Safety assessment of 16 sweeteners for the Korean population using dietary intake monitoring and poundage method

References

• Abraham RR, Davis M, Yudkin J, Williams R. 1981. Controlled clinical trial of a new non-calorigenic sweetening agent. J Human Nutr. 35:165–172.
   PubMedGoogle Scholar
• Adamson RH, Sieber SM. 1983. Chemical carcinogenesis studies in nonhuman primates. In: Langenbach R, Nesnow S, Rice JM, editors. Organ and species specificity in chemical carcinogenesis. New York: Springer US; p. 129–156.
   Google Scholar
• Akerblom HK, Koivukangas T, Puukka R, Mononen M. 1981. The tolerance of increasing amounts of dietary xylitol in children. Int J Vitam Nutr Res. 22:53–66.
   Google Scholar
• Amyes SJ, Aughton P, Brown PM, Lee P, Ashby R. 1986. 1,6-Dichloro-1,6-dideoxy-ß-d-fructofuranosyl-4-chloro-4-deoxy-d-galactopyranoside (TGS): 104-week combined toxicity and oncogenicity study in CD rats with in utero exposure. Section II: toxicity and oncogenicity study. Unpublished report from Life Science Research Ltd., Essex, U.K. Submitted to the World Health Organization by Tate & Lyle.
   Google Scholar
• Auerbach O, Garfinkel L. 1989. Histologic changes in the urinary bladder in relation to cigarette smoking and use of artificial sweeteners. Cancer. 64:983–987.
   PubMed Web of Science ®Google Scholar
• Barriocanal LA, Palacios M, Benitez G, Benitez S, Jimenez JT, Jimenez N, Rojas V. 2008. Apparent lack of pharmacological effect of steviol glycosides used as sweeteners in humans. A pilot study of repeated exposures in some normotensive and hypotensive individuals and in Type 1 and Type 2 diabetics. Regul Toxicol Pharmacol. 51:37–41.
   PubMed Web of Science ®Google Scholar
• Bircher J. 1982. Treatment of portal systemic encephalopathy with lactitol. Unpublished letter from the University of Bern, submitted by CCA to WHO.
   Google Scholar
• Cavalcante da Silva GE, Assef AH, Albino CC, Ferri LAF, Tasin G, Takahashi MH, Filho WE, Bazotte RB. 2006. Investigation of the tolerability of oral stevioside in Brazilian hyperlipidemic patients. Braz Arch Biol Technol. 49:583–587.
   Web of Science ®Google Scholar
• Chappel CI. 1992. A review and biological risk assessment of sodium saccharin. Regul Toxicol Pharmacol. 15:253–270.
   PubMed Web of Science ®Google Scholar
• Chung MS, Suh HJ, Yoo W, Choi SH, Cho YJ, Cho YH, Kim CJ. 2005. Daily intake assessment of saccharin, stevioside, d-sorbitol and aspartame from various processed foods in Korea. Food Addit Contam. 22:1087–1097.
   PubMed Web of Science ®Google Scholar
• Cohen SM, Arnold LL, Emerson JL. 2008. Safety of saccharin. Agro Food Industry Hi-Tech. 19:24–28.
   Web of Science ®Google Scholar
• Coquet B, Rondot G, Mary MC. 1980. Thirteen-week oral toxicity study in the rat with Lycasin(R) 80/55. Unpublished report from Institut Francais de Recherches et Essais Biologiques, l’Arbresle, France. Submitted to WHO by Roquette Freres.
