Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Dusemund Birgit, Kos 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, Glandorf Boet, Gropp Jürgen, Herman Lieve, Rychen Guido, Saarela Maria, Anguita Montserrat, Galobart Jaume, Holczkecht Orsolya, Manini Paola, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi
EFSA J. 2020 Apr 30;18(4):e06075. doi: 10.2903/j.efsa.2020.6075. eCollection 2020 Apr.
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 l-glutamine (≥ 98.0%) produced by fermentation using a genetically modified strain of (NITE BP-02524). It is intended to be used in feed for all animal species and categories as nutritional additive (amino acid) and as sensory additive (flavouring compound). Viable cells of the production strain and its recombinant DNA were not detected in the additive. l-Glutamine manufactured by fermentation using NITE BP-02524 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l-glutamine produced by fermentation using NITE BP-02524 in animal nutrition is considered safe for all animal species when applied as a nutritional additive to achieve an adequate amino acid profile in feed and to overcome potential glutamine shortages during critical periods of life. The proposed use level (25 mg/kg feed) when used as sensory additive (flavouring compound) is safe for all animal species. The uses of l-glutamine produced using NITE BP-02524 as nutritional additive or as flavouring compound are considered safe for the consumer. l-Glutamine produced using NITE BP-02524 is not toxic by inhalation, is non-irritant to skin and eyes and is not a skin sensitiser. l-Glutamine produced using NITE BP-02524 is considered safe for the environment. l-glutamine is a non-essential amino acid and it plays a physiological role as such. Recent evidence shows that glutamine may act as conditionally essential amino acid mainly in growing animals and has some specific effects e.g. in improving intestinal development and immune response. This amino acid produced by fermentation using NITE BP-02524 is regarded as an efficacious source of glutamine for all animal species. For supplemental l-glutamine to be as efficacious in ruminants as in non-ruminants, it would require protection against degradation in the rumen. The use of l-glutamine as sensory additive at 25 mg/kg feed is considered efficacious.
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）被要求就使用基因改造的[具体菌株名称未给出]（NITE BP - 02524）发酵生产的L - 谷氨酰胺（≥98.0%）的安全性和有效性发表科学意见。它拟用作所有动物种类和类别的饲料中的营养添加剂（氨基酸）和感官添加剂（调味化合物）。在该添加剂中未检测到生产菌株的活细胞及其重组DNA。使用[具体菌株名称未给出]NITE BP - 02524发酵生产的L - 谷氨酰胺在生产菌株的基因改造方面不会引起任何安全问题。当用作营养添加剂以在饲料中实现足够的氨基酸谱并克服生命关键时期潜在的谷氨酰胺短缺时，使用[具体菌株名称未给出]NITE BP - 02524发酵生产的L - 谷氨酰胺在动物营养中对所有动物种类都被认为是安全的。当用作感官添加剂（调味化合物）时，建议的使用水平（25毫克/千克饲料）对所有动物种类都是安全的。使用[具体菌株名称未给出]NITE BP - 02524生产的L - 谷氨酰胺作为营养添加剂或调味化合物对消费者被认为是安全的。使用[具体菌株名称未给出]NITE BP - 02524生产的L - 谷氨酰胺吸入无毒，对皮肤和眼睛无刺激性，且不是皮肤致敏剂。使用[具体菌株名称未给出]NITE BP - 02524生产的L - 谷氨酰胺被认为对环境是安全的。L - 谷氨酰胺是一种非必需氨基酸，并且它发挥着这样的生理作用。最近的证据表明，谷氨酰胺可能主要在生长动物中作为条件必需氨基酸起作用，并且具有一些特定作用，例如在改善肠道发育和免疫反应方面。使用[具体菌株名称未给出]NITE BP - 02524发酵生产的这种氨基酸被认为是所有动物种类谷氨酰胺的有效来源。为使补充的L - 谷氨酰胺在反刍动物中与在非反刍动物中一样有效，需要防止其在瘤胃中降解。以25毫克/千克饲料的用量使用L - 谷氨酰胺作为感官添加剂被认为是有效的。
