Guidance on protocol development for EFSA generic scientific assessments

Abstract

EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and subquestions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; andnot covered in this guidancegenerating empirical evidence ex novo. The guidance is complemented by a standalone 'template' for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.

Re‐evaluation of certain aspects of the EFSA Scientific Opinion of April 2010 on risk assessment of parasites in fishery products, based on new scientific data. Part 1: ToRs1–3

“…The planning of the methods for conducting the assessment (‘how’) consists of specifying the evidence needs and the methods for answering each AQ, including the uncertainty analysis. Protocol development followed the draft framework for protocol development for EFSA's scientific assessments (EFSA Scientific Committee, 2023 ).…”

Guidance on risk–benefit assessment of foods

“…Application of other EFSA Guidance is advised as relevant to the context of the assessment, such as protocol development, combined exposure to multiple chemicals (Mixtures), Read‐across, Benchmark Dose modelling, Uncertainty assessment, etc. (EFSA Scientific Committee, 2018 , 2021b , 2022 , 2023 ).…”

“…Before embarking on the assessment of risks and benefits, the assessor(s) is advised to clarify and define the scope of the assessment in the process of problem formulation. If RBA is performed in a regulatory context, 17 the assessor should consult the risk–benefit manager in an iterative manner during this preparatory phase (EFSA Scientific Committee, 2023 ). In such a case, a tiered approach offers a versatile strategy to proceed through an RBA according to needs and data availability.…”

“…number of food components (e.g. contaminants, nutrients), foods to be assessed, as well as the intake scenarios, in line with EFSA Guidance on protocol development (EFSA Scientific Committee, 2023 ).…”

BSE risk posed by ruminant collagen and gelatine derived from bones

“…For more details, the EU summary report on TSE can be consulted. The latest edition was published in 2023 (EFSA, 2023 ). The EU summary report includes data from the 27 Member States (MS, EU27), the United Kingdom (in respect of Northern Ireland), plus eight non‐EU reporting countries: Bosnia and Herzegovina, Iceland, Montenegro, North Macedonia, Norway, Serbia, Switzerland and Turkey.…”