Required Report - public distribution

**Date:** 9/17/2007

**GAIN Report Number:** CH7070

CH0000

**China, Peoples Republic of**

**FAIRS Subject Report**

**Food Recall Regulation**

**2007**

**Approved by:**

![](media/image1.wmf)William Westman

U.S. Embassy Beijing

**Prepared by:**

Mark Petry and Wu Bugang

**Report Highlights:** The General Administration of Quality
Supervision, Inspection and Quarantine of the People's Republic of China
published the "Regulation on the Administration of Food Recalls
(Regulation 98)" on August 27, 2007. This regulation entered into force
on the date of publication.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Beijing \[CH1\]

\[CH\]

**Summary**

The General Administration of Quality Supervision, Inspection and
Quarantine (AQSIQ) of the People's Republic of China published the
Regulation on the Administration of Food Recall (Regulation 98) on
August 27, 2007. This decree entered into force on the date of
publication. This report contains an official translation published by
the Government of China.

While this regulation provides for clarifications to China's
comprehensive food recall system, it does not provide details about the
competent authorities responsible for each action. While AQSIQ is
responsible for only one portion of China's domestic regulation and
enforcement of food safety, the duties and responsibilities of the other
ministries are not clearly defined by this measure.

BEGIN TRANSLATION

**Decree of the General Administration of Quality**

**Supervision, Inspection and Quarantine of the People's**

**Republic of China**

**No.98**

***The Regulation on the Administration of Food Recalls,*** which have
been reviewed and adopted at the executive meeting of General
Administration of Quality Supervision, Inspection and Quarantine on July
24,2007, are hereby promulgated and shall enter into force as of the
date of their promulgation.

Minister Li Changjiang

> August 27, 2007

**The Regulation on the Administration of Food Recall**

**Chapter 1 General Rules**

**Article 1** The Regulation is formulated to strengthen the supervision
of food safety to avoid and reduce hazards caused by unsafe food, and to
protect the health and life of the consumer according to such laws and
regulations as Law on Product Quality of People's Republic of China,
Food Hygiene Law of People's Republic of China and Special Regulations
of the State Council on Strengthening Safety Supervision and
Administration of Food and Other Products.

**Article 2** Recall of food manufactured and sold within the territory
of People's Republic of China as well as its supervision and
administration activities shall abide by this Regulation.

**Article 3** Unsafe food referred to in the Regulation means food that
is proved to have or will potentially do harm to human health,
including,

(1)A food that has induced food poisoning or food-borne disease, or
caused damage to human health, even caused death;

(2)A food that probably will induce food poisoning or food-borne
disease, or will damage human health;

(3)A food containing ingredient that may induce health hazard for
certain group of people, but doesn't mark on the food label and
instruction, or with incomplete and indefinite mark.

(4)Other unsafe foods provided for in relevant laws and regulations.

**Article 4** Recall referred to in this Regulation means an activity
that the producer of the food duly eliminates or reduces the hazard of
food safety for a certain batch or category of unsafe food due to the
cause of its production through replace, refund, supplement or
modification of consumption instructions according to specified
procedure.

**Article 5** The General Administration for Quality Supervision,
Inspection and Quarantine (hereinafter referred to as AQSIQ), within the
scope of its functions and powers, organizes and coordinates nation-wide
supervision and administration of food recall.

The authority in charge of quality supervision, inspection and
quarantine at the level of province, autonomous region or municipality
directly under the central government (hereinafter referred to as
Provincial-level Quality and Technique Supervision Authority) shall be
responsible for organizing and carrying out supervision and
administration of food recall within local administrative region
according to the relevant law

**Article 6** AQSIQ and the Provincial-level Quality and Technique
Supervision Authority organization to establish an expert committee for
food recall (hereinafter referred to as Expert Committee), to provide
technical support for investigation of food safety hazard and assessment
of food safety hazard.

**Article 7** AQSJQ shall strengthen the construction of information
systems on food recall management, organize to establish the information
management system of food recall, as well as uniformly collect analyze
and handle relevant food recall information.

