Twenty questions about ANSES and the authorisation of plant protection products

It is a product consisting of one or more active substances and co-formulants  . Such products are mainly intended to protect plants from pests, ensure their preservation or destroy unwanted vegetation. They are governed by European Regulation (EC) No 1107/2009.

An active substance may be a synthetic chemical compound, plant extract, pheromone or micro-organism that has action against a pest or on a plant or part of a plant regarded as undesirable. An active substance has a specific property:  fungicide, insecticide, herbicide, growth regulator, nematicide, etc.

Co-formulants are also added to give the product characteristics that suit the way it is applied. Examples include anti-foaming agents, thinners and wetting agents.

To be used in France, a plant protection product must have a marketing authorisation (MA), which is valid for specific uses. A use combines three elements: the crop + the function or application method + the target to be controlled, e.g. "vine + treatment of aerial parts + mildew".

For each use, the MA specifies the product's characteristics and how it may be used: the plant concerned, the targeted pest, the quantity and frequency of application, etc. It also lays down the protective measures to be applied for humans (product applicators or crop workers), including the wearing of personal protective equipment (such as overalls, masks and gloves), and for the environment, depending on the specific risks to water and ecosystems.

ANSES assesses the efficacy of these products and the risks to human health and ecosystems posed by their use, and takes decisions on MA applications. It therefore issues, refuses and withdraws MAs for plant protection products in France. The decisions are signed by the Director General of ANSES.

All these decisions are published and accessible on the ANSES website, along with the assessment findings on which the decisions are based.

ANSES also makes proposals on improving methodologies for assessing active substances at European level.

Act no. 2014-1170 of 13 October 2014, known as the Act on the future of agriculture, food and forestry, appointed ANSES as the national competent authority for issuing MAs.

Up until the end of 2014, the Agency only assessed the efficacy and the health and environmental risks associated with the use of each product. It sent its conclusions to the Directorate General for Food, within the Ministry of Agriculture, which then took the decision whether or not to issue marketing authorisation.

European legislation lays down uniform criteria for assessment and decision-making under Regulation (EU) No 546/2011. These criteria are supplemented by a number of French texts, on the protection of bees, for example.

The studies that ANSES examines must concern the product as it would be marketed: same composition, same application doses. The aim is to assess its efficacy and the risks associated with its use for humans (applicators, crop workers, bystanders and residents, consumers), the environment, flora and fauna.

Find out more about risk assessments of plant protection products before they are placed on the market.

There is no European definition of the concept of biocontrol product. Specific to France (definition of biocontrol mentioned in Article L. 253-6 of the French Rural and Maritime Fishing Code), this concept covers macro-organisms (ladybirds, for example) and plant protection products containing micro-organisms, chemical mediators (pheromones, kairomones) and natural substances of plant, animal or mineral origin (such as sulphur, ferric phosphate, paraffin oil, laminarin, orange essential oil, pelargonic acid, etc.).

Find out more about biocontrol solutions

The socio-economic impact of issuing or refusing an MA is not one of the harmonised legal assessment and decision-making criteria in Europe.

The sole aim of the scientific assessment is to verify the product’s efficacy and safety for human health and ecosystems, in accordance with rules that have been harmonised at European level. If the assessment concludes that there is a risk to humans or the environment, the regulations will not allow an MA to be issued or renewed, even if this product’s absence from the market would have a major socio-economic impact.

Only in certain cases: this is mandatory when the active substance is a "candidate for substitution" due to its unfavourable toxicological profile or because it is particularly persistent (Article 50.1 of Regulation (EC) No 1107/2009). ANSES must compare each use of the product containing the active substance with existing treatment solutions, in order to prioritise the safest approach with similar performance for a given use, wherever possible. In practice, ANSES identifies all the other products on the market for the same use and, if there are enough of them, with varied modes of action and posing fewer risks, then the new use is not authorised.

