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对饲料添加剂甘氨酸铜用于所有动物物种重新授权的评估(森齐姆有限公司)

Assessment of the feed additive copper bilysinate for all animal species for the renewal of its authorisation (Senzyme GmbH).

作者信息

Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Galobart Jaume, Pizzo Fabiola, Tarrés-Call Jordi, Vettori Maria Vittoria, Navarro-Villa Alberto

出版信息

EFSA J. 2025 Apr 24;23(4):e9356. doi: 10.2903/j.efsa.2025.9356. eCollection 2025 Apr.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper bilysinate as nutritional feed additive for all species and categories. The additive is currently authorised for use in all animal species (3b411). The applicant has provided evidence that the additive, in powder or granule forms, complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of copper bilysinate under the current authorised conditions of use is safe for the target species, consumers and the environment. Regarding user safety, both forms of the additive are not irritant to the skin, but the powder product is an eye irritant. Both forms of the additive should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

摘要

应欧盟委员会的要求,欧洲食品安全局被要求就双赖氨酸铜作为所有物种和类别营养饲料添加剂的安全性和有效性发表科学意见。该添加剂目前被批准用于所有动物物种(3b411)。申请人已提供证据证明该添加剂的粉末或颗粒形式符合授权条件。动物饲料添加剂和产品或物质专家小组(饲料添加剂专家小组)确认,在当前批准的使用条件下使用双赖氨酸铜对目标物种、消费者和环境是安全的。关于使用者安全,该添加剂的两种形式对皮肤均无刺激性,但粉末产品对眼睛有刺激性。该添加剂的两种形式均应被视为皮肤和呼吸道致敏剂。吸入和皮肤接触被视为有风险。在授权续期时无需评估该添加剂的有效性。

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Assessment of the feed additive copper bilysinate for all animal species for the renewal of its authorisation (Senzyme GmbH).
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