Safety of hydroxytyrosol as a novel food pursuant to Regulation (EC) No 258/97

EFSA Journal

Volumn 15, Issue 3, 2017, Pages

  Turck, Dominique ^a   Bresson, Jean Louis ^a   Burlingame, Barbara ^a   Dean, Tara ^a   Fairweather Tait, Susan ^a   Heinonen, Marina ^a   Hirsch Ernst, Karen Ildico ^a   Mangelsdorf, Inge ^a   McArdle, Harry J ^a   Naska, Androniki ^a   Neuhüauser Berthold, Monika ^a   Nowicka, Gra_Zyna ^a   Pentieva, Kristina ^a   Sanz, Yolanda ^a   Siani, Alfonso ^a   Sjüodin, Anders ^a   Stern, Martin ^a   Tomée, Daniel ^a   Vinceti, Marco ^a   Willatts, Peter ^a   Engel, Karl–Heinz ^a   Marchelli, Rosangela ^a   Püoting, Annette ^a   Poulsen, Morten ^a   Schlatter, Josef ^a   Turla, Emanuela ^a   van Loveren, Henk ^a   more..

^a NONE

Author keywords

hydroxytyrosol; ingredient; novel food; safety

Indexed keywords

EID: 85137718595     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/J.EFSA.2017.4728     Document Type: Article

References (44)

