Safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)

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‐n...

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Autores principales:	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Gabriele Aquilina, Georges Bories, Paul George Brantom, Jürgen Gropp, Kettil Svensson, Luca Tosti, Montserrat Anguita, Jaume Galobart, Paola Manini, Jordi Tarrès‐Call, Fabiola Pizzo
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	3‐nitrooxypropanol 3‐NOP 3‐nitrooxypropionic acid NOPA ruminants methane reduction Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/0ea42bdf23314dc383562d9a5203d485
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spelling	oai:doaj.org-article:0ea42bdf23314dc383562d9a5203d4852021-12-02T17:55:57ZSafety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)1831-473210.2903/j.efsa.2021.6905https://doaj.org/article/0ea42bdf23314dc383562d9a5203d4852021-11-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6905https://doaj.org/toc/1831-4732Abstract 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.EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenGabriele AquilinaGeorges BoriesPaul George BrantomJürgen GroppKettil SvenssonLuca TostiMontserrat AnguitaJaume GalobartPaola ManiniJordi Tarrès‐CallFabiola PizzoWileyarticle3‐nitrooxypropanol3‐NOP3‐nitrooxypropionic acidNOPAruminantsmethane reductionNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 11, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	3‐nitrooxypropanol 3‐NOP 3‐nitrooxypropionic acid NOPA ruminants methane reduction Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	3‐nitrooxypropanol 3‐NOP 3‐nitrooxypropionic acid NOPA ruminants methane reduction Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Paul George Brantom Jürgen Gropp Kettil Svensson Luca Tosti Montserrat Anguita Jaume Galobart Paola Manini Jordi Tarrès‐Call Fabiola Pizzo Safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)
description	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.
format	article
author	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Paul George Brantom Jürgen Gropp Kettil Svensson Luca Tosti Montserrat Anguita Jaume Galobart Paola Manini Jordi Tarrès‐Call Fabiola Pizzo
author_facet	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Paul George Brantom Jürgen Gropp Kettil Svensson Luca Tosti Montserrat Anguita Jaume Galobart Paola Manini Jordi Tarrès‐Call Fabiola Pizzo
author_sort	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
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)
title_short	Safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)
title_full	Safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)
title_fullStr	Safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)
title_full_unstemmed	Safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)
title_sort	safety and efficacy of a feed additive consisting of 3‐nitrooxypropanol (bovaer® 10) for ruminants for milk production and reproduction (dsm nutritional products ltd)
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/0ea42bdf23314dc383562d9a5203d485
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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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