Following a request from the European Commission, the EFSA 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 the product EnzaPro containing viable cells/spores of strains of Bacillus velezensis (DSM 21836) and Bacillus licheniformis (ATCC 53757) and an endo-1,4-β-xylanase produced by a genetically modified strain of Komagataella phaffii (DSM 33574) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The strains B. velezensis DSM 21836 and B. licheniformis ATCC 53757 were considered to meet the qualified presumption of safety (QPS) requirements. The K. phaffii xylanase production strain is genetically modified. No viable cells and no recombinant DNA of the genetically modified production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the xylanase production strain. EnzaPro is safe for all poultry species for fattening or reared to the point of lay at the proposed conditions of use. The FEEDAP Panel concluded that the use of EnzaPro in animal nutrition is safe for the consumers and the environment. EnzaPro is not a skin irritant but should be considered an eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. Due to the lack of data, the FEEDAP Panel could not conclude on the efficacy of EnzaPro for the target species. EnzaPro is compatible with diclazuril, halofuginone and nicarbazin.

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Komagataella phaffii DSM 33574, and viable spores of Bacillus velezensis DSM 21836 and Bacillus licheniformis ATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.) / Bampidis V.; Azimonti G.; Bastos M.D.L.; Christensen H.; Dusemund B.; Fasmon Durjava M.; Kouba M.; Lopez-Alonso M.; Lopez Puente S.; Marcon F.; Mayo B.; Pechova A.; Petkova M.; Ramos F.; Sanz Y.; Villa R.E.; Woutersen R.; Dierick N.; Glandorf B.; Martelli G.; Anguita M.; Brozzi R.; Galobart J.; Ortuno J.; Pettenati E.. - In: EFSA JOURNAL. - ISSN 1831-4732. - ELETTRONICO. - 20:10(2022), pp. e07606.1-e07606.16. [10.2903/j.efsa.2022.7606]

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Komagataella phaffii DSM 33574, and viable spores of Bacillus velezensis DSM 21836 and Bacillus licheniformis ATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.)

Martelli G.;
2022

Abstract

Following a request from the European Commission, the EFSA 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 the product EnzaPro containing viable cells/spores of strains of Bacillus velezensis (DSM 21836) and Bacillus licheniformis (ATCC 53757) and an endo-1,4-β-xylanase produced by a genetically modified strain of Komagataella phaffii (DSM 33574) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The strains B. velezensis DSM 21836 and B. licheniformis ATCC 53757 were considered to meet the qualified presumption of safety (QPS) requirements. The K. phaffii xylanase production strain is genetically modified. No viable cells and no recombinant DNA of the genetically modified production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the xylanase production strain. EnzaPro is safe for all poultry species for fattening or reared to the point of lay at the proposed conditions of use. The FEEDAP Panel concluded that the use of EnzaPro in animal nutrition is safe for the consumers and the environment. EnzaPro is not a skin irritant but should be considered an eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. Due to the lack of data, the FEEDAP Panel could not conclude on the efficacy of EnzaPro for the target species. EnzaPro is compatible with diclazuril, halofuginone and nicarbazin.
2022
Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Komagataella phaffii DSM 33574, and viable spores of Bacillus velezensis DSM 21836 and Bacillus licheniformis ATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.) / Bampidis V.; Azimonti G.; Bastos M.D.L.; Christensen H.; Dusemund B.; Fasmon Durjava M.; Kouba M.; Lopez-Alonso M.; Lopez Puente S.; Marcon F.; Mayo B.; Pechova A.; Petkova M.; Ramos F.; Sanz Y.; Villa R.E.; Woutersen R.; Dierick N.; Glandorf B.; Martelli G.; Anguita M.; Brozzi R.; Galobart J.; Ortuno J.; Pettenati E.. - In: EFSA JOURNAL. - ISSN 1831-4732. - ELETTRONICO. - 20:10(2022), pp. e07606.1-e07606.16. [10.2903/j.efsa.2022.7606]
Bampidis V.; Azimonti G.; Bastos M.D.L.; Christensen H.; Dusemund B.; Fasmon Durjava M.; Kouba M.; Lopez-Alonso M.; Lopez Puente S.; Marcon F.; Mayo B.; Pechova A.; Petkova M.; Ramos F.; Sanz Y.; Villa R.E.; Woutersen R.; Dierick N.; Glandorf B.; Martelli G.; Anguita M.; Brozzi R.; Galobart J.; Ortuno J.; Pettenati E.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/908461
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