1. Antolovich M, Bedgood Jr DR, Bishop AG, Jardine D, Prenzler PD and Robards K, 2004. LC-MS investigation of oxidation products of phenolic antioxidants. Journal of Agricultural and Food Chemistry, 52, 962–971.
2. Attya M, Benabdelkamel H, Perri E, Russo A and Sindona G, 2010. Effects of conventional heating on the stability of major olive oil phenolic compounds by tandem mass spectrometry and isotope dilution assay. Molecules, 15, 8734–8746.
3. Auñnon-Calles D, Canut L and Visioli F, 2013a. Toxicological evaluation of pure hydroxytyrosol. Food and Chemical Toxicology, 55, 498–504.
4. Auñnon-Calles D, Giordano E, Bohnenberger S and Visioli F, 2013b. Hydroxytyrosol is not genotoxic in vitro. Pharmacological Research, 74, 87–93.
5. Bai C, Yan X, Takenaka M, Sekiya K and Nagata T, 1998. Determination of synthetic hydroxytyrosol in rat plasma by GC-MS. Journal of Agricultural and Food Chemistry, 46, 3998–4001.
6. Bianco A and Uccella N, 2000. Biophenolic components of olives. Food Research International, 33, 475–485.
7. Bianco A, Buiarelli F, Cartoni G, Coccioli F, Jasionowska R and Margherita P, 2003. Analysis by liquid chromatography-tandem mass spectrometry of biophenolic compounds in olives and vegetation waters, Part I. Journal of Separation Science, 26, 409–416.
8. Bitler CM, Matt K, Irving M, Hook G, Yusen J, Eagar F, Kirschner K, Walker B and Crea R, 2007. Olive extract supplement decreases pain and improves daily activities in adults with osteoarthritis and decreases plasma homocysteine in those with rheumatoid arthritis. Nutrition Research, 27, 470–477.
9. de Bock M, Derraik JG, Brennan CM, Biggs JB, Morgan PE, Hodgkinson SC, Hofman PL and Cutfield WS, 2013. Olive (Olea europaea L.) leaf polyphenols improve insulin sensitivity in middle-aged overweight men: a randomized, placebo-controlled, crossover trial. PLoS ONE, 8, e57622.
10. Brenes M, Garcia A, Dobarganes MC, Velasco J and Romero C, 2002. Influence of thermal treatments simulating cooking processes on the polyphenol content in virgin olive oil. Journal of Agricultural and Food Chemistry, 50, 5962–5967.
11. Christian MS, Sharper VA, Hoberman AM, Seng JE, Fu L, Covell D, Diener RM, Bitler CM and Crea R, 2004. The toxicity profile of hydrolyzed aqueous olive pulp extract. Drug and Chemical Toxicology, 27, 309–330.
12. D’Angelo S, Manna C, Migliardi V, Mazzoni O, Morrica P, Capasso G, Pontoni G, Galletti P and Zappia V, 2001. Pharmacokinetics and metabolism of hydroxytyrosol, a natural antioxidant from olive oil. Drug Metabolism and Disposition, 29, 1492–1498.
13. D’Antuono I, Garbetta A, Ciasca B, Linsalata V, Minervini F, Lattanzio VM, Logrieco AF and Cardinali A, 2016. Biophenols from table olive cv Bella di Cerignola: chemical characterization, bioaccessibility, and intestinal absorption. Journal of Agricultural and Food Chemistry, 64, 5671–5678.
14. Di Maio I, Esposto S, Taticchi A, Selvaggini R, Veneziani G, Urbani S and Servili M, 2011. HPLC-ESI-MS investigation of tyrosol and hydroxytyrosol oxidation products in virgin olive oil. Food Chemistry, 125, 21–28.
15. Dolan LC, Hofman-Huther H and Amann N, 2014. Hydroxytyrosol: lack of clastogenicity in a bone marrow chromosome aberration study in rats. Biomed Central Research Notes, 7, 923.
16. EFSA (European Food Safety Authority), 2011. Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment. EFSA Journal 2011;9(3):2097, 34 pp. doi:10.2903/j.efsa.2011.2097
17. EFSA Scientific Committee, 2001. Scientific Opinion on genotoxicity testing strategies applicable to food and feed safety assessment. EFSA Journal 2011;9(9):2379, 69 pp. doi:10.2903/j.efsa.2011.2379
18. Fito M, de la Torre R, Farre-Albaladejo M, Khymenetz O, Marrugat J and Covas MI, 2007. Bioavailability and antioxidant effects of olive oil phenolic compounds in humans: a review. Annali dell’Istituto Superiore di Sanita, 43, 375–381.
19. Gonzalez-Santiago M, Fonolla J and Lopez-Huertas E, 2010. Human absorption of a supplement containing purified hydroxytyrosol, a natural antioxidant from olive oil, and evidence for its transient association with low-density lipoproteins. Pharmacological Research, 61, 364–370.
20. Harlan CCR, 2013. Study title: ‘chromosome aberration test in human lymphocytes in vitro with hydroxytyrosol’. Study Report 1485600.
21. Harlan Laboratories SA, 2013. Study title: ‘13-week toxicity study, oral (gavage) in rat with a 4-week recovery period’. Study Report S35528.
22. Heilman J, Anyangwe N, Tran N, Edwards J, Beilstein P and Lopez J, 2015. Toxicological evaluation of an olive extract, H35: subchronic toxicity in the rat. Food and Chemical Toxicology, 84, 18–28.
