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China: Dairy Product Quality and Safety Regulations

(Nov. 3, 2008) On October 9, 2008, and effective the same day, China State Council issued Regulations on Supervision and Administration of Dairy Product Quality and Safety (Dairy Product Regulations). The new provisions come in the wake of China's “milk scandal,” in which widespread illness and some infant deaths from kidney stones resulted from contaminated infant formula. Melamine, an industrial chemical used as a filler to mimic a higher protein level, but lacking in nutritional value had been added to the products. Public exposure of the scandal resulted in the issuance in September and October of tighter controls on milk and milk products through a series of circulars issued by various government ministries. The first round of new measures covered such matters as a new limit of a one-milligram maximum of melamine per kilogram of infant formula, stipulation of market inspections for liquid milk with melamine content, repair of the milk product market distribution chain, foodstuff safety for children, clinical treatment of kidney stones in infants, and financial support for the milk industry.(Crisis Management Helps China's Dairy Industry Recover, XINHUA, Sept. 25, 2008, available at; Yu Le, China Milk Victims May Have Reached 94,000, REUTERS AFRICA, Oct. 8, 2008, available at; Chinese Eggs Tainted with Excessive Melamine, MSNBC, Oct. 26, 2008, available at

The 64 provisions of the October Dairy Product Regulations “tighten control of how milk-yielding animals are bred, how raw milk is purchased and the production and sales of dairy food,” and also impose heavier punishments on violators of safety standards and on quality control departments that do not carry out their duties. (China Sets New Standards for Dairy Industry, XINHUA, Oct. 10, 2008, available at The Regulations clearly state that those who raise and breed milch livestock, those who procure raw milk, and manufacturers and sellers of dairy products bear the primary responsibility for dairy product quality and safety (art. 3), while the local government above the county level is generally liable for the supervision and management of diary products' quality and safety within its administrative region (art. 4, para. 1).When an accident involving dairy product quality and safety occurs, it is to be reported promptly and handled in accordance with relevant laws and administrative regulations; where there are serious consequences or adverse influences, the liability of responsible persons of the relevant government or department will be pursued according to law (art. 5). (Ru pin zhiliang anquan jiandu guanli tiaoli [Regulations on supervision and administration of dairy product quality and safety], National People's Congress official website, Oct. 10, 2008, available at Some other highlights of the Dairy Product Regulations are:

Prohibitions Against Additives

The Dairy Product Regulations forbid the adding of any substance during the production, purchase, storage, transport, or sale of raw milk. In processing milk products, including infant formula non-food chemical substances or other substances that are possibly harmful to human health may not be added (art. 6, para. 4, & art. 7). Th

ey also ban the use, by those who raise and breed milch livestock, of any feed, feed additives, veterinary drugs, or other substances “directly or potentially harmful to animal and human health whose use is banned by the state” (art. 14, para. 1).

Health authorities under the State Council are charged with formulating national quality and safety standards for raw milk and milk products, and with their timely revision on the basis of risk monitoring and assessment. The standards should include, among other features, restrictions on the amounts in milk products of pathogenic microorganisms, pesticide residue, veterinary drug residue, heavy metals, and other hazardous substances in dairy products. In addition, there should be standard health requirements for the milk product production process, universally used methods and rules for milk product testing, and quality requirements for milk product safety (art. 6, paras. 1-3).

New hygiene requirements stipulate that raw milk, supplements, and additives used in making products should conform to the national standards for milk product quality and safety. Furthermore, processed milk products should undergo pasteurization, high-temperature sterilization, ultra-high sterilization, or other effective sterilization methods; production of bacteria for fermentation purposes should be unadulterated and regularly evaluated to prevent bacterial pollution (art. 6, paras. 1-3). The Dairy Product Regulations also forbid the sale of raw milk beyond its stipulated shelf-life (art. 14, para. 2).


Raw milk purchasing centers must obtain licenses, issued by the local government's domestic animal veterinary medicine department, through meeting certain listed conditions. Dairy product producers are prohibited from purchasing raw milk from unlicensed work units and individuals. The raw milk purchasing centers must be operated by dairy product producers, milch livestock raising and breeding farms, or milk farm cooperatives; no other entities or individuals may operate the centers or purchase raw milk (art. 20, paras. 1 & 3). Those who engage in dairy product production activities must meet certain stipulated conditions and obtain a foodstuff production license (art. 28, para. 1).

