On February 26, 2016, the China Food and Drug Administration (CFDA) promulgated the Administrative Measures on the Registration and Record Filing of Health Foods (Measures). The Measures will take effect on July 1, 2016. By then, the current Administrative Measures on the Registration of Health Foods (for Trial Implementation), which was published on April 30, 2005, will be repealed.
In July 2015, CFDA published the draft Administrative Measures on the Registration and Record Filing of Health Foods for public comment (Draft for Comments). The dual-track registration and record filing regime and the catalog administration system have attracted widespread attention from within the industry. The formal promulgation of the Measures elaborates on the regulatory requirements of the registration and record filing models in the Food Safety Law. The Measures provide the applicable scopes, the approval authorities and the registration mechanism and the record filing mechanism procedures, respectively. Under the Registration of Health Foods Measures (for Trial Implementation), the review and approval regime on health food functions on a case-by-case basis. The CFDA is in charge of registration while the provincial food and drug administrations are responsible for accepting the registration application documentations for domestic health foods registration, conducting procedural reviews, and conducting on-site examinations and sample testing.
Pursuant to the Measures, the functions and authorities of the different levels of the food and drug administrations are as follows: the CFDA is responsible for the registration of health foods and the record filing of nutritional health foods such as vitamin supplements and minerals which are imported into China for the first time; the provincial food and drug administrations administrate the record filing of health foods within their respective jurisdictions, and cooperate with the CFDA regarding on-site examinations of health food registrations; and the food and drug administrations at the county level are responsible for the supervision and administration of registered and record-filed health food within their jurisdictions and matters entrusted to them by higher administrations. Delegating the health food record filing authority to the provincial food and drug administrations, other than nutritional health foods such as vitamin supplements and minerals imported into China for the first time, conforms to the trend of streamlining and simplifying administrative tasks in China. While regulatory access thresholds have not been lowered, such delegation demonstrates an emphasis on ex post facto supervision and an improvement in the efficiency of the administrative approval process.
Compared to the Draft for Comments which has 63 articles, the Measures add further content and has 75 articles. The Measures strengthen the regulation of health food registration certificates and specify the information required in health food registration certificates and their attachments. The Measures also reinforce the penalties for health food registration and record filing offences. For instance, if the registration applicant withholds the truth or provides false documentations to apply for registration, or acquires the health food registration certificate through illegitimate means such as fraud and bribery, the Measures provided that violators are subject to criminal liability if such misconduct constitutes a crime. In addition, the Measures have strict rules on the labeling and instructions of the products to prevent customers from being misled.
As we mentioned in Significant Future Developments in the Regulation of Health Foods in China published on the KWM WeChat platform in August 2015, the Draft for Comments requires that that registration applicants for imported health food be the “legal holder of the product in the market”. However, such phrase is not specifically defined, so it is hard to tell whether the phrase is the same as or similar to the concept of a “marketing authorization holder”. The Measures provide that the applicant for imported health food registration and record filling shall be the overseas manufacturer of the marketed health food (referring to legal persons or other organizations whose products comply with the marketing requirements of the countries (regions) where they are located). Furthermore, under the Draft for Comments, the transfer of technologies is under the registration change regime, while the Measures state that if the health food registrant transfers technologies, the transferee shall file a new registration application under the instruction of the transferor and the technical requirements of the products shall be the same as the original application documentations. The reviewing and evaluation authority shall simplify the examination procedure according to the rules. For imported health food enterprises and health food enterprises that intend to transfer technology, these changes merit special attention.
Indications to Enterprises
The health food market in China is developing rapidly and has great potential. It has attracted the attention of domestic and overseas investors and manufacturers. Prior to the promulgation of the Measures, some enterprises have made arrangements to acquire the equities of health food companies to seize market opportunities. The co-existence of registration and record filing mechanisms is great news for the industry.
When the Measures become effective, the procedure for health food registration will be optimized, and parts of the health food formerly under the registration regime are now subject to record filing. If the documentations of such health food comply with the requirements, the record filing will be finished immediately. The changes in the regulatory mechanisms will greatly shorten the waiting time for companies to obtain administrative licenses. As such, such companies can launch their products to the market earlier to make profits. For imported health foods, even though the record filing procedure only covers nutritional health foods such as vitamin supplements and minerals imported into China for the first time, and nutrition is required to be listed in the catalog of raw materials for health food, it provides convenience for overseas manufacturers to export their products to China as a health food rather than as a common food. Given the changes in the health food regulatory models, it is foreseeable that significant changes in the industry structure may take place in the near future.
We have noted that in mid-February, the CFDA published the Catalog of Raw Materials for Health Food (the first batch) – the Catalog of Raw Materials for Nutrient Supplementation of Health Food (Draft for Comments) for public comment. In addition, the Measures set forth that the CFDA shall timely make and publish service guidelines for registration applicants and detailed review rules for the convenience of the registration applicants. We understand that the CFDA may promulgate more detailed rules and regulations directed at the operational level in the future. We will continue to follow developments with respect to the publication of the relevant service guidelines, detailed rules and the catalogs of health food raw materials.