Voluntary Report - public distribution

**Date:** 6/22/2005

**GAIN Report Number:** CH5050

CH5050

**China, Peoples Republic of**

**FAIRS Product Specific**

**Interim Administrative Measures for Health Food Registration**

**2005**

**Approved by:**

![](media/image1.wmf)Maurice House

U.S. Embassy Beijing, Office of Agricultural Affairs

**Prepared by:**

Wu Bugang

**Report Highlights:**

This is an unofficial translation of Decree 19 the Interim
Administrative Measures for Health Food Registration published by the
State Food and Drug Administration on April 30, 2005. These measures go
into effect on July 1, 2005. Exporters should carefully study the
regulation and consult the importers to ensure their interpretation is
accurate.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Beijing \[CH1\]

\[CH\]

Table of Contents

[**Executive Summary 3**](#executive-summary)

[Decree No. 19 of the State Food and Drug Administration
3](#decree-no.-19-of-the-state-food-and-drug-administration)

[Administrative Measures for Health Food Registration (interim)
3](#interim-administrative-measures-for-health-food-registration)

[Chapter I General Principles 3](#chapter-i-general-principles)

[Chapter II Application, Examination and Approval
4](#chapter-ii-application-examination-and-approval)

[Chapter III Raw Materials and Supplementary Materials
11](#chapter-iii-raw-materials-and-supplementary-materials)

[Chapter IV Labels and Specifications
12](#chapter-iv-labels-and-specifications)

[Chapter V Testing 13](#chapter-v-testing)

[Chapter VI Re-registration 14](#chapter-vi-re-registration)

[Chapter VII Re-examination 15](#chapter-vii-re-examination)

[Chapter VIII Legal Liabilities 15](#chapter-viii-legal-liabilities)

[Chapter IX Supplementary Provisions
17](#chapter-ix-supplementary-provisions)

[Appendix I Application Items for Product Registration
17](#appendix-i-application-items-for-product-registration)

[Appendix II Application Items for Alteration
19](#appendix-ii-application-items-for-alteration)

[Appendix III Application Items for Technical-Transfer Product
Registration
21](#appendix-iii-application-items-for-technical-transfer-product-registration)

[Appendix IV Application Items for Re-registration
22](#appendix-iv-application-items-for-re-registration)

# Executive Summary

On April 30, 2005, the State Food and Drug Administration (SFDA)
published the Interim Administrative Measures for Health Food
Registration. These measures stipulate that SFDA and its subsidiaries
are responsible for assessment and review of food safety, effectiveness,
quality control, and content of labeling before a health food is
registered. Health food registration also covers alteration and
technology transfer. SFDA authorized testing agencies are responsible
for conducting sample testing on toxicology, functionality (including
human and animal trial), stability, and so on. Health food labeling
should indicate materials (ingredients), dosage, quality standards,
shelf life, and applicable groups.

An imported health food must be registered at SFDA or their provincial
offices by its Chinese representative office or Chinese agent. Refer to
the Appendixes for detailed documentation requirements for imported
health food registration, re-registration, and technology transfer.

A full text of this regulation in Chinese is posted on SFDA web site
([www.sfda.gov.cn](http://www.sfda.gov.cn/)).

BEGIN TRANSLATION

# Decree No. 19 of the State Food and Drug Administration

Reviewed and approved by the State Food and Drug Administration (SFDA),
the Interim Administrative Measures for Health Food Registration was
hereby promulgated and shall go into effect as of July 1, 2005.

Director Zheng Xiaoyu

> April 30, 2005

# Interim Administrative Measures for Health Food Registration

## Chapter I General Principles

**Article 1** These Measures are formulated in accordance with the Food
Hygiene Law of the People's Republic of China and the Administrative
Licensing Law of People's Republic of China to standardize the
registration of health food, ensure the quality of health food, and
guarantee the human food safety.

**Article 2** Health food in the Measures refers to food claiming that
it has certain health improving functions or is able to supply vitamins
and mineral. It is good for a particular group of people and able to
adjust body functions. But, it is not used to cure certain diseases. It
will not have any form of harm whether it is acute or sub-acute or
chronic.

