Abstract
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.
Keywords: Sensory additive, flavourings, dihydrochalcones, neohesperidine dihydrochalcone, safety
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) ; 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. EFSA Journal 2011;9(12):2444. [13 pp.]. doi: 10.2903/j.efsa.2011.2444.
Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Reinhard Kroker, Lubomir Leng, Anne‐Katrine Lundebye Haldorsen, Secundino Lopez Puente, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen, Johannes Westendorf
Correspondence: feedap@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group on Feed Flavourings, including Paul Brantom, Joaquim Brufau, Gérard Pascal and Guido Reychen, for the preparatory work on this scientific opinion.
Adoption date: 15 November 2011
Published date: 2 December 2011
Question number: EFSA‐Q‐2010‐01229
On request from: European Commission
References
- Borrego F and Montijano H, 2001. Neohesperidine Dihydrochalcone. In: Nabors LO. Alternative sweeteners. Third Edition, Marcel Dekker, Inc., New York, 87–104. [Google Scholar]
- Borrego F, 2010. Metabolism and Toxicology of NHDC. Neohesperidine dihydrochalcone. Unveröffentliches Manuskript, 20 May 2010, Barcelona. [Google Scholar]
- Braune A, Engst W and Blaut M, 2005. Degradation of neohesperidin dihydrochalcone by human intestinal bacteria. Journal of Agricultural Food Chemistry 53, 1782–1790. [DOI] [PubMed] [Google Scholar]
- Canales I, Borrego F and Lindley MG, 1993. Neohesperidin dihydrochalcone stability in aqueous buffer solutions. Journal of Food Science, 58, 589–591. [Google Scholar]
- EFSA Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) , 2010. Scientific Opinion on Flavouring Group Evaluation 32 (FGE.32). Flavonoids (Flavanones and dihydrochalcones) from chemical groups 25 and 30. EFSA Journal, 8 (9): 1065. [Google Scholar]
- European Pharmacopeia (PhEur) , 2010. Neohesperidin‐dihydrochalcone, Monograph (MG) 1547. 7th Edition. Strasbourg, France. Council of Europe (COE) – European Directorate for the Quality of Medicines. [Google Scholar]
- Horowitz RM, Gentili B, 1991. Dihydrochalcone sweeteners from citrus flavanones. In: Nabors LO, Gelardi RC (Eds.). Alternative Sweeteners. 2nd Ed. Marcel Dekker, Inc., New York, 97–115. [Google Scholar]
- Lindley M, 2006. Other Sweeteners (16). In: Mitchell H, Sweeteners and sugar alternatives in food technology. Blackwell Publishing, 331–360. [Google Scholar]
- Montijano H, Borrego F, Tomas‐Barberan FA and Lindley MG, 1997. Stability of neohesperidine dihydrochalcone in a lemonade system. Food Chemistry, 58, 1, 13–15. [Google Scholar]
- EC (European Commission) , 1989, online. Reports of the Scientific Committee for Food (Twenty‐first series). Directorate‐General Internal Market and Industrial Affairs. Available from ec.europa.eu/food/fs/sc/scf/reports/scf_reports_21.pdf
- EC (European Commission) , 1995. First annual report on chemically defined flavouring substances. May 1995, 2nd draft prepared by the SCF Working Group on Flavouring Substances (Submitted by the SCF Secretariat, 17 May 1995). CS/FLAV/FL/140‐Rev2. Annex 6 to Document III/5611/95, European Commission, Directorate‐General III, Industry.
- Shaw LJ, Morris P and Hooker JE, 2006. Perception and modification of plant flavonoid signals by rhizosphere microorganisms. Environmental Microbiology, 8, 1867–1880. [DOI] [PubMed] [Google Scholar]