   Google Scholar
• Danks A, Hooks W, Ashby R, Whitney JC. 1984. Talin: four-week dietary study in rats to investigate thyroid function. Unpublished report No. TYL/073/TAL from Life Science Research, Stock, England. Submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• Eaton KK, Daniel JW, Snodin DJ, Higginbotham JD, Stanworth DR, Al-Mosawie T. 1981. Talin protein: assessment in man for oral allergenicity on challenge testing. Unpublished report submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• EFSA. 1995. Scientific Committee on Food: opinion on saccharin and its sodium, potassium and calcium salts. European Food Safety Authority. http://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scf_7_out26_en.pdf
   Google Scholar
• EFSA. 2000a. Opinion on the re-evaluation of acesulfame K with reference to the previous SCF opinion of 1991, SCF/CS/ADD/EDUL/194 final. European Food Safety Authority. http://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scf_out52_en.pdf
   Google Scholar
• EFSA. 2000b. Scientific Committee on Food: opinion of the Scientific Committee on Food on sucralose. European Food Safety Authority. http://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scf_out68_en.pdf
   Google Scholar
• EFSA. 2010. Scientific opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA J. 8:1537. European Food Safety Authority.
   Google Scholar
• EFSA. 2013. Scientific opinion on the re-evaluation of aspartame (E951) as a food additive. EFSA J. 11:3496. European Food Safety Authority.
   Google Scholar
• Elcock M, Morgan RW. 1993. Update on artificial sweeteners and bladder cancer. Regul Toxicol Phar. 17:35–43.
   PubMed Web of Science ®Google Scholar
• Ferri LAF, Alves-Do-Prado W, Yamada SS, Gazola S, Batista MR, Bazotte RB. 2006. Investigation of the antihypertensive effect of oral crude stevioside in patients with mild hypertension. Phytother Res. 20:732–736.
   PubMed Web of Science ®Google Scholar
• Gallandre F. 1978. Mutagenicity studies with xylitol using various methods for Hoffman-La Roche Laboratories. Submitted to the World Health Organization by F. Hoffman La Roche Co., Ltd., Basel, Switzerland.
   Google Scholar
• Goldenthal EI. 1997. 13-week dietary toxicity study in rats with Hystar liquid carbohydrates products. Unpublished report from MPI Research, Mattawan, Michigan, USA, to Lonza, Inc., Fair Lawn, New Jersey, USA. Submitted to WHO by the International Diabetic Federation, Brussels, Belgium.
   Google Scholar
• Griffiths JC, Borzelleca JF, St Cyr J. 2007. Sub-chronic (13-week) oral toxicity study with d-ribose in Wistar rats. Food Chem Toxicol. 45:144–152.
   PubMed Web of Science ®Google Scholar
• Ha MS, Ha SD, Choi SH, Bae DH. 2013. Assessment of Korean consumer exposure to sodium saccharin, aspartame and stevioside. Food Addit Contam Part A. 30:1238–1247.
   PubMed Web of Science ®Google Scholar
• Herbold B. 1978. Palatinit (Bay i 3930) Salmonella/microsome test to investigate point mutagenicity. Unpublished pharmaceutical report No. 7578 from Bayer A.G., Wuppertal, F.R.G. Submitted to WHO by Bayer A.G.
   Google Scholar
• Higginbotham JD, Snodin DJ, Eaton KK, Daniel JW. 1983. Safety evaluation of thaumatin (Talin protein). Food Chem Toxicol. 21:815–823.
   PubMed Web of Science ®Google Scholar
• Hiroyuki I. 1981. Incidence of brain tumors in rats fed aspartame. Toxicol Lett. 7:433–437.
   PubMed Web of Science ®Google Scholar
• Howe GR, Burch JD, Miller AB, Morrison B, Gordon P, Weldon L, Chambers LW, Fodor G, Winsor GM. 1977. Artificial sweeteners and human bladder cancer. Lancet. 310:578–581.
   Google Scholar
• Hummler H. 1976. Cancerogenese Untersuchungen mit Xylit an der Maus. Unpublished interim report from Huntingdon Research Centre, submitted to the World Health Organization by Hoffmann La Roche and Co., Basel, Switzerland.
