Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive

EFSA Journal

Volumn 11, Issue 3, 2013, Pages

[No Author Info available]

Author keywords

CAS Registry Number calcium salt: 3536 49 0; CAS Registry Number sodium salt: 129 17 9; E 131; food colouring substance; Patent Blue V

Indexed keywords

EID: 85046898751     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2013.2818     Document Type: Article

References (57)

1. Baranowska I, Zydron M and Szczepanik K, 2004. TLC in the analysis of food additives. Journal of Planar Chromatography-Modern TLC 17(1), 54–57.
2. Barthelmes L, Goyal A, Sudheer P and Mansel RE, 2010. Investigation of anaphylactic reaction after Patent Blue V dye injection. The Breast 19, 516–520.
3. Bézu C, Coutant C, Salengro A, Daral E, Rouzier R, and Uzan, 2010. Anaphylactic response to blue dye during sentinel node biopsy. Surgical Oncology 20(1), 55–59.
4. BIBRA (British Industrial Biological Research Association), 1982. Report No.82/67. A review of the toxicology of 9 food colours. Volume 2. Critical evaluation of the available data. Patent Blue V. 42–67.
5. Chadwick BL, Hunter ML, Evans MT and Hunter B. 1990. Allergic reaction to the food dye Patent Blue V. British Dental Journal 168(10), 386–387.
6. ChemIDplus Advanced (via internet, 2012). Accessible via: chem.sis.nlm.nih.gov/chemidplus/.
7. Dixit S, Khanna SK and Das M, 2010. Simultaneous determination of eight synthetic permitted and five commonly encountered non permitted food colors in various food matrixes by high-performance liquid chromatography. Journal of AOAC International 93(5), 1503–1514.
8. Durnev AD, Oreshchenko AV, Kulakova AV and Beresten NF, 1995. Analysis of cytogenetic activity of food dyes. Voprosy Meditsinskoi Khimii 41, 50–53.
9. Eberlein-König B, Rakoski J, Behrendt H and Ring J. 2004. Use of CD63 expression as a marker of in vitro basophil activation in identifying the culprit in insect venom allergy. Journal of Investigational Allergology Clinical Immunology 14(1), 10–16.
10. EC, 2001. Report from the Commission on dietary food additive intake in the European Union, 542 final.
11. EFSA, 2008. Safety of aluminium from dietary intake Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC). Adopted on 22 May 2008. The EFSA Journal (2008) 754, 1–34.
12. EFSA (European Food Safety Authority), 2011a. Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database. EFSA Journal 2011; 9(3):1970. [27 pp.] doi:10.2903/j.efsa.2011.1970.
13. EFSA (European Food Safety Authority), 2011b. 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.
14. FSA (Food Standards Agency), 2003. Survey of colours in soft drinks. Food Survey Information Sheets. No.37/03 May 2003. Available at: www.food.gov.uk/multimedia/pdfs/fsiscoloursinfoods032003.pdf.
15. FSA (Food Standards Agency), 2002. Survey of colours in sweets. Food Survey Information Sheets. No. 23/02 April 2002. Available at: www.food.gov.uk/multimedia/pdfs/23sweets.pdf.
16. FSAI (Food Safety Authority of Ireland), 2009. A Surveillance Study on Levels of Artificial Colours and Sweeteners in Irish Retail Products. Available at: www.fsai.ie/assets/0/86/204/7f60074b-56eb-4fa2-ac6c-e013e20b9e7d.PDF.
17. Galloway SM, Aardema MJ, Ishidate M Jr., Ivett JL, Kirkland DJ, Morita T, Mosesso P and Sofuni T, 1994. International Workshop on Standardisation of Genotoxicity Test Procedures. Report from the Working Group on in vitro Tests for Chromosomal Aberrations. Mutation Research 312, 241–261.
18. Gubbini L, Cardamonie G, Volterra-Veca L, Bruzzone ML, Conti G, 1975. Mutagenicity testing of environmental chemical dyes. Atti. Ass. Genet. Ital. 20, 43–44.
