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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/

 

FRANCE: Update of the declaration cerfa form

ANSES has updated on 01.09.2020 the general note for the submission of applications for a marketing authorisation or a permit for plant protection products. It introduces the second version of the explanatory note No 52174 and its related declaration form No 15723 (cerfa form used for changes in the name or address of a company or for the addition or change of the manufacturing site for a product already authorised).

The main changes in the second version of Cerfa No 15723 are as follows:

  • Delation of the former name of the company in the case of a change in the name of the company holding the authorisation (item 4).
  • Addition of the SIRET number and intra-community VAT number in the case of a change of address of the company holding the authorisation (item 5).
  • Addition of item 8 to list the products concerned by a change of name or address of a company. The trade names and authorisation numbers of the products concerned by the declaration must be completed. It is not necessary to list the second trade names.

 

To download: 

General note for the submission of applications (cerfa forms and explanatory notes) (01.09.2020, in french)

Explanatory note for filling the declaration form for a marketing authorisation or a permit Cerfa No 52174#02 (in French)

Declaration form for a marketing authorisation or a permit Cerfa No 15723*02 (word) Cerfa No 15723*02 (pdf) (in French)

 

See also our previous articles: 

FRANCE: Update of the explanatory note and of the application cerfa form!

 

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

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

 

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

The note concerning the procedures for submitting dossiers during the period of confinement has been updated and extends until 31 August 2020 the four submission procedures previously communicated (see our previous article).

 

To download: 

Applications for pesticide products, fertilisers and crop supports, and adjuvants – Covid-19: new procedures for submitting dossiers, updated version to 17/07/2020. (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: Plant protection substances of concern

As part of the French government plan for a less pesticide-dependent agriculture, a CGAAER-CGEDD-IGAS inspection mission listed in 2017 some of the active substances of concern the most frequently identified or mentioned in monitoring reports.

ANSES was seized on 10 July 2018 in order to conduct an expert appraisal of these substances of concern. The corresponding Opinion has just been published.

Based on the findings of this mission report, and taking into account the ban of some substances and the subsequent withdrawal of a number of products, ANSES updated the list of active substances requiring particular attention.

ANSES recommend the non renewal of mancozeb, considered by ECHA as a category 1B reproductive toxicant, and of thiophanate-methyl, classified as a category 2 mutagen.

Moreover, without waiting for the EU renewal assessment of active substances, ANSES also undertake for the 2020-2021 period, a re-assessment of the risks posed by the products containing:

– substances recently classified by ECHA as category 1B carcinogens or reproductive toxicants: 8-hydroxyquinoline, ipconazole, flurochloridone, spirodiclofen, halosulfuron-methyl;

– the active substance prosulfocarb, for which the risk for bystanders and residents will be re-assessed as a result of contaminations of nearby non-target crops, which lead to a change of conditions of use.

Lastly, ANSES start the assessment of the endocrine-disruptor properties of prochloraz without waiting for a possible EU renewal application for this substance.

 

To download: 

Anses Opinion on the plant protection substances identified as giving rise to concern in the CGAAER-CGEDD-IGAS report on the use of plant protection products (in French)

 

Our previous article :

FRANCE : Action plan for plant protection products

 

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

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

 

FRANCE – ANSES: Impacts of Ordinance 2020-306 on grace periods

Ordinance 2020-306 of 25 March 2020 was published in the OJ as part of the health emergency period linked to the spread of Covid-19. The ordinance aims to extend deadlines during the health emergency period and to adapt administrative procedures during this same period.

The provisions of this ordinance directly impact the terms of withdrawal of plant protection products, fertilisers or adjuvants when the grace periods granted have expired or expire between 12 March 2020 and the expiration of a period of one month from the date of cessation of the declared state of health emergency (currently set as of 24 May 2020) i.e. to date 24 June 2020.

In this context, ANSES published a Note concerning the impact of this Ordinance on grace periods which can only be applied within the timelines set at European level.

The grace periods are extended by 3 months (article 3) after the date of cessation of the state of health emergency, that is to say until 24 August 2020, within the limit of 6 months for sale and distribution, and an additional 12 months for the storage and use of existing stocks, unless:

– a European implementing regulation for non-renewal of the approval provides for shorter periods;

– grace periods have been voluntarily limited for reasons of protection of human and animal health or the environment.

