in order to avoid its use and this, until its return to service.

– All information related to artificial contaminations must be clearly indicated and described in the trial dossier. 

 

To download: Reference document GEP 2020 (in French)

 

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

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EUROPE – EFSA: Guidance on risk assessments for substances, impurities and transformation products that may have stereoisomers

EFSA has published a guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities. The document also proposes guidance to be used for active substances that, without containing any stereogenic element, may generate transformation products or metabolites  that do contain them. As a general principle, stereoisomers need to be treated as different chemical components for the risk assessment.

The draft version was proposed to public consultation in April – May 2019. A report presenting the  comments received and how they have been considered by EFSA has been made available.

In this guidance, Regulation (EU) 283/2013 on the data requirements for the plant protection active  substances is analysed, and recommendations are given on how to best address and assess the data requirements for active substances containing stereoisomers. Furthermore, the guidance gives recommendations on how to make the best  use of the available information to perform the risk assessment of these substances, particularly in situations when the information on individual isomers is not available or difficult to obtain, with the primary objective to reduce the need to repeat vertebrate animal testing.

One special situation is when active substances, that without containing any stereogenic element, may generate transformation products that do contain them. In these cases, it is appropriate to refer to metabolites containing stereoisomers. For these substances, the guidance should not be applied to the active substance but should be applied to assess metabolites that contain a stereogenic element.

 

To download: 

Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

Outcome of the public consultation on the draft guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

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

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