3.141.  The 13th Five-Year Food Safety Plan (2016–2020) has served as China's main guiding document for the recent reforms of its food safety system. The Plan considered sound food safety governance as a pivotal element for the development of the food industry. As indicated during the previous Review, targeted reform areas included increasing inspections and testing, improving food safety standards and their integration with relevant international standards, upgrading research and testing capacities, and strengthening the enforcement of food safety laws and regulations. The 14th Five-Year Plan for the Modernization of Market Regulation takes the same approach and lays out, among other things, several general pillars to guide the authorities' efforts in improving the food and drug safety system.[215] Throughout the duration of the Plan's implementation, China aims to further enhance the quality and safety supervision across the entire food supply chain through a scientifically grounded approach. This entails prioritizing the alignment of general food safety standards, including those for pesticide residues, veterinary drug residues, heavy metals, food contaminants, and pathogenic microorganisms. Additionally, efforts will focus on advancing and updating fundamental food safety standards, product specifications, labelling requirements, and inspection methodologies essential for industrial development, while also streamlining enforcement mechanisms. Furthermore, there is a commitment to intensify supervision of imported food safety to effectively mitigate risks associated with imported products

3.142.  China's sanitary and phytosanitary (SPS) framework is mainly regulated through the Food Safety Law (2009, last revised in 2021), the Law on Quality and Safety of Agricultural Products (2006, last revised in 2022), the Law on Animal Epidemic Prevention (1997, last revised in 2021), the Law on the Entry and Exit of Animal and Plant Quarantine (1992, last revised in 2009), the Regulations on Plant Quarantine (enacted in 1983, last revised in 2017), the Law on Inspection of Import and Export Commodities (1989, last revised in 2022), and their implementing measures and regulations. The Biosafety Law was adopted in October 2020 and came into effect on 15 April 2021. The law implemented guidelines covering various aspects including preventing and controlling infectious diseases, regulating biotechnology research and applications, ensuring safety and practices in biological laboratories, safeguarding biological and human genetic resources, preventing the spread of invasive species, conserving biodiversity, and taking steps to counter bioterrorism.[216] These primary laws and regulations continue to serve as the basis for the making and enforcement of the country's health standards for produced and traded animal, plant, and food products

3.143.  The institutional framework did not undergo any significant change during the review period. The National Health Commission is responsible for risk assessment, risk surveillance, and the establishment of national standards for food safety. The SAMR's main role in the SPS framework continues to include policy formulation, the emergency response system, investigation of major food safety incidents, and food safety inspections. The Ministry of Agriculture and Rural Affairs (MARA) deals with, inter alia, the safety and quality of agricultural products; early warning in collaboration with relevant international arrangements; and drafting measures administering entry and exit of animals and plants, including quarantine and prohibitions. The GACC is responsible for drafting measures administering entry and exit of animals and plants, including quarantine and prohibitions. It oversees the quarantine and health inspection procedures for the entry and exit of animals, plants, and their products and liaises with MARA to determine and adjust the related catalogues

3.144.  Within the GACC, the SPS Notification and Enquiry Division in the Research Centre for International Inspection and Quarantine Standards and Technical Regulations remains China's WTO SPS Enquiry Point, and the WTO Notification and Enquiry Centre within MOFCOM is its national notification authority.[217]

3.145.  In accordance with the Food Safety Law, all imported food, food additives, and related products must adhere to China's food safety standards. According to the authorities, during the review period, regulations pertaining to food safety standards in China were adopted by the National Health Commission, MARA, and the SAMR. These include the 2021 regulations establishing the Maximum Residue Limits of Pesticides in Foods (GB2763-2021), the 2022 Maximum Residue Limits of 41 Veterinary Drugs in Foods (GB31650.1-2022), and the 2022 Maximum Residue Limits of 112 Pesticides in Foods (GB2763.1‑2022). The authorities note that pursuant to the Food Safety Law, China adopts national food safety standards in accordance with internationally accepted principles. On the safety standards of food, animals, plants, and relevant products, MARA indicated that by end-March 2024, China had cumulatively 13,755 national standards

