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On October 11, 2024, China State Administration of Market Regulation (SAMR) unveiled two drafts regarding the filing of health food, namely, Dosage Forms and Technical Requirements for Health Food Filing (2024 Edition) and List of Auxiliary Materials for Health Food Filing and Terms of Use (2024 Edition). The current editions of these two regulations are released in 2021.
These two drafts aim to add candy products and beverages as two newly permitted dosage forms in terms of health food filing and update requirements for corresponding health food products. Public comments can be submitted to [email protected] by November 10.
1. New Dosage Forms and Technical Requirements
Compared to the current 2021 version, the 2024 draft introduces key changes as the followings:
Three dosage forms (namely, mixtures, tea preparations (bagged tea), and pastes) are added as permitted dosage forms in terms of the filing of ginseng, American ginseng, and Ganoderma products from May 1, 2024. Check ChemLinked News for more details. Products in the form of mixtures, tea preparations (bagged tea), and pastes should comply with the current edition of the Chinese Pharmacopoeia and meet the relevant provisions of GB 16740-2014 Health Food.
Two dosage forms (namely, candy products and beverages) are proposed to be included for the first time, as revealed in the 2024 draft. Notably, candy products are further categorized into three dosage forms, including candy, chocolate, and jelly. Products in the form of candy products and beverages should comply with corresponding technical requirements stated in Annexes of this regulation. If the national food safety standards for these forms are updated with new usage requirements, the corresponding quality and safety indicators must also be met.
Stakeholders can put forward applications to SAMR regarding the addition of other common food forms into the scope of health food filing. These food forms must have corresponding national or industry quality standards.
Requirements for the labeling of pretreated raw materials are clarified. Pretreated raw materials, such as those that are premixed, embedded, or microencapsulated, must be clearly labeled in the production process, with their names and the type of pre-treatment (premixing, embedding, microencapsulation, etc.) clearly specified.
2. Updated List of Auxiliary Materials
Compared to the current 2021 version, the 2024 draft introduces key changes as the followings:
National food safety standards for 17 auxiliary materials are updated, such as GB 1886.352 for β-cyclodextrin, GB 1886.357 for Indigo Carmine Aluminum Lake, and GB 1886.341 for Titanium Dioxide.
National food safety standards for 8 auxiliary materials are added, such as GB 31640 for Edible Alcohol, GB 1903.27 for Galactooligosaccharides, and GB 1903.40 for Fructooligosaccharide.
Standard bases for 19 auxiliary materials are updated, such as GB 1900 for Butylated Hydroxytoluene (BHT), GB 1886.87 for Beeswax, and GB 29988 for Potassium Alginate (Alginate Potassium).
Daily consumption limits for solid and liquid preparations have been removed. The current limits in the 2021 version are based on the 2005 guidelines. With the revision of the general rules for preparations in the current Chinese Pharmacopoeia and the release of supporting documents for the health food raw materials catalog, the daily intake of solid preparations may exceed 20g (such as protein powder products). For liquid preparations limits, certain oral preparations included in the current Chinese Pharmacopoeia, as well as some approved health foods in oral preparations, also exceed 30ml. The newly added beverage dosage forms will also have a daily intake limit exceeding 30ml.
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