19. Harp BP, Miranda-Bermudez E, Baron CI and Richard GI, 2012. Qualitative identification of permitted and non-permitted colour additives in food products. Food Additives and Contaminants 29, 886–896.
20. Haveland-Smith RB and Combes RD, 1980. Screening of food dyes for genotoxic activity. Food and Cosmetics Toxicology 18, 215–221.
21. IARC (International Agency for Research on Cancer), 1987. Blue VRS. IARC Monograph on the evaluation of carcinogen risk of chemicals in man, Volume 16, p. 163.
22. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. S2A, S2B.
23. IFREB, 1978a. Essai toxicologique de 3 mois par incorporation dans le régime chez le chien Beagle. Institut Français de Recherches et Essais Biologiques Colourant E 131 (Bleu Patent V). IFREB Report N° 806216, 1978 (unpublished report).
24. IFREB, 1978b. Essai de tératogénèse par voie orale chez le rat. Institut Français de Recherches et Essais Biologiques. IFREB Report N° 811229, 1978 (unpublished) (as referred to by SCF, 1983).
25. IFREB, 1981. Carcinogenicity study in the OFI mouse with colouring agent E 131 Patent Blue. Institut Français de Recherches et Essais Biologiques. IFREB Report N°.110203, 1981 (unpublished report) (only summary available).
26. JECFA (Joint Expert Committee on Food Additives), 1970. 13th report, WHO/FAO Joint Expert Committee on Food Additives. Toxicological evaluation of some food colours, emulsifiers, stabilizers, anti-caking agents, and certain other substances. WHO Food Additives Series, 70.36. Available at: whqlibdoc.who.int/trs/WHO_TRS_445.pdf.
27. JECFA (Joint Expert Committee on Food Additives), 1975. 18th report, WHO/FAO Joint Expert Committee on Food Additives. Toxicological evaluation of some food colours, enzymes, flavour enhancers, thickening agents, and certain other food additives. WHO Food Additives Series, No. 6. Available at: whqlibdoc.who.int/trs/WHO_TRS_557.pdf.
28. JECFA (Joint Expert Committee on Food Additives), 1982. WHO Food Additives Series, No. 17. Toxicological evaluation of certain food additives. Available at: www.inchem.org/documents/jecfa/jecmono/v17je01.htm.
29. JECFA (Joint Expert Committee on Food Additives), 2004. 63rd meeting, Joint FAO/WHO Expert Committee on Food Additives. Aluminium Lakes of Colouring Matters, General Specifications (via internet, 2006). Accessible via: www.fao.org/ag/agn/jecfa-additives/specs/Monograph1/Additive-013.pdf.
30. JECFA (Joint FAO/WHO Expert Committee on Food Additives), 2006. Aluminium lakes of colouring matters. General specifications. Available at: www.fao.org/ag/agn/jecfa-additives/specs/monograph3/additive-013.pdf.
31. JECFA (Joint FAO/WHO Expert Committee on Food Additives), 2008. Combined compendium of food additive specifications - all specifications monographs from the 1st to the 69th meeting (1956–2008). FAO JECFA Monographs Series, No. 1 Volume 1–3.
32. Johansson SGO, Nopp A, Öman H, Stahl-Skov P, Hunting AS and Guttorsen AB. 2010. Anaphylaxis to Patent Blue V. II. A unique Ig-E mediated reaction. Allergy 65, 124–129.
33. Kirschbaum J, Krause1 C, Pfalzgraf S and Brückner H, 2003. Development and evaluation of an HPLC-DAD method for determination of synthetic food colorants. Chromatographia 57, Suppl. 1, 115–119.
34. LEMM, 1978a. Etude de la distribution chez le rat du Bleu Patent ou E131 marqué au 14C. Fascicule I Annexe. Laboratoire d' Etudes du métabolisme des Médicaments 1978 (unpublished report).
35. LEMM, 1978b. Etude de la distribution chez le rat du Bleu Patent ou E131 marqué au 14C. Fascicule I. Laboratoire d' Etudes du métabolisme des Médicaments 1978 (unpublished report).
