- Administrative Measures on Health Food Registration and Filing (click here) released on March 1, 2016 will come into force on July 1, 2016.
- Health Food Raw Materials Directory (the first batch) –Nutrition Supplement Raw Materials (Vitamins and Minerals) Directory (Draft) (click here) released on February 17, 2016 was seeking for public comments until March 4, 2016.
- Name List of Excipients available for Health Food Filing (the first batch) (Draft) and Name List of Health Food Filing Excipients Needed Further Argument (Draft) (click here) released on May 30, 2016 was seeking for public comments until June 11, 2016.
- Revised Health Food Raw Materials Directory (the first batch) –Nutrition Supplement Raw Materials (Vitamins and Minerals) Directory (Draft) released on June 2, 2016 was seeking for public comments until June 11, 2016.
Compared with the first Draft, the Revised Health Food Raw Materials Directory (the first batch) –Nutrition Supplement Raw Materials (Vitamins and Minerals) Directory (Draft) has some changes listed as follows:
| Changes | Specific contents |
| Quantity of compounds | There are still 22 kinds of vitamin supplementation and mineral substance contained in the Directory (Draft). Molybdenum, chromium and iodine are still not available for filing as nutrient supplements. The number of compounds raw materials has been increased, from 61 to 67. |
| 6 compounds are removed |
|
| 12 compounds are added | Calcium glycerophosphate, manganese gluconate, zinc citrate (trihydrate), zinc lactate, L-Se-methylselenocysteine, copper gluconate, thiamin mononitrate, cyanocobalamin, nicotinamide, sodium ascorbate, L - ascorbic acid - 6 – palmitate (Ascorbyl palmitate) and Vitamin E succinate calcium are newly added. |
| Change of daily edible amount | The daily maximum edible amount of calcium, manganese, iron, selenium, copper, vitamin A, vitamin D vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, biotin, choline, vitamin C, vitamin K, pantothenic acid and vitamin E for most target users is higher. Requirements for health food filing are much lower. |
Key Point When Using the Raw Materials
1. The value marked on the label of the nutrient supplements for filing and the scope of nutrient contents listed in the technical requirements shall not exceed the recruitment amount for target users;
2. If a foreign manufacturer of health food raw materials hopes to put its products into the Health Food Raw Materials Directory, the manufacturer shall, in accordance with relevant requirements of Administrative Measures on Health Food Function Directory and Food Raw Material Directory, apply for the approval.
3. Dosages of nutrient supplements for filing shall not be: sustained release preparation, controlled release preparation, sublingual absorption preparation, enteric-coated preparation, spray preparation and so on. As a result, it is recommended that enterprises should not apply for filing for the above mentioned dosages.
If you have any questions or recommendations about the new draft, please don’t hesitate to contact us. We are ready to offer help or convey your comments to CFDA.
Contact us
Ms. Cathy Yu Team Leader of Food Safety and Regulatory Affairs Department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
Email: cathy.yu@cirs-group.com
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
Email: cathy.yu@cirs-group.com
