Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on the food colour Red 2G (E128) based on a request from the Commission related to the re-evaluation of all permitted food additives

EFSA Journal

Volumn 5, Issue 7, 2007, Pages

[No Author Info available]

Author keywords

Acid Red 1; afc panel; CAS 3734 67 6; E 128; efsa; Ext. D C Red no 11; Food colour; opinion; Red 2G

Indexed keywords

EID: 85078389569     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2007.515     Document Type: Article

References (48)

1. BIBRA (1965). Acute and short-term feeding studies on Red 2G with associated haematological investigations, British Industrial Biological Research Association, Research Report 3/1965. Unpublished report submitted to WHO (as referred to by JECFA, 1981).
2. Bomhard, E. M. and Herbold, B. A. (2005). Genotoxic activities of aniline and its metabolites and their relationship to the carcinogenicity of aniline in the spleen of rats. Crit. Rev. Toxicol., 35, 783–835
3. Cambridge, G. W. et al. (1980). Teratology study on Red 2G in the Colworth Wistar Rat. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
4. ChemIDplus Advanced (via internet, 2006). Accessible via: chem.sis.nlm.nih.gov/chemidplus/
5. CIIT (1982). 104-Week Chronic Toxicity Study in Rats. Aniline Hydrochloride. Final Report. Hazleton Laboratories America Inc., Project No. 2010-101, Virginia, USA.
6. Codex Alimentarius (via internet, 2006). Accessible via: www.codexalimentarius.net/gsfaonline/index.html
7. Daniel, J. W. (1962). The excretion and metabolism of edible colours. Tox. Appl. Pharmacol., 4, 572 (described in JECFA 1981 without reference; original study revisited).
8. EC (1994) Directive 94/36/EC of the European Parliament and the Council of 30 June 1994 on colours for use in foodstuffs.
9. EC (1995) Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs.
10. Edwards, C. N. and Combes, R. D. (1983). Studies on the mutagenicity of commercial preparations of the food colour Red 2G after purification or oxidation. Mut. Res., 117, 127–134 (as referred to by TemaNord, 2002).
11. Edwards, C. N. and Combes, R. D. (1981). An evaluation of the Drosophila zeste somatic eye mutation test for the detection of genotoxic azo dyes and an aromatic amine. Mut. Res., 84, 221–226 (as referred to by TemaNord, 2002).
12. Edwards, C. N. and Combes, R. D. (1984). Mutagenicity studies of urine and faecal samples from rats treated orally with the food colourings Brown FK and Red 2G. Food Chem. Toxicol., 22, 593–597 (as referred to by TemaNord, 2002).
13. EPA. Report Doc #88-890000051NTIS, 1988 (as referred to by TemaNord, 2002).
14. EPA. Report Doc #89-890000082NTIS, 1989 (as referred to by TemaNord, 2002).
15. EU, 2004. European Chemicals Bureau. Institute for Health and Consumer Protection. European Union Risk Assessment Report on Aniline. Volume 50.
16. Freifield, H., Schilowa, A. and Ludwinowsky, R. (1937). Heinz bodies and methaemoglobin formation in poisoning by compounds containing amino and nitro groups. Folia Haematol., 56, 333–342 (as referred to by JECFA, 1981).
17. Gellatly, J. B. M. and Burrough, R. (1966). Effects of diets containing aniline and metabolites of aniline on spleen weights; pathology. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd (as referred to by JECFA, 1981).
18. Gellatly, J. B. M. and Burrough, R. (1967). Pathology of Red 2G and phenylhydroxylamine in fat diets. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
19. Gellatly, J. B. M., Salmond, G. and Burrough, R. (1966). Sub-acute toxicity of Red 2G; pathology. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
20. Haveland-Smith, R. B., Combes, R. D. and Bridges, B. A. (1979). Methodology for the testing of food dyes for genotoxic activity: Experiments with Red 2G (C.I. 18050). Mut. Res., 64, 241–248 (as referred to by JECFA, 1981).
21. Haveland-Smith, R. B. and Combes, R. D. (1980a). Screening of food dyes for genotoxic activity. Food Cosmet. Toxicol., 18, 215–221 (as referred to by JECFA, 1981).
22. Haveland-Smith, R. B. and Combes, R. D. (1980b). Genotoxicity of the food colours Red 2G and Brown FK in bacterial systems. Use of structurally-related dyes and azo-reduction. Food Cosmet. Toxicol., 18, 223–228 (as referred to by JECFA, 1981).
