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Scientific Opinion on the safety and efficacy of L‐threonine produced by Escherichia coli for all animal species based on a dossier submitted by HELM AG on behalf of Meihua Holdings Group Co. Ltd

机译:基于HELM AG代表美华控股集团有限公司提交的档案,关于大肠杆菌生产的L-苏氨酸对所有动物种类的安全性和有效性的科学意见

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The subject of this assessment was the L‐threonine produced by a genetically modified strain of Escherichia coli. L‐Threonine is an essential amino acid for all animal species. It is widely used in the feed industry to optimise dietary protein intake. The amino acid L‐threonine itself is considered safe for target animals, consumers and the environment. However, the recipient strain and its genetic modification, including the presence or absence of an antibiotic resistance gene in the product under assessment, are insufficiently characterised. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot make a conclusion on the safety of the product L‐threonine produced by fermentation with this recombinant strain of E. coli for target animals, consumers, users and the environment. Regardless of the assessment of the genetic modification, the FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of L‐threonine via water for drinking and feed. There are no concerns for users in respect of irritation to skin or eyes. In the absence of any data on sensitisation, it must be concluded that the product may have the potential to be a dermal sensitiser and should be handled accordingly. The level of endotoxins present in the product and its dusting potential indicate an inhalation risk for the user. The product is considered an efficacious source of the amino acid L‐threonine for all animal species. For the supplemental L threonine to be as efficacious in ruminants as in non‐ruminant species, it must be protected against degradation in the rumen.
机译:该评估的对象是由转基因大肠杆菌生产的L-苏氨酸。 L-苏氨酸是所有动物物种的必需氨基酸。它在饲料工业中广泛用于优化膳食蛋白质的摄入。氨基酸L-苏氨酸本身被认为对目标动物,消费者和环境都是安全的。但是,受体菌株及其遗传修饰,包括所评估产品中是否存在抗生素抗性基因,都无法充分表征。因此,动物饲料中使用的添加剂和产品或物质小组(FEEDAP)不能就用该重组大肠杆菌菌株发酵生产的L-苏氨酸产品对目标动物,消费者,使用者和动物的安全性做出结论。环境。无论对遗传修饰的评估如何,FEEDAP专家组都对通过水同时饮用和喂养L-苏氨酸的安全性感到担忧。使用者无需担心刺激皮肤或眼睛。在没有有关敏化作用的任何数据的情况下,必须得出结论,该产品可能具有成为皮肤敏化剂的潜力,应进行相应的处理。产品中存在的内毒素水平及其粉尘潜力表明使用者有吸入危险。该产品被认为是所有动物物种中氨基酸L-苏氨酸的有效来源。为了使补充的苏氨酸在反刍动物中的功效与在非反刍动物中的一样,必须保护其免受反刍动物降解的影响。

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    《EFSA Journal》 |2015年第3期|共17页
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