3.146.  On 12 April 2021, China adopted the Measures for the Administration of Safety of Imported and Exported Food (GACC Announcement No. 249), which entered into force on 1 January 2022. The regulation provides details on the GACC rules on safety inspection and assessment of imported food products and measures to mitigate food safety risks. It also has requirements on labelling of food products (Section 3.3.2.4)

3.147.  The Measures require importers to obtain quarantine clearance from the GACC prior to importation, if they intend to export a new type of food to China, or if the food originates from an entity affected by a notable outbreak of animal or plant disease. This principle is also applicable when the exporting territory experiences substantial alterations to its food safety regulations. In such instances, the Measures empower the GACC to initiate an evaluation of the territory's food safety regulations

3.148.  In cases of high risk, more drastic measures can be taken by the authorities. For instance, if there are food safety incidents in the exporting entity, the GACC might opt, inter alia, to (i) intensify inspections on the relevant imported food, or (ii) suspend or ban imports when the exporting entity is experiencing an epidemic affecting plants and animals, or if there is evidence of imported food contaminated by pathogens. The Measures also outline the procedure for termination and extension of such measures

3.149.  The Measures mandate that all foreign food production companies intending to export food to China are required to register with the GACC. Before the Measures, only manufacturers of meat products, aquatic products, dairy products, and bee products were required to register with the GACC. This system was updated by the Measures, which have repealed the Import and Export Food Safety Measures adopted in 2011, and specific measures on exported and imported honey, aquatic products, meat products, and dairy products.[218] The authorities indicate that the registration system is based on science and risk assessment. It also considers the food safety management situation of different countries/regions

3.150.  In the context of the new registration system, the 2021 Regulations on the Registration and Administration of Overseas Manufacturers of Imported Food outline the specific steps and documentation necessary for this registration process.[219] The GACC divided the registration into two models. The first model, under which manufacturers can be registered by the simplified "self‑application" mode (direct application by the manufacturer), covers most categories of food. In addition, companies that produce certain categories of food are subject to stricter registration requirements and can only register if they are recommended by the authorities of the territory in which they are located.[220] In this case of "official recommended registration" mode, the competent authorities shall inspect their recommended enterprises and submit the relevant inspection materials confirming that such enterprises have met the requirements. Some of China's trading partners have raised concerns about the rationale of imposing these requirements on all food products, irrespective of their risk profiles. Some have also expressed concern over the Measures for being, inter alia, "overly burdensome" and more trade restrictive than necessary.[221] The authorities contend that the GACC has successively issued the interpretation of the Regulations, guidelines, and various supporting documents and forms for registration application. The GACC has also held briefings and training with trading partners, and established a specific contact point for the Regulations

3.151.  The animal and plant health protection framework did not undergo noticeable reforms. The 1997 Law on Animal Epidemic Prevention seeks to administer, prevent, contain, and eradicate the spread of animal diseases, with a view to safeguarding the production and safety of the breeding industry and protecting human health

3.152.  The 2006 Law on Quality and Safety of Agricultural Products administers the safety standards and the supervision and inspection protocols governing agricultural products. It was amended on 2 September 2022, and came into effect on 1 January 2023. The revision aimed to harmonize its provisions with those of the Food Safety Law, in particular with regard to the newly adopted National Food Safety Standard Maximum Residue Limits of Pesticides in Food

3.153.  From April 2021 to March 2024, China notified some 101 SPS measures to the WTO (regular and emergency measures), of which 2 were emergency measures affecting specific Members.[222]

3.154.  In January 2022, notification was made on emergency measures that establish plant quarantine requirements for imports of pinewood (including logs and sawn timbers) from seven entities (Canada, Japan, the Republic of Korea, Mexico, Portugal, Spain, and the United States) suffering from Bursaphelenchus lignicolus.[223] The measures require that pre-export testing be undertaken by the relevant authorities in the exporting country, to ensure log exports are free of Bursaphelenchus lignicolus and fumigated subsequently. Sawn timbers must undergo a heat treatment, and pinewood must enter China enter through designated ports

