Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 25 August 2016
This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed.
Over the past 30 years, China, a developing nation with a huge population and large geographical heterogeneity, has made significant advancements from a nation with frequent shortages of food to eliminate hunger. Along with the significant changes in peoples' lifestyle and food supply, China's food industry has undergone revolutionary regulatory change. However, there is a conflict between traditional household based agriculture, numerous small food businesses and increasing consumer demands for a safe, high-quality food supply. Food (manufacturers) producers, traders (distributors) and global regulatory bodies have a responsibility to meet these consumer demands and ensure food safety. Social governance is now recognized as an efficient way to meet the demands of consumers for an improved food supply.
The national food safety control system in China has experienced a change from management by a few ministries to management by multiple ministries, a move resulting in fragmentation. In the 1980s, there were only two ministries in charge of food safety control.2 The Ministry of Health (MOH) had the overall responsibility of food safety supervision and management, including imported food control. The Ministry of Agriculture (MOA) controlled primary agricultural products production, such as the planting and breeding process.
In 2004, the State Council decided different ministries should share responsibility for the various segments of the whole food chain, from farm to table. Consequently, the MOA, MOH, General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), State Administration of Industry and Commerce (SAIC) and State Food and Drug Administration (SFDA) all became responsible for the control of various parts of the food chain.3 There were many "loopholes" in this fragmented food safety control system and subsequent problems developed.
An example was the case of about 300,000 infants developing urinary system stones after consuming melamine-tainted Sanlu infant formula in 2008.4 Numerous raw milk collection stations were found to be the main location of milk adulteration, where water and melamine were added to raw milk. However, as a very important part of the dairy value chain, the milk collection stations were neither regulated by the MOA as a primary agricultural product, nor regulated by AQSIQ as part of the food production process. There was a regulatory gap within the dairy production chain. Although the State Council eventually decided milk collection stations should be regulated by the agricultural sector; the change was too late to prevent the melamine event.
In order to reduce regulatory loopholes and delegate clear responsibility, the 2013 12th National People's Congress decided to make further reforms of the national food
safety control system (Figure 1).5 In addition to the MOA's continuing responsibility for primary agricultural food products control, the newly established China Food and Drug Administration (CFDA) was given the responsibility of controlling remaining parts of the food chain, such as manufacturing, transportation, storage, distribution and restaurants and catering. Because the CFDA also serves as the Standing Office of the Food Safety Commission of State Council, it also has responsibilities in policy formulation and planning, comprehensive coordination, handling of major incidents and major information dissemination. The MOH or the Health and Family Planning Commission (HFPC) retained responsibility for monitoring and surveillance, risk assessment and standard development and promulgation. The SAIC was no longer responsible for food safety control, but still regulated food advertisement. The AQSIQ is now only responsible for the inspection of import and export food and the control of food contact materials manufacturing. With fewer ministries involved in the national control system, the new system has the advantage of avoiding gaps within food chain control. However, some experts feel there is still room for further reforms and improvements.
Before the promulgation of 2009 Food Safety Law,6 China had three national food standard systems, each based on different national laws and with different responsible ministries. In addition to the Food Hygiene Standards promulgated by the Ministry of Health based on the Food Hygiene Law,7 there also were Food Quality Standards promulgated by AQSIQ based on the Product Quality Law,8as well as the Agricultural Products Quality and Safety Standards promulgated by the Ministry of Agriculture based on the Agricultural Product Quality Safety Law.9
All three sets were national standards and all were mandatory with hygiene indicators (e.g., total bacteria count) and safety indicators (e.g., limit for lead). However, these three sets of standards did not converge and in some cases, they contradicted each other. The biggest problem was the boundary between hygiene standards and quality standards was unclear. This put the food business in a very difficult situation.10 For example, in the case of inorganic arsenic limits in foods, the Food Hygiene Standard (GB-2762-2005)11 stated it was 0.05 mg/kg for poultry meat. However, according to the Food Quality Standard (GB-16869-2005),12 it was 0.5 mg/kg for fresh and frozen poultry products, a difference of 10 times between the two standards. All of these standards were in effect at the same time.13 By 2009, there were nearly 5,000 food standards in China.14
In order to avoid having multiple conflicting national food standards, the 2009 Food Safety Law stipulated that only the national food safety standards were mandatory and the Food Hygiene Law changed to Food Safety Law and Food Hygiene Standards changed to Food Safety Standards accordingly.
