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EUROPE-EFSA: Recurring Issues in Ecotoxicology

EFSA published a technical report on the outcome of expert’s discussions in Ecotoxicology that took place during Pesticide Peer Review Meeting 185 in October 2018.

Numerous general and specific issues are addressed. The specific issues discussed are related to risk assessment for terrestrial vertebrates, aquatic organisms, non-target arthropods, soil organisms and non-target terrestrial plants.

 

To download: 

Outcome of the Pesticides Peer Review Meeting on general recurring issues in ecotoxicology – EFSA Supporting publication 2019:EN-1673.

 

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

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EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published

In March 2019, the European Commission mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295). In this context, EFSA just released the timelines for the guidance review (available to download below).

The first consultation will begin in a few weeks. Stakeholder and Member State representatives will be invited to give their views on the current guidance document. As announced in May 2019, the stakeholder feedback will be provided by a consultation group which has been selected by EFSA. The details of the consultation group members has also been released by EFSA (available to download below).

After a full public consultation to be held during summer 2020, the publication of the final revised guidance should be published in March 2021.

 

To download: 

Outline of the revision of the guidance on the risk assessment of plant protection products and bees

Meeting of the Selection Board for EFSA’s Stakeholder Consultation Group for the review of the Bee Guidance Document

 

See also our previous articles:

EUROPE-EFSA: Consultative Group for the Review of the Bee Guidance Document 2013

 

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

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

 

EUROPE-EFSA: Consultative Group for the Review of the Bee Guidance Document 2013

In March 2019, the European Commission (EC) mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295) which has still not been adopted at EU level. The scope of the mandate is to revise several areas of the current guidance document as asked by Member States and stakeholders and by considering new scientific evidence that has become available since its publication in 2013.

In particular, the EC asked for a review focused on:

  • Bee background mortality,
  • Exposure routes,
  • The list of bee-attractive crops,
  • The methodology with regard to higher tier testing.

For the purpose of the revision of the guidance, EFSA is setting up a stakeholder consultative group which will be consulted at various stages during the review and provide input to the EFSA scientific working group charged with revising the document. A call for stakeholder expert representatives was started by EFSA on 8 May 2019 with a deadline for application on 21 May 2019 (Please refer to Call to EFSA stakeholder organisations below). EFSA will select for the consultative group a maximum of 14 stakeholder  expert representatives from the nomination received.

Besides, Member State’ experts will also be consulted during the revision process and a public consultation and workshop will be held once a draft of the revised document is available.

Further details including timelines about how EFSA plans to address the mandate will be published by July 2019. According to EFSA, the revised guidance is to expected in 2021.

 

To download:

Call to EFSA stakeholder organisations for nominating stakeholder experts to the ad hoc EFSA Bee Guidance Stakeholder Consultation Group

 

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

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EUROPE – EFSA: Issues in Physical and Chemical Properties and Analytical Methods

EFSA published a technical report on the outcome of expert’s discussions in the area of physical and chemical properties and analytical methods that took place during a Pesticide Peer Review Meeting in November 2018.

The main issues identified are related to (i) the quality and level of details of the renewal assessment reports and (ii) the adherence to the new data requirements, in particular regarding analytical methods and general issues regarding the assessment of the impurity profiles and specifications of the technical material. Discussions which focused mainly on national authorisation of Plant Protection Products (PPP) were not included in this EFSA technical report.

The main topics addressed are:

  • CRD guidance on physical and chemical properties
  • Physical-chemical properties of active substances and PPP
  • Revision of some guidance documents
  • Methods used for the generation of pre-approval data
  • Monitoring methods for body fluids and tissues
  • Evaluation of extraction efficiency in residue analytical methods
  • Guidance of isomers
  • Impurities
  • Five representative batches
  • Confirmation of analyte identification (active substance, relevant and significant impurities)
  • LOQ for relevant and significant impurities (5 batch analysis)
  • Detected but not quantified impurities (5 batch analysis)
  • Specifications
  • Microorganisms
  • Equivalence assessment issues for PPP authorisation at MS level

For each issue addressed in the document, a background is presented followed by the outcome of discussions reflecting the opinion of the majority of the participating experts and the associated EFSA proposals.

 

To download:

Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods – EFSA Supporting publication 2019:EN-1623

 

See also our previous articles:

EFSA: Issues in physical-chemical properties and analytical methods

 

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

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

 

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

EFSA published a technical report to describes  the administrative requirements for the preparation  and submission of the dossier to support an application  for the approval, the amendment of approval or the renewal  of an existing approval of a pesticide active substance.

The  procedure  and the associated  timelines for handling  applications for approval,  from their submission to the adoption and publication of the EFSA conclusion are also described.

This document also provides additional guidance with the aim to enhance the quality of dossiers and assessment  reports. It provides instructions, guidance and templates for both the applicant and Rapporteur Member  State on how data should be presented in the dossier and in the assessment report.

The  document finally presents  the different possibilities applicants  have to interact with EFSA staff under this peer review process and the support initiatives available during the different stages of the application life-cycle.

 

To download:

Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances

 

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

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EUROPE – EFSA: Database on processing techniques and factors

EFSA is conducting pan-European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA’s comprehensive food consumption database and pesticide-specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and worldwide.

