Mono- and Diglycerides of Fatty Acids

About

What it is and where it shows up.

Mono- and diglycerides of fatty acids (E471) are mixtures of glycerol mono-, di-, and tri-esters of fatty acids derived from food oils and fats; they are not a discrete chemical substance but a complex mixture that may contain more than 50 different glyceride species. They are widely used in food as emulsifiers, starch complexing agents, and aerating agents to improve texture, shelf life, and consistency.

Safety summary

The regulatory and scientific consensus.

EFSA concluded in 2017 that there is no need to set a numerical Acceptable Daily Intake (ADI) and no risk to health at current exposure levels for the general population; JECFA similarly assigned a 'not limited' ADI in 1973. However, E471 can contain process contaminants including glycidyl fatty acid esters (which have genotoxic and carcinogenic potential) and 3-MCPD esters, and if manufactured from hydrogenated oils may carry trans fatty acids; the EU imposed new maximum purity limits for these contaminants effective July 2023. Infants below 16 weeks of age represent a sensitive subpopulation for whom EFSA performed a dedicated safety assessment, concluding no safety concern at permitted levels in infant formulae.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorised under Regulation (EC) No 1333/2008 Annexes II and III as a Group 1 food additive. No numerical ADI set (EFSA 2017). Commission Regulation (EU) 2023/1428 (effective 30 July 2023) updated purity specifications in Regulation (EU) No 231/2012, setting maximum limits for glycidyl fatty acid esters (≤10 mg/kg interim, ≤5 mg/kg final), 3-MCPD, erucic acid, arsenic, lead, cadmium, and mercury. Use in infant formulae restricted to 0.4 g/L (Annex III).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. INS 471 is allowed as an emulsifier in extruded foods at GMP, and in infant formula at a maximum of 0.4 g per 100 mL of product ready for consumption. Also listed as a processing aid for extruded foods at GMP in the FSSAI 2024 active processing aids list.source
FDA (Food and Drug Administration) (United States)	Approved	Generally Recognized As Safe (GRAS) under 21 CFR 184.1505. Usage is not limited beyond levels consistent with Good Manufacturing Practice (GMP). Also permitted as a surface finishing agent at GMP levels.source

Who should approach with care

Whose guidance would steer them away.

Infants — EFSA conducted a dedicated safety assessment for infants below 16 weeks of age and recommended strict purity limits (glycidyl esters, 3-MCPD) in infant formulae; use is restricted to a maximum of 0.4 g/100 mL in infant formulae under both EU and FSSAI regulations.

Heart Disease — E471 manufactured by glycerolysis of hydrogenated oils may contain significant amounts of trans fatty acids, which are associated with increased cardiovascular risk; EFSA's 2018 call for data explicitly flagged trans fatty acid content as a concern requiring minimisation to the lowest technologically achievable level.

Other — Individuals with heightened sensitivity to genotoxic contaminants (e.g., cancer patients, immunocompromised persons) should note that glycidyl fatty acid esters found as impurities in E471 have recognised genotoxic and carcinogenic potential, prompting the EU to set new maximum limits effective July 2023.

Research citations

The sources behind this verdict.

1FSSAI. Food Safety and Standards (Infant Nutrition and Health) Regulations – Version II (04.01.2024), 2024. fssai.gov.in
2other. Commission Regulation (EU) 2023/1428 of 7 July 2023 amending Regulation (EU) No 231/2012 as regards specifications for mono- and diglycerides of fatty acids (E 471), 2023. eur-lex.europa.eu
3EFSA. Opinion on the re-evaluation of mono- and diglycerides of fatty acids (E 471) as food additive in foods for infants below 16 weeks of age and follow-up of their re-evaluation as food additives for uses in foods for all population groups, 2021. efsa.europa.eu
4PubMed. Opinion on the re-evaluation of mono- and diglycerides of fatty acids (E 471) as food additive in foods for infants below 16 weeks of age and follow-up of their re-evaluation as food additives for uses in foods for all population groups, 2021. pubmed.ncbi.nlm.nih.gov
5EFSA. Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives, 2017. efsa.europa.eu

Independently researched6 citations