About
Aloe vera extract is derived from the leaves of Aloe barbadensis Miller and encompasses several distinct fractions: the inner leaf gel (polysaccharide-rich, low anthraquinone), the latex (anthraquinone-rich exudate), and whole leaf extract (combination of both). It is widely used in food supplements, functional beverages, and flavouring applications for purported digestive, antioxidant, and general wellness benefits.
Safety summary
Non-decolorized whole leaf extract of aloe vera has been classified by IARC as a possible human carcinogen (Group 2B) based on clear evidence of large-intestine carcinogenicity in rats, and EFSA (2018) concluded that hydroxyanthracene derivatives (HADs) naturally present in aloe leaf preparations are genotoxic and likely carcinogenic, with no safe daily intake establishable. Oral ingestion of aloe preparations has been associated with adverse effects including diarrhea, hypokalemia, pseudomelanosis coli, and kidney failure. Purified inner leaf gel with HAD content below trace thresholds shows a markedly more favourable toxicological profile, but regulatory uncertainty over commercially available products persists.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Banned | Commission Regulation (EU) 2021/468 (OJ 2021 L 96, p. 6) placed 'preparations from the leaf of Aloe species containing hydroxyanthracene derivatives' in Part A of Annex III to Regulation (EC) No 1925/2006, prohibiting their addition to food or use in the manufacture of food. EFSA (2018) found hydroxyanthracene derivatives (aloe-emodin, emodin, danthron) genotoxic in vitro and in vivo and could not establish a safe daily intake; the European Commission subsequently drafted the ban in 2020 and enacted it in 2021. Aloe preparations not containing HADs (e.g., highly purified inner leaf gel) are not explicitly covered by Part A, but market compliance is under ongoing scrutiny.source |
| FDA (Food and Drug Administration) (United States) | Approved | Aloe vera is approved by the FDA as a natural flavouring substance in food under 21 CFR 172.510. However, in 2002 the FDA issued a final rule stating that aloe is no longer generally recognized as safe and effective (GRAS/E) as a nonprescription (OTC) laxative drug ingredient. It remains permissible as a dietary supplement ingredient and food flavouring; no formal GRAS notice has been filed covering all extract types.source |
Who should approach with care
Research citations
- 1PubMed. Aloe gel-base food products: Chemical, toxicological, and regulatory aspects, 2020. pubmed.ncbi.nlm.nih.gov
- 2EFSA. Safety of hydroxyanthracene derivatives for use in food, 2018. efsa.europa.eu
- 3IARC. Some Drugs and Herbal Products – IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 108, 2016. publications.iarc.who.int
- 4PubMed. Aloe vera: A review of toxicity and adverse clinical effects, 2016. pubmed.ncbi.nlm.nih.gov
- 5other. Clear Evidence of Carcinogenic Activity by a Whole-Leaf Extract of Aloe barbadensis Miller (Aloe vera) in F344/N Rats, 2013. pmc.ncbi.nlm.nih.gov
