In March 2019, SAMR issued a list of health food raw materials for comments. It is proposed five raw materials including Coenzyme Q10, Fish oil, Sporoderm-broken of Ganoderma Lucidum spores powder, Spirulina and Melatonin. After collecting and summarizing feedback, the Center for Food Evaluation, State Administration for Market Regulation successively carried out follow-up work. After sorting out the technical requirements, available dosage forms, auxiliary materials, product testing indicators, and main production processes for raw materials, the supporting documents of the five raw materials for filling health food have been formed.

On August 12, 2020, the State Administration for Market Regulation issued an announcement on the public soliciting opinions on the technical requirements of five materials in the List of Health Food Raw Material of the filling health food including Coenzyme Q10 (draft for comments), and solicited comments on related supporting documents. The deadline for feedback is September 12, 2020.

Technical requirements for raw materials

Different from vitamin and mineral products, five raw materials including Coenzyme Q10 have respectively established technical requirements that reflect the characteristics of health food raw materials.

Main production processes

Based on the product dosage forms proposed for filing for each of the five raw materials when the technical requirements of the raw materials were consulted, the powder dosage form of Sporoderm-broken of Ganoderma Lucidum spores powder was adopted. The dosage forms of these five health food raw materials this time include tablets, granules, hard capsules, soft capsules, and powders.

Available auxiliary materials for filing products

Determine the list of available auxiliary materials for the five filing products (hereinafter referred to as List of Available Auxiliary Materials). After comparison, it is found that the used auxiliary materials are basically in the published List of Available Auxiliary Materials for Health Food Filing Products and Their Use Regulations (2019 Edition). When products are filed in the future, in principle, the filing applicant should use the auxiliary materials in the List of Available Auxiliary Materials; if the auxiliary materials in the List of Available Auxiliary Materials for Health Food Filing Products and Their Use Regulations are used and do not belong to the List of Available auxiliary materials, the basis for the selection of auxiliary materials and dosage shall be provided. For products that use flavorings and colorings, the types of use are no longer limited.

Product technical indicators

According to the technical indicators of each raw material, and referring to the product technical requirements of each dosage form in the present vitamin and mineral filing products, the product technical indicators of each raw material and dosage form are respectively refined.