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 65 authorisations and 17 parallel trade permits for plant protection products containing this substance will be withdrawn from 04 July 2021.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/