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Toxicity of tartrazine
Scientific review report
5. International regulatory status
Colouring agents have a unique status as pharmaceutical excipients and most regulatory agencies hold lists of colours that may be used in medicinal products. Restrictions or bans on the use of some colouring agents have been imposed in some countries, while the same colours may be permitted for use in a different country. As a result, the same colour (including tartrazine) may have a different regulatory status in different territories of the world.
Tartrazine (E 102) is authorised as a food additive in the EU1 and is allowed to be used in medicines for oral use. The primary legislation governing colouring agents that may be used in medicinal products is Council Directive 78/25/EEC of 12 December 19772. This Directive links pharmaceutical requirements with those of foods in the EU. There is a clause in EEC Directive 78/25 that states, "Experience has shown that on health grounds there is no reason why the colouring matters authorized for use in foodstuffs intended for human consumption should not also be authorized for use in medicinal products." The Scientific Committee on Medicinal Products and Medical Devices (SCMPMD) on 21 October 1998 alluded to this clause in respect of other colourants; there is no specific opinion of the this committee (SCMPMD) on the use of tartrazine. But the European Commission has provided guidance on cross references to the current food colour legislation as contained in Council Directive 94/36/EC3.
In the EU, Directive 89/107/EEC as well as Regulation (EC) 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, which has applied from 20 January 2010, require that food additives must be monitored and re-evaluated whenever necessary in the light of new scientific information. Accordingly, a re-evaluation of tartrazine (E102) was undertaken by the European Food Safety Agency (EFSA) in 2009.
Tartrazine is permitted for use in oral medicines and must always be declared on the label.
Permitted in drugs for internal and external use (Food and Drug Regulations [C.R.C., c 870, Section C.01.040.2])4.
In the USA, 21 CFR 74.1505, 82.51 and 82.705 clearly state that "FD&C Yellow #5 (and associated lakes) may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice."
There is a restriction in 21 CFR 74.1505 for prescription drugs that states that the labels for these products must bear the following warning statements: "This product contains FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity".
- http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:006:0020:0063:EN:PDF (pdf,165kb)
- http://ec.europa.eu/health/files/eudralex/vol-1/dir_1978_25/dir_1978_25_en.pdf (pdf,25kb)
- http://ec.europa.eu/food/fs/sfp/addit_flavor/flav08_en.pdf (pdf,697kb)