Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs

Abstract The additive Ronozyme® HiPhos M/L is a preparation of 6‐phytase produced by a genetically modified strain of Aspergillus oryzae. It is intended to be used as a zootechnical feed additive for poultry and pigs. The final enzyme preparation contains no cultivable production organisms or recomb...

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Main Author: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO)
Format: Article
Language:English
Published: Wiley 2012-01-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2012.2527
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO)
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO)
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO)
collection DOAJ
description Abstract The additive Ronozyme® HiPhos M/L is a preparation of 6‐phytase produced by a genetically modified strain of Aspergillus oryzae. It is intended to be used as a zootechnical feed additive for poultry and pigs. The final enzyme preparation contains no cultivable production organisms or recombinant DNA, given the limits of detection. Based on the trials provided, it was concluded that Ronozyme® HiPhos is safe for chickens for fattening, turkeys for fattening, laying hens, weaned piglets and sows when used at the maximum recommended dose. This conclusion can be extended to all poultry species and pigs for fattening. The fermentation product is non‐genotoxic and there are no concerns for consumer safety. It is not an irritant to skin or eye but in the absence of data should be treated as a skin sensitiser. Since the additive is practically dust free, respiratory exposure from the solid preparation is unlikely. The liquid formulation is only used in contained environments. The active substance of Ronozyme® HiPhos M/L is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risks for the environment are expected and no further environmental risk assessment is required. The additive has the potential to improve phosphorus utilization in all poultry at the minimum dose of 500 FYT/kg complete feed, as demonstrated in short‐term trials with chickens and turkeys for fattening, and laying hens. Improved phosphorus utilization was also seen in weaned piglets and pigs for fattening at the minimum dose of 500 FYT/kg complete feed, and at the minimum dose of 1000 FYT/kg complete feed for sows. The use of the additive allows the use of diets with a lower level of inorganic phosphorus, which may in turn reduce the excretion of phosphorus.
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spelling doaj-art-e8c09013ebf44c27a1e62593fdb584d42025-08-20T02:48:51ZengWileyEFSA Journal1831-47322012-01-01101n/an/a10.2903/j.efsa.2012.2527Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigsEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO)Abstract The additive Ronozyme® HiPhos M/L is a preparation of 6‐phytase produced by a genetically modified strain of Aspergillus oryzae. It is intended to be used as a zootechnical feed additive for poultry and pigs. The final enzyme preparation contains no cultivable production organisms or recombinant DNA, given the limits of detection. Based on the trials provided, it was concluded that Ronozyme® HiPhos is safe for chickens for fattening, turkeys for fattening, laying hens, weaned piglets and sows when used at the maximum recommended dose. This conclusion can be extended to all poultry species and pigs for fattening. The fermentation product is non‐genotoxic and there are no concerns for consumer safety. It is not an irritant to skin or eye but in the absence of data should be treated as a skin sensitiser. Since the additive is practically dust free, respiratory exposure from the solid preparation is unlikely. The liquid formulation is only used in contained environments. The active substance of Ronozyme® HiPhos M/L is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risks for the environment are expected and no further environmental risk assessment is required. The additive has the potential to improve phosphorus utilization in all poultry at the minimum dose of 500 FYT/kg complete feed, as demonstrated in short‐term trials with chickens and turkeys for fattening, and laying hens. Improved phosphorus utilization was also seen in weaned piglets and pigs for fattening at the minimum dose of 500 FYT/kg complete feed, and at the minimum dose of 1000 FYT/kg complete feed for sows. The use of the additive allows the use of diets with a lower level of inorganic phosphorus, which may in turn reduce the excretion of phosphorus.https://doi.org/10.2903/j.efsa.2012.2527Ronozyme® HiPhosphytasesafetyefficacygenetically modified microorganismspoultry
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and EFSA Panel on Genetically Modified Organisms (GMO)
Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs
EFSA Journal
Ronozyme® HiPhos
phytase
safety
efficacy
genetically modified microorganisms
poultry
title Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs
title_full Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs
title_fullStr Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs
title_full_unstemmed Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs
title_short Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6‐phytase) as a feed additive for poultry and pigs
title_sort scientific opinion on the safety and efficacy of ronozyme r hiphos m l 6 phytase as a feed additive for poultry and pigs
topic Ronozyme® HiPhos
phytase
safety
efficacy
genetically modified microorganisms
poultry
url https://doi.org/10.2903/j.efsa.2012.2527
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