Ethanol – permitted even in children’s syrups, a substance indispensable for disinfection, naturally occurring in fruits and vegetables – may be banned in cosmetic products, where it serves as a solvent for many ingredients, despite the fact that there are virtually no alternatives.
| Chemical formula: C₂H₅OH or CH₃CH₂OH
Molar mass: 46.07 g/mol Boiling point: 78.37 °C (173.1 °F) |
Ethanol (also called ethyl alcohol, grain alcohol, drinking alcohol, or simply alcohol) is a clear, colorless, and volatile liquid (C₂H₅OH), used as the primary ingredient in alcoholic beverages and as a solvent, disinfectant, and preservative.
Especially its antimicrobial properties, for different industrial & domestic usage, are indispensable. It is the cheapest, environmental friendly (natural or natural derived and biodegradable) effective biocide.
Ethanol is central nervous system depressant and psychoactive compound.
Its chronic consumption is associated with health risks including developmental toxicity, neurotoxicity, and potential fatality at high concentrations.
Its psychoactive properties, combined with high, legal availability and acceptance of abuse, make alcohol one of the most important criminogenic factors.
Notes:
- High-ethanol cosmetics may be irritating or drying to sensitive skin.
- Ethanol is not banned in cosmetics, but its use could be affected if it is reclassified as a CMR substance (Category 1B) – ongoing process
- There is an ongoing debate about reclassifying ethanol as a CMR substance and the consequences of Reg. 1223/2009 art. 15.
✅ Applications of Ethanol
🍷 1. Food and Beverages
- Active ingredient in alcoholic drinks (beer, wine, spirits)
- Used in flavor extracts (e.g., vanilla extract)
- Solvent for food colorings and preservatives
💊 2. Pharmaceuticals and Medicine
- Solvent for drug formulations (e.g., tinctures, syrups)
- Disinfectant and antiseptic (skin and surface sanitation)
- Used in cough medicines and mouthwashes
- Preservative in herbal and homeopathic remedies
🧴 3. Cosmetics and Personal Care
- Solvent in perfumes, deodorants, hairsprays, aftershaves
- Antimicrobial agent in hand sanitizers and toners
- Preservative and penetration enhancer
🧪 4. Chemical Industry
- Intermediate for producing ethyl esters, acetic acid, etc.
- Used in laboratory settings as a cleaning and extraction solvent
🚗 5. Fuel and Energy
- Bioethanol used as a renewable fuel or fuel additive (E10, E85)
- Used in stoves and camping fuel as a clean-burning source
🧼 6. Cleaning and Sanitation
- Ingredient in household and industrial cleaners
- Surface disinfectants in healthcare and food industries
🧬 7. Biotechnology
- Used in DNA extraction and protein precipitation
- Solvent and sterilizer in lab environments
The comparison of ethanol content in common foods versus the safe limit defined by EMA for children (6 mg/kg body weight → 0.12 g for a 20 kg child):
| Product | Ethanol Content (g/kg) | Estimated Intake per Serving (g) |
|---|---|---|
| Pear juice | 0.31 | 0.155 |
| Apple juice | 0.22 | 0.110 |
| Canned sweet corn | 1.09 | 0.164 |
| Pickles (fermented) | 0.85 | 0.085 |
| Ketchup / Tomato paste | 0.47 | 0.024 |
| Spice paste (garlic, chili) | 0.73 | 0.037 |
| Sauerkraut | 0.40 | 0.040 |
| Yogurt (natural, plain) | 0.10 | 0.015 |
Ethanol content in cosmetics, medicinal products, and biocides:
🧴 1. Cosmetics
| Product | Typical Ethanol Content | Function |
|---|---|---|
| Perfumes / Eau de toilette | 60–95% | Fragrance carrier, solvent |
| Spray deodorants | 30–70% | Antibacterial, fast-drying |
| Hand sanitizing gels | 60–80% | Antiviral and antibacterial action |
| Facial toners | 5–30% | Astringent, preservative |
| Aftershave lotions | 40–70% | Antiseptic, cooling effect |
💊2. Medicinal Products (Drugs & Medical Devices)
| Product | Ethanol Content | Remarks |
|---|---|---|
| Medicinal syrups (e.g. herbal) | 1–25% (up to 5 g/100 ml) | EMA: doses >75 mg/kg require warning labels |
| Tinctures / herbal drops | 40–70% | High-ethanol content; traditional remedies |
| Antiseptic wound cleansers | 60–70% | Antiseptic; low systemic exposure due to evaporation |
| Mouthwashes | 5–20% | Not recommended for children without supervision |
🔍 EMA Guidelines:
- Safe dose for children:
- <15 mg/kg body weight = safe
- 75 mg/kg body weight = must be labeled with warnings
- Ethanol content must be declared in the patient leaflet
🧪 3. Biocidal Products (Disinfectants)
| Product | Ethanol Content | Typical Use |
|---|---|---|
| Hand disinfectants | 60–85% | Skin disinfection |
| Surface disinfectants (e.g., kitchen) | 70–90% | Household and professional surface cleaning |
| Antibacterial sprays / gels | 60–70% | Quick hand sanitization |
Literature:
- EMA (2010) Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children
- EFSA (2009) Conclusion on pesticide peer review regarding the risk assessment of the active substance ethanol. EFSA Scientific Report(2009) 215, 1–48.
- Reimann Hauke, Zimmermann Birgit, Eckert Elisabeth, Lassek, Eva. (2023). Risk assessment of low-dose ethanol in food. Food and Chemical Toxicology. 173. 113633. 10.1016/j.fct.2023.113633.
- Chung E, Reinaker K, Meyers R. Ethanol Content of Medications and Its Effect on Blood Alcohol Concentration in Pediatric Patients. J Pediatr Pharmacol Ther. (2024) Apr;29(2):188-194. doi: 10.5863/1551-6776-29.2.188. Epub 2024 Apr 8. PMID: 38596428; PMCID: PMC11001219.
- Gürler, W. Martz, B. Taştekin, T. Najafova, R.B. Dettmeyer ,Estimates of Non-Alcoholic Food-Derived Ethanol and Methanol Exposure in Humans Journal of Analytical Toxicology, (2022), Vol. 46, pp. 200–210 M. DOI:10.1093/jat/bkaa198
