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SANCO/2012/11251 rev. 5 (22 March 2019) – DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)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

 

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

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.

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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

 

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EUROPE: publication of the 12th ATP to CLP

The 12th adaptation to technical progress (ATP) of the CLP Regulation was published on 28 March 2019.

This amends Annexes I to VI to take account of the sixth and seventh revised editions of the Globally Harmonized System (GHS) of classification and labelling of chemicals. In particular, these revisions of the GHS introduce a new hazard class for desensitised explosives and a new hazard category, pyrophoric gases, within the hazard class flammable gases.

Other changes include adaptations to the criteria for substances and mixtures which in contact with water emit flammable gases, the generic cut-off values; the general provisions to classify aerosol forms of mixtures; and the detail of the definitions and classification criteria as appropriate for the hazard classes explosives, flammable gases, flammable liquids, flammable solids, acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation, respiratory and skin sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity and aspiration hazard.

In addition, amendments are introduced to some hazard and precautionary statements.

This Regulation shall apply from 17 October 2020.

 

To download:

Commission Regulation (EU) 2019/521 of 27 March 2019 amending, for the purposes of its adaptation to technical and scientific progress Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

 

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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 – EFSA: Update of the Pesticide Residue Intake Model 3 (PRIMo rev. 3.1)

EFSA has released the revision 3.1 of the Pesticide Residue Intake Model. The following modifications were introduced:

  • A new spreadsheet was added to facilitate the conversion of MRLs derived from the European Commission database in a format compatible with PRIMo;
  • Correction of a number of large portion consumption data;
  • Correction of unit weight data;
  • Correction of TMDI calculation;
  • Correction of the calculation of the threshold residue in processed products (IESTI case 2a and 2b);
  • Editorial modifications.

A comparison of old and new versions indicates that the revisions impact the acute risk assessment, for several commodities, but not the chronic risk assessment.

To download:

Pesticide Residue Intake Model – EFSA PRIMo revision 3.1 (update of EFSA PRIMo revision 3), EFSA Supporting publication 2019:EN-1605

EFSA PRIMo revision 3.1 (spreadsheet)

See also our previous articles:

EUROPE: New version of the Pesticide Residue Intake Model (PRIMo rev. 3)

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FRANCE: Update of the official list of biocontrol products – February 2019

The French Ministry of Agriculture, Food and Forestry has published a new update of the official list of biocontrol plant protection products in accordance with articles L.253-5 and L.253-7 of the Rural Code. This note reminds that the law No. 2018-938 of 30 October 2018 for achieving a balance in trade relations in the agricultural sector and for healthy, sustainable and affordable food (also called EGalim) has completed the biocontrol provisions introduced by the French Law for agriculture, food and forestry of 13 October 2014. The EGalim law plans in particular a National strategic deployment plan for biocontrol products that will be presented in the year 2019.

The biocontrol plant protection products from the list are exempted from the ban on discounts, rebates and price reductions and from the implementation of specific risk mitigation measures to protect residents set by the EGalim law (Articles 74 and 83).

As a reminder, it has to be noted that only the biocontrol products having the claim « emploi autorisé dans les jardins » (EAJ) can be used by non-professional users (as well as  the EAJ products considered as low risk or authorised for organic farming).

To download: Note DGAL/SDQSPV/2019-144 of 13.02.2019 (in French)

See also our previous articles:

FRANCE: New Agriculture and Food law published

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FRANCE – ANSES: recommendations to strengthen the protection of bees

As part of the French action plan on plant protection products (PPP) and on a less pesticide-dependent agriculture, ANSES was seized mid-2018 by the Ministries of Agriculture and Ecological Transition to make recommendations aimed at strengthening the regulatory framework for the protection of bees and other pollinating insects.

ANSES was notably asked to review the requirements to obtain an exemption like a “Bee claim”, as defined by the French decree of 28 November 2003. As a reminder, this national measure supplements and strengthens the European legislation as regards the use of insecticides and acaricides. It bans the spray application of these PPP during flowering and/or honeydew production periods, except in the case of a justified exemption and the attribution of a “Bee claim”.

