Safety and efficacy of a feed additive consisting of a flavonoid-rich dried extract of Citrus × aurantium L. fruit (bitter orange extract) for use in all animal species (FEFANA asbl)

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a dried flavonoid-rich extract of Citrus × aurantium L. fruit (bitter orange extract), when used as a sensory additive for all animal species. The use of the additive in feed was not expected to increase the exposure to furocoumarins of those target species that are already fed citrus by-products to a relevant extent (< 5%). For dog, cat and ornamental fish, not normally exposed to citrus by-products, no conclusion could be drawn. The FEEDAP Panel concluded that the additive under assessment is safe up to the maximum proposed use level of 400 mg/kg for veal calf (milk replacer), sheep, goat, horse and salmon. For the other species, the calculated maximum safe concentration in complete feed is 102 mg/kg for chicken for fattening, 151 mg/kg for laying hen, 136 mg/kg for turkey for fattening, 182 mg/kg for piglet, 217 mg/kg for pig for fattening, 268 mg/kg for sow, 259 mg/kg for dairy cow and 161 mg/kg for rabbit. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed, except dog, cat and ornamental fish. No concerns for consumer safety were identified following the use of the additive up to highest safe level in feed for the target animals. The extract under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. Since the additive contains 5-methoxypsoralen, it may cause phototoxicity. The use of the extract in animal feed under the proposed conditions was not expected to pose a risk for the environment. Bitter orange extract was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Keywords: (‐)-synephrine; 5‐methoxypsoralen; Citrus × aurantium L.; bitter orange extract; flavonoids; flavouring compounds; safety; sensory additives.

Figure 1

Molecular structures, Chemical Abstract System (CAS) numbers and synonyms of the ten flavonoids under assessment (in bold) and of structurally related glycosides and aglycones

Figure 2

Metabolic interconversion of flavone and flavanone aglycons derived after hydrolysis of glycosides present in Citrus × aurantium fruit extract