Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Herman Lieve, Anguita Montserrat, Innocenti Matteo L, Pettenati Elisa, Tarrés-Call Jordi, Pizzo Fabiola, Brozzi Rosella
EFSA J. 2024 Jul 31;22(7):e8950. doi: 10.2903/j.efsa.2024.8950. eCollection 2024 Jul.
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of liquid l-lysine base produced with a genetically modified strain of as a nutritional feed additive for all animal species. The l-lysine base liquid produced with NRRL B-67535 and NRRL B-67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include NRRL B-68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B-68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l-Lysine base produced using NRRL B-68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l-Lysine base produced with NRRL B-68248 is considered to be 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.
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂和产品或物质专家小组（FEEDAP）被要求就使用转基因菌株生产的液体L-赖氨酸碱作为所有动物物种的营养饲料添加剂的安全性和有效性发表科学意见。用NRRL B-67535和NRRL B-67439生产的L-赖氨酸碱液体目前被批准作为所有动物物种的营养添加剂。本申请旨在修改当前授权，将NRRL B-68248纳入生产菌株。新的生产菌株在用于生产目的时符合安全合格推定方法。它被明确鉴定为[具体菌种名称未给出]，并且未显示含有对人和兽医重要的抗生素的获得性抗微生物耐药性决定因素。所有引入的序列或突变被认为是安全的，并且在最终产品中未检测到NRRL B-68248菌株的活细胞或DNA。因此，最终产品不存在与生产菌株相关的任何安全问题。使用NRRL B-68248生产的L-赖氨酸碱对目标物种、消费者或环境不构成风险。该添加剂被认为对皮肤或眼睛无刺激性，也不是皮肤致敏剂。用NRRL B-68248生产的L-赖氨酸碱被认为是用于非反刍动物物种的必需氨基酸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。
