Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Dusemund Birgit, Fašmon 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, Glandorf Debora, Tosti Luca, Anguita Montserrat, Brozzi Rosella, Firmino Joana, Galobart Jaume, García Cazorla Yolanda, Ortuño Casanova Jordi, Pettenati Elisa, Revez Joana, Tarrés-Call Jordi
EFSA J. 2022 Oct 25;20(10):e07612. doi: 10.2903/j.efsa.2022.7612. eCollection 2022 Oct.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride produced by NITE BP-02917 as nutritional and as sensory (flavouring compound) feed additives for all animal species. The production strain did not carry ■■■■■ antimicrobial resistance genes and no viable cells of the production strain were detected in the final products. ■■■■■ However, since no sequences of concern remained in the production strain, the potential presence of that DNA did not raise safety concerns. The use of the three forms of l-lysine produced by NITE BP-02917 in supplementing feed to compensate for l-lysine deficiency in feedingstuffs was safe for the target species. This conclusion would also cover the use as a sensory additive. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of the three forms of l-lysine produced by NITE BP-02917 in animal nutrition was considered safe for the consumers and for the environment. Concentrated liquid l-lysine, l-lysine HCl and concentrated liquid l-lysine HCl were not considered to have the potential to cause respiratory toxicity, or skin sensitisation. l-Lysine HCl and concentrated liquid l-lysine HCl were not considered skin and eye irritants. Concentrated liquid l-lysine, due to its high pH, might be corrosive for skin and eyes. The three forms were considered an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. The three forms of the additive were also considered efficacious as feed flavouring compounds under the proposed conditions of use.
应欧盟委员会的要求,欧洲食品安全局被要求就日本技术评价研究所BP - 02917生产的浓缩液状L-赖氨酸、L-赖氨酸盐酸盐和浓缩液状L-赖氨酸盐酸盐作为所有动物物种的营养性和感官性(调味化合物)饲料添加剂的安全性和有效性发表科学意见。生产菌株未携带■■■■■抗菌抗性基因,且在最终产品中未检测到生产菌株的活细胞。■■■■■然而,由于生产菌株中不存在令人担忧的序列,该DNA的潜在存在并未引发安全问题。日本技术评价研究所BP - 02917生产的三种形式的L-赖氨酸用于补充饲料以弥补饲料中L-赖氨酸的缺乏,对目标物种是安全的。这一结论也适用于作为感官添加剂的使用情况。饲料添加剂和动物营养产品专家委员会确定了在饲料和饮用水中同时添加氨基酸时存在营养失衡风险和卫生问题。日本技术评价研究所BP - 02917生产的三种形式的L-赖氨酸用于动物营养被认为对消费者和环境是安全的。浓缩液状L-赖氨酸、L-赖氨酸盐酸盐和浓缩液状L-赖氨酸盐酸盐不被认为具有引起呼吸道毒性或皮肤致敏的潜力。L-赖氨酸盐酸盐和浓缩液状L-赖氨酸盐酸盐不被认为是皮肤和眼睛刺激物。浓缩液状L-赖氨酸由于其高pH值,可能对皮肤和眼睛有腐蚀性。这三种形式被认为是非反刍动物必需氨基酸L-赖氨酸的有效来源。对于反刍动物,要使补充的L-赖氨酸与非反刍动物一样有效,需要防止其在瘤胃中降解。在所提议的使用条件下,这三种形式的添加剂也被认为是有效的饲料调味化合物。