TBHQ (E319): What the Sources Found

Tertiary-butylhydroquinone (TBHQ) is the antioxidant the food industry lists as E319. In our table it is low risk: it takes 6 of the 33 additive points off a product's score for a child.

In short

Low risk. 6 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, Peer-reviewed, FDA, each one below.

What TBHQ does to a score

A packaged food starts with 33 points for what is in its ingredient list. TBHQ takes 6 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.2016.4363 (EFSA Journal 2016;14(1):4363)
ADI 0.7 mg/kg bw (JECFA 1998, confirmed by EFSA 2004). 'using the maximum permitted levels, exposure estimates exceed the ADI ... at the high level for toddlers and children, however, in the refined exposure scenarios, the ADI was not exceeded in any of the population groups.' The 2004 opinion had also flagged that infant-formula use could push infants over the ADI.
Peer-reviewed Alarming impact of the excessive use of tert-butylhydroquinone in food products: a narrative review, Toxicol Rep 2022; doi:10.1016/j.toxrep.2022.04.027
Reviews immunomodulatory and endocrine signals for TBHQ (Nrf2 activation, altered T-cell responses) that are not reflected in current regulatory status.
FDA 21 CFR §172.185 (TBHQ)
Permitted in the US, limited to 0.02% of the oil/fat content of the food.

Why this class

A credible adverse or precautionary signal that stops short of every Moderate and High criterion: peer-reviewed adverse findings not yet reflected in regulatory status, an exposure exceedance confined to high-percentile or single-event estimates, or a precautionary regulatory step short of those criteria — a reduced ADI, a data limitation noted without an adverse conclusion, a narrowed or conditioned authorisation, or a child-focused assessment or school-food law that covers the additive as part of a class.

Our confidence in this row's classification is medium. 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.