On February 20, 2021, the SAMR issued the Available Auxiliary Ingredients and the Use Regulations for Filing Health Food (2021 Edition) and Dosage Form and Technical Requirements of Filing Health Food (2021 Edition), which included powder and gummy in filing health food. It will come into effect on June 1, 2021.

Powder & gummy are included in filing health food

On the basis of previously approved tablets, hard capsules, soft capsules, oral solvents, and granules, two new dosage forms, powder and gummy, have been added.

It is clear that the vitamins and minerals that have been included in the Catalogue of Health Food Ingredients can be used in powder and gummy.

For filing health food of Coenzyme Q10, Fish oil, Sporoderm-broken of ganoderma lucidum spores powder, Spirulina and Melatonin, only Sporoderm-broken of ganoderma lucidum spores powder can be used in powder form.

Technical requirements for different dosage forms of filing health food are clarified

Tablets, hard capsules, soft capsules, oral solvents, and granules are the dosage forms included in the current Chinese Pharmacopoeia. The indicators set in the technical requirements refer to the current Chinese Pharmacopoeia and the National Food Safety Standard Health Food.

Two new dosage forms of filing health food, powder and gummy, belong to the form of food, and there are not corresponding national standards for their technical indicators. Their technical indicators need to comply with the Dosage Form of Filing Health Food Technical Requirements for Powder (2021 Edition) and the Dosage Form of Filing Health Food Technical Requirements for Gummy (2021 Edition).

Available auxiliary ingredients for filing health food are updated

This time, the Available Auxiliary Ingredients and the Use Regulations for Filing Health Food (2021 Edition) is also released. Compared with the 2019 Edition, a new available auxiliary ingredient, hydroxypropyl starch empty capsules, is added.

At the same time, it stipulates the auxiliary ingredients and their use standards which cannot be used in powder and gummy, and allowable usage in gummy production.

With the release of Catalog of Five Health Food Raw Materials Including Coenzyme Q10, the filing health food ingredients are no longer just vitamins and minerals, and more functional ingredients can be filed. At the same time, the inclusion of powders and gummy into filing health food has also further expanded the dosage forms of filing health food. The expansion of ingredients and dosage forms will further promote the diversified development of health food industry and enhance industry self-confidence.

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Powder and Gummy are Officially Included in Filing Health Food