Table 6 Phase 2 evaluation summary on the adequacy testing of existing guidance documents on production and manufacturing processes. 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 minimised B. subtilis strain expressing a heterologous protein is expected to be grown in the typical fermentation conditions used for bacilli. The downstream processes for the protein purification do not differ from those of enzymes produced in GM strains of B. subtilis.	Adequate	No update needed
2 and 3	The production process of xenobionts (containing XNA and producing xenoproteins) needs the provision of xenocomponents.	Not fully adequate	Update is recommended for xenobionts containing XNA, XNA precursors and producing xenoproteins
4	The Aspergillus oryzae strain is produced following the typical fermentation conditions used for fungi; the organism is killed during downstream processing.	Adequate	No update needed
5	The production of autotrophic yeast is an innovative process requiring adaptations from current fermentation processes.	Adequate	No update needed
6 and 11	The production of cyanobacteria is not covered by the current guidance.	Not fully adequate	Update is recommended for protists/microalgae
10	The production of bacteriophages is not covered by current guidance.	The BIOHAZ Panel guidance (2010) is not detailed and hence not sufficient.	Update is recommended for bacteriophages and can be done based on gained experience
7, 8, 9, 12, 13 and 15	To scale up the production of the engineered strains, regular fermentation conditions are expected to be used.	Adequate	No update needed
14	The production process of plant viruses is covered by Regulation (EU) No 283/2013.	Adequate	No update needed