Filing Product Technical Requirements on 5 Health Food Raw Materials (Draft) for Public Comments Again

On August 12, 2020, SAMR issued Filing Product Technical Requirements of Health Food Raw Material Directory for Coenzyme Q10, broken Ganoderma lucidum spore powder, spirulina, fish oil and melatonin (Draft) (referred to Technical Requirements (Draft)) for public comments. The deadline for comments is September 12, 2020.

Since the first release of the draft for public comments on April 2019, SAMR Food Review Center has successively carried out the development of supportive documents which are now released as well for public comments. The information of the documents includes available excipients for each raw material, available dosage forms for each raw material, product technical requirements, and main production processes. In order to help you quickly obtain key information, CIRS will make you understand the important content of Technical requirements (Draft) and main production processes (Draft) and the important items in the draft:

1. Add the test report including all items listed in the raw material technical requirements

Different from vitamin and mineral filing products, technical requirements of the five raw materials are established to reflect the characteristics of the raw materials, which is important to the control of the quality and safety of raw materials and the product. Otherwise, after the product is completed, some characteristic indicators in the product technical requirements cannot be tested, thus, testing in advance is necessary.

As the quality of filing products would be affected by the quality of raw materials, applicants is required to submit the all-item test report issued by qualified institution/agency when applying for filing products.

2. Establish the list of available excipients for each raw material

The lists of available excipients for Coenzyme Q10, broken Ganoderma lucidum spore powder, spirulina, fish oil and melatonin (referred to the lists of available excipients) have been established in the Technical Requirements (Draft).

When applying for filing of products, applicants should use the excipients in the list of available excipients in principle. If applicants use the excipients in the Available Excipients for Health Food Filing and Their Usage Rules and not in the list of available excipients, the selection basis of the excipient and its usage should be submitted. If food flavours and colours can be used in this kind of product, the types of food flavours and colours are not limited.

3. Add powder dosage form and related product production process

Based on the feedback and suggestions from the first Draft, the Technical Requirements (Draft) added powder dosage form of broken Ganoderma lucidum spore powder.

The available dosage forms for the five raw materials include tablet, granule, hard capsule, soft capsule and powder. The production processes of the first four dosage forms are described in accordance with the main production processes for vitamin and mineral filing products. The production process of powder has been well studied before, which is included in the usable production process this time.

4. Clarify the indicators that should be added in the product technical requirements

According to the technical indicators of each raw material and product technical requirements of each dosage form in the current filing products, the product technical indicators of each raw material and each dosage form have been refined. The indicators that do not need to be tested for the finished product and the indicators that should be added in the product technical requirements have been clarified in the product technical requirements. Taking spirulina as an example, its technical requirements should also meet the following requirements: ①[physical and chemical indicators]: add "crude polysaccharide"; ②[Characteristic Component]: at least include "β-carotene" and "phycocyanin"; ③[microbiological indicator]: add "vibrio parahaemolyticus".

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Reference:

• SAMR Notice (2020.08.12)
• SAMR Issued the Draft on Health Food Raw Material Directory of 5 Active Ingredients