   Google Scholar
• Hunter B, Colley J, Street A, Heywood R, Prentice D, Magnusson G. 1978. Xylitol tumorigenicity and toxicity study in long-term dietary administration to rats. Unpublished report from Huntingdon Research Centre, submitted to World Health Organization by F. Hoffman La Roche Co., Ltd., Basel, Switzerland.
   Google Scholar
• JECFA. 1974. Seventeenth report of the Joint FAO/WHO Expert Committee on Food Additives, World Health Organization. WHO Technical Report Series, 539; FAO Nutrition Meetings Report Series, 53.
   Google Scholar
• JECFA. 1981. Evaluation of certain food additives and contaminants. Twenty-fifth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, 669.
   Google Scholar
• JECFA. 1982. Evaluation of certain food additives Food Additives, Twenty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives Series, 17.
   Google Scholar
• JECFA. 1983. Evaluation of certain food additives Food Additives, Twenty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives Series, 18.
   Google Scholar
• JECFA. 1986. Evaluation of certain food additives Food Additives, Twenty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives Series, 20.
   Google Scholar
• JECFA. 1987. Evaluation of certain food additives Food Additives, Tirthieth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, 751.
   Google Scholar
• JECFA. 1991. Evaluation of Certain Food Additives and Contaminants (Thirty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, 806.
   Google Scholar
• JECFA. 1993. Evaluation of certain food additives and contaminants (Forty-first report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, 837.
   Google Scholar
• JECFA. 1999. Evaluation of certain food additives Food Additives, Forty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series,884.
   Google Scholar
• JECFA. 2000. Evaluation of certain food additives Food Additives, Fifty-first report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, 891.
   Google Scholar
• JECFA. 2008. Evaluation of certain food additives (Sixty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, 952.
   Google Scholar
• KNHNES 2013. Korea National Health and Nutrition Examination Survey. https://knhanes.cdc.go.kr
   Google Scholar
• Lee Y, Do B, Lee G, Lim HS, Yun SS, Kwon H. 2017. Simultaneous determination of sodium saccharin, aspartame, acesulfame-K and sucralose in food consumed in Korea using high-performance liquid chromatography and evaporative light-scattering detection. Food Addit Contam Part A. 34:666–677.
   Google Scholar
• MacLeod GL, Eaton KK, Daniel JW, Snodin DJ, Higginbotham JD, Waite D. 1981. Assessment of oral sensitisation and irritation when formulated in peppermint chewing gum. Unpublished report submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• Magnuson BA, Burdock GA, Doull J, Kroes RM, Marsh GM, Pariza MW, Spencer PS, Waddell WJ, Walker R, Williams GM. 2007. Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies. Crit Rev Toxicol. 37:629–727.
   PubMed Web of Science ®Google Scholar
• McConnell RG 1973. SC-18862: two-year toxicity study in the rat. Unpublished report from Hazleton Laboratories, Inc., submitted to the World Health Organization by G. D. Searle & Co., Skokie, Il, USA.
   Google Scholar
• MFDS. 2011. Risk assessment guideline. Ministry of Food and Drug Safety. http://nifds.go.kr/nifds/02_research/sub_09_03.jsp?mode=view&article_no=4767&pager.offset=0&board_no=167&default:category_id=519
   Google Scholar
• MFDS. 2012–2014a. Annual report of food and food additives production. Ministry of Food and Drug Safety. http://www.mfds.go.kr/index.do?mid=1589
   Google Scholar
• MFDS. 2012-2014b. Annual report of imported food test. Ministry of Food and Drug Safety. http://www.mfds.go.kr/index.do?mid=1590
   Google Scholar
• MFDS. 2015. Regulation on risk assessment methods and procedures. Ministry of Food and Drug Safety. http://www.mfds.go.kr/index.do?x=0&searchkey=charge_dept&mid=1013&searchword=y=0&division=&pageNo=1&seq=9915&sitecode=2015-08-21&cmd=v
   Google Scholar
• MFDS. 2016. Korea food additives code. Ministry of Food and Drug Safety. http://www.mfds.go.kr/eng/index_do?nMenuCode=120&page=1&mode=view&boardSeq=70005
   Google Scholar
• Morgan RA, Wong O. 1985. A review of epidemiological studies on artificial sweeteners and bladder cancer. Food Chem Toxicol. 23:529–533.
