On February 1, 2021, SAMR issued a notice on the Technical Requirements of Five Ingredients in the Catalogue of Health Food Ingredients of Filing Health Food including Coenzyme Q10 and the corresponding interpretation, it will come into effect on June 1, 2021.
Technical Requirements indicates the specific provisions on the available dosage forms, auxiliary materials and technical requirements for Coenzyme Q10, Fish oil, Sporoderm-broken of ganoderma lucidum spores powder, Spirulina and Melatonin, respectively. And the corresponding interpretation provides further explanation on the raw material use, main production process, available auxiliary materials and scope for the filing health food products of these five ingredients.
Antion found that the requirements of these five health food ingredients are different from vitamin and mineral health foods, which include:
Usage of ingredients
These five health food ingredients cannot be used together with any other health food ingredients in the Catalogue, only single-formula products can be filed (note: melatonin can be used together with vitamin B6), however, vitamins and minerals can be mixed with other health food ingredients in the Catalogue.
Available dosage forms
The available dosage forms of these five health food ingredients are respectively indicated in the Technical Requirements. For vitamin and mineral products, the available dosage forms include tablets, hard capsules, soft capsules, oral liquid, and granules. In addition, gummy and powder will be available in the future.
Available auxiliary materials
The available auxiliary materials of these five health food ingredients are also respectively clarified in the Technical Requirements. For vitamin and mineral products, the available auxiliary materials used needs to meet the requirements of the Auxiliary Materials for Filing Health Food and Their Use Regulations (2019 Version).
As shown in the figure below, the requirements to be met by filing health food have all been clarified, enterprises need to prepare in accordance with these four aspects, specific regulatory requirements can be viewed by clicking the link at the end of the article.
If you want to further understand the relevant regulations or the filing health food related matters, please feel free to contact us!
Lillian Fan
Tel: 010-51301566
email: Lillian.fan@ruibole.com
Read more:
Auxiliary Materials Available for Filling Health Food Revised
Two Catalogues about Health Foods (2020 Revision) was Issued
Analysis| Coenzyme Q10, Fish Oil and Melatonin can do filing!