The Administrative Measures for the Registration and Recordal of Health Food (“Measures”) adopted and promulgated by China Food and Drug Administration ("CFDA") on 4 February 2016 have come into force on 1 July 2016.
The above Measures give more clarity to health food manufacturer or distributor in terms of manufacturing and importing of health food in China.
The Measures provide a new two-track administrative system and a more efficient guideline for health food industry. Compared with the current regulation (i.e. Trial Implementation of Health Food Registration, “Trial Implementation”), the Measures simplify and optimise the procedure for health food registration, and parts of the health food (formerly subject to registration process) are now subject to recordal. This will help to shorten the period to meet regulatory compliance of health food on the Chinese market. The new regime is also beneficial for foreign health food manufacturers who mainly carry out these goods through online sale, mainly those who manufacture nutrition complements, such as vitamin and minerals.
According to the 2015 annual report issued by CFDA in February 2016, 987 registrations of health food cases have been approved and 513 alteration application cases have been approved in the year 2015. It can be expected that after the promulgation of the Measures, the number of both registered and recorded health food will have a much faster growth in the near future.
Two-track Administrative System
The Measures have introduced a combination of registration procedure and recordal procedure in the place of a single registration procedure stipulated under the Trial Implementation. For those health food which must be registered at the level of the CFDA, the Measures set up a more detailed and clearer procedure. For those that meet the conditions of recordal, the Measures simplify the procedure and documentation requirement and shorten the time limit.
1. Registration System
According to the Measures, registration means a systematic evaluation and review of relevant registration application documents of the health food in respect of safety, health functions and quality controllability before making a decision on approving or rejecting registration.
The following health food shall be subject to registration:
- health food using raw materials beyond the Raw Materials Catalogue for Health Food ("Non-catalogue Raw Materials");
- health food imported for the first time in China, with the exception of those providing nutrition complements, such as vitamins and minerals (which are subject to recordal procedures). “First time” means either formula or applicant company is different from those of the already-imported health food.
The registration shall mainly be subject to the following conditions:
- Applicant. Applicants for registration of domestic health food shall be legal entities or other organisations incorporated within China. The applicants for registration of the imported health food shall be overseas manufacturers of marketed health food. Registration of imported health food must be handled through the applicant's representative office in China or an authorised third party agency in China.
- Application Documents. The Measures illustrate the documents required for registration of health food.
- application form and letter of commitment on the legal liability for the authenticity of application documents;
- copy of the business registration document of the applicant;
- research report of health food, including researchers, research period and process, data from trial or larger scale production; analysis and relevant scientific ground for the safety, health functions and quality controllability of the Non-catalogue Raw Materials and the product; technical requirements of the product derived from research results;
- formula description, including name, dosage, manufacturing process and quality standards of raw and auxiliary materials. If necessary, the basis of using such raw materials, the specific part used, inspection certificate and variety identification report shall be furnished as required;
- description of the manufacturing process of the product, including flowchart and instructions as well as critical control points and instructions;
- evaluation of safety and health functions, including evaluation of safety, health functions and human consumption testing of the Non-catalogue Raw Materials and the product; testing reports of functional/key ingredients, hygiene, stability; illicit drug testing reports, etc.;
- types, names and relevant standards of packaging materials that have immediate contact with health food;
- sample of label and instructions; documents from retrieval system proving the generic name of the product is different from registered product name;
- three packaged samples in minimum size for sale;
- other documents related to registration evaluation.
In the case of the health food which is imported for the first time in China, the following supplementary documents shall be submitted:
- the qualification certificate to prove the applicant is an overseas manufacturer of the health food;
- a document stating the health food has been marketed for at least one year on the foreign market, or a safety report of overseas marketing and human consumption;
- relevant laws, regulations and standards regarding technology of health food applicable in the country (region) of origin or by international organisations;
- samples of packaging, label and instructions of the product marketed in the country (region) of origin.
- Time Limit. Based on the Measures, if all documents have met the requirements and they are complete and if evaluation authorities decide not to make any on-site inspection or if the applicant does not issue any re-test application, it will take approximately 118 working days for the CFDA to issue a registration certificate.
