Views: 40 Author: Site Editor Publish Time: 2024-10-11 Origin: Site
Specification for the development of health food with raw materials of medicinal materials
Recently, the State Administration of Market Regulation issued the "health food raw materials ginseng ginseng ganoderma lucidum record product technical requirements" (hereinafter referred to as "technical requirements"), to ginseng, American ginseng, Reishi mushroom as raw materials of health food implementation of record management.
This is also the first time that Chinese traditional Chinese medicine raw materials of health food are included in the record management.
There are many kinds of Chinese medicinal materials, which can be roughly divided into plants, animals and minerals. Plant Chinese herbs such as ginseng, astragalus, angelica, etc.; animal Chinese herbs such as scorpion, ground dragon, turtle worm, etc.; mineral Chinese herbs such as pearl, magnet, etc.
In addition to the traditional Chinese patent medicine and Chinese herbal medicine decoction pieces, Chinese medicinal materials are increasingly widely used in health food, special medical formula products, medicine and food identical common food and other aspects.
In December 2023, the State Administration of Market Regulation issued the "Catalogue of Health Food Raw Materials Ginseng", "Ginseng of Health Food Raw Materials" and "Catalogue of Health Food Raw Materials Ganoderma". When the raw materials listed in the raw material list are recorded, only one side raw material can be used, and can not be reused with other raw materials.
The "Technical Requirements" issued by the Market Supervision Administration points out that when the unilateral products of ginseng, American ginseng and ganoderma lucidum are filed, the available dosage forms include tablets (lozenge tablets, chewable tablets, oral tablets), hard capsules, soft capsules, powder, oral liquid, mixture, granule, paste, tea agent (bagged tea agent). When the above raw materials are made into liquid preparations for product filing, the maximum daily consumption amount of the preparations is no longer limited on the basis of ensuring the accurate daily consumption amount of the raw materials.
The Technical Requirements emphasize that the registered products should conform to the traditional eating methods, traditional eating groups and traditional processing techniques. At the same time, the applicant is required to have their own ability to process health food, and implement the main responsibility of the applicant. Those that are not qualified for the time being shall not be included in the record administration. While inheriting the traditional health care culture, to ensure the safety and effectiveness of the record products.
Ensure the safety of raw materials of Chinese medicinal materials
When Chinese medicinal materials are used as raw materials for health food, we need to pay attention to quality factors such as their variety, use parts, origin, planting methods and years, harvesting and processing methods, and pay more attention to safety indicators such as pesticide residues, heavy metals and mycotoxins.
The Technical Requirements indicate the raw material source requirements. When filing products, the raw materials must meet the requirements of the food safety Law and other relevant laws and regulations. Should indicate the varieties of raw materials base source, origin (region), suppliers (not more than 2), quality standards (including technical indicators should at least meet the technical requirements of raw material directory), including raw material suppliers shall have legal qualification, business license should include at least raw materials or yinpian sales scope of business. The provincial market regulatory department in the ginseng, ginseng, ganoderma lucidum health food for the record in the process of management and traceability, should according to the health food raw material directory of raw material technical requirements, and reference to the current Chinese pharmacopoeia, food safety national standards to strengthen the raw material pesticide residues, heavy metals and other safety indicators and related to product quality and safety of exogenous material detection and supervision.