Octyl gallate (E311): What the Sources Found

Octyl gallate is the antioxidant the food industry lists as E311. In our table it is high risk: it takes 30 of the 33 additive points off a product's score for a child.

In short

High risk. 30 of the 33 additive points come off a product that carries it.
No child flag. Nothing below is written about children specifically, so the class is the same at every age.
3 citations from EFSA, Law, FDA, each one below.

What Octyl gallate does to a score

A packaged food starts with 33 points for what is in its ingredient list. Octyl gallate takes 30 of the 33 additive points off a product's score. 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.2015.4248 ('Scientific Opinion on the re-evaluation of octyl gallate (E 311) as a food additive')
Metabolism data insufficient to justify read-across from propyl gallate; database too limited to establish an ADI or apply a margin-of-safety approach — safety could not be confirmed.
Law Commission Regulation (EU) 2018/1481 (CELEX 32018R1481)
E 311 (and E 312) deleted from the Union list of authorised food additives; recital 9 records that after the 2017 call for data no business operator committed to providing the requested toxicological data; foods lawfully placed on the market could be sold only until 2019-04-25.
FDA eCFR search of 21 CFR — no direct food-additive or GRAS listing for octyl gallate
No US food-additive authorisation located; not a US-market ingredient.

Why this class

IARC Group 1 or 2A with a dietary exposure route; or EFSA has withdrawn or negated a safety conclusion; or EFSA’s own exposure assessment finds a child age group exceeding the ADI at mean intake; or the substance is banned or formally being phased out for food use by the EU, by the US FDA, or under a US state law.

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