- Remedies. In case the registration application is rejected by the CFDA, the applicant may file a written application for administrative reconsideration with the CFDA or initiate an administrative litigation with the people's court.
- Assignment of Technology. In case the registered health food related technology is assigned, the assignee shall submit again the application for registration and the technical requirements shall be consistent with that in original application documents. The evaluation institution shall streamline the evaluation process. This implies that the transfer of registration or recordal through technology transfer alone would not be possible in practice.
2. Recordal System
The recordal of health food means the filing process under which a health food manufacturer, pursuant to statutory procedures, criteria and requirements, submits the documents of a product evidencing its safety, health functions and quality controllability to the CFDA for record, disclosure or future reference.
Manufacture and importation of the following health food shall be subject to recordal:
- health food using raw materials which are included in the Raw Materials Catalogue for Health Food (“Raw Materials Catalogue”);
- the imported health food that are imported into China for the first time which provide nutrition complements such as vitamin and minerals. Such nutrition complements must be the substances that are included in the Raw Materials Catalogue, such as beta-carotene, Iactochrome, vitamin B6, calcium carbonate, magnesium chloride, etc.
The recordal shall mainly be subject to the following conditions:
- Applicant. Applicant for domestic health food recordal shall be the manufacturer of such health food. Applicants for imported health food recordal shall be overseas manufacturers of marketed health food. The Measures are unclear whether recordal of imported health food can be handled through the applicant's representative office in China or an authorised third party agency in China. Considering that recordal procedure is more simplified than registration, we presume that recordal can be handled by a representative office or a third party agent.
- Application Documents. Application documents for recordal of health food is simplified. Compared with the required documents for registration under the Measures, there is no need to submit research report and sample of the health food. Due to the fact that health food to be recorded will not be evaluated or inspected, the applicant is still required to submit the testing reports issued by a qualified test institution.
- Time Limit.Upon receiving the recordal application documents, the CFDA shall approve the recordal on the spot if the submitted documents are in compliance with relevant requirements, or notify the applicant to make corrections or submit additional documents if the submitted documents do not comply with relevant requirements.
3. Health Food Registered before the Measures
For those health food which have already been registered, if these food meet the standard for recordal procedure, and if the health food registration certificate has expired and the applicant wants to renew the certificate, or if the applicant wants to change the registered information (ex: name, specification, function of health food, etc.), such procedure shall be handled according to the recordal procedure.
Competent Administrative Authorities
The Measures clarify that:
- The CFDA shall be responsible for the registration of domestic health food and the recordal of health food that provide nutrition complements such as vitamins and minerals and which are imported into China for the first time.
- The Food and Drug Administration (“FDA”) at the provincial or municipal level shall be responsible for the recordal of health food within their respective jurisdictions.
- The FDA at the city or county level shall be responsible for supervising and administering the health food registered and recorded within their respective jurisdictions.
Name of Health Food
The name of health food shall consist of brand name, generic name and property name. The Measures set up several rules regulating the name of health food, for instance, the name of the health food shall not contain false, exaggerated or absolute words; express or implied words conveying disease prevention and treatment functions; words associated with human tissues or organs and some other misleading words, etc.
Besides, to avoid confusion, it is further provided that a formula of health food cannot be registered or recorded under two different product names. One product name cannot be registered or recorded for two different formulas.
Administration and Supervision
The CFDA will promulgate the service guidelines and detailed review rules for health food registration procedure, in order to facilitate applicants filing applications.
The Measures further stipulate that unless state secrets or trade secrets are involved, the CFDA or the FDA shall, within 20 working days of the date of registration and/or recordal, publish the catalogue and relevant information of the registered or recorded health food on their official websites.
The Measures provide for several penalties measures, including fine (RMB 10,000 to RMB 30,000), injunction forbidding registration of health food within a certain period of time (1 year or 3 years). In case of violation of the Measures, criminal liability can be also pursued.
Following the promulgation of the Measures, more supplementary or detail rules and regulations are expected to come into force, such as the Raw Materials Catalogue for Health Food (1st batch) published on the CFDA’s website on 15 February 2016 for opinion; the List of Excipients for Health Food Recordal (1st batch) published on 25 May 2016 for opinion; and Rules on Review of Production Licensing for Health Foods published on 19 May 2016 for opinion.