Other national or industry standards were not mandatory. Beginning in 2009, the MOH or the Health and Family Planning Commission (HFPC) worked in collaboration with other ministries and related industry associations to clean-up approximately 4,800 existing standards, integrated into about 1,000 standards by the end of 2016. Currently, Chinese National Food Safety Standards are divided into the following categories: general (horizontal) standards, commodity/product (vertical) standards, hygiene practices and laboratory testing methods.15 The structure of the standards system (Figure 2) is very similar to the Codex standards.16
The new food standard system in China is improved and advanced compared to the 2009 food standard system. Using the new "Standards for Uses of Additives in Food Contact Materials and Products, GB-9865-2016"17 as an example and in comparison with and the original standard "Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials, GB-9685-2008,"18 it is clear the new standards are aligned with the international standards and more practical in implementation. Changes include:
However, compared to the Codex standards and standards in most developed countries, the following continue to be major problems in food safety standards in China:
Before 2013, there were no regulations and standards for Food for Special Medical Purposes (FSMP) in China. There was no unanimous view regarding whether FSMP should be regulated as food or drug. FSMP products, all imported, were only used in large hospitals. The lack of FSMP regulations and standards greatly hampered the production and use of FSMP in China although the demand for such products continues to increase.
Along with the process of cleaning up and integrating existing standards, a set of FSMP standards targeted at specific diseases or health conditions in specific subpopulations were developed and promulgated by the MOH or National Health and Family Planning Commission (NHFPC). The set of standards include: Food for Special Medical Purposes (GB-29922 -2013),20 Food for Special Medical Purposes Intended for Infants (GB-25596-2010)21 and Good Manufacturing Practice for Food for Special Medical Purposes (GB-29923-2013).22 By referring to related Codex standards and corresponding standards in the European Union and US, these standards, a first in China, clarified which foods were to be used for special medical purposes. FSMP are foods categorized as "foods for special dietary uses" and also regulated under Food Safety Law. It is expected the three FSMP standards will play important roles in the promotion of the proper use of FSMP in clinical medicine and improving nutrition support to meet the needs of patients. This development also reflects the improvement of the Chinese food standards system and how it is aligned with international standards.
According to the newly revised Food Safety Law, effective October 2015,23 the FSMP is positioned as one of the special food categories with two others—infant formula and health foods (functional foods). Article 80 of the Law stipulates FSMP products shall be registered with the China Food and Drug Administration (CFDA). The applicant will provide information on product formula, production techniques, label, instruction and materials indicating product safety, nutritional adequacy and clinical effects. Corresponding regulations on registration requirements are being developed by CFDA, which will be applicable to both domestic and imported FSMP products. For domestic products, a special production license, authorized by CFDA, is required.
"Health foods" is a term used in China for foods with special health functions or vitamins and minerals or for special targeted populations to adjust body functions. These foods are not for the treatment of diseases and should not cause any acute, subacute or chronic hazards to human body.24 Health foods are allowed to make functional claims on their labels according to the list of functions announced by CFDA (Table 1).25 Vitamin and mineral supplements are regulated as health foods; however, they are not allowed to make functional claims.
For the past 20 years, health foods have been required to be registered on an individual product basis. In this case, more than 300 fish oil products have been registered and each application was individually reviewed and approved. According to the revised Food Safety Law (October 2015), this rule was changed26 although CFDA continues to be responsible for the regulatory control of health foods. The revised law stipulates CFDA will promulgate a catalogue of raw materials for health food, including the name, use level and corresponding functions. Health foods that use raw materials outside the catalogue of raw materials for health food or for health food imported for the first time, must register with CFDA. However, vitamin and/or mineral supplements do not need registration. Alternatively, notification with CFDA or provincial FDA is required. Other health foods are required to notify the provincial FDA.
These requirements represent a significant change from the previous registration requirements on individual product basis. Detailed requirements for registration and notification are provided in the Regulations for the Registration and Notification of Health Foods promulgated by CFDA on 26 February 2016,27 which was effective on 1 July 2016. It was expected the catalogue of raw materials for health food will be issued before the end of June 2016.
The Chinese government regards food safety as one of its top priorities. National leaders have made frequent remarks conveying the government's determination to control food safety in China.28, 29 Food safety in China is not only a public health issue, but also a political issue related to social development and social stability. However, China continues to be considered a "developing country." The infrastructure of the agriculture and food industry with small scale and non-standardized operations are still far behind those of the more advanced countries. Food safety issues cannot be changed dramatically until agriculture and food industry production is scaled-up and standardized in China. Further changes in the food safety regulatory framework in China should continue to take into consideration international standards and be reflective of the current state of the agriculture and food industry.
Dr. Junshi Chen has been in nutrition and food safety research for more than 50 years. Since 2011, Chen has been the senior research professor for the China National Centre for Food Safety Risk Assessment. He is the chairperson of the Chinese National Expert Committee for Food Safety Risk Assessment and vice-chairperson of the National Food Safety Standard Reviewing Committee. Internationally, he serves as the chairperson of the Codex Committee on Food Additives (CCFA) and member of the WHO Food Safety Expert Panel. He has played key roles in developing FSMP standards in China, including organizing workshops and draft preparation as well as national expert review. Chen is a graduate of Beijing Medical College. He can be contacted at firstname.lastname@example.org.
Cite as: Chen, J., "China Food Safety Regulatory Framework." Regulatory Focus. August 2016. Regulatory Affairs Professionals Society.
Tags: Food Safety