There is another possibility for substitution in the Regulation, this time irrespective of the status of the active substance, when there are "non-chemical alternatives in general use in France". This only applies in exceptional cases (Article 50.2 of Regulation (EC) No 1107/2009). In France, it was used with respect to glyphosate.

ANSES has set up its organisation to ensure that scientific assessment is performed independently of the examination of dossiers with a view to issuing or refusing authorisation. In practical terms, this means that the work is carried out by two different departments.

As with all the risk assessments it carries out, ANSES relies on committees of external experts. They are bound by the strict ethical framework set up by the Agency. The assessment findings are published with the decisions.

Products are assessed on the basis of scientific evidence provided by manufacturers in their MA applications, which include ad hoc studies and information from the scientific literature. Any manufacturer applying for an MA is required to demonstrate in advance, in a complete dossier, that the product complies with the European Union's uniform decision criteria. The Agency systematically checks the scientific validity of the manufacturers' data and their compliance with regulatory requirements.

The Agency also takes account of data from the scientific literature, the phytopharmacovigilance scheme and its own expert appraisal work in risk assessment, where available.

o, active substances are approved for the entire European Union by the competent authorities in the Member States. In France, the Ministry of Agriculture is the competent authority for approving active substances.

However, ANSES is involved in the European-level scientific assessment of active substances coordinated by the European Food Safety Authority (EFSA), on the basis of ad hoc studies and scientific literature provided by manufacturers.

The European Commission uses EFSA's conclusions as a basis for its proposals to the Member States: an approval regulation if the active substance meets the required conditions, or otherwise a non-approval regulation. Regulations granting approval for a defined period or refusing approval for an active substance are voted on by the representatives of the Member States, through a specific Standing Committee on the Food Chain and Animal Health.

It is only once an active substance has been approved at European level that it can be used in a plant protection product. This requires an additional application from the manufacturers concerned with a view to obtaining a national MA for each product incorporating this approved active substance.

Everything you need to know about the assessment of plant protection active substances

This committee deals with plant protection products, as well as biocidal products, fertilisers and growing media. Its members are all qualified individuals, including representatives from the agricultural production sector, healthcare professionals, agronomists and environmental specialists.

Its role is to advise the Director General of ANSES, at his request, on the conditions of use of products, the applicability of certain risk management measures, the health, environmental, agronomic and socio-economic benefits of certain products or approaches, and the identification of priority study topics.

It is therefore not involved in the product assessments or in deciding whether or not to authorise the placing on the market of a particular product.

Find out more about ANSES's MA Monitoring Committee (in French)

The risks of harmful effects on humans, animals and the environment are not solely contingent on the active substance: they vary according to the product's composition and presentation (liquid, powder, etc.), the intended agricultural practices (doses, type of application, etc.) and the agricultural/climate/soil situations.

Moreover, an active substance is approved at European level on the basis of a "representative" use of a product containing it. All other uses and products must therefore be assessed when MA applications are submitted.

Examining each product ensures that it is safe, its uses have been assessed and its conditions of use specified. Product MAs take account of the diversity and any specificity of cropping practices, as well as advances in knowledge of the risks associated with these products. Even if the active substance has been approved at European level, marketing authorisations are regularly refused for some of a product's uses. 

Several situations are possible:

• New evidence indicates unacceptable risks to health or the environment: the MA must be revised to amend the conditions of use and, if this is not possible, the MA must be withdrawn as soon as possible, regardless of the timetable for re-examining the active substance, as indicated in the legislation (Article 44 of Regulation (EC) No 1107/2009).
• The active substance contained in the product is no longer approved: all products containing it must therefore be withdrawn from the market.
• The active substance has just been re-assessed and re-approved: if manufacturers wish to renew the MAs for products containing it, they must submit their dossiers within three months. MAs without a renewal dossier will not be maintained. For the others, the old MAs are extended while the dossier is assessed. Following this assessment, if the risk of harmful effects is deemed unacceptable, the MA is withdrawn.
• The MA holder requests its withdrawal, for commercial reasons for example.

