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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 – 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/

 

FRANCE: Withdrawal of 5 active substances-based products

As a result of the entry into force of Regulations (EU) 2020/1280 of 14 September 2020, 2020/892 of 29 June 2020, 2020/1276 of 11 September 2020 and 2020/1498 of 15 October 2020 concerning respectively the non-renewal of benalaxyl, beta-cyfluthrin, bromoxynil and thiophanate-methyl approval, ANSES will withdraw from the first half of 2021, 14 authorisations and 3 parallel trade permits for plant protection products containing these substances.

In the context of the expiry of the approval of the active substance spirodiclofen on 31.07.2020, ANSES has also withdrawn, from 07 December 2020, one authorisation and 3 parallel trade permits for plant protection products containing this substance.

Active substance Benalaxyl Beta-cyfluthrin Bromoxynil Thiophanate-methyl Spirodiclofen
Withdrawal date 05.04.2021 20.01.2021 17.03.2021 19.04.2021 07.12.2020
End of sales and distribution 05.07.2021 20.04.2021 17.03.2021 19.04.2021 31.01.2021
End of use of the stocks of products 05.10.2021 20.07.2021 17.09.2021 19.10.2021 31.07.2021

 

To download: 

List of withdrawal of products based on benalaxyl, beta-cyfluthrin, bromoxynil and thiophanate-methyl (in French)

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

 

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

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

 

FRANCE – ANSES: Procedures for updating PPE in marketing authorisations

Following the entry into force on 1 January 2020 of the Order of 27 December 2019 on measures for the protection of persons using plant protection products, users should replace the personal protective equipment (PPE) currently mentioned in the marketing authorisations by equipment complying with the new requirements.

On 26 November 2020, ANSES published a note on procedures for updating PPE:

  • For marketing authorisations issued before 1 January 2020, the user will have to replace the PPE, but without notifying it to ANSES.
  • For marketing authorisations issued after 1 January 2020, a request to update PPE is sent to the authorisation holder, who will have to reply within 2 months by email.
  • For all new marketing authorisation applications submitted from 26 November 2020, PPE proposed by the applicant must comply with the new requirements.
  • For the applications currently under instruction, applicants are encouraged to send a single letter to ANSES to update the PPE in all applications under examination. For each application (including the type of application, the brand name of the product and ANSES reference number), a table of equivalence between the PPE initially proposed and the updated PPE must be provided. If no letter is provided, a request to update PPE will be sent directly to the applicants by ANSES departments.

 

The PPE updates concern in particular clothing and gloves:

PPE type Old requirements New requirements
Clothing Water-repellent working coveralls (polyester 65% / cotton 35% – minimum weight 230 g/m²) Clothing PPE certified NF EN ISO 27065/A1
Reusable gloves Nitrile gloves certified EN 374-3 Nitrile gloves certified NF EN ISO 374-1/A1 and NF EN 16523-1+A1 (type A)
Single use gloves Single use nitrile gloves certified EN 374-2 Single use nitrile gloves certified NF EN ISO 374-1/A1 and NF EN ISO 374-2 (types A, B or C)

 

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 1 of 26.11.2020 (in French)

Order of 27 December 2019 relating to measures for the protection of persons using plant protection products (in French)

 

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

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

 

FRANCE – ANSES: Covid-19 – Revision of temporary procedures for submitting dossiers

Following the application of the new lockdown period due to a resurgence of the COVID-19 outbreak, the note concerning the procedures for submitting dossiers has been updated and applies from 30 October 2020 and at least until 01 December 2020 or up to the end of the lockdown in France.

Thus, the four submission procedures previously communicated (see our previous article), are still possible. Please note that for both cases of dossiers submitted on a secure platform (“Mes Echanges” or others), all the elements of the dossier can be submitted in a single compressed file (.zip, .7z, .rar, …).

 

To download: 

Applications for pesticide products, fertilisers and crop supports, and adjuvants – Covid-19: further revision of the procedures for submitting dossiers, updated version to 29/10/2020. (in French)

 

See also our previous articles: 

FRANCE – ANSES: Covid-19 – New temporary procedures for submitting dossiers

 

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

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

 

FRANCE – ANSES: Glyphosate – Publication of decisions and results of the comparative assessment

Following the renewal of the approval of the active substance glyphosate, ANSES issued on 30 September 2020 decisions on 6 applications of renewal and 3 new applications for marketing authorisation for plant protection products. Three renewal applications and one new application for authorisation were refused due to a potential risk of adverse effects on human health due to the possible formation of the relevant impurity N-nitrosoglyphosate during the storage of the product.

 

In parallel, ANSES has also published on 09 October 2020 the results of its comparative assessment carried out under Article 50.2 of the European Regulation (EC) 1107/2009. Thus, the practical or economic drawbacks of currently available non-chemical alternatives have been identified for the 4 main areas of agricultural uses: fruit trees, viticulture, arable crops and forestry. ANSES based the assessment on different sources of information among them three reports issued by INRAE (INRAE’s report on fruit trees, INRAE’s report on  viticulture and INRAE’s report on arable crops) and data provided by ONF (“Office National des Forêts” / National Forestry Office) and CNPF (“Centre National de la Propriété Forestière” / National Center for forest ownership).

The conclusions are the following:

Uses Fruit trees Viticulture Arable crops (cereals, oilseeds, peas…) Forestry
Possible alternatives = Ban on using glyphosate Between the rows:

– Mechanical weeding

– Grassed areas

Between the rows:

– Mechanical weeding

– Grassed areas

When the plot has been ploughed between two crops Alternative non-chemical methods for killing tree stumps
Substitution not possible = Authorised use of glyphosate Mechanical weeding  not possible:

– Mechanical harvesting of fruits on the ground

– Bushy crops

Unavailability in the short term of agricultural machinery for weeding under the row

Mechanical weeding  not possible: steeply sloping or terraced vineyards, stony ground, rootstock nurseries

Unavailability in the short term of agricultural machinery for weeding under the row

In situations of regulated mandatory control Forest maintenance during the stand establishment period

Forest nurseries and seed orchards

Restriction of rates Maximum 900 g of glyphosate per year and per hectare and application limited to 40% of the plot area = 60% reduction of the maximum rate currently authorised Maximum 450 g of glyphosate per year and per hectare and application limited to 20% of the plot area = 80% reduction of the maximum rate currently authorised Maximum 1080 g of glyphosate per year and per hectare = 60% reduction of the maximum rate currently authorised /

As for the non-crop uses of glyphosate, they cannot be fully substituted by non-chemical alternatives. Reducing the use of glyphosate in these different situations cannot therefore be addressed by a restriction laid down in the marketing authorisations, but needs to be considered as part of a change in weed-control practices.

These restrictions will now be taken into account and will apply to each product placed on the market and within 6 months for products which were renewed.

 

To download: 

Comparative assessment report – Products containing glyphosate – Examination of alternatives in arboriculture (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in viticulture (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in arable crops (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in forestry (in French)

 

See also our previous articles: 

FRANCE – ANSES: Withdrawal of 36 glyphosate-based products

FRANCE: Glyphosate phase-out plan issued

 

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

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

 

ANSES – E-Phy: Website evolution

A new FAQ section as well as an access to the contact form are now available on the E-Phy website, via the footer banner. The FAQ section contains the questions most frequently asked by the users and the answers provided. Any remark, suggestion to improve the interface of the website or any request to correct data will be sent by using the contact form.

 

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

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