Scientific Opinion on the safety of Solanum glaucophyllum standardised leaves as feed material


Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2015;13(1):3967 [43 pp.].
Panel members at the time of adoption
Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.

The Panel wishes to thank the members of the Working Group on Vitamins, including Georges Bories, Jürgen Gropp and Alberto Mantovani, for the preparatory work on this scientific opinion and EFSA staff Montserrat Anguita, José Cortinas Abrahantes and Paola Manini for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
10 December 2014
Published in the EFSA Journal
16 January 2015
European Food Safety Authority (EFSA), Parma, Italy

Solanum glaucophyllum standardised leaves (PAN) is a mixture of irradiated Solanum glaucophyllum ground leaves and wheat middlings to ensure a concentration of minimum 10  mg glycosylated 1,25-dihydroxycholecalciferol/kg feedingstuff. Glycosylation of the vitamin molecule affected biopotency in poultry and rats, but not in ruminants. Up to 1 000 mg PAN/kg complete diet was considered safe for chickens and piglets. PAN concentrations meeting the chicken’s requirement for vitamin D in diets without supplemental vitamin D3 could not be established. No evidence for an improvement of zootechnical parameters by PAN in diets already supplemented with vitamin D3 was provided for chickens, laying hens and piglets. In dairy cows, PAN had the potential to be efficacious in the prevention of milk fever. However, a feeding regime ensuring its safe use at efficacious doses has not yet been established. No data on safety and efficacy of PAN for other animal species and categories were provided. A water-soluble extract of Solanum glaucophyllum was not genotoxic. A no observed adverse effect level could be not derived from sub-acute toxicity studies in rabbits. A benchmark dose lower confidence limit (BMDL05) based on an increase in plasma calcium in a 28-day repeat dose rat study corresponded to 2 900–3 500 mg PAN/kg diet. Maternal toxicity and fetotoxicity were observed in rats and rabbits at all extract doses tested. An overall safe dose of PAN was not identified from the available toxicological data in laboratory animals. Since PAN did not increase the concentration of 1,25-dihydroxycholecalciferol in animal tissues, the use of PANin animal nutrition is safe for consumers. Inhalation of PAN could be hazardous. PAN was not irritant to skin and eyes and unlikely to cause skin sensitisation. Considering the content of 1,25-dihydroxycholecalciferol in PAN its use in animal nutrition would not pose a risk to the environment.

Solanum glaucophyllum, Solanum glaucophyllum standardised leaves, calcitriol, 1,25-dihydroxycholecalciferol, vitamin D, efficacy, safety
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