Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca, Kouba Maryline, López-Alonso Marta, Puente Secundino López, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Bories Georges, Gropp Jürgen, Galobart Jaume, Innocenti Matteo Lorenzo, Ortuño Jordi, Pizzo Fabiola, Rossi Barbara, Tarrés-Call Jordi, Vettori Maria Vittoria, Radovnikovic Anita
EFSA J. 2023 Oct 25;21(10):e08342. doi: 10.2903/j.efsa.2023.8342. eCollection 2023 Oct.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 μm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就碱式氯化铜(三水合)作为营养性饲料添加剂的授权续期申请评估提供一份科学意见。该添加剂目前被授权用于所有动物物种(3b409)。申请人请求对当前的授权规范进行修改:(i)用斜氯铜矿取代α晶型副氯铜矿;(ii)从授权规范中删除晶体多晶型物之间的比例;(iii)将粒径小于50μm的颗粒的最低含量从1%改为5%。饲料添加剂和动物营养产品专家小组认为,所提议的修改不会引起对目标物种安全性的担忧,并且当该添加剂以最高授权水平使用时,对目标物种和消费者而言仍然是安全的。关于对环境的安全性,在所提议的使用条件下,该添加剂用于陆生动物饲料和陆基水产养殖被认为是安全的。现有数据不允许饲料添加剂和动物营养产品专家小组就该添加剂用于海水网箱时对海洋沉积物的安全性得出结论。该添加剂对皮肤无腐蚀性,但对眼睛和皮肤有刺激性。由于含有镍,它被认为是一种皮肤和呼吸道致敏剂。在授权续期的背景下,无需评估该添加剂的功效。