**Article 3** The Measures apply to the registration of domestic and
imported health food within the territory of the People's Republic of
China.

**Article 4** Health food registration refers to that further to the
application filed by the applicant, the State Food and Drug
Administration, in accordance with the legal procedure, conditions and
requirements, conducts a systematic review of the safety, effectiveness,
quality control of health food and the content of the instruction. The
State Food and Drug Administration decides whether to permit it to enter
the process of examination and approval of its registration. It includes
examinations and approvals of applications for product registration,
alteration, and technology transfer product registration.

**Article 5** The State Food and Drug Administration is responsible for
the regulation of national health food registration and examination and
approval of health food.

Drug (Food) administrative departments in provinces, autonomous regions
and municipalities entrusted by the State Food and Drug Administration,
are responsible for examining domestic health food registration
application package, checking the experiments of health food that
applies for registration and sample experimental production, and
arranging for the examination of samples.

The examination agencies designated by the State Food and Drug
Administration are responsible for the health food safety toxicology
test, functionality test (including animal test or human trial test),
effective or marker ingredient test, hygiene test, and stability test.
They will carry out the sample product test and reexamination test.

**Article 6** The management of health food registration should follow
the principles of being scientific, open, equal, fair, effective and
convenient.

## Chapter II Application, Examination and Approval

Section One General Provisions

**Article 7** A health food registration applicant refers to those who
files health food registration application, bears relevant legal
responsibilities, and is granted health food approval certificate after
the application is approved.

A domestic applicant is legally registered citizen, legal person or
other organization in China.

An overseas applicant refers to legitimate foreign health food
manufacturers. When an overseas applicant intends to handle the imported
health food registration, it should be done by its the Chinese
representative offices or the Chinese agents.

**Article 8** A health food registration application includes
applications for product registration, alteration and technology
transfer product registration.

**Article 9** The State Food and Drug Administration and drug (food)
administrative departments in provinces, autonomous regions, and
municipalities should publish health food registration application
materials submitted and relevant registration application forms, where
the application is processed.

**Article 10** Health food registration applicants should submit
complete documents the registration requires in accordance with the
Measures that supply authentic information, and be responsible for the
authenticity of the documents and other materials submitted.

**Article 11** Applicants are allowed to correct the mistakes in
submitted application materials if they can be corrected immediately.

**Article 12** When materials applicants submit are not complete and
disagree with legal forms, drug (food) administrative departments in
provinces, autonomous regions and municipalities and the State Food and
Drug Administration should, immediately or within five days, inform
applicants of all the materials required at one time. If the
notification is overdue, the day when the application materials are
received is taken as the day when it is accepted. If the application is
denied being processed, the applicant should be notified in writing of
the reasons.

**Article 13** In the course of examination, if any further materials
are required, the State Food and Drug Administration should inform the
applicant at one time. An applicant, after receiving the notification,
should supply the materials required within five months. If the
applicant fails to do so, the examination will be terminated. Under
special circumstances where the applicants are unable to supply the
required materials in the due time, an applicant should file written
application to the State Food and Drug Administration and make
explanations. The State Food and Drug Administration should respond with
a decision within 20 days.

**Article 14** If any materials for registration application are
supplemented, the original examination period is extended by 30 days.
The alteration application is extended by 10 days.

**Article 15** If the product is granted registration after examination
by law, the State Food and Drug Administration should issue health food
approval certificate to the applicant application within the period as
stipulated, and send it to the applicant within 10 days. If the
application is denied, the State Food and Drug Administration should
inform the applicant of the denial and explain the reason of rejection
within the period as stipulated, and inform applicants of the rights to
apply for reexamination in accordance with laws and administrative
reconsideration, or file administrative litigation.

**Article 16** The State Food and Drug Administration and drug (food)
administrative authorities in provinces, autonomous regions and
municipalities should notify of the interested parties, if any party
with strong interests with the registration application is found in
course of examination of health food registration application.
Applicants and stakeholders can submit paper-based materials to
articulate and appeal or request a hearing in accordance with laws.