23. Hughes, J. P. and Treon, J. F. (1954). Erythrocytic inclusion bodies in the blood of chemical workers. Arch. Hyg. occup. Med., 10, 192–202 (as referred to by JECFA, 1981).
24. th report (1981a). FAO/WHO Joint Expert Committee on Food Additives. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 16.
25. th report (1981b). FAO/WHO Joint Expert Committee on Food Additives. Evaluation of certain food additives. WHO Technical Report Series, No. 669.
26. rd meeting (2004) (via internet, 2006). Joint FAO/WHO Expert Committee on Food Additives. Aluminium Lakes of Colouring Matters, General Specifications. Accessible via: www.fao.org/ag/agn/jecfa-additives/specs/Monograph1/Additive013.pdf
27. Jenkins, F. P. and Campbell, P. J. (1966). Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever ltd. (as referred to by JECFA, 1981).
28. Jenkins, F. P. et al. (1966a). Metabolism of Red 2G by rat liver homogenate. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
29. Jenkins, F. P. (1966b). Metabolism of Red 2G (protein binding capacity). Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
30. Jenkins, F. P. at al. (1966c). Effects of diets containing aniline and metabolites of aniline on spleen weights. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
31. Jenkins, F. P. et al. (1966d). Sub-acute toxicity of Red 2G. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
32. Jenkins, F. P., Salmond, G. and Gellatly, J. B. M. (1966e). Sub-acute toxicity of Red 2G in sausage meat. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
33. Jenkins, F. P. et al. (1967). Effect of Red 2G and phenylhydroxylamine on spleen weight. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
34. Jenkins, F. P. et al. (1972). The no-effect dose of aniline in human subjects and a comparison of aniline toxicity in man and rat. Food Cosmet. Toxicol., 10, 671–679(as referred to by JECFA, 1981).
35. Jenkins, F. P., Kennedy, S. and Williams, T. C. (1980). Erythropoiesis in the Colworth Wistar rat fed Red 2G. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
36. Kiese, M. (1959). Significance of the oxidation of aniline to nitrosobenzene for the formation of methemoglobin after absorption of aniline into the organism. Arch. exp. Path. Pharmak., 235, 360–364 (as referred to by JECFA, 1981).
37. NCI (1978). Bioassay of Aniline Hydrochloride for Possible Carcinogenicity. CAS No. 142-04-1. Technical Report Series No. 130, NTIS PB-287539, National Cancer Institute Bethesda, USA.
38. Parke, D. V. (1960). Studies in detoxication 84. The metabolism of 14C aniline in the rabbit and other animals. Biochem. J., 77, 493–503 (as referred to by JECFA, 1981).
39. Priestley, G. and O'Reilly, W. J. (1966). Protein binding and the secretion of some azo dyes in rat bile. J. Pharm. Pharmacol., 18, 41–45 (as referred to by JECFA, 1981).
40. Rodek, H. and Westhaus, H. (1952). Aniline poisoning in nurslings from ink and labeling dyes. Arch. Kinderh., 145, 77–90 (as referred to by JECFA, 1981).
41. Rofe, P. (1957). Azo dyes and Heinz bodies. Brit. J. ind. Med., 14, 275–280 (as referred to by JECFA, 1981).
42. Ryan, A. J. and Wright, S. E. (1961). The excretion of some azo dyes in rat bile. J. Pharm. Pharmacol., 13, 492–495 (as referred to by JECFA, 1981).
43. st series), opinion expressed 1974, p. 17, 19, 24. Accessible via: ec.europa.eu/food/fs/sc/scf/reports_en.html
44. TemaNord (2002). Food additives in Europe 2000; Status of safety assessments of food additives presently permitted in the EU. TemaNord 2002:560. Accessible via: www.norden.org/pub/sk/showpub.asp?pubnr=2002:560
45. Unilever (1974). Unpublished review of the biological effects of food colour Red 2G dated November 1974. Submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
46. Walker, R. (1971). Personal communication to E. M. den Tonkelaar, National Institute of Public Health, Bilthoven, Netherlands (as referred to by JECFA, 1981).
47. EFSA (2005). Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances which are both Genotoxic and Carcinogenic. (Request No EFSA-Q-2004-020; adopted on 18 October 2005). (ADOPTED ON 18 OCTOBER 2005). The EFSA Journal, 282, 1–31. www.efsa.europa.eu/en/science/sc_commitee/sc_opinions/1201.html
48. Filipsson, A.F., Sand, S., Nilsson, J, and Victorin, K. 2003. The benchmark dose method-Review of available models, and recommendations for application in health risk assessment. Crit. Rev. Toxicol., 33(5), 505–542.