There are several reasons for this:

• A Member State may adopt regulatory measures in addition to the European framework, to go further than European legislation and prohibit the use of certain products on its territory. This is known as "gold-plating". France, which has adopted general measures to protect bees, also banned the use of products containing active substances from the neonicotinoid class, in a law passed in 2018. As a result of this law, ANSES therefore had to introduce a restriction in the MAs for these products;
• MA applications are not necessarily submitted by manufacturers in all Member States, nor are they examined according to the same timetable from one country to another. Moreover, manufacturers do not necessarily apply for marketing authorisation for the same uses from one country to another. The authorisation status may also play a role, for example the fact that the product is available under an exemption in another Member State;
• The scientific assessment of the environmental fate of products takes account of the different agricultural/climate/soil situations specific to each country, and may therefore differ from country to country;

The assessment of an MA application is based on the methods and criteria in force at the time it was submitted. Science evolves and product assessment is becoming increasingly sophisticated, with the sole aim of protecting the health of humans and the environment. A product that was assessed and authorised in another country several years ago may be refused authorisation when assessed using current methods and criteria.

No, it is not enough for a plant protection product to be authorised in a European Member State for it to be authorised in France, and vice versa, in accordance with the legislation. Any Member State may refuse to authorise a product on its territory if, due to its characteristics, the product poses a risk there to human or animal health or the environment.

When ANSES receives an application for mutual recognition from a manufacturer, it first ensures that it is compatible with national law and with local agricultural and climatic conditions. In accordance with European law, it refers to European guidance documents to verify this.

Over the period January 2018-December 2024, out of the 108 mutual recognition dossiers processed by ANSES, 55 MAs were granted, i.e. 51% of applications.

In the event of an emergency situation, to protect certain crops or plants, the European regulation enables the use of plant protection products that are not normally authorised for such uses, by means of a derogation limited to 120 days (Article 53 of Regulation (EC) No 1107/2009).

This derogation, which is granted in France by the Ministry of Agriculture, means that the pest in question can be controlled immediately if no other solution is available.

For almost all crops, product assessments are carried out by zone. Three zones have been defined in Europe according to their agricultural, soil and climate conditions: the North, Central and South zones. France is in the South zone.

With this zoning system, the European Union has reconciled the need to take account of very different agricultural contexts from one end of Europe to the other, with the importance of harmonising product assessments as far as possible and pooling assessment efforts.

Within a zone, the assessments are therefore pooled: one Member State is appointed to assess the product, then the other Member States can comment on this assessment and use it for MA applications submitted in their own countries. Some of the assessments conducted by ANSES have therefore served as the starting point for processing identical MA applications submitted in other countries in the South zone, and vice versa.

Once applied to crops, these products or their residues can have effects on health and the environment. ANSES runs a national phytopharmacovigilance scheme to monitor adverse effects attributable to these products and act accordingly.

Find out more about phytopharmacovigilance

Plant health is also one of ANSES's health missions. The ANSES Plant Health Laboratory conducts research into pests, resistance to plant protection treatments and other control methods. ANSES also co-manages the national epidemiological surveillance platform for plant health, particularly with a view to monitoring the emergence of new hazards.

Find out more about the activities of our Plant Health Laboratory

ANSES carries out expert appraisal work in risk assessment in order to document certain emerging or poorly understood risks associated with plant protection products. To do this, it relies on the most appropriate expert group(s): CES on plant health, biotechnologies, or plant protection products.

Find out more about ANSES's risk assessment activities

In order to hold discussions with stakeholders on the current state of knowledge, health risk assessment methodologies and current scientific debates, ANSES runs a permanent platform for dialogue on its activities relating to plant protection products.

Find out more about the platform for dialogue on marketing authorisations for plant protection products