Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Durjava Mojca Fašmon, 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, Holczkencht Orsolya, Manini Paola, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi
EFSA J. 2020 Nov 10;18(11):e06285. doi: 10.2903/j.efsa.2020.6285. eCollection 2020 Nov.
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 concentrated liquid l-lysine (base) and l-lysine monohydrochloride (HCl) produced using KCCM 80190 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l-lysine. The production strain is genetically modified. It does not carry acquired antimicrobial resistance genes and no viable cells of the production strain nor its DNA were detected in the final products. Therefore, the additives do not pose any safety concern regarding the genetic modifications. Concentrated liquid l-lysine (base) and l-lysine HCl produced by KCCM 80190 do not represent a risk for the target species, the consumer and the environment. From the results of studies on the safety for the user of concentrated liquid l-lysine (base) and l-lysine HCl produced by a different production strain, it was possible to conclude on the safety for the user of the products under assessment. Concentrated liquid l-lysine (base) produced by KCCM 80190 is considered hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l-Lysine HCl produced by KCCM 80190 is considered hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l-lysine (base) and l-lysine HCl are considered 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.
应欧盟委员会要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就使用KCCM 80190生产的浓缩液态L-赖氨酸（碱）和L-赖氨酸盐酸盐用作所有动物物种饲料和饮用水的营养添加剂提供科学意见。活性物质为L-赖氨酸。生产菌株经过基因改造。最终产品中未检测到获得性抗菌抗性基因，也未检测到生产菌株的活细胞及其DNA。因此，这些添加剂在基因改造方面不存在任何安全问题。KCCM 80190生产的浓缩液态L-赖氨酸（碱）和L-赖氨酸盐酸盐对目标物种、消费者和环境均无风险。根据对另一种生产菌株生产的浓缩液态L-赖氨酸（碱）和L-赖氨酸盐酸盐使用者安全性研究的结果，可以得出被评估产品使用者安全性的结论。KCCM 80190生产的浓缩液态L-赖氨酸（碱）被认为吸入有害，但对皮肤和眼睛无刺激性，且不是皮肤致敏剂。KCCM 80190生产的L-赖氨酸盐酸盐被认为吸入有害，对皮肤无刺激性，但对眼睛有轻度刺激性，且不是皮肤致敏剂。浓缩液态L-赖氨酸（碱）和L-赖氨酸盐酸盐被认为是反刍动物必需氨基酸L-赖氨酸的有效来源。要使补充的赖氨酸在反刍动物中与在非反刍动物中一样有效，需要防止其在瘤胃中降解。
