Updated: Feb 7, 2022
The European Food Safety Authority (EFSA) is currently evaluating the safety of all food additives that are approved for use in the European Union, beginning with the 45 food colors that are currently approved for use. In November, 2009, The European Commission examined Quinoline Yellow (E104), Sunset Yellow FCF (E110), Ponceau 4R (E124), Tartrazine (E102), Azorubine/Carmoisine (E122) and Allura Red AC (E129) in response to the so-called “Southampton study”, which suggested that ingestion of certain mixtures of these colors and the preservative sodium benzoate is associated with hyperactivity in children. After reviewing all of the available evidence, EFSA reduced the Acceptable Daily Intakes (ADIs) for three of the “Southampton Colors” (Quinoline Yellow, Sunset Yellow FCF and Ponceau 4R) (1). In April, 2010, after evaluating three additional colors (Brilliant Black BN (E151), Brown HT (E155) and Brown FK (E154), EFSA concluded that the ADI for Brown HT should also be reduced (2). Stay tuned for evaluations on Amaranth (E123) and Litholrubine BK (E180), which are expected to be finalized by June, 2010.
The colors that have been evaluated by EFSA are used in foods commonly ingested by children, such as soft drinks, bakery products, desserts and confectionery. Based on current estimates of exposure from several European countries, EFSA concluded that the new ADIs for Quinoline Yellow, Sunset Yellow FCF and Ponceau 4R and Brown HT could be exceeded by adults and children who regularly consume foods containing these colors, because their use is prevalent.
As of July of 2010, EFSA will require products containing any of six “Southampton study” color additives to carry the following warning label: “name (or E number of the colour(s): may have an adverse effect on activity and attention in children)” (3), even though the agency concluded that available data (including the Southampton study), “did not substantiate a causal link between the individual colours and possible behavioural effects” (1). This rule can be interpreted as a way of curtailing consumption of the “Southampton study” colors to levels lower than the revised ADIs, without an outright ban, and is in accordance with EFSA’s “Precautionary Principle” policy (4).
Three of the colors that have been evaluated are currently permitted for use in the US (the “Southampton colors” Allura Red (FD&C Red #40), Tartrazine (FD&C Yellow #5) and Sunset Yellow FCF (FD&C Yellow #6)). Because the warning label for the “Southamption colors” is expected to decrease use of these colors in food, there will be an increased demand for new food colors. Color additive petitions are required by FDA for all new color additives, including those from natural sources.