MGH

Definition

MGH™ is a process — built on the right flower.

Honey is a botanical extract. The medicinal chemistry of the flower carries into the honey, so the source plant matters: Leptospermum scoparium delivers DHA that converts to MGO; other floras bring peroxide, polyphenols or defensin-1. MGH™ is the controlled process that takes that raw chemistry and makes it sterile, stable, dose-defined and regulator-ready.

The criteria

The five conditions a honey must satisfy.

  1. 01

    Defined botanical source[2,4,10]

    The flower sets the ceiling. Leptospermum scoparium / polygalifolium for DHA→MGO; Buckwheat, Honeydew or Tualang for polyphenols; greenhouse-controlled floras for batch consistency. MGH™ starts with knowing — and specifying — the plant.

  2. 02

    Validated sterilisation[6,9]

    Typically gamma irradiation at a dose validated against bioburden — not heat, which destroys MGO precursors and enzymatic activity. E-beam for thin formats; EtO only for carriers, not the honey itself.

  3. 03

    Documented bioburden[6]

    A pre-sterilisation bioburden specification appropriate for the route of administration (topical wound, ocular, mucosal).

  4. 04

    Stable activity profile[7,8,9]

    Identifiable, quantifiable functional markers (MGO, DHA, water activity, pH) that survive the sterilisation step.

  5. 05

    Regulatory traceability[3,5]

    CE / FDA / TGA / MDR pathway with claim-substantiation files: debridement and moist wound healing on pack; antimicrobial off pack.

The regulatory gap

No government has written an MGH™ standard. So we built one.

There is no Codex, ISO, EU, FDA, TGA or MPI monograph titled 'Medical Grade Honey'. The category sits in the white space between food law (which governs honey as an edible commodity) and medical device law (which governs the finished dressing, gel or spray). Our working specification stitches the two together — anchored in food-grade authority, lifted to medical-device discipline.

01

Codex Alimentarius (CXS 12-1981) as the floor[1]

The FAO/WHO Codex standard for honey defines authenticity, composition and contaminant limits accepted in over 180 countries. We adopt it as the baseline for sugar profile, diastase, electrical conductivity, insoluble matter and free acidity on the raw honey before sterilisation. It is the most widely recognised food-grade reference and the right starting point — but it was written for honey on a supermarket shelf, not on a wound bed.

02

Local government overlays (NZ MPI, AMHA, EU directives)[2,3,4,10]

Where the source country has a recognised monofloral standard we layer it on: New Zealand MPI's 5-attribute scientific definition for Manuka (4-methoxyphenyllactic acid, 2-methoxyacetophenone, 3-phenyllactic acid, 2-methoxybenzoic acid + Leptospermum DNA); the Australian Manuka Honey Association MGO/Leptosperin schedule; the EU Honey Directive 2001/110/EC. These give botanical authenticity the food code alone cannot.

03

Medical-device discipline on top (ISO 13485, EU MDR, FDA 510(k))[3,5,6]

On top of the food-grade base we apply the medical-device quality system: ISO 13485 manufacturing, validated gamma sterilisation to ISO 11137, bioburden control to ISO 11737, and a CE / FDA / TGA technical file substantiating debridement and moist wound healing claims. This is the layer that turns a compliant honey into a compliant device.

Where Codex stops applying

Not every food-grade rule survives the move to MGH™.

Codex was drafted to keep honey honest as a food. Several of its provisions are either irrelevant to, or actively in tension with, the way MGH™ is manufactured and dispensed. We document the deviations rather than hide them.

  • Heat-treatment tolerance[1,8,9]

    Codex tolerates pasteurisation that protects shelf-life. MGH™ rejects it: heat collapses DHA→MGO conversion and enzymatic peroxide activity. We sterilise by validated gamma, not heat.

  • Moisture ceiling[1]

    Codex permits up to 20% moisture (23% for heather). MGH™ tightens this — under 20% — to preserve osmotic debridement and resist fermentation across a multi-year shelf life.

  • Labelling and claims[3,5]

    Codex governs food labelling. MGH™ labels are governed by EU MDR / FDA 21 CFR 801 / TGA — a different claims grammar entirely.

  • Blending rules[1,2]

    Codex permits blending of honeys from multiple origins. MGH™ requires single-origin or fully-traceable blends with documented activity per lot.