Quality supervision authorities at all levels establish the quality
safety files of food producers in their administrative regions, and are
responsible for collection, analysis and handling of relevant food
safety hazards and information management system of food recall, and
report to the next higher level of authority

**Article 8** The food producer shall establish comprehensive product
quality safety files and relevant management systems, shall accurately
record and keep such information as raw and supplemental materials
purchase, production and processing, warehousing and transportation,
sales and product mark in the production link, and keep the files of
consumer complaints, accidents of food-borne disease, accident record of
food poisoning as well as information on dispute of food hazards, etc.

Article 9 The food producer shall timely report all relevant information
of food safety hazards to the provincial-level or municipal quality
supervision authorities where it is located, including consumer
complaints and accident record of food poisoning, etc. It is prohibited
to conceal or falsely report the fact that the food is harmful to human
health.

**Chapter 2 Investigation and assessment of food safety hazards**

**Article 10** To adjust whether a food is unsafe, it shall conduct
investigation of food safety hazards and assessment of food safety
hazards.

**Article 11** Investigation of food safety hazards mainly includes:

(1 ) Whether meet the safety requirements of food safety laws,
regulations or standards;

\(2\) Whether contain non-edible raw accessorial materials, add
non-edible chemical substances or use non-food as food;

(3)Composition and proportion of main consumption crowd of the food;

\(4\) Quantity, batch n umber or category and circulation region and
scope of food existing potential safety hazards.

**Article 12** Assessment of food safety hazards mainly includes:

(1 ) Food poisoning or food-borne disease induced by the food, or
hazards of the food for human health, or possibility of inducing above
hazards;

\(2\) Hazards and influences of the unsafe food on main consumption
crowd;

\(3\) Seventy and urgency degree of the hazard;

\(4\) Short-term and long-term consequences of the hazard.

**Article 13** The food producer shall immediately conduct investigation
of food safety hazards arid assessment of food safety hazards if it
knows that there is potential safety hazard in its products, or receive
written notice of food safety hazards investigation from the
Provincial-level Quality and Technique Supervision Authority where it is
located.

The food producer shall timely submit the reports on investigation and
assessment of food safety hazards to the Provincial-level Quality and
Technique Supervision Authority through the municipal quality
supervision authority where it is located, and the content of the
reports on investigation and assessment shall include what mentioned in
Articles 8, 11 and 12 of the Regulation.

**Article 14** For the food producer who fails to conduct investigation
of food safety hazards and assessment of food safety hazards after
reception of the notice, or for any unsafe food confirmed by
investigation and assessment, the local provincial-level quality
supervision department shall organize the Expert Committee to conduct
investigation of food safety hazards and assessment of food safety
hazards, and make a determination.

**Article 15** The food producer and distributor shall cooperate with
the Provincial-level Quality and Technique Supervision Authority in the
investigation of food safety hazards, and shall not refuse on the ground
that the food has passed any conformity review.

**Article 16** If there is any discrepancy between the result of
investigation of food safety hazards and assessment of food safety
hazards for the food producer and the result concluded by the Expert
Committee organized by the local Provincial-level Quality and Technique
Supervision Authority the Provincial-level Quality and Technique
Supervision Authority may adopt such ways as hearings, and make a
decision of confirmed result.

**Article 17** Any unsafe food caused by the reason of production
confirmed by investigation and assessment of food safety hazard, shall
confirm the recall class, to recall.

**Article 18** Based on the severity of food safety hazard, food recall
is divided into three classes:

(1 ) Class I Recall: recall of food that has induced or will potentially
induce food poisoning or food-borne disease, which has caused serious
harm to human health, even death, or unsafe food with a wide scope of
circulation and great social influence;

\(2\) Class II. Recall: recall of food that has induced or will
potentially induce food poisoning or food-borne disease, which has
caused avenge harm to human health, or unsafe food with smaller scope of
circulation and less social influence;

\(3\) Class III Recall: recall of food that has induced or will
potentially induce food poisoning or food-borne disease, which has
caused slight harm to human health, or unsafe food not included in
paragraph 3), Article 3 of the Regulation.

**Chapter 3 Implementation of food recall**

**Section 1. Voluntary Recall**

**Article 19** The food producer shall instantly put a halt on the
production and selling of any **unsafe** food that is confirmed to be
recalled.

