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CIRS FAQ: Is it Possible to Keep the Health Food Formula Secret during Compliance Applications? Vol. 07, 2023

from CIRS by

China,Health,Food,Formula,Registration,Filing

We’ve translated a selection of some frequently asked questions on the applications of health food to help you understand the current requirements in China.

Q1: In the process of health food applications, is it possible to not provide the complete formula?

A1: No. Complete product formula information, including the names and usage amounts of raw materials and other ingredients, must be provided during the process of health food application.

Q2: When filing a health food, how do you set the scope of testing and inspection for its functional ingredients?

A2: Nutrition supplements: the vitamin content must be within [80%-180%] of the labeled value; the mineral content must be within [75%-125%]. Both values must be consistent with the daily intake towards the appropriate crowd stipulated in the Health Food Raw Material Directory.

Non-nutrition supplements: the indicators of the scope shall be set following the stipulations of the Health Food Raw Material Directory, e.g., daily intake, technical requirements, and others. The minimum value of the indicator shall be consistent with the labeled value.

Q3: Is it necessary to present the entrusted manufacturer information in the qualification certifying documents during the filing of imported health food?

A3: The qualification certifying documents, proving the filing applicant of an imported health food is its corresponding overseas manufacturer, must include the following parts:

  • the name of the issuing organization;
  • the name and address of the manufacturer;*
  • the product name; and
  • the issuing date.

The “manufacturer” mentioned above is the filing applicant. Thus, there is no need to present the entrusted manufacturer information.

Q4: If an overseas enterprise entrusts another overseas enterprise to produce a health food, it is necessary to include the information of the entrusted enterprise on the Chinese label?

A4: There is no need to present the name, address, and contact information of the entrusted enterprise (manufacturer) on the Chinese label. However, according to the Regulations of the People's Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food (GACC Decree No. 248), the registration number approved by China or the country of the entrusted enterprise shall be marked on the inner packaging (smallest sales unit) and outer packaging (transportation packaging).

Q5: Can I paste the registration number of the imported health food on Chinese packages that were made in advance?

A5: No. According to the Regulations of the People's Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food (GACC Decree No. 248), the Chinese label of imported health food must be directly printed on the packaging of the smallest sales unit, which means that sticking a label on top is not allowed.

If you need any assistance or have any questions, please contact us via service@cirs-group.com.

Further Information

Vol. 01, 2023 FAQs on Health Food Registration and Filing in China

Vol. 02, 2023 The Precondition to Health Food Application in China

Vol. 03, 2023 Applicants’ Qualifications for the Registration of New Food Raw Material (Novel Food) in China

Vol. 04, 2023 Technical Requirements for New Food Additives Applications in China

Vol. 05, 2023, Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production?

Vol. 06, 2023, Is There Any Protection Period for Newly Approved New Food Additives?

  

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