**Article 17** The State Food and Drug Administration should provide
information on health food registration application accepted to be
processed, examination process and health food successfully registered
on its official website.

**Article 18** The State Food and Drug Administration should make
adjustment of functions, evaluation of health food, testing methods and
evaluation technical standards in accordance with the development of
science and technology, and make it public.

**Section Two Product Registration Application, Examination and
Approval**

**Article 19** Product registration applications include domestic health
food registration application and imported health food registration
application.

Domestic health food registration application refers to the registration
application of health food that the applicants intend to manufacture and
sell in China.

Imported health food registration application refers to the registration
application of health food which has been manufactured and sold overseas
for above a year and intends to be sold within the territory of China.

**Article 20** An applicant, before applying for health food
registration, should make relevant research.

As research is finished, an applicant should supply the sample and
relevant materials to testing agencies designated by the State Food and
Drug Administration for testing and examination.

If the functions of health food submitted are within those published by
the State Food and Drug Administration, applicants should supply product
research and development report to the testing agency designated. If the
functions of the health food submitted are out of that published,
applicants should carry out animal test and human trial test and supply
product research and development report for the testing agency.

The product research and development report should include information
on basic concept of the research and development, function screening
process and expected effects. Function research and development report
should include information on the name of the function, the reason for
application, function testing, evaluation methods and test results.
Unable to carry out animal tests and human trial tests, applicants
should articulate reasons why they are unable to do so in the function
research and development report and supply relevant materials.

**Article 21** Receiving the sample and relevant materials supplied by
an applicant, testing agencies should, in accordance with health food
examination and evaluation technical norms published by the State Food
and Drug Administration and the testing methods published by other
relevant departments or offered by the enterprise, carry out safety
toxicology tests, function tests, effective, or marked, ingredients
tests, hygiene tests and stability tests. If the functions of the health
food submitted are out of those published the State Food and Drug
Administration, the testing agencies should check its function tests,
testing methods and test results, and provide test reports.

**Article 22** After testing agencies provide test reports, an applicant
may apply for health food registration.

**Article 23** To apply for domestic health food registration, an
applicant should, in accordance with Measures, fill in the Application
Form for Domestic Health Food Registration, and send the application
materials and sample products to drug (food) administrative departments
in provinces, autonomous regions and municipalities.

**Article 24** Receiving the application materials and sample products,
drug (food) administrative departments in provinces, autonomous regions
and municipalities should review whether the form of application
materials are standard and complete, and send out application accepted
to be processed /rejection notification within five days.

**Article 25** Over the approved registration application, drug (food)
administrative departments in provinces, autonomous regions and
municipalities should check testing and sample production sites, choose
samples used for tests and provide suggestions that are sent to the
State Food and Drug Administration along with application materials
within 15 days after the application is received. Meanwhile, drug (food)
administrative departments in provinces, autonomous regions and
municipalities should send testing notifications to the approved testing
agencies and supply samples for tests.

**Article 26** Health food samples used for registration application
should comply with Good Manufacture Practice for Health Food. So should
its manufacturing process.

**Article 27** Within 50 days after receiving the test notification and
sample products, testing agencies should carry out examination over the
sample and reexamination, send the test report to the State Food and
Drug Administration, and send the report to drug (food) administrative
departments in provinces, autonomous regions and municipalities and
applicants. In exceptional cases where the test agencies are unable to
finish the work in due time, the test agencies should report to the
State Food and Drug Administration and drug (food) administrative
departments in provinces, autonomous regions and municipalities, and
attach written explanations.

**Article 28** Receiving the examination reports from drug (food)
administrative departments in provinces, autonomous regions and
municipalities, application dossiers and sample products, the State Food
and Drug Administration should arrange food, nutrient, medical,
pharmaceutical and other technical personnel to review the application
dossiers of those that meet the requirements in terms of technology and
administration within 80 days, and make a decision after the
examination. If granted registration, applicants should be issued
Domestic Health Food Registration Certificate.

