Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Gropp Jürgen, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wester Pieter, Costa Lucio, Dierick Noël, Leng Lubomir, Manini Paola, Tarrés-Call Jordi, Wallace Robert John
EFSA J. 2018 Jul 12;16(7):e05335. doi: 10.2903/j.efsa.2018.5335. eCollection 2018 Jul.
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 betaine anhydrous produced ■■■■■ as a nutritional additive to be used in feed for all food-producing animal species except rabbits. Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous tissues of vertebrates as an osmolyte ensuring osmoprotection. Betaine anhydrous (97%, 96% or 91%) is considered safe for the target species at a maximum supplementation rate of 2,000 mg betaine/kg complete feed. The use of betaine anhydrous (97%, 96% and 91%) as a feed additive up to a supplementation of 2,000 mg/kg complete feed does not pose concerns to consumer safety. The betaine liquid product contains a high proportion of unknown material (about 30% on dry matter basis). The FEEDAP Panel therefore cannot conclude on the safety of the liquid form of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety for the user. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has a potential to become efficacious in food-producing animal species and categories when administered via feed, especially when methyl groups from methionine or choline are limiting. The FEEDAP Panel made a recommendation on the use of the additive in premixtures without choline chloride.
应欧盟委员会要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就无水甜菜碱作为营养添加剂用于除兔以外的所有食品生产动物饲料的安全性和有效性发表科学意见。甘氨酸甜菜碱（甜菜碱）在生物体内的转甲基反应中作为甲基供体。甜菜碱作为一种渗透剂存在于脊椎动物的许多组织中，可确保渗透保护。无水甜菜碱（97%、96%或91%）在完全饲料中最大添加量为2000毫克甜菜碱/千克时，对目标物种被认为是安全的。使用无水甜菜碱（97%、96%和91%）作为饲料添加剂，添加量高达2000毫克/千克完全饲料，对消费者安全不存在担忧。甜菜碱液体产品含有高比例的未知物质（以干物质计约为30%）。因此，FEEDAP专家小组无法就该添加剂液体形式对目标物种和消费者的安全性得出结论。在缺乏数据的情况下，FEEDAP专家小组无法就对使用者的安全性得出结论。在饲料中添加无水甜菜碱对环境不存在风险。当通过饲料给药时，甜菜碱在食品生产动物物种和类别中具有发挥功效的潜力，特别是当蛋氨酸或胆碱的甲基供应受限的时候。FEEDAP专家小组就该添加剂在不含氯化胆碱的预混料中的使用提出了建议。
