Food agency to review safety of azo dyes used in drugs
The EFSA has now set a timeline for re-evaluating key safety questions about the colourings at the request of the European Parliament which asked the Helsinki-based agency to look into the matter back in July.
Earlier this year the EFSA published a review of the so-called Southampton study, which caused a stir last year when it pointed to a “small and statistically significant” effect of dietary exposure to two mixtures of four synthetic colours, plus a sodium benzoate preservative, on allergenicity, activity and attention in children.
And just last week, the European Commission adopted the FIAP (Food Improvement Agent Package), which mandates a warning label to be carried on products using any of the six colours linked to allergic reactions and hyperactivity. Once endorsed by the European Parliament and Council the FIAP is likely to come into effect in early 2009
The EFSA’s allergenicity evaluation will look at 10 azo-dyes, namely tartrazine (E102); sunset yellow (E110); carmoisine (E122); amaranth (E123); ponceau 4R (E124); allura red AC (E129); brilliant black (E151); brown FK (E 154); brown HT (E155); and lithol rubine BK (E180).
All these are colourings that can be added to medicinal products, as laid down by Annex I of Directive 94/36/EC on colours for use on foodstuffs.
The EFSA said its Panel on dietetic products, nutrition and allergies (NDA) will adopt an opinion on allergenicity of the 10 azo dyes by the end of 2009.
Meanwhile, the EFSA’s Panel on food additives and nutrient sources added to food (ANS) will provide a full re-evaluation of the six additives examined in the Southampton study (five azo dyes and one preservative - i.e. tartrazine; sunset yellow; carmoisine; ponceau 4R; allura red AC, and quinoline yellow (E104) by June 2009.
That will be followed by a full re-evaluation of the allergenicity of the five other azo dyes (i.e. E123; E151; E154, E155; E180) by March 2010, said the EFSA.
