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, Mantovani Alberto, Wallace Robert John, Tarrés-Call Jordi, Ramos Fernando
EFSA J. 2019 Mar 21;17(3):e05643. doi: 10.2903/j.efsa.2019.5643. eCollection 2019 Mar.
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 using CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate). Owing to the uncertainties regarding the possible genetic modification of the strain used to obtain the production strain CCTCC M 2015595 and on the possible presence of viable cells and DNA of the production strain in the final product, the FEEDAP Panel cannot conclude on the safety of the additives l-lysine HCl and l-lysine sulfate produced with CCTCC M 2015595 for the target species, the consumers, the users and the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via water for drinking. In the absence of data, the FEEDAP Panel cannot conclude on the safety of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l-lysine for all animal species. For these products to be as efficacious in ruminants as in non-ruminant species, they 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）被要求就使用中国典型培养物保藏中心（CCTCC）M 2015595生产的L-赖氨酸盐酸盐和L-赖氨酸硫酸盐用作所有动物物种饲料和饮用水中的营养添加剂提供科学意见。活性物质为L-赖氨酸，它以两种不同形式生产（盐酸盐或硫酸盐）。由于用于获得生产菌株CCTCC M 2015595的菌株可能存在基因改造以及最终产品中可能存在生产菌株的活细胞和DNA的不确定性，FEEDAP专家小组无法就使用CCTCC M 2015595生产的L-赖氨酸盐酸盐和L-赖氨酸硫酸盐添加剂对目标物种、消费者、使用者和环境的安全性得出结论。对于这两种产品，FEEDAP专家小组担心当添加剂通过饮用水给药时对目标物种的安全性。在缺乏数据的情况下，FEEDAP专家小组无法就添加剂对使用者的安全性得出结论。所评估的产品被认为是所有动物物种的氨基酸L-赖氨酸的有效来源。为使这些产品在反刍动物中与在非反刍动物物种中一样有效，它们需要防止在瘤胃中降解。
