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首页> 外文期刊>EFSA Journal >Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces?cerevisiae CNCM I‐3060 (selenised yeast inactivated) for all animal species
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Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces?cerevisiae CNCM I‐3060 (selenised yeast inactivated) for all animal species

机译：对所有动物物种的酿酒酵母CNCM I-3060（硒化酵母灭活）产生的硒代蛋氨酸授权更新申请的评估

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The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I‐3060 (selenised yeast inactivated) (Sel‐Plex?) for all animal species. In 2006, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive; subsequently it was authorised in the EU. The evidence provided indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. In particular, the Panel confirms that the use of Sel‐Plex? in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Sel‐Plex? is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. In the context of the current application, the Panel reviewed toxicological studies; based on two repeated‐dose studies on rats and dogs, it is concluded that the toxic potential of Sel‐Plex? is only related to its selenium content. New data on characterisation of the additive and studies on effects on skin and eyes led the Panel reconsider the safety for the user. The Panel concluded that the additive is hazardous upon inhalation and a likely respiratory sensitiser; owing to the high dusting potential, persons handling the additive are at risk by inhalation. It is considered not irritant to the eyes and skin. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel.
机译：动物饲料中使用的添加剂和产品或物质小组（FEEDAP）被要求就更新酿酒酵母CNCM I-3060（硒化酵母灭活）（Sel- Plex？）适用于所有动物物种。 2006年，FEEDAP小组对添加剂的安全性和有效性发表了意见。随后获得了欧盟的批准。提供的证据表明，目前市场上的添加剂符合授权条件。没有发现新的证据使FEEDAP小组重新考虑其先前针对目标物种，消费者和环境的安全性得出的结论。小组特别确认是否使用了Sel-Plex？如果Sel-Plex饲料中硒的最大添加量为0.2 mg / kg，对动物营养的危害不会对消费者构成威胁？硒含量未超过规定值，但饲料中的总硒含量最高为0.5 mg / kg。在目前的申请范围内，专家小组审查了毒理学研究;基于对大鼠和狗的两次重复剂量研究，得出的结论是Sel-Plex？的潜在毒性？仅与硒含量有关。关于添加剂特性的新数据以及对皮肤和眼睛的影响研究使专家小组重新考虑了用户的安全性。专家小组的结论是，该添加剂在吸入时可能有害，可能会引起呼吸道过敏。由于高粉尘的可能性，操作添加剂的人员有吸入危险。它被认为对眼睛和皮肤没有刺激性。小组提出了关于被评估添加剂的面额的建议。

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