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EUROPE: Adoption of new EPPO Standards PP 1/306 and PP 1/307 and revision of EPPO Standard PP 1/226

Two new EPPO Standards (PP 1/306(1) and PP 1/307(1)) adopted in September 2018 and the revision of EPPO standards PP 1/226 also dated September 2018 have just been published:

  • The EPPO Standard “PP 1/306 (1) General principles for the development of co-formulated mixtures of plant protection products” sets the definition of a co-formulated mixture and provides guidance for the justification for using mixtures from the point of view of efficacy, plus an examination of the appropriateness of such mixtures in terms of managing resistance. Additional information for specific product types and situations  are provided, the EPPO Standard “PP 1/277 Insecticide co-formulated mixtures” is therefore withdrawn and replaced by this new Standard;
  • The EPPO Standard “PP1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products” considers the possible impacts of biologically significant changes in chemical composition of PPPs and the requirements to support such changes, the circumstances in which a change in formulation type may be supported by a more limited data package and also discusses the development of a new product which is to be based on the principle of comparing with, and ‘bridging’ to, an existing formulation;
  • The EPPO Standard “PP 1/226(2) Number of efficacy trials”, which provides guidance on the number of trials in target crops needed to demonstrate the efficacy of a plant protection product (PPP) at the recommended dose, has been updated to the version PP1/226(3). The revision follows the adoption of EPPO standard PP 1/307(1).

 

To download:

PP 1/226(3) Number of efficacy trials

PP 1/306 (1) General principles for the development of co-formulated mixtures of plant protection products

PP1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products

 

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FRANCE: New update of the memo relative to trials and experiments of regulated products

ANSES has issued a new version of the Memo relative to trials and experiments of regulated products (plant protection products/fertilisers) dated 01/09/2017; the previous Memo was dated 19/06/2017. The changes are as followpermiss:

The form to be filled in for an application for plant protection product trial permit (CERFA 15720*01) as well as the explanatory note (Cerfa N°52171#01) are specified.

In the case of fertilisers and crop substrates, the amount of the fee levied by ANSES (fixed by the decree of 12 April 2017 – Article 7, point V and IX, paragraph 2, entered into force on 01/07/2017) for a trial permit application was revised and set at 1000 € for a single product and 2000 € for a set of products.

 

To download (in French):  

Note relative aux essais et expérimentations de produits réglementés (produits phytopharmaceutiques / matières fertilisantes) actualisée au 01/09/2017

Arrêté du 12 avril 2017 fixant le barème de la taxe fiscale affectée perçue par l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative à la mise sur le marché des produits phytopharmaceutiques et de leurs adjuvants, des matières fertilisantes et de leurs adjuvants et des supports de culture

 

See also our previous articles:

FRANCE: Update of the memo relative to trials and experiments of regulated products

FRANCE – Anses : New fees

 

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

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

EUROPE: New EPPO standard on efficacy evaluation for low-risk plant protection products is published

The EPPO standard “PP 1/296 (1) Principles of efficacy evaluation for low-risk plant protection products” has been first approved in September 2017 and released on 13 October 2017.

This Standard describes the principles for determining the requirements for an efficacy evaluation of low-risk plant protection products in a registration procedure, based on addressing the data requirements as specified by Regulation (EC) 1107/2009. This standard is intended for the harmonization of requirements for the efficacy evaluation of low-risk plant protection products to facilitate their placement on the market.

This document provides a framework for the minimum efficacy data requirements needed to demonstrate that a low-risk plant protection product is sufficiently effective and crop safe for authorisation, taking into consideration that a more specialised approach may be used compared to other plant protection products because they often have different properties and modes of action, and that a more flexible efficacy evaluation may be followed.

 

To download: PP 1/296 (1) Principles of efficacy evaluation for low-risk plant protection products

 

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

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

FRANCE: Update of the memo relative to trials and experiments of regulated products

ANSES has issued a new version of the Memo relative to trials and experiments of regulated products (plant protection products/fertilisers) dated 19/06/2017; the previous Memo was dated December 2016. The main changes are as follows:

  • Plant protection products:
    • Revision of the amount of the fee levied by ANSES (fixed by the decree of 12 April 2017 – Articles 4 and 5, entered into force on 01/07/2017) when applying for a trial permit. The trials are divided into two categories: research trials and experiments, and development trials and experiments, with two levels of fees. A reduced fee is introduced for biocontrol products.
    • Introduction of a definition for the term “experimental site”.
    • Effective implementation of the SIDEP service online (https://sidep.anses.fr/#/login) since 06/04/2017 to manage two categories of declarations:
      • The declaration prior to the trial setting up in the context of exemptions to applications for trial permits, to be submitted to SIDEP no later than 10 working days prior to the implementation of the trial or experiment;
      • The declaration of setting up (before the end of the assessmentsand no later than 20 days after the first application of the products tested) and end of officially recognised trials (no later than 20 days after the end of the assessments or crop destruction).
  • Fertilisers and crop substrates: revision of the amount of the fee levied by ANSES (fixed by the decree of 12 April 2017 – Article 7, point V, entered into force on 01/07/2017): fixing a single tariff of 1000 € per request.

 

To download (in French):  

Note relative aux essais et expérimentations de produits réglementés (produits phytopharmaceutiques / matières fertilisantes) actualisée au 19/06/2017

Arrêté du 12 avril 2017 fixant le barème de la taxe fiscale affectée perçue par l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative à la mise sur le marché des produits phytopharmaceutiques et de leurs adjuvants, des matières fertilisantes et de leurs adjuvants et des supports de culture

 

See also our previous articles:

FRANCE – Anses : New fees

FRANCE – Memo relative to trials and experiments

 

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

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

FRANCE: Memo relative to trials and experiments

ANSES have issued a memo summarising the requirements for:

  • Applications for trial permits (replacing ‘ADE’), including:
    • Exemption from trial permit applications
    • Preliminary declaration of trials
    • Exemption of crop destruct
  • The declaration of officially recognised trials

Memo relative to trials and experiments of regulated products (plant protection products / fertilisers) (in French)

 

Note that a new version of the declaration form of EOR trials (06.07.2016) is available:

Form for the declaration of officially recognised trials (in French)

 

See also our previous articles:

FRANCE: new form for the declaration of Officially Recognised Trials

FRANCE: the order for the “Exemption from application for trial permit” is published!

 

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

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

 

FRANCE: new form for the declaration of Officially Recognised Trials

In France, this new form to be sent to ANSES replaces Coleor portal that served to date for the declaration of Officially Recognised Trials.

This form meets the requirements of Article 9 of the Order of 26 April 2007. It should be sent to ANSES when setting up trials before the end of the assessments and 20 days at the latest after the first application of the test products, and when closing the trials 20 days at the latest after the end of the assessments or crop destruct.

It should be sent both for trials that are conducted following an application for trial permit and for trials carried out under an “exemption from application for trial permit” (see our previous article).

 

For download:

Declaration of Officially Recognised Trials:

Form (in French)

Order of 26 April 2007 (in French)

Declaration of trials carried out under an “exemption from application for trial permit”:

Form (in French)

Order of 9 February 2016 (in French)

 

Our previous article:

FRANCE: the order for the “Exemption from application for trial permit” is published!

 

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

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