Published: 8 April 2026
The EU Library gathers guidance documents related to food safety and produced by EU national competent organisations and risk assessors.
The EU 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.
Showing 14 documents
Original title:Intégration de l’exposome dans les travaux de l’Anses
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:The ANSES guidance “Intégration de l’exposome dans les activités de l’Anses” (2022-METH-0197) explores how the exposome concept—which encompasses the full array of environmental, chemical, biological, physical, psychosocial, and socio-economic influences over an individual’s life—can be integrated into the Agency’s risk assessment and health evaluation activities. The report surveys existing definitions, data sources, methods, and tools relevant to exposome research, and identifies challenges in applying them in regulatory or public health contexts. It emphasizes the need for holistic exposure tracking (multiple sources, multiple pathways, temporal dynamics), incorporation of inter- and intra-individual variability, and dealing with mixtures of stressors. The guidance proposes a roadmap for operationalizing exposome approaches within ANSES: selecting priorities, developing or adapting measurement and modelling tools, ensuring data interoperability, and embedding these approaches in expert assessments. Overall, the document aims to modernize risk evaluation by shifting from single-agent, single-pathway assessments toward more integrated, realistic representations of human exposures over life.
OPINION of the National Agency for Food, Environmental and Occupational Health & Safety on a supporting document for the guidelines of the decree of March 7, 2011 concerning the evaluation of antimicrobial efficacy of processing aids used as decontamination agents for foodstuffs of plant origin
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à un document d’appui aux lignes directrices de l’arrêté du 7 mars 2011 relatives à l’évaluation de l'efficacité antimicrobienne des auxiliaires technologiques utilisés comme agents de décontamination des denrées d’origine végétale
Food Domain: Food Processing aids
Abstract/Summary:This ANSES guidance document provides updated scientific and technical support for evaluating the antimicrobial efficacy of food Processing aids used as decontamination agents for plant-based food products. The document replaces earlier recommendations and clarifies the requirements for dossiers submitted for authorization under French regulation. It outlines the types of data needed to demonstrate efficacy, including microbiological testing against bacteria, viruses, fungi, and parasites.
OPINION of the French Agency for Food, Environmental and Occupational Health Safety on a guide for assessing the specific health risk of nanomaterials in products intended for food
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à un guide d’évaluation du risque sanitaire spécifique aux nanomatériaux dans les produits destinés à l’alimentation
Food Domain: Food Contact Materials; Food Improvement Agents;…
Abstract/Summary:This ANSES guidance document provides a framework for assessing health risks associated with nanomaterials in food products. The document highlights the lack of harmonized regulations and the coexistence of multiple definitions of nanomaterials across different EU legislative texts, which creates confusion. ANSES proposes a structured approach to evaluate potential health risks, including hazard identification, exposure assessment, and toxicological analysis. While the two methodologies developed by EFSA (2018) and ANSES are based on broadly similar risk assessment concepts and methodologies, ANSES proposed specific variations in relation to regulatory definitions, particle size measurements, dissolution properties and hazard identification. This guide is a continuation of the work initiated by ANSES, contributing to the scientific debate and the search for the most appropriate method for assessing the health risks posed by manufactured nanomaterials.
Original title:AVIS de l'Anses relatif aux lignes directrices pour l'évaluation des allégations en alimentation animale - Evaluation des dossiers de preuve des allégations fonctionnelles
Food Domain: Animal Feed
Abstract/Summary:This ANSES Opinion presents guidance for evaluating dossiers that support functional claims about animal feed (i.e. claims that a feed has specific beneficial effects). The document outlines the principles and criteria that competent authorities or experts should apply to assess whether submitted evidence is sufficient, reliable, and biologically plausible. Key elements include: (1) defining the claimed effect precisely; (2) establishing a credible mode of action or causal mechanism; (3) demonstrating effect size, consistency, and reproducibility across studies; (4) assessing the quality, relevance, and internal validity of trials (including controls, randomization, blinding, statistical methods); (5) integrating lines of evidence (in vivo, in vitro, mechanistic) and resolving contradictions; (6) considering dose-response relationships and exposure relevance; and (7) evaluating uncertainties and potential biases. The guidance emphasizes transparency in justifying judgments and the need for dossiers to present all relevant data, including negative studies or anomalies, and to allow assessment of robustness and generalizability of the claimed effect.
OPINION of the French Agency for Food, Environmental and Occupational Health Safety regarding the update of the guidelines for the evaluation of guides to good hygiene practices and the application of HACCP principles
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à l’actualisation des lignes directrices pour l’évaluation des guides de bonnes pratiques d’hygiène et d’application des principes HACCP (GBPH)
Food Domain: Biological Hazards; Contaminants; Allergens
Abstract/Summary:This ANSES guidance document updates the evaluation framework for guides to good hygiene practices and the application of HACCP principles in the food sector. It aims to ensure that these guides remain aligned with current scientific knowledge, regulatory requirements, and practical realities in food production. The document outlines criteria for assessing the relevance, clarity, and effectiveness of hygiene guides, emphasizing their role in supporting food business operators in managing risks and complying with food safety regulations. It also provides methodological recommendations for drafting and reviewing the guides.