3.155.  In addition, the emergency notification in the Announcement by the GACC on suspending imports of all aquatic products from Japan was made in 2023.[224] The authorities contend that this is an emergency provisional measure, aiming at seeking to fully guard against the risk of radioactive contamination of food products caused by the discharge of nuclear contaminated water from Fukushima in Japan, as well as protecting the health of consumers. They mentioned they have been actively pursuing further information essential for the assessment, yet the outcomes thus far have not met expectations

3.156.  During the review period, 13 STCs, involving Chinese measures, were raised in the WTO SPS Committee (Table 3.18). Source: WTO SPS Information Management System. Viewed at: http://spsims.wto.org

3.157.  Inspections for the purposes of SPS measures, including quarantine procedures, remained broadly unchanged during the review period. The GACC is in charge of entry/exit inspection as well as administering quarantine. In accordance with the Law on Entry and Exit Animal and Plant Quarantine, the Law on Import and Export Commodity Inspection, and their Implementation Regulations, the Catalogue of Entry-Exit Commodities Subject to Inspection and Quarantine sets out the list of animals, plants, and related products subject to inspection and quarantine upon entry, exit, or transit through China. The latest revision of the Catalogue was made through GACC Announcement No. 79, 2022. Inspection and quarantine can also be required for some products not listed in the Catalogue but found to carry unexpected issues of concern

3.158.  For imports subject to quarantine, importers must submit their application, together with relevant documents, to the GACC. The GACC is mandated to issue a quarantine permit or notify refusal within 20 working days of receipt. By law, large or medium-sized breeding animals shall be subject to quarantine in animal isolation facilities for 45 days; incoming aquatic animals intended for breeding, cultivation, and ornamental purposes shall undergo a mandatory quarantine for at least 14 days in designated quarantine facilities; and other import animals shall be subject to quarantine for 30 days. If items subject to quarantine fail to pass the quarantine inspection, the GACC will issue a Quarantine Treatment Notice and inform the owner or their representative to carry out necessary treatments such as disinfection

3.159.  According to the authorities, since 2021, 22.74% of large and medium-sized animals failed pre-inspection upon arrival. Appeals can be made in accordance with relevant laws and regulations

3.160.  Exports of animals, plants, and their products listed in the Catalogue must also adhere to the quarantine regulations. Exporters are required to seek quarantine approval from the GACC at the designated port of export prior to shipping the goods

3.161.  In principle, as per the Implementing Regulations for the Law on Inspection of Import and Export Commodity, importers have the option to request re-inspection within seven days of receiving the inspection report if they disagree with the findings

3.162.  Animals, plants, and their products also require sanitary or phytosanitary certificates from the relevant authority of the exporting country or region (except as otherwise provided)

3.163.  In April 2023, MARA released the Detailed Rules for the Review of Gene-edited Plants for Agricultural Purposes (Trial Edition) to guide the safety assessment procedures and support research organizations undertaking R&D. The Rules specify the standards of classification and the content of review for gene-edited plants. For gene-edited plants that do not contain exogenous genes, if the data obtained from tests indicate that the plants will not pose an environmental safety risk, the safety certificates necessary for the production of genetically modified plants can be directly applied

3.114.  The Standardization Law (1988), amended in 2018, and the Regulations for the Implementation of the Standardization Law (1990) constitute China's main legislation on standards. The Standardization Law lays out the process of formulating and implementing standards. These aim to enhance the quality of products and services; promote scientific and technological progress; ensure human health, security, and property; safeguard national and eco‑environmental security; and raise the overall level of economic and social development.[193]

3.115.  The SAMR, established in 2018, is responsible for standards development and for law enforcement and market supervision related to product quality, food safety, measurement, certification, accreditation, and standards. Under the SAMR, the Standardization Administration of China (SAC) is responsible for unified supervision and overall coordination of standardization work, and it also represents China in international standardization organizations. The China National Certification and Accreditation Administration (CNCA) is responsible for unified governing, supervision, and coordination of certification, accreditation, inspection, and testing in the field of conformity assessment; it represents China in international conformity assessment organizations. It is also in charge of the implementation and supervision of the China Compulsory Certificate (CCC) scheme

3.116.  New standards-related rules promulgated by the SAMR during the review period include revised Measures on the Administration of National Standards (entry into force 1 March 2023), revised Measures on the Administration of Sector Standards (expected entry into force 1 June 2024), and Measures on the Management of Agricultural and Rural Standardization (expected entry into force 1 July 2024)

