Scientific Opinion on the safety and efficacy of neohesperidine dihydrochalcone when used as a sensory additive for piglets, pigs for fattening, calves for rearing and fattening, lambs for rearing and fattening, dairy sheep, ewes for reproduction, salmonids and dogs

摘要

Neohesperidine dihydrochalcone (NHDC) is an artificial sweetener derived from neohesperidine extracted from the immature fruit of Citrus aurantium (bitter orange), or obtained from naringin, the main flavonoid in Citrus paradisii (grapefruit). It is intended for use as a sensory additive (functional group: feed flavourings) at a maximum recommended dose of 35 mg NHDC/kg complete feed or 5 mg NHDC/L water for drinking. The use levels of up to 35 mg NHDC/kg feed and 5 mg NHDC/L water for drinking proposed by the applicant are safe for piglets (sucking and weaned), pigs for fattening, calves for rearing, calves for fattening, lambs for rearing, lambs for fattening, dairy sheep, ewes for reproduction, salmon and trout, and dogs, with a margin of safety ranging from 3 to 8. Given the likely rapid metabolism and excretion of NHDC, it would not be expected to accumulate in edible tissues of mammals and poultry given this substance in feed. In consequence, the exposure of consumers to NHDC in food would not be significantly increased by its use as a feed additive for mammals and poultry. However, the lack of data on metabolism and residues in fish precludes an assessment of consumer exposure from this source. No data relevant to an assessment of user safety was made available. The applicant considers that the additive in solid form is a possible respiratory irritant. In view of the fast degradation expected for NHDC and its metabolites, no impact on the environment is foreseen from the use of NHDC in animal feed. Since its function in feed is essentially the same as that in food, no further demonstration of efficacy is considered necessary.