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, 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 21;20(10):e07613. doi: 10.2903/j.efsa.2022.7613. eCollection 2022 Oct.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-lysine monohydrochloride and l-lysine sulfate produced by CGMCC 17927, when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine, and it was produced in two different forms: monohydrochloride (HCl) or sulfate salts. The production strain was genetically modified. Neither viable cells nor recombinant DNA of the production strain were detected in the final products. Therefore, the Panel concluded that the additives did not pose any safety concern regarding the production strain. The use of l-lysine HCl and l-lysine sulfate produced by the strain CGMCC 17927 in supplementing feed to compensate for l-lysine deficiency in feedingstuffs was safe for the target species. 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 both forms of l-lysine produced by fermentation using CGMCC 17927 in animal nutrition was considered safe for the consumers and for the environment. Exposure of users through inhalation to l-lysine HCl and l-lysine sulfate produced with CGMCC 17927 was considered very likely. In absence of data, the FEEDAP Panel could not conclude on the potential of both forms of the additive to be irritant for skin and eyes or to be dermal sensitisers. l-Lysine HCl and l-lysine sulfate were considered as efficacious sources 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.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就中国普通微生物菌种保藏管理中心17927生产的L-盐酸赖氨酸和L-硫酸赖氨酸用作所有动物物种的饲料和饮用水营养添加剂一事提供科学意见。活性物质为L-赖氨酸，它以两种不同形式生产：盐酸盐（HCl）或硫酸盐。生产菌株经过基因改造。在最终产品中未检测到生产菌株的活细胞或重组DNA。因此，专家小组得出结论，这些添加剂在生产菌株方面不存在任何安全问题。使用中国普通微生物菌种保藏管理中心17927生产的L-盐酸赖氨酸和L-硫酸赖氨酸补充饲料以弥补饲料中L-赖氨酸的不足，对目标物种是安全的。FEEDAP专家小组确定了同时在饲料和饮用水中添加氨基酸时存在营养失衡风险和卫生问题。使用中国普通微生物菌种保藏管理中心17927发酵生产的两种形式的L-赖氨酸用于动物营养被认为对消费者和环境是安全的。认为使用者通过吸入接触中国普通微生物菌种保藏管理中心17927生产的L-盐酸赖氨酸和L-硫酸赖氨酸的可能性很大。由于缺乏数据，FEEDAP专家小组无法就两种形式添加剂对皮肤和眼睛的刺激性或皮肤致敏性潜力得出结论。L-盐酸赖氨酸和L-硫酸赖氨酸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物种一样有效，则需要防止其在瘤胃中降解。
