[Updated] China's Registration Channel of Health Food Reopens, as Disclosed by a Series of Key Regulations

Updated:

Following the release of the Health Function Catalogue Allowed for Health Food Claims Non-Nutrient Supplement (2023) and its supportive documents, the SAMR has initiated the process of "certificate renewal and replacement" for health food.

On December 26, 2023, the SAMR introduced the draft of Key Points for Centralized Certification Review of "Dual No Health Food" in Production and on Sale. The term "Dual No Health Food" refers to products that received registration approval from the former Ministry of Health (MOH) and the State Food and Drug Administration (SFDA) between 1996 and 2004, with no validity period or technical requirements for their registration certificates. This regulation aims to establish validity periods for these registration certificates, standardize health function claims, enhance product label instructions and technical requirements. Also, it aims to provide guidelines for issuing new registration certificates, establish a regulatory connection between health food registration and production licensing, and clarify the primary responsibility of production enterprises.

If you need the assistance with the renewal of health food certificates, please feel free to contact us.

On August 31, 2023, the State Administration for Market Regulation (SAMR) published five regulations concerning health food with immediate effect. These regulations signify the resumption of the health food registration mechanism's normal operations, which will have a significant impact on the registration process for new health food products going forward. The five regulations are:

Major Contents and Interpretations

1. Function Catalogue Allowed for Health Food Claims Non-Nutrient Supplement (2023) (hereafter as "the Catalogue")

In the past, there was a lack of regulatory foundation to support the existing functional claims for non-nutrient supplements in China. The release of the Catalogue addresses this regulatory gap and officially specifies that currently there are only 24 recognized health functions allowed for claims in China. Three functions previously included are officially removed due to their inconformity with the concept of health functions, namely, promoting lactation, improving growth and development, and improving skin oil content. Moreover, compared to the previous catalogue, slight revisions have been made to the wordings of these 24 health function claims.

2. Evaluation and Testing Method for Health Food Functions (2023) (hereafter as "the Method")

As a new version of inspection and evaluation methods that supports the Catalogue, the Method systematically re-organizes the approved health functions and their corresponding evaluation methods that have been used for registration since 1995, especially in the aspects of functional claims, evaluation methods, etc. Importantly, the Method changes the previously mandatory approaches as recommended. Furthermore, individuals, enterprises, research institutions, and social groups have the opportunity to propose new evaluation methods for the 24 health functions in the Catalogue based on scientific research and sound argumentation.

Essentially, the previous version of the Evaluation and Testing Method for Health Food Functions (2003) was abolished in 2018. This led to the suspension of the health food registration mechanism, particularly affecting imported health food products. As a result, no imported products have obtained a registration certificate since 2018. However, with the unveiling of the Method, the previously closed registration mechanism will reopen and operate more smoothly. This allows new health food products to undergo market access through the registration mechanism once again.

3. Technical Guideline for Testing and Evaluation of Health Food Functions (2023) (hereafter as "the Technical Guideline")

The Technical Guideline provides clear guidance on the fundamental principles of evaluating and testing health food functions through animal experiments and human experiments. It also outlines the factors that need to be considered when conducting functional evaluations.

For instance, when determining the intake levels adopted in evaluations, it emphasizes the necessity to consider not only the general population but also special groups such as children, pregnant women, and individuals with high intake levels. These considerations ensure that the evaluations are comprehensive and take account for the specific requirements of different population segments.

4. Ethical Review Guideline for Health Food Human Consumption Test (2023) (hereafter as "the Ethical Review Guideline")

The Ethical Review Guideline outlines the ethical review process for conducting human consumption trials on health food products. It suggests establishing an ethical review committee within the institutions, which is responsible for evaluating the ethical aspects of the trials and providing final assessment results based on their findings. The committee should consist of professionals with diverse academic backgrounds with the conducting of independent, objective, impartial, and timely reviews of human consumption trial projects as its primary responsibility.

5. Interpretations on Health Function Catalogue Allowed for Health Food Claims Non-Nutrient Supplement (2023) and Its Supportive Documents (hereafter as "the Interpretations")

The document provides an explanation of the background and process behind the release of this regulation. Its primarily outlines the requirements for implementing the above regulations and how products should adjust under the transition from old to new regulations. Specifically, for health food products already available in the market, they must undergo necessary adjustments within a five-year period following the release of the regulation. Here are the guidelines:

For products that currently possess functions listed among the 24 approved functions, adjustments should be made according to the attached "Requirements for Correspondence and Evaluation of Functions between Old and New Health Claims" in the Interpretations. Notably, for products with eight specific functions, they are required to redo tests such as human consumption trials and animal experiments to smoothly transition to the new function claims.
Products whose functions do not fall within the 24 functions have two options. Enterprises can either apply to include the corresponding health functions in the Catalogue according to Administrative Measures on Directory of Health Food Raw Materials and Directory of Health Functions, or seek a change in health functions as per Administrative Measures for Registration and Filing of Health Foods, which means relinquishing the existing unlisted health functions and transitioning them to the approved 24 functions.
For products with registration certificates indicating "no expiration date and no product technical requirements", depend on their actual production requirements and regulatory conditions, enterprises may apply for certificate replacement in accordance with the prevailing regulations.

ChemLinked's Comments

In 2017, China introduced the dual track system for market access of health food, allowing products to enter the market through either filing or registration. However, the registration mechanism faced challenges shortly after its implementation due to the lack of regulatory support. Consequently, product filing became the predominant method for market access, particularly for imported products.

The release of these regulations now signifies the reopening of the registration mechanism by Chinese authorities, which is highly beneficial for health food enterprises. Additionally, China has recently issued requirements for new health function registration, encouraging enterprises to engage in independent innovation and research, thereby fostering market vitality (check ChemLinked News for more information). These regulatory actions contribute to the establishment of more standardized regulations within the health food industry in China and provide new opportunities for enterprises to thrive.

We have been equipped with a professional technician team to provide one-stop registration service with expertise and efficiency. Our services include:

Feasibility assessment (formula check, data gap analysis, test analysis, budget evaluation, etc.)
Health food registration (product research, dossier preparation & submission, test monitoring, communication with SAMR, etc.)
Health food filing (product research, dossier preparation & submission, test monitoring, communication with SAMR, etc.)

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