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Polysorbates 20, 60, 65 and 80) Original: Japanese Provisional translation Evaluation Report of Food Additives Polysorbates (Polysorbates 20, 60, 65 and 80) June 2007 Food Safety Commission Contents History of deliberation.......................................................................................................1 Members of the Food Safety Commission.........................................................................1 Expert members of the Expert Committee on Food Additives, Food Safety Commission.…………1 Evaluation results on the Health Risk Assessment of Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80 as food additives...................................................................................................2 Summary.............................................................................................................................................. 2 1. Introduction...................................................................................................................................... 3 2. Background...................................................................................................................................... 3 3. Outline of the designation of food additives.................................................................................... 3 4. Name, etc. ........................................................................................................................................ 3 (1) Polysorbate 20 ....................................................................................................................... 4 (2) Polysorbate 60 ....................................................................................................................... 4 (3) Polysorbate 80 ....................................................................................................................... 4 (4) Polysorbate 65 ....................................................................................................................... 5 5. Safety ............................................................................................................................................... 5 (1) Disposition (absorption, distribution, metabolism, excretion and degradation)........................... 5 (2) Toxicity...................................................................................................................................... 6 (1) Acute toxicity......................................................................................................................... 6 (2) Repeated-dose toxicity ........................................................................................................... 6 (3) Genotoxicity........................................................................................................................... 8 (4) Carcinogenicity ...................................................................................................................... 9 (5) Other carcinogenicity (combined administration with a known carcinogen)......................... 11 (6) Reproductive and developmental toxicity............................................................................. 12 (7) Local irritation...................................................................................................................... 14 (8) Sensitization ......................................................................................................................... 15 6. Evaluation in international organizations ...................................................................................... 15 (1) Evaluation in JECFA ............................................................................................................... 15 (2) Evaluation in the Science Committee on Food (SCF) ............................................................... 15 (3) Evaluation in the U.S. Food and Drug Administration (FDA) .................................................. 16 (4) Evaluation in the International Agency for Research on Cancer (IARC) .................................. 16 7. Estimation of the daily intake ....................................................................................................... 16 8. Evaluation results........................................................................................................................... 17 [References] ....................................................................................................................................... 19 Safety study results of polysorbate 20 ...............................................................................................24 Safety study results of polysorbate 60 ...............................................................................................26 Safety study results of polysorbate 65 ...............................................................................................29 Safety study results of polysorbate 80 ...............................................................................................31 〈History of deliberation〉 October 8, 2003 Request for the food safety risk assessment related to designation of food additives by the Minister of Health, Labour and Welfare, and acceptance of relevant documents October 16, 2003 15th Meeting of the Food Safety Commission (requested items were explained) October 29, 2003 1st Meeting of the Expert Committee on Food Additives April 27, 2004 8th Meeting of the Expert Committee on Food Additives July 28, 2004 11th Meeting of the Expert Committee on Food Additives September 8, 2004 12th Meeting of the Expert Committee on Food Additives April 13, 2006 31st Meeting of the Expert Committee on Food Additives March 23, 2007 42nd Meeting of the Expert Committee on Food Additives April 12, 2007 186th Meeting of the Food Safety Commission (report) April 12 - May 11 2007 Hearing of public opinions and information May 29, 2007 44th Meeting of the Expert Committee on Food Additives June 5, 2007 Report from the chairman of the Expert Committee on Food Additives to the chairman of the Food Safety Commission June 7, 2007 193rd Meeting of the Food Safety Commission (report) (Notified to the Minister of Health, Labour and Welfare as of the same date) 〈Members of the Food Safety Commission〉 Expires on June 30, 2006 Dr. Masaaki Terada (chairman) Dr. Yasuhiko Nakamura Dr. Tadao Terao (deputy chairman) Dr. Seiichi Honma Dr. Naoko Koizumi Dr. Takeshi Mikami Dr. Motoko Sakamoto Expires on December 20, 2006 Dr. Masaaki Terada (chairman) Dr. Kazumasa Nomura Dr. Takeshi Mikami (deputy chairman) Dr. Keiko Hatae Dr. Naoko Koizumi Dr. Seiichi Honma Dr. Taku Nagao Enter on December 21, 2006 Dr. Takeshi Mikami (chairman) Dr. Keiko Hatae Dr. Naoko Koizumi (deputy chairman＊) Dr. Masao Hirose＊＊ Dr. Taku Nagao Dr. Seiichi Honma Mr. Kazumasa Nomura ＊ Enter on February 1, 2007 ＊＊ Enter on April 1, 2007 〈Expert members of the Expert Committee on Food Additives, Food Safety Commission〉 From September 25, 2003 to September 30, 2005 Dr. Shoji Fukushima (chairman) Dr. Yasuo Ono Dr. Yasushi Yamazoe (deputy chairman) Dr. Akiyoshi Nishikawa Dr. Kazuhide Inoue Dr. Makoto Hayashi Dr. Katsumi Imaida Dr. Kunitoshi Mitsumori Dr. Makoto Ema Dr. Nobuo Yoshiike Enter on October 1, 2005 Dr. Shoji Fukushima (chairman) Dr. Kikue Kubota Dr. Yasushi Yamazoe (deputy chairman) Dr. Emi Nakashima Dr. Mayumi Ishizuka Dr. Akiyoshi Nishikawa Dr. Kazuhide Inoue Dr. Makoto Hayashi Dr. Katsumi Imaida Dr. Kunitoshi Mitsumori Dr. Makoto Ema Dr. Nobuo Yoshiike Dr. Yasuo Ono 〈Expert witness （Pesticides Expert Committee）〉 Masato Naya 1 Evaluation Report of Food Additives “Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80” June, 2007 Food Safety Commission [Summary] Assessment of the effect of food on health of “Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80” (CAS number.: 9005-64-5, 9005-67-8, 9005-71-4 and 9005-65-6), an food additive used as the emulsifier, was performed by using various study data. The data used for the assessment included those of repeated-dose toxicity, carcinogenicity, reproductive and developmental toxicity, genotoxicity and etc.. No essential differences in disposition or adverse effects were observed among 4 polysorbates, and they were therefore treated as one group. Study results of the polysorbates, showed no carcinogenicity and genotoxicity. In repeated-dose toxicity studies, diarrhea was observed as a major symptom. In a single-dose neurodevelopmental toxicity study with rats by Brubaker et al., behavioral changes were observed in litters of treated rats and an additional study to confirm these effects was therefore carried out. Maternal toxicity occurs in a 7.5 vol% treated group, and in litter decreased weight gain, a lower avoidance rate in a conditioned avoidance response study, and etc. were observed. In a ≤1% treated group, there was no effect on the mother rats and their subsequent generations (F1). The lifetime cancer risk which was in turn calculated from the estimated consumption in the U.S. Levels and lifetime cancer risk due to impurities contained in the polysorbates was considered to be very low, based on the estimated consumption in Japan, were estimated to be less than one millionth of the genotoxic carcinogen level that can generally be ignored. The risk management organization should, however, continue to reduce the residues at a technically possible level. Based on the occurrence of diarrhea in rats fed polysorbate 60 in a 13
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