Sunset Yellow FCF - Regulation

Regulation

As a result of these potential health issues, there have been calls for the withdrawal of Sunset Yellow from food use.

On 6 September 2007, the British Food Standards Agency revised advice on certain artificial food additives, including E110. The report said, "This has been a major study investigating an important area of research. The results suggest that consumption of certain mixtures of artificial food colours and sodium benzoate preservative are associated with increases in hyperactive behaviour in children.

"However, parents should not think that simply taking these additives out of food will prevent hyperactive disorders. We know that many other influences are at work but this at least is one a child can avoid."

On 10 April 2008, the Foods Standard Agency called for a voluntary removal of the colours (but not sodium benzoate) by 2009. In addition, it recommended there should be action to phase them out in food and drink in the European Union (EU) over a specified period.

Sunset Yellow is banned in Norway and Finland.

In 2008, a proposed EU deal specified that food and drinks containing any of six artificial colourings that may be linked to hyperactive behaviour in children will have to carry warnings, including Sunset Yellow. The requirement would apply to imports, as well as those made in the EU. Hundreds of products containing the colourings are expected to disappear from shops in the period 2008-2010 following the Food Standards Agency's (FSA) call for a voluntary ban on their use in food products. UK ministers have agreed that the six colourings will be phased out by 2009.

EFSA decided in 2009 to lower the acceptable daily intake (ADI) for Sunset Yellow FCF from 2.5 mg/kg to 1.0 mg/kg bodyweight per day. Impurities in production may leave unsulphonated aromatic amines in concentrations of 100 mg/kg which may be associated with carcinogenicity. Also a study found that mixtures of four synthetic colours plus the preservative sodium benzoate (E211) cause increased hyperactivity in humans. Sensitivity reactions may occur when Sunset Yellow FCF is mixed with other synthetic colours.

Also, the EFSA panel noted the JECFA limit for lead is ≤ 2 mg/kg, whereas the EC specification is ≤ 10 mg/kg. The colour additive can also increase the intake of aluminium beyond the tolerable weekly intake (TWI) of 1 mg/kg/week. Therefore, the limit for aluminum may become adjusted to accommodate for this.

On June 30, 2010, the Center for Science in the Public Interest (CSPI) called for the FDA to ban Yellow 6. The CSPI said, "These synthetic chemicals do absolutely nothing to improve the nutritional quality or safety of foods, but trigger behavior problems in children and, possibly, cancer in anybody."

On September 9, 2011, the European Union announced that they would be reducing the maximum permitted concentration of sunset yellow (in drinks) from 50mg/L to 20mg/L. The proposed change to be adopted by the end of the year.