Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Innocenti Matteo, Ortuño Jordi, Pettenati Elisa, García-Cazorla Yolanda
EFSA J. 2023 Oct 18;21(10):e08105. doi: 10.2903/j.efsa.2023.8105. eCollection 2023 Oct.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of K-9 Heritage Probiotic Blend® when used as a zootechnical additive (functional group: gut flora stabilisers) for dogs. The product under assessment is based on viable cells of IDAC 210415-01, IDAC 210415-02, IDAC 051120-02 and IDAC 181218-03. The FEEDAP Panel was not in the position to conclude on the identification of the strains and, therefore, the safety of the product cannot be based on the presumption of safety of the active agents. The Panel notes that the use of IDAC 181218-03 represents a safety concern because it harbours an acquired antimicrobial resistance gene. Moreover, the hazard related to the presence of additional antimicrobial resistance genes in the active agents cannot be excluded. No tolerance trials on the target animals have been provided. Therefore, the Panel is not in the position to conclude on the safety of the additive for dogs. Regarding the user safety, the Panel cannot conclude on the irritant potential of the additive for skin or eyes due to the absence of data. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a skin sensitiser. The use of K-9 Heritage Probiotic Blend® in animal nutrition represents a safety concern for the environment due to the potential carryover of at least an antimicrobial resistance gene. The FEEDAP Panel is not in the position to conclude on the efficacy of K-9 Heritage Probiotic Blend® for the target species.
应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求就K-9 Heritage Probiotic Blend®用作犬类动物饲养添加剂（功能组：肠道菌群稳定剂）时的安全性和有效性发表科学意见。所评估的产品基于IDAC 210415-01、IDAC 210415-02、IDAC 051120-02和IDAC 181218-03的活细胞。饲料添加剂和动物产品中微生物风险评估小组无法就菌株的鉴定得出结论，因此，产品的安全性不能基于活性剂的安全推定。该小组指出，使用IDAC 181218-03存在安全问题，因为它含有一个获得性抗菌抗性基因。此外，不能排除活性剂中存在其他抗菌抗性基因所带来的危害。未提供在目标动物上的耐受性试验。因此，该小组无法就该添加剂对犬类的安全性得出结论。关于使用者安全，由于缺乏数据，该小组无法就该添加剂对皮肤或眼睛的刺激性潜力得出结论。鉴于活性剂的蛋白质性质，该添加剂应被视为呼吸道致敏原。无法就其成为皮肤致敏原的可能性得出结论。由于至少有一个抗菌抗性基因可能残留，K-9 Heritage Probiotic Blend®在动物营养中的使用对环境构成安全问题。饲料添加剂和动物产品中微生物风险评估小组无法就K-9 Heritage Probiotic Blend®对目标物种的有效性得出结论。