3.117.  In October 2021, the CPC Central Committee and the State Council issued the National Standardization Development Outline; an action plan for its implementation was issued in July 2022. The Outline establishes "four transformations" on standardization as the goal to be achieved by 2025: (i) equal emphasis on the government and the market; (ii) application to the whole economy and society; (iii) standards mutually promoted by domestic and international perspectives; and (iv) quality and efficiency.[194]

3.118.  Based on the Outline, the SAC issued National Standard Project Guidelines in 2022 and 2023, requiring and encouraging the central and subcentral governments and industry associations to work on standards setting.[195] The objectives of the 2023 National Standard Project Guidelines are to promote the development of standardization; strengthen the transformation of scientific and technological outcomes; promote the convergence of standards along the industrial production chain; advance the opening to international standards and systems; and strengthen the effective supply of domestic standards.[196] Major objectives for 2025 include a 50% target for the proportion of standards-related research results in key technologies, and a conversion rate of 85% of international into national standards

3.119.  The China Standards 2035 plan lays out a blueprint for the Government and leading technology companies to set global standards for emerging technologies like 5G Internet, the Internet of Things, and artificial intelligence (AI). It will work in concert with China's other industrial policies – namely Made in China 2025 – as a tool to help China become a global leader in high-tech innovation

3.120.  China is a member of various international organizations related to standards, such as the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and the International Telecommunication Union (ITU)

3.121.  The authorities indicate that China has been increasingly active in setting global standards for emerging technologies.[197] The key areas of China's standardization research include AI, quantum information, biotechnology, high-speed railways, NEVs, intelligent networked vehicles, and robots.[198]

3.122.  The Standardization Law classifies China's standards into five categories: national, sector, local, association, and enterprise. The national standards include voluntary and mandatory standards; sector and local standards are voluntary

3.123.  As at January 2024, there were 44,332 national standards (2,023 mandatory and 42,309 voluntary), and 601 guiding technical documents.[199] Between 2,000 and 3,000 national standards are adopted every year (Table 3.17). The authorities indicate that over 80% of national standards are aligned to international standards. In key-equipment manufacturing and new-generation information technology, the international standards conversion rate has exceeded 90%; for the standards of key consumer products, the level of consistency with international standards has risen to 95%

3.124.  China adopted a wide variety of new sector- and product-based national standards during the review period. New mandatory standards adopted concerned feed additives, oil tankers, medical electrical equipment, energy consumption, and pollution control. New voluntary standards were adopted on biometric data interchange formats, information security technology, and formats for additive manufacturing. During the review period, China increasingly developed standards related to digitalization and new technology. The authorities indicate that, for example, China adopted more than 10 new standards related to smart cities

3.125.  The Research Center for International Inspection and Quarantine Standards and Technical Regulations under the GACC is China's TBT Enquiry Point and responsible for submitting TBT notifications

3.126.  Between January 2021 and February 2024, China submitted 315 TBT notifications, mostly under Article 2.9 of the TBT Agreement.[200] The majority of the technical regulations notified aim to protect human health and safety, ensure quality requirements, or prevent deceptive practices towards consumers

3.127.  Between January 2021 and February 2024, a total of 21 TBT-related specific trade concerns (STCs) were raised by other Members against China. Eight of these STCs were newly raised.[201]

3.128.  Between January 2021 and February 2024, China raised 65 TBT-related STCs against other Members

3.129.  No major changes have taken place in the legislation and institutional design governing China's certification system. China administers both compulsory and voluntary certification systems, the latter related to management, services, and organic and green products. The compulsory product certification system applies to both domestic products and imports, based on national mandatory standards. According to the SAMR, as of March 2024, 3.824 million certifications have been issued, mainly in the Guangdong, Jiangsu, and Zhejiang provinces

3.130.  In September 2022, the SAMR released its 14th Five‑Year Plan for the development of certification, accreditation, inspection, and testing. The Plan contains several tasks related to enhancement of industrial capacity, promotion of industrial and supply chain modernization, manufacturing optimization and upgrading, and enhancement of international cooperation

