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On July 1, 2016, China announced the formal implementation of the new health food registration and filing system. CFDA also released relevant supplementary requirements thereafter. This article contains updated information on impact of these rules with a particular emphasis on detailing conditions where under the new rules previously registered products would now be subject to filing requirements (comparatively reduced regulatory compliance burden).
Some Background
The definition of Health food in China is “Food Products which claim to have a specific health function or supplement one’s vitamins or minerals. Health food is suitable for the consumption by specific groups of people and has the effect of regulating human body functions, but is not used for the purpose of treating diseases, which will not have any form of harm whether it is acute, sub-acute or chronic to human body.”
In the Chinese law, it is divided in two subcategories: Health food with functional claims that have physiological effects on the human body and nutrient supplements with vitamins and minerals as major ingredients but without providing energy or other active ingredients. In talking about health food regulation in China, registration and filing are two distinct procedures that have a different scope. Health food with functional claims requires registration, while nutrient supplements require filing, introduced in order to provide a procedure faster than registration. For imported health foods produced in oversea manufacturers, both registration and filing shall be applied with CFDA.
What are the most relevant recent changes?
After the announcement on the 17th of November 2016 of the update of the rules for the registration of health food, China CFDA on 12th January 2017 released finalized version of the first batch of approved health food raw materials (vitamins/minerals and regulated dosages).
The substances included in this list are all subject to health food filing rather than health food registration. The approved health food raw materials include 24 categories of nutrients and 69 approved compound sources, all of which are approved for use in nutrient supplements. The permitted daily intake of many health food raw materials has also been reset, especially maximum daily intake, including calcium, selenium, vitamin A, vitamin D, etc. Nutrients and compound not listed are not approved for use unless added later. In addition, on 2 May 2017, China’s CFDA also finalized and released the “Health Food Filing Guidance”, as well as auxiliary material directory for health food filing and major production techniques. CFDA has been accepting health food filing application since May 1, 2017.
Change of online declaration of health food
Applicants wishing to register a new health food product or make technology improvements (including those uploading labels, technologic requirements and other materials) should provide certifications according to the following proceedings:
-1 the applicant obtains a declaration template from the download center of health food registration center of CFDA website
-2 according to the requirements, when the registration work is done, all digital and paper versions of the registration materials can be sent to CFDA as we describe in the following sections.
Previously registered health food subject to expedited health food filling
Original registrants of nutrient supplements (vitamin and mineral supplements only) shall submit their applications to CFDA in order to shift from registration to filing. If the provided information meets the requirements, electronic registration information of the product will be sent to the filing department. Meanwhile, the applicant will receive a written notice that invites him to submit filing application to the filing management department.
The following documents are required:
Modified application form and Letter of commitment entitling the applicant for legal responsibility over the authenticity of the materials.
Before the new system is implemented, please have a look at this section of SDA website to download templates of these documents.
The Application Form to modify registration into filing, stamped and signed by a legal representative.
Photocopy of Business license, company code, organization code and any other applicant identification documents.
Copies of health Food Registration Certificate and its attachments (not yet registered products don’t need this)
Procedures to pass from registration to filling for already registered products
1. Formal implementation of the new registration system
After the applicant inputs required information in the filing management information system（at the website http://bjba.zybh.gov.cn/）,they should click on “obtain registration username”, fill in account information and choose “Original Registrants” to then fill in company information and the information about the previously registered product, and upload all the scanned documents.
Registrants who already registered products before can then click on “Register Application Record”, fill in the relevant information for Original Health Food and after that upload all the scanned materials.
After the applicant submitted the application form, he should at the same time send paper version documents to the relevant office.
After receiving the documents and completing the audit, the applicant will be notified through SMS and from now will be able to check the status of his application.
After the original registrant qualification is confirmed, the applicant can be filed in the health food filing system.
2. After the formal implementation of the new registration system
The applicant has to submit the application in the health food registration system according to the renewed requirements. After the notification document is available and the original registrant qualification is confirmed, the applicant can do the filing.
If an applicant’s registration was accepted before the release of the directory of approved health food raw materials, they can directly apply for filing according to the renewed requirements with the CFDA technical evaluation institution. After the original applicant qualification is confirmed, they can apply for filing in the health food filing system.
In the following cases a product cannot use an original registrant's qualification:
The applicant doesn’t comply with Administrative Measures for Registration and Filing of Health Foods, Guideline for Health Food Filing Application (Trial) and other requirements.
The information in the main identification documents and the registration certificate are not consistent, or the applicant fails to provide consistent identification materials.
For no relevant reasons the applicant fails to apply in time for the transition between registration and filing.
The applicant provides the application after the publication of the Health Food Raw Materials Directory and its raw materials are contained in the directory and comply with the requirements.
The new product was already refused registration in the past.
Even though it was registered in the past, following reasons linked to health claims, safety and quality control the product encountered a denial for the registration.
Registration certificate has authenticity issues.
Other circumstances not pertaining to the transition between registration and filing.
SUNOTA Folic Acid Tablets: a Case Study
On July 7 2017, “SUNOTA Folic Acid (B9) Tablets” (善元堂牌叶酸片), received the first domestic health food filing certificate in China since the Administration Measures on Heath Food Registration and Filing came into force on July 1, 2016.
This chart shows some of this product’s features as publicly disclosed in the documents provided by Guangdong FDA.
| Name | Type | Function | Standard | Compliance with Requirements | Content for 500 mg tablet |
| Folic acid | Raw Material | Folic Acid Supplement (active principle) | GB 15570 | Meets the requirements set in Nutrient Supplement Raw Materials Directory | 0.3 mg |
| Sorbitol | Subsidiary Material | Excipient, for dilution | GB 1886.187 | Adheres to the limits set by production requirements | 394.7mg |
| Microcrystalline cellulose | Subsidiary Material | Bulking agent, disintegrant, binder | GB 1886.103 | Adheres to the limits set by production requirements | 100mg |
| Magnesium stearate | Subsidiary Material | Lubricant, fluidity enhancer, making the tablet surface smoother | GB 1886.91 | Adheres to the limits set by production requirements | 5mg |
This case shows us 3 major features of the new filling system:
-Filing can be completed within several working days from submitting all the required materials to obtaining the certificate
-Formula and process information is fully disclosed as all the filing materials are open to the public
-Submitting self-test and designated authority report can help to improve the efficiency of application
Health food filing is much easier than registration in China. As the first filing number has been given out, more health food filing certificates will be issued in the future.
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