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Safety and efficacy of a feed additive consisting of a tincture derived from roots of Gentiana lutea L. (gentian tincture) for use in all animal species (FEFANA asbl)

机译:饲料添加剂的安全性和有效性该饲料添加剂组成的龙胆Lutea L.(珍贵的酊剂)根源以供所有动物物种(Fefana asbl)使用

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摘要

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Gentiana lutea L. (gentian tincture) when used as a sensory feed additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 4.3%. The product contains on average 0.0836% polyphenols (of which 0.0463% are flavonoids and 0.0027% xanthones) and 0.0022% gentiopicroside. The FEEDAP Panel concludes that gentian tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for short‐living animals (animals for fattening). The FEEDAP Panel considers that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. Considering the genotoxic potential of gentiopicroside and xanthones (gentisin and isogentisin), no conclusions can be drawn for long‐living animals (companion animals, horses and animals for reproduction). No safety concern would arise for the consumer from the use of gentian tincture up to the highest safe level in animal nutrition. In the absence of data, no conclusions can be drawn on the potential of the tincture to be a dermal/eye irritant or a skin sensitiser. The data available do not allow to conclude on risks of genotoxicity and carcinogenicity for dermal exposure. Use of the tincture derived from G. lutea as a flavour in animal feed is not expected to pose a risk for the environment. Since G. lutea and gentian root extract are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under application.
机译:遵循欧盟委员会的请求后,动物饲料(进料)中使用的eFSA组成部分(进料)的添加剂和产品或物质均有关龙胆卢其L的根源的安全和疗效提供科学意见。(龙胆酊剂)当用作所有动物物种的感觉饲料添加剂时。该产品是A■■■■■溶液,干物质含量约为4.3%。该产物平均含有0.0836%的多酚(其中0.0463%是黄酮类化合物和0.0027%x原蝶啉)和0.0022%龙胆醇。进料面板的结论是,龙胆酊剂在最大拟议使用水平为50毫克/千克的短生动物(动物用于肥胖)的最高使用量。进料面板认为,在饮用水中使用的是安全的,条件是添加剂的总每日摄入量不会超过通过饲料消耗时被认为是安全的每日量。考虑到神经胆甙和Xanthones(Gentisin和Isogentisin)的遗传毒性潜力,可以为长生动动物(伴侣动物,马和繁殖)抽取得出结论。消费者从使用绅士酊达到动物营养中最高安全水平的消费者不会产生任何安全问题。在没有数据的情况下,没有结论可以吸引酊剂的潜力是皮肤/眼睛刺激物或皮肤敏感剂。可用的数据不允许在真皮暴露的遗传毒性和致癌性的风险上得出结论。使用从G. Lutea衍生的酊剂作为动物饲料的味道,预计不会对环境产生风险。由于G. Lutea和龙胆根提取物被公认为香料食品,并且它们在饲料中的功能基本上与食物中的功能基本相同,因此申请下的酊剂不需要进一步证明疗效。

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