The revised Food Safety Law, which will become effective on 1 October 2015, stipulates that health food shall be regulated by the catalog of raw materials for health food and the catalog of the functions of health food (New Food Safety Law). Moreover, under the New Food Safety Law, registration and record filing will co-exist and replace the current registration-only regime. The China Food and Drug Administration (CFDA) released three draft administrative measures on 28 July 2015 for public comment. They are the Administrative Measures on the Registration and Record Filing of Health Food (Draft for Comments) (Registration and Record Filing Measures), the Administrative Measures on the Catalogs of Health Food Functions and Raw Materials (Draft for Comments) (Catalog Measures) , and the Administrative Measures on the Labels of Health Food (Draft for Comments) (Labeling Measures and together with the Registration and Record Filing Measures and the Catalog Measures, the Draft Administrative Measures).
The New Food Safety Law categorizes health food as a type of special food which is subject to strict regulatory oversight and administration. The Draft Administrative Measures elaborate on the administrative procedures and requirements for health food based on the New Food Safety Law. If implemented, these administrative measures will dramatically change the landscape of China’s health food industry. The dual-track registration and record filing regime and the catalog administration system have attracted widespread attention from within the industry.
Implementing the dual-track registration and record filing regime
The Registration and Record Filing Measures sets forth that from the date when it becomes effective, the current Administrative Measures on the Registration of Health Food (for Trial Implementation), which was published on 30 April 2005 (Registration of Health/Functional Foods Measures), would be repealed. Once effective, the Registration and Record Filing Measures, along with the Catalog Measures and the Labeling Measures will bring significant changes to China’s health food industry.
The Registration and Record Filing Measures elaborate on the dual-track regime of registration/record filing described in the New Food Safety Law and provides more specific information about the principle of risk management by different administrative levels, and the respective scope, approving authorities, and procedures of the registration and record filing regime.
Under the Registration of Health Food Measures, the examination and approval regime functions on a case-by-case basis, and the CFDA as well as the provincial food and drug administration are in charge of registration. In comparison, the Registration and Record Filing Measures delegates the power of review and approval to different levels of the food and drug administration in Chapter I “the General Principles”. The CFDA is responsible for the registration of health food and the record filing of nutritional health food such as vitamin supplements and minerals which are imported into China for the first time. The provincial food and drug administrations manage the record filing of health foods within their respective jurisdictions and matters entrusted to them by the CFDA such as change registrations, renewal applications, etc. This delegation of approval power 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, improvement in the efficiency of the administrative approval process, and serves as inspiration for enterprises to innovate.
Elaborating on the catalog administration regime
The New Food Safety Law sets forth the administrative regime with respect to the catalog of raw materials for health food and the catalog of health food functions. The Catalog Measures (1) demonstrate the importance regulators attach to the regulation of raw materials in health food and (2) define the catalog of raw materials and the catalog of health food functions. The catalog of health food functions is a catalog of health food functions that can be used to describe health food. It was formulated through systematic assessments and verifications, has specific assessment measures and judgment criteria, and contains the names of the health food functions and their corresponding instructions. The catalog of raw materials for health food is defined as the catalog of raw materials that can be used in health food and the corresponding relevant information formulated through assessment regarding their safety and functions. Such catalog shall include the names of the raw materials, compatibility, dosage, health functions that are permitted to be claimed, quality standards, functional components, assessment measures, and the relevant instructions.
According to the Catalog Measures, the CFDA, jointly with the National Health and Family Planning Commission (NHFPC) and the State Administration of Traditional Chinese Medicine (SATCM and together with the CFDA and the NHFPC, the Catalog Authorities) shall be responsible for formulating and adjusting the catalog of health food functions and the catalog of raw materials. The Catalog Authorities will establish an expert committee to review the catalogs. The catalogs will be dynamically administrated. They will be promptly revised and published based on scientific research and the registration status of the health food.
It is foreseeable that the health food industry will change if the relevant health food administrative measures are finalized and implemented. Some health food manufacturers and industrial associations have commented on several aspects such as the level of the Draft Measures and the lack of standards for raw material extracts. We have also noted that since the catalog of raw materials for health food and the catalog of health food functions have not been published yet, the specific raw materials that are included in the catalogs are not yet known. In addition, the Registration and Record Filing Measures do not specify the relevant concepts and the requirements for application documents. For example, the Registration and Record Filing Measures state that the applicant for the registration of imported health food shall be a “legal holder of the product in the market”. However, the term is not specifically defined, so it is hard to tell whether the term is the same as or similar to the concept of a ‘marketing authorization holder’. Another example is that the Registration and Record Filing Measures do not specify whether the products sold in the market or samples of three consecutive batch numbers mentioned in the relevant documents for the registration application of an imported health food must be manufactured by the applicant itself or whether commissioned manufacturing is allowed. In addition, the Registration and Record Filing Measures do not specify how to deal with changes to the status of a health food that is already registered. Thus, we understand that the CFDA may promulgate further rules and regulations. We will continue to follow developments with respect to the promulgation of detailed rules and catalogs.
(This article was originally written in Chinese, and the English version is a translation.)
Editor’s note: This article was simultaneously published on Chinalawinsight.com