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, Groop Jürgen, Anguita Montserrat, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi
EFSA J. 2021 Apr 30;19(4):e06538. doi: 10.2903/j.efsa.2021.6538. eCollection 2021 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 a feed additive consisting of vitamin K (phytomenadione) produced by chemical synthesis when used as a nutritional additive in complementary feed of horses at a maximum supplemental level of 14 mg vitamin K/horse per day. The use of vitamin K1 is safe when used as a feed additive for horses under the proposed conditions of use. The use of vitamin K1 in nutrition of horses under the proposed conditions of use is considered safe for the consumer and the environment. No exposure of users by inhalation is expected. The Panel cannot conclude on the potential of the additive to be a skin and eye irritant. Vitamin K1 is considered a moderate dermal sensitiser. Vitamin K1 is an effective source of vitamin K in horse nutrition. The Panel recommends that the specifications of the additive refer to the substance-related impurities listed in the most updated monograph of the European Pharmacopoeia.
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）被要求就一种由化学合成生产的维生素K（植物甲萘醌）组成的饲料添加剂的安全性和有效性提供科学意见，该添加剂用作马匹补充饲料中的营养添加剂时，最大补充水平为每匹马每天14毫克维生素K。在拟议的使用条件下，将维生素K1用作马匹的饲料添加剂是安全的。在拟议的使用条件下，将维生素K1用于马匹营养对消费者和环境而言被认为是安全的。预计使用者不会通过吸入接触到该添加剂。专家小组无法就该添加剂成为皮肤和眼睛刺激物的可能性得出结论。维生素K1被认为是一种中度皮肤致敏剂。维生素K1是马匹营养中维生素K的有效来源。专家小组建议该添加剂的规格应参考欧洲药典最新专论中列出的与物质相关的杂质。
