EUROPE – EFSA: Public consultation: Updated guidance on the assessment of human exposure in risk assessment for plant protection products

EFSA has launched a public consultation on a draft updated guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products.

The draft updated guidance now includes the greenhouse uses. The default values for crop parameters and for human parameters have been revised. The calculator for exposure assessment has also been revised as an online tool (available on the R4EU platform) including new scenarios, updated default values, revised crop groupings, as well as improved functionalities such as exposure estimates for several active substances in a product, calculation of safe re-entry interval and generation of a report.

The public consultation is opened until 09 May 2021.

 

To download: 

Draft updated EFSA Guidance and its annexes

 

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

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EUROPE – COM: Publication of the list of co-formulants banned in PPP

Following the public consultation of 16 January 2020 on the draft list of co-formulants banned in plant protection products and its revision in May 2020 (see our previous articles), the Commission published on 4 March 2021 on the Official Journal of the European Union the Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009 listing co-formulants which are not accepted for inclusion in plant protection products.

The Regulation (EU) 2021/383 thus lists the co-formulants which are banned in the composition of plant protection products and adjuvants. Member states must then review the composition of the products currently authorised and withdraw or amend as soon as possible the authorisations of products containing these banned co-formulants, with a maximum deadline of 24 March 2023. Grace periods are set at a maximum of 3 months for sale and distribution and 9 additional months for the disposal, storage and use from the date of amendment or withdrawal of the authorisation.

However, the co-formulants listed in the annex may be present as unintentional impurities in other authorised co-formulants at a concentration not exceeding 0.1 % w/w in the finished plant protection product or adjuvant. For one co-formulant (Benzo[def]chrysene, CAS number 50-32-8, EC number 200-028-5), this limit is lowered to 0.01 % w/w in the finished product (specific concentration limit related to CMR properties).

 

To download: 

COMMISSION REGULATION (EU) 2021/383 of 3 March 2021 amending Annex III to Regulation (EC) No 1107/2009 of the European Parliament and of the Council listing co-formulants which are not accepted for inclusion in plant protection products

 

See also our previous articles: 

EUROPE – COM: Update of the draft list of co-formulants banned in PPP

EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP

 

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

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

 

EUROPE – EFSA: Guidance document on active substance applications for approval and renewal and on MRL applications

EFSA published on 03 March 2021 a technical report describing the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment or the renewal of approval of an active substance, and for applications for setting of maximum residue levels (MRLs). This guidance document is applicable for all applications submitted as of 27 March 2021.

This document describes the procedures and the timelines for handling these applications and also includes the new requirements related to the implementation of the Transparency Regulation (Regulation (EU) 2019/1381). The different support initiatives available and the interaction between the applicant, EFSA members and RMS/Co-RMS from the preparation of the application (pre-submission phase) to the adoption and publication of the EFSA’s conclusions or reasoned opinions are presented.

Eventually, a practical guidance for applicants and Member States also describes the key technical points for preparing dossiers and assessment reports under Regulation (EC) No 1107/2009 with the aim to enhance their quality.

 

To download: 

EFSA Supporting publication 2021:EN-6464: Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure

 

See also our previous articles: 

EUROPE-EFSA: Guidance on active substance applications for approbation and renewal

 

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

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

 

EUROPE – COM: Publication of a new guidance document on analytical methods

On 24 February 2021, the European Commission has published a new guidance document (SANTE/2020/12830, Rev.1) on pesticide analytical methods for risk assessment and post-approval control and monitoring control.

This document has been finalised in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF – section Phytopharmaceuticals – Pesticides Residues) on 22-23 February 2021. It supersedes guidance documents SANCO/3029/99 (requirements for analytical methods used in pre-registration for risk assessment) and SANCO/825/00 (requirements for analytical methods for post-approval control and monitoring purposes) and is applicable since 01 March 2021.

The main directives of these two previous documents are restated, but further details and explanations have been included. New points are also developed:

  • Possible use of isotopically labelled internal standard for methods using mass spectrometry as detection system.
  • If a hydrolysis step is necessary (if esters, amides and/or conjugates are included in the residue definition and that the structures of the conjugates are unknown or no conjugate standard is available), the efficiency of hydrolysis step must be demonstrated.
  • Individual recovery data must be detailed in addition to mean recoveries for each matrix and each fortification level.
  • Further explanations on matrix effects and mathematical formula to calculate them.
  • For the analytical calibration, the suitability of the chosen function should preferably be demonstrated by a residual analysis rather than reporting the coefficient of correlation (r) or determination (R²).
  • The limit of detection (LOD) must be determined and correspond to the lowest calibration standard (preferably in matrix) rather than calculated from the signal-to-noise ratio in control samples.
  • Examples for acceptable/non-acceptable deviations of an independent laboratory validation (ILV) from the primary method.
  • Stability of the extracts and standards must be demonstrated.
  • Extraction efficiency must be demonstrated in accordance with the guidance document SANTE 2017/10632 Rev. 3.
  • For the post-approval control and monitoring methods, the following are now required:
    • the determination of the residues in honey (primary method + confirmatory method + ILV);
    • an ILV for the determination of residues in drinking water or groundwater; 
    • an analytical method for the determination of residues in body fluids and tissues, regardless the toxicological classification of the active substance and/or metabolites (primary method + confirmatory method).

