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Health
20 December 2023

Mapping of Data Requirements and Assessment Methodologies Linked to the Regulatory Frameworks and Remits of the Relevant EU Agencies (ECHA, EFSA and EMA) and EC Scientific Committees (SCCS and SCHEER)

The European Food Safety Authority (EFSA) commissioned RPA Europe and FoBiG to carry out the study ‘Mapping of data requirements and assessment methodologies linked to the regulatory frameworks and remits of the relevant EU Agencies (ECHA, EFSA and EMA) and EC Scientific Committees (Scientific Committee on Consumer Safety, SCCS, and Scientific Committee on Health, Environmental and Emerging Risks, SCHEER)’ (service contract OC/EFSA/FIP/2022/01 managed by the EFSA Unit on Food Ingredients and Packaging). The general objective was to collect and analyse data requirements (DRs) and risk assessment methodologies (RAMs) applied within the regulatory frameworks of EFSA, the European Chemicals Agency (ECHA), the European Medicines Agency (EMA), SCCS and SCHEER. For comparative analysis, a digital data inventory containing 230 records on legal acts, guidance and other documents related to DRs and RAMs was developed. Based on a comparative analysis methodology, the database of DRs and RAMs across different regulatory frameworks was created by extracting information on DRs (with respect to substance identity, physico‐chemical and environmental fate properties as well as ecotoxicity and toxicity and target organism safety) and RAMs (for the environment, human health and target organisms) from relevant documents. The study identified inconsistencies within regulatory areas in some cases, e.g. between legal acts and guidance documents. Furthermore, it found differences between regulatory frameworks in the DRs and RAMs with respect to terminology, general and detailed DRs and RAMs, the quality standards for experimental studies and other issues. Based on the identified differences and the potential for harmonisation across the regulatory frameworks, several recommendations were outlined in the study that involve addressing specific as well as more principal and structural differences.