   PubMed Web of Science ®Google Scholar
• Nasrallah SM, Iber FL. 1969. Mannitol absorption and metabolism in man. Am J Med Sci. 258:80–88.
   PubMed Web of Science ®Google Scholar
• NIFDSE. 2016. National Institute of Food and Drug Safety Evaluation. http://www.nifds.go.kr/nifds/upload/risk/01%20safety%2Assessment%20of%20Sweeteners(web).pdf. http://www.nifds.go.kr/nifds/02_research/sub_09-10jsp?mode=view&articleno=10134&pager.offset=0&board_no=197
   Google Scholar
• Nordic Council of Ministers, Copenhagen. 2002. Food additives in Europe 2000. Status of safety assessments of food additives presently permitted in the EU.
   Google Scholar
• NTP. 1982. Carcinogenesis bioassay of d-mannitol (CAS No. 69-65-8) in F344/N rats and B6C3F1 mice (feed study). National Toxicology Program, Technical Report Series, 236.
   Google Scholar
• Palmer AK, Bottomley AM, Wight DGD, Cherry CP. 1978. Effect of xylitol on reproductive functions of multiple generations in the rat. Final report. Unpublished report from Huntingdon Research Centre, Huntingdon, Cambridgeshire, England; submitted to the World Health Organization by F. Hoffman La Roche Co., Ltd., Basel, Switzerland.
   Google Scholar
• Peters R, Lock RH. 1958. Laxative effect of sorbitol. Br Med J. 2:677.
   PubMed Web of Science ®Google Scholar
• Reuzel PGJ, van der Heijden CA. 1977. Long-term (two-year) oral toxicity study with Hoe 0-95K in beagle dogs. Report No. 5280. Unpublished report of CIVO TNO Zeist. Submitted to WHO by Hoechst A.G.
   Google Scholar
• Risch HA, Burch JD, Miller AB, Hill GB, Steele R, Howe GR. 1988. Dietary factors and the incidence of cancer of the urinary bladder. Am J Epidemiol. 127:1179–1191.
   PubMed Web of Science ®Google Scholar
• Salminen SJ. 1982. Investigations of the toxicological and biological properties of xylitol [dissertation]. Guilford (UK): University of Surrey.
   Google Scholar
• Schoenig GP, Goldenthal EI, Geil RG, Frith CH, Richter WR, Carlborg FW. 1985. Evaluation of the dose response and in utero exposure to saccharin in the rat. Food Chem Toxicol. 23:475–490.
   PubMed Web of Science ®Google Scholar
• Seifert J, Frelich A, Shecterle L, St Cyr J. 2008. Assessment of haematological and biochemical parameters with extended d-ribose ingestion. J Int Soc Sports Nutr. 5:13.
   PubMed Web of Science ®Google Scholar
• Shephard NW, Kyffin P 1984. A tolerance study in normal subjects of varying doses of TGS administered continuously for a period of 13 weeks. Unpublished report from Medical Science Research, Beaconsfield, U.K. Submitted to the World Health Organization by Tate & Lyle.
   Google Scholar
• Sinkeldam EJ, Dreef-van der Meulen HC. 1983. Life-span oral toxicity and carcinogenicity study with Palatinit in rats. Unpublished report No. V 83.412/292021 from Centraal Instituut voor Voedingsonderzoek (CIVO/TNO), Zeist, The Netherlands. Submitted to WHO by Bayer A.G.
   Google Scholar
• Sinkeldam EJ, Hollanders VMH, Woutersen RA. 1982. Multigeneration study with lactitol in rats. Unpublished report from CIVO-TNO, submitted by CCA to WHO.
