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China Food and Food Packaging Law
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Year in Review 2017
Zai Jian Rooster, Ni Hao Dog: Keller and Heckman's Year in Review of China's
Food and Food Packaging Laws
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As China finishes celebrating the beginning of 2018 and says "zai jian" to the Year of the Rooster and "ni hao" to the Year of the Dog, it's a perfect time, from a regulatory perspective, to reflect on what we have seen in 2017 on China's food and food packaging laws and where we see things heading in 2018. From the outset, we can say that, in 2017, we saw a clear continuation of the country's shaping of its food regulatory system and, in 2018, we anticipate that food safety will remain a top priority. This was made clear when, in July 2017, China's State Council's Office, the highest administrative body, published the National Nutrition Plan (2017-2030)[1], a long-term plan aimed to further enhance public health and food safety by developing seven implementing strategies and six action items, including, improving the regulatory system, strengthening food safety assessment and supervision, and advancing nutrition for infants, elderly people, and those in less developed regions.
In Part I below, we first look at the food side and then in Part II, we turn our attention to the food packaging side.
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To Contact
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The Bund Center
Suite 3604
222 Yan'an Dong Lu
Shanghai 200002
P.R. China
Phone: +86 21 6335 1000
Fax: +86 21 6335 1618
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published this year per the government's 2018 legislative plan.[2]
With the promulgation of the new regulations for health foods in 2016, and further details regarding the new notification system for certain health foods (e.g., vitamins/minerals) becoming available in 2017, we are likely to see further clarification in 2018 as more and more health products are entering the marketplace. I
n 2017 the government also started its amendment on the most important food safety national standards per its legislative agenda for food standards, including standards pertaining to food additives, general food labeling, and nutrition labeling.[3] In 2018, some government agencies are likely to be restructured and their responsibilities reassigned per the 13th Five-year Plan for Market Supervision.
We summarize below some of the important regulatory changes that took place in 2017 and discuss our outlook on what we can expect in 2018.
Mandatory National Food Safety Standards regarding food additives and food labeling were under revision in 2017; however, many have not yet been finalized.[4] A revised draft standard for the use of food additives in food (GB 2760)[5] was released in December 2017, which was reported in our
CRM article last month where we outlined some "flavorful and unflavorful changes" impacting the food industry. Further, GB 7718 for prepackaged labeling and GB 28050 for nutrition labeling are in the process of being amended. Revised drafts of these two standards are expected to be made available in 2018 for industry to review and comment.
Under the revised nutrition labeling standard, w
e anticipate that
more nutrients such as sugars, vitamin A, calcium and saturated fat will be subject to declaration in the nutrition information panel, and that new rules regarding serving size for different food categories may be developed.
Also, allergen labeling likely will become mandatory in line with the draft Implementing Regulation of the FSL.[6] Undoubtedly, the further development and amendment of various food safety standards will remain the focus of the Chinese food authorities in 2018 and beyond.
Voluntary Food Standards have surfaced to cope with the standard-oriented food regulatory system in China. The promulgation of the Law on Standardization in 2017,[7] for the first time, defines "Group Standard," a new type of industry-developed voluntary standard. The food industry has actively responded to this development. For instance, the China Food Industry Association has drafted two Group Standards, i.e., the
General Guideline for Food Shelf Life (T00/CNFIA 001-2017) and the
Standard for Foods with Coloring Properties (T00/CNFIA 101-2017).[8] Both standards entered into force on January 1, 2018. However, given these are industry-driven and voluntary in nature, with no reference in the Food Safety Law, it remains to be seen whether these standards will be accepted by the local enforcement agencies.
Genetically Modified Organisms (GMO) Regulations with respect to government responsibility were amended in 2017. Specifically, the Agricultural GMO Safety Committee ("Committee") of the State Council was empowered to conduct a safety evaluation both after the application and before the issuance of certificates. The Agricultural Administrative Department under the State Council and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)'s subsidiaries - CIQs at local ports - will take the lead on the GMO issues during the import and export processes. To change the status quo, the National Health and Family Planning Commission (NHFPC) and Ministry of Agriculture (MOA) met in 2017 to discuss relevant issues and clarified the approval process for GM-derived enzymes for food use. Guidance documents to address the petition procedure are expected to be published soon; we anticipate this will help clarify the situation and jump start the GM clearance process in 2018 and beyond.
Professional Consumers continued to be very active in 2017. "Professional Consumer" is a term used to describe individuals or groups of individuals whose sole aim is to seek profit based on alleged non-compliance of a food product, by purchasing foods and then pursuing compensation by going after food companies and claiming damages under the FSL. Courts and administrative agencies have started to take a more critical look at the "professional consumer" to avoid the use of the FSL for profit-making purposes, by taking steps to ensure there is a better balance between consumer protection and food safety. Notably, in January 2018, the Shenzhen Special Economic Zone published its Food Safety Supervision Rules[9] to only protect good-faith bona fide consumers who purchase foods for daily consumption; this establishes a viable legal basis for companies doing business in Shenzhen to seek to exclude a claim brought by a professional consumer when it can be proven the purchase was made merely to seek a profit. More background about professional consumers may be found in our prior CRM Alert- Handling Professional Consumers A New Challenge to Doing Business in China.
