Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use

Andersson, Hans; Arpaia, Salvatore; Bartsch, Detlef K.; Casacuberta, Josep; Davies, Howard V.; Jardin, Patrick du; Flachowsky, Gerhard; Herman, Lieve; Jones, Huw; Kärenlampi, Sirpa; Kiss, J.; Kleter, Gijs; Kuiper, H.A.; Messéan, Antoine; Nielsen, Kaare M.; Perry, J. N.; Pöting, Annette; Sweet, Jeremy; Tebbe, Christoph C.; Wal, Jean‐Michel

doi:10.2903/j.efsa.2011.2193

Cited by 189 publications

(78 citation statements)

References 9 publications

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“…The Panel considered that in line with the guidance on genetically modified microorganisms (GMO Panel, 2011) there were no safety concerns for consumers from the genetic modification described.…”

Section: Discussionmentioning

confidence: 99%

“…Safety aspects of the genetic modification: Information relating to the GMM and comparison of the GMM with its conventional Overall, the Panel considered that in line with the guidance on genetically modified microorganisms (GMO Panel, 2011) there were no safety concerns from the genetic modification described.…”

Section: Description Of the Genetic Modification Processmentioning

confidence: 99%

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Scientific Opinion on the safety of the change in the production method of L-glutamic acid (E620), monosodium L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-L-glutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-glutamate

2015

EFSA Journal

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European Food Safety Authority (EFSA), Parma, Italy ABSTRACTThe Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion evaluating the safety of the change in the production method for the production of L-glutamic acidThe L-glutamic acid is produced by the genetically modified Corynebacterium glutamicum EA-12 strain. The recipient strain Corynebacterium glutamicum strain 2256 has been recommended for Qualified Presumption of Safety (QPS) status. No antibiotic resistance genes were left in the genome and neither the production strain nor its recombinant DNA were detected in the final product. The Panel considered there were no safety concerns for consumers from the genetic modification. The proposed uses or use levels of L-glutamic acid and its salt derivatives produced with the current strain and the new genetically modified microorganism (GMM) strain will be identical and thus the Panel considered that the exposure to the food additive will remain unaffected. Provided that the L-glutamic acid and its salts both produced with the current strain and with the GMM strain are equal in the specifications and physicochemical characteristics, the biological and toxicological data for the L-glutamic acid and its salts produced with the current strain are considered by the Panel to support the safety of the food additives produced with the GMM strain. The Panel concluded that there are no safety concerns from the change in the production method of the food additives L-glutamic acid (E620), monosodium L- Safety of the change in the production method of glutamates (E 620-E 625)EFSA Journal 2015;13(1):3981 2 SUMMARYThe European Commission requests the European Food Safety Authority to provide a scientific opinion on the safety of the change in the production method for the production of L-glutamic acid (E620), monosodium L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-Lglutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-(E625) in accordance with Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.The L-glutamic acid considered in the present opinion is produced by the genetically modified Corynebacterium glutamicum EA-12 strain. The recipient strain Corynebacterium glutamicum strain 2256 has been recommended for QPS (Qualified Presumption of Safety) status. No antibiotic resistance genes were left in the genome due to the genetic modification. The Panel noted that neither the production strain nor its recombinant DNA were detected in the final product.The Panel considered that in line with the guidance on genetically modified microorganisms (GMO Panel, 2011) there were no safety concerns for consumers from the genetic modification described.The information provided by the applicant on the manufacturing of the food additives, i.e. the fermentation conditions and the steps employed for isolation and purification, was considered sufficient. The available compositional...

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Section: Discussionmentioning

confidence: 99%

Section: Description Of the Genetic Modification Processmentioning

confidence: 99%

Scientific Opinion on the safety of the change in the production method of L-glutamic acid (E620), monosodium L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-L-glutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-glutamate

2015

EFSA Journal

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“…The approach followed by the FEEDAP Panel to assess the safety of concentrated liquid L-lysine (base), L-lysine monohydrochloride and L-lysine sulfate (solid or liquid) is in line with the principles laid down in Regulation (EC) No 429/2008 7 and the relevant guidance documents: Guidance on nutritional additives (EFSA FEEDAP Panel, 2012a), Guidance for establishing the safety of additives for the consumer (EFSA FEEDAP Panel, 2012b), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012c), Guidance on the assessment of bacterial resistance to antibiotics of human or veterinary importance (EFSA FEEDAP Panel, 2012d), Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018), Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (EFSA GMO Panel, 2011) and Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (EFSA BIOHAZ Panel, 2013, 2017.…”

Section: Methodologiesmentioning

confidence: 99%

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Additives¹,

Bampidis²,

Azimonti³

et al. 2019

EFS2

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The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP or C. glutamicum KCCM 11117P; and l‐lysine HCl produced by C. glutamicum NRRL B‐50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP, C. glutamicum NRRL B‐50547 or C. glutamicum KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l‐Lysine HCl is not hazardous by inhalation. The use of C. glutamicum DSM 24990 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5–30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of C. glutamicum KCCM 10227 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies.