After an analysis of all available data (in particular those coming from national monitoring networks), ANSES issued the following recommendations:

  • Extend the ban of spraying insecticides and acaricides during flowering and/or honeydew production periods:  
    • to all PPP sprayed during these periods,
    • to all PPP containing systemic active substances and sprayed before flowering of the crop or used as seed treatments,
    • including, microbial-based PPP.
  • Require new types of studies to obtain the exemption “Bee claim” (including for products already authorised) or for the use of systemic active substances via spray application before flowering of the crop or via seed treatments:
    • Honeybees (A. mellifera)
      • Larval toxicity test following repeated exposure (OECD GD 239),
      • Study of effects other than brood development following a chronic exposure (laboratory test on adult bees, 20-30 days exposure) – after validation of the test,
      • Study of long-term effects following an acute exposure (hypopharyngeal gland development) – after validation of the test, and
      • Study of behavioral effects (homing capacity of forager bees) – after validation of the test – in the case of insecticides targeting the central nervous system.
    • Bumblebees (B. terrestris)
      • Acute oral and contact toxicity tests, and
      • Toxicity tests under more realistic conditions (e.g. tunnel) – after validation of the tests

ANSES also reiterates its previous recommendations made to protect bees in the context of the French decree of 28 November 2003 (2013-SA-0234 – in French): irrespective of the crop concerned, PPP with an exemption “Bee claim” should only be applied after sunset and within the next three hours, with measures to ensure operator safety.

Finally, while the “new” EFSA Guidance on Bees (EFSA Journal 2013;11(7):3295) has still not been implemented at EU level, ANSES will start an update of the risk assessment approach for bees and other pollinators. This work will be based on the methodology proposed by EFSA, in particular for the chronic risk assessment for bees (adults and larvae), and by taking into account different exposure scenarios.

To download (in French):

AVIS de l’Anses relatif à l’évolution des dispositions réglementaires visant à protéger les abeilles et les insectes pollinisateurs sauvages (Saisine 2018-SA-0147)

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FRANCE: Glyphosate phase-out plan issued

The measures of the glyphosate phase-out plan launched by the government to put an end to the main uses of glyphosate by 2020 and to all its uses by 2022 were disclosed on 17 January 2019.

The animation and the follow-up of this action plan are entrusted to a “Task Force” gathering the Ministry of Agriculture and Ministry of Ecological and Solidarity Transition, INRA (French National Institute for Research in Agriculture), ACTA (network of French Agricultural Institutes) and APCA (Chambers of Agriculture Assembly) and chaired by Prefect Pierre-Étienne Bisch, appointed inter-ministerial coordinator of the glyphosate phase-out plan on 1st  December 2018. The coordinator, who will be responsible for reporting on actions taken and progress made every three months to ministers and parliamentarians, was auditioned by the National Assembly on 17 January 2019.

Among the measures of this action plan, a resource center was put online on 1st February 2019 to make available to the whole agricultural profession existing solutions to get out of glyphosate. The contributions, intended to get extended, come from farmers and field experiences, and can be consulted through summary articles, technical sheets and farmer experiences organised by sectors.


The press release also reminds the existence of the websiteglyphosate.gouv.fr” presented by the government on 22 November 2018, intended to monitor the number of farmers having stopped any use of glyphosate or engaged in this way. A start-up will also be launched during the first quarter of 2019 to allow the emergence of digital tools to support farmers.

Finally, this press release informs that, following the glyphosate approval by the European Commission for 5 years, ANSES will re-assess applications for renewal of approvals for PPPs containing glyphosate with paying particular attention to certain points such as their genotoxic potential and the conformity of the co-formulants used, the protection of operators, the protection of groundwater and biodiversity, which might lead to restrictions of use.

ANSES will carry out a comparative assessment of the products remaining authorised by the end of 2020 with the support of INRA, after which only uses without alternative will be maintained.
In accordance with the regulation renewing the approval of glyphosate, ANSES will restrict the pre-harvest use of glyphosate to spot application in all approvals, and thus withdraw all broadcast herbicidal uses before harvest.

See also our previous articles:

FRANCE: Towards glyphosate phase out

EUROPE: Renewal of glyphosate approval

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FRANCE: Withdrawal of products based on thiram

As a result of the entry into force of Regulation (EU) 2018/1500 concerning the non-renewal of thiram approval, ANSES has withdrawn 10 authorisations and 3 parallel trade permits for plant protection products containing this active substance.

The authorisations are withdrawn on 30.01.2019 (withdrawal decisions).

The end of sales and distribution is set on 30.04.2019 for foliar applications.

The end of sales and distribution is set on 31.07.2019 for seed treatment applications.

The end of use of the stocks of products is set on 30.04.2019 for foliar applications.

The end of use of the stocks of products is set on 31.01.2020 for seed treatment applications.

The end of use of treated seeds  is set on 31.01.2020.

To download: List of withdrawal of products based on thiram (in French)

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