Identifiers
Functions
Regulatory treatment of manuka honey varies by market and product category. In the EU, honey (MEL) is an active cosmetic ingredient with no restrictions or concentration limits, functioning as a skin-conditioning emollient, humectant, and moisturizer. In the US, its primary component D-fructose is an FDA food additive used as a flavor enhancer, nutritive sweetener, and processing aid, with specific food category standards. In Australia and New Zealand, D-fructose is listed on industrial chemical inventories but lacks individual approval, requiring group standard coverage. For food use, US FDA regulations apply; for cosmetics, EU and other regional cosmetic regulations govern.
4 regulations
D-Fructose is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of D-Fructose are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 101.9 | 21 CFR 101.9 | Labeling Standards | authorized | View |
| 131.111 | 21 CFR 131.111 | Labeling Standards | authorized | View |
| 131.112 | 21 CFR 131.112 | Labeling Standards | authorized | View |
| 131.170 | 21 CFR 131.170 | Labeling Standards | authorized | View |
| 131.200 | 21 CFR 131.200 | Labeling Standards | authorized | View |
| 131.203 | 21 CFR 131.203 | Labeling Standards | authorized | View |
| 131.206 | 21 CFR 131.206 | Labeling Standards | authorized | View |
| 133.179 | 21 CFR 133.179 | Labeling Standards | authorized | View |
| 146.132 | 21 CFR 146.132 | Labeling Standards | authorized | View |
| 155.170 | 21 CFR 155.170 | Labeling Standards | authorized | View |
Sweetest of the sugars found in fruits and honey; Added to ice cream to prevent sandiness; [Merck Index] Used as a preservative and as an intravenous infusion in parenteral feeding; [ChemIDplus] Used as an additive to food/foodstuffs and in pharmaceuticals; [IUCLID] Used as flavoring agent or adjuvant, formulation aid, nutritive sweetener, processing aid, solvent, stabilizer or thickener, and texturizer for foods; [FDA]
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: FLAVOR ENHANCER | authorized |
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: FORMULATION AID | authorized |
| FDA Technical Effect: NUTRITIVE SWEETENER | authorized |
| FDA Technical Effect: PROCESSING AID | authorized |
| FDA Technical Effect: SOLVENT OR VEHICLE | authorized |
| FDA Technical Effect: STABILIZER OR THICKENER | authorized |
| FDA Technical Effect: TEXTURIZER | authorized |
1 regulation
Reg. (EU) 2015/1392, Reg. (EU) No 540/2011
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 57-48-7 | SOR/94-311 | DSL | authorized |
Conditions
This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.
Record details
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 2341 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Record details
1 regulation
Chemical: D-Fructose
1 regulation
Fructose: Does not have an individual approval but may be used as a component in a product covered by a group standard. It is not approved for use as a chemical in its own right.
Key conditions affecting compliance include: in the EU, honey has no cosmetic restrictions or maximum concentration limits, but must be used within its function as a skin-conditioning agent. In the US, D-fructose as a food additive must comply with specific food category standards (e.g., 21 CFR 101.9, 131.111) and may require reporting under TSCA CDR if manufactured or imported. In New Zealand, D-fructose is not individually approved and must be covered by a group standard. For powdered forms, EU REACH notes airborne particles can reach nuisance concentrations, requiring dust control measures.
Before launch, confirm the product category (food, cosmetic, or industrial) and applicable regional regulations. For cosmetics, verify honey (MEL) is listed as active with no restrictions in the target market. For food, ensure D-fructose meets FDA food additive standards and category-specific requirements. For industrial uses, check TSCA CDR reporting obligations and New Zealand group standard coverage. Also assess physical form: powdered honey may trigger EU REACH dust nuisance concerns. Documentation should include ingredient specifications, CAS numbers (e.g., 8028-66-8 for honey), and any required regulatory submissions.
The available regulatory position is insufficient for a full decision because it addresses D-fructose and honey (MEL) generically, not manuka honey specifically. No evidence covers manuka-specific regulations, authentication standards, or unique compound requirements (e.g., methylglyoxal). The EU cosmetic listing shows no restrictions, but this does not confirm safety for all applications. US FDA data covers D-fructose as a food additive, not honey as a whole. New Zealand and Australian inventory statuses are for D-fructose, not honey. Therefore, a compliance assessment cannot rely solely on this evidence for manuka honey claims or market entry.
No recent regulatory changes or effective dates are identified in the evidence. The EU cosmetic regulation lists honey (MEL) as active with no restrictions, but no amendment dates are provided. US FDA food additive standards for D-fructose are referenced without effective dates. TSCA CDR reporting requirements are ongoing, but no recent changes are noted. New Zealand and Australian inventory statuses are current but not dated. Therefore, no material regulatory changes or upcoming deadlines can be confirmed from the supplied evidence.