Supervision and Inspection

The Dairy Product Regulations state that the various departments concerned are to strengthen supervision and inspection of milk product quality and safety. Moreover, the departments of animal husbandry veterinary medicine, quality supervision, and industry and commerce administration are to conduct supervisory spot checks at regular intervals. Those who conduct sample testing of milk products are prohibited from collecting any fees; the necessary expenses are to be paid by the government financial authority concerned (art. 46).

Penal Provisions

Raw milk purchasers and dairy product producers that add non-foodstuff chemical substances or other substances potentially harmful to human health to the raw milk or dairy product in such a way as to constitute a crime under China's Criminal Law (art. 144) will be pursued for criminal liability and have their licenses revoked; if such acts do not constitute a crime, the perpetrators will face confiscation of the illegal proceeds and products and related tools and equipment, a fine, and license revocation (art. 54) The same types of punishments apply to producers or sellers of dairy products that do not conform to national standards of dairy product quality and safety, except that criminal liability will pursued in accordance with article 143 of the Criminal Law (art. 55).

Heavier punishments for violators of the Dairy Product Regulations are to be applied to infant milk powder producers who add chemical substances not for use in foodstuffs or other substances potentially harmful to human health, and to infant milk powder producers or sellers whose products have insufficient nutritional ingredients and which are not in conformity with the national standards of dairy product quality and safety (art. 58). Administrative penalties are
set forth for breeders of milch livestock, raw milk purchasers, and dairy product producers who fail to report and handle food quality and safety accidents after they occur; if their acts constitute a crime, they will be subject to criminal liability (art. 59).

Responsible officials of the departments of veterinary medicine, health, quality supervision, and industrial and commercial administration who do not carry out their official duties as stipulated under the Dairy Product Regulations, resulting in repercussions, or who abuse their official authority will be blacklisted or demoted, or, where serious consequences result, removed from their official duties or expelled from office. If their acts constitute a crime, they will be pursued for criminal liability (art. 62).

Since the issuance of the Dairy Product Regulations, the central government has published the National Standard on Instant Detection of Melamine, on October 15 (National Standard on Instant Detection of Melamine Issued, General Administration of Quality Inspection, Supervision and Quarantine [GAQISQ] website, Oct. 17, 2008, On October 13, dairy producers were ordered to test all dairy products produced before September 14, in accordance with the temporary restrictions on melamine levels; on October 11, the government “ordered all supermarkets, shops and grocery stores nationwide to immediately take off shelves and stop selling all milk powder and liquid milk produced before Sept. 14.” (Notice Issued to Recall and Test Dairy Products Produced Before Sept. 14, GAQISQ website, Oct. 17, 2008, available at

In addition, Premier Wen Jiabao announced on October 25, 2008, that China will improve its food safety. Attributing the milk scandal to a failure of regulation, Wen pledged that the scandal “will spur the introduction of China's first major food safety law and that China's food exports will meet international standards.” The Premier emphasized: “[i]n every link and every process, we need to put in place effective and powerful regulatory measures.” (China Says It Will Improve Food Safety, AP, Oct. 25, 2008, available at

Others contend, however, that the problem might not be the lack of regulations, but a surfeit of them; while the existing laws cover the main aspects of food safety, there is a failure to enforce them at the central and the local levels, and there may also be too many authorities involved. (Mark Schaub, Milk Mayhem – China Food Safety System in Flux, CHINA LAW INSIGHT, Sept. 26, 2008, available at In the view of World Health Organization official Jorgen Schlundt, the food safety system in China is “disjointed,” and “poor communications between dispersed ministries and agencies may have prolonged the outbreak of melamine poisoning.” (China Reviews Tougher Food Safety Laws amid UN Criticism, TIMETURK, Oct. 23, 2008, available at
.) Another complicating factor in the milk scandal seemed to be that the GAQSIQ, which oversees product quality in China, gave inspection-free status to a number of the country's large dairy companies. The GAQSIQ cancelled this exemption-from-inspection system on September 18, 2008. (Schaub, supra.)