Caramel (E150): What the Sources Found

Caramel is the colour the food industry lists as E150. In our table it is moderate risk: it takes 15 of the 33 additive points off a product's score for a child.

In short

Moderate risk. 15 of the 33 additive points come off a product that carries it.
Flagged for young children. Set only where EFSA’s own exposure assessment shows toddlers or children exceeding or approaching the ADI, or where a regulator used explicitly child-specific language. For a child under 6 it moves one class up.
3 citations from EFSA, OEHHA, each one below.

What Caramel does to a score

A packaged food starts with 33 points for what is in its ingredient list. Caramel takes 15 of the 33 additive points off a product's score, and a child under 6 sees it one class higher again. Scan the pack in Sito and the score you get is the one for your own child's age, with this additive named in the reasons. How we score has the whole method.

What the sources found

Every classification in our table comes from the citations below, and nothing else. They are quoted as the source wrote them.

EFSA 10.2903/j.efsa.2011.2004
Group ADI 300 mg/kg bw/day for E 150a-d; E 150c given a lower individual ADI of 100 mg/kg bw/day because of possible immune effects of its constituent THI. SUPERSEDED IN PART: this opinion's finding that combined MEAN intake for children exceeds the group ADI at maximum reported use levels is superseded by the 2012 refined assessment below (refined combined means 12-105 mg/kg bw/day, all below the 300 group ADI). The 2011 mean exceedance is therefore not a current finding: EFSA itself has refined away the evidence behind it, and it supports no High-risk basis.
EFSA 10.2903/j.efsa.2012.3030
Refined exposure assessment. E 150c: toddlers (and adults) may still exceed the INDIVIDUAL ADI of 100 mg/kg bw/day at the upper end of 95th-percentile exposure — the sole basis for this row's higher-concern-for-young-children flag. E 150d: NO exceedance — toddler 95th-percentile exposure reaches at most 136 mg/kg bw/day against the group ADI of 300. 'The combined exposure estimates of the four caramel colours do not exceed the group ADI for any population group.'
OEHHA Prop 65, 4-methylimidazole (listed 2011), NSRL 29 ug/day
4-MEI in ammonia/sulphite-ammonia caramels is Prop 65 listed.

Why this class

IARC Group 2B; or an EFSA re-evaluation that flagged genotoxicity data gaps, found safety could not be assessed on the available data, or cut the ADI citing child exposure; or an EU harmonised classification of the substance as a reproductive or developmental hazard; or an EU withdrawal of one authorised food use while others remain; or an OEHHA/Proposition 65 listing; or membership of the Southampton-six colourants.

Our confidence in this row's classification is low. Medium or low does not mean the evidence is weak; it means something about the row is still being pinned down, usually a regulatory status confirmed from one source rather than two.