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“…The possible presence is a concern because such DNA, which may carry antibiotic resistance genes that could be present on plasmids, might be transferred to pathogenic bacteria present in the environment, including the animal gut. Moreover, if viable production strain cells or its recombinant genes were present in the product, its environmental impact should be assessed according to the 'Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use' (EFSA GMO Panel, 2011). Therefore, the EFSA FEEDAP Panel cannot conclude on the environmental safety of the product L-Threonine from E. coli DSM 26131, associated with the genetic modification.…”

Section: Safety For the Environmentmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of l‐threonine produced by Escherichia coli strains NRRL B‐30843, DSM 26131, KCCM11133P or DSM 25085 for all animal species based on a dossier submitted by AMAC EEIG

Feed¹

2015

EFS2

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This opinion concerns L-threonine as a feed additive produced by four different strains derived from Escherichia coli K-12. Three strains are genetically modified (GM): NRRL B-30843, KCCM11133P and DSM 26131. L-Threonine produced by E. coli DSM 26131 could not be assessed because of the insufficient molecular characterisation of the genetic modification, and the lack of data on both the absence of the production strain and its recombinant DNA from the final product. No safety concerns were found in the products related to the genetic modification of the other GM strains or to antibiotic resistance of the producer strains. L-Threonine products made by fermentation using E. coli strains NRRL B-30843, KCCM11133P and DSM 25085 are free of the production strain and have a high purity (≥ 98.8 %). L-Threonine, technically pure, produced by E. coli strains NRRL B-30843, KCCM11133P and DSM 25085 is safe for the target animals when used in appropriate amounts to supplement threonine-deficient feeds, for the consumer of animal products and for the environment. The FEEDAP Panel considers that L-threonine produced by E. coli strains NRRL B-30843, KCCM11133P or DSM 25085 is not an irritant to eyes and skin, and is not a skin sensitiser. There is no risk from inhalation of L-threonine, but concerns may arise from the content of endotoxins in the products. These L-threonine products are considered an efficacious source of the amino acid L-threonine for all animal species. For L-threonine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns regarding the safety of the simultaneous oral administration of L-threonine via water for drinking and feed. L-Threonine is an essential amino acid for all animal species. It is commonly considered the second and third limiting amino acid in cereal-based diets for pigs and poultry, respectively. It is widely used in the feed industry to optimise dietary protein.Three of the strains are GM: E. coli NRRL B-30843, E. coli DSM 26131 and E. coli KCCM11133P. The final product obtained from E. coli strain NRRL B-30843 contains no cultivable production organisms or recombinant DNA. The product from E. coli strain KCCM11133P contains no cultivable production organisms, but the possible presence of fragments spanning the full length of recombinant genes cannot be ruled out. However, no genes of concern remain in the production strain KCCM11133P. No safety concerns were found in these two products related to the genetic modification. The genetic modification of E. coli DSM 26131 and its possible consequences for the product could not be assessed because of insufficient data.L-Threonine products made by fermentation with E. coli strains NRRL B-30843, KCCM11133P or DSM 25085 are free of the production strain and have a high purity (≥ 98.8 %). No recombinant DNA could be detected in L-threonine produced by fermentation of the GM strains E. col...

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Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use

Cited by 189 publications

References 9 publications

Scientific Opinion on the safety of the change in the production method of L-glutamic acid (E620), monosodium L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-L-glutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-glutamate

Scientific Opinion on the safety of the change in the production method of L-glutamic acid (E620), monosodium L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-L-glutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-glutamate

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Scientific Opinion on the safety and efficacy of l‐threonine produced by Escherichia coli strains NRRL B‐30843, DSM 26131, KCCM11133P or DSM 25085 for all animal species based on a dossier submitted by AMAC EEIG

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