FRANCE: Withdrawal of chlorpyrifos and chlorpyrifos-methyl-based products

As a result of the entry into force of Regulations (EU) 2020/18 and 2020/17 of 10 January 2020 concerning respectively the non-renewal of chlorpyrifos and chlorpyrifos-methyl approval, ANSES has withdrawn, from 16 February 2020, 9 authorisations and 1 parallel trade permit for plant protection products containing these substances.

The end of sales and distribution is set on 16.04.2020.

The end of use of the stocks of products is set on 16.04.2020.

 

To download: 

List of withdrawal of products based on chlorpyrifos and chlorpyrifos-methyl (in French)

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

 

EUROPE: Update of analytical guidance document for residues

Guidance document SANTE/12682/2019 “Analytical quality control and method validation procedures for pesticide residues analysis in food and feed” supersedes guidance document SANTE/11813/2017 from 01 January 2020. 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.

Main changes with respect to the previous version are:

  • a clarification about the non-inclusion of the contribution of sampling to measurement uncertainty in the document, as sampling is not part of the measurement.
  • the use of representative analytes for calibration is no longer relevant: all analytes must now be calibrated in every batch of samples.
  • the need to use calibration standards at the beginning and at the end of the sample sequence to ensure the detectability of the analytes.
  • an explanation of the different approaches to correct the residues when the mean recovery is outside of 80-120 %.
  • the addition of an appendix to clarify the rounding rules of the results and the interpretation of the compliance of these results with respect to measurement uncertainty.

 

To download: 

SANTE/12682/2019 – Analytical quality control and method validation procedures for pesticide residues analysis in food and feed

 

See also our previous articles: 

EUROPE: Update of analytical guidance documents

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

 

FRANCE: Update of the French GEP reference document

The reference document of Good Experimental Practice (GEP) related to the accreditation to conduct officially recognised efficacy trials (Revision of 2 February 2020) supersedes the same guidance document (Revision of 1 November 2013) from 1st June 2020. This document is the French Reference document on Good Experimental Practice according to EPPO Standard PP 1/181 in accordance with Section 6 of the annex to regulation (EU) No. 284/2013 of 1 March 2013.

Main changes with respect to the previous version are:

– Update of the method to register officially recognised efficacy trials using SIDEP system (‘Système d’Information pour la Déclaration des Essais de Produits’) on ANSES website instead of COLEOR website. Also, this declaration (or other elements transmitted to allow this declaration) must be kept for at least 5 years.

– Deletion of the term “trials series” in the guidance document.

– Regarding staff monitoring, authorisation and aptitude must be reviewed periodically and their skills confirmed. Also, company must ensure of the homogeneity of practices between operators (observations and assessments).

– The map for access to the  trial and trial map must be precise enough to know exactly the trial location. 

– More details relating to crop destruction are awaited (such as, the name of the responsible person , the estimated quantity, the date and the method of destruction ). In addition, the destruction method must be defined in the trial protocol.

– All information related to subcontracted services (trial and data phases ) and subcontractor legal name must be clearly indicated in the trial dossier and trial report.

– When a material or an equipment is defective and out of order, it must be identified as such in order to avoid its use and this, until its return to service.

– All information related to artificial contaminations must be clearly indicated and described in the trial dossier. 

 

To download: Reference document GEP 2020 (in French)

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

FRANCE: Safety distances near habitations, better understanding

The Ministry of Agriculture has published a comprehensive memo (in French) on the implementation of safety distances for residents.

In particular a list of the products concerned by the incompressible safety distance of 20 meters is made available.

A series of questions and answers aimed at clarifying the implementation of this new system is also given.

 

To download: 

List of products concerned by the incompressible safety distance of 20 mètres (in French)

”Question-answer” on the implementation of the Decree No. 2019-1500 of 27 December 2019 and of the Order of 27 December 2019 (in French)

 

See also our previous articles: 

FRANCE – Implementation of the New System for Protecting Residents from PPP Spray Drift

FRANCE – Public consultation: new system for protecting residents when using plant protection products

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

 

EUROPE – COM: Update of Working Document on the evaluation of MRL confirmatory data with PRIMo rev. 3.1

The Commission published an update of SANTE/10235/2016 – Rev. 4 “WORKING DOCUMENT on the evaluation of data submitted to confirm MRLs following the review of existing MRLs”. The update concerns the implementation of PRIMo rev 3.1 to article 10 applications and article 12 confirmatory data (Regulation (EC) 396/2005) pending with EFSA on 01.01.2020 or submitted to EFSA as from 01.01.2020. 

For chronic risk assessment STMR values should be used for all existing uses and uses under confirmatory data evaluation. For acute risk assessment only uses subject to confirmatory data should be assessed. When concerns are identified, a stop-the-clock of maximum 2 months is allocated.

This updated working document is accompanied by the Minutes of a PAFF Residues meeting. Special cases on the implementation of PRIMo rev 3.1 in outstanding and future MRL evaluation are developed. Basically it applies since 01.01.2020. Further details are given in the document.

 

To download: 

SANTE/E4/VW 10235/2016 – Rev. 4 WORKING DOCUMENT on the evaluation of data submitted to confirm MRLs following the review of existing MRLs

Agreed approach on implementation of the PRIMO model rev. 3.1. – PAFF residues 25-26 November 2019, agenda item 5

 

See also our previous articles: 

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

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

EUROPE – COM: updated AIR4 and AIR5 work programme

The AIR4 and AIR5 work programmes for active substances renewal have just been updated by DG SANTE following the recent publication of Regulation (EU) 2020/103 amending Regulation (EU) No 844/2012 as regards the provisions necessary for the implementation of the renewal procedure under Regulation (EC) No 1107/2009.

