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, Cubadda Francesco, Dierick Noël, Flachowsky Gerhard, Glandorf Boet, Herman Lieve, Mantovani Alberto, Saarela Maria, Wallace Robert John, Anguita Montserrat, Tarrés-Call Jordi, Ramos Fernando
EFSA J. 2019 May 3;17(5):e05689. doi: 10.2903/j.efsa.2019.5689. eCollection 2019 May.
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-leucine produced by fermentation with NITE BP-02351 when used as nutritional additive or as feed flavouring compound in feed and water for drinking for all animal species. The product under assessment is l-leucine produced by fermentation with a genetically modified strain of (NITE BP-02351). The production strain and its recombinant DNA were not detected in the final products. l-Leucine, manufactured by fermentation with NITE BP-02351, does not give rise to any safety concern to the production strain. The use of l-leucine produced with NITE BP-02351 is safe for the target species when used to supplement the diet in appropriate amounts. It is safe at the proposed use level of 25 mg/kg when used as flavouring compound for all animal species. The use of l-leucine produced by fermentation with NITE BP-02351 in animal nutrition raises no safety concerns for consumers of animal products. The additive is not irritating to the skin or eyes and is not a skin sensitiser. There is a risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of l-leucine produced by NITE BP-02351 as feed additive does not represent a risk to the environment. The additive l-leucine produced by NITE BP-02351 is regarded as an effective source of the amino acid l-leucine when used as nutritional additive. For the supplemental l-leucine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. It is also considered efficacious as feed flavouring compound under the proposed conditions of use.
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NITE BP - 02351发酵生产的L - 亮氨酸作为营养添加剂或饲料调味化合物用于所有动物物种的饲料和饮用水时提供科学意见。所评估的产品是使用转基因菌株（NITE BP - 02351）发酵生产的L - 亮氨酸。在最终产品中未检测到生产菌株及其重组DNA。使用NITE BP - 02351发酵生产的L - 亮氨酸对生产菌株不会引起任何安全问题。当以适当剂量用于补充日粮时，使用NITE BP - 02351生产的L - 亮氨酸对目标物种是安全的。当用作所有动物物种的调味化合物时，在建议的使用水平25mg/kg下是安全的。使用NITE BP - 02351发酵生产的L - 亮氨酸用于动物营养对动物产品消费者不存在安全问题。该添加剂对皮肤和眼睛无刺激性，不是皮肤致敏剂。处理该添加剂的人员存在因吸入内毒素而接触的风险。使用NITE BP - 02351生产的L - 亮氨酸作为饲料添加剂对环境不构成风险。当用作营养添加剂时，NITE BP - 02351生产的添加剂L - 亮氨酸被视为氨基酸L - 亮氨酸的有效来源。为使补充的L - 亮氨酸在反刍动物中与非反刍动物物种中一样有效，需要防止其在瘤胃中降解。在建议的使用条件下，它也被认为是有效的饲料调味化合物。
