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, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Costa Lucio, Dierick Noël, Flachowsky Gerhard, Glandorf Boet, Herman Lieve, Kärenlampi Sirpa, Leng Lubomir, Mantovani Alberto, Wallace Robert John, Aguilera Jaime, Tarrés-Call Jordi, Ramos Fernando
EFSA J. 2019 Jan 31;17(1):e05532. doi: 10.2903/j.efsa.2019.5532. eCollection 2019 Jan.
The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l-lysine (base), l-lysine monohydrochloride (HCl) and l-lysine sulfate products manufactured using different strains of . New information on the safety of these products was provided by the applicant. The recipient strain KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l-lysine (base) and l-lysine HCl produced by KCTC 12307BP or KCCM 11117P; and l-lysine HCl produced by NRRL B-50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l-lysine (base) and l-lysine HCl produced by KCTC 12307BP, NRRL B-50547 or KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l-Lysine HCl is not hazardous by inhalation. The use of DSM 24990 in the production of l-lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5-30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of KCCM 10227 in the production of l-lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies.
欧洲食品安全局动物饲料添加剂和产品（FEEDAP）小组先前（2016年）无法就使用不同菌株生产的某些浓缩液体L-赖氨酸（碱）、L-赖氨酸盐酸盐（HCl）和L-赖氨酸硫酸盐产品的安全性得出结论。申请人提供了这些产品安全性的新信息。受体菌株KCTC 12307BP符合安全评估的合格安全性推定（QPS）方法，基因改造未引入任何安全问题，其基因组中也没有残留导入的抗生素抗性基因。即使最终产品中生产菌株和/或其重组DNA的存在与否仍存在不确定性，这些也不会引发安全问题。由KCTC 12307BP或KCCM 11117P生产的液体L-赖氨酸（碱）和L-赖氨酸HCl；以及由NRRL B-50547生产的L-赖氨酸HCl被认为对目标物种、消费者和环境是安全的。关于对使用者的安全性，由KCTC 12307BP、NRRL B-50547或KCCM 11117P生产的浓缩液体L-赖氨酸（碱）和L-赖氨酸HCl对皮肤或眼睛无刺激性，且不是皮肤致敏剂。L-赖氨酸HCl吸入无危害。在生产L-赖氨酸硫酸盐中使用DSM 24990被认为对目标物种、消费者、使用者或环境是安全的。只要总硫摄入量符合既定科学机构的建议，在建议的0.5 - 30 g赖氨酸硫酸盐/千克全价饲料添加水平内，预计对目标物种不会产生负面影响。在生产L-赖氨酸硫酸盐中使用KCCM 10227在抗微生物耐药性方面被认为对目标物种、消费者、使用者和环境是安全的。只要总硫摄入量符合既定科学机构的建议，在常见添加水平内预计对目标物种不会产生负面影响。
