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FRANCE: Towards glyphosate phase out

The renewal of the glyphosate approval for five years was adopted in December 2017 by the European Commission. The evaluation by ANSES (French Agency for Food, Environmental and Occupational Health & Safety) of applications for the renewal of authorisation of glyphosate-based PPPs according to Article 43 of Regulation (EC) 1107/2009 is in progress.

To date, 190 glyphosate-based products are authorised in France or benefit from a parallel trade permit. 58 applications for PPPs renewal and 11 applications for new PPPs approval were submitted to ANSES. Regarding the 132 products for which  renewal application was submitted, ANSES notified the products’ holders of the expiry of approvals or parallel trade permits as from 15 December 2018. The list of products concerned has been published on the E-phy website.

For products intended for professional use, the end of sale and distribution of the products is set to 15/03/2019 and the end of use of the products and stocks is set to 15/06/2019.
For products intended for amateur use, no grace period is granted in view of the entry into force on 1 January 2019 of the Labbé’s law (February 2014) amended by the Energetic transition law (August 2015) and the Potier’s law (March 2017), prohibiting the marketing and holding of non-professional PPPs.

ANSES announces that the evaluation of the new approval applications and renewal applications will be finalized before 31 December 2020, within the three-year period announced by the government.

In addition, the evaluation of the new approval applications and renewal applications will be conducted on the basis of a comparative assessment of the products: based on the information that will be provided on the available alternatives commonly used in France, particularly by INRA (French National Institute for Research in Agriculture), ANSES will compare, for each use, glyphosate products with the non-chemical methods of prevention or control that are available. For each glyphosate-based product, uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

Finally, in order to support farmers foregoing glyphosate use, the government launched a website sharing experiences from farmers who have already taken part in this initiative and describing possible alternatives to glyphosate. The website also records the plots declared without glyphosate in each department as well as the number of farmers having stop any use of glyphosate and engaged in this way.

 

To download:

Liste des produits à base de glyphosate faisant l’objet d’un retrait du marché à compter du 15 décembre 2018 (in French)

 

See also our previous articles:

EUROPE: Renewal of glyphosate approval

 

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

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

France: comparative assessment (Order and Guidance document)

An order and a guidance document on comparative assessment (Article 50) have just been published in France.  Since 01 August 2015, for PPP containing a substance candidate for substitution (CfS) (list of candidates for substitution), information on comparative assessment must be submitted in dRR Part A of the application if France is the zRMS and in a National addendum to Part A if France is not the zRMS.

The comparative assessment is carried out in several steps. For each step, the applicant shall give detailed information as defined by the French Ministry of Agriculture’s Order.

  • Preliminary step: For PPPs containing CfS but where it is necessary to acquire experience first through using that product in practice, the comparative assessment will not be implemented. The authorisation will be granted once for a period not exceeding five years. For instance:

    • new PPPs containing a new active substance approved under Regulation (EC) No 1107/2009 and a candidate for substitution,

    • a new active substance/use combination,

    • a significant advance enabling exposure to be reduced (e.g. formulation type),

    • a new combination of active substances having real agricultural advantages or enabling the authorised doses to be lowered.

For applications not falling within the framework mentioned above, a comparative assessment shall be carried out for every use in the application.

  • Step 1: Taking into account minor uses, resistance management, regulated pest control measures

    • Minor uses:  potential consequences of substitution for the major uses on the minor uses of the product;

    • Resistance management: number of modes of action available for a use and/or role of the candidate substance in the resistance management strategy;

    • Regulated pest control measures: information if the PPP is a significant component of the strategy for controlling a regulated quarantine pest or a pest subject to mandatory control measures.

  • Step 2: Comparison with other available solutions

    • Identification of other available solutions for the specified use (non-chemical prevention or control methods and other authorised PPP);

    • Practical and economic disadvantages of other available solutions;

    • Efficacy of other available solutions.

  • Step 3: Comparison of risks to Human or animal Health or the environment

    • first, criteria that led to the status of candidate for substitution;

    • if necessary, complete risk profiles and risk management measures.

The comparative assessment will conclude for each specified use if substitution is considered or not. Substitution will be considered if there is a non-chemical prevention or control method or an authorised PPP, identified at the end of step 3, that is significantly safer for human or animal health or the environment.

French Order (23/07/2015): Arrêté_20150731.pdf

Anses Guidance document (31/07/2015, English): DAMM-DocumentGuide EvaluationPPPv1EN.pdf

 

Lynxee consulting’s team is very much involved in comparative assessment and can prepare this assessment for you.

Contact us!

 

Sanco 13170 (14 July 2015) on Renewal of the Authorisation of PPP according to Article 43

This guidance document, updated on 14 July 2015, has been developed to elaborate the procedures for the renewal of authorisations of PPPs according to Article 43 of Regulation (EC) No. 1107/2009.

The procedures described only apply to renewals of authorisations based on active substances for which approval is renewed under the Regulation (EC) No. 1107/2009, and where safe uses have been demonstrated.

Lynxee consulting focuses on the key steps of the renewal of the authorisation of a PPP according to Article 43:

Steps

What to submit?

When to submit?