**Article 29** Applying for imported health food registration, an
applicant should, in accordance with Measures, fill in the Application
Form for Imported Health Food Registration, and send application
materials and sample products to the State Food and Drug Administration.

**Article 30** Within five days after receiving the application
materials and sample products, the State Food and Drug Administration
should examine whether the form of application materials are standard
and complete, and send accepted to be processed/rejection notifications.
Over the application that meeting the requirements, the State Food and
Drug Administration should send test notification and sample products
used for tests to the designated testing agencies within five days after
the application is accepted. If needed, the State Food and Drug
Administration may examine the manufacturing site and experiment site.

**Article 31** Within 50 days after receiving the test notification and
sample products, the testing agencies should carry out examination over
the sample and reexamination, send the test report to the State Food and
Drug Administration, and send the report to applicants. In exceptional
cases where the test agencies are unable to finish the work in due time,
the test agencies should report to the State Food and Drug
Administration and drug (food) administrative departments in provinces,
autonomous regions and municipalities, and attach written explanations.

**Article 32** Within 80 days after the application is accepted to be
processed, the State Food and Drug Administration should arrange food,
nutrient, medical, pharmaceutical and other technical personnel to carry
out technical examination of application materials and administrative
examination, and make a decision over the examination. If granted
registration, applicants should be issued Imported Health Food Approval
Certificate.

**Article 33** Health Food Approval Certificate will be effective within
5 years after issued. The format for the batch number of domestic health
food approval is state food hygiene mark G+4 digit year number+4 digit
batch number. The format for the batch number of imported health food
approval is state food hygiene mark J+4 digit year number+4 digit batch
number.

Section Three Alteration Application and Approval

**Article 34** Alteration application refers to that an applicant
applies to change health food approval certificate and its attached
contents.

**Article 35** An applicant applying for alteration should be the holder
of health materials food approval certificate.

**Article 36** The name, raw materials and supplementary, manufacturing
techniques, eating instruction, applicable population and other items,
which is crucial to the security of the drug, of the health food in
health food approval certificate cannot be altered.

**Article 37** The health food that enlarges applicable population, or
narrows down inapplicable population, and alters notices, functions,
intakes, product standards, best before date and quality standards
should be the product that has been manufactured and sold. The newly
added functions must be those within what the State Food and Drug
Administration published.

**Article 38** Applying for altering the contents of Domestic Health
Food Approval Certificate and its attachments, an applicant should fill
in the Application Form of Domestic Health Food Alteration, and send
relevant materials and instruction to food (drug) administrative
departments in provinces, autonomous regions and municipalities where
the applicant is located.

**Article 39** Drug (food) administrative departments in provinces,
autonomous regions and municipalities should examine whether the form of
materials are standard and complete, within five days after receiving
the application materials, and send accepted to be processed or
rejection notifications.

**Article 40** Over application for alteration of name, best before
date, intake, narrowing down the group of people applicable, and
enlargement of the group of people, inapplicable, drug (food)
administrative departments in provinces, autonomous regions and
municipalities should provide the results of examination within 10 days
after receiving the materials, and deliver that, along with application
materials, to the State Food and Drug Administration.

The State Food and Drug Administration should, within 40 days after
receiving the results of examinations and application materials, arrange
food, nutrient, medical, pharmaceutical and other technical personnel to
examine the application materials, and make a decision over it. If
granted alteration, applicants should be issues Domestic Health Food
Alteration File, and copied to drug (food) administrative departments in
provinces, autonomous regions and municipalities.

**Article 41** Over the application for alteration of product quality
and standards, drug (food) administrative departments in provinces,
autonomous regions and municipalities should provide the results of
examination and conclusions within 10 days after the application is
processed, send that, along with application materials, to the State
Food and Drug Administration, and meanwhile send test notifications to
the approved testing agencies and offer samples for test.

Testing agencies that receive test notifications and samples, should
carry out examinations within 30 days, send test reports to the State
Food and Drug Administration and copy it to the drug (food)
administrative body that sends the test notifications and applicants.

