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Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)
- Source :
- EFSA Journal, Vol 16, Iss 11, Pp n/a-n/a (2018)
- Publication Year :
- 2018
- Publisher :
- Wiley, 2018.
-
Abstract
- The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.027 mg TOS/kg body weight (bw) per day in European populations. 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. In this study, effects were seen in the control group on reproductive parameters (particularly the seminiferous epithelium atrophy in the testes) at incidences that far exceeded the background range. Consequently, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, including haematological parameters and the immunology cohort, was conducted. The Panel identified a no observed adverse effect level at the highest dose tested of 1,101.3 mg TOS/kg bw per day. When compared with the dietary exposure, resulted in a sufficiently high margin of exposure (at least 40,000). 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. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
- Subjects :
- 1,4‐β‐D‐xylan xylanohydrolase
Allergy
No-observed-adverse-effect level
EC 3.2.1.8
Veterinary (miscellaneous)
Developmental toxicity
TP1-1185
Plant Science
Biology
medicine.disease_cause
Microbiology
0404 agricultural biotechnology
medicine
TX341-641
Food science
xylanase
Nutrition. Foods and food supply
business.industry
Chemical technology
04 agricultural and veterinary sciences
Food safety
medicine.disease
040401 food science
food enzyme
endo‐1
Genetically modified organism
4‐β‐xylanase
Toxicity
Xylanase
Animal Science and Zoology
Parasitology
business
Genotoxicity
Food Science
Subjects
Details
- ISSN :
- 18314732
- Volume :
- 16
- Database :
- OpenAIRE
- Journal :
- EFSA Journal
- Accession number :
- edsair.doi.dedup.....4e11f8d2e2ec82305f61ca38eacea15e