Classification
Product TypeIngredient
Product FormPowder or Oil Suspension
Industry PositionNutraceutical / Health Food Ingredient
Market
Menaquinone-7 (vitamin K2, MK-7) in China is primarily relevant as a nutrient ingredient used in the “health food” (dietary supplement) regulatory framework. China’s Health Food Raw Material Directory for nutrient supplements (2023 edition) explicitly lists vitamin K2 in both fermentation-produced and synthetic forms with referenced regulatory/standard bases. Market access for finished health food products hinges on choosing the correct pathway (filing vs registration) under SAMR’s Measures for the Registration and Filing of Health Foods, which can be a gating factor for commercialization. For export-facing ingredient suppliers, alignment with importing-market specifications (e.g., EU novel food specifications for menaquinone-7, including isomer/purity expectations) and documentation readiness are recurring buyer requirements.
Market RoleDomestic regulated supplement-ingredient market (health food nutrient-supplement use permitted for vitamin K2 in official directory; trade balance not verified)
Domestic RolePermitted nutrient raw material for China “health food” (nutrient supplement) filings when used in accordance with the official raw material directory and applicable standards.
Specification
Physical Attributes- Often traded as a yellow powder or oil suspension (noting EU novel food specifications for menaquinone-7).
- Light/oxidation sensitivity is commonly managed via opaque, oxygen-barrier packaging and controlled storage conditions (buyer specification dependent).
Compositional Metrics- EU novel food specifications for synthetic Vitamin K2 (menaquinone-7) include limits on cis-isomer and require a defined menaquinone-7 content with minimum all-trans proportion.
- EU novel food specifications for microbiologically produced Vitamin K2 (menaquinone-7) list Bacillus subtilis spp. natto and Bacillus licheniformis as sources and allow powder or oil suspension forms.
Grades- Buyer specifications frequently distinguish by source route (synthetic vs microbiological/fermentation) and by isomer profile (all-trans vs cis isomers), referencing major-market specifications (e.g., EU novel food specifications).
Packaging- Typical trade packaging is light-protective and oxygen-limiting (e.g., foil laminate bags or amber containers), with COA and batch identification aligned to buyer traceability expectations.
Supply Chain
Value Chain- Microbiological production route: fermentation (listed microbial sources in EU specs) → downstream extraction/purification → formulation into powder or oil suspension → batch COA release → domestic “health food” customer supply or export shipment.
- Synthetic production route: chemical synthesis → purification and isomer control → formulation (often powder) → batch COA release → domestic “health food” customer supply or export shipment.
Temperature- Quality preservation is typically managed by protecting from heat, light, and oxygen during storage and transport (specific set-points depend on supplier specification and formulation).
Atmosphere Control- Oxygen exposure management (sealed containers; sometimes inert headspace depending on supplier SOP) is commonly emphasized in buyer specifications for sensitive nutraceutical actives.
Shelf Life- Shelf life is strongly influenced by formulation (powder vs oil suspension), packaging barrier performance, and exposure to light/oxygen; buyers often require stability support and re-test periods by batch.
Freight IntensityLow
Transport ModeAir
Risks
Labor And Human Rights HighChina-origin supply chains that are linked (directly or indirectly) to Xinjiang Uyghur Autonomous Region (XUAR) inputs or entities on the UFLPA Entity List face a rebuttable presumption of forced labor for U.S. importation, which can result in detention, seizure, or exclusion unless the importer rebuts with clear and convincing evidence.Implement end-to-end supply-chain mapping and documentation (including upstream input origins), screen for XUAR/entity-list exposure, maintain a ready-to-submit evidence package for CBP applicability reviews, and avoid commingled/opaque input streams where traceability cannot be demonstrated.
Regulatory Compliance MediumMisclassification of the finished product’s China market-entry pathway (filing vs registration) or mismatch between the Vitamin K2 raw material used (e.g., fermentation vs synthetic identity/standard basis) and the official health food raw material directory can block or delay commercialization in China’s “health food” channel.Confirm directory alignment and intended claims/function positioning early; if outside directory scope or otherwise not eligible for filing, plan for registration timelines and dossier requirements under SAMR rules.
Food Safety MediumMenaquinone-7 ingredient acceptance in strict importing markets can be sensitive to isomer profile and impurity limits (e.g., cis-isomer limits and minimum all-trans proportion in EU specifications); inconsistent assay/isomer composition in commercial products has been documented in the supplement market and can trigger buyer rejection or recall risk.Specify and test all-trans content and cis-isomer/impurity limits in the COA, qualify laboratories/methods, and align supplier specifications to target-market standards (e.g., EU novel food specifications where applicable).
Labor & Social- Forced labor and human-rights due diligence scrutiny for China-linked supply chains (including Xinjiang Uyghur Autonomous Region exposure risk) can create downstream shipment detention/seizure risk in the U.S. under the Uyghur Forced Labor Prevention Act (UFLPA).
FAQ
Is vitamin K2 (menaquinone-7/MK-7) listed in China’s official nutrient-supplement health food raw material directory?Yes. The Health Food Raw Material Directory for Nutrient Supplements (2023 edition) lists Vitamin K2 and distinguishes fermentation-produced and synthetic forms, with referenced regulatory/standard bases in the directory.
When is registration required instead of filing for health food products in China?Under China’s Measures for the Registration and Filing of Health Foods, products using raw materials outside the official health food raw material directory and many first-time imported health foods generally require registration, while eligible vitamin/mineral nutrient supplements can follow the filing pathway.
What specifications matter most for MK-7 when selling into strict importing markets from China?Importing-market specifications can be sensitive to isomer profile and impurity limits. For example, EU novel food specifications for menaquinone-7 include defined content requirements and limits for cis-isomer/impurities, and buyers often align COA requirements to those kinds of benchmarks.