TY - JOUR

T1 - Evaluation of existing guidelines for their adequacy for the food and feed risk assessment of microorganisms obtained through synthetic biology

AU - EFSA Scientific Committee, null

AU - More, Simon John

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Bragard, Claude

AU - Halldorsson, Thorhallur

AU - Hernández-Jerez, Antonio

AU - Bennekou, Susanne Hougaard

AU - Koutsoumanis, Kostas P

AU - Lambré, Claude

AU - Machera, Kyriaki

AU - Mullins, Ewen

AU - Nielsen, Søren Saxmose

AU - Schlatter, Josef

AU - Schrenk, Dieter

AU - Turck, Dominique

AU - Younes, Maged

AU - Herman, Lieve

AU - Pelaez, Carmen

AU - van Loveren, Henk

AU - Vlak, Just

AU - Revez, Joana

AU - Aguilera, Jaime

AU - Schoonjans, Reinhilde

AU - Cocconcelli, Pier Sandro

N1 - https://doi.org/10.2903/j.efsa.2022.7479

PY - 2022/8/16

Y1 - 2022/8/16

N2 - Abstract EFSA was asked by the European Commission to evaluate synthetic biology (SynBio) developments for agri-food use in the near future and to determine whether or not they are expected to constitute potential new hazards/risks. Moreover, EFSA was requested to evaluate the adequacy of existing guidelines for risk assessment of SynBio and if updated guidance is needed. The scope of this Opinion covers food and feed risk assessment, the variety of microorganisms that can be used in the food/feed chain and the whole spectrum of techniques used in SynBio. This Opinion complements a previously adopted Opinion with the evaluation of existing guidelines for the microbial characterisation and environmental risk assessment of microorganisms obtained through SynBio. The present Opinion confirms that microbial SynBio applications for food and feed use, with the exception of xenobionts, could be ready in the European Union in the next decade. New hazards were identified related to the use or production of unusual and/or new-to-nature components. Fifteen cases were selected for evaluating the adequacy of existing guidelines. These were generally adequate for assessing the product, the production process, nutritional and toxicological safety, allergenicity, exposure and post-market monitoring. The comparative approach and a safety assessment per se could be applied depending on the degree of familiarity of the SynBio organism/product with the non-genetically modified counterparts. Updated guidance is recommended for: (i) bacteriophages, protists/microalgae, (ii) exposure to plant protection products and biostimulants, (iii) xenobionts and (iv) feed additives for insects as target species. Development of risk assessment tools is recommended for assessing nutritional value of biomasses, influence of microorganisms on the gut microbiome and the gut function, allergenic potential of new-to-nature proteins, impact of horizontal gene transfer and potential risks of living cell intake. A further development towards a strain-driven risk assessment approach is recommended.

AB - Abstract EFSA was asked by the European Commission to evaluate synthetic biology (SynBio) developments for agri-food use in the near future and to determine whether or not they are expected to constitute potential new hazards/risks. Moreover, EFSA was requested to evaluate the adequacy of existing guidelines for risk assessment of SynBio and if updated guidance is needed. The scope of this Opinion covers food and feed risk assessment, the variety of microorganisms that can be used in the food/feed chain and the whole spectrum of techniques used in SynBio. This Opinion complements a previously adopted Opinion with the evaluation of existing guidelines for the microbial characterisation and environmental risk assessment of microorganisms obtained through SynBio. The present Opinion confirms that microbial SynBio applications for food and feed use, with the exception of xenobionts, could be ready in the European Union in the next decade. New hazards were identified related to the use or production of unusual and/or new-to-nature components. Fifteen cases were selected for evaluating the adequacy of existing guidelines. These were generally adequate for assessing the product, the production process, nutritional and toxicological safety, allergenicity, exposure and post-market monitoring. The comparative approach and a safety assessment per se could be applied depending on the degree of familiarity of the SynBio organism/product with the non-genetically modified counterparts. Updated guidance is recommended for: (i) bacteriophages, protists/microalgae, (ii) exposure to plant protection products and biostimulants, (iii) xenobionts and (iv) feed additives for insects as target species. Development of risk assessment tools is recommended for assessing nutritional value of biomasses, influence of microorganisms on the gut microbiome and the gut function, allergenic potential of new-to-nature proteins, impact of horizontal gene transfer and potential risks of living cell intake. A further development towards a strain-driven risk assessment approach is recommended.

KW - agri-food use

KW - food

KW - feed

KW - genetically modified microorganism (GMM)

KW - guidance

KW - risk assessment

KW - synthetic biology

U2 - 10.2903/j.efsa.2022.7479

DO - 10.2903/j.efsa.2022.7479

M3 - Journal article

C2 - 35991959

VL - 20

SP - 1

EP - 58

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 8

M1 - e07479

ER -