Product Recall Laws in China
Xiangwen Liu
Partner
King & Wood PRC Lawyers
Public Database for Product Recall
Xiangwen LiuKing & Wood PRC Lawyers | 2011
I. Legal Framework of Product Recall
General laws and regulations applicable to all products
The Law of PRC on Protection of Consumers’ Rights and Interests (1993)
Article 18: “Business operators shall, upon discovery of serious defects of the commodities or services they supply which are likely to harm personal or property safety even though the commodities are appropriately applied or services are received in a correct way, immediately report to the administrative departments concerned and inform the consumers, and adopt measures to prevent from damage.”
I. Legal Framework of Product Recall
General laws and regulations applicable to all products
The Tort Law of PRC (2009)
Article 46: “Where a product is found to be defective after it is put into circulation, the manufacturer and the seller shall give timely warnings, recall the defective product, or take other remedial measures. If any damage is caused due to failing to take remedial measures in time or the ineffectiveness of the said measures, the manufacturer and the seller shall bear tort liability.”
I. Legal Framework of Product Recall
General laws and regulations applicable to all products
Special Provisions of the PRC State Council on Strengthening Safety Supervision and Administration of Food and Other Products (2007)
Article 9: “When finding potential safety risk in products that may cause injury to human health and life safety, manufacturers shall publicize relevant information to the society, notify sellers to stop the sales, notify consumers to cease using the products, recall the products actively and report the relevant information to the regulatory authorities concerned. Sellers shall cease to sell the products immediately. When finding potential safety risk in products that may cause injury to human health and life safety, sellers marketing such products shall cease to sell the products immediately, notify manufacturing enterprises or suppliers and report the relevant information to the regulatory authorities concerned.”
I. Legal Framework of Product Recall
Specific regulations concerning particular products
Provisions on the Administration of the Recall of Defective Auto Products (adopted jointly by AQSIQ, State Development and Reform Commission, Ministry of Commerce and
General Administration of Customs in March 2004)
Food Safety Law (Article 53 on establishment of national recall system for food) (adopted by NPC in Feb. 2009) Provisions on the Administration of the Recall of Food (adopted by AQSIQ in July 2007)
Provisions on the Administration of the Recall of Toys (adopted by AQSIQ in Aug. 2007)
Measures for the Administration of the Recall of Drugs (adopted by State Food and Drug Administration in Dec. 2007)
Measures on the Administration of the Recall of Medical Devices (adopted by Ministry of Health in May 2011)
II. Administrative Authorities
State Food and Drug Administration
General Administration of Quality Supervision,
Inspection and Quarantine
III. Reporting Obligations
According to relevant recall laws and regulations, the manufacturer or the distributor shall notify the administrative authority immediately, if it obtains any safety hazards-related information which reasonably supports that the product is defective and unsafe.
Such information includes but not limited to: product injury accidents; claims or complaints from consumers; recall of the same product in other countries.
The report can be made online or in written.
IV. General Recall Procedures
The detailed procedures vary with different products or industries involved, but generally speaking, the recall procedures in China can be divided into three phases:
Phase One: Defect Investigation
The following circumstances may be deemed as product defects under PRC Laws:
irrational dangers with identical characteristics that widely exist in a certain batch, type or class of products due to design and manufacture, which may endanger the safety of the person or property;
non-compliance with relevant national safety standards; lack of clear and complete warning or indications on product labels or
instructions, which may endanger the safety of the person or property;
IV. General Recall Procedures
Phase Two : Voluntary or Compulsory Recall The manufacturer may recall the defective products voluntarily upon confirmation of
the defects. The administrative authority may issue a notice of compulsory recall under the
following circumstances: the manufacturer internally conceal food safety hazards or refuses to recall the
defective products; the defect is detected and confirmed to have potential safety problems in the
state supervision spot tests; the recall of defective products fails to reach the anticipated purpose due to the
faults of the manufacturer, which has caused reoccurrence or expansion of damages.
Phase Three: Outcome Appraisal Based on the progress reports and recall records submitted by the manufacturer, the
administrative authority shall conduct an outcome appraisal to determine whether the recall measures adopted are sufficient to eliminate the risks and defects.
V. Legal Liabilities
Illegal Conducts Administrative Liability
Failure or refuse to conduct defect investigation
Failure to recall the products voluntarilywith the knowledge of the defects
Refuse to recall the products uponreceipt of the notice of compulsory recall
Failure to report the recall progress to the administrative authority regularly
Manufacturer:Warning, order to rectify and recall, fine up to 3 times of value involved
Distributor:Warning, order to stop selling,
and fine of 1,000 to 50,000 RMB
The recall shall not exempt the manufacturer from the civil, administrative or criminal liabilities arising in connection with the defective products under other PRC laws. But where the manufacturer voluntarily recall products to eliminate the damages, its legal liabilities under other laws may be mitigated.
V. Legal Liabilities
Non-compliance with the recall laws may not constitute crimes in itself. But producing or marketing fake or substandard products is prohibited by the Criminal Law of PRC.
Illegal Conducts Criminal Liability
Producing or marketing fake or substandard products
Fines up to two times of the amount of earning
Confiscation of
property
orProducing or marketing fake or inferior medicines
Producing or marketing toxic or substandard food
Producing or marketing substandardmedical apparatus and instruments
15-years imprisonmentor
life imprisonment
imprisonment less than 10years, life imprisonment
or death
imprisonment less than 10years or life imprisonment
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