China SAMR Consults on Technical Requirements of Filing Health Food Using Coenzyme Q10 and Other Four Substances as Raw Materials

Powder is newly included as the permitted dosage form for health food subject to filing, but currently it only applies to ganoderma lucidum spore products. Raw material full-items quality inspection reports for products using these five materials are required in filing application.

On August 12^th, China SAMR opened the draft of Technical Requirements of Filing Health Food Products Using Coenzyme Q10, Broken Ganoderma Lucidum Spores, Spirulina, Fish Oil, and Melatonin as Raw Material for public feedback^[1]. The exposure draft mainly specifies the permitted auxiliary ingredients, dosage forms, technical requirements and manufacturing techniques for the filing of health food using these five ingredients respectively as major ingredient. Any comments shall be sent back prior to Sep. 12, 2020.

In March 2019, SAMR consulted on technical requirements of coenzyme Q10, melatonin, fish oil, reishi shell-broken spore powder and spirulina, intending to add them into the Health Food Raw Materials Directory.^[2] The exposure draft issued this time serves as the supportive document and details the production requirements for health food using these materials.

Auxiliary ingredient

Permitted Auxiliary Ingredient Lists are detailed for products using these five substances as the raw material (hereinafter “these five products”). For example, 24 kinds of auxiliary ingredients could be used to produce broken ganoderma lucidum spore products, including vitamin E, edible corn starch, olive oil, etc.

To get such products filed, applicant should use auxiliary ingredients in the Permitted Auxiliary Ingredient List. However, if the auxiliary ingredient used in filing products do not belong to the Permitted Auxiliary Ingredient List, but is listed in the List of Auxiliary Materials for Health Food Filing and Terms of Use (2019 edition), applicants should provide supportive proof for using this ingredient and its dosage. For products added with food flavouring and coloring, flavoring and coloring types are no longer limited.

Dosage forms

The dosage forms involved in these five products include tablet, granule, hard capsule, soft capsule and powder. Powder is a newly added dosage form for the filing of health food products, but by now it is only allowable for ganoderma lucidum spore products. Manufacturing techniques of the other four dosages follows that of vitamin & mineral products.

Material	Dosage form
Coenzyme Q10	Tablet (oral, lozenge, chewable), granule, hard capsule, and soft capsule.
Broken ganoderma lucidum spores	Tablet (oral), granule, hard capsule, and powder.
Spirulina	Tablet (oral), granule, hard capsule.
Fish oil	Soft capsule
Melatonin	Tablet (normal, lozenge), granule, hard capsule, and soft capsule.

Technical requirements

Generally speaking, the technical requirements for filing these five products should follow the requirements of the corresponding dosage form. Microbiological indexes of all products should conform to GB 16740 Standard for Health Food. Besides, the draft also stipulates some additional requirements for each material, such as active ingredient, physical and chemical indexes, identification indexes.

It is noteworthy that when applying for health food filing, applicant should provide a full-items quality inspection report of the raw material together with other documents. This is not required for vitamin & mineral products.