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SANCO/2012/11251 rev. 5 (22 March 2019) – DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)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

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