Safety evaluation of the food enzyme β-amylase from genetically modified Bacillus licheniformis strain NZYM-JA

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Safety evaluation of a β-amylase food enzyme obtained from wheat (Triticum spp.)

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Safety evaluation of the food enzyme endo-1,4-β-xylanase from genetically modified Aspergillus niger strain XYL

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Safety evaluation of the food enzyme α-amylase from a genetically modified Aspergillus niger (strain NZYM-SB)

Acknowledgements: The Panel wishes to thank EFSA staff members: Jaime Aguilera, Ana Gomes,Christine Horn, Joaquim Maia and Annamaria Rossi for the support provided to this scientic outputPublisher PD

Safety evaluation of the food enzyme β-galactosidase from the genetically modified Escherichia coli NCIMB 30325

Abstract The food enzyme is a β‐galactosidase (β‐D‐galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modified Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The β‐galactosidase encoding gene is introduced into the recipient strain of E. coli using a self‐replicating plasmid which also contains a gene, which confers resistance to an antibiotic listed as a critically important antimicrobial. This gene was detected in the food enzyme. The absence of viable cells of the production strain in the food enzyme was not demonstrated. The food enzyme is intended to be used only for the production of a mixture of galacto‐oligosaccharides (GOS). Genotoxicity tests did not raise a safety concern. Subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 900 mg total organic solids (TOS)/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Given the risk associated with the presence of antibiotic resistance gene in the food enzyme and the lack of data showing the absence of viable cells, the Panel concludes that the use of β‐galactosidase produced with the genetically modified E. coli NCIMB 30325 cannot be considered safe

Safety evaluation of the food enzyme trypsin from porcine pancreas

The food enzyme trypsin (EC 3.4.21.4) is extracted from porcine pancreas by Ningbo Linzyme Biosciences Co., Ltd. It is intended to be used for the hydrolysis of whey proteins for use in infant formulae and follow‐on formulae. Based on maximum use levels and the maximum permitted protein content in infant formula, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 16.8 mg TOS/kg body weight (bw) per day for infants. In the toxicological evaluation, clinical studies with pancreatic enzymes were considered. Hypersensitivity to the pharmaceuticals was identified as the major side effect. However, allergic reactions to porcine pancreatic enzymes in hydrolysed foods have not been reported. The Panel considered that a risk of allergic sensitisation to this food enzyme after consumption of products prepared by hydrolysis of milk proteins could not be excluded in infants, but it considered the likelihood to be low. Based on the origin of the food enzyme from an edible tissue of pigs, the data provided by the applicant, the information from the evaluation of clinical studies based on pancreatic enzymes and the estimated dietary exposure, the Panel concluded that the trypsin from porcine pancreas does not give rise to safety concerns under the intended conditions of use

Scientific Opinion on the safety evaluation of the food enzyme endo-polygalacturonase from the genetically modified Aspergillus luchuensis strain FLYSC

The food enzyme endo‐polygalacturonase ((1→4)‐α‐d‐galacturonan glycanohydrolase; EC 2.3.1.15), is produced with the genetically modified Aspergillus luchuensis strain FLYSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in fruit and vegetable processing for juice production. Based on the maximum use level, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.138 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 800 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 5,800. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded for individuals sensitised to cedar or grass pollen or maize. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use

Scientific Opinion on the safety evaluation of the food enzyme catalase from porcine liver

The food enzyme catalase (EC 1.11.1.6) is obtained from porcine liver by Laboratorios Arroyo S.A. It is intended to be used in a broad range of food processes. The Panel noted that the manufacturing process involved the use of a solvent not permitted in the production of food ingredients which include food enzymes. In addition, the evidence provided showed that the manufacturing process could not be guaranteed to inactivate viruses originating from the starting material, including the human zoonotic pathogen Hepatitis E virus. Consequently, the Panel concluded that the use of catalase extracted from porcine liver may present a health risk