Soya Lecithin
Also known as: soy lecithin, soybean lecithin, emulsifer soya lecithin
FDA GRAS under 21 CFR 184.1400 with no use limit beyond cGMP. EFSA's 2017 and 2020 re-evaluations of lecithins (E322) found no need for a numerical ADI and no safety concern at refined exposure assessments — including for infants.
What it is
A naturally occurring mixture of phospholipids (phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol) extracted from soybean oil, typically as a byproduct of oil refining.
Emulsifier (keeps oil and water phases stable), wetting agent, antioxidant synergist, and viscosity modifier in chocolate.
Why it's flagged
- must be labeled for soy allergen disclosure even though residual protein is minimal
- trace residual soy protein could theoretically affect highly soy-allergic individuals
What regulators actually say
"Lecithin is affirmed as Generally Recognized As Safe (GRAS) and is used in food with no limitation other than current good manufacturing practice."
"There was no need for a numerical ADI for lecithins (E 322) and ... there was no safety concern for the general population from more than 1 year of age at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive."
Regulatory status
United States — FDA
GRAS (21 CFR 184.1400)
European Union — EFSA
permitted (E322); no numerical ADI; no safety concern
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