Safety and efficacy of a feed additive consisting of Solanum glaucophyllum leaf extract for dairy cows and other dairy ruminants (Herbonis Animal Health Gmbh)

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](2)D(3)) as the active substance and the bolus containing SGE‐derived 1,25[OH](2)D(3) as 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 μg of SGE‐derived 1,25[OH](2)D(3) during 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](2)D(3) preparation 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 μg of SGE‐derived 1,25[OH](2)D(3) in 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.