Table 2.

Table summarising the areas of assessment for the QPS approach and for each EFSA food and feed safety risk assessment area when microorganisms are considered

QPS assessment remit	Feed area assessment remita	Food Ingredients area assessment remitb	Pesticides area assessment remitc	Nutrition area assessment remitd
1. Identity: taxonomy identification parameters	Verification of species and strain Certificate of deposit in a culture collection	Verification of species and strain Certificate of deposit in a culture collection	Verification of species and strain Certificate of deposit in a culture collection	Verification of species and strain Certificate of deposit in a culture collection (for Health Claims and Novel Foods (NF))
2.1. Body of Knowledge: history of safe use in the food and feed chain	Other authorisations and uses Description of the genetic modifications Confirm genetic stability	Other authorisations of the same strain lineage Description of the genetic modifications Confirm genetic stability	Proposed uses Historical background Organisms genetically modified should comply to the GMO Regulation Confirm genetic stability	History of safe use (for NF)
2.2 Body of Knowledge: general ecology/distribution in ecosystems	Origin to be declared Production of antimicrobial compounds	Production of antimicrobial compounds	Origin (geographical and place in the ecosystem) and natural occurrence (if possible at strain level) Ability to colonise available niches Production of antimicrobial compounds	Out of the scope of the specific Regulation
3.1. Safety concerns: virulence/pathogenicity/toxigenicity for humans	Pathogenicity potential and virulence factors Production of toxins and toxic secondary metabolites	Pathogenicity potential and virulence factors Production of toxins and toxic secondary metabolites	Pathogenicity potential and virulence factors Possible toxicity of secondary metabolites	Pathogenicity potential and virulence factors (for NF)
3.2. Safety concerns: virulence/pathogenicity/toxigenicity for animals (domestic and wild)	Pathogenicity potential and virulence factors Production of toxins and toxic secondary metabolites	Out of the scope of the specific Regulation	Adverse effects of organism or metabolites on non‐target animals (in the environment)	Out of the scope of the specific Regulation
3.3. Safety concerns: virulence/pathogenicity for plants	Out of the scope of the specific Regulation	Out of the scope of the specific Regulation	Adverse effects of organism or metabolites on non‐target vascular plants and algae (in the environment)	Out of the scope of the specific Regulation
3.4. Safety concerns: antimicrobial resistance	Verification of the absence of antimicrobial resistance associated with acquired genes	Verification the of absence of antimicrobial resistance associated with acquired genes	Verification of the absence of antimicrobial resistance and of possible transfer of genes coding for resistance	Verification of the absence of antimicrobial resistance associated with acquired genes (for NF)
3.5. Safety concerns: environmental safety	Genetically modified microorganisms (GMMs): deliberate release GMMs: the absence of viable cells GMMs: the absence of recombinant DNA Effect on water and soil	Not direct applicable within Food Enzymes legislation: Microorganisms used for production purposes, including GMMs: the absence of viable cells GMMs: the absence of recombinant DNA	Risk for non‐target organisms (which are not vertebrate animals or plants), arising from exposure to the microorganism and its secondary metabolites remaining in or on plants or plant products, in soil water and air	Out of the scope of the specific Regulation
4.1. End use: intended exposure to viable cells of animals and consumers	Tolerance studies in target animals Toxicological studies in vitro and in laboratory animals	Not direct applicable within Food Enzymes legislation: Microorganisms used for production purposes, including GMMs: the absence of viable cells GMMs: the absence of recombinant DNA	End use is intended exposure of a target organism, i.e. organisms that are: 1) pathogenic to or damage/consume plants or plant commodities; or 2) unwanted plants (weeds). Efficacy investigations are required for these purposes	Intended exposure of viable cells to consumers (for NF)
4.2. End use: enzymes/metabolites producer: no or limited exposure to viable cells	Microorganisms used for production purposes, including GMMs: absence of viable cells GMMs: absence of recombinant DNA Tolerance studies in target animals Toxicological studies in vitro and in laboratory animals	Microorganisms used for production purposes, including GMMs: absence of viable cells GMMs: absence of recombinant DNA	When there are no viable cells in a plant protection product then it is regulated as a chemical (not a microorganism) even if it was produced by microbial fermentation	(for NF)

GMM: genetically modified microorganisms; NF: novel food.

^aBased on the specific Feed Regulation (EC) No 1831/2003 and Regulation (EC) No 429/2008.

^bBased on the specific FIP/GMMs Regulation: absence of recombinant DNA (under Reg. 1829/2003).

^cBased on the specific Pesticides Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

^dBased on the specific Health Claims Regulation (EU) No 1924/2006 and Novel foods Regulation (EU) 2015/2283.