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 6 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.
Food Domain: Biological Hazards; Contaminants; Food Contact…
Abstract/Summary:The document provides a comprehensive framework for assessing health risks from environmental chemical and microbiological exposures. It follows international standards, including EFSA, WHO, and Codex Alimentarius methodologies. Risk assessment steps include hazard identification, hazard characterization, exposure assessment, and risk characterization. It covers both microbiological (e.g., pathogens in food and water) and toxicological (e.g., heavy metals, pesticides) risks. Special topics include endocrine disruptors, nanomaterials, genotoxicity, and non-testing methods like QSAR and TTC. Practical examples include risk assessments for lead and atrazine in drinking water, PAHs in food, and nickel from cookware. The document emphasizes the importance of data quality, transparency, and multidisciplinary collaboration. It provides tools and models for predictive microbiology and chemical exposure estimation. Regulatory frameworks from the EU and international bodies are integrated throughout the guidelines. The aim is to standardize national approaches, improve assessment quality, and support public health protection.
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.
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.