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

on the Wiley Online Library

Metadata

Panel members at the time of adoption

Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

Abstract

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]2D3) as the active substance and the bolus containing SGE‐derived 1,25[OH]2D3 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]2D3 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]2D3 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]2D3 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.

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