CFDA Health Food Review Center Issued Detailed Provisions about Excipients for Health Food Filing

According to the requirements of Available Excipients for Health Food Filing and Their Usage Rules (Trail) , CFDA Health Food Review Center has drafted detailed provisions for the usage of food flavoring in solid preparation and liquid preparation, the usage of coating premix agents and the usage of excipients in the preparation process of embedded and microencapsulated raw materials. All these provisions have been approved by CFDA Special Food Registration and Administration Department and are disclosed to the public on September 5 and September 7, 2017.

1. Information about food flavoring

Filling requirements

I. The applicant shall fill in the specific name of the food flavoring. There is no need to list its components, but “commitment of using the flavoring without violation” should be submitted. II. The food flavoring shall meet the requirements of GB 30616 Food Flavoring. III. If there are unsuitable crowd or warning for the individual flavor (such as vanillin), related information should be indicated in the product specification.

Selection of flavor in product

I. If the applicant fill in one kind of food flavoring, he can select the flavor corresponding to the food flavoring in product name, or do not choose the flavor. II. If the applicant fills in several kinds of food flavoring, he can select the flavor corresponding to one main food flavoring in product name, or do not choose the flavor. III. The alternative flavors in the system are from the previous approved products. Health Food Review Center will update the alternative flavors timely according to the approval of health food registration and filing.

2. Information about coating premix agents

I. The components of coating premix agents should be included in GB 2760 the Usage of Food Additives or Chinese Pharmacopoeia. The dosage can be appropriate as required in production.

II. When filling in the information of coating premix agents, there is no need to list the specific dosage of each component.

III. The quality requirements of coating premix agents should be filled in product technical requirements. Pharmaceutical coating premix agents with Registration Approval Number should provide the approved quality standard.

3. Information about embedded and microencapsulated raw materials

I. The excipients for preparation of embedded and microencapsulated raw materials should be included in GB 2760 the usage of food additives and Available Excipients for Health Food Filing and Their Usage Rules (Trail) . The dosage can be appropriate as required in production.

II. When filling in the excipients for preparation of embedded and microencapsulated raw materials, if the excipient is same as the other excipient in the filing product, in the product formula automatically generated by filing system, the excipient won’t be listed repeatedly and the dosage will be the cumulative dosage. They shall not exceed the available excipients and the maximum levels.

III. The quality requirements of the embedded and microencapsulated raw materials should be filled in product technical requirements.

Further Information

Official Notice