经过评估,专家小组认为,在特定的使用条件下,该添加剂对消费者和环境是安全的。部分原文报道如下:
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Solanum glaucophyllum leaf extract (SGE) as a nutritional additive for dairy cows and other dairy ruminants. However, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered the glycosides of 1,25-dihydroxycholecalciferol (1,25[OH]
2D
3
) as the active substance and the bolus containing SGE-derived 1,25[OH]2D3as the preparation of the additive. The product is intended to be administered to dairy ruminants during the pre-parturient (period from 9 days before calving to immediately before calving). The FEEDAP Panel concluded that the administration of one bolus, the preparation of the additive as applied in the animal studies evaluated, containing 500 g of SGE-derived 1,25[OH]2D3during the pre-parturient period is safe for cows. Owing to the lack of data, the Panel could not conclude on the safety for of a subsequent administration of a second bolus or on the safety of another SGE-derived 1,25[OH]2D3preparation for use in dairy ruminants other than cows (Bos taurus). The Panel considered that, under the specified conditions of use, the product is safe for the consumer and the environment. The bolus, a preparation containing SGE, as a source of the active substance, is not irritating to skin and eyes and it is not a sensitiser. Exposure via inhalation is unlikely. The Panel concluded that the administration of the bolus, the preparation of the additive as applied in the animal studies evaluated, containing 500 g of SGE-derived 1,25[OH]2D3in a period from 9 days before calving to immediately before calving has the potential to prevent hypocalcaemia in dairy cows. Owing to the lack of data with another preparation, the Panel could not conclude on the efficacy in other dairy ruminants.
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