About
Malic acid is a naturally occurring dicarboxylic acid found in fruits (especially apples) and is an intermediate in the citric acid cycle in all living organisms. It is used in processed foods as an acidity regulator, flavouring agent, and taste enhancer to impart a tart, fruity flavour and to control pH.
Safety summary
JECFA established an ADI of 'not specified' for malic acid as early as 1969, confirmed in 1980, indicating no numerical daily intake limit is required at normal food use levels. No carcinogenicity, genotoxicity, or significant toxicity concerns have been identified in authoritative reviews; both L- and DL-forms are readily metabolised by humans. High intake of acidic food additives like malic acid may contribute to dental enamel erosion, particularly in children with frequent exposure to acidic beverages and confectionery.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved under Regulation (EC) No 1333/2008 as an acidity regulator and flavouring in numerous food categories. A formal re-evaluation by EFSA was initiated with a public call for data issued July 2024 (under Regulation (EU) No 257/2010); re-evaluation opinion is pending. L-malic acid is also authorised as a food flavouring (FL-No 08.017).source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | Retained as an approved food additive under assimilated Regulation (EC) No 1333/2008 post-Brexit. Conditions of use align with former EU framework.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved as an acidity regulator at GMP (Good Manufacturing Practice) levels under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. No specific maximum numerical limit set; use governed by GMP principles.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed as GRAS (Generally Recognized as Safe) under 21 CFR 184.1069 for use as a direct human food ingredient (flavouring agent, pH control agent, and multipurpose additive). Also listed at 21 CFR 582.1069 as GRAS for use in animal feed.source |
Who should approach with care
Research citations
- 1WHO. JECFA Monograph – Malic acid (DL-): 13th JECFA meeting (1969), confirmed 1980; JECFA No. 619. fao.org
- 2FDA. 21 CFR 184.1069 – Malic acid (GRAS direct food additive listing). accessdata.fda.gov
- 3EFSA. Call for data for the re-evaluation of malic acid and malates (E 296; E 350-352) as food additives, 2024. efsa.europa.eu
- 4FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 – Appendix A; and Compendium of Food Additives Regulations (Version II, 04.01.2024), 2024. fssai.gov.in
- 5EFSA. Scientific Opinion on the safety and efficacy of malic acid and a mixture of sodium and calcium malate when used as technological additives for all animal species (EFSA FEEDAP Panel, 2014), 2014. efsa.europa.eu
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