Q&As on the Latest Regulations regarding Health Food and Requirements for Replacement of Old Certificate

CIRS is set to host a free webinar to interpret the latest regulations regarding health food and requirements for the replacement of old certificates between April 2 and April 16, 2024 in different languages (Chinese, English, Japanese and Korean). The webinar aims at introducing the latest regulations regarding health food, the process and requirements for change of health food registration certificate for products with no validity period and technical requirements, to assist businesses in gaining a better understanding of health food regulatory requirements, thus supporting them in smoothly completing the renewal process within the five-year transition period.

The English session is scheduled for April 16, you may click this link to learn more details and register for it.

The Chinese session was hosted on April 2 and many questions were raised during the training. We have collected the questions and made a Q&A summary as follows:

Q1: If a health food contains raw materials not included in the list of foods with medicinal properties, can I still apply for certificate replacement?

A1: Yes. Raw materials permitted for use in health food are not limited to those with medicinal properties. Applicants are advised to check whether there are other valid basis for use, such as being commonly used in food or classified as a new food raw material. If no such basis exists, consider adjusting the formula or conducting a safety assessment on the ingredient as a new health food raw material. However, this may also increase the testing requirements for the final product.

Q2: Can a company without a production license apply for certificate replacement? Or is it possible to commission other companies to carry out production first before applying?

A2: No. Companies without a valid production license cannot apply for certificate replacement. However, they can commission a licensed company for production and then proceed with the application process.

Q3: Can a company obtain a production license for resuming manufacturing and selling products with old certificates? Will local governments allow this to be implemented?

A3: If it qualifies for obtaining the license, yes. According to the Key Review Points for Change of Registration Certificate for Health Foods with No Validity Period and No Technical Requirements in Production and Sale (Draft) (hereinafter referred to as the Draft), provincial-level market supervision authorities will continue to issue production licenses according to existing regulations during the transition period, without requiring certificate replacement as a prerequisite for issuance or renewal.

Q4: Can the acid value range be expanded?

A4: Yes. Adjusting the acid value range falls under the revision of quality control indicators. It is stipulated in the Draft that, for technical requirements involving the addition or revision of quality control indicators, a revision explanation and corresponding hygiene, stability, and efficacy/characteristic component test reports must be submitted.

Q5: Concerning the health function of alleviating physical fatigue, what are the prohibited ingredients requiring testing?

A5: The prohibited ingredients and test methods are outlined in Part 4 of the Guidelines for Physicochemical and Hygiene Indicators Testing and Evaluation of Health Foods (2020 Edition). However, it does not explicitly specify the correspondence between prohibited ingredients and health functions. Based on our experience, this typically requires testing for the following prohibited ingredients as listed in the guidelines:

• 2-Hydroxypropyl Nortadalafil;
• 2-Hydroxyethyl Nortadalafil;
• Vardenafil Acetyl Analogue;
• 5-[2-Ethoxy-5-[(4-Methyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-1,6-dihydro-1-Methyl-3-(2-Methylpropyl)-7H-pyrazolo[4,3-d]pyriMidin-7-one;
• ...

Q6: Are manufacturing and sales records required for health food products currently in production and sale to apply for certificate replacement?

A6: Yes. According to the Draft, products with no validity period and no technical requirements must have manufacturing and sales records to be eligible for certificate replacement.

Q7: Do I need to supplement methodological validation if the test methods in the previous certificate are self-developed?

A7: Yes. The Draft specifies that in cases where the product's technical requirements involve the addition or revision of efficacy/characteristic component indicators, and where test methods for physicochemical indicators are self-developed, relevant research materials such as methodological validation must be provided.

Q8: Are Ginseng radix et rhizoma and Panacis quinquefolii radix eligible for liquor preparations filing?

A8: The Technical Requirements of Filing Product with Health Food Raw Material (Ginseng radix ET rhizome, Panacis quinquefolii radix, Ganoderma) (Draft) specifies that for products using liquor preparations, the production and technical requirements shall comply with the current Pharmacopoeia of the People’s Republic of China. Therefore, it can be inferred that this practice is feasible. However, it’s subject to the official announcement.

Q9: For products with the health claim of enhancing immunity, if the original function test evaluation is based on the 1996 version of test methods released by the former Ministry of Health (MOH), and the 2003 version of immune function tests have been subsequently conducted, are additional animal functional tests required for this time?

A9: No. Test reports conducted in accordance with the 2003 version of function test methods can be provided.

According to the Directory of Health Functions Available to Be Claimed by Health Food - Non-nutrition Supplements (2023 Version) and the supporting documents, if the evaluation requirements and standards of the original function test report are lower than that of the current ones, health function re-evaluation materials for the corresponding products is required when adjusting the previous health claims. In that case, function test reports redone according to Testing and Evaluation Methods for Health Food Functions (2023 Version), the 2012 revised and published notice from the former China Food and Drug Administration (CFDA) on the Publication of 9 Health Function Evaluation Methods Including Anti-oxidant, or the Technical Specifications for Health Food Testing and Evaluation (2003 Version) can be provided.

Q10: When will the official version of the Draft be released?

A10: It is expected to be released in 2024. As specified in the Key Points for Special Food Safety Supervision in 2024 issued by the State Administration for Market Regulation (SAMR), the release of key points for certificate replacement of health food with no technical requirements and no validity period is part of the work focus in 2024.

We have made a list of all the free webinars scheduled for 2024 for your reference: CIRS Food – Upcoming Free Webinars in 202 4. If you are interested in global hot topics of food compliance, our webinars will be unmissable to you.

If you need any assistance or have any questions, please contact us viaservice@hfoushi.com.

Further Information

Change of Health Food Registration Certificate Service in China

China Officially Released the Function Evaluation Methods for Health Food: Summary of Key Changes