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Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiaeCBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o).

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Title: Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiaeCBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o).
Authors: Bampidis, Vasileios (AUTHOR), Azimonti, Giovanna (AUTHOR), Bastos, Maria de Lourdes (AUTHOR), Christensen, Henrik (AUTHOR), Dusemund, Birgit (AUTHOR), Durjava, Mojca Fašmon (AUTHOR), Kouba, Maryline (AUTHOR), López‐Alonso, Marta (AUTHOR), López Puente, Secundino (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), Gropp, Jürgen (AUTHOR), Anguita, Montserrat (AUTHOR), Pizzo, Fabiola (AUTHOR)
Source: EFSA Journal. Aug2023, Vol. 21 Issue 8, p1-13. 13p.
Subject Terms: *Allergens, Feed additives, Calcifediol, Swine, Poultry
Company/Entity: European Commission , European Food Safety Authority
Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25‐hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25‐OH‐D3 remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. [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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  Data: Safety and efficacy of a feed additive consisting of 25‐hydroxycholecalciferol produced with Saccharomyces cerevisiaeCBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o).
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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="%22Durjava%2C+Mojca+Fašmon%22">Durjava, Mojca Fašmon</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="%22López+Puente%2C+Secundino%22">López Puente, Secundino</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="%22Gropp%2C+Jürgen%22">Gropp, Jürgen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Anguita%2C+Montserrat%22">Anguita, Montserrat</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pizzo%2C+Fabiola%22">Pizzo, Fabiola</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Aug2023, Vol. 21 Issue 8, p1-13. 13p.
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  Data: *<searchLink fieldCode="DE" term="%22Allergens%22">Allergens</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+additives%22">Feed additives</searchLink><br /><searchLink fieldCode="DE" term="%22Calcifediol%22">Calcifediol</searchLink><br /><searchLink fieldCode="DE" term="%22Swine%22">Swine</searchLink><br /><searchLink fieldCode="DE" term="%22Poultry%22">Poultry</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22European+Commission%22">European Commission</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25‐hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25‐OH‐D3 remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]
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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.2023.8168
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