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On Aug 20, 2019, China State Administration for Market Regulation (SAMR) released decree No.13, publicizing Administrative Measures on Directory of Health Food Raw Materials and Directory of Health Functions(“保健食品原料目录与保健功能目录管理办法” in Chinese) and announcing its effective date (Oct. 1).[1]
The measures apply to the formulation, adjustment and publication of Directory of Health Food Raw Materials and Directory of Health Functions. It specifies basic requirements for health food raw materials and function claims, prohibitions, procedures of expanding the lists, application documentation and so forth.[2]Under the new system companies and individuals will be able to propose the addition of new ingredients to the health food raw materials directory and also expand the permitted functional claims.
Under the old regulatory framework there was an underutilized mechanism in place that would in theory allow the inventory of approved raw materials to be expanded and the list of functional claims to be appended. Under this system SAMR would designate qualified agencies to conduct studies on certain raw materials or functional claims before approving or rejecting the claim or the ingredient. In practice this mechanism led to stagnation within the approved health food raw materials list and saw no major changes to the list of approved functional claims.
Please check out the full text (bilingual) of the measures here.
Health Food Administration in China
In China’s health food management system, health foods certification requires a product to be either registered or filed depending on the labeling claims made on the product and the specific characteristics of the product. For health foods whose raw materials which are not in the Directory of Health Food Raw Materials[3] and List of Auxiliary Materials for Health Food Filing and Terms of Use (Trial)[4]published in 2017, they are subject registration and require systematic evaluation (clinical, toxicological, physiochemical) to substantiate the functional claims used on these products. Products which use ingredients listed in the lists of health food raw materials and auxiliary materials can be filed. At present, only minerals and vitamins with appropriate nutrient supplementation claims can be filed.[5]
Earlier this year China solicited public feedback on the cancellation and adjustment of health function claims[6] and appending health food positive list with 5 new functional ingredients[7]. The publication of Administrative Measures on Directory of Health Food Raw Materials and Directory of Health Functions will optimize the procedure and efficiency of the management of health food ingredients and function claims and offer both domestic and international stakeholders a more rationale route to market for foods bearing functional claims.
Webinar Plan in September
Considering this is a reformative change to health food industry, ChemLinked is to host a webinar on proposing to add new ingredients/function claims to the existing “positive lists” in September. Please subscribe to ChemLinked or scan the following QR code to follow ChemLinked WeChat account for information of the upcoming webinar.
If you are interested in applying for approval of a new health food raw material, please contact ChemLinked for consultation and compliance service.
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