23. Kirkland D, Edwards J, Woehrle T and Beilstein P, 2015. Investigations into the genotoxic potential of olive extracts. Mutation Research. Genetic Toxicology and Environmental Mutagenesis, 777, 17–28.
24. Kountouri AM, Mylona A, Kaliora AC and Andrikopoulos NK, 2007. Bioavailability of the phenolic compounds of the fruits (drupes) of Olea europaea (olives): impact on plasma antioxidant status in humans. Phytomedicine, 14, 659–667.
25. Miro-Casas E, Farre Albadalejo M, Covas Planells MI, Fito Colomer M, Lamuela Raventos RM and de la Torre Fornell R, 2001a. Tyrosol bioavailability in humans after ingestion of virgin olive oil. Clinical Chemistry, 47, 341–343.
26. Miro-Casas E, Farrée AM, Covas MI, Ortuñno J, Menoyo E, Lamuela RM and de la Torre R, 2001b. Capillary gas chromatography mass spectrometry quantitative determination of hydroxytyrosol and tyrosol in human urine after olive oil intake. Analytical Biochemistry, 294, 63–72.
27. Miro-Casas E, Covas MI, Farre M, Fito M, Ortuno J, Weinbrenner T, Roset P and de la Torre R, 2003. Hydroxytyrosol disposition in humans. Clinical Chemistry, 49, 945–952.
28. Neveu V, Perez-Jimenez J, Vos F, Crespy V, du Chaffaut L, Mennen L, Knox C, Eisner R, Cruz J, Wishart D and Scalbert A, 2010. Phenol-Explorer: an online comprehensive database on polyphenol contents in foods. Available online: http://phenol-explorer.eu/compounds
29. OECD (Organisation for Economic Co-operation and Development), 1997a. Test No. 471: bacterial reverse mutation test. In: OECD guidelines for the testing of chemicals, Section 4: Health effects, 11 pp.
30. OECD (Organisation for Economic Co-operation and Development), 1997b. Test No. 473: in vitro mammalian chromosome aberration test. In: OECD guidelines for the testing of chemicals, Section 4: Health effects, 10 pp.
31. OECD (Organisation for Economic Co-operation and Development), 1998a. Test No. 408: repeated dose 90-day oral toxicity study in rodents. In: OECD guidelines for the testing of chemicals, Section 4: Health effects, 10 pp.
32. OECD (Organisation for Economic Co-operation and Development), 1998b. OECD Principles of good laboratory practice (as revised in 1997). OECD series on principles of good laboratory practice and compliance monitoring, number 1, ENV/MC/CHEM(98)17, 41 pp.
33. OECD (Organisation for Economic Co-operation and Development), 2014. Test No. 475: mammalian bone marrow chromosomal aberration test. In: OECD guidelines for the testing of chemicals, Section 4: Health effects, 16 pp.
34. Raederstorff D, 2009. Antioxidant activity of olive polyphenols in humans: a review. International Journal for Vitamin and Nutrition Research, 79, 152–165.
35. Romani A, Mulinacci N, Pinelli P, Vincieri FF and Cimato A, 1999. Polyphenolic content in five tuscany cultivars of Olea europaea L. Journal of Agricultural and Food Chemistry, 47, 964–967.
36. Seprox BIOTECH SL, 2013 (unpublished). Study title: ‘pharmacokinetics of 3,4-hydroxyphenylacetic acid (DOPAC), hydroxytyrosol and hydroxytyrosol acetate after one single oral administration to Sprague Dawley rats’. Study Report N-01460.
37. de la Torre R, 2008. Bioavailability of olive oil phenolic compounds in humans. Inflammopharmacology, 16, 245–247.
38. Tuck KL, Freeman MP, Hayball PJ, Stretch GL and Stupans I, 2001. The in vivo fate of hydroxytyrosol and tyrosol, antioxidant phenolic constituents of olive oil, after intravenous and oral dosing of labeled compounds to rats. Journal of Nutrition, 131, 1993–1996.
39. Visioli F, Galli C, Bornet F, Mattei A, Patelli R, Galli G and Caruso D, 2000a. Olive oil phenolics are dose-dependently absorbed in humans. FEBS Letters, 468, 159–160.
40. Visioli F, Caruso D, Galli C, Viappiani S, Galli G and Sala A, 2000b. Olive oils rich in natural catecholic phenols decrease isoprostane excretion in humans. Biochemical and Biophysical Research Communications, 278, 797–799.
41. Visioli F, Galli C, Grande S, Colonnelli K, Patelli C, Galli G and Caruso D, 2003. Hydroxytyrosol excretion differs between rats and humans and depends on the vehicle of administration. Journal of Nutrition, 133, 2612–2615.
42. Vissers MN, Zock PL, Roodenburg AJ, Leenen R and Katan MB, 2002. Olive oil phenols are absorbed in humans. Journal of Nutrition, 132, 409–417.
43. Vissers MN, Zock PL and Katan MB, 2004. Bioavailability and antioxidant effects of olive oil phenols in humans: a review. European Journal of Clinical Nutrition, 58, 955–965.
44. Vivotecnia Research, 2010. Study title: ‘bacterial reverse mutation test’. Study Report B-01108.