Linked to more hyperactivity in children, as part of a mixture
A 2007 trial paid for by the UK Food Standards Agency gave 153 three-year-olds and 144 children aged 8 to 9 either drinks with six artificial colours, including E124, plus sodium benzoate, or a dummy drink. The children were clearly more hyperactive after the coloured drinks. European reviewers said this showed a small effect in some children, but not enough on its own to change the daily limit. The agency then asked makers to drop the six colours, and since 2010 the law has required a warning on any product that uses them.
Children aged 3 and 8 to 9 from the general population were more hyperactive after a mixture of six artificial colours including E124, plus sodium benzoate, than after a dummy drink. Neither the children nor the researchers knew which was which.
2007Randomised trial in peopleMcCann et al., The Lancet
Reviewers said the Southampton study gave limited evidence of a small effect on activity and attention in some children, but could not by itself justify changing the daily limit.
2009Regulator reviewEFSA Scientific Opinion on the re-evaluation of Ponceau 4R (E124) as a food additive, EFSA Journal 1328
Kidney damage in mice led to a six-fold cut in the daily limit
In 2009 European reviewers cut the daily limit from 4mg to 0.7mg per kg of body weight. The reason was a long-term mouse study that found kidney inflammation when the dye made up 0.25% of the diet or more. Long-term studies in rats and mice found no cancer. In 2015 reviewers found that children aged 1 to 10, and adults who eat a lot of coloured food, can still go over the lower limit if makers use the most the law allows.
A long-term mouse study found more kidney inflammation when the dye made up 0.25% and 1.25% of the diet. The highest dose with no effect was 70mg per kg of body weight a day. Dividing by 100 as a safety margin gave the new limit of 0.7mg, almost six times lower than the old 4mg.
2009Regulator reviewEFSA ANS Panel, Scientific Opinion on the re-evaluation of Ponceau 4R (E 124), EFSA Journal 1328
Children aged 1 to 10 who eat a lot of coloured food, and adults who eat the most, can go over the 0.7mg limit when foods contain the most the law allows. Reviewers called this a possible concern for those groups.
2015Regulator reviewEFSA, Refined exposure assessment for Ponceau 4R (E 124), EFSA Journal 4073
Long-term studies in rats and mice found no sign that it causes cancer, and it did not damage DNA in standard lab tests.
2009Regulator reviewEFSA ANS Panel, Scientific Opinion on the re-evaluation of Ponceau 4R (E 124), EFSA Journal 1328
One mouse study found chromosome damage near the old daily limit
Lab tests and cancer studies have mostly been negative, and European reviewers concluded there is no cancer risk. But a 1993 study in living mice found that a dose of 4mg, which the authors said was near the old daily limit, caused significant chromosome damage in bone marrow cells. The authors said the dye should be taken off the approved list. Reviewers in 2009 accepted the evidence was mixed, but judged that on balance it did not show a risk of cancer or DNA damage at permitted levels.
In male mice, Ponceau 4R caused a significant number of chromosome breaks at a lowest effective dose of 4mg, near the daily limit of the time. The authors recommended removing it from the list of food dyes.
1993Animal studyPubMed 8330485, in vivo cytogenetic study in male mice
Researchers identified the substances Ponceau 4R breaks down into when light fades it in drinks, and tested whether those could damage DNA in bacteria.
2016Lab studyAnalytical Methods, RSC Publishing
May set off reactions in people sensitive to aspirin, and worsen asthma
As an azo dye, Ponceau 4R may set off reactions in people who are sensitive to salicylates, the family aspirin belongs to. It is also reported to release histamine in the body, which can make asthma worse in susceptible people. These are not true allergies. They are intolerance reactions, and they can depend on the amount eaten.
As an azo dye, Ponceau 4R may bring on intolerance reactions in people sensitive to salicylates, and can release histamine, which may worsen asthma.
ReferenceFood-Info.net, Wageningen University food additives reference