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

/in /by Émilie Vianay

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SANCO/2012/11251 rev. 5 (22 March 2019) – DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)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

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

 

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

/in , , /by Adrien Margerit

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

/in /by Émilie Vianay

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.

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