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Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG).

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Title: Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG).
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), Galobart, Jaume (AUTHOR), Pettenati, Elisa (AUTHOR), Ortuño, Jordi (AUTHOR)
Source: EFSA Journal. Jan2023, Vol. 21 Issue 1, p1-15. 15p.
Subject Terms: *Allergens, Feed additives, Piglets, Chickens, Aspergillus, Swine breeding, Television networks
Company/Entity: European Commission , European Food Safety Authority
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 endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not rise concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on its potential as a dermal sensitiser. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel concluded that the additive is efficacious as a zootechnical additive in chickens for fattening and weaned piglets at the minimum recommended level of 10 FBG/kg 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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  Data: Safety and efficacy of a feed additive consisting of endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG).
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Jan2023, Vol. 21 Issue 1, p1-15. 15p.
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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="%22Piglets%22">Piglets</searchLink><br /><searchLink fieldCode="DE" term="%22Chickens%22">Chickens</searchLink><br /><searchLink fieldCode="DE" term="%22Aspergillus%22">Aspergillus</searchLink><br /><searchLink fieldCode="DE" term="%22Swine+breeding%22">Swine breeding</searchLink><br /><searchLink fieldCode="DE" term="%22Television+networks%22">Television networks</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>
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  Label: Abstract
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  Data: 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 endo‐1,3(4)‐beta‐glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not rise concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on its potential as a dermal sensitiser. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel concluded that the additive is efficacious as a zootechnical additive in chickens for fattening and weaned piglets at the minimum recommended level of 10 FBG/kg feed. [ABSTRACT FROM AUTHOR]
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  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.2023.7703
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