Documents d'orientation et autres documents relatifs aux méthodologies d'évaluation
Un ensemble exhaustif de pratiques d’évaluation scientifique guident les experts de l’EFSA dans leurs travaux et les aident à produire des avis et des rapports qui respectent les normes scientifiques les plus élevées.
Ce corpus de bonnes pratiques couvre tant les aspects purement scientifiques que les aspects liés aux procédures appliquées dans le circuit d’évaluation scientifique de l’EFSA. Elles définissent les principes et le fondement scientifique des évaluations, ainsi que d'autres aspects importants tels que les données nécessaires à l’évaluation et le format de ces données, les critères requis en matière de conception des études ou encore les normes à respecter pour la production de rapports.
- Documents d'orientation transsectoriels– documents d’orientation élaborés par le comité scientifique/EFSA relatifs aux principes généraux d'évaluation (par ex. analyse de l'incertitude, rapports statistiques, structure des productions scientifiques) et applicables à l'ensemble ou à la plupart des domaines de travail de l'EFSA.
- Documents d'orientation sectoriels – documents d’orientation élaborés par les groupes scientifiques ou les unités de l'EFSA et utilisés par les scientifiques de l'EFSA, par d'autres organes scientifiques et par les parties prenantes, en particulier les pétitionnaires qui soumettent des dossiers à des fins d’évaluation scientifique.
- Autres méthodologies d’évaluation – produites par le personnel scientifique de l'EFSA et soumises à un examen par des experts indépendants, ces documents peuvent inclure des approches et des procédures méthodologiques, des bilans sur l’état des connaissances scientifiques les plus récentes en matière de meilleures pratiques d’évaluation au niveau international, ou encore des rapports d'analyse sur des outils d'évaluation nouveaux ou en développement.
Nous nous efforçons d’améliorer constamment nos pratiques d'évaluation et nous nous employons à élaborer en permanence de nouveaux documents d’orientation et à affiner nos recommandations et nos procédures de travail afin de nous maintenir à la pointe des progrès scientifiques au niveau international et satisfaire ainsi les besoins inhérents à la science réglementaire.
Categories of EFSA guidance documents
Based on their main purpose, applicability (cross-cutting vs. sector specific), content and adopting body, EFSA GD are classified into five categories. As this classification entered into force in 2026, guidance documents published previously may not fully reflect these provisions.
Adopted by the EFSA Scientific Committee. See here for the Scientific Committee work programme on cross-cutting GD. (N.B. Before 2026 cross-cutting GD could also be adopted by EFSA.)
| Purpose | Contents |
|---|---|
To set out and provide instructions for applying methodologies that are applicable across multiple EFSA domains and beyond, to promote harmonisation. The methodologies outlined in these guidance documents are implemented throughout the various EFSA sectors, including those pertaining to regulated products and applications, either directly or after incorporation into sector-specific GD (category 2). These GD may apply to all EFSA sectors or only some. | a. Study design and conduct (cross-cutting) This can include principles, rules, criteria and/or detailed descriptions related to any type of study (e.g. experimental or observational), measurement and laboratory technique. Laboratory techniques may include, for example, detection methods, molecular characterisation methods, or DNA A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life sequencing methodologies. b. Cross-cutting methodologies, principles and criteria for the scientific assessment process conducted by risk assessors |
Adopted by the sector-related scientific panel or, for GD on plant protection products, also by EFSA.
| Purpose | Contents |
|---|---|
To set out and provide instructions to: i) support applicants to prepare dossiers within sector-specific areas of EFSA, and/or ii) support risk assessors to conduct scientific assessments within sector-specific areas within EFSA’s remit. These GD incorporate and/or refer to, as appropriate, cross-cutting methodologies described in category 1 GD. | a. Study design and conduct (sector-specific) This may include principles, rules, criteria and/or detailed descriptions related to any type of study (e.g. experimental or observational), measurement and laboratory technique. Laboratory techniques may include for instance detection methods, molecular characterisation methods, or DNA sequencing methodologies. For regulated products and applications, to guarantee the fulfilment of data requirements, EFSA relies on internationally recognised test guidelines on study design and conduct. When such guidelines are unavailable or require adaptation for EFSA's specific needs, EFSA develops its own guidance. b. Sector-specific methodologies, principles and criteria for scientific assessment processes conducted by risk assessors. |
Adopted by EFSA.
| Purpose | Contents |
|---|---|
To set out and provide instructions for applying standards for data collection and data submission that are applicable across multiple EFSA domains and beyond, to ensure consistency and accuracy. The standards and concepts described in these guidance documents are implemented throughout the various EFSA sectors either directly or after incorporation into sector-specific GD for data submissions (category 4 GD). | Cross-cutting standards for data collection and data submission These include models, catalogues, ontologies, business rules. These GD may explain the rationale that led to the decision to adopt a concept/standard and the related benefits and implications. |
Adopted by EFSA.
| Purpose | Contents |
|---|---|
| To set out and provide instructions for applying standards for sector-specific data collection and submission. These may be for monitoring programmes or for application dossiers. They may include the rationale that led to the decision to adopt a concept/standard and the subsequent benefits and implications. These GD incorporate, as appropriate, cross-cutting concepts described in category 3 GD. | a. Study design and conduct for data collection for monitoring programmes. b. Standards for sector-specific data collection and submission for monitoring programmes and application dossiers. |
Adopted by EFSA.
| Purpose | Contents |
|---|---|
| To provide administrative and procedural support for the preparation and submission of applications/notifications and other dossiers for which EFSA is requested to issue a scientific output. They are for use by applicants/notifiers and interested operators/parties. | Administrative requirements, procedures and timelines for the pre-submission phase of the applications/notifications, dossiers and from the submission to publication of a scientific output. For example, notification of studies, pre-submission advice or confidentiality and transparency, public consultation, submission of additional data. These GD may also describe the available support. |
Catalogue of EFSA Guidance Documents
The Catalogue of EFSA Guidance Documents provides a comprehensive and easily accessible resource, allowing users to find and retrieve all EFSA guidance documents.
EU Library of Food Safety Guidance
In 2024, EFSA and EU Member States agreed to gather all relevant guidance documents related to food safety and produced by EU national competent organisations and risk assessors to create an EU Library of Food Safety Guidance Documents.
The Library includes entries collected by members of EFSA’s Advisory Forum with the support of the national Focal Points. It will be updated at least annually to ensure the inclusion of any new guidance and updates of existing ones.
The EU Library represents an important first step towards the joint development of guidance. It also serves as a tool to identify potential divergencies on data requirements and risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation methodologies. These two features align with the principles of the “One Substance, One Assessment” approach.