Table 1.

Methodology of the SynBioM FF WG to address the Terms of Reference of the mandate

	Phase 1 evaluation	Phase 2 evaluation	Phase 3 evaluation
Aim	ToRs 2 and 3: Evaluation, section by section, of the adequacy and applicability of available risk assessment approaches for current and near‐future SynBioM developments and to identify potential new hazards	ToRs 2 and 3: Test the adequacy of existing guidance documents in a realistic/most relevant scenario and identify potential new hazards	ToR4: Perform an overall gap analysis that could not be captured by the previous phases
Approach	Analysis of existing EFSA guidances and underlying EU legislation, having a broad spectrum of microorganisms and applications in mind	Identification and selection of case studies focusing on the current status of SynBioM developments. In total, 15 cases were selected to challenge the existing guidelines and to identify possible limitations	Identification of gaps disconnected from the existing guidance documents listed in Section 2.3 or disconnected from the selected cases
Outcome	Table 2 and Section 3	Section 2.2 The results of Phase 2 are prevalently presented in table format after each section in Section 3. It is underlined that these findings do not represent an in‐depth and comprehensive risk assessment of the (hypothetical) cases.	Outlooks for the future in Section 4