  • Bioburden[1,6]

    Codex is silent on microbial load below pathogen thresholds. MGH™ specifies pre-sterilisation bioburden to ISO 11737 — non-negotiable for a wound product.

  • Adulteration testing[1,2,10,11,12]

    Codex authenticity tests (C4 sugar, SCIRA, NMR) remain in force — we keep them and add Leptospermum DNA / leptosperin / lepteridine for botanical authenticity beyond the food brief.

The result is a hybrid specification: Codex + local monofloral standard + medical-device QMS. No single regulator has written it. Until one does, this is the template we hold ourselves — and our suppliers — to.

Selected references

  1. Codex Alimentarius Commission. Revised Codex Standard for Honey, CXS 12-1981 (Rev. 2 2001). FAO/WHO. CXS_012e.pdf.
  2. New Zealand Ministry for Primary Industries. Criteria for identifying mānuka honey — A summary of the mānuka honey science programme. mpi.govt.nz.
  3. European Union. Council Directive 2001/110/EC relating to honey (as amended by 2014/63/EU). Official Journal.
  4. Australian Manuka Honey Association. AMHA Mark — authenticity and quality standard (MGO + leptosperin). manukaaustralia.org.au.
  5. ISO 13485:2016 — Medical devices — Quality management systems.
  6. ISO 11137 — Sterilization of health care products — Radiation; ISO 11737-1 — Determination of bioburden.
  7. Stephens JM et al. Phenolic compounds and methylglyoxal in NZ mānuka and kānuka honeys. Food Chemistry. 2010;120(1):78–86.
  8. Adams CJ, Manley-Harris M, Molan PC. The origin of methylglyoxal in NZ mānuka honey. Carbohydrate Research. 2009;344(8):1050–1053.
  9. Atrott J, Haberlau S, Henle T. Formation of methylglyoxal from dihydroxyacetone in mānuka honey. Carbohydrate Research. 2012;361:7–11.
  10. Kato Y et al. Authentication of mānuka honey by measuring leptosperin. J. Agric. Food Chem. 2014;62(27):6400–6407.
  11. Daniels BJ et al. Isolation and synthesis of lepteridine from mānuka honey. J. Agric. Food Chem. 2016;64(24):5079–5084.
  12. Bong J, Loomes KM, Schlothauer RC, Stephens JM. Fluorescence markers in some New Zealand honeys. Food Chemistry. 2016;192:1006–1014.

Botanical chemistry

Other medicinal flowers that carry into honey.

Manuka is the proven case, but it isn't the only medicinal plant bees forage. Where the flower's secondary metabolites are nectar-soluble or non-volatile, traces — and sometimes meaningful quantities — carry into the finished honey. The list below is the credible shortlist where peer-reviewed chemistry exists.

Manuka

Leptospermum scoparium

Carries: DHA → MGO (stable, dose-quantifiable)

The reference case. Nectar-borne dihydroxyacetone converts to methylglyoxal over months — survives gamma.

Tea tree / Jelly-bush

Leptospermum polygalifolium / Melaleuca spp.

Carries: DHA → MGO; trace terpenes

Australian Leptospermum cousins frequently equal or exceed NZ Manuka MGO. True Melaleuca (tea tree) honey is rarer but shares the antimicrobial heritage of the genus.

Thyme

Thymus vulgaris

Carries: Phenolics, thymol traces

Mediterranean thyme honey carries a measurable phenolic load; in vitro activity against S. aureus and Candida documented.

Eucalyptus

Eucalyptus spp.

Carries: 1,8-cineole traces, polyphenols

Eucalypt honeys retain low-level volatiles from the parent tree; studied in respiratory and oral applications.

Lavender

Lavandula angustifolia

Carries: Linalool traces, flavonoids

French lavender honey shows antioxidant and mild antibacterial activity attributable to flavonoid carry-over.

Sidr (Christ's thorn)

Ziziphus spina-christi

Carries: Saponins, polyphenols

Long ethnomedical history in Yemen and the Levant; emerging lab data on antibacterial and antifungal activity.

Chestnut

Castanea sativa

Carries: Tannins, kynurenic acid

Distinctly bitter European honey with high polyphenol load; studied for anti-inflammatory and gut-mucosal effects.

Linden / Lime

Tilia spp.

Carries: Farnesol, flavonoids

Traditional sedative and antitussive use mirrors the parent tree's herbal pharmacology.

