Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer(®) 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd).
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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DOI：
10.2903/j.efsa.2021.6905
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发表时间：
2021-11
期刊：
影响因子：
--
通讯作者：
Pizzo F
中科院分区：
文献类型：
--
作者：
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP);Bampidis V;Azimonti G;Bastos ML;Christensen H;Dusemund B;Fašmon Durjava M;Kouba M;López-Alonso M;López Puente S;Marcon F;Mayo B;Pechová A;Petkova M;Ramos F;Sanz Y;Villa RE;Woutersen R;Aquilina G;Bories G;Brantom PG;Gropp J;Svensson K;Tosti L;Anguita M;Galobart J;Manini P;Tarrès-Call J;Pizzo F
根据欧盟委员会的要求，EFSA被要求就Bovaer®10作为反刍动物用于牛奶生产和繁殖的动物技术添加剂的安全性和有效性发表科学意见。根据现有的ADME数据，活性物质3-硝氧基丙醇(3-NOP)在目标物种中的全身接触或接触毒性部位不太可能，其遗传毒性尚未完全阐明。因此，FEEDAP专家小组得出结论，在最高推荐水平下，Bovaer®10对奶牛是安全的。然而，由于不能确定安全边际，FEEDAP专家小组无法对该添加剂对其他动物物种/类别的安全性作出结论。FEEDAP专家小组认为，消费者接触到了3-硝氧基丙酸(NOPA)，这是3-NOP的代谢物之一。根据所提供的研究，NOPA没有遗传毒性。FEEDAP专家小组的结论是，在拟议的使用条件下，在动物营养中使用Bovaer®10与消费者安全和环境无关。FEEDAP专家小组的结论是，如果吸入活性物质3-NOP可能是有害的。它对皮肤有刺激性(但没有腐蚀性)，对眼睛有刺激性，但它不是皮肤敏感剂。由于3-NOP的遗传毒性尚未完全阐明，吸入该添加剂可能会给使用者带来额外的风险。专家小组的结论是，在拟议的使用条件下，该添加剂有可能在奶牛身上有效地减少肠道甲烷的产生。这一结论被外推到所有其他用于产奶和繁殖的反刍动物。
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.
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影响因子：
3.3
作者：
Rychen, Guido;Aquilina, Gabriele;Martino, Laura
通讯作者：
Martino, Laura
影响因子：
3.3
作者：
Bampidis, Vasileios;Bastos, Maria;Azimonti, Giovanna
通讯作者：
Azimonti, Giovanna
影响因子：
3.3
作者：
Rychen, Guido;Aquilina, Gabriele;Innocenti, Matteo Lorenzo
通讯作者：
Innocenti, Matteo Lorenzo
影响因子：
3.2
作者：
Wang, M.;Sun, X. Z.;Tan, Z. L.
通讯作者：
Tan, Z. L.
影响因子：
1.8
作者：
Huhtanen, P.;Ramin, M.;Hristov, A. N.
通讯作者：
Hristov, A. N.