About
Lecithins are naturally derived mixtures or fractions of phosphatides (including phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, and phosphatidylserine) obtained by physical procedures from animal or vegetable foodstuffs such as soy, sunflower, rapeseed, and egg yolk. They are widely used as emulsifiers, stabilisers, and dispersing agents in chocolate, baked goods, margarines, and infant formula.
Safety summary
EFSA concluded in 2017 that there is no need for a numerical ADI and no safety concern for the general population aged over one year at reported use levels of E322 as a food additive. Residual proteins in commercial lecithin preparations derived from soy or egg may trigger hypersensitivity reactions in sensitised individuals, as evidenced by rare post-marketing allergy reports. Special monitoring of cumulative choline intake is recommended when lecithins are used in infant formulae also supplemented with choline or choline salts, given choline's role as a precursor to the neurotransmitter acetylcholine.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised food additive under Regulation (EC) No 1333/2008, Annex II and Annex III. EFSA ANS Panel 2017 re-evaluation concluded no numerical ADI is required and no safety concern exists for the general population above 1 year of age at reported use levels. EFSA FAF Panel 2020 follow-up opinion additionally cleared use in infant formula (FC 13.1.1) and foods for special medical purposes (FC 13.1.5.1) up to the maximum permitted level. EU specifications are defined in Commission Regulation (EU) No 231/2012.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 as INS 322 (including 322(i) and 322(ii)). GMP-level permission in most food categories (e.g. bread, dairy-based drinks). Maximum 0.5 g per 100 ml in all types of infant formula and 1500 mg per 100 g in certain other categories per the Compendium updated January 2024.source |
| FDA (Food and Drug Administration) (United States) | Approved | Lecithin is affirmed as Generally Recognized As Safe (GRAS) under 21 CFR 184.1400 for use in food at levels consistent with good manufacturing practice (GMP); no numerical maximum daily intake is specified.source |
Who should approach with care
Research citations
- 1FDA. 21 CFR §184.1400 – Lecithin (GRAS listing). accessdata.fda.gov
- 2FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 – Compendium Version II (04.01.2024), 2024. 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
- 6PubMed. Re-evaluation of lecithins (E 322) as a food additive, 2017.