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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 12th, 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.

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