Safety and efficacy of l‐cysteine hydrochloride monohydrate produced by fermentation using Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a flavouring additive for all animal species

flavouring additive, l‐cysteine monohydrochloride monohydrate, Escherichia coli KCCM 80180, Escherichia coli KCCM 80181, feed additive
First published in the EFSA Journal
10 février 2020
Adopted
10 janvier 2020
Type
Scientific Opinion

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Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of l‐cysteine monohydrochloride monohydrate produced by fermentation using two genetically modified strains of Escherichia coli K12 (Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181) as a flavouring additive for all animal species. No safety concerns are derived from the use of these strains as production strains of the additive. The FEEDAP Panel concludes that l‐cysteine hydrochloride monohydrate, produced by E.coli KCCM 80180 and KCCM 80181 at concentrations up to 25 mg/kg complete feed, is safe for the target species, for the consumer and for the environment. The product is proposed to be classified as respiratory irritant; however, exposure by inhalation is unlikely. l‐Cysteine hydrochloride monohydrate produced by E.coli KCCM 80180 and E.coli KCCM 80181 was shown to be a skin and eye irritant but not a skin sensitiser. Since l‐cysteine hydrochloride monohydrate is used in food as flavouring, it is to be expected that it can provide a similar function in feed and no further demonstration of efficacy is necessary when used at concentrations up to 25 mg/kg complete feed and the corresponding concentration in water.

Substances
L-Cysteine hydrochloride monohydrate
Cas: 7048-04-6
Inchi: InChI=1S/C3H7NO2S.ClH.H2O/c4-2(1-7)3(5)6;;/h2,7H,1,4H2,(H,5,6);1H;1H2/t2-;;/m0../s1
Iupac: (2R)-2-amino-3-sulfanylpropanoic acid;hydrate;hydrochloride
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6003
EFSA Journal 2020;18(2):6003
Question Number
On request from
European Commission