Imported Foods are going to face certification requirements according to the draft
Measures for the Administration of Certificates Attached to Foods Exported to China[10], which has been notified to the World Trade Organization (WTO) in June of last year. The Measures specify that foods exported to China must be accompanied with an official certificate issued by a competent authority in the exporting country/region confirming that the food is manufactured under proper government supervision and is suitable for human consumption. Under the proposed measures, there is no distinction between high risk and low risk foods, and thus, most exported foods will need to have accompanying certificates.
Various trade partners with China have sent comments to Beijing opposing the requirements or requesting modifications as such certificate requirement is not consistent with the risk-based food management principle set forth in the FSL. (Please see our prior CRM Alert-
AQSIQ Gives Food Industry Two-Tear Extension on Imported Foods Certification Requirement) To give more time to the industry for their full cooperation, the Chinese government postponed its enforcement of this certification requirement until September 30, 2019. We will certainly watch this issue closely, as it will remain problematic if adopted in its present form.
Chinese Food Importers/Agents
play more and more of a role in ensuring food safety. On September 13, 2017, China notified the WTO of its
Draft Measures for the Supervision and Administration of Food Safety for Import and Export Foods
("Draft Measures"),[11] which mandates that Chinese food importers vet foreign food manufacturers to make sure that the manufacturers control food safety risk and ensure compliance with China's legal requirements. In other words, companies that export food to China are likely to face more scrutiny from their Chinese partners
who
bear the obligation to perform various food safety verification measures under the Draft Measures. Both foreign food manufacturers and Chinese importers who fail to comply with the laws and regulations will be put on AQSIQ's black list[12], and subject to additional measures for future imports. A noteworthy point regarding imports is that, in 2017, after a 14-year prohibition, China reopened the door to US beef.
Labeling of Imported Prepackaged Foods will be strictly scrutinized, not only during the import process, but also during post-market surveillance. On December 12, 2017, AQSIQ notified the WTO of its Administrative Measures on Labeling Inspection of Imported Foods ("Administrative Measures"),[13] which states that, when the labeling of an imported food fails to comply with China's legal requirements, the food should be recalled per Article 63 of the FSL.[14]
Health Food
notification system for vitamins and minerals was implemented in 2017. Hundreds of nutrient supplements have passed the notification process after the release of guidance documents by CFDA, which detail the notification requirements, including the
Inventory of Ingredients for Health Foods
,
Inventory of Health Functions Permissible for Health Foods
,[15]
Working Guidance for Health Food Notification
,[16]
Excipients May Be Used in the Health Foods Subject to Notification and their Usage Rules
,
Major Manufacturing Processes for Health Foods Subject to Notification
[17
]
, and CFDA's
Announcement of Launching Online System for Formula (Recipe) of Health Foods Subject to Notification
[18]. The new notification system is believed to boost and promote the development of the health food industry in China, as the industry has long complained about the lengthy process to obtain registration for health foods.
However, the notification system at the current stage targets limited products, like vitamins and minerals, which does not necessarily benefit other types of health foods, such as plant-derived extracts.
Infant and Young Children Formula milk powder products, starting in 2017, are subject to formula registration. CFDA published S
ervice Guideline for the Registration Approval of Infant and Young Children Formula Milk Powder Products[19]and the
Application Materials and Requirements for the Registration of Infant and Young Children Formula[20]. By January 23, 2018, CFDA has approved 1040 infant formula milk powder products from 139 enterprises.[21] In the meantime, formulated foods for infants and young children other than milk powder products (e.g., soybean or soy protein based) will be subject to a separate notification mechanism as proposed in CFDA's draft
Management Measures for the Notification of Infant Formula Food[22], which were released for comments in January 2018. In this notification, manufacturers are expected to report product information (e.g., product formula development report, raw materials and food additives, products labels, etc.) to the food and drug administrators at the provincial level for recordkeeping purposes.
Foods for Special Medical Purposes (FSMP) are subject to strict regulatory scrutiny. To guide the industry in the mandatory registration required by the registration regulations for FSMP in 2016[23], CFDA published
Registration and Approval Guideline for FSMP[24] and
Application Materials and Requirements for FSMP Registration.[25] It should be noted that the deadline for FSMP registration has been extended to the end of 2018.[26]
Cross-border E-commerce (CBEC) policy implementation has been further postponed until the end of 2018 so that industry has an additional year to prepare for the upcoming regulatory requirements.[27] During the transitional period, food products like dietary supplements, may be imported via CBEC without pre-market clearance like those imported in traditional trade. The recipe of infant formula milk powder, however, must be registered with CFDA prior to its importation to China starting January 1, 2018 (Please see detailed information in our prior CRM Alert-
Regulatory Landscape of Cross-Border E-Commerce in China Enters a New Spring). Since the transitional period is set to expire at the end of 2018, industry should watch closely for further policy and guidance from Beijing. We anticipate more regulations are likely to be put in place to ensure safety of foods sold online.
