EUROPE: Update of guidance document on zonal evaluation, mutual recognition, withdrawal and amendment of authorisations

The European Commission has published an update of the guidance document SANCO/13169/2010 Rev. 11 on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009. This version updates the revision of July 2014. It has been finalised in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) on 25 January 2021 and applies to all applications submitted from 01 March 2021.

This new revision now includes the procedures to be followed for applications of plant protection products authorisation according to Article 34 of Regulation (EC) No 1107/2009 (exemption from the submission of studies), withdrawals or amendments of an authorisation (Articles 44 and 45) and grace periods under Article 46. The procedures for placing on the market of low-risk plant protection products according to Article 47 are also described and appendices have been added.

The guidance document also highlights the importance of the zonal evaluation procedure for any application for new authorisations, which will then be subject to commenting from other Member States in the zone. Appendix 1 on the commenting requirements for each type of application has thus been updated.

Also note the ongoing implementation of the Plant Protection Products Application Management System (PPPAMS) on which the applicants are encouraged to use to submit their application (already suitable for Art. 33, Art. 40-42 and Art. 53).

 

To download: 

SANCO/13169/2010 Rev. 11 – Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009

 

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

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

 

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

The overview of the applications for renewal of approval under article 14 of Regulation (EC) No 1107/2009  for the active substances of the AIR4 and AIR5 programmes have just been updated by DG SANTE.

Updates had already been published in January 2021. In the new versions of February 2021, the deadlines for the submission of the renewal application of some active substances of the AIR4 and AIR5 programmes have been extended according to the Regulation (EU) 2020/1740. For memory, this regulation applies from 27 March 2021 for all active substances whose approval period expires on or after 27 March 2024. Applications according to the new rules must be submitted no later than 3 years before the expiry of the active substance.

 

To download: 

SANTE-2016-11734–rev 24 (February 2021): AIR IV renewal programme applications for renewal of approval

SANTE-2019-13022–rev 6 (February 2021): The 5th renewal programme applications for renewal of approval

 

See also our previous articles: 

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

EUROPE – COM: Updated overview of AIR5 applications

 

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

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

 

FRANCE: Ban of Neonicotinoids – the 2021 Derogation for Sugar Beets Validated

The Order authorising for 120 days in 2021 the use of sugar beet seeds treated with imidacloprid- and thiamethoxam-based plant protection products is released.

Following the public consultation and the meeting of the dedicated Supervisory Board, the final text includes a possibility to anticipate the seeding, planting or re-planting of the crops mentioned in Appendix 2. Anticipation will be possible after having implemented mitigation and compensation measures (listed in Appendix 2bis) to ensure “an equivalent level of protection for pollinators and biodiversity”. Anticipation measures are provided for maize (untreated crop buffer, planting of melliferous flora) and for oilseed rape (seeding of a mixture of rapeseed with at least 50% of an early variety in untreated plots).

A new Order will be issued to precise the rules for the anticipation. It will be based on an Opinion of Anses (to be released) assessing the levels of protection resulting from the mitigation and compensation measures.

 

To download (in French): 

Joint Ministerial Order of 5 February 2021 as regards the provisional authorisation of sugarbeet seeds treated with imidacloprid- or thiamethoxam-based plant protection products.

Outcome of the Public Consultation

Rationale for the Joint Ministerial Decision

 

See also our previous articles: 

FRANCE: Neonicotinoids – Public Consultation on the 2021 Derogation Draft Order

FRANCE: Ban of Neonicotinoids – A Derogation for Sugar Beets

 

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

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

 

EUROPE: Guidance on Aged Sorption Studies Adopted

The final version of the guidance document on aged sorption studies of plant protection products in soil was endorsed at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF meeting) of 25-26 January 2021.

The final version integrates the revisions suggested by the EFSA PPR panel (EFSA Journal 2015;13(7):4175 and EFSA Journal 2018; 16(8);5382). Additional comments from Member States made at SCoPAFF meetings between May 2019 and January 2021 will be considered in a later revision of the document.

The guidance document was drafted in order to provide a framework on how to conduct and interpret experimental studies aiming to demonstrate an increase in pesticide sorption with time and how to integrate the results in regulatory higher tier risk assessments. This framework was built on the basis of a literature review, experimental work and extensive modelling.

Only aged sorption as investigated in laboratory studies is under the scope of this document. Field studies being much more complex, further development and tests with real world data would be needed.

The guidance document addresses the following topics:

  • Modelling of aged sorption and conceptual definition of equilibrium sorption;
  • Experiments to derive aged sorption parameters;
  • Fitting of kinetic models to data from aged sorption studies;
  • Aged sorption in the tiered pesticide leaching assessment;
  • Special consideration for metabolite.

This new guidance document will apply from 1 April 2021 (date of dossier submission).

 

To download: 

Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments – SANTE/12586/2020–REV 0 – 26 January 2021

 

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

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