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, Leng Lubomir, Mantovani Alberto, Wallace Robert John, Tarrés-Call Jordi, Ramos Fernando
EFSA J. 2019 Jan 31;17(1):e05538. doi: 10.2903/j.efsa.2019.5538. eCollection 2019 Jan.
The product subject of this assessment is l-valine produced by fermentation using a non-genetically modified strain of (KCCM 11201P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations below thresholds specified by EFSA, thus . KCCM 11201P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of . were detected in the final product. The amount of identified material exceeded ■■■■■% on 'as is' basis, and no impurities of concern were detected. The use of l-valine produced by . KCCM 11201P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. The product l-valine produced by . (KCCM 11201P) is considered not to be an irritant or a dermal sensitiser, and does not cause acute inhalation toxicity. The additive is an effective source of valine for all species. For the supplemental l-valine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial degradation in the rumen.
本次评估的产品对象是使用（KCCM 11201P）非转基因菌株发酵生产的L-缬氨酸。它拟用于所有动物种类和类别的饲料及饮用水中。生产菌株的物种身份已得到确认，且该菌株在低于欧洲食品安全局规定阈值的抗生素浓度下敏感，因此，KCCM 11201P可通过安全合格假定（QPS）方法被视为安全。在最终产品中未检测到（菌株名称缺失）的活细胞。以“原样”为基础，已鉴定物质的含量超过■■■■■%，且未检测到令人关注的杂质。当以适当剂量添加到日粮中时，由（菌株名称缺失）KCCM 11201P生产的L-缬氨酸对目标物种、消费者和环境而言是安全的。由（菌株名称缺失）（KCCM 11201P）生产的产品L-缬氨酸被认为不是刺激性物质或皮肤致敏剂，也不会引起急性吸入毒性。该添加剂是所有物种缬氨酸的有效来源。为使补充的L-缬氨酸在反刍动物中与在非反刍动物物种中一样有效，需要对其进行保护以防在瘤胃中被微生物降解。
