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SANCO/2012/11251 rev. 5 (22 March 2019) – DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)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

 

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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.

 

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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

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UK: Final commenting phase on the guidance on physico-chemical data

In 2015, a guidance document on the physical, chemical and technical data required to support the registration/authorisation of plant protection products under Regulation (EC) 1107/2009 was published on the HSE website. This National guidance has since been through commenting phases with other EU Member States, EFSA, Industry and wider Stakeholders in order to become an EU harmonised guidance document.

The updated harmonised version reviewed by CRD further to the consultation processes is now available for final comments. The final commenting phase will be completed by 14 May 2018.

Version for commenting:  Guidance document for the generation of data on the physical, chemical and technical properties of Plant Protection Products (PPPs) under Regulation (EC) 1107/2009.

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EUROPE: Update of analytical guidance documents

Two updated guidance documents have been published by the European Commission as regards analytical methods:

Guidance document on analytical quality control and method validation procedures for pesticide residues analysis in food and feed – SANTE/11813/2017 rev.0, 21 – 22 November 2017

It supersedes guidance document SANTE/11945/2015 and will be implemented by 01 January 2018. It describes the method validation and analytical quality control requirements to support the validity of data used for checking compliance with maximum residue limits, enforcement actions, or assessment of consumer exposure to pesticides in the EU.

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods – SANTE 2017/10632 rev.3, 22 November 2017

The purpose of this guidance document is to give advice on when and how to assess the suitability of the extraction procedures applied in pesticide residue analytical methods, e.g. as required for post-registration monitoring methods in the guidance document SANCO/825/00. However, it is not restricted to post-registration monitoring methods and it is also applicable for pre-registration residue analytical methods used for the quantification of residues in supervised field trials. The guidance document has been developed primarily for the evaluation of extraction efficiency of analytical methods for plant matrices, but the basic principles are also applicable for products of animal origin.

The procedure for evaluating extraction efficiency concerns the data requirements for:

– applications for new active substance approval and renewal of active substances  submitted 2 years after agreement on this document;

– new product authorisations and renewal of product authorisations (the data requirements used for the latest renewal or approval should be considered; no additional proof of extraction efficiency will be required when no change of the MRLs is needed);

– applications for new MRLs made 2 years after agreement on this document;

– MRL reviews and specific MRL assessments (pre- and post-registration analytical methods in line with this document will only be required if it was required for the latest approval or renewal. In case that for the Art. 12 MRL reviews and Art. 43 MRL assessments crops out of the scope of the approval or renewal process are considered, additional proof of extraction efficiency might be required but not available. In those cases no new studies should be requested at this stage; however they will need to be made available at the occasion of a new MRL application or at the next renewal of the substance).

– quality control and method validation procedures for pesticides residues in food and feed (see guidance document SANTE/11945/2015 superseded by guidance document SANTE/11813/2017).

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EFSA Public consultation: Guidance for the identification of biological relevance of adverse/ positive health effects from experimental animal and human studies

The public consultation on the draft guidance document of the EFSA Scientific Committee on the identification of biological relevance of adverse/ positive health effects from experimental animal and human studies is opened until 1st May 2017.

Generic issues and criteria are given to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a positive health effect) or not. The opinion clarifies a number of definitions and concepts, such as, responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modelling approaches, etc. It also proposes several case studies.

For more information, see EFSA website.

 

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EFSA Public consultation: Guidance on The Use of the Weight of Evidence Approach in Scientific Assessments

The public consultation on the draft guidance document of the EFSA Scientific Committee on The Use of the Weight of Evidence Approach in Scientific Assessments is opened until 1st May 2017.

The guidance document addresses the use of the weight of evidence in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA’s remit are annexed to the guidance document to illustrate the applicability of the proposed approach.

 

For more information, see EFSA website.

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EUROPE: Updates of AIR 3 and AIR 4 Guidance documents

A number of SANCO and SANTE guidance documents have been updated:

AIR 3 Programme 

SANCO/10148/2014 – Rev. 11 – January 2017 – Applications for renewal of approval of active substances submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

AIR 4 Programme 

SANTE-2016-10616–rev. 6 – February 2017 – Draft working document – AIR IV Renewal Programme

SANTE-2016-11734–rev. 3 – February 2017 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

 

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EUROPE: New update of SANCO 7525/VI/95 on comparability, extrapolation, group tolerances and data requirements for setting MRLs

Revision 10.2 of Guidance document SANCO 7525/VI/95 concerning residue trials was adopted by the European Commission on 23 September 2016 and became effective immediately.

This new revision applies to new applications but also to those applications where assessment was already carried out by a Member State under the previous version. In such cases EFSA should use the new version to make its assessment. Where applications are already advanced in the EFSA assessment procedure and use of the new guidance would delay the overall procedure, no retroactive amendments should be carried out. The same principles apply to the Art. 12 review process.

The update concerns Table 3 (recommended extrapolations) and Table 4 (Addendum to Table 3). Some mistakes/errors detected after the adoption of version 10.1 were corrected and some clarifications were made.

To download:

SANCO 7525/VI/95 Rev. 10.2 – GUIDANCE DOCUMENT Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs

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