   Google Scholar
• Sinkeldam EJ, Woutersen RA, Hoetmer A 1981. One-year feeding study with Palatinit in rats. Unpublished report No. V 81.416/212021 from Centraal Instituut voor Voedingsonderzoek (CIVO/TNO), Zeist, The Netherlands. Submitted to WHO by Bayer A.G.
   Google Scholar
• Squire RA. 1985. Histopathological evaluation of rat urinary bladders from the IRDC two-generation bioassay of sodium saccharin. Food Chem Toxicol. 23:491–497.
   PubMed Web of Science ®Google Scholar
• Stokes AF, Belger A, Banich MT, Bernadine E. 1994. Effects of alcohol and chronic aspartame ingestion upon performance in aviation relevant cognitive tasks. Aviat Space Env Med. 65:7–15.
   PubMedGoogle Scholar
• Tacquet A, Devulder AB. 1978. Study of the clinical and biological tolerance of Lycasin 80/55 in man. Unpublished report from Hopital Calmette, Lille, France. Submitted to WHO by Roquette Freres.
   Google Scholar
• Tamta A, Chaudhary M, Sehgal R. 2009. A 28-day sub-acute toxicity study in Swiss albino mice to evaluate toxicity profile of neurotol plus (mannitol and glycerol combination). Int J Biomed Sci. 5:428.
   PubMedGoogle Scholar
• Tesh JM, Davidson EJ, Willoughby CR. 1977a. Talin: test for dominant lethality in the male mouse. Unpublished report No. 77/TYL11/096 from Life Science Research, Stock, England. Submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• Tesh JM, Earthy M, Tesh SA, Willoughby CR. 1977b. Talin: effects of oral administration upon pregnancy in the rat. Unpublished report No. 77/TYL10/179 from Life Science Research, Stock, England. Submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• Tesh JM, Willoughby CR. 1986. 1,6-Dichloro-1,6-dideoxy-ß-d-fructofuranosyl-4-chloro-4-deoxy-alpha-d-galactopyranoside (TGS): two generation reproductive study in rats. Unpublished report from Life Science Research Ltd., Essex, U.K. Submitted to the World Health Organization by Tate & Lyle.
   Google Scholar
• Til HP, Hollanders VMH, Woutersen RA. 1982. Life-span oral carcinogenicity study with lactitol in mice. Unpublished report by CIVO-TNO, submitted by CCA to WHO.
   Google Scholar
• Tompkins GD, Enticknap JB. 1984. A comparison of the effects on the chemical and cellular composition of blood following the administration of thaumatin and egg albumin to human subjects for 13 weeks. Unpublished report submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• Toyoda K, Matsui H, Shoda T, Uneyama C, Takada K, Takahashi M. 1997. Assessment of the carcinogenicity of stevioside in F344 rats. Food Chem Toxicol. 35:597–603.
   PubMed Web of Science ®Google Scholar
• Volz M. 1976. Unpublished Research Report No. 01-L42-0177-76. Submitted to WHO by Hoechst A.G.
   Google Scholar
• Wheeler ML, Fineberg SE, Gibson R, Fineberg N. 1990. Metabolic response to oral challenge of hydrogenated starch hydrolysate versus glucose in diabetes. Diabetes Care. 13:733–740.
   PubMed Web of Science ®Google Scholar
• Wood CM. 1984. 90-day toxicity study in the rat by dietary admixture; further microscopic examination of thyroids from rats in study TAL/1/81. Unpublished report from Toxicol Laboratories Ltd., Ledbury, England. Submitted to WHO by Tate & Lyle PLC.
   Google Scholar
• Zartarian V, Bahadori T, McKone T. 2005. Adoption of an official ISEA glossary. J Expo Sci Environ Epidemiol. 15:1–5.
   Web of Science ®Google Scholar