Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd).
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| Title: | Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd). |
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| Authors: | Bampidis, Vasileios, Azimonti, Giovanna, de Lourdes Bastos, Maria, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca Fašmon, Kouba, Maryline, López-Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Aquilina, Gabriele, Bories, Georges, Brantom, Paul George |
| Source: | EFSA Journal. Nov2021, Vol. 19 Issue 11, p1-35. 35p. |
| Subject Terms: | *Allergens, *Animal nutrition, *Feed industry, Feed additives, Ruminants, Dairy cattle, Milk yield, Milk quality |
| 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 safety and efficacy of Bovaer® 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3-nitrooxypropanol (3-NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer® 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3-nitrooxypropionic acid (NOPA), which is one of the 3-NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer® 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3-NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3-NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction. [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.) | |
| Database: | GreenFILE |
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| Header | DbId: 8gh DbLabel: GreenFILE An: 153742750 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Bampidis%2C+Vasileios%22">Bampidis, Vasileios</searchLink><br /><searchLink fieldCode="AR" term="%22Azimonti%2C+Giovanna%22">Azimonti, Giovanna</searchLink><br /><searchLink fieldCode="AR" term="%22de+Lourdes+Bastos%2C+Maria%22">de Lourdes Bastos, Maria</searchLink><br /><searchLink fieldCode="AR" term="%22Christensen%2C+Henrik%22">Christensen, Henrik</searchLink><br /><searchLink fieldCode="AR" term="%22Dusemund%2C+Birgit%22">Dusemund, Birgit</searchLink><br /><searchLink fieldCode="AR" term="%22Durjava%2C+Mojca+Fašmon%22">Durjava, Mojca Fašmon</searchLink><br /><searchLink fieldCode="AR" term="%22Kouba%2C+Maryline%22">Kouba, Maryline</searchLink><br /><searchLink fieldCode="AR" term="%22López-Alonso%2C+Marta%22">López-Alonso, Marta</searchLink><br /><searchLink fieldCode="AR" term="%22López+Puente%2C+Secundino%22">López Puente, Secundino</searchLink><br /><searchLink fieldCode="AR" term="%22Marcon%2C+Francesca%22">Marcon, Francesca</searchLink><br /><searchLink fieldCode="AR" term="%22Mayo%2C+Baltasar%22">Mayo, Baltasar</searchLink><br /><searchLink fieldCode="AR" term="%22Pechová%2C+Alena%22">Pechová, Alena</searchLink><br /><searchLink fieldCode="AR" term="%22Petkova%2C+Mariana%22">Petkova, Mariana</searchLink><br /><searchLink fieldCode="AR" term="%22Ramos%2C+Fernando%22">Ramos, Fernando</searchLink><br /><searchLink fieldCode="AR" term="%22Sanz%2C+Yolanda%22">Sanz, Yolanda</searchLink><br /><searchLink fieldCode="AR" term="%22Villa%2C+Roberto+Edoardo%22">Villa, Roberto Edoardo</searchLink><br /><searchLink fieldCode="AR" term="%22Woutersen%2C+Ruud%22">Woutersen, Ruud</searchLink><br /><searchLink fieldCode="AR" term="%22Aquilina%2C+Gabriele%22">Aquilina, Gabriele</searchLink><br /><searchLink fieldCode="AR" term="%22Bories%2C+Georges%22">Bories, Georges</searchLink><br /><searchLink fieldCode="AR" term="%22Brantom%2C+Paul+George%22">Brantom, Paul George</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Nov2021, Vol. 19 Issue 11, p1-35. 35p. – Name: Subject Label: Subject Terms Group: Su Data: *<searchLink fieldCode="DE" term="%22Allergens%22">Allergens</searchLink><br />*<searchLink fieldCode="DE" term="%22Animal+nutrition%22">Animal nutrition</searchLink><br />*<searchLink fieldCode="DE" term="%22Feed+industry%22">Feed industry</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+additives%22">Feed additives</searchLink><br /><searchLink fieldCode="DE" term="%22Ruminants%22">Ruminants</searchLink><br /><searchLink fieldCode="DE" term="%22Dairy+cattle%22">Dairy cattle</searchLink><br /><searchLink fieldCode="DE" term="%22Milk+yield%22">Milk yield</searchLink><br /><searchLink fieldCode="DE" term="%22Milk+quality%22">Milk quality</searchLink> – Name: SubjectCompany Label: Company/Entity Group: Su 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 safety and efficacy of Bovaer® 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3-nitrooxypropanol (3-NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer® 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3-nitrooxypropionic acid (NOPA), which is one of the 3-NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer® 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3-NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3-NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab 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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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.2903/j.efsa.2021.6905 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 35 StartPage: 1 Subjects: – SubjectFull: Allergens Type: general – SubjectFull: Animal nutrition Type: general – SubjectFull: Feed industry Type: general – SubjectFull: Feed additives Type: general – SubjectFull: Ruminants Type: general – SubjectFull: Dairy cattle Type: general – SubjectFull: Milk yield Type: general – SubjectFull: Milk quality Type: general – SubjectFull: European Commission Type: general – SubjectFull: European Food Safety Authority Type: general Titles: – TitleFull: Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Bampidis, Vasileios – PersonEntity: Name: NameFull: Azimonti, Giovanna – PersonEntity: Name: NameFull: de Lourdes Bastos, Maria – PersonEntity: Name: NameFull: Christensen, Henrik – PersonEntity: Name: NameFull: Dusemund, Birgit – PersonEntity: Name: NameFull: Durjava, Mojca Fašmon – PersonEntity: Name: NameFull: Kouba, Maryline – PersonEntity: Name: NameFull: López-Alonso, Marta – PersonEntity: Name: NameFull: López Puente, Secundino – PersonEntity: Name: NameFull: Marcon, Francesca – PersonEntity: Name: NameFull: Mayo, Baltasar – PersonEntity: Name: NameFull: Pechová, Alena – PersonEntity: Name: NameFull: Petkova, Mariana – PersonEntity: Name: NameFull: Ramos, Fernando – PersonEntity: Name: NameFull: Sanz, Yolanda – PersonEntity: Name: NameFull: Villa, Roberto Edoardo – PersonEntity: Name: NameFull: Woutersen, Ruud – PersonEntity: Name: NameFull: Aquilina, Gabriele – PersonEntity: Name: NameFull: Bories, Georges – PersonEntity: Name: NameFull: Brantom, Paul George IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 11 Text: Nov2021 Type: published Y: 2021 Identifiers: – Type: issn-print Value: 18314732 Numbering: – Type: volume Value: 19 – Type: issue Value: 11 Titles: – TitleFull: EFSA Journal Type: main |
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