China health food regulatory updates were announced by the State Administration for Market Regulation (SAMR) on August 31, 2023, covering:
- Catalogue of health functions permitted to be claimed by health food non-nutrient supplements (2023 Edition)
- Technical guidelines for testing and evaluation of health food functions (2023 Edition)
- Methods for testing and evaluation of health food functions (2023 Edition)
- Ethical review guidelines for health food human consumption test (2023 Edition)
China has been actively reforming and strengthening its food safety regulations in recent years. The foundation for the current health food regulations lies in the “Food safety law” which allows health foods to make specific health claims. In this blog post, we will explore the key aspects of these regulations, their implications, and how your company can navigate the evolving regulatory landscape in China successfully.
Positioning of “Methods for testing and evaluation of health food functions (2023 Edition)”
“Methods for testing and evaluation of health food functions (2023 Edition)” is a set of inspection and evaluation methods designed to complement the “Health food function catalogue of non-nutrient supplements (2023 Edition)”. It systematically reviews approved registered health functions and their corresponding evaluation methods since 1995, especially the ones outlined in the former Ministry of Health’s technical specifications for health food inspection and evaluation (2003 Edition) and the Food and Drug Administration’s 2012 revision of the “Notice on issuing 9 health function evaluation methods, including antioxidant function evaluation method.” These revisions focus on aspects like functional claims and evaluation methods, shifting from mandatory methods to recommended ones.
Transition period for products with health functions listed in the 2023 edition catalog
For products with health functions listed in the “Functional Catalog of Non-Nutrient Supplements (2023 Edition),” a 5-year transition period is set from the date of this announcement. This period aims to standardize the registration and filing of product health function claims. The “Health Food Raw Material Catalog” has been adjusted according to the “Functional Catalog of Non-Nutrient Supplements (2023 Edition),” and a document titled “Correspondence and Functional Evaluation Connection Requirements for Old and New Health Function Claims” has been formulated. For products already filed, applicants can apply to change the health function name. For registered products, certificate holders can apply for a change in the health function name separately or during other application processes, such as modifications or renewals.
Transition for products not listed in the 2023 edition catalog
For products already registered but with health functions not yet included in the “Catalogue of health functions permitted to be claimed by health food non-nutrient supplements (2023 Edition)”, a 5-year period from the date of this announcement allows for the inclusion of these functions in the catalog or for changing health functions according to the requirements set out in the catalogue.
Transition for registered products with certificates without expiry dates and product technical requirements
For registered products with certificates lacking expiry dates and product technical requirements, provincial-level market supervision departments should propose opinions for certificate renewal based on actual production technical requirements and regulatory situations. Registered individuals can apply to the evaluation agency for converting or adding health function claims listed in the “Catalogue of health functions permitted to be claimed by health food non-nutrient supplements (2023 Edition)”, and the review agency should conduct evaluation certificate conversion work in accordance with the Food Safety Law and relevant regulations.
Health Food Registration Inspection Agencies’ Inspection Basis
From the date of announcement (August 31, 2023) onwards, health food registration inspection agencies can carry out product function evaluation tests and related work for registered health foods in line with the “Methods for testing and evaluation of health food functions (2023 Edition)”.
Technical evaluation rules for health food with new functions (Trial implementation)
On August 28, 2023, the SAMR announced the trial implementation of technical evaluation rules for health food with new functions to come into effect immediately. Read our blog post here for more information.
Further information
Read the original SAMR announcement for China health food regulatory updates in August 2023.
Contact us to learn more about our service support for health food products in China.