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FRENCH REPUBLIC Ministry for Agriculture and Food

ORDER of
establishing the content of application files for marketing authorisations and permits for fertilisers, fertiliser additives and cultivation substrates, as well as the criteria to be taken into account when preparing the elements required for the evaluation

NOR: AGRG1811613A
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10 April 2020

Official Journal of the French Republic (JORF) No 0085 of 7 April 2020

Text No 11

Order of 1 April 2020 establishing the content of application files for marketing authorisations and permits for fertilisers, fertiliser additives and cultivation substrates, as well as the criteria to be taken into account when preparing the elements required for the evaluation

NOR: AGRG2008998A

ELI:https://www.legifrance.gouv.fr/eli/arrete/2020/4/1/AGRG2008998A/jo/texte

Public concerned: holders of, and applicants for, marketing authorisations for fertilisers, fertiliser additives and cultivation substrates.

Subject: content of application files for marketing authorisations, experimentation permits and introduction permits for fertilisers, their additives and cultivation substrates; content of notifications and declarations relating to these products.

Entry into force: the text shall enter into force on [1 February 2020].

Notice: the order establishes the content of the file to be submitted to the National Agency for Food, Environmental and Occupational Health & Safety for each type of application, notification and declaration relating to authorisations or permits for fertilisers, fertiliser additives and cultivation substrates.

References: this order is issued pursuant to Articles R255-13 and R255-14 of the Rural and Maritime Fishing Code. It may be consulted on the Légifrance website (http://www.legifrance.gouv.fr).
Entry into force: the text shall enter into force on the day after its publication.

Notice: the Order establishes the content of the file to be submitted to the National Agency for Food, Environmental and Occupational Health & Safety for each type of application, notification and declaration relating to authorisations or permits for fertilisers, fertiliser additives and cultivation substrates.

References: the Order is issued pursuant to Articles R255-13 and R255-14 of the Rural and Maritime Fishing Code. It may be consulted on the Légifrance website (http://www.legifrance.gouv.fr).

The Minister for Agriculture and Food,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency;

Having regard to the Rural and Maritime Fishing Code, particularly Articles R255-13 to R255-14 thereof;
Having regard to the Rural and Maritime Fishing Code, in particular Articles R255-13 to R255-14 thereof;

Having regard to Decree No 80-478 of 16 June 1980 implementing Article L412-1 of the Consumer Code concerning fertilisers and cultivation substrates;


Article 1

The provisions of this order shall apply to fertilisers, fertiliser additives and cultivation substrates, hereinafter referred to as ‘products’ and understood to mean ‘a product or group of products’ within the meaning of Article R255-1 of the Rural and Maritime Fishing Code.

Article 2 – Common provisions

Any applications for marketing authorisations, experimentation permits or product introduction permits, or any application to amend, renew or withdraw such authorisations or permits, as well as any notification or declaration relating to these products, shall be submitted to the National Agency for Food, Environmental and Occupational Health & Safety (ANSES). They shall take the form of a file written in French, except in the case of the specific provisions provided for in Article 3.
Scope.

The provisions of this Order shall apply to fertilisers, fertiliser additives and cultivation substrates, hereinafter referred to as ‘products’ and understood to mean ‘a product or group of products’ within the meaning of Article R255-1 of the Rural and Maritime Fishing Code.

Article 2

Common provisions.

Any applications for marketing authorisations, experimentation permits or product introduction permits, or any application to amend, renew or withdraw such authorisations or permits, as well as any transmission of information, notification or declaration relating to these products, shall be submitted to the National Agency for Food, Environmental and Occupational Health & Safety (ANSES). They shall take the form of a file written in French, except in the case of the specific provisions provided for in Article 3.

This file shall include:

1. a covering letter;

2. a form duly completed in accordance with its accompanying notes, dated and signed. The form and the notes are available on the ANSES website;

3. where applicable, the additional elements necessary for examination and evaluation of the application or for registration of the notification or declaration, as provided for in Articles 3 to 7 of this order.
1. A covering letter, the transmission of information and the notification or declaration.

2. A form duly completed in accordance with its accompanying notes, dated and signed. The form and the notes are available on the ANSES website.

3. Where applicable, the additional elements necessary for examination and evaluation of the application or for registration of the notification or declaration, as provided for in Articles 3 to 6 of this Order.

Each file shall be presented in the form of a digital version submitted on a data storage medium. It may also include a paper version, in duplicate and accompanied by an attestation identifying the documents in paper format and the documents in electronic format.

The file shall be submitted in accordance with the notes accompanying the submission form.

The products to which the application relates shall be characterised in accordance with the annex to this order and with the guidelines for evaluating application files for Marketing Authorisations (MA) or permits for fertilisers, fertiliser additives and cultivation substrates, available on the ANSES website.

