Safety evaluation of a lactase enzyme preparation derived from Kluyveromyces lactis

Coenen, T.M.M.; Bertens, A.M.C; Hoog, S.C.M de; Verspeek-Rip, C.M.

doi:10.1016/s0278-6915(00)00053-3

Cited by 26 publications

(13 citation statements)

References 6 publications

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“…Indeed this biocatalyst presents optimal conditions near those of milk being extracted from dairy yeast. This characteristic makes it safe for use in food systems (GRAS) (34).…”

Section: Methodsmentioning

confidence: 99%

Production of Low-Lactose Milk by Means of Nonisothermal Bioreactors

et al. 2004

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The effect of the immobilization time on the activity of immobilized beta-galactosidase from K. lactis was investigated. Six biocatalytic membranes, different only for the time of the enzyme immobilization, were obtained by using nylon membranes grafted with glycidyl methacrylate (GMA) and activated by hexamethylenediamine (HMDA) and glutaraldehyde (Glu), used as spacer and coupling agent, respectively. Comparison between the isothermal and nonisothermal yield of these biocatalytic membranes was carried out in the process of lactose hydrolysis in milk. All of the results, reported as a function of the immobilization time, have evidenced the influence of our variable parameter on the activity of the catalytic membranes. The membrane giving highest yield under isothermal and nonisothermal conditions was that obtained with 2 h of immobilization time. The industrial application of these membranes has been discussed in terms of percentage reduction of the production times.

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“…Indeed this biocatalyst presents optimal conditions near those of milk being extracted from dairy yeast. This characteristic makes it safe for use in food systems (GRAS) (34).…”

Section: Methodsmentioning

confidence: 99%

Production of Low-Lactose Milk by Means of Nonisothermal Bioreactors

et al. 2004

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“…Kluyveromyces marxianus and K. lactis are associated with 8 smear-ripened cheeses and contribute to the aromas that cheeses develop. These species are considered to be generally regarded as safe organisms and have been approved as a food additive (Coenen, Bertens et al 2000).…”

Section: Is the Body Of Knowledge Sufficient?mentioning

confidence: 99%

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

2007

EFSA Journal

367

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“…The no-observed-adverse-effect level (NOEAL) was determined to be 40 g/kg·BW/day for male and female rats [28]. Coenen reported a lactase enzyme preparation derived from Kluyveromyces lactis that had a one-day NOAEL in the acute toxicity study under 10,000 mg/kg body weight, and the preparation did not induce noticeable signs of toxicity at that dosage, even after 28 days of feeding [37].…”

Section: Discussionmentioning

confidence: 99%

Toxicological Evaluation of Lactase Derived from Recombinant Pichia pastoris

Zou

Liu

et al. 2014

PLoS ONE

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A recombinant lactase was expressed in Pichia pastoris, resulting in enzymatic activity of 3600 U/mL in a 5 L fermenter. The lactase product was subjected to a series of toxicological tests to determine its safety for use as an enzyme preparation in the dairy industry. This recombinant lactase had the highest activity of all recombinant strains reported thus far. Acute oral toxicity, mutagenicity, genotoxic, and subchronic toxicity tests performed in rats and mice showed no death in any groups. The lethal dose 50% (LD50) based on the acute oral toxicity study is greater than 30 mL/kg body weight, which is in accordance with the 1500 L milk consumption of a 50 kg human daily. The lactase showed no mutagenic activity in the Ames test or a mouse sperm abnormality test at levels of up to 5 mg/plate and 1250 mg/kg body weight, respectively. It also showed no genetic toxicology in a bone marrow cell micronucleus test at levels of up to 1250 mg/kg body weight. A 90-day subchronic repeated toxicity study via the diet with lactase levels up to 1646 mg/kg (1000-fold greater than the mean human exposure) did not show any treatment-related significant toxicological effects on body weight, food consumption, organ weights, hematological and clinical chemistry, or histopathology compared to the control groups. This toxicological evaluation system is comprehensive and can be used in the safety evaluation of other enzyme preparations. The lactase showed no acute, mutagenic, genetic, or subchronic toxicity under our evaluation system.

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Safety evaluation of a lactase enzyme preparation derived from Kluyveromyces lactis

Cited by 26 publications

References 6 publications

Production of Low-Lactose Milk by Means of Nonisothermal Bioreactors

Production of Low-Lactose Milk by Means of Nonisothermal Bioreactors

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

Toxicological Evaluation of Lactase Derived from Recombinant Pichia pastoris

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