The State Food and Drug Administration should arrange food, nutrition,
medical, nutrient, pharmaceutical and other technical personnel to carry
out technical examination of the application materials and
administrative examination within 50 days after receiving the
examination reports, and make a conclusion over the examination. If
granted alteration, applicants should be issues Domestic Health Food
Alteration File that is copied to drug (food) administrative departments
in provinces, autonomous regions and municipalities.

**Article 42** Applying for altering the contents of Imported Health
Food Approval Certificate and its attachment, an applicant should fill
in the Application Form for Imported Health Food Alteration, and send
relevant materials and instruction to the State Food and Drug
Administration.

**Article 43** The State Food and Drug Administration should check
whether the form of application materials are standard and complete
within five days after receiving the application materials, and send out
accepted to be processed or rejection notifications.

**Article 44** Over application for altering the product name, best
before date, intake, narrowing down the group of people applicable, and
enlargement of the group of people inapplicable, notice and functions,
the State Food and Drug Administration should arrange food, nutrient,
medical, pharmaceutical and other technical personnel to carry out
technical examination of its application materials and administrative
examination within 40 days after the application is processed, and
provide results of examination. If granted alteration, applicants should
be issued Imported Health Alteration File.

**Article 45** Over the application for altering the product standards,
quality standard and the overseas location where foreign health food
producers manufacture the products imported to China, the State Food and
Drug Administration should send to designated testing agencies test
notifications and samples to be tested within five days after the
application is processed. If needed, the State Food and Drug
Administration may carry out on-site examination of that health food
production site.

Testing agencies that receive test notifications and samples, should
carry out examinations of the sample within 30 days, send test reports
to the State Food and Drug Administration and applicants.

The State Food and Drug Administration, within 50 days after the
application is received, arrange food, nutrient, medical, pharmaceutical
and other technical personnel to carry out technical examination of
application materials and administrative examination and make a
conclusion. If granted alteration, applicants should be issued Imported
Health Food Alteration File.

**Article 46** Over application for altering the name, address and
China's representative agent of the applicant, the applicant should, in
accordance with Measures, fill in the Memo Form for Domestic Health Food
Alteration or the Memo Form for Imported Health Food Alteration within
20 days after that item is altered, and send that, along with relevant
materials, to the State Food and Drug Administration for memo.

**Article 47** The valid period of Health Food Alteration File is
identical to that in the certificate before alteration. When the valid
period of the File expires, they should be re-registered all together.

**Article 48** Requests for re-issuance of health food certificate, an
applicant should send written application and instruction to the State
Food and Drug Administration. Applying for reissuing due to loss, an
applicant should send the original copy of the national newspaper where
the loss declaration is published. Applying for reissuing due to damage,
an applicant should send back original health food approval certificate.
If qualified after examination, health food approval certificate will be
reissued, and use the previous serial number, and the expiration date
does not change. Reissued health food approval certificate should bear
the previous approval date and print words of "reissued".

**Section Four Technology Transfer Product Registration Application and
Approval**

**Article 49** Technology transfer product registration application
refers to that holders of the health food approval certificates transfer
the rights to sell and manufacturing technologies to another health food
manufacturer, and, along with that health food manufacturer, apply for a
new health food approval certificate for the transferees.

**Article 50** The domestic transferee of the rights to sell and
technology must be enterprises that legally obtain the health food
hygiene approval certificates and comply with Good Manufacture Practice
for Health Food.

Foreign transferees must be enterprises that meet the local production
quality management requirements.

**Article 51** Transferor should sign contract with transferees,
transferring all the technology to transferees and guiding transferees
till the transferees produce three batches of products meeting the
quality requirements in a row.

**Article 52** In cases where more than one holder own the health food
approval certificate, when transferring the technology, they should
co-sign the transfer contract.

**Article 53** When health food with the Domestic Health Food Approval
Certificate or Imported Health Food Certificate is transferred within
China, health food certificate holders and transferees should co-sign
the Application Form for Domestic Health Food Technology Transfer
Registration or the Application Form for Imported Health Food Technology
Transfer Registration, and send relevant materials and samples to drug
(food) administrative body where the transferee is located, along with
the transfer contract.

