Benefit-risk assessment of cinnamon
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15 July 2010
EMA/HMPC/246773/2009
Committee on Herbal Medicinal Products (HMPC)
Assessment report on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum
Draft
Based on Article 10a of Directive 2001/83/EC as amended (well-established use)
Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use)
| Herbal substance(s) (binomial scientific name of the plant, including plant part) | Cinnamomum verum J. S. Presl. Nees, dried bark |
|---|---|
| Herbal preparation(s) | a) Comminuted herbal substance
b) Liquid extract (DER 1:1) extraction solvent: 70% ethanol c) Tincture (ratio of herbal substance to extraction solvent 1:5) extraction solvent 70% ethanol d) Essential oil obtained by steam distillation from the cortex |
| Pharmaceutical forms | Comminuted herbal substance as herbal tea for oral use.
Herbal preparation in liquid dosage forms. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
Note: This draft Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Cinnamomum verum J. S. Presl, cortex and corticis aetheroleum. It should be noted that this document is a working document, not yet fully edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this draft assessment report. The publication of this draft assessment report has been agreed to facilitate the understanding by Interested Parties of the assessment that has been carried out so far and led to the preparation of the draft monograph.
Introduction
Description of the herbal substance(s), herbal preparation(s) or combinations thereof
- Herbal substance(s)
1. Cinnamomum verum J. S. Presl. (=Cinnamomum zeylanicum Nees), dried bark, freed from the outer cork and the underlying parenchyma (ESCOP, 2003; European Pharmacopoeia 6.2, 2009).
2. Cinnamomum verum J. S. Presl. is also known by the synonym Cinnamomum zeylanicum Blume and is member of Lauraceae family (Keller 1992).
This assessment report does not evaluate Cinnamomum aromaticum Nees (synonym: Cinnamomum cassia Blume), cortex although they are both comparable in composition and widely used in flavouring agents in foods and in pharmaceutical and cosmetic preparations (Kommission E, 1990; Barnes et al., 2007).
The drug consists of the dried bark, freed from the outer cork and the underlying parenchyma, of the shoots grown cut stock of Cinnamomum verum J. S. Presl. The matt pieces of bark, 0.2-0.7 mm thick and in the form of single or double compound quills, are light brown on the outside and somewhat darker on the inside. The surface is longitudinally striated and the fracture is short and splintery. It contains not less than 12 ml/kg essential oil obtained by steam distillation It has a characteristic and pleasantly aromatic odour. Its taste is pungently spicy, somewhat sweet and mucilaginous, and only slightly sharp (Bisset, 1994).
Cinnamon bark contains up to 4% of essential oil consisting primarily of cinnamaldehyde (60-75%), cinnamyl acetate (1-5%), eugenol (1-10%) (WHO Vol. 1999), β-caryophyllene(1-4%), linalool (1-3%) and 1.8-cineole (1-2%) (ESCOP, 2003).
Other constituents are oligopolymeric procyanidins, cinnamic acid, phenolic acids, pentacyclic diterpenes cinnzeylanol and it's acetyl derivative cinnzeylanine and the sugars mannitol, L-arabino-D-xylanose, L-arabinose, D-xylose, α-D-glucane as well as mucilage polysaccharides (Hänsel et al., 1992, ESCOP, 2003).
The essential oil of the bark is described in the European Pharmacopoeia 6.2 (2009) . There exists a summary report on the essential oil of cinnamon bark. This report has been made by the Committee for Veterinary Medicinal Products. According to this information the oil mainly contains cinnamaldehyde (55-76%), eugenol (5-18%) and saffrole (up to 2%). This document refers also to human use (CVMP 2000).
Cinnamon bark oil may be adulterated with cinnamon leaf oil and oil of cassia (Price & Price, 2007).
Figure 2: eugenol
- Herbal preparation(s)
a) Comminuted herbal substance
b) Liquid extract (DER 1:1) extraction solvent: 70% ethanol
c) Tincture (ratio of herbal substance to extraction solvent 1:5) extraction solvent: 70% ethanol
d) Essential oil obtained by steam distillation from the cortex
- Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable.
See overview data from member states.
Vitamin(s)
The drug contains per 100 g:
- vitamin A: 260 IU - thiamine: 0.02 mg - riboflavin: 0.14 mg - niacin: 1.3 mg - ascorbic acid: 28 mg
(Duke, 1988)
Mineral(s)
The drug contains per 100 g:
- Ca: 1.228 mg - P: 61 mg - Fe: 38 mg - Mg: 56 mg - Na: 26 mg - K: 500 mg - Zn: 2 mg
(Duke, 1988)