**Article 20** Relevant distributors shall be informed to stop selling,
and the consumer shall be informed to stop consuming within I day, 2
days and 3 days upon confirmation of unsafe food that shall be recalled
for Class I Recall, Class II Recall and Class III Recall, respectively.

**Article 21** The food producer shall report to the quality supervision
authority at provincial level or above according to relevant provisions
of AQSIQ when releases the information on food recall to the public.

**Article 22** The food producer shall submit the food recall plant o
the Provincial-level

Quality and Technique Supervision Authority through the municipal
quality supervision authority where it is located within 3 days, 5 days
and 7 days upon confirmation of unsafe food that shall be recalled for
Class I Recall, Class II Recall and Class III Recall, respectively.

**Article 23** The food recall plan submitted by the food producer
mainly includes:

(1 ) Information on stopping the production of the unsafe food;

\(2\) Information on informing the distributor to stop selling the
unsafe food;

\(3\) Information on informing the consumer to stop consuming the unsafe
food;

(4)Category cause, potentially affected people, severity and urgency
degree of the food safety hazard;

(5)Content of the recall measure, including implementing organization,
contact methods and specific measure, scope and timing of the recall,
etc.;

(6)Expected effect of the recall;

(7)Treatment measures after the food is recalled.

**Article 24** The food producer shall submit periodical progress
reports of the food recall to the Provincial-level Quality and Technique
Supervision Authority through the municipal quality supervision
authority where they are located every 3 days, 7 days and 15 days since
the date of recall for Class I Recall, Class II Recall and Class III
Recall, respectively.

If there is change in the food recall plan, the food producer shall give
an explanation in the periodical progress report of the food recall.

The local municipal quality supervision authority or above shall raise
treatment opinion for the periodical progress report of the food recall,
and inform the food producer and report to the local provincial-level
quality supervision department.

**Section 2. Compulsory Recall**

**Article 25** In the event that one of the following circumstances is
confirmed, AQSIQ shall order the food producer to recall the unsafe
food, and may release relevant food safety information as well as
consumption caution information, or take other measures to avoid the
hazard:

(I)The food producer purposely conceals food safety hazards, or does not
take recall action when it shall actively recall;

(2)The food safety hazard has been extended or recurs due to the faulty
of the food producer;

(3)The food produced by the food producer has been found to have
potential safety hazard which may damage human health and life safety
during national supervisory random inspection.

The food producer shall instantly put a halt to the production and
selling of unsafe food after receiving the notice of Compulsory Recall.

**Article 26** The food producer shall send a notice according to the
stipulation in Article 20 of this regulation after receiving the notice
of Compulsory Recall.

The food producer shall prepare the food recall report according to the
stipulation in Article 23 of this regulation simultaneously, and
immediately implement the recall after obtaining approval from the
Provincial-level Quality and Technique Supervision Authority through the
municipal quality supervision authority where it is located according to
the deadline provided in Article 22 of this regulation; in the event
that the food recall report is not approved, the food producer shall
implement the recall according to requirements after modifying the
report.

**Article 27** The food producer shall submit periodical progress
reports of the food recall according to the stipulation in Article 24 of
this regulation.

The local municipal quality supervision authority or above shall raise
treatment opinion for the periodical progress report of the food recall
according to this regulation, and report relevant cases to next superior
authority until the Provincial-level Quality and Technique Supervision
Authority.

**Section 3. Assessment and supervision of the recall**

**Article 28** The food producer shall keep the recall record, including
the batch number, quantity, proportion, cause, and result, etc. of the
food recall.

**Article 29** The food producer shall submit the recall conclusion
report to the local Provincial-level Quality and Technique Supervision
Authority within 15 days as of the deadline of food recall; for
compulsory recall, it shall be reported to AQSIQ.

**Article 30** The Provincial-level Quality and Technique Supervision
Authority where the food producer locates shall organize the Expert
Committee to review the recall conclusion report, assess the effect of
the recall, and inform the food producer of the review result in
writing; for compulsory recall, it shall be reported to AQSIQ for
filing.

In the event that the quality supervision authority at provincial level
or above where the food producer locates doesn't consider the recall has
the expected effect the food producer shall be informed to continue
recalling or re-recall the food.

