EUROPE – EFSA: Issues in Physical and Chemical Properties and Analytical Methods
29 April 2019
EUROPE-EFSA: Consultative Group for the Review of the Bee Guidance Document 2013
13 May 2019
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SANCO/2012/11251 rev. 5 (22 March 2019) – DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)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
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