EUROPE–EFSA: Environmental exposure and risk assessments for transition metals

Transition metals can be used as active substances in plant protection products (PPPs). Due to their specific behaviour in the environment, they are not fully covered by existing risk assessment guidances.

EFSA was thus asked by the European Commission to prepare a statement that provides a framework for conducting the environmental exposure, hazard characterisation and risk assessment for transition metals when used as active substances according to Regulation (EC) No 1107/2009.

The statement and the outcome of the public consultation performed form 3 August to 21 September 2020 were published on 29 March 2021.

In this statement, the EFSA’s PPR panel proposes to start with a preliminary phase in which monitoring data of transition metals in environmental compartments are compiled. Then a first assessment step is performed considering metal natural background and anthropogenic residue levels and assuming fully bioavailable residues. If higher assessment steps are performed, reduced bioavailability of residues from past applications could be considered. However, for freshly added transition metals such as PPP, equilibrium cannot be assumed.

For addressing speciation and bioavailability issues, models and scenarios including environmental processes and parameters relevant to the fate and behaviour of transition metals in water, sediment and soils would need to be adapted or developed. Care should be taken to avoid unnecessary complexity. All developments should follow current EFSA guidance documents.

If refined approaches have been used in the risk assessment of PPPs containing metals, post-registration monitoring and controlled long-term studies should be conducted and assessed.

Lastly, the statement highlights that the prospective risk assessment of metal-containing PPPs can only cover a defined period as there are limitations in the long-term hazard assessment due to issues of non-degradability. It is therefore recommended to consider these aspects in any risk management decisions and to align the environmental risk assessment with the goals of other overarching legislative frameworks.

 

To download: 

Statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP)

 

Outcome of the Public Consultation on the draft statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP)

 

 

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FRANCE – ANSES: Implementation of the regulatory provisions on banned co-formulants

Following the publication of the list of co-formulants banned in plant protection products (PPP), adjuvants and mixed products (Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009), ANSES published on 24 March 2021 a note concerning the implementation of these new regulatory provisions.

  • For all on going applications for marketing authorisation submitted before 24.03.2021 for products containing a co-formulant listed in Annex III: an application for a non-significant change of composition should be submitted before 24 September 2021 under the form of dossiers of “Application for modification of declared information in a pending application” (PMOI). In the absence of such an application, the marketing authorisation will not be granted.

  • For all marketing authorisations existing on 24.03.2021: all authorisation holders will receive a letter from ANSES asking them to fill in the Table of banned coformulants and to send it back by 31 May 2021 at the latest. Holders of marketing authorisation should indicate whether they will apply for a non-significant change of composition. The compliance with the deadline of 31 May 2021 is a prerequisite for maintaining the authorisations. If an application for a non-significant change of composition is planned, the marketing authorisation holder must submit it before 24 March 2022 or face authorisation withdrawal. A modification of the marketing authorisation will be issued in case of positive conclusions of evaluation of the composition change.

 

Removal procedure

ANSES will proceed quickly to the analysis of all the received answers. In case of withdrawal, a letter of withdrawal intention will be sent to the marketing authorisation holders who will have 10 working days to submit their observations. These will be analysed by ANSES which will decide to maintain the marketing authorisations or to withdraw them by 24 March 2023 at the latest.

Grace periods may not exceed 3 months for sale and distribution and 9 additional months for the disposal, storage and use for the withdrawn products.

 

To download: 

ANSES note – Implementation of the regulatory provisions on banned co-formulants – Version 1 of 24.03.2021 (in French)

Table of banned coformulants to be sent by 31 May 2021

 

See also our previous articles: 

EUROPE – COM: Publication of the 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/

 

FRANCE – ANSES: Product labelling following PPE updates in marketing authorisations

On 02.03.2021, ANSES published an update of its note on the procedure for updating personal protective equipment (PPE) in marketing authorisations.

As a reminder, all dossiers for which a marketing authorisation was issued after 1 January 2020 required an update of the PPE by the authorisation holders. ANSES has then issued decisions amending the marketing authorisations. The updated note indicates in particular that this PPE review does not require to update the labels, in accordance with Article R253-42-II of the French Rural Code, for the products already labelled before the date of decision amending the marketing authorisations.

 

To download: 

ANSES Note – Updating of personal protective equipments mentioned in the marketing authorisations of plant protection products, in application of article 15 of the Order of 04 May 2017 amended by the Order of  27 December 2019 – Version 2 of 02.03.2021 (in French)

 

See also our previous articles: 

FRANCE – ANSES: Procedures for updating PPE in marketing authorisations

 

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

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EUROPE: 27 March 2021, new rules for confidentiality claims for dossiers

The Transparency Regulation (EU) 2019/1381 entered into force on 27 March 2021.

From this date, new rules apply as regards the confidentiality of dossiers.

The applicants who want to request for certain information to be kept confidential pursuant to article 63 of Regulation (EC) 1107/2009 amended by Regulation (EU) 2019/1381 should submit with their applications the form « Request for certain information to be kept confidential » available in Annex 10 of the guidance document SANCO/13169/2010 Rev. 11 on zonal assessment, mutual recognition, withdrawal and amendment of authorisations.

By default, only the information regarding the identity of authors of vertebrate studies are considered as confidential. For all the other data for which confidentiality is claimed, the applicants must justify their request in the form. The applicants should demonstrate that the disclosure of such information potentially harms their interests to a significant degree.

See also our previous article:

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

 

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

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EUROPE :Révision of EPPO Standard PP 1/239 “Dose expression for plant protection products”

The EPPO Standard “PP 1/239 (2) Dose expression for plant protection products” has been updated to the version PP 1/239 (3) and published on 24/02/2021. The revision follows the EPPO Workshop on harmonized dose expression for the zonal evaluation of plant protection products in high growing crops (Vienna, October 2016).

This standard includes :

– Different dose expressions available according to the type of crop.

– Definitions of terms commonly used in the description of the dose expressions.

– Methods to calculate the different dose expressions for high growing crops, and also to calculate their interconversion.

– Specific parameters to be recorded to determine a dose but also to be able to convert it to another dose expression.

– Harmonized procedures on the measurement of individual plant parameters in the field to facilitate consistent approaches.

To download: 

PP 1/239 (3) Dose expression for plant protection products

http://lynxee.consulting/europe-guide-concernant-lexpression-de-dose-cultures-verticales-belgique-zone-centre/.

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

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EUROPE–EFSA: New version of PERSAM tool for PECsoil calculations

A new version (v3.0.5) of the PERSAM tool to conduct PECsoil calculations in agreement with the new EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (EFSA Journal 2017;15(10):4982) was recently released.

The list of the issues solved in versions v3.0.1 to v3.0.5 can be found in Section 1.2.2 (p. 8-9) of the updated PERSAM user manual, that comes with the tool (it can also be downloaded further below). PERSAM 3.0.5 can be downloaded via the ESDAC website (a request form should be fulfilled to receive a download link).

Further details on the issues can be found in the Bug fixing & update report recently released by EFSA (to be downloaded below).

 

To download: 

Update of PERSAM software models for predicting environmental concentrations in soil in permanent crops and annual crops: User manual PERSAM 3.0.5. EFSA Supporting publication 2021:EN-1756.

Software tool for calculating the predicted environmental concentrations (PEC) of plant protection products (PPP) in soil for permanent and annual crops: Bug fixing & update report. EFSA Supporting publication 2021:EN-6484.

 

See also our previous articles: 

EUROPE – EFSA: New version of PERSAM tool for PECsoil calculations

EFSA : Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil

 

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

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

 

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.

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