FRANCE – ANSES: Update of the memo on grace periods and label update

On 27.04.2021, ANSES published an update of its note on the grace periods granted and deadlines to update labels in case of withdrawal, amendment or non-renewal of a marketing authorisation or a parallel trade permit for plant protection products.

The update concerns the amendment of conditions for setting grace periods or the addition of new cases involving the determination of the grace periods.

Thus, in the case of a withdrawal of a marketing authorisation or a permit, following the expiry of the active substance approval, grace periods of 6 and 12 months are established for respectively the sale and distribution and for the storage and use of the existing stocks, except for cases where ANSES is aware of harmful effects of the product on human or animal health or of unacceptable effects on the environment (Case n°1).

The conditions for setting grace periods have been added in the following cases:

  • Withdrawal of a marketing authorisation or a parallel trade permit achieved more than one year after the date of the active substance renewal for a marketing authorisation renewal dossier not fulfilled within the deadlines or abandoned by the company (Case n°2b).
  • Withdrawal or amendment of a marketing authorisation following a scientific assessment, in particular after the instruction of a marketing authorisation renewal application (Case n°3).
  • Withdrawal or amendment of a marketing authorisation for a resale product or withdrawal of a parallel trade permit following a scientific assessment of the reference product or identical product authorised in France (Case n°3).

 

To download: 

ANSES note – Grace periods granted by ANSES and deadlines to update labels in case of withdrawal, amendment or non-renewal of a marketing authorisation or a parallel trade permit for plant protection products – Updated version of 27.04.2021 (in French)

 

See also our previous articles: 

FRANCE – ANSES: Memo on grace periods and label update

 

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

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

 

FRANCE: Withdrawal of mancozeb-based products

As a result of the entry into force of Regulation (EU) 2020/2087 of 14 December 2020 concerning the non-renewal of mancozeb approval,  65 authorisations and 17 parallel trade permits for plant protection products containing this substance will be withdrawn from 04 July 2021.

The end of sales and distribution is set on 04.07.2021.

The end of use of the stocks of products is set on 04.01.2022.

 

To download: 

List of withdrawal of products based on mancozeb (in French)

 

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

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

 

FRANCE – ANSES: Amendment of marketing authorisations of metalaxyl-M-based products

As a result of the entry into force of Regulation (EU) 2020/617 of 05 May 2020 concerning the renewal of metalaxyl-M approval and restricting the use for seed treatments, ANSES has amended 5 authorisations for plant protection products containing this substance.

The decisions amending the authorisations have already been published since 26 February 2021, but they will only apply from 01 June 2021 for seed treatment uses. Thus, the seeds treated with products containing metalaxyl-M shall only be sown in greenhouses.

The concerned products are:

– APRON XL

– INFLUX XL and its second brand name CELEST XL

– INFLUX QUATTRO

– VIBRANCE SB

– WAKIL XL and its second brand name WAKIL 325

 

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

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

 

FRANCE: Update of the national catalog of plant protection uses

The Order of 12 April 2021, published in the Official Journal of the French Republic of 21 April 2021, repeals the Order of 26 March 2014 on the implementation of the national catalog of plant protection uses.

This Order takes into account the latest updates of the catalog by providing adaptations of marketing authorisations (Annexes 1 and 2). It also defines the scope of the use and lists the transitional uses (Annex 3). An “Experimentation” section has also been included in the catalog for each use in order to identify the main pests representative of the use and for which biological efficacy data are expected.

 

To be noted:

Annex 2 of the new catalog of uses lists the correspondences between the old and the new wordings of the plant protection uses. If necessary, updates of this annex will be published in the Official Bulletin of the Ministry of Agriculture. ANSES will adapt the marketing authorisations and parallel trade permits within 6 months following the application date of the Order. A 6-month period will also apply following the publication of an amendment of this annex 2. The modifications of authorisation will be made public directly on the Ephy website. The products whose first marketing authorisation is granted within 18 months following the publication of amendment of Annex 2 may still be sold and used until stock depletion and without updating labels. Products firstly authorised after this 18-month period will have to be labelled in accordance with the amendments of Annex 2.

Applications for marketing authorisations and parallel trade permits will have to be in compliance with the new version of the catalog of uses at least 6 months after its publication. Applications submitted before this deadline may refer to the old version.

However, applications for marketing authorisations cannot refer to the transitional uses listed in the Annex 3 of the catalog of uses in force at the time of the submission, except for applications for marketing authorisation for resale products, generic products or parallel trade permits. The corresponding uses listed in this annex should be used.

 

To download: 

Order of 12 April 2021 on the implementation of the national catalog of plant protection uses specified in the marketing authorisation and parallel trade permit decisions of plant protection products and adjuvants (in French)

Technical instruction DGAL/SDQSPV/2021-278 (12.04.2021): National catalog of plant protection products (in French)

 

See also our previous articles: 

FRANCE: National PPP uses catalog – New DGAL memo

FRANCE: Focus on the changes in the catalog of uses

 

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

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

 

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)

 

 

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

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

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.

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

 

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.

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

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/