In order to smoothly advance the filing work, the Food Inspection Center of the State Administration of Food and Drug Administration is responsible for drafting the technical requirements that should be met during the filing of five health food ingredients such as Coenzyme Q10. The State Administration for Market Supervision and Administration has solicited opinions from the society and is now publishing.

1. Relevant regulations on the use of raw materials

When filing products using the above-mentioned raw materials, the raw materials shall meet the following requirements:

(1) When filing products with five raw materials including coenzyme Q10, only melatonin can be used in combination with vitamin B6, and the other four raw materials cannot be used in combination with any other raw materials.

(2) When applying for product filing, the filing person should submit a full project inspection report issued by a legally qualified inspection agency in accordance with the technical requirements of raw materials in the "Safety and Health Function evaluation Materials". The inspection agency shall conduct inspections strictly in accordance with the raw material technical requirements in the health food raw material catalog, and make a conclusion on whether the inspection results issued by the raw materials for inspection meet the current regulations. The inspection report is from the date of issuance to the date of submission of the filing application in the health food filing management information system, and the report is valid for 2 years.

2. The main production process at the time of product filing

When the five health food raw materials such as Coenzyme Q10 are put on record, the recordable dosage forms include tablets, granules, hard capsules, soft capsules, and powders.

3. The regulations on the use of available excipients for registered products

In order to steadily advance the filing of approved coenzyme Q10 and other five raw materials for the filing of products, when using the above raw materials for product filing, the auxiliary materials should meet the requirements:

(1) only the excipients in the list of "available excipients" corresponding to the technical requirements of each raw material recordable product can be used.

(2) For the excipients that are not in the "Available Excipients" list in the technical requirements for the filing of various raw materials, and the excipients are listed in the "Regulations on Available Excipients and Their Use of Health Food Filing Products (2021 Edition)", when applying for product filing, they are listed in "Others "Materials indicating product safety and health functions" should also provide:

A. Can support product safety and functional evaluation data: including toxicological evaluation test and functional evaluation test data of stereotyped products (including all auxiliary materials), or literature data of products with the same formula.

B. The basis for the use of excipients, the necessity of the process, the stability of the product, the packaging materials that directly contact the product, do not undergo chemical changes, do not affect the testing of the product, the formability and stability of the formulation and other aspects of research and development data (including test data, index selection Wait).

C. The recorder's commitment to ensure that the use of the auxiliary materials can ensure the safety of the product.

(3) During the filing of each raw material product, the three raw materials of Coenzyme Q10, Spirulina, and Melatonin can be used in the filing products of food flavors and pigments, and the types of food flavors and pigments are no longer restricted; Coenzyme Q10, wall-broken Ganoderma lucidum spore powder, spiral When filing tablets with the four raw materials of algae and melatonin, if a pre-mixed agent is used, it shall comply with the relevant requirements of the "Regulations on Available Excipients and Use of Health Food Filing Products (2021 Edition)".

4.Product technical index requirements when filing products

Coenzyme Q10 and other five raw materials for filing products, in addition to setting the technical indicators according to the requirements of each dosage form, they should also comply with the technical indicators in the technical requirements of each raw material filing product.

In the five kinds of raw material catalog record product technical requirements, the source of the raw materials must be specified (including raw material manufacturers and raw material enterprise standards, etc.).

5. Regarding the scope of products that can be registered for five raw materials such as Coenzyme Q10

According to Article 76 of the Food Safety Law, Article 9 and Article 45 of the Measures for the Administration of Health Food Registration and Filing, the health food that uses raw materials other than the health food raw material list and the health food imported for the first time shall Registered by the Food and Drug Administration of the State Council. However, if the first imported health food is supplemented with vitamins, minerals and other nutrients, it shall be reported to the Food and Drug Administration of the State Council for record. This time, five raw materials including Coenzyme Q10 are included in the list of health food raw materials. Each raw material has a corresponding health function and is not a supplement of nutrients such as vitamins and minerals. Therefore, in accordance with the requirements of the above regulations, five raw materials such as Coenzyme Q10 are used for unilateral products The filing is only for domestic health food, excluding health food imported for the first time.

For health foods that have been approved and re-imported into China, they do not need to renew their registration. They should apply for confirmation of the qualifications of the original registrant before the validity period of the approval certificate and transfer to record management. For imported health foods that have accepted registration applications before the issuance of the raw materials catalog, those using raw materials in the health food raw materials catalog will also be transferred to the record management as the original registrant.

6.Regarding the transition from registration to filing

For products that have obtained the certificate of approval, or have accepted the application for registration of health food before the release of the health food raw material catalog, the raw materials of which are included in the health food raw material catalog, and the amount or effect does not meet the requirements of the health food raw material catalog, the registration applicant or If the certificate holder agrees to adjust the product dosage or efficacy according to the health food raw material catalog, it can also be the original registrant. For products accepted after the release of the raw material catalog, the review concluded that they will not be registered and cannot be used as the original registrant's product. For registered products with irregular raw material names, they should be standardized as the raw material names in the health food raw material catalog and transferred to record management. For example, the standard for tuna oil is fish oil.

7.Product filing matters of broken Ganoderma lucidum spore powder

According to the previous study on the raw material "Ganoderma lucidum spore powder" included in the list of health food raw materials and the analysis of previously approved single-party products of Ganoderma lucidum spore powder, the raw materials used in approved registered health foods are mostly broken Ganoderma spore powder or use Ganoderma spore powder Then proceed to the wall breaking process. therefore:

(1) For registered health foods that have obtained the approval certificate or the health food raw material catalogue after the release, the unilateral products that use broken Ganoderma lucidum spore powder as the raw material or use Ganoderma lucidum spore powder as the raw material and then undergo the wall breaking process should be directly converted to Record management.

(2) If the registration applicant or certificate holder who adopts unbroken Ganoderma lucidum spore powder agrees to adjust according to the health food raw material catalog, they can apply for the record as the original registrant. For those unilateral products that still insist on using the unbroken Ganoderma lucidum spore powder to apply for registration, the comparative study data with the broken Ganoderma lucidum spore powder should be provided.

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