Assessing Good Experimental Practices (GEP)
A laboratory that inspects the toxicity or efficiency of pesticides, for example, must obtain GEP approval if it wants its results to be recognised officially. In 2006, the management and assessment of conformity with good experimental practices was transferred to Cofrac.
Cofrac provides support to the French General Directorate of Food (Direction générale de l’alimentation - DGAL) to assess the conformity of the bodies conducting officially-recognised tests with the principles of "good experimental practices" (GEP) defined by the French Ministry of Agriculture.
In 2017, 113 good experimental practices applications were processed by Cofrac on behalf of the Ministry of Agriculture.
Good Experimental Practices: what's it all about?
GEP approval is issued by the Ministry of Agriculture, through Cofrac, which is responsible for auditing the candidate body. Objective: ensuring compliance with the GEP requirements. This approval is granted for a period of five years, for one or more sectors of activity, and for one or more sites.
In concrete terms, the "Requirements for good experimental practices" from the French Ministry of Agriculture defines "the mode of organisation of the experimentation networks and the conditions under which tests are planned, conducted, inspected, recorded and exploited with a view to obtaining reliable and comparable data". Accordingly, Cofrac assesses and inspects various aspects including the competence of the personnel, the equipment used or the protocols followed by the inspection body, on behalf of the DGAL.
"Officially-recognised tests": what are these?
According to the Rural Code (article R 253-14), "officially-recognised" tests are those conducted by a natural person or legal entity approved to this end by the Ministry of Agriculture, and which are subject to declarations to this ministry. These tests, which benefit from official recognition, serve as a basis for compiling biological records in the framework of the authorisation process for marketing phytosanitary products.
Good experimental practices: what is the role of Cofrac?
Cofrac is responsible for reviewing applications for assessment of conformity with the GEP principles but also for monitoring the bodies that have already obtained this approval. Our teams therefore manage the renewal of approvals and their extension to new sectors of activity and/or new experimentation units. For this, we organise assessment visits and guarantee the qualification and follow-up of the technical experts and assessment team managers conducting them.
GEP approval: The assessment process in four steps
1. Review of the request & submission of the application
2. Signing of an agreement
3. Assessment phase
4. Decision and notification
Preliminary review phase
Anybody applying for approval for conducting officially-recognised tests sends an approval request to DGAL with a copy to Cofrac. This written request marks the start of the review of the application. For this, the request must specify the object of the application and the administrative information (identification of the candidate entity, contact details of the person in charge, etc.). Upon receipt of this letter of intent, Cofrac transmits to the applicant the application forms.
Signing an agreement
At the end of the assessment request review phase, an agreement is drawn up, specifying the respective rights and obligations of Cofrac and the candidate body.
The initial assessment systematically includes an inspection visit to the central unit of the experimentation network and an assessment of all the sectors of activity for which the body is requesting approval. The team of assessors is proposed by Cofrac and submitted for acceptance to the candidate body.
The assessment can draw on various key elements :
analysis of procedures, of operating methods, and of records gathered prior to the visit and consulted on site, documentary traceability of the services carried out ;
interviews with personnel ;
witnessing of biological experiments: weighing ;
witnessing of current tests (preferably), or simulation of spraying, etc.
Decision and notification
Cofrac transmits the assessment reports to DGAL within three weeks after the end of the assessment. They are then reviewed by the GEP Committee (DGAL/Cofrac). Upon advice from this Committee, DGAL then notifies the bodies of the ministerial decision and sends a copy to Cofrac. The approval decision is issued within three months after the submission of the assessment report.
Find out more
- Concerning the regulations and the terms of assessment, including in the case of renewal or extension :
- Concerning the associated fees :