Health food registration regulations: comprehensive inventory and analysis here
Health food has gone through 30 years, with various successes and failures. Today we have reached a crossroads. Looking back on regulations and looking forward to the future, especially in this era, it is important, necessary and necessary.
In the near future, our company will conduct a comprehensive inventory and analysis of health food regulations over the past 30 years, set up a microscope, magnifying glass and telescope for everyone, review our stage and path, and let our friends review and observe.
Health food has gone through 30 years, with various successes and failures. Today we have reached a crossroads. Looking back on regulations and looking forward to the future, especially in this era, it is important, necessary and necessary.
In the near future, our company will conduct a comprehensive inventory and analysis of health food regulations over the past 30 years, set up a microscope, magnifying glass and telescope for everyone, review our stage and path, and let our friends review and observe.
First of all, health food registration refers to the process in which health food manufacturers submit materials indicating product safety, health functions and quality controllability to the food and drug regulatory authorities for archiving, disclosure and review in accordance with legal procedures, conditions and requirements. The registration of health food in the People's Republic of China must comply with the following regulations:
|
Serial number |
Regulation name |
|
1 |
Guidelines for Registration of Health Foods (Trial) Food and Drug Supervision Special Administration [2017] No. 37 |
|
2 |
Management Measures for Registration and Filing of Health Foods State Food and Drug Administration Order No. 22 |
|
3 |
Interpretation of "Health Food Registration and Filing Management Measures" |
|
4 |
Announcement No. 7, 2021, of the State Administration for Market Regulation on the release of "Available Excipients and Usage Regulations for Health Food Registration Products (2021 Edition)" and "Dosage Forms and Technical Requirements for Health Food Registration Products (2021 Edition)" |
As the catalog of health food registration raw materials continues to expand, the operation and reform of the dual-track system for health food registration and registration continues to deepen, and the regulatory pattern of "registration is for the majority, registration is for the minority" has been initially formed and continuously optimized and improved, and the institutional costs of production enterprises and regulatory authorities have been further reduced.
The current catalog of health food raw materials can be divided into two categories according to health functions. One category is nutrient supplement raw materials, including 24 kinds of nutrients such as calcium and magnesium, corresponding to a variety of compound sources. The scope of application, daily dosage, efficacy, etc. need to meet the requirements of the "Health Food Raw Material Catalog Nutrient Supplements (2023 Edition)"; the other category is non-nutrient supplement raw materials. Since 2020, three batches of non-nutrient supplement raw material catalogs have been released, with a total of 10 substances.
一、Regulations and documents related to nutrient supplement raw materials
|
Serial number |
Regulation name |
|
1 |
Announcement on the release of the "Health Food Raw Materials Catalog Nutrient Supplements (2023 Edition)", the "Health Food Raw Materials Catalog Nutrient Supplements Allowed for Claims of Health Foods (2023 Edition)" and the "Health Food Raw Materials Catalog Soy Protein Isolate" and "Health Food Raw Materials Catalog Whey Protein" |
|
2 |
Health Food Raw Materials Catalog Nutrient Supplements (2023 Edition) |
|
3 |
Catalog of health functions allowed for health food claims Nutrient supplements (2023 version) |
|
4 |
Interpretation document of "Health Food Raw Materials Catalog Nutrient Supplements (2023 Edition)" |
二、Summary of non-nutrient supplement raw material regulatory documents and related situations
（一）Regulations and documents on five health food raw materials including Coenzyme Q10
|
Serial number |
Regulation name |
|
1 |
