Assessment of commercial plant protection preparations prior to marketing

Procedure

Assessing plant protection products before they can be placed on the market takes place in the framework of European Regulation (EC) No 1107/2009, whose provisions Member States are required to implement. This assessment is divided into two steps:

1. The first step, carried out at European level, focuses on assessing the hazards and risks associated with the active substances used in the plant protection products. This phase is coordinated at European level by the European Food Safety Authority (EFSA), which relies on the collective assessments conducted by the Member States (ANSES for France).

2. The second step involves assessing the benefits and risks associated with commercial preparations.

Since June 2011, plant protection preparations are no longer assessed by each Member State, but according to geographical zone. Three zones have been defined in the European Union. France belongs to the southern zone, along with Bulgaria, Greece, Spain, Italy, Cyprus, Malta and Portugal. Within a given zone, manufacturers wishing to apply for authorisation of a plant protection preparation may submit their application to any Member State in the zone. The assessment conducted by the requested Member State is then valid for all other countries in the zone.

Assessment dossiers for the preparations are then examined by a rapporteur Member State in the zone where an application for authorisation for one or more specific uses has been submitted for the preparation. The other Member States in the zone are given the opportunity to comment on this assessment.

In France, manufacturers submit to ANSES an application for marketing authorisation that includes all the scientific data required to conduct an assessment of the risks associated with the use of the products The authorisation procedure then involves verifying that the products contain only substances authorised for the specified use and that, under normal conditions of use, they are effective and have no unacceptable effects on human or animal health, or on the environment, according to the criteria set by the regulations. This procedure also includes requirements for packaging and labelling.

These applications are assessed at ANSES as part of a multidisciplinary adversarial collective expert appraisal process. This involves drafting assessment reports and publishing scientific opinions. On the basis of these reports and opinions, as of 1 July 2015 the Agency is responsible for taking decisions on whether or not plant protection products receive marketing authorisation. These assessment reports are also made available to the other Member States under the zonal assessment scheme.

Scientific assessment

Assessment of active substances used in plant protection preparations and of the preparations themselves, with a view to authorising their marketing, is strictly regulated and harmonised at European level by Regulation (EC) No 1107/2009.
The process is divided into three steps:

1. ANSES first verifies the validity of the scientific data provided by the manufacturers, and their compliance with regulatory requirements,

2. It then assesses the efficacy of the products and the risks of their use, and provides a report summarising both efficacy and risks. The risk assessment concerns safety to humans (individuals applying the products, workers, bystanders near the application site, in addition to consumers, through residues in food and water), the environment (surface and groundwater, air, soil), fauna and flora.

3. Lastly, it draws up recommendations for use of the products. 

It involves the following:

• the Agency’s scientific assessors: these multidisciplinary teams bring together a variety of complementary skills (researchers, agronomists, chemists, pharmacists, environmental engineers, veterinarians) ;
• two expert committees (one on chemical plant protection products, and one on beneficial plant micro-organisms and macro-organisms). These committees are made up of scientists, professors from the public school system and researchers from outside the Agency acting in a personal capacity and selected according to criteria of competence and independence following a public call for applications.

Each internal and external experts involved in assessing dossiers must fill out a public declaration of interests (PDI) that is published on the Agency’s website.

Conclusions issued by the Agency

The applications submitted by manufacturers cover a variable number of intended uses.  Each use concerns a plant species (or agricultural group of plants), a target pest (or group) and a method of treatment or a function, and is accompanied by conditions of use such as the dose to be used, the period and frequency of use, and the agricultural practices associated with the treatment. As part of its assessment, the Agency’s conclusions are specified for each use and may propose more restrictive conditions of use than those in the petitioner’s initial application. 

The findings of the assessment therefore summarise any risks identified during the assessment and the agronomic benefits for the intended uses. They provide conclusions as to the acceptability of the risks, based on the criteria laid down in Regulation (EC) No 1107/2009. They also establish best practices for use and, if necessary, introduce restrictions on use depending on the identified risks. They may also make recommendations concerning post-authorisation monitoring.

The Agency considers that its Opinion is:

• favourable, when the entire application is deemed compliant;
• favourable with restrictions, when the opinion is favourable for some of the requested uses or when restrictive conditions of use are recommended in relation to the application;
• unfavourable, when the Agency recommends that all requested uses be rejected.

Each year, ANSES processes just over 300 applications for authorisation for new plant protection products, and applications for renewal of an existing product’s authorisation after review, all of which must undergo in-depth assessment. Based on 2010 data, a quarter of such assessments result in an unfavourable opinion. Moreover, a large majority of favourable opinions are accompanied by restrictions on use relative to the petitioner’s initial application. All opinions issued by ANSES and all of its studies are systematically published and are available on its website.

Marketing authorisation decisions

The placing of plant protection products on the market is subject to an official authorisation issued by ANSES as of 1 July 2015, based in particular on the conclusions of its assessment opinions, including conditions of use that comply with the principles of good agricultural practice.

Decisions are based on the guidelines set down by the Agency specifying the criteria taken into account in the decision-making process for marketing authorisations, based on the results of scientific assessments, in compliance with European regulations.  

The Agency may also consult a monitoring committee, which provides additional insight alongside the scientific assessment, to ensure that the mandatory risk management measures required by the MA framework are workable and effective in real-life situations, in light of the constraints of field practices.

These decisions are valid for 10 years, after which petitioners are required to submit a new application for authorisation. Products are also subject to re-examination once the conclusions of the EU assessment of the active substances they contain are made available. ANSES reassesses the entire dossier and takes into account all the field data and the latest scientific knowledge available regarding the product’s potential impact on humans and the environment.

The catalogue of plant protection products that have been approved in France, together with their uses, is held in a database managed by ANSES (e-phy.agriculture.gouv.fr).