GACC Decree 248 Announcing the Regulations of the People's
Republic of China on the Registration and Administration of
Overseas Producers of Imported Food
The Regulations of the People's Republic of
China on the Registration and Administration of Overseas
Producers of Imported Food was reviewed and passed in the
executive meeting of the General Administration of Customs on
March 12, 2021, and is hereby issued, and shall come into force
on January 1, 2022. The Administrative Measures for Registration
of Overseas Producers of Imported Food, released as Decree 145
of the former General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ) on March 22, 2012, revised by
GACC Decree No. 243 on November 23,
2018, is abolished at the same
time.
Minister Ni Yuefeng April 12, 2021
Regulations of the People's Republic of China
on the Registration and Administration of Overseas Producers of
Imported Food
Chapter I
General Provisions
Article 1 To
strengthen the registration management of overseas producers of
imported foods, these Regulations are formulated in accordance
with provisions of the Food Safety Law of the People's Republic
of China and its implementing regulations, the Law of the
People's Republic of China on Import and Export Commodity
Inspection and its implementing regulations, Law of the People's
Republic of China on the Entry and Exit Animal and Plant
Quarantine and its implementation regulations, the Special
Provisions of the State Council on Strengthening the Supervision
and Administration of Food and Other Products Safety, as well as
relevant administrative regulations.
Article 2 These
Regulations apply to the registration management of overseas
manufacturers, processors, and storage facilities (hereinafter
referred to as “overseas producers of imported foods”) that
export foods to China.
The overseas producers of imported foods
mentioned in the above paragraph do not include facilities
engaging in the production, processing, and storage of food
additives and food-related products.
Article 3 The
General Administration of Customs of the People’s Republic of
China (GACC) is
responsible for the registration management of overseas
producers of imported
foods.
Article 4
Overseas producers of imported foods shall obtain registration
with GACC.
Chapter II Conditions and Procedures for
Registration
Article 5 The
registration conditions for overseas producers of imported foods
are as follows:
1.
The food safety management system of the country/region where
the producer is
located (“country/region”) has passed GACC’s equivalence
assessment or review;
2.
(The producer was) established with approval by the competent
authority of the country/region, and (the producer is) under
effective oversight by
the competent authority;
3.
(The producer) has an established, effective food safety and
sanitation management system and food defense system, legally
produces and exports food in the country/region, and ensures
that foods exported to China comply with relevant Chinese laws,
regulations, and national
food safety
standards;
4.
(Foods export to China) conform with relevant inspection and
quarantine that have been agreed upon after discussion by GACC
and the competent authorities of the
country/region.
Article 6
Registration of overseas producers of imported foods include: 1)
recommendation for registration by competent authority of the
country/region, and 2) application for registration by a
producer.
GACC, based on analysis of various factors,
including sources of raw materials, production and processing
techniques, historical data about food safety, consumer groups,
consumption methods of food, and in consideration of
international practices, determines the method for registration
of overseas producers of imported food and the required
application materials.
If risk analysis or evidence presents that
risks of a certain category of food has changed, GACC may adjust
the registration method and required application materials for
overseas producers of the corresponding food.
Article 7
Overseas producers of the following foods shall be recommended
by the competent authorities of their countries/regions to GACC
for registration: meat and meat products, sausage casings,
aquatic products, dairy products, bird nests and bird nest
products, bee products, eggs and egg products, edible oils and
fats, oilseeds, stuffed wheaten products, edible grains, milled
grain industry products and malt, fresh and dehydrated
vegetables and dried beans, condiments, nuts and seeds, dried
fruits, unroasted coffee beans and cocoa beans, foods for
special dietary purposes, and health foods.
Article 8 The
competent authority of the country/region shall examine and
inspect the facility to be recommended for registration; after
confirming that the facilities conform with the registration
requirements, (the competent authority of the country/region)
recommends the producers to GACC for registration, and submit
the following application materials:
1.
Letter of recommendation by the competent authority of the
country/region;
2.
List
of (recommended) producers and the producers’ application for
registration;
3.
Documents certifying identification of the producer, such as the
business license issued by the competent authority of the
country/region;
4.
Statement that the producer recommended by the competent
authority of the
country/region conform with requirements of these Regulations;
5.
Reports of examinations/inspections/review conducted by the
competent authority of
the country/region to relevant
producers.
If necessary, GACC may request documents
related to the producer’s food safety, sanitation, and food
defense system, such as floor plans of the
factory/workshops/cold storages, and the processing flow chart;
etc.
Article 9
Overseas producers of foods other than those listed in Article 7
of these Regulations shall, by themselves or by agents, file
applications for registration with GACC and submit the following
application materials:
1.
Producer’s application for facility
registration;
2.
Documents certifying the identification of the facility, such as
business license issued by
the competent authority of the
country/region;
3.
Statement by the producer that it conforms with requirements of
these Regulations.
Article 10 The
application for facility registration shall contain the
following information: name of the producer, country/region
where the producer is located, address of the production site,
legal representative, contact person, contact information,
registration number approved by the competent
authority of the country/region, the type of
food for registration, type of production, and production
capacity, etc.
Article 11
The application materials for facility
registration shall be submitted in Chinese or English. If
relevant countries (regions) and China have separate agreements
on registration method and application materials, (registration)
shall be carried out following the agreement.
Article 12
Competent authority of the country (region)
or overseas producers of imported foods shall be held
accountable for truthfulness, completeness, and legality of the
submitted materials.
