China has released a draft revised Food Safety National Standard for the nutritional fortifier ergocalciferol (Vitamin D?) for public consultation, replacing GB 14755-2010. The revision formally shifts Vitamin D? from the category of food additive to food nutritional fortifier, aligning with its practical use in fortified foods and updating technical and safety requirements.
Key revisions include updated HPLC detection wavelength and system suitability requirements, revised lead limits and arsenic testing methods, expanded manufacturing scope (UV irradiation of ergosterol followed by purification), and updates to the infrared reference spectrum. The standard defines Vitamin D? as C??H??O? (molecular mass 396.66) and specifies sensory characteristics: colorless or white, odorless, needle-like crystals or crystalline powder.
Physicochemical specifications include:
Vitamin D? content: 98.0%103.0%
Specific optical rotation: +102.0 to +107.0
Mass absorption coefficient (265 nm): 4649
Ergosterol residue: ?0.2%
Reducing substances: ?0.002%
Toxic element limits are set at:
Lead (Pb): ?2 mg/kg
Total arsenic: ?2 mg/kg
Detailed analytical methods are provided, including infrared identification, UV detection, and normal-phase HPLC to separate Vitamin D? from related substances such as Vitamin D? and sterol derivatives.
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