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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: 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

 

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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

 

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

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 released two reports this summer.

The first report is the outcome of the EFSA collection of evidence on background bee mortality rates and in particular considering realistic beekeeping management and natural background mortality. A systematic literature review was supplemented with a survey sent to European bee keepers. The collection, which covers the tree bee groups (honey bees, bumble bees and solitary bees), provides solid grounds on background mortalities and will serve as a base for the revision of the EFSA guidance (2013).

The EFSA working group also published a supporting document addressed to risk managers about possible approaches to defining the specific protection goals (SPGs) that will be used in the EFSA guidance (2013) review. The document proposes 4 alternative approaches:

  1. Establish acceptable effect based on long-term colony survival, or,
  2. Derive threshold of acceptable effect on colony size based on their natural variability, or,
  3. Define acceptable levels on colony/population size (approach currently considered in the EFSA guidance 2013), or,
  4. Define levels of acceptable impact on the provision of the ecosystem services.

More details on approaches and associated pros and cons are available in the report (see the link below).

For the next step, risk managers will have to decide which of the approaches EFSA should use for the revision of the guidance. It is noted that the initial schedule is slightly delayed as this step was initially expected to be done by end of May 2020.

As a reminder, the publication of the revised EFSA guidance on bees is scheduled for Q1 2021.

 

To download: 

EFSA’s review of the evidence on bee background mortality – EFSA Supporting publication 2020:EN-1880.

Supporting document for risk managers on specific protection goals for bees – 22 June 2020.

 

See also our previous articles:

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

 

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

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

 

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.

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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 – COM: Guidances update on active substance applications for approbation and renewal

Further to the publication of EFSA “Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances”, several SANCO Guidance documents have been updated to ensure consistency:

 

SANCO/2012/11251 rev. 5 (22 March 2019) – DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)

Changes were made to provide updates to process and clarifications on certain elements related to the renewal process.

Entry into force: for applications for renewal of approval submitted after 1 April 2019.

 

SANCO/12580/2012- rev. 4 (22 March 2019) – Guidance document on preparing lists of test and study reports according to Article 60 of Regulation (EC) No 1107/2009

The format for lists of studies has been updated to ensure that it is indicated whether a study was used in a previous EU assessment or, when the information is available, whether the study was already submitted in the framework of National authorisations.

Entry into force: for (supplementary) dossiers submitted on or after 1 October 2019.

 

SANCO/10181/2013- rev. 4 (22 March 2019) – Guidance for applicants on preparing dossiers for the approval of a chemical new active substance and for the renewal of approval of a chemical active substance according to Regulation (EU) No 283/2013 and Regulation (EU) 284/2013

The special case of the non-submission of particular studies required by the EU legislation has been amended.

Entry into force: for (supplementary) dossiers submitted on or after 1 October 2019.

 

SANCO/12592/2012- rev.2 (22 March 2019) – Combined Template to be used for Assessment Reports according to Regulation (EC) No 1107/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272/2008

Updates were made to add a statement to each section cover page to explain how information is presented, to amend the sections in Volume 1 where the summary of the assessment of endocrine disrupting properties is made, and to revise the format of the table of lists of tests and studies.

Entry into force: For Assessment Reports submitted by MS to EFSA from 1 April 2019 as a minimum the revised Volume 1 should be used and the statement should be added to each section cover page. The revised templates are fully applicable for dossiers submitted from 1 April 2019.

 

See also our previous articles:

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

EUROPE: Combined template to be used for assessment reports and proposals for classification

 

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

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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: Update of EC Guidance on Generating and Reporting Methods of analysis (SANCO/3030/99 rev.5)

Revision 5 of the Guidance on Generating and Reporting Methods of analysis (SANCO/3030/99 rev.5) was published on 22.03.19. This general update is based on the EU Member States and EFSA comments, derived from experience with application. This revision also aims to comply with the Regulations (EU) No. 283/2013 and 284/2013 requirements, which address the development of analytical methods required for pre-registration and for post-registration control and monitoring purposes, and to improve a common understanding on the required validation data.

This revision will entry into force for dossiers submitted on or after 01.10.2019.

 

To download:

SANCO/3030/99 rev.5 – Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013.

 

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

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EUROPE: Guidance for the dose expression for vertical crops (Belgium and Central zone)

This guidance document, drawn up in December 2017 and which has just been published, explains how Belgium has been dealing for many years with the expression of the doses per hectare Leaf Wall Area (LWA) for the application of plant protection products to the canopy of vertical crops. This document contains all the information necessary to allow approval holders of plant protection products to calculate a dose per hectare of LWA and to prepare the application dossier according to the Belgian requirements. Meanwhile, the completeness check procedure and the draft Registration Report format have also been adapted. The guidance document thus contains both instructions for approval holders and for the Authorities on the assessment of the applications for authorisation. These new criteria will apply to all applications submitted in Belgium after 31st December 2018.

At last, this document reminds decisions made for the Central zone regarding the dose expression for vertical crops:

  • The LWA concept should first become effective in the efficacy evaluation in grapevine, pome fruit and high growing vegetables;
  • In these crops, application dossiers for new products (under Article 33) will only be accepted when trials were planned and carried out based on LWA (to become effective from 01.01.2020);
  • Accordingly, the respective trials must be planned and carried out based on LWA (to become effective from 01.01.2018);
  • The LWA dose rate shall be indicated in the GAP table.

To download: Dose expression for vertical crops

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

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