36. LEMM, 1978c. Séparation des métabolites radioactifs du Bleu Patent-14C (E131). Fascicule II. Laboratoire d'Etudes du métabolisme des Médicaments 1978 (unpublished report).
37. LEMM, 1978d. Etude sur la répartition du E 131–14C chez le chien. Fascicule III. Laboratoire d'Etudes du métabolisme des Médicaments 1978 (unpublished report).
38. Masannat YA, Hanby A, Horgan K and Hardie LJ, 2009. DNA Damaging Effects of the Dyes Used in Sentinel Node Biopsy: Possible Implications for Clinical Practice. Journal of Surgical Research 154, 234–238.
39. Minioti KS, Sakellariou CF, Thomaidis NS, 2007. Determination of 13 synthetic food colorants in water-soluble foods by reversed-phase high-performance liquid chromatography coupled with diode-array detector. Analytica Chimica Acta 583(1), 103–10.
40. Misra RN and Misra B, 1986. Genetic toxicological testing of some dyes by the micronucleus test. Mutation Research 170, 75–78.
41. OECD, 2010. Test No. 487: In vitro Mammalian Cell Micronucleus Test, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing.
42. OECD, 1997. Test No. 473: In vitro Mammalian Chromosome Aberration Test, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing.
43. Patsovskii AP, Rudometova NV and Kamentsev YS, 2004. Electrophoretic determination of synthetic dyes in alcoholic beverages. Journal of Analytical Chemistry 59, 150–154.
44. Perez-Urquiza M and Beltran JL, 2000. Determination of dyes in foodstuffs by capillary zone electrophoresis. Journal of Chromatography A 898(2), 271–5.
45. SCF (Scientific Committee for Food), 1983. Reports from the Scientific Committee for Food (14th series), opinion expressed on 7 July 1983. Available at: ec.europa.eu/food/fs/sc/scf/reports/scf_reports_14.pdf.
46. Scherer K, Studer W, Figueiredo V, Bircher A. 2006. Anaphylaxis to isosulfan blue and cross reactivity to Patent Blue V: case report and review of the nomenclature of vital blue dyes. Annals of Allergy Asthma and Immunology 96, 497–500.
47. Serdar M and Knežević, 2009. Simultaneous LC analysis of food dyes in soft drinks. Chormatographia 70, 1519–1521.
48. Seeberg AH, Mosesso P, Forster R, 1988. High-dose-level effects in mutagenicity assays utilising mammalian cells in culture. Mutagenesis 3, 213–218.
49. Scotter M J and Castle L, 2004. Chemical interactions between additives in foodstuffs: a review. Food Additives and Contaminants 21(2), 93–124.
50. TemaNord, 2002. Food additives in Europe 2000; Status of safety assessments of food additives presently permitted in the EU. TemaNord 2002: 560, 112–115.
51. Tennant, 2006. Screening of Colour Intakes from Non-Alcoholic Beverages. Report prepared for the Union of European Beverages Associations (UNESDA). December 2006.
52. Truhaut R, 1962. Aliment. et Vie, 50, 77 (as referred to by JECFA, 1975).
53. Tsopelas C and Sutton R, 2002. Why certain dyes are useful for localizing the sentinel lymph node. J. Nuclear Med. 43 (10), 1377–1382.
54. Tuzimski T, 2011. Determination of sulfonated water-soluble azo dyes in foods by SPE couple with HPTLC-DAD. Journal of Planar chromatography 24(4), 281–289.
55. Tuzimski T and Woźniak, 2008. Application of solid-phase extraction and planar chromatography with diode-array detection to the qualitative and quantitative analysis of dyes in beverages. Journal of Planar chromatography 21(2), 89–96.
56. Viola M and Nosotti A, 1978. Application of the Ames test to some coloring agents. Boll. Chim.Farm. 117, 402–415.
57. Yoshioka N and Ichihashi K, 2008. Determination of 40 synthetic food colors in drinks and candies by high-performance liquid chromatography using a short column with photodiode array detection. Talanta 74(5), 1408–13.