On Feb. 17, 2016, China Food and Drug Administration (CFDA) released the first batch of approved health food raw materials, which will be open for public consultation until Mar. 4, 2016.
The first batch of approved health food raw materials mainly includes raw materials for nutrient supplements. The compounds used in nutrient supplements shall conform to the requirements of the raw material directory. Any compounds used that are out of the scope of the directory shall be applied for approval in accordance with “Administrative Measures on Health Food Raw Material Directory and Health Function Directory”.
The following requirements have also been proposed in the directory:
- Premix feed is prohibited to be used as health food raw materials.
- The applicable scope of the directory also includes nutrient supplements for young children.
- The major dosage form of nutrient supplements filed with CFDA should be in tablets, capsules, granules, powder or oral liquid rather than sustained-release preparations, controlled release preparations, sublingual absorption preparations, gastro-resistant preparations or sprays.
- The daily intake of nutrient supplements should be small. The total intake of nutrient supplements made in granular form and powder shall not be more than 20g per day. Nutrient supplements in oral liquid shall not be more than 30ml per day.
- The marked value of nutrient supplements and the content value of nutrients in product technical requirements shall be within the permitted supplementing scope of all nutrients.
The nutrient supplements filed with CFDA shall also comply with “GB 16740-2014 National Food Safety Standard Health Food”, and “Administrative Measures on Health Food Labeling”.