Appendix 1 lists all foodstuffs of plant origin and processed commodities and the group of matrices associated with them (high-water, high-acid, high-oil, dry or difficult to analyse commodities) and Appendix 2 gives an overview of methods required.

 

To download: 

SANTE/2020/12830, Rev.1 (24.02.2021) – Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes

 

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

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

 

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/

 

FRANCE: Specific provisions for the ban extension of plant protection products in 2022

Since 1 January 2017, the Labbé’s law aims to better regulate the use of plant protection products in France by banning their use for amenity areas, forest and areas accessible or open to the public (excluding biocontrol products officially listed by the Ministry of Agriculture in accordance with articles L.253-5 and L.253-7 of the Rural Code, low-risk products or organic farming products). Since 1 January 2019, this ban has been extended to all non-professional users.

On 21 January 2021, the Order of 15 January 2021 was published in the Official Journal of French Republic as regards measures to protect people when using plant protection products in private properties, places frequented by the public and places for collective use and amending the Order of 4 May 2017 as regards the placing on the market and the use of plant protection products and their adjuvants referred to in Article L. 253-1 of the French Rural Code.

This Order extends the Labbé’s law bans on the use of plant protection products to various places frequented by the public or for collective use as of 1 July 2022, such as:

  • Private residential properties;
  • Hotels, collective inns, campsites and residential leisure parks;
  • Cemeteries and columbariums;
  • Family gardens and amusement parks;
  • Commercial and service areas;
  • Workplaces;
  • Educational institutions;
  • Health facilities;
  • Social and medico-social facilities;
  • Childminder homes;
  • Sport equipments;
  • Aerodromes (excluding areas requiring treatment for safety reasons).

The ban does not apply to treatments and measures necessary for the destruction and prevention of the spread of regulated harmful organisms, or to treatments necessary for the control of significant health hazard threatening the historical or biological legacy.

Regarding sport equipments (large sport grounds, hippodromes, tennis courts, golf courts and practices), an exemption will be granted until 1 January 2025 for uses with no suitable alternative technical solution for achieving the quality required in the context of official competitions.

 

To download: 

Order of 15 January 2021 as regards measures to protect people when using plant protection products in private properties, places frequented by the public and places for collective use and amending the Order of 4 May 2017 as regards the placing on the market and the use of plant protection products and their adjuvants referred to in Article L. 253-1 of the French Rural Code (in French)

 

See also our previous articles: 

FRANCE – Public consultation: Extension of the ban of plant protection products in 2022

 

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

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

 

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

Following the adoption in mid-December 2020 of the Law No. 2020-1578 establishing a possibility of temporary derogations from the ban on neonicotinoids and other substances having the same mode of action in case of emergency situations for sugar beets (see our previous article), a public consultation on a draft Order setting the derogation conditions for 2021 is launched from 04 to 25 January (consultation page).

The draft Order provides for a 120-day authorisation of two imidacloprid- and thiametoxam-based products for sugar beet seed treatment.

The publication of this draft Order is accompanied by a note of the National Research Institute for Agriculture, Food and Environment (INRAE) defining the criteria for assessing pest pressure on beets and defining the expected level of emergency for this crop:

  • Aphid populations presence in autumn;
  • Viral presence in autumn;
  • Seasonal weather forecast (initialised on 1st December).

INRAE analysis for 2021 could not rule out a level of risk similar to the previous year. It led the Ministry of Agriculture to anticipate with the preparation and the public consultation of this decree. It is however noted that prior to the release of the Order, an update of weather forecast data may be made to confirm or reject the need for such a derogation.

The Annexes associated with the draft Order detail the conditions of use of the two plant protection products referred to (Annex 1) and the restrictions on crops that may be seeded, planted or re-planted afterwards in treated fields, to limit potential impacts on pollinators (Annex 2).

Accordingly, to protect pollinators, a list of authorised succeeding crops for 2022, 2023 and 2024 is provided. Farmers will also have to limit weed flowering in succeeding crops and to limit intermediate attractive crops.

The conditions of use also stipulates that:

  • adequate seed drilling equipment shall be used “to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission”;
  • the farmer shall check that “the treated seeds must be entirely incorporated in the soil” and “ensure that the product is also fully incorporated at the end of rows” and “remove spillages”;
  • treated seeds can only be sown once a year and once every three years in the same field.

These measures were proposed by the Ministry on the basis of the ANSES Opinion of 23 December 2020.

 

To download (in French): 

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

Anses Opinion of 23 december 2020 as regards mitigation measures that shall be included in any derogations from the ban on neonicotinoids and other substances having the same mode of action.

Note from Inrae – Criterion to justify the need for a derogation.

 

See also our previous articles: 

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/