The cases of the products concerned are listed at the end of the Note.

 

To download: 

Ordinance No.2020-306 of 25 March 2020 as regards the extension of deadlines that expire during the health emergency period and the adaptation of administrative procedures during this same period   (in French)

ANSES – 14.04.2020 – Note to owners of marketing authorisations and parallel permits regarding the impact of Ordinance No.2020-306 of 25 march 2020 on the terms of withdrawal of products, i.e. on grace periods (in French)

 

To further understand: 

Bulletin of 26 March 2020 – Bulletin presenting the provisions of Title 1 of Ordinance No.2020- 306 of 25 Mars 2020 as regards the extension of deadlines that expire during the health emergency period and the adaptation of administrative procedures during this same period (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 – New temporary procedures for submitting dossiers

In view of the current Covid-19 situation, ANSES has adapted its organisation to allow authorisation and parallel trade permit holders (plant protection products, fertilisers, adjuvants) to submit their dossiers in a dematerialised and secure manner.

Thus, 4 temporary submission procedures are possible:

  • Submission of the dossier on a secure platform of your choice

→ Send an information email to damm.uia@anses.fr, with the following subject: MISE A DISPOSITION D’UNE DEMANDE – NOM PRODUIT – Application code XXXX”. The information on download as well as the duration of availability of the files should be specified.

  • Submission of the dossier on the secure platform of ANSES “Mes Echanges”

→ Send an email to damm.uia@anses.fr, with the following subject: “DEMANDE D’OUVERTURE D’UN DOSSIER SUR MES ECHANGES – NOM PRODUIT – Application code XXXX”. The submission terms, with a link and a password will be sent back by ANSES.

  • Submission of “small” dossiers by email

→ Send the dossier by email to damm.uia@anses.fr, with the following subject: “DEPOT D’UN DOSSIER – NOM PRODUIT – Application code XXXX”. The dossier, with all the required data, must be sent in only one email.

  • Submission by post

→ The mail is picked up twice a week by ANSES. The received dossiers are still registered and handled by the administrative unit.

 

For the first 3 procedures, dossiers should be sent in electronic format (CD/DVD) at the end of confinement. A declaration of identity between data sent dematerialised and data on CD/DVD should also be provided with the application. It should specify the e-mail address of the sender, and the date and time of the email sent.

 

To download: 

Applications for pesticide products, fertilisers and crop supports, and adjuvants – Covid-19: new procedures for submitting dossiers (in French)

 

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

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

 

FRANCE: Withdrawal of desmedipham-based products

As a result of the entry into force of Regulation (EU) 2019/1100 of 27 June 2019 concerning the non-renewal of desmedipham approval, ANSES has withdrawn, from 01 January 2020, 7 authorisations and 12 parallel trade permits for plant protection products containing this substance.

The end of sales and distribution initially set on 01.04.2020 is extended by two months, so up to 01.06.2020.

The end of use of the stocks of products is set on 01.07.2020.

 

To download: 

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

 

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

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

 

FRANCE: Withdrawal of chlorpyrifos and chlorpyrifos-methyl-based products

As a result of the entry into force of Regulations (EU) 2020/18 and 2020/17 of 10 January 2020 concerning respectively the non-renewal of chlorpyrifos and chlorpyrifos-methyl approval, ANSES has withdrawn, from 16 February 2020, 9 authorisations and 1 parallel trade permit for plant protection products containing these substances.

The end of sales and distribution is set on 16.04.2020.

The end of use of the stocks of products is set on 16.04.2020.

 

To download: 

List of withdrawal of products based on chlorpyrifos and chlorpyrifos-methyl (in French)

 

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

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

 

FRANCE: Withdrawal of chlorpropham-based products

As a result of the entry into force of Regulation (EU) 2019/989 of 17 June 2019 concerning the non-renewal of chlorpropham approval, ANSES has withdrawn 22 authorisations and 8 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 08.04.2020.

The end of use of the stocks of products is set on 08.08.2020.

 

To download: List of withdrawal of products based on chlorpropham (in French)

 

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

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