The Food Safety Law of the People’s Republic of China (the “New Law”) came into force on 1 October 2015. The New Law, as issued by the Chinese Standing Committee of the National People's Congress, implements a new, comprehensive and practicable administrative regime for health food and replaced the 2009 version of the law.
Content
Main amendments under the New Law
1) Catalogue of Health Food Ingredients and Catalogue of Health Food Functions
The new catalogues specify the type of ingredients that may be used in health foods and the purposes for which such health foods may claim to be used.
2) Registration procedure
Different registration procedures are required, depending on the nature of the heath food. Health foods using ingredients which are not listed in the Catalogue of Health Food Ingredients, as well as first-time imported health foods, must be registered with the China Food and Drug Administration (the “CFDA”). First-time imported health foods which are deemed to be vitamins, minerals or other nutrients must complete the CFDA’s record-filing requirements. Certain other health foods must complete the local Food and Drug Administration’s (“FDA”) record-filing processes.
3) Advertisement
Health food advertisements require the approval of the local FDA. Their content must be true and legitimate and must not claim to have functions involving the prevention or treatment of disease. The advertisement must include the statement, "this product does not serve as a substitute for medicine".
4) Liability
The following actions may lead to administrative, civil or criminal liability:
- manufacturing and conducting business activities relating to unregistered health foods which require registration (as set out at part 2 above), or manufacturing which does not comply with the registered technical requirements;
- failure to complete the record-filing process with the relevant authority, or manufacturing which does not comply with the recorded technical requirements; or
- making false promotions in advertisements to defraud consumers, or promoting advertisements or content which has not been approved by the relevant authority.
The authority may fine those who violate the regulations. They also have the power to revoke relevant licences. If any of the acts listed above result in a violation of the criminal law, additional punishments may be applied.
Supplementary Reforms
To support reform in this sector, China’s health food authorities have issued various laws and regulations.
The Regulation on the Implementation of the Food Safety Law (Revised Draft for Comment) (the “Draft Regulation”) was promulgated on 9 December 2015 and was open for comments until 8 January 2016. The Draft Regulation strengthens the regulations in respect of the basic systems for food safety, the responsibilities of food manufacturers and business operators, food safety supervision and regulation requirements, and the shared oversight of the food authorities and the society for food safety, amongst other matters.
The Administrative Measures for Food Production Licensing and the Administrative Measures for Food Operation Licensing, were implemented on 1 October 2015. These regulations require health food producers to submit any relevant production quality management system documents and product registration and filing documents to the CFDA, in addition to meeting the broader licensing conditions for common food.
The Announcement on Matters relating to Further Regulation of the Naming of Health Food (the “Announcement”) came into force on 25 August 2015. According to the Announcement, health foods whose names contain wording which relates to their function are prohibited. Any such names were required to have been amended (with the approval of CFDA) by 31 December 2015. As of 1 May 2016, no health food with such a name may be produced. The CFDA have offered the concession that any health food which had been produced up to this point may be sold until the stated expiry date.
The Administrative Measures for the Supervision and Inspection of Food Production and Operation (Draft for Comment) (the “Draft”) was promulgated on 31 August 2015. The Draft requires enterprises producing health food to establish a quality management system for food production and conduct regular self-inspection on the operation of the system, as well as submitting a self-inspection report to the local food and drug administration at the county level.
On 28 July 2015, the CFDA suggested administrative measures to deal with matters associated with the regulation of health foods including:
- the Administrative Measures for Health Food Registration and Filing which clarify the registration and the basic registration alteration requirements for health foods, as well as the relevant filing requirements and extension of registration requirements;
- the Administrative Measures for Health Food Labelling which stipulate the requirements for the content and form of health food labels and introduce prohibitive requirements on labelling and illegal liabilities; and
- the Administrative Measures for the Health Food Function Catalogue and Raw Material Catalogue which stipulate the authorities that may draft and issue the catalogues and the process for drafting and updating the catalogues. It also gives requirements on the functions or content that can be included in the corresponding catalogue.
Under the Interim Provisions on the Publication of Food Advertisements (Revised Draft) (Draft for Comment) (“Draft 2”), promulgated by the State Administration for Industry and Commerce (“SAIC”), no advertisements on health foods should be published without prior examination and approval of their content by the examining authorities. Certain material publicised in advertisements on health foods will be subject to the requirements set out in the CFDA’s approved instruction books and may not be changed arbitrarily. The Draft also sets out a range of content that may not be included in advertisements for health food. The phrase, “this product cannot substitute medicines”, must be clearly stated on any health food advertisements.
Conclusion
New measures affecting the production, registration and advertisement of health foods demonstrate the Chinese authorities’ determination to improve regulation in the industry. Commentators have suggested that the New Law will have a transformative effect on China’s health food industry as it requires much more stringent management on behalf of health food companies. It is evident that the Chinese government is in the process of implementing a detailed and thorough reform which will hopefully be implemented through proper use of the new liabilities.
Further rules and regulations may be published in following days. We will continue to follow any such developments.
Practical Suggestion
The immediate future is likely to be a challenging time for the health food industry in terms of compliance. Health food companies and advertisers should review their business processes to ensure that they conform to the requirements of the New Law.