3.131.  The CNCA is responsible for product certification. Certification and accreditation are regulated by the Product Quality Law, the Import and Export Commodity Inspection Law, and the Regulation on Certification and Accreditation (amended in November 2020), as well as various measures such as Measures for the Administration of Certificate Bodies (amended in November 2020), and the Measures for the Administration of Certification Certificates and Certification Marks. Since June 2022, the China National Accreditation Service for Conformity Assessment (CNAS) offers a new category of accreditation services, for approval and verification purposes. The CNCA has authorized 34 accredited bodies, including 22 accredited certification bodies, 2 accredited Validation and Verification Bodies, 9 accredited laboratories, and 1 inspection body.[202]

3.132.  Regulations on the Administration of Compulsory Product Certification and the Measures for the Administration of Compulsory Product Certification Bodies, Inspection Bodies and Laboratories, both amended in 2022, govern China's compulsory certification system and clarify the duties of regulators.[203] The 2022 amendments reflect the shift in responsibility to the SAMR in 2021, without containing any substantial change

3.133.  The purpose of China's compulsory certification system is to protect national security, prevent fraudulent acts, protect human health or safety, protect animal and plant life or health, and protect the environment.[204] Under the system, the relevant domestic products and imports must be certified and marked with the CCC certification before sale. The products subject to compulsory product certification are listed in the Compulsory Product Certification Catalogue (CCC Catalogue), which was last renewed in 2023.[205] There are two types of assessments: third-party assessment and self-declaration. The CCC Catalogue lists 96 products including electronic equipment, machinery, and automobiles; self-declaration is possible for 19 products

3.134.  Several laws and regulations establish labelling and packaging rules, mainly on food, drugs, cosmetics, and medical devices. The National Health Commission is responsible for food label standards, while the National Medical Products Administration (NMPA) under the SAMR is responsible for regulations on drugs, cosmetics, and medical devices

3.135.  The Food Safety Law requires domestic and imported pre-packaged food and food additives to have labels in Chinese containing information such as the date of production, ingredients, the name of the producer, and the origin of the food. Prepacked food without correct Chinese labels may not be imported.[206] The Regulations on the Implementation of the Food Safety Law reiterate this requirement.[207] In addition, various rules provide additional details on food labelling and packaging, including the National Safety Standard General Rules for the Nutrition Labelling of Pre-packaged Foods (GB28050-2011), the National Food Safety Standard General Rules for the Labelling of Pre-packaged Foods (GB7718-2011), and the National Food Safety Standard General Rules for Labelling of Pre-packaged Foods for Special Dietary Uses (GB13432-2013)

3.136.  Labelling and packaging requirements for drugs and cosmetics are laid out in the Drug Administration Law, the Regulation for the Implementation of the Drug Administration, the Pharmaceutical Administration Law, the Product Quality Law, and the Regulations on the Supervision and Administration of Cosmetics

3.137.  During the review period, several changes and updates took place, especially on label defects. Regarding food labelling, the Measures of Supervision, Inspection and Administration of Food Production and Operation came into effect in March 2022, clarifying the authority and the criteria for defects in labels.[208] The Measures of Import and Export Food Safety effective from January 2022 require the Chinese label of imported health food and food for special dietary used to be printed on the smallest package.[209]

3.138.  The National Food Safety Standard General Rules for the Labelling of Pre-packaged Foods (GB7718-2011) are currently under revision, involving the following changes: requirements for digital and quantitative labelling, and labelling of dates and of allergens in food

3.139.  In May 2021, the MNPA issued the Administrative Measures on Cosmetic Labelling, which requires cosmetic producers to update labelling by May 2023.[210] According to policy interpretation, it aims to unify the previous regulations and standards and to effectively address false and exaggerated claims. The main contents include the definition of cosmetic labels, details of requirements, prohibited label content, and specific circumstances of label defects.[211] In response, some Members raised an STC on the measure.[212]

3.140.  In addition, the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics came into effect in January 2022; Articles 35-37 clarify the circumstances of label defects.[213] The Provisions for Supervision and Administration of Online Drug Sales, effective since December 2022, regulate online sales of prescription drugs and prohibit the display of the label and the package of prescription drug on the main web page.[214]