Scientific and technical support note from the French Agency for Food, Environmental and Occupational Health Safety related to "rules for the constitution of applications for authorization of food processing aids and the acceptance of theoretical calculations related to exposure assessment"
Original title:NOTE d’appui scientifique et technique de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative aux « règles de constitution des dossiers de demande d’autorisation d’auxiliaires technologiques et l’acceptation des calculs théoriques en lien avec l’évaluation de l’exposition »
Food Domain: Food Processing aids
Abstract/Summary:This ANSES guidance document provides scientific and technical support for preparing application dossiers for the authorization of food processing aids under French regulation. It describes three methods to estimate consumer exposure to residues, degradation products, and reaction by-products. The document outlines a tiered approach to dossier preparation based on usage levels and expected residue concentrations. It details the required administrative, technical, and toxicological data, including substance identity, manufacturing process, technological role, and analytical methods.
ANSES methodological guide for the planning of expert assessments, uncertainty analysis, literature review, and evaluation of the weight of evidence
Original title:Guide méthodologique de l’Anses pour la planification des expertises, l’analyse d’incertitude, la revue de la littérature et l’évaluation du poids des preuves
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:This methodological report by ANSES (GT ACCMER) aims to operationalize previous recommendations from GT MER by adapting them into a pragmatic framework for internal use. It offers guidance on planning expert assessments, conducting literature reviews, evaluating the weight of evidence, and analyzing uncertainties systematically in risk evaluation contexts. The document also provides decision criteria for choosing methods proportionate to the complexity, data availability, and stakes of each expertise. Key features include standardized review protocols, dual independent assessments, structured integration of evidence lines, transparent justification of methodological choices, and graded expression of confidence or uncertainty. By embedding these processes into the organisational practices of ANSES and allowing iterative refinement during pilot implementation, the report seeks to enhance consistency, rigour, reproducibility and transparency across the Agency’s expert assessments.
Original title:Prise en compte de l’incertitude en évaluation des risques : revue de la littérature et recommandations pour l’Anses
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:This ANSES guidance (Prise en compte de l’incertitude en évaluation des risques) reviews scientific concepts and methodologies for treating uncertainty within risk assessment, and offers recommendations tailored to ANSES practices. It begins by defining types and sources of uncertainty (e.g. data gaps, model assumptions, variability) and reviews methods (probabilistic models, sensitivity analysis, scenario analysis, expert elicitation, qualitative approaches). It proposes a structured workflow: planning the uncertainty analysis, identifying and characterizing uncertainties in each assessment step, propagating uncertainties through the model, and communicating them transparently. The document emphasizes distinguishing uncertainty from variability, documenting assumptions and choices, expressing confidence levels or degrees of uncertainty, and using both quantitative and qualitative approaches when appropriate. In its annex (“illustrations and updates”), the working group recommends explicitly integrating uncertainty analysis and weight-of-evidence elements into assessments. Overall, the guidance seeks to improve robustness, clarity and consistency in how ANSES deals with uncertainty in scientific assessments.
Evaluation of the weight of evidence at ANSES: critical review of the literature and recommendations at the hazard identification stage
Original title:Évaluation du poids des preuves à l’Anses: revue critique de la littérature et recommandations à l’étape d’identification des dangers
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:This guidance report by ANSES critically reviews existing literature on the “weight of evidence” (WoE) approach as applied in the hazard identification phase of risk assessment, and makes methodological recommendations to harmonize internal practices. It defines key concepts (e.g. line of evidence, WoE, systematic review), proposes a four-step framework (planning, establishment of evidence lines, integration, expression of conclusions), and evaluates ~25 methods from the literature according to criteria of directionality, relevance, and feasibility. The report then compares these with current practices at ANSES and formulates concrete recommendations to improve transparency, reproducibility and consistency in expert assessments. Recommendations include use of formal reading grids, dual independent review, meta-analysis or multicriteria methods where possible, explicit justifications of choices, and graded expression of evidence strength. The document aims to strengthen the credibility and robustness of scientific expertise within ANSES.
