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Safety and efficacy of the feed additive consisting of 6‐phytase (produced by Aspergillus oryzaeDSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd).

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Title: Safety and efficacy of the feed additive consisting of 6‐phytase (produced by Aspergillus oryzaeDSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd).
Authors: Bampidis, Vasileios (AUTHOR), Azimonti, Giovanna (AUTHOR), Bastos, Maria de Lourdes (AUTHOR), Christensen, Henrik (AUTHOR), Dusemund, Birgit (AUTHOR), Fašmon Durjava, Mojca (AUTHOR), Kouba, Maryline (AUTHOR), López‐Alonso, Marta (AUTHOR), Puente, Secundino López (AUTHOR), Marcon, Francesca (AUTHOR), Mayo, Baltasar (AUTHOR), Pechová, Alena (AUTHOR), Petkova, Mariana (AUTHOR), Ramos, Fernando (AUTHOR), Sanz, Yolanda (AUTHOR), Villa, Roberto Edoardo (AUTHOR), Woutersen, Ruud (AUTHOR), Aquilina, Gabriele (AUTHOR), Svensson, Kettil (AUTHOR), Zeljezic, Davor (AUTHOR)
Source: EFSA Journal. Jan2023, Vol. 21 Issue 1, p1-14. 14p.
Subject Terms: *Allergens, Swine breeding, Swine farms, Piglets, Feed additives, Animal weaning, Swine, Soybean meal
Abstract: The additive RONOZYME® Hiphos (GT/L) contains 6‐phytase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae, it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 22594 for A. oryzae DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain A. oryzae DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its recombinant DNA were detected in an intermediate product representative of both final forms of the additive. RONOZYME® Hiphos (GT/L) was considered safe for poultry, pigs for fattening, weaned piglets and sows at the recommended inclusion levels of 500–4,000 FYT/kg complete feed. The use of RONOZYME® Hiphos GT and L manufactured with the production strain A. oryzae DSM 33699 raised no concerns for consumers. In the absence of data on the final formulations, the Panel could not conclude on the potential of the additive to be irritant to eyes or skin, or a skin sensitiser. Due to the proteinaceous nature of the active substance, the additive was considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33699 raises no safety concerns for the environment. The additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at 500 FYT/kg complete feed. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Label: Title
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  Data: Safety and efficacy of the feed additive consisting of 6‐phytase (produced by Aspergillus oryzaeDSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd).
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  Data: <searchLink fieldCode="AR" term="%22Bampidis%2C+Vasileios%22">Bampidis, Vasileios</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Azimonti%2C+Giovanna%22">Azimonti, Giovanna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bastos%2C+Maria+de+Lourdes%22">Bastos, Maria de Lourdes</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Christensen%2C+Henrik%22">Christensen, Henrik</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dusemund%2C+Birgit%22">Dusemund, Birgit</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fašmon+Durjava%2C+Mojca%22">Fašmon Durjava, Mojca</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kouba%2C+Maryline%22">Kouba, Maryline</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22López‐Alonso%2C+Marta%22">López‐Alonso, Marta</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Puente%2C+Secundino+López%22">Puente, Secundino López</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Marcon%2C+Francesca%22">Marcon, Francesca</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mayo%2C+Baltasar%22">Mayo, Baltasar</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pechová%2C+Alena%22">Pechová, Alena</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Petkova%2C+Mariana%22">Petkova, Mariana</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ramos%2C+Fernando%22">Ramos, Fernando</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sanz%2C+Yolanda%22">Sanz, Yolanda</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Villa%2C+Roberto+Edoardo%22">Villa, Roberto Edoardo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Woutersen%2C+Ruud%22">Woutersen, Ruud</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Aquilina%2C+Gabriele%22">Aquilina, Gabriele</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Svensson%2C+Kettil%22">Svensson, Kettil</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zeljezic%2C+Davor%22">Zeljezic, Davor</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Jan2023, Vol. 21 Issue 1, p1-14. 14p.
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  Data: *<searchLink fieldCode="DE" term="%22Allergens%22">Allergens</searchLink><br /><searchLink fieldCode="DE" term="%22Swine+breeding%22">Swine breeding</searchLink><br /><searchLink fieldCode="DE" term="%22Swine+farms%22">Swine farms</searchLink><br /><searchLink fieldCode="DE" term="%22Piglets%22">Piglets</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+additives%22">Feed additives</searchLink><br /><searchLink fieldCode="DE" term="%22Animal+weaning%22">Animal weaning</searchLink><br /><searchLink fieldCode="DE" term="%22Swine%22">Swine</searchLink><br /><searchLink fieldCode="DE" term="%22Soybean+meal%22">Soybean meal</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: The additive RONOZYME® Hiphos (GT/L) contains 6‐phytase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae, it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 22594 for A. oryzae DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain A. oryzae DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its recombinant DNA were detected in an intermediate product representative of both final forms of the additive. RONOZYME® Hiphos (GT/L) was considered safe for poultry, pigs for fattening, weaned piglets and sows at the recommended inclusion levels of 500–4,000 FYT/kg complete feed. The use of RONOZYME® Hiphos GT and L manufactured with the production strain A. oryzae DSM 33699 raised no concerns for consumers. In the absence of data on the final formulations, the Panel could not conclude on the potential of the additive to be irritant to eyes or skin, or a skin sensitiser. Due to the proteinaceous nature of the active substance, the additive was considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33699 raises no safety concerns for the environment. The additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at 500 FYT/kg complete feed. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.2903/j.efsa.2023.7698
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