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. 2022 Aug 16;20(8):e07479. doi: 10.2903/j.efsa.2022.7479

Table 4 Phase 2 evaluation summary on the adequacy testing of existing guidance documents for the categorisation of the GMMs and their products for risk assessment purposes of the EFSA GMO Panel (2011) guidance. Per default the existing guidance refers to the case study Table 3, and if needed an additional guidance is mentioned

Case

Cat.

Specific evaluations of the case, including intended and unintended effects Conclusions on the adequacy of existing guidance Updates recommended for future guidance

1

Cat. 1/2

The absence of viable cells and DNA of the production strain, required by the existing guidance, this is an evaluation criterion that applies to this SynBioM enzyme producer with minimised genome.

Adequate.

It should be noted that Categories 1 and 2 are not distinguished in practice.

Merge Categories 1 and 2 into one single category in future updates of the guidance

2

Cat. 1/2

The antimicrobial xenopeptide contains new‐to‐nature non‐canonical amino acids. The absence of viable cells and DNA of the production strain is the prerequisite to include the products in Cat. 1 or 2.

Adequate.

It should be noted that Categories 1 and 2 are not distinguished in practice.

Merge Categories 1 and 2 into one single category in future updates of the guidance

3

Cat. 1–4

The XNA‐containing bacterial cells may be present in the end‐product; however, the organism is not able to propagate without external addition of xenonucleotides and the XNA is not able to be stabilised after horizontal gene transfer. If absence of viable cells and XNA of the production strain is demonstrated the products falls into Cat. 1 or 2. The absence of viable cells should be demonstrated for Cat. 3. Adequate No update needed

4

Cat. 3

A. oryzae has been modified to improve the soy sauce fermentation. Heat treatment during food processing eliminates viable cells but not DNA. Adequate No update needed

5

Cat. 3

Yeast, able to growth on CO2, can be used for food/feed biomasses production. The absence of viable cells should be demonstrated to accomplish the Cat. 3 requirements. Adequate No update needed

6

Cat. 3

The cyanobacterium metabolism has been refluxed to increase biomass production for food/feed product. The absence of viable cells should be demonstrated to accomplish the Cat. 3 requirements. Adequate No update needed

7

Cat. 4

Engineered viable Leuconostoc citreum bacterium highly expressing riboflavin. The bacterium can be added to fermented bioactive products. Adequate No update needed

8

Cat. 4

Engineered viable Lactococcus lactis bacterium highly expressing GSH and SAM and with increased adhesive capacity. Adequate No update needed

9

Cat. 4

Engineered live Lacticaseibacillus casei bacterium improved in acetoin production to be used in dairy fermentation. Adequate No update needed

10

Cat. 4

To be used as decontaminating agent, being based on viable bacteriophages reprogramed to broaden the host range against Listeria spp. Not fully adequate. Update recommended: This section of the guidance should be extended to include viable bacteriophages

11

Cat. 4

Viable cyanobacterium cells expressing antibodies against Campylobacter spp. Adequate No update needed

12

Cat. 4

Viable Lactococcus lactis expressing viral antigens aimed to improve animal welfare by protecting chickens against IBDV. Adequate No update needed

13

Cat. 4

Viable Pseudomonas simiae, P. putida and Ralstonia sp. cells able to improve P‐solubilisation in soil at the root level. Adequate No update needed

14

Cat.4

Viable CTV expressing dsRNA in the phloem of plants aimed to inactivate an insect vector of a plant pest. Adequate No update needed

15

Cat.4

Snodgrassella alvi colonisation of the gut of the honeybee as defence against infections with the DWV virus and the Varroa mite. Adequate No update needed