EU Library of Food Safety Guidance Documents

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.

https://www.bfr.bund.de/cm/364/guideline-for-the-assessment-of-health-risks.pdf
Original title:Leitfaden für die Bewertung gesundheitlicher Risiken
Food Domain: Contaminants; Biological Hazards; Veterinary…
Abstract/Summary:The German Federal Institute for Risk Assessment (BfR) has the legal mandate to estimate and assess the risks to human health presented by food and animal feed, substances, microorganisms, products and procedures. The BfR also provides information about potential, identified and assessed risks, and recommends measures necessary for risk mitigation or avoidance. In certain circumstances, it is also necessary to assess the benefits of substances, products and procedures. The assessment process is documented and explained in full. By providing a comprehensive and understandable presentation of the scientific basis of its assessments, the BfR makes an important contribution to risk communication. One aspect of risk communication, among other things, is the exchange of information and scientific opinion concerning risks between all target groups, which include consumers, government, research and public institutions, industry bodies, non-governmental organisations and the media. As a result of this independent scientific assessment, research and clear-cut communication of health risks the BfR actively contributes to the safety of food and feed, products and chemicals. The present ‘Guideline for the assessment of health risks’ serves to implement the theoretical principles mentioned in practice and, therefore, assure the quality of risk assessments and other health statements published by the BfR.
https://www.bfr.bund.de/cm/349/guidance-on-uncertainty-analysis-in-exposure-assessment.pdf
Original title:Leitfaden zur Unsicherheitsanalyse in der Expositionsschätzung
Food Domain: Contaminants; Biological Hazards; Veterinary…
Abstract/Summary:This guidance document delineates the procedure recommended by the BfR Committee for Exposure Assessment and Exposure Standardisation and the BfR Committee on Evidence- based Methods in Risk Assessment for recording, describing and evaluating uncertainties in connection with public health related scientific statements. It primarily refers to the application of uncertainty analysis in the field of exposure assessment. Since exposure assessment is an essential part of risk assessment, it is recommended that the outlined principles should also be applied to the risk assessment process as a whole. In principle, this guidance follows the previously published guidance documents of EFSA (EFSA Scientific Committee et al., 2018; IPCS & IOMC, 2008). The development of standardised procedures for uncertainty analysis, especially in the area of hazard characterisation, is currently subject to intensive discussion and considerable collaborative efforts at the international level, so that an update of this guidance may be necessary in the future. The primary purpose of uncertainty analysis is to increase transparency regarding all elements of risk assessment and exposure estimation. In particular, uncertainty analysis should enable consumers, decision-makers and stakeholders to better understand risk assessments and to make their own decisions on a well-founded basis. Therefore, the uncertainty analysis should include the subject and question of the assessment, as well as the definition of the required protection goal. Deficits in knowledge about scenarios, models and parameters must also be described in an appropriate manner. This ensures that risk assessments contribute to informed decision-making under conditions of uncertainty.