Safety & Quality
East Cape mānuka oil has a strong safety profile. It has been classified as safe and tolerable for human use (CAS (US & EU) 223749-44-8; CTFA monograph ID 10572 and EINECS 425-630-7).
Therapeutic Good Administration (TGA) has classified mānuka oil as an approved herbal substance for use in listed medicines (topical treatments and mouth wash).
East Cape mānuka oil comes with full traceability from plant source to oil and independent analysis and certification of all batches.
Irritation Potential and skin tolerance
Human Repeat Insult Patch Testing with 50 people showed that 2% East Cape mānuka oil has good skin compatibility and does not cause any sensitising effects (Eurofins Romania 2021).
A recent review article makes the following observations (Matthew et al., 2020):
- Gel formulations containing >10% mānuka oil (did not induce acute skin sensitivity in mice).
- The irritation potential of 10% mānuka oil was tested on the chorioallantoic membrane of chicken egg and using the Eyetex and Skintex assays. All three tests deemed the product to be non-irritant, non-comedogenic and well tolerated on skin.
- The product safety report on b-triketone rich mānuka Oil (<5%) according to EC Regulation 1223/2009 detailed high skin tolerance and good cosmetic acceptance. There was no skin sensitization. No irritation was noted on testing the formulation on rabbit eye mucous membranes.
Mānuka Oil (<5%) did not demonstrate genetic toxicity after a micronucleus test in TK6 Human lymphoblastoid cells and bacterial reverse mutation test in Salmonella typhimurium and Escherichia coli. Acute toxicities were LD50 = 1061 mg/kg body weight and LD50 > 2000 mg/kg body weight for oral and dermal administration, respectively.
Reference: Matthew, C. et al., (2020) Mānuka Oil – A Review of Antimicrobial and Other Medicinal Properties, Pharmaceuticals 2020, 13, 343; doi:10.3390/ph13110343, published online 26 October 2020.
In their 2014 e-book, EO Safety – A Guide for Healthcare Professionals, (Churchill Livingstone Elsevier), R. Tisserand, R. Young make the following observations on mānuka oil: “No known hazards or contraindications. No information found on adverse skin reactions. No reasons to suspect any kind of toxicity. Mānuka oil was not significantly cytotoxic to cultured human umbilical vein endothelial cells, contains no carcinogens and displays some anti-carcinogenic activity’
East Cape mānuka oil from New Zealand comes with full traceability from plant source to oil, and the following quality guarantees, certifications, registrations and memberships:
- Guaranteed triketone levels e.g. MBTK™ 20+
- Ecocert Cosmos certified
- Verified non-GMO
- Not tested on animals
- The International Fragrance Association
- REACH compliance
- Halal and Kosher certified
- International Federation of Essential Oils & Aroma Trades (IFEAT) membership
Safe, effective & market ready
This data shows East Cape mānuka oil is safe and well tolerated in dermal or oral formulations and is ready for inclusion in globally marketed skincare and therapeutic products.