OPINION of the National Agency for for Food, Environmental and Occupational Health & Safety on "Recommendations for the development of a good practice guide to ensure animal welfare"
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à des « Recommandations pour l’élaboration d’un guide de bonnes pratiques pour assurer le bien-être animal »
Food Domain: Animal Welfare
Abstract/Summary:This ANSES Avis provides recommendations for drafting Guides of Best Practices (GBP) to ensure animal welfare. The guidance is intended to help ANSES evaluate such GBP and to assist professionals in producing them. It emphasizes that GBP should be consistent, transparent, and scientifically grounded while remaining practical for intended users and adaptable to evolving knowledge. Animal welfare is defined as a multidimensional state reflected by satisfying physiological and behavioral needs and the ability to cope with environment. The document proposes a template for GBP, covering sections including objectives, scope (species, settings, actors), regulatory foundation, risk/factor analysis, description of recommended practices, control strategies, indicators, glossary, and annexes. Controls are categorized into first-level (operator self-checks), second-level (periodic internal sampling checks), and third-level (external audits or certification). The GBP should include strategies for monitoring, corrective actions, and updates over time. A multi-stakeholder drafting committee is recommended, involving operators, scientists, regulatory bodies, and external experts. The Avis underscores the importance of clarity, readability, and transparency of decision logic; and it encourages periodic revision and evaluation of GBP based on evidence, indicators, and feedback.
OPINION of the French Agency for Food, Environmental and Occupational Health and Safety relating to the revision of the guidelines for the assessment of risks to humans of the constituents of cleaning products for materials and objects intended for contact with foodstuffs
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à la révision des lignes directrices pour l'évaluation des risques pour l'homme des constituants des produits de nettoyage des matériaux et objets destinés au contact avec des denrées alimentaires
Food Domain: Food Contact Materials
Abstract/Summary:This ANSES guidance document provides updated scientific and technical support for preparing application dossiers for the authorization of the constituents of cleaning products for FCM. The document replaces earlier recommendations and clarifies the requirements for dossiers submitted for authorization under French regulation. It outlines the types of data needed to demonstrate food safety. It details the required administrative, technical, and scientific data including substance identity, impurities, analytical methods, toxicological data (following a tiered approach base on exposure levels), conditions of use, exposure estimates to residues in food.
Food Domain: GMO
Abstract/Summary:This ANSES guidance opinion presents recommendations for statistically analysing 90-day rat feeding studies used in GMO risk assessment. It reviews common practices—parametric and non-parametric tests, data transformations, mixed models for repeated measures, and equivalence testing—and discusses their strengths and limitations. The document emphasises the importance of identifying and handling outliers, ensuring assumptions (e.g. normality, homoscedasticity), and choosing appropriate models for repeated data (e.g. weight curves). To reduce false negatives, ANSES recommends relaxing the Type I error level (e.g. setting α = 10 %) to increase statistical power, while correcting for multiple comparisons (e.g. via False Discovery Rate). Power analyses are advocated to determine sample sizes or assess post hoc detectability of effects. For many parameters, adequate power may require increasing group sizes from the standard 10 to about 20 animals per sex/group. Equivalence testing is discussed but it is difficult to use these tests for analysing data from toxicological tests on laboratory animals as the results can only be interpreted if a large number of animals per group and per sex. Finally, ANSES advises making raw data available and using graphical representations of effect sizes to enhance transparency and expert interpretation.
Original title:Une méthode qualitative d’estimation du risque en santé animale
Food Domain: Animal Health
Abstract/Summary:This methodological document, titled A qualitative risk assessment method in animal health, presents a structured qualitative approach for estimating risks in veterinary contexts. It frames risk analysis according to the standard phases: hazard identification, risk assessment, risk management, and risk communication. The document proposes a decision-aiding tool using categorical scales (e.g. negligible, low, medium, high) to rate likelihoods and consequences, and to combine them into qualitative risk levels. It emphasizes using expert judgment in a transparent, documented way, integrating epidemiological, biological, and managerial data. The method suggests steps to define the context, identify hazards and pathways, evaluate the probability of occurrence and magnitude of impact, and characterize resulting risk. Uncertainties should be explicitly stated, and assumptions recorded. The guidance also underscores that qualitative approaches should be proportionate to available data and resource constraints, and may serve as a preliminary screening tool before more quantitative analyses. In sum, it offers a pragmatic, transparent framework to support decision-making in animal health when quantitative data are limited.
OPINION of the French Food Safety Agency on the preparation of risk assessment dossiers related to the use of plastic materials treated with ionizing radiation and intended to come into contact with foodstuffs: Guidelines
Original title:AVIS de l’Agence française de sécurité sanitaire des aliments relatif à la constitution des dossiers d’évaluation des risques sanitaires liés à l’emploi de matériaux plastiques traités par rayonnements ionisants et destinés au contact de denrées alimentaires : Lignes directrices
Food Domain: Food Contact Materials
Abstract/Summary:This document provides guidance to applicants submitting applications on FCM treated with ionizing radiation and intended to come into contact with foodstuffs, which are to be evaluated by Anses. It describes the administrative and scientific requirements for the preparation of the dossier submitted for authorization under French regulation.