Soy Lecithin | whatsinit

About

What it is and where it shows up.

Soy lecithin is a mixture of phospholipids—primarily phosphatidylcholine, phosphatidylethanolamine, and phosphatidylinositol—extracted as a by-product of soybean oil processing. It is widely used in food as an emulsifier, stabiliser, and dispersing agent in products such as chocolate, baked goods, margarine, and infant formula.

Safety summary

The regulatory and scientific consensus.

JECFA assigned an ADI of 'not limited' in 1974 and EFSA's 2017 re-evaluation concluded no genotoxicity or carcinogenicity concern and no numerical ADI is necessary for the general population. Soy lecithin may retain residual soy protein, posing an allergen risk for soy-sensitive individuals; soybeans and their derivatives (including lecithins) are mandatory declared allergens under EU Regulation No 1169/2011. Animal studies at high dietary concentrations (≥5% in the diet) raised signals of neurodevelopmental effects during gestation and lactation, prompting EFSA to call for additional developmental neurotoxicity data (OECD TG 426) before its use in infant formula for babies under 16 weeks of age can be fully endorsed.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorised as E322 under Annex II and III to Regulation (EC) No 1333/2008; JECFA ADI 'not limited'; EFSA 2017 re-evaluation found no safety concern for reported uses in the general population; use in infant formula for infants below 16 weeks of age is under review pending a developmental neurotoxicity study (OECD TG 426); EU specifications require toluene-insoluble matter (residual protein) ≤0.3% w/wsource
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Lecithin (INS 322(i)) approved for all foods at GMP levels per FSSAI Food Safety and Standards (Food Products Standards and Food Additives) Regulations, Appendix C (Version 1, September 2023); maximum 0.5 g per 100 ml product-ready-for-consumption permitted in all types of infant formula under FSSAI Infant Foods Regulationssource
FDA (Food and Drug Administration) (United States)	Approved	Listed as GRAS under 21 CFR 184.1400; permitted in food at GMP (Good Manufacturing Practice) levels as an emulsifier, stabiliser, and release agent; soy is a major food allergen requiring mandatory labelling under FALCPAsource

Who should approach with care

Whose guidance would steer them away.

Other — Individuals with confirmed soy allergy should avoid soy lecithin, as commercial samples can contain residual soy proteins (up to 0.3% w/w per EU specifications) sufficient to trigger allergic reactions in sensitised patients, with the lowest eliciting dose in soy-allergic individuals reported at 0.2 mg soy protein per EFSA NDA Panel 2014 data.

Infants — EFSA (2020) identified unresolved neurodevelopmental data gaps for lecithin (E 322) specifically in foods for infants below 16 weeks of age, and the safety assessment for this age group remains under review; use in infant formula at this age should only proceed under medical or dietetic supervision.

Research citations

The sources behind this verdict.

1FDA. 21 CFR § 184.1400 – Lecithin (GRAS Affirmation). ecfr.gov
2FSSAI. Appendix C — Food Safety and Standards (Food Products Standards and Food Additives) Regulations: List of Processing Aids and Additives, Version 1, 2023. fssai.gov.in
3EFSA. Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups, 2020. efsa.europa.eu
4PubMed. Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups, 2020. pubmed.ncbi.nlm.nih.gov
5EFSA. Re-evaluation of lecithins (E 322) as a food additive, 2017. efsa.europa.eu
6FSSAI. , 2011.

Independently researched7 citations