In these new versions of the work programmes, the submission date of the supplementary dossiers for the substances with an expiry date as from 13 May 2023 is set to 33 months instead of 30 months before the expiry of the approval.

 

To download: 

SANTE-2016-10616-rev 12 (February 2020): Draft working document AIR IV renewal programme

SANTE-2018- 10048–rev 3 (February 2020): Draft working document establishing the fifth renewal programme

 

See also our previous article: 

EUROPE: Synchronisation of the renewal procedure for active substances with the harmonised classification process

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

FRANCE: Withdrawal of chlorpropham-based products

As a result of the entry into force of Regulation (EU) 2019/989 of 17 June 2019 concerning the non-renewal of chlorpropham approval, ANSES has withdrawn 22 authorisations and 8 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 08.04.2020.

The end of use of the stocks of products is set on 08.08.2020.

 

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

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

FRANCE – Implementation of the New System for Protecting Residents from PPP Spray Drift

With the entry into force on 01 January 2020 of the Order and Decree of 27 December 2019 that aim at strengthening the protection of residents living nearby crop areas treated with plant protection products (PPP), the French Ministry of Agriculture and Food has published a Technical Instruction providing additional details to the Prefects and to the (Regional) Departments for Food, Agriculture and Forestry (DRAAF and DAAF) for the implementation of the new system.

As a reminder, from 01 January 2020, new minimum safety distances apply between PPP spreading zones (in agricultural and non-agricultural areas) and residential areas or places with vulnerable people. Safety distances can be reduced near homes via Charters of Commitments at the departmental level proposed by PPP users. These Charters will be subject to public consultation and will become applicable after their approval by the Prefects.

The Instruction specifies that to date only drift reduction technologies approved by the French Ministry of Agriculture for their effectiveness can allow a reduction in safety distances. In the future, alternative methods (e.g. hedges, nets) could be taken into account providing that studies demonstrate their effectiveness and that the methods are acknowledged by Anses.

The Instruction reminds that in the absence of an approved Charter, or when the commitments of the approved Charter cannot be implemented, PPP applications must comply with safety distances, without any reduction possible. However, users involved in a draft Charter proposal subject to public consultation are allowed to anticipate the reductions in safety distances – provided drift reduction technologies as defined in Annex 4 to the Order of 27 December 2019 are applied – pending approval of the Charter and until 30 June 2020.

Finally, the Prefects will have to ensure that before 30 June 2020, the existing measures for the protection of vulnerable people (set in application of Article L.253-7-1 of the French Rural Code) are consistent with the new Order of 27 December 2019: i.e. the safety distances must at least be equal to that defined in the Order.

 

To download: 

Technical Instruction DGAL/SDQSPV/2020-87 of 03 february 2020 as regards enforcement of the new system for protecting residents protection des riverains that might be exposed to plant protection products (No. NOR AGRG2003727C) (in French).

 

See also our previous articles: 

FRANCE – Enforcement of the new system for protecting residents when using plant protection products

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

 

EUROPE: Synchronisation of the renewal procedure for active substances with the harmonised classification process

Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amends Regulation (EU) No 844/2012 as regards the provisions necessary for the implementation of the renewal procedure for active substances under Regulation (EC) No 1107/2009.

A 3-month additional time is allowed to the rapporteur Member State for preparing the draft renewal assessment report of the active substance (RAR) and the dossier of harmonised classification and labelling submitted to the European Chemicals Agency (ECHA). In consequence, the European Food Safety Authority (EFSA) will also have these 3 additional months for preparing its conclusion. In return, the period allowed to the applicants will be reduced by 3 months between the submission of the application of renewal and the submission of the supplementary dossiers.

Thus, supplementary dossiers should be submitted no later than 33 months, instead of 30 months, before the expiry of the approval. 

The rapporteur Member State will have 13 months, instead of 12 months, to prepare and submit the renewal assessment report (RAR) to the Commission and to EFSA. Additional information requests to the applicants and consultation of EFSA and other member states do not lead to an extension of the period of 13 months.

The rapporteur Member State should submit at the latest at the time of submission a proposal to ECHA to obtain an opinion on harmonised classification of the active substance at least for the following hazard classes: 

  • explosives,
  • acute toxicity, 
  • skin corrosion/irritation, 
  • serious eye damage/eye irritation,
  • respiratory or skin sensitisation,
  • germ cell mutagenicity,
  • carcinogenicity,
  • reproductive toxicity,
  • specific target organ toxicity, single exposure,
  • specific target organ toxicity, repeated exposure,
  • hazardous to the aquatic environment.

The Committee for Risk Assessment from ECHA should adopt the opinion within 13 months from the submission of the dossier.

 

These new implementations apply to renewal procedures of active substances for which the approval period expires on or after 13 May 2023, excepted the substances for which supplementary dossiers have already been submitted before 17 January 2020.

 

To download: 

COMMISSION IMPLEMENTING REGULATION (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances

 

Lynxee consulting’s team is at your disposal to answer your questions.

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

 

LYNXEE: Appointment of Chloé Trinchese as Expert in Physico-chemistry and Analytical methods

Lynxee consulting’s team is pleased to announce the appointment of Chloé Trinchese.

As a Chemical Engineer, Chloé began her career in formulation laboratories and then worked for ANSES (French Agency for food, environmental and occupational health and safety) as a scientific assessor in the Physical-chemistry and Analytical Methods Unit. She was in charge of the assessment of the relevant sections of the dossiers of authorisation for plant protection products and active substances.

With 5 years of experience in scientific assessment, Chloé joined Lynxee consulting, where she is involved, among others, in the drafting of registration dossiers.

Lynxee consulting’s team welcomes Chloé and encourages you to entrust her with the drafting of your dRR (Physico-chemical properties and analytical methods). You will appreciate the quality and rigour of her work.