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Safety and efficacy of Nutrase P (6-phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds
- Source :
- EFSA Journal, EFSA Journal, Vol 18, Iss 11, Pp n/a-n/a (2020)
- Publication Year :
- 2020
-
Abstract
- Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.
- Subjects :
- safety
040301 veterinary sciences
Veterinary (miscellaneous)
efficacy
Plant Science
TP1-1185
010501 environmental sciences
Biology
medicine.disease_cause
01 natural sciences
Microbiology
law.invention
0403 veterinary science
Amp resistance
law
Ornamental plant
medicine
TX341-641
Food science
0105 earth and related environmental sciences
6‐phytase
Strain (chemistry)
Nutrition. Foods and food supply
Chemical technology
poultry
A protein
04 agricultural and veterinary sciences
Genetically modified organism
zootechnical additives
Scientific Opinion
Recombinant DNA
Animal Science and Zoology
Parasitology
Phytase
Genotoxicity
Food Science
Subjects
Details
- ISSN :
- 18314732
- Volume :
- 18
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- EFSA journal. European Food Safety Authority
- Accession number :
- edsair.doi.dedup.....593c922ce48177c98aaf79841cc54f15