**Article 54** Drug (food) administrative departments in provinces,
autonomous regions and municipalities should review whether the form of
application materials are standard and complete within five days after
receiving the application materials, and send accepted to be processed
or rejection notifications.

Over technology transfer product registration application that meets the
requirements, drug (food) administrative departments in provinces,
autonomous regions and municipalities should offer the results of
examination within 10 days after the application is processed, send the
application materials to the State Food and Drug Administration, and
send to testing agencies test notifications and samples for tests.

**Article 55** Testing agencies that receive the test notification and
sample should carry out examination of samples within 30 days, send the
test report to the State Food and Drug Administration, and copy it to
the drug administrative body that notifies the agency to conduct
examination and applicants.

**Article 56** The State Food and Drug Administration should provide the
results of examination within 20 days after receiving the examination
results, application materials and examination reports of the sample. If
granted registration, the transferees are issued new domestic health
food approval certificate and a new serial number. But, the valid period
of the certificate does not change. Meanwhile, the Domestic Health Food
Approval Certificate or the Imported Health Food Approval Certificate
obtained by transferor should be cancelled.

　　

**Article 57** When the health food with Imported Health Food Approval
Certificate is transferred outside China, health food certificate
holders and transferees should co-sign the Application Form for Imported
Health Food Technology Transfer Product Registration, and send relevant
materials and samples to the State Food and Drug Administration, along
with transfer contract.

The State Food and Drug Administration should check whether the form of
application materials are standard and complete and send accepted to be
processed or rejection notifications within 5 days after the application
materials are received. Over those meeting the requirements, the
Administration should send to testing agencies test notifications and
samples for tests within 5 days after the application is processed. If
needed, the State Food and Drug Administration may carry out on-site
examination of the transferee's production.

**Article 58** Testing agencies that receive the test notifications and
samples should carry out examination of the samples within 30 days, send
the test report to the State Food and Drug Administration, and copy that
to applicant. The State Food and Drug Administration should provide
results of examination within 20 days after receiving the sample test
report. If granted registration, transferees are issued a new Imported
Health Food Approval Certificate and a new serial number. But, the valid
period of the certificate does not change. The Imported Health Food
Approval Certificate the transferor obtained will be cancelled.

## Chapter III Raw Materials and Supplementary Materials

　

**Article 59** Raw materials of health food refer to the primary
materials that related to the functions of health food. Supplementary
materials of health food refer to excipients or other added materials
that are used to produce health food.

**Article 60** Raw materials and supplementary materials used in the
production of health food should comply with the national standards and
hygiene requirements. In absence of national standards, the industry
standards or self-stipulated standards can be used. Relevant materials
on raw materials and supplementary materials should be supplied.

**Article 61** Raw materials and supplementary materials used to produce
health food should be safe and not harmful to human health. Materials
that can be used in producing food with a limit can exceed that limit as
stipulated by the government.

　　

**Article 62** Raw materials and supplementary materials that the State
Food and Drug Administration and other government departments prohibit
from being used in producing health food should be used to produce
health food.

**Article 63** Raw materials and supplementary materials that the State
Food and Drug Administration stipulates can be used in producing health
food and that the Ministry of Health approves can be consumed and used
to produce normal food can be used as the raw materials and
supplementary materials to produce health food.

　

**Article 64** If raw materials and supplementary materials that are
used in producing health food the applicants applies for registration
are uncovered by Article 63. The applicant should, in accordance with
Measures, supply the toxicology evaluation test report of that raw
material and supplementary material and relevant food safety materials.

**Article 65** The State Food and Drug Administration should, in
accordance with development of science and technology, make it public
the material list of what can be used and what is prohibited.

**Article 66** Raw materials and supplementary materials used is
producing imported health food should comply with China's regulations on
raw materials and supplementary materials used to produce health food.

## Chapter IV Labels and Specifications

**Article 67** When applying for health food registration, an applicant
should submit a draft script of product specification and labels.

