Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, 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, Herman Lieve, Anguita Montserrat, Galobart Jaume, Tarrés-Call Jordi, Pettenati Elisa
EFSA J. 2021 Dec 9;19(12):e06977. doi: 10.2903/j.efsa.2021.6977. eCollection 2021 Dec.
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 the safety and efficacy of a feed additive consisting of l-isoleucine produced by KCCM 80185 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified, does not carry acquired antimicrobial resistance genes and no viable cells of the production strain were detected in the final product. The FEEDAP Panel could not exclude the presence of recombinant DNA from the production strain in the product. However, since no sequences of concern remain in the final production strain, the potential presence of recombinant DNA in the final product does not raise any safety concerns. The Panel concluded that the additive is safe for the target species, for the consumer and for the environment under the proposed conditions of use. Regarding the use in water, the FEEDAP Panel reiterated its concerns over the safety of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. The FEEDAP Panel concluded that l-isoleucine produced by KCCM 80185 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. However, due to the high dusting potential, exposure to dust might be a hazard for the user. l-Isoleucine produced by KCCM 80185 is considered as an efficacious source of the essential amino acid l-isoleucine for non-ruminant animal species. For the supplemental l-isoleucine 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）被要求就一种由KCCM 80185生产的L-异亮氨酸作为营养添加剂用于所有动物物种的饲料和饮用水时的安全性和有效性发表科学意见。生产菌株经过基因改造，不携带获得性抗菌抗性基因，且在最终产品中未检测到生产菌株的活细胞。FEEDAP专家小组无法排除产品中存在来自生产菌株的重组DNA。然而，由于最终生产菌株中不存在令人担忧的序列，最终产品中重组DNA的潜在存在不会引发任何安全问题。专家小组得出结论，在所提议的使用条件下，该添加剂对目标物种、消费者和环境都是安全的。关于在水中的使用，FEEDAP专家小组重申了其对通过饮用水和饲料同时施用L-异亮氨酸的安全性的担忧，这是由于存在营养失衡的风险和卫生原因。FEEDAP专家小组得出结论，KCCM 80185生产的L-异亮氨酸被认为吸入无毒，对皮肤或眼睛无刺激性，也不是皮肤致敏剂。然而，由于其扬尘可能性高，接触粉尘可能对使用者构成危害。KCCM 80185生产的L-异亮氨酸被认为是用于非反刍动物物种的必需氨基酸L-异亮氨酸的有效来源。要使补充的L-异亮氨酸在反刍动物中与在非反刍动物物种中一样有效，则需要防止其在瘤胃中降解。