Announcement of the State Administration for Market Regulation, National Health Commission, and State Administration of Traditional Chinese Medicine on the release of a catalog of five health food raw materials including Coenzyme Q10 |
|
2 |
Interpretation of "Coenzyme Q10 and other five health food raw material catalogs" |
|
3 |
Supporting interpretation of "Coenzyme Q10 and other five health food raw material catalogues" |
|
4 |
Announcement of the State Administration for Market Regulation on the release of "Dosage forms and technical requirements for registered products of five health food raw materials including Coenzyme Q10" (No. 4, 2021) |
（二）Soy protein isolate, whey protein health food raw material regulatory documents
|
Serial number |
Regulation name |
|
1 |
Announcement on the release of the "Health Food Raw Materials Catalog Nutrient Supplements (2023 Edition)", the "Health Food Raw Materials Catalog Nutrient Supplements Allowed for Claims of Health Foods (2023 Edition)" and the "Health Food Raw Materials Catalog Soy Protein Isolate" and "Health Food Raw Materials Catalog Whey Protein" |
|
2 |
Interpretation document of "Health Food Raw Materials Catalog Nutrient Supplements (2023 Edition)" |
|
3 |
Interpretation documents of "Health Food Raw Material Catalog: Soy Protein Isolate" and "Health Food Raw Material Catalog: Whey Protein" |
|
4 |
Announcement of the State Administration for Market Regulation on the release of "Dosage forms and technical requirements for registered products of health food raw materials, soy protein isolate and whey protein" |
|
5 |
Release of dosage forms and technical requirements for two registered health food raw material products |
（三）Regulations and documents on ginseng, American ginseng and Ganoderma lucidum health food raw materials
|
Serial number |
Regulation name |
|
1 |
Announcement No. 57 of 2023 on the release of the catalog of three types of health food raw materials including ginseng |
|
2 |
Announcement No. 18 of 2024 by the State Administration for Market Regulation on the issuance of the "Technical Requirements for Registration Products of Health Food Ingredients Ginseng, American Ginseng and Ganoderma Lucidum" |
（四）Summary of regulations and dosage of 10 raw materials for non-nutrient supplements
Table 1 Summary of regulations on 10 raw materials for non-nutrient supplements
|
Serial number |
Catalog Raw Material Name |
Announcement Time |
Announcement Title |
|
1 |
Coenzyme Q10 |
2020.11.23 |
Announcement on the release of a catalog of five health food raw materials including Coenzyme Q10 |
|
2 |
Broken Ganoderma Spore Powder |
|
|
|
3 |
Spirulina |
|
|
|
4 |
Fish oil |
|
|
|
5 |
Melatonin |
|
|
|
6 |
Soy protein isolate |
2023.6.2 |
Announcement on the release of the "Health Food Raw Materials Catalog Nutrient Supplements (2023 Edition)", "Health Food Raw Materials Catalog Nutrient Supplements Allowed for Claims of Health Foods Nutrient Supplements (2023 Edition)" and "Health Food Raw Materials Catalog Soy Protein Isolate" and "Health Food Raw Materials Catalog Whey Protein" |
|
7 |
Whey protein |
|
|
|
8 |
Ginseng |
2023.12.18 |
Announcement on the release of the raw material catalog of 3 kinds of health food including ginseng |
|
9 |
American ginseng |
|
|
|
10 |
Ganoderma lucidum |
|
|
Table 2 Summary of daily dosage of 10 raw materials of non-nutrient supplements
|
Serial number |
Name of raw material |
Daily dosage (Dosage range) |
Suitable groups |
Unsuitable groups |
Precautions |
|
1 |
Coenzyme Q10 |
30-50mg |
Adult |
Children, pregnant women, wet nurses, people with allergies |
People taking therapeutic drugs should consult their doctor before consuming this product |
|
2 |
Broken Ganoderma Spore Powder |
1-4g |
People with low immunity |
Children, pregnant women and wet nurses |
|
|
3 |
Spirulina |
3-4g |
People with low immunity |
Infants, pregnant women and wet nurses, and people with allergies |
|
|
4 |
Fish oil |
Not more than 4.0g (the amount of EPA+DHA is not less than 1.0g) |
People with high blood lipids |
Children, pregnant women, wet nurses; people with bleeding tendencies and bleeding diseases; people with liver insufficiency |
Not recommended for those allergic to seafood |
|
5 |
Melatonin |
1-3mg |
Adult |
Children, pregnant women and wet nurses |
Those engaged in driving, mechanical operations or dangerous operations should not consume it before or during operation. Patients with autoimmune diseases (rheumatoid, etc.) and hyperthyroidism should use with caution. |