Notification of the application

to each MS where renewal of authorisation is seek

  • notification form

By the deadline for the submission of the supplementary dossier for the renewal of the active substance

First step application

to the zRMS and cMS

  • updated template of the notification form;

  • indication of agreement on the studies which are needed and where possible an expected timeframe,

  • indication on which parts of the risk assessment need updating (preferably agreed in pre-submission meetings with zRMS);

  • a “data matching list” regarding references relied upon (where relevant).

2 months following the publication of the EFSA conclusions

Second step application

to the zRMS and cMS

  • a copy of the authorisation;

  • any new information required as a result of amendments in data requirements, and criteria (changes to  endpoints arising from the active substance renewal);

  • evidence/justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;

  • any information to demonstrate that the product complies with the requirements (conditions and restrictions) set out in the Regulation on the renewal of the approval of the active substance;

  • a report on the monitoring information, where the authorisation was subject to monitoring;

  • a complete updated draft Registration Report in which the changes to the risk assessment are highlighted;

  • a list of intended uses including a statement that no significant changes compared to previous authorisations (in the zone) exists.

  • a justification for each data point for which not all information is available as specified in Article 43(2) (outstanding data)

  • a comparative assessment for products containing candidates for substitution (to be assessed by each MS)

Within 3 months from the date of entry into force of the decision of renewal of the approval of the active substance.

At the same time the

application should be included into the EU PPP Application management System.

Data protection

The applicant may seek advice by the individual MS about the status of protected/non-protected studies.

The data generated because they were necessary for the renewal of the authorisation benefit from a data protection period of 30 months from the applicability of the decision of renewal of the authorisation.

New information related to active substance renewal

The applicant shall take into account the list of “old” and “new” studies and the list of critical endpoints that have been changed during the active substance renewal procedure in order to build the updated draft Registration Report of the PPP renewal.

Outstanding data at the 3 months deadline

Five circumstances can result in data being outstanding.The applicant must provide an appropriate justification for each situation where data is missing at the three months deadline.

The data directly related to a (new) endpoint as listed in EFSA conclusion and for which the time is too short to produce the requested study should be submitted as soon as possible taking into account the time necessary to conduct the studies (generally within 2 years).

Timelines

The zonal RMS should complete its assessment of the new information 6 months after receipt of the information (this period includes a 3 week commenting time for the applicant and the MSs of the relevant zone(s)). And then this allows 3 months for the other MSs to conduct comparative assessment (if necessary) and to decide on the renewal of their authorisations.

After every step in the procedure the EU PPP Application management System should be updated respectively by the applicant or by the concerned MS.

Products containing more than one active substance

For products containing two or more active substances the applicant shall apply for a renewal of authorisation after the renewal of each active substance contained in the PPP.

However, if the PPP contains two or more active substances and the approval of the second active substance expires within 12 months of the first one, zRMS and MSs should evaluate the data submitted for both active substances after the data for the second active substance are submitted.

 

http://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents/docs/gd_renewal_1107-2009_rev_13.pdf

 

Lynxee consulting’s team is at your disposal to manage the renewal process of your products.
Contact us! http://lynxee.consulting/en/contact/

 

ANSES : Public consultation on guidelines for the issue of approval decisions

As of next summer, ANSES, in addition to its role of scientific assessment, will also issue approvals for plant protection products, fertilisers and crop supports and adjuvants.

For transparency, ANSES has developed guidelines to clarify the principles applied by the Agency for issuing approval decisions. These guidelines are subject to public consultation from 12 May 2015 to 5 June 2015.

 

What can we learn?

  • Decisions taken by the Agency shall be notified to the applicant and will be published in the electronic register of decisions of ANSES, accessible on the Agency website as soon as possible. The conclusions of the assessment will be published in parallel on the same website.

Non-confidential parts of the zonal “Registration Report” (parts A and B), produced by ANSES, will also be made available on its website to provide access in much more detail to the results of the assessment.

  • In some cases, further assessment of the dossier by the DAMM may be required by the nature of the application and / or the result of the assessment, in order to prepare the draft decision. The cases identified are:
    • the case where all or part of the risk management measures associated with the results of the assessment raises questions in terms of feasibility and acceptability in practice to ensure its effectiveness;
    • the case where new data from either the assessment, including data subsequent to the renewal of approval of active substance, or of monitoring networks;
    • the case where data on sanitary and phytosanitary consequences of plant protection issues deserve to be taken into account in the decision process;
    • the case where the product contains an active substance leading to the implementation of comparative assessment and where a thorough analysis on practical / economic consequences of various possible alternatives is needed.
  • The comparative assessment of the product is made in compliance with European guidelines:
    • guidance document SANCO / 11507/2013 Rev.12, “Guidance Document on Comparative Assessment and Substitution of Plant Protection Products in according with Regulation (EC) No 1107/2009”, published by the European Commission dated 10 October 2014;
    • EPPO guidelines PP 1/271 (1), “Guidance on comparative assessment”, published in 2011 by the European and Mediterranean Plant Protection Organisation.

When it is implemented, comparative assessment will be a specific document showing responses at different stages of the process. This document will be attached to the conclusions of the assessment and made public with the conclusions of the assessment.

https://www.anses.fr/fr/documents/Lignes_directrices_PPP.pdf