**Article 31** The food producer shall timely conduct remedial treatment
for the unsafe food. Those foods that are subject to destroy according
to relevant regulations shall be destroyed timely.

The food producer shall keep detailed records for post treatment of the
recalled food, and report to the local municipal quality supervision
authority, subjecting to supervision of the Provincial-level Quality and
Technique Supervision Authority.

**Article 32** The quality supervision authorities at provincial level
or above shall supervise the recall progress and the post treatment
process of the recalled food conducted by the food producer within their
functions and powers specified.

**Article 33** Any unit and individual may complain or claim to the
quality supervision authorities at all levels about any behavior in
violation of the provision of this regulation, as well as relevant
situation of recall implementation and the food producer shall not
restrict with any means. Authorities accepting such complaints or claims
shall timely make an investigation and handle in a secret manner.

**Chapter 4. Legal Responsibilities**

**Article 34** While implementing the food recall, the food producer
isn't exempt from other legal responsibilities it shall bear according
to the law.

The food producer who actively recalls the product may be given a less
or mitigated punishment.

**Article 35** The food producer who violates Article 19 or Paragraph 2
of Article 25 of this regulation and do not put to a halt production and
selling of unsafe food shall be given a warning, and be ordered to
remedy within a prescribed time limit; if it fails to remedy within the
prescribed time limit, it shall be fined no more than 30,000 RMB; in the
case of violation of relevant laws and regulations, it shall be subject
to provisions thereof.

**Article 36** The food producer who is under any of the following
circumstances shall be given a warning, and be ordered to remedy within
a prescribed time limit; if it fails to remedy within the prescribed
time limit, it shall be imposed upon a fine of no more than 20,000 RMB.

(1)Has received the notice of food safety hazards investigation from the
quality supervision authority, but fails to make an investigation in
time;

(2)Refuses to cooperate with the quality supervision authority in the
investigation of food safety hazards;

(3)Fails to submit the reports on investigation and assessment of food
safety hazards according to requirements of this regulation.

**Article 37** The food producer who violates Articles 20, 21, 22, 23,
24, 26, 27 and 29 of this regulation, shall be given a warning, and be
ordered to remedy the situation within a prescribed time limit; if it
fails to remedy within the prescribed time limit, it shall be imposed
upon a fine of no more than 30,000 RMB; in the case of violation of
relevant laws and regulations, it shall be subject to provisions
thereof.

**Article 38** The food producer who violates obligations provided for
in Article 28 of this regulation shall be given a warning. and be
ordered to remedy within a prescribed time limit; if it fails to remedy
within the prescribed time limit, it shall be imposed upon a fine of no
more than

20,000 RMB.

**Article 39** The food producer who violates obligations provided for
in Article 31 of this regulation, shall be given a warning, and be
ordered to remedy within a prescribed time limit; if it fails to remedy
within the prescribed time limit, it shall be imposed upon a fine of no
more than 30,000 RMB; in thee case of violation of relevant laws and
regulations, it shall be subject to provisions thereof.

**Article 40** Any officer engaged in food recall management, and
experts appointed to conduct investigation of food safety hazards and
assessment of food safety hazards, or staff, fabricates or distributes
any false information, violates the confidentiality provision, forges or
provide relevant false conclusions or opinions, shall be given a
administrative penalty according to the law; shall be liable for
compensation responsibilities for any loss there from; if any crime is
constituted, shall be subject to criminal liabilities.

**Article 41** Administrative penalties provided for in this regulation
are en forced by the quality supervision authority at and above the
county level within the scope of its functions and power according to
the law. Where it is otherwise provided for the administrative
punishment authority in the laws and administrative regulations, the
relevant laws and administrative regulations shall prevail.

**Chapter 5. Supplementary Provisions**

**Article 42** Recall management of I/E food is implemented by the Exit
& Entry Inspection and Quarantine Agency according to relevant
provisions of AQSIQ.

**Article 43** Specific requirements for information release and
document format involved in this regulation are prepared by AQSTQ
separately

**Article 44** The power to interpret this regulation shall remain with
AQSIQ.

**Article 45** This Provision will come into force from the date of its
promulgation.