Improved Opportunities for Health Food Supplements Brands in China

Since the new Health Food law came into force in 2016, foreign supplement brands have struggled to comply with the strict requirements for product registration and filing – the so-called “Blue Hat” registrations. One of the biggest stumbling blocks has been the limited number of raw materials allowed into Chinese dietary supplements. So far, only 22 vitamins and minerals has been approved as active ingredients into dietary supplements. With the new law, companies can apply for new raw materials by adhering to the guidelines provided by SAMR. In addition, health food with specific health functions (functional health food) such as “alleviating constipation” or “improving immune system” have previously been restricted to a total of 27 function claims. Now the SAMR will open up for applications for new function claims that fall outside the existing list of pre-approved claims.

ADMINISTRATIVE MEASURES ON HEALTH FOOD RAW MATERIAL DIRECTORY AND HEALTH FUNCTION DIRECTORY

On 20 August 2019 SAMR published the Administrative Measures on Health Food Raw Material Directory and Health Function Directory, which will come into force on 1 October 2019. According to this regulation, any entity or individual, on the basis of relevant research, will be able to apply for a new health function for registration or new raw material for incorporation into the filing catalogue.

NEW RAW MATERIAL APPPLICATION

  • Pre-Requisites For Listing New Raw Materials In The Health Food Filing Catalogue

New raw materials shall meet the following requirements:

  1. has a history of domestic and international consumption, and has been proven safe and approved for use in the registration of health foods
  2. is included into the current health function directory catalogue
  3. corresponding technical requirements, scope of use, efficacy, production process, testing methods, etc, can be standardised
  • New Raw Material Application Dossier Requirements
  1. The name of the raw material and, if necessary, additional information, such as the Latin scientific name, source, specifications, etc.
  2. Dosage directories and its health function
  3. Technological requirements, quality standards, functional or active ingredients, corresponding content levels and detection methods, relevant instructions and precautions for suitable and unsuitable populations, etc.
  4. Adverse reaction reports on any conditions after human consumption
  5. Other relevant materials such as the basis for inclusion in the catalogue.
  • New Raw Materials Application Process
  1. Application dossier submission to SAMR
  2. Technical evaluation by SAMR
  3. Preliminary examination of the evaluated materials
  4. Draft announcement for public opinion
  5. Follow-up adjustment based on public opinion
  6. An adjusted raw material catalogue issue

NEW HEALTH FUNCTION CLAIM APPLICATION

  • Pre-Requisites For New Health Function Application

New health function shall meet the following requirements:

  1. Aimed to supplement dietary nutrients, maintain and improve the health of the body or reduce the risk factors of disease
  2. There is a clear demand by consumers and is well-understood and recognized
  3. It has sufficient scientific basis and scientific evaluation methods and criteria
  4. TCM related function conforms to the TCM theoretical basis
  5. Clearly outlines unsuitable and suitable population usage scope
  • New Health Function Application Dossier
  1. The name of the health function, its explanation, mechanism and basis
  2. Research reports on the health function and other relevant scientific materials
  3. Evaluation methods and criteria for the health function, and function test reports
  4. Domestic and international research material for the same or similar function
  5. Adverse reaction reports on any conditions after human consumption
  6. Other relevant scientific literature materials or others
  • Health Function Application Process
  1. Application dossier submission to SAMR
  2. Technical evaluation by SAMR
  3. Preliminary examination of the evaluated materials
  4. Draft announcement for public opinion
  5. Follow-up adjustment based on public opinion
  6. An adjusted health function issue

So far SAMR has not clarified the details regarding both application procedures, it is expected that SAMR will publish follow-up guidelines within the next couple of months. Knudsen&CRC will follow the development and share the updates.

The official announcement can be found here (in Chinese) .

For more information on the new health food regulations, , please contact us on info@knudsenchina.com

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