EFSA therefore launched the project “Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2”. The main overall objective of the project is to develop a database of processing types and processing factors compatible with the EFSA food classification and description system FoodEx 2.

On 26 November 2018, EFSA published a series of 3 external scientific reports as part of this project. Each report corresponds to one of the three objectives:

– Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

– Objective 2: Linking the processing techniques investigated in regulatory studies with the EFSA food classification and description system FoodEx2

– Objective 3: European database of processing factors for pesticides in food

The coding system (objective 2) and the  database (objective 3) are also provided as Excel spreadsheets.

 

To download:

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the EFSA food classification and description system FoodEx2

Appendix A -FoodEx 2 Coding system

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

EU processing factors database

 

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

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

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

EFSA published the outcome of the data collection conducted with the aim of developing a unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. This data collection, outsourced to a consortium consisting of the Alterra institute (Wageningen University, the Netherlands), the Austrian Agency for Health & Food Safety (AGES) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), was initiated in 2015.

Data were collected among the data submitted in active substance and plant protection product dossiers and via a systematic literature review. Data were scored on the basis of quality criteria and organised in 3 Excel spreadsheets (one for birds, one for mammals and one for residue studies), that can be downloaded as Supplements to the report.

The ecological information collected for birds and mammals consisted of data used (or that could be used) for the determination of focal species (notably, the frequency of observation in the field and the frequency of observation per survey), the estimation of the proportion of an animal’s daily diet obtained in a treated habitat (PT) and the assessment of the composition of the diet obtained from a treated area (PD). Entries for 18-21 crop groups, 150 bird species and 70 mammal species were collected. Nearly half of the records for birds come from protected company study reports while it is less than 10% for mammals.

The information gathered on residues focussed on initial residue levels and on residue decline (notably, DT50 and DT90). Entries for 190 substances and 18 crop groups were collected. Around 75% of these records come from protected company study reports.

In a first step, the databases may be used by EFSA and Member states for the peer review of active substances and for the registration of plant protection products in order to reach a higher level of harmonisation and more robust assessments. In a second step, EFSA planned to use the databases as inputs for the revision of the guidance on birds and mammals (EFSA Journal 2009; 7(12):1438).

 

To download:

Lahr et al., 2018 – EFSA Supporting publication 2018:EN-1513: Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals (the report and the 3 databases as supplements).

 

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

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EUROPE: EFSA Public consultation – threshold of toxicological concern approach

The public consultation on the guidance document proposed by EFSA for the use of the threshold of toxicological concern (TTC) is opened from 13 November 2018 to 08 January 2019.

This document updates the Scientific Committee opinion of 2012 by considering the latest developments in the field. This is a guidance for EFSA’s scientific panels and staff for the use of the TTC approach as a screening and prioritisation tool for the safety assessment of chemicals, when hazard data are incomplete and human exposure can be estimated as low.

The TTC approach is not applicable where substance-specific data exist or where they are required under EU legislation.

To download: Public consultation: guidance on threshold of toxicological concern approach (en anglais)

 

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

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EUROPE – EFSA: Recurring issues in mammalian toxicology

During the EFSA peer review of pesticide active substances under Regulation (EC) No. 1107/2009, several aspects in the area of mammalian toxicology were identified by EFSA that needed discussion with experts from National Authorities in order to enhance the harmonisation of the risk assessment of active substances.

A new discussion was held at the Pesticide Peer Review Meeting 170 of December 2017. Recommendations were made on:

  • Genotoxicity of plant protection products
  • Use of (Q)SARs
  • Use of Read-Across approaches for metabolites

These recommendations will be applied during the EFSA peer review of the active substances.

 

In addition, brief discussions of the following topics were also made:

  • EFSA guidance 2016 on the residue definition
  • EFSA guidance 2017 on dermal absorption
  • Current and planned EFSA activities in the area of pesticides:
    • Developmental neurotoxicity
    • Cumulative assessment groups
    • Epidemiology
    • Planned workshops (in vitro comparative metabolism, phototoxicity, historical control data)
    • Update of EFSA guidance 2014 on the assessment of exposure of operators, workers, residents and bystanders

 

To download:

EFSA Technical Report – Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology (25 August 2018)

 

See also our previous articles:

EUROPE – EFSA: Recurring issues in mammalian toxicology

 

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

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

 

EFSA: Issues in physical-chemical properties and analytical methods

During the EFSA peer review of pesticide active substances under Regulation (EC) No 1107/2009, several aspects in the area of identity and analytical methods were identified by EFSA and Member States that needed discussion with experts from national Authorities in order to enhance the harmonisation of the risk assessment of active substances.

The main issues identified were related to the quality and level of details of the assessment reports and the adherence to the new data requirements, in particular regarding analytical methods and issues related to the assessment of the impurity profiles and the proposed specifications.

All these issues were discussed in a general meeting. Recommendations were compiled on the basis of the discussions and conclusions achieved at the meeting. These recommendations will be applied during the EFSA peer review of the active substances, and are expected to provide additional clarifications to applicants and rapporteur Member States regarding the scientific interpretation of the relevant guidance documents when preparing the dossiers and the draft/renewal assessment reports.

 

To download:  Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods

 

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

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