|
6 |
Soybean Isolated |
Protein 6-25g |
Adults with low immunity due to insufficient protein intake |
Children |
The recommended overall daily protein consumption for adults is 60g, which can be consumed within the dosage range based on personal daily consumption. It is not recommended for people who are not obviously deficient in protein. People allergic to plant proteins should not use it. Use with caution in patients with renal insufficiency. Pregnant women and nursing mothers are advised to consult clinicians and nutrition professionals. |
|
7 |
Whey protein |
Protein 6-25g |
Adults with low immunity due to insufficient protein intake |
Children |
The recommended overall daily protein consumption for adults is 60g, which can be consumed within the dosage range based on personal daily consumption. It is not recommended for people who are not obviously deficient in protein. People allergic to animal proteins should not use it. Use with caution in patients with renal insufficiency. Pregnant women and nursing mothers are advised to consult clinicians and nutrition professionals. |
|
8 |
Ginseng |
1-3g |
People who are prone to fatigue and those with low immunity |
Children, pregnant women, wet nurses; people with damp-heat constitution and yin deficiency constitution |
It should not be used together with Chinese herbal medicines and their products containing Veratrum and Wulingzhi. It is not recommended for people with colds, thick and greasy tongue coating, and those who are prone to getting angry. Long-term consumption is recommended based on personal physique. |
|
9 |
American ginseng |
1.5-3g |
People who are prone to fatigue and those with low immunity |
Children, pregnant women and wet nurses |
It should not be used together with Chinese herbal medicines and their products containing Veratrum and Wulingzhi. It is not recommended for people with colds or thick tongue coating. |
|
10 |
Ganoderma lucidum |
4-6g |
People with low immunity |
Children, pregnant women and wet nurses |
|
Table 3 Summary of effects of 10 raw materials of non-nutrient supplements
|
Serial number |
Name |
Efficacy |
Raw material execution standards |
Registration product dosage form |
|
1 |
Coenzyme Q10 |
Enhance immunity |
"Health Food Ingredients Catalog Coenzyme Q10" |
Tablets (oral tablets, buccal tablets, chewable tablets), granules, hard capsules, soft capsules |
|
2 |
Broken Ganoderma Spore Powder |
Antioxidant |
"Health Food Ingredients Catalog Broken Ganoderma Spore Powder" |
Tablets (oral tablets), granules, hard capsules, powder |
|
3 |
Spirulina |
Enhance immunity |
"Health Food Ingredients Catalog Spirulina" |
Tablets (oral tablets, chewable tablets), granules, hard capsules |
|
4 |
Fish oil |
Enhance immunity |
"Health Food Ingredients Catalog Fish Oil" |
Soft capsule |
|
5 |
Melatonin |
Assist in lowering blood lipids |
"Health Food Ingredients Catalog Melatonin" |
Tablets (oral tablets, lozenges), granules, hard capsules, soft capsules |
|
6 |
Soybean separation |
Improve sleep |
"Health Food Ingredients Catalog Soy Protein Isolate" |
Powder |
|
7 |
Whey protein |
Enhance immunity |
"Health Food Ingredients Catalog Whey Protein" |
Powder |
|
8 |
Ginseng |
Enhance immunity and relieve physical fatigue |
Raw materials should comply with the current version of the Chinese Pharmacopoeia for the same category. For raw materials that have national food safety standards, safety indicators (including pesticide residues and heavy metals) should also comply with current standards. |
Tablets (buccal tablets, chewable tablets, oral tablets), hard capsules, soft capsules, powders, oral liquids, mixtures, granules, ointments, teas (tea bags) |
|
9 |
American ginseng |
Helps enhance immunity and relieve physical fatigue |
|
|
|
10 |
Ganoderma lucidum |
Helps strengthen immunity |
|
|
Health food registration management will meet the people’s growing diversified needs for health products. With the continuous introduction of health food raw material catalogs and the continuous enrichment of dosage forms, product types and dosage forms have become more diversified.
The passing years are spent with laughter, and the future is promising.
Health care needs come from all walks of life and ages, and also come from our knowledge and sharing.
