The Parma based agency was asked to determine whether the colours, authorised for use in a range of bakery and other food products, should be included in Annex IIIa of Directive 2000/13/EC, as amended, which establishes a list of food ingredients that are known to trigger allergies or intolerances, and must be labelled on foods accordingly.
The EFSA Panel on Dietetic Products, Nutrition and Allergies found no data to show that Tartrazine (E 102), Sunset yellow (E 110), Carmoisine (E 122), Amaranth (E 123), Ponceau 4R (E 124), Allura Red (E 129), Brilliant Black BN (E151), Brown FK (E 154), Brown HT (E 155) and Litholrubine BK (E 180) would trigger severe adverse reactions.
The colours have been re-evaluated by EFSA for their safety in the frame of re-evaluation of all food additives. Azo dyes have been prioritized since a number of them were included in the notorious Southampton study which found a link between cocktails of certain food colourings and hyperactivity in children.
As of July 2010, products containing any of the so-called Southampton Six food colours, which have been linked to hyperactivity in children, have to carry a warning on packaging under European law.
However, as this warning will be off-putting for consumers, food firms have been reformulating their products, using alternatives to the colours in question: Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow (E110), Carmoisine (E122), Ponceau 4R (E124) and Allura Red (E129).
EFSA reports that a number of case reports have been published describing intolerance reactions to azo dyes since the description of adverse reactions to the colour Tartrazine over 50 years ago.
However, the Parma based agency said there have been shortcomings in most of these reviews.
“Most published reports have been inadequately controlled, non-blinded and performed without an appropriate follow-up period to assess the effects of an exclusion diet, and therefore, it is uncertain whether the reported adverse reactions were indeed due to oral exposure to Tartrazine,” added the EFSA panel.
The Panel’s opinion states that only a few cases of intolerance reactions to colour mixtures including azo-dyes have been reported in sensitive individuals following double-blind placebo-controlled food challenge (DBPCFC) principles after exclusion diets.
“Intolerance reactions include urticaria, periorbital oedema, facial flushing, as well as higher hyperactivity scores in children,” notes the Panel, referring to data on a few cases of intolerance reactions to Tartrazine and Ponceau 4R, and to a lesser extent to Sunset Yellow FCF and Amaranth, following DBPCFC procedures after exclusion diets.
EFSA reports that there is no data on sensitivity to azo colours: Brown FK, Brown HT, Litholrubine BK, Brilliant Black BN, Carmoisine, and Allura Red AC, and added that there are no reports of well-documented cases of intolerance reactions after oral exposure.
However, the scientists caution that the absence of data on adverse clinical reactions after oral exposure could be due to the lack of clinical awareness of this occurring and subsequent underreporting.
The EFSA opinion can be found here.