Buckwheat

Fagopyrum esculentum

Carries: Rutin, phenolics

Highest phenolic content of common honeys. Cochrane-grade evidence as a paediatric cough antitussive.

Not every medicinal compound makes the journey. Volatile terpenes (the active fraction of true tea tree oil, for example) largely evaporate during nectar ripening — which is why tea tree honey is not tea tree oil. The compounds that survive are water-soluble or non-volatile: sugar-derived (DHA, MGO), peptides (defensin-1), and stable polyphenols.

On-pack vs off-pack

What you can — and cannot — say.

On pack (claimable)

  • ›Debridement via osmotic action (high sugar)
  • ›Moist wound healing environment (under 20% moisture)
  • ›Maintenance of optimal pH for healing
  • ›Reduction of malodour

Off pack (educational)†

  • ›Antimicrobial / antibacterial activity
  • ›Biofilm disruption
  • ›Antioxidant capacity
  • ›Anti-scar / re-epithelialisation support
  • ›Antibiotic re-sensitisation (efflux pump inhibition)

Common questions

What buyers and clinicians ask about MGH™.

›Is there an official MGH™ standard?

No. There is no Codex, ISO, EU, FDA, TGA or MPI monograph titled 'Medical Grade Honey'. The category sits between food law (which governs honey as an edible commodity) and medical-device law (which governs the finished dressing). The working spec stitches the two together: Codex CXS 12-1981 as the food-grade floor, plus ISO 13485 / ISO 11137 / ISO 11737 discipline on top.

›What must an MGH™ Certificate of Analysis (COA) show?

A defensible COA shows: botanical attestation (leptosperin, Leptospermum DNA or pollen), MGO assay by HPLC with the labelled value retained post-sterilisation (industry norm ≥95%), pre-sterilisation bioburden under ISO 11737-1, sterilisation dose validated under ISO 11137 (typically VDmax₂₅ to a 10⁻⁶ SAL), water activity, HMF, pH, and stability data — real-time at 25 °C/60% RH and accelerated at 40 °C/75% RH — out to the labelled expiry.

›MGH™ vs Manuka honey vs table honey — what is the difference?

Table honey is a food. Manuka honey is a monofloral honey from Leptospermum scoparium with quantifiable MGO. MGH™ is a process applied to a qualifying honey (typically Manuka): gamma sterilisation to a documented SAL, controlled bioburden, dose-defined activity, and a CE / FDA / TGA technical file substantiating debridement and moist-wound-healing claims.

›Does gamma irradiation destroy MGO?

No. Methylglyoxal is a small, stable α-keto aldehyde — covalent bonds, no labile structure for ionising radiation to cleave at the doses used (typically 25 kGy). Validated lots show ≥95% MGO retention against the labelled value. Heat pasteurisation, by contrast, collapses the DHA→MGO conversion and is rejected for MGH™ product.

›What MGO level counts as a clinical Manuka spec?

MGO is the directly-measured methylglyoxal concentration in mg/kg — the dominant non-peroxide antibacterial in Manuka honey. For clinical wound use, MGO ≥ 400 mg/kg is the working floor; ≥ 550 mg/kg is the common spec for biofilm-burdened chronic wounds. A medical-grade dossier should also declare DHA and a stability curve over shelf life, not a single release number.

External evidence

Peer-reviewed and institutional sources on MGH™.

The literature and hospital-system reviews we sit alongside. Use these as primary sources; we annotate and apply them to buyer and regulatory decisions.

Related reading

Continue reading

About MGH™

The standard, in full

Base standard plus sector add-ons: testing, processing, sterilisation and regulatory support.

Varieties

Manuka, Jarrah, Sidr & more

Therapeutic honeys that qualify under MGH™, with their activity markers and use cases.

The Science

Chemistry, MGO & sterilisation

How methylglyoxal forms, why it survives gamma irradiation, and what the other honeys bring to the table.

Applications

Clinical use cases & evidence

Wound care, ophthalmology, antimicrobial stewardship and emerging frontiers — with trial identifiers.

For patients

Medical honey patient guide

A plain-English walkthrough for patients and carers using honey dressings.

Bibliography

Definition & 101 key studies

The Peters et al. 2025 refined MGH standard, plus the full PubMed evidence cluster behind it — grouped by topic.

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