Food Law News - EU - 2005

EFSA Press Release, 12 September 2005

CONTAIMINANTS - EFSA reviews toxicological data of illegal dyes in food

The European Food Safety Authority (EFSA) has published a review of the toxicological data on illegal dyes found in food to date in the EU and on other unauthorised dyes which could raise concern in the future should they be used in foods.

In the wake of the Sudan I and Para Red alerts in the United Kingdom and other European Union countries at the beginning of the year, the European Commission asked EFSA to carry out a review of the toxicological data available for several dyes which have been found to be illegally present in food. Such illegal dyes* have found their way into food sold in the EU mainly through their presence in imported spices and ingredients. EFSA's task was to review the toxicological data on the seven illegal dyes found to date in foods in the EU and to review data on other industrial dyes not authorised for food use which could be candidates for future concern were they to be present in foods.

EFSA's Scientific Panel on food additives (AFC**) has published a review of two key groups of dyes. The first group, i.e. those illegal food dyes found so far in Europe , were Sudans I to IV, Para Red, Rhodamine B and Orange II. According to EFSA's Scientific Panel these dyes are or may be both genotoxic*** and carcinogenic****, with the exception of Orange II. While this particular dye is possibly genotoxic, data are lacking to determine whether it is also carcinogenic. The Opinion provides a detailed toxicological review for each dye, in terms of genotoxicity, carcinogenicity and chemical similarities.

The second group consists of the following:

EFSA's AFC Panel says that the following from the second group of dyes should be viewed as genotoxic or carcinogenic or both: Acid Red, Sudan Red 7B, Metanil Yellow, Auramine, Congo Red, Butter Yellow, Solvent Red I, Naphthol Yellow, Malachite Green, Leucomalachite Green, Ponceau 3R, Ponceau MX and Oil Orange SS. A detailed toxicological review is also provided for each dye in terms of both their genotoxic and carcinogenic properties.

Dr. Herman Koëter, EFSA's Deputy Executive Director and Director of Science explained: “EFSA's AFC Panel could not carry out a full risk assessment of these dyes because the available data are clearly inadequate. However, the review carried out by the Panel of the limited toxicological data confirms the suspected carcinogenic and/or genotoxic potential of those dyes which Member States and the Commission already had on their target list of dyes not authorised for food. It also identifies other dyes which could raise concern should they be used illegally in food.”

The full text of the opinion is available on the EFSA website at:

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