Scientific Opinion on the safety ofSolanum glaucophyllumstandardised leaves as feed material

Abstract

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 D 3 could not be established. No evidence for an improvement of zootechnical parameters by PAN in diets already supplemented with vitamin D 3 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 (BMDL 05 ) 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 PAN in 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. SUMMARYFollowing 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 of leaves of Solanum glaucophyllum (SG) as feed material. The scientific opinion should cover, in particular, the content of glycosides of 1,25-dihydroxycholecalciferol in the ground leaves and the supply with and the physiology of vitamin D in the target species.In the view of the EFSA FEEDAP Panel, Solanum glaucophyllum standardised leaves (PAN) was a compound feed. It consisted of a mixture of irradiated Solanum glaucophyllum ground leaves and wheat middlings to ensure a concentration of minimum 10 mg glycosylated 1,25-dihydroxycholecalciferol (1,25(OH) 2 D 3 )/kg feedingstuff.Glycosylation of the vitamin molecule affected biopotency in poultry and rats, but not in ruminants.The species-related differences in biopotency of glycosylated 1,25(OH) 2 D 3 prevented the setting of a universal vitamin D bioequivalence of PAN in terms of international units.Based on the limited number of endpoints, up to 1 000 mg...

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

“…The main active components responsible for the vitamin D‐like activity of S. glaucophyllum are the glycosides of calcitriol. According to the previous opinion of the FEEDAP Panel (EFSA FEEDAP Panel, 2015 ) ‘Glycoside conjugation to hydroxy groups of the aglycone occurs at C1, C3 and C25. The molecular distribution of glycosyl moieties has been found to be 1–12 hexose units per aglycone; a mono‐glycoside as well as di‐ and tri‐glycosides have been identified’.…”

“…EFSA issued an opinion on the safety and efficacy of S. glaucophyllum standardised leaves when used as a feed material (EFSA FEEDAP Panel, 2015 ).…”

“…Administration of calcitriol before parturition is expected to stabilise blood calcium and to provide enough Ca for milk production. The FEEDAP Panel already concluded in 2015 (EFSA FEEDAP Panel, 2015 ) that S. glaucophyllum leaves have ‘the potential to be efficacious in the prevention of milk fever in dairy cows. This conclusion is extended to other dairy ruminants’.…”

Safety of vitamin D3 addition to feedingstuffs for fish

“…In 2012, 2013 and 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued three opinions on the safety and efficacy of vitamin D 3 (cholecalciferol) as an additive to feed and water for drinking for all animal species (EFSA FEEDAP Panel, 2012a, 2014, 2015. The FEEDAP Panel noted that whereas for many terrestrial species (turkeys for fattening, equines, bovines, ovine and pigs) the current maximum authorised contents of vitamin D 3 in feeds do not provide any margin of safety, no safety concern was identified for the use of vitamin D 3 in fish.…”

“…Moreover, a few plants (e.g. Solanum glaucophyllum and Trisetum flavescens) are known to produce vitamin D 3 -related metabolites (EFSA FEEDAP Panel, 2015). Both forms of the vitamin can also be produced by chemical synthesis.…”