What does a marketing authorisation approval application contain?
The application for approval, prepared in accordance with the Decree of 21 December 1998, must be comprised of an application form describing the product (Cerfa form 11385#01), an administrative file and a technical file.
The technical file contains four sections:
- public health, environment and safety (including the product’s Safety Data Sheet);
- agricultural information (including a demonstration of the product’s efficacy);
- analytical data (showing all the tests that must have been performed by a COFRAC-accredited laboratory on programme 108 or by an equivalent body (standard NF ISO 17025);
- any other information (including any scientific or technical publications presented to support the application).
ANSES’s assessment of the application
Applications for approval are carefully analysed by ANSES’s Regulated Products Assessment Department (DEPR), and are submitted for collegial assessment by an Expert Committee.
The DEPR delivers its findings and based on them, in keeping with restricted regulatory criteria, the Agency's Market Authorisations Department (DAMM) takes a decision on whether or not to grant the approval.
An authorisation remains valid for ten years.
When the product, or an identical product, has been officially authorised in one of the European Economic Area countries, a simplified procedure may be used.
Products exempted from marketing authorisation
Fertilisers, fertiliser adjuvants and growing media may be placed on the market by waiver, without prior authorisation:
- if they comply with a French standard made mandatory by a Ministerial Order published in the Official Journal;
- if they comply with a European Union regulation that does not require prior marketing authorisation from a Member State;
- if they comply with specifications approved by regulations guaranteeing their efficacy and safety;
- if they are natural substances for biostimulant use authorised in accordance with the special procedure laid down in the second paragraph of Article L.253-1 of the French Rural and Maritime Fishing Code;
- if they are waste, residues or effluents from facilities defined in Articles L.214-1 and L.511-1 of the French Environmental Code, when their evacuation or discharge onto agricultural land as fertilisers is covered by a spreading plan guaranteeing the absence of harmful effects on human and animal health and the environment;
- or if they are raw organic matter or growing media of natural origin, obtained from natural materials without any chemical treatment and which are by-products of an agricultural holding or a non-agricultural animal farming or keeping facility when they are transferred directly by the holding operator or the facility manager.
Withdrawal, reassessment and renewal of MA approvals
Throughout the whole period covered by the authorisation, the person in charge of marketing the products is required to inform the authorities of any new facts that may modify the information provided in the application for authorisation. At any time, if the competent authorities consider, for reasons relating to advances in knowledge or the product’s conditions of use, that the criteria regarding its efficacy and safety are no longer met, they may withdraw the approval to market or import the product.
Before the end of the 10-year authorisation period, a renewal may be granted upon submission of an application containing the same type of information as the original application, in order to allow a new assessment of the product's efficacy and safety.