Article 13 GACC
or GACC entrusted institutions set up review teams to conduct
evaluations and reviews of the overseas producers applying for
registration. The evaluation is conducted in forms of document
review, video inspection, and/or on-site inspection. A review
team is composed of two or more reviewers.
Overseas producers of
imported foods and the competent authorities of the country
(region) shall assist
(GACC) in carrying out the aforementioned evaluation and
review.
Article 14 GACC
shall, based on the evaluation and review, register the overseas
producers that meet the requirements, and grants them China
registration numbers; (GACC) notifies the competent authority of
the country/region or the overseas producers in writing (of the
registration). GACC denies registration of overseas producers
that do not meet the requirements and notifies the competent
authority of the country/region or the overseas producers in
writing (of the
denial).
Article 15 A
registered producer shall mark the Chinese registration number
or the registration number approved by the competent authority
of the country/region on the inner and outer packaging of the
foods exported to China.
Article 16
The registration for overseas producers of imported foods will
be valid for five years.
GACC determines the
starting and the ending dates of the validity period of
registration when it
registers an overseas producer of imported
foods.
Article 17 GACC
publishes lists of oversea producers of imported foods that
receive registration in a unified way.
Chapter III Registration Management
Article 18 GACC
or its entrusted institutions set up review teams to conduct
re-evaluation on whether the overseas producers of imported food
continuously meet the registration requirements. A review team
is composed of two or more reviewers.
Article 19 If
an overseas producer’s registration information changes while
the registration is valid, it shall submit application for
change to GACC through the application path, and submit the
following materials:
1.
A
table that exhibits the changed information (and the original information);
2.
Supporting materials related to the changed
information
GACC changes the registration information if
it deems (such information) can be changed.
In cases of changed
production site, legal representative, or registration number in
the country/region
where the producer is located, (the overseas producer) shall
re-apply for registration, and the original China registration
number will automatically become
invalid.
Article 20 If
an overseas producer of imported foods intends to renew its
registration, it shall, within three to six months before the
registration expires, apply to GACC for renewal of registration
through the registration application path.
Application materials for registration
renewal should includes:
1.
Application for renewal of
registration;
2.
Statement promising to continuously conform with the
registration requirements.
GACC renews registration of producers that
conform with the registration requirements and extends the valid
period of registration for five years.
Article 21 If a
registered overseas producer of imported foods falls under any
of the following circumstances, GACC will revoke its
registration, notify the competent authority of the
country/region or the registered facility, and issue a public
announcement thereof:
1.
(The
producer) fails to apply for registration renewal following
relevant provisions;
2.
The
competent authority or the overseas producer apply to revoke the registration;
3.
The
producer no longer conforms with provisions in Article 5.2 of
these Regulations.
Article 22 The
competent authorities of the countries (regions) shall have
effective oversight of the registered producers, urge them to
continuously conform to the registration requirements. Finding
incompliance to the registration requirements, the competent
authorities shall take control measures immediately, suspend
food export by relevant producer to China, until (the producer)
conforms to registration requirements after taking rectification
measures.
Finding itself unable to conform with the
registration requirements, an overseas producer of imported
foods shall voluntarily suspend its food exports to China, take
immediate rectification measures until it conforms to
registration requirements.
Article 23
Finding a registered facility no longer conforms with the
registration requirements, GACC shall instruct the facility to
make rectification measures within a given time period and shall
suspend imports from the producer during the rectification
period.
If imports by a foreign competent
authority-recommended producer are suspended, the competent
authority shall urge the producer to complete rectification
within the given time period and shall submit to GACC a written
rectification report and a written statement confirming (the
producer) conforms with the registration requirements.
If imports by a self-registered or
agent-registered producer are suspended, the producer shall
complete the rectification within the given time period and
submit a written rectification report and a written statement
confirming (it) conforms with the registration requirements.
GACC reviews the rectification by the
producers; passing GACC review, food imports from relevant
producers are resumed.
Article 24 If a
registered overseas producer of imported foods falls under any
of the following circumstances, GACC shall revoke its
registration and issue a public announcement thereof:
1.
Severe food safety incidents of imported foods caused by the producer;
2.
Food safety problems detected in foods exported to China in the
entry inspection and
quarantine, and the circumstance is
serious;
3.
Significant problems exist in the producer’s food safety and
sanitation management,
which cannot ensure its food export to China conforms with
safety and sanitation
requirements;
4.
The
producer fails to meet the registration requirements after
taking rectification
measures;
5.
(The
producer) provides false materials or conceals relevant
facts;
6.
(The
producer) refuse to cooperate with GACC in reviews and incident investigations;
7.
(The producer) leases, lends, transfers, or resells its
registration number, or claims
another producer’s registration
number.
Chapter IV Supplementary Provisions
Article 25
When an international organization or a foreign competent
authority issues a notification of a disease/epidemic, or (GACC)
detects a serious disease/epidemic outbreak or public health
incident in its
inspection and quarantine, GACC will issue a
public announcement suspending food imports from the
country/region. During the import suspension, GACC will not
accept applications for registration by food producers in the
country/region.
Article 26 The
competent authority of the country (region) in these Regulations
refers to government agencies in charge of safety and sanitation
oversight of food producing facilities in the country/region.
Article 27 GACC
is responsible for the interpretation of these Regulations.
Article 28
These Regulations come into effect on January 1, 2022. The
Administrative Measures for Registration of Overseas Producers
of Imported Foods, released as Decree 145 of the former General
Administration of Quality Supervision, Inspection and Quarantine
(AQSIQ) on March 22, 2012, revised by GACC Decree No. 243 on
November 23, 2018, is abolished at the same time.
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