II.
Food Packaging Laws
Many revised Food Packaging Standards went into effect in 2017, including:
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Standard No.
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National Food Safety Standard Scope
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GB 9685-2016
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Uses of Additives in Food-contact Materials and Articles
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GB 4806.1-2016
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General Safety Requirements for Food-contact Materials and Articles
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GB 4806.6-2016
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Food-contact Use Plastic Resins
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GB 4806.7-2016
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Food-contact Use Plastic Materials and Articles
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GB 4806.8-2016
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Food-contact Use Paper, Paperboard and Paper Articles
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GB 4806.9-2016
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Food-contact Use Metal Materials and Articles
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GB 4806.10-2016
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Food-contact Use Coatings and Coating Layers
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GB 4806.11-2016
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Food-contact Use Rubber Materials and Articles
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For more details, please refer to previous Keller and Heckman China Regulatory Matters (CRM) newsletters.[28] A new Guideline Book was issued on June 1, 2017 by China's National Center for Food Safety Risk Assessment (CFSA) on the implementation of GB 9685-2016 ("Implementation Guidance"). The Implementation Guidance includes discussions on the background, principles, and history of the
revision process leading to the current GB 9685 Standard, as well as interpretations of each section of the GB 9685-2016 Standard.[29]
Functional Barrier Concept was formally adopted in GB 4806.1-2016, which is consistent with that of the EU Plastics Regulation. In particular, substances that are not in direct contact with food, and are separated from food by a functional barrier, may be used provided that the amount migrating to food does not exceed 0.01 mg/kg. The functional barrier doctrine does not, however, apply to substances that are carcinogenic, mutagenic, reproductive toxins (CMR) or nano substances. The introduction of the functional barrier provides industry with a very useful vehicle such that industry may lawfully use unapproved substances without obtaining premarket approval, provided that all the requirements for the functional barrier under GB 4806.1-2016 are met. Of course, analysis based on the functional barrier concept must be made on a case-by-case basis.
Declaration of Compliance (DoC) becomes a new requirement for industry. The DoC requirement is discussed generally in GB 4806.1-2016, which states the DoC shall
include the laws, regulations and standards that are followed, list of restricted substances and the restrictions, and total migration level compliance (only for the formed articles), etc. Such provisions, however, are not very instructive and lack clear guidance for industry to follow. We note that, in this respect, it is essential to keep in mind that the goal of providing the DoC is to ensure that there is sufficient information to conduct a safety assessment on the food contact materials and articles; each individual product may require a separate analysis to ensure that the statutory requirements are satisfied and the goal is achieved.
Looking toward 2018, the development of GB food packaging standards will continue to be one of the focuses of the Chinese authorities. Standards that are expected to be finalized in 2018 include the adhesives standard and the composite materials/articles standard. These two long-awaited standards will fill in the gaps and serve as statutory sources industry can rely on when marketing these materials. Some other standards have been listed on plans for amendments, including GB 4806.7-2016 on plastic articles and GB 4806.8-2016 on paper and paperboard.
******
Should you have any questions regarding the above or compliance with China's food and food packaging regulations, please do not hesitate to contact David Ettinger (
ettinger@khlaw.com), Jenny Li (
li@khlaw.com), Yin Dai (
dai@khlaw.com), or Eric Gu (
gue@khlaw.com) at Keller and Heckman's Shanghai Representative Office, or your ordinary contact at Keller and Heckman LLP.
[2]
国家食品药品监督管理总局
2018年立法计划
[4]
Such as GB10765- Infant Formula Food, GB 10767- Formula Food for Older Infant and Young Children; GB25596- Infant Formula Food for Special Medical Purposes; GB29922- Food for Special Medical Purposes.
[14]
Non-compliant food that is recalled due to defects with its product labeling or instruction manual can be sold once the defects are mitigated, provided the product safety is assured and the mitigation measure that has been taken is declared.
[15]
CFDA
关于发布《保健食品原料目录（一）》和《允许保健食品声称的保健功能目录（一）》的公告
[16]
CFDA
关于印发保健食品备案工作指南（试行）的通知
[17]
CFDA
关于印发《保健食品备案产品可用辅料及其使用规定（试行）》《保健食品备案产品主要生产工艺（试行）》的通知
食药监特食管
[2017]36
号
[19]
婴幼儿配方乳粉产品配方注册审批服务指南
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"China Regulatory Matters" (CRM) is an e-newsletter prepared by the Shanghai Office of Keller and Heckman LLP. CRM is intended to update you in a timely manner on any significant Chinese regulatory changes in the areas of food, food packaging, cosmetics, environmental, and chemical control.
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Shanghai Office
Keller and Heckman LLP established an office in Shanghai to meet the rising demand for global regulatory advice from companies operating in Asia. By combining a thorough understanding of trade and regulatory policymaking with expertise on the region's diverse laws and regulations, we assist clients in developing global best practices and meeting regulatory requirements to market their products throughout Asia. For more information,
click here.
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