Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Kos Durjava Mojca, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Cocconcelli Pier Sandro, Glandorf Boet, Herman Lieve, Maradona Miguel Prieto, Saarela Maria, Anguita Montserrat, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pizzo Fabiola, Tarrés-Call Jordi, Pettenati Elisa
EFSA J. 2021 Mar 8;19(3):e06450. doi: 10.2903/j.efsa.2021.6450. eCollection 2021 Mar.
The feed additive under assessment (trade name: Miya-Gold S) is based on viable spores of FERM BP-2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya-Gold S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya-Gold S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya-Gold S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 10 CFU/kg complete feedingstuff. Miya-Gold S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.
正在评估的饲料添加剂（商品名：Miya-Gold S）以FERM BP - 2789的活孢子为基础。它被批准用于小型禽类（不包括产蛋鸡）、断奶仔猪和小型断奶猪种、蛋鸡、育肥火鸡和种用火鸡。本意见涉及Miya-Gold S在已有授权的物种/类别中续期授权的申请，用于育肥鸡的授权（此前的授权已过期），以及将使用范围扩大到哺乳仔猪和小型哺乳猪种。申请人提供了证据表明市场上现有的添加剂符合授权条件。没有新的证据会使专家小组重新考虑之前的结论，即在当前和先前授权的使用条件下，Miya-Gold S对动物物种/类别、消费者和环境仍然是安全的。这一结论也适用于提出使用申请的新目标物种。关于对使用者的安全性，专家小组得出结论，该添加剂对皮肤和眼睛无刺激性，不能排除经呼吸道致敏的可能性。在蛋鸡、育肥火鸡和种用火鸡、小型禽类（不包括产蛋鸡）、断奶仔猪和小型断奶猪种的授权续期的背景下，无需评估Miya-Gold S的功效。该添加剂在育肥鸡、哺乳仔猪和小型哺乳猪种中，添加量为每千克全价饲料2.5×10 CFU时可能有效。Miya-Gold S与癸氧喹酯、地克珠利、拉沙洛西、马杜霉素铵、那拉菌素、那拉菌素/尼卡巴嗪、莫能菌素钠、氯苯胍、盐霉素钠和赛杜霉素兼容。
