Table 11 Phase 2 evaluation summary on the adequacy testing of existing guidance documents for allergenicity. Per default the existing guidance refers to the case study Table 3, and if needed an additional guidance is mentioned

Case	Specific evaluations of the case, including intended and unintended effects	Conclusions on the adequacy of existing guidance	Updates recommended for future guidance
1	The allergenicity potential of the heterologous protein produced by the minimised genome B. subtilis strain can be assessed using the approach developed for food enzymes and GMMs.	Adequate	No updates needed
2 and 3	The XNA and xenoproteins could trigger allergic reactions.	Not fully adequate	Research is needed for allergenicity assessment of new‐to‐nature products
4	Killed SynBio Aspergillus oryzae cells remain in the product which are not belonging to a normal diet.	Adequate	No update needed
5	The biomass contains SynBio yeast cells that may be present in normal diets; the autotrophic nature would not be expected to trigger extra allergenic reactions.	Adequate	No update needed
6, 11 and 13	The product contains SynBio cyanobacteria (biomass or viable cells) that are not belonging to a normal diet.	Adequate	No update needed
7–9	The strains engineered in these cases do not introduce new proteins and therefore, they are not expected to trigger allergenic reactions.	Adequate	No update needed
10	Bacteriophages: the potential for allergenicity can be tested with bioinformatics.	Adequate	No update needed
12	Lactococcus lactis chassis is commonly consumed as part of the normal diet. The heterologous protein contains part of a viral and Salmonella antigens.	Adequate	No update needed
14	Oral intake of the plant virus expressing dsRNA needs to be assessed but is not expected to trigger allergenicity by humans or animals. The amount of RNAs taken up and absorbed after oral ingestion is considered negligible (EFSA 2014, EFSA 2018).	Adequate	No update needed
15	The honey is expected to contain the Snodgrassella alvi bacterium expressing dsRNA, similarly as is the natural strain. The dsRNA is not expected to be present in honey.	Adequate	No update needed