　　

**Article 68** The script of labels and specifications of health food to
be registered should include product name, major raw materials and
supplementary materials, effective and marker ingredients and content,
functions, people applicable, people inapplicable, intake and the method
of intake, standards, best before date, storage methods and other
important notes.

　　

The label of the health food allowed to go to market should comply with
relevant national regulations.

**Article 69** Naming of health food should comply with following
principles:

1)  In compliance with relevant national laws, regulations, standards;

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1)  Reflecting the true nature of the product, clear, easy to understand
    and in compliance with Chinese language.

2)  Using the name of medicine that has been registered is not allowed.

**Article 70** Name of health food should consist of three parts---brand
name, general name and attribute name. They must comply with principles
below:

1)  Brand name can use the registered product trademark or other names;

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1)  General name should be accurate and scientific, and is not allowed
    to make an explicit or implicit statement of therapeutical effects
    or exaggerate the function;

2)  Attribute name should state the product's authentic configuration,
    the statement should be standard accurate.

**Article 71** The State Food and Drug Administration should, in
accordance with relevant national standards, stipulations, application
materials and sample test results, examinate the draft script of the
label and specification.

## Chapter V Testing

**Article 72** Safety toxicology test refers to that designated testing
agencies, in accordance with the health food safety toxicology
examination procedures and examination methodology published by the
State Food and Drug Administration, carry out animal tests to check
whether the sample food from the applicants is safe to eat. If
necessary, human trial test should be carried out.

　　

Function test refers to that the designated testing agencies, in
accordance with the health food function examination procedures and
examination methodology published by the State Food and Drug
Administration or provided by the enterprise, carry out animal tests, or
human trial tests, to check whether the sample food from the applicants
have the health improvement functions.

Effective or marker ingredients test refers to that designated testing
agencies, in accordance with the health food effective or marker
ingredient examination procedures published by the State Food and Drug
Administration and other relevant departments or provided by the
enterprises, examinate the content of the sample's effective marker
ingredients and the change of that content within the valid period.

Hygiene test refers to that designated testing agencies, in accordance
with the examination procedures published by relevant government sectors
or provided by the enterprises, examinate the submitted sample's hygiene
indicators and other indicators related to the product quality (except
the effective or marker ingredients).

　

Stability test refers to that testing agencies, in accordance with the
examination methodologies published by relevant government sectors or
provided by the enterprises, examinate the change of the submitted
sample's hygiene indicators and other indicators during the valid period
(in addition to effective or marker ingredients).

　

Sample test refers to that testing agencies, in accordance with the
quality standards the applicants submit, carry out a comprehensive
examination of the sample sent by food and drug administrative
departments.

　

Reexamination refers to that testing agencies conduct reexamination of
the effective or marker ingredient examination methodologies the
applicants submit.

　　

**Article 73** The State Food and Drug Administration is responsible for
designating the test agencies for health food tests, sample tests and
reexamination. The specific procedures of that will be drafted later.

**Article 74** Designated testing agencies should, in accordance with
health food test and examination technology standards and examination
methods published by other relevant departments, present test report in
due time. Health food examination technology standards should be drafted
and published by the State Food and Drug Administration.

　

**Article 75** Designated testing agencies should, in accordance with
the service standard, price standard and legal conditions stipulated by
the government, offer applicants with secure, convenient, stable and
reasonably priced service, and fulfill the obligations of service.

**Article 76** Designated testing agencies should act legally, ensure
the tests are scientific, standard, open, fair, equal and honest.

**Article 77** Applicants should provide food and drug administrative
departments with required materials and cooperate in selecting samples
for tests and offer standard materials for tests.

　

**Article 78** Testing agencies that are responsible for the sample
tests and reexamination tests of health food submitted should not be
allowed to carry out the product test of that product.

## Chapter VI Re-registration

**Article 79** Health food re-registration refers to that the State Food
and Drug Administration, according to an applicant's application and
statutory procedures, conditions and requirements, examine whether to
extend the valid period of the health food approval certificate when it
expires.

The applicant for re-registration should be the holder of the health
food approval certificate.

　

**Article 80** An applicant who has to extend the valid period of the
health food approval certificate should apply for re-registration three
months prior to the expiration of the valid period.