Article 3 – Marketing authorisations

I.- Applications for product marketing authorisations or for renewal or amendment thereof, with the exception of the application referred to in paragraph III, shall include the following additional elements for the purposes of the evaluation referred to in Article L255-7 of the Rural and Maritime Fishing Code:

traceability data for the product and each of the raw materials, for the production sites and for the manufacturing sites, if different;
The products to which the application relates shall be characterised in accordance with the Annex to this Order and with the ‘guidelines for evaluating application files for Marketing Authorisations (MA) or permits for fertilisers, fertiliser additives and cultivation substrates’, available on the ANSES website.

Article 3

Marketing authorisations.

I. - Applications for product marketing authorisations or for renewal or amendment thereof, with the exception of the applications referred to in paragraphs III and IV, shall include the following additional elements for the purposes of the evaluation referred to in Article L255-7 of the Rural and Maritime Fishing Code:

traceability data for the product and its raw materials, at the production and manufacturing sites, if different;

full details of the composition of the product;


in the case of marketing authorisation renewal applications, the results of the production monitoring analyses as well as any additional post-authorisation data that may be required under the conditions of the initial decision;

the proposed label or product information sheet showing the details that the applicant wishes to appear on the labelling;
the proposed label or product information sheet;

the product safety data sheet provided for in Article 31 of the above-mentioned Regulation (EC) No 1907/2006 and a list of all of the raw materials used.

The summary reports, studies and essays may be written in English.

II. - Product marketing authorisation applications based on mutual recognition as per Article R255-17 of the Rural and Maritime Fishing Code shall include the following additional elements:

an attestation identifying the product to which the application applies, which is lawfully

placed on the market in the reference Member State;

full details of the composition of the product;

a copy of the administrative decision, standard or regulatory text under which placement on the market in the reference Member State is authorised, together with its French or English translation;

a template of the label of the product placed on the market in the reference Member State, as well as its translation in French or English;

the list of crops intended to receive the product and the conditions of use. For each crop or each type of soil, the applicant should specify in particular the application method, the minimum and maximum dosages per application and per hectare, the annual number of applications and the period and/or the growth stage of application. Risk management measures may be proposed;

the proposed label or product information sheet;

the product safety data sheet provided for in Article 31 of the above-mentioned Regulation (EC) No 1907/2006 and a list of all of the raw materials used.

III. - The marketing authorisation application for a product identical to a product that has already been authorised shall include the following additional elements:

traceability data for the product at the production and manufacturing sites, if different;

an attestation identifying the requested product in relation to the reference product;

the proposed label or product information sheet.

IV. - Applications to amend product marketing authorisations in order to authorise one or more additional uses or procedures shall include the following additional elements for each of these:

an agronomic summary report and test reports establishing the efficacy of the product in terms of its specifically claimed effects under the prescribed conditions of use;

a summary report and study reports establishing that the product has no harmful effects on human or animal health or the environment under the prescribed conditions of use;

the proposed label or product information sheet.

The summary reports, studies and essays may be written in English.

Article 4

Experimentation permit.

I. - Applications for product experimentation permits or renewals thereof shall include the following additional elements for the purposes of the evaluation referred to in Article L255-8

of the Rural and Maritime Fishing Code:

traceability data for the product and its raw materials, at the production and manufacturing sites, if different;

full details of the composition of the product;

product characterisation analysis reports;

the product safety data sheet provided for in Article 31 of Regulation (EC) No 1907/2006 and a list of all of the raw materials used.

The summary reports, studies and essays may be written in English.

II.- Product marketing authorisation applications based on mutual recognition as per Article R255-17 of the Rural and Maritime Fishing Code shall include the following additional elements:

an attestation identifying the product to which the application applies, which is lawfully placed on the market in the reference Member State;

full details of the composition of the product;

a copy of the administrative decision, standard or regulatory text under which the product placed on the market in the reference Member State is authorised, together with its French translation;

the crops intended to receive the product and its conditions of use. For each crop or type of soil, the applicant should specify in particular the application method, the minimum and maximum dosages per application and per hectare, the annual number of applications and the period and/or the growth stage of application. Risk management measures may be proposed;

the proposed label or product information sheet;

the product safety data sheet provided for in Article 31 of Regulation (EC) No 1907/2006 and a list of all of the raw materials used.

III.- Applications to amend product marketing authorisations in order to authorise one or more additional uses shall include the following additional elements for each additional use:

an agronomic summary report and test reports establishing the efficacy of the product in terms of its specifically claimed effects under the prescribed conditions of use;

a summary report and study reports establishing that the product has no harmful effects on human or animal health or the environment under the prescribed conditions of use;

the proposed label or product information sheet showing the details that the applicant wishes to appear on the labelling.

The summary reports, studies and essays may be written in English.

Article 4 – Experimentation permits

I.- Applications for product experimentation permits or renewals thereof shall include the following additional elements for the purposes of the evaluation referred to in Article L255-8 of the Rural and Maritime Fishing Code:

traceability data for the product and each of the raw materials, for the production sites, and for the manufacturing sites, if different;

full details of the composition of the product;

product characterisation analysis reports;

the product safety data sheet provided for in Article 31 of Regulation (EC) No 1907/2006 and a list of all of the raw materials used.