　

**Article 81** To apply for domestic health food re-registration, an
applicant should, in accordance with regulations, fill in the
Application Form for Domestic Health Food Re-registration, and send the
application materials to the drug (food) administrative body where the
applicant is located.

　　

**Article 82** Drug (food) administrative departments in provinces,
autonomous regions and municipalities should check whether the form of
application materials are standard and complete within five days after
the application materials are received, and send out acceptation or
rejection notifications.

**Article 83** Over the re-registration applications that meet the
requirements, drug (food) administrative departments in provinces,
autonomous regions and municipalities are commissioned by the State Food
and Drug Administration to provide results of examination within 20 days
after the application is processed and copy that to the State Food and
Drug Administration for check.

　

**Article 84** The State Food and Drug Administration should provide
examination results within 20 days after the examination opinions are
received. If within 20 days no notification of denial of re-registration
is issued, drug (food) administrative departments in provinces,
autonomous regions and municipalities issue applicants certificates of
re-registration. If the applicant is denied re-registration, the State
Food and Drug Administration should notify drug (food) administrative
departments in provinces, autonomous regions and municipalities of
informing applicants of denial of re-registration and offering
explanations.

**Article 85** To apply for re-registration of imported health food, an
applicant should, in accordance with regulations, fill in Application
Form for Imported Health Food Re-registration, and send application
materials to the State Food and Drug Administration.

**Article 86** The State Food and Drug Administration should check
whether form the application materials are standard and complete within
five days after the application materials are received, and send out
accepted to be processed or rejection notifications.

**Article 87** Over the re-registration application that meets the
requirements, the State Food and Drug Administration should make a
verdict within 20 days after the application is processed. If granted
re-registration, applicants are issued re-registration certificates. If
unable to meet the requirements, applicants should be issued
notifications of denial of re-registration and informed of reasons.

　

**Article 88** In cases below, health food are refused re-registration:

1)  Unable to apply for re-registration in due time;

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1)  Cancel health food approval certificate in accordance with relevant
    laws and regulations;

2)  Raw materials and supplementary materials and products with problems
    in food safety;

3)  Materials or manufacturing techniques used in production of health
    food is incompatible with the existing regulations;

4)  Other cases in which there is conflict with relevant national
    regulations.

**Article 89**, The State Food and Drug Administration should make
announcements about refused re-registration; cancel its health food
approval serial number.

## Chapter VII Re-examination

**Article 90** If an applicant disagrees with the refusal made by the
State Food and Drug Administration, the applicant may write to the State
Food and Drug Administration to ask for re-examination and attach
reasons for re-examination within ten days after receiving the
notification of denial of re-registration.

**Article 91** Receiving the request for re-examination, the State Food
and Drug Administration should, in accordance with previous application
period and, make re-examination. If the denial of re-registration is
cancelled, the applicant should be issued health food approval
certificates. If the verdict is unchanged, a second request for
re-examination will not be accepted. However, an applicant may, in
accordance with relevant laws, ask the State Food and Drug
Administration for administrative reconsideration or turn to the
People's court for administrative litigation.

**Article 92** The scope of re-examination is confined to previous
application items and application materials.

## Chapter VIII Legal Liabilities

　　

**Article 93** In cases below, the State Food and Drug Administration
may, in accordance with the requests of the stakeholder or its
responsibilities, follow the Article 69 of Administrative Licensing Law
to take actions after checking:

1)  A staff of administrative departments abuses his or her powers to
    grant registration;

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1)  Exceeding one's statutory authority to grant registration;

2)  Violate legal regulations to grant registration;

3)  Granting registration to a unqualified applicant or applicant unable
    to meet the legal requirements;

4)  In cases where in accordance with laws, administrative departments
    may cancel health food approval certificates.

　　

**Article 94** In cases below, the State Food and Drug Administration
should cancel the according health food approval serial number:

1)  A health food approval certificate holder applies for cancellation;

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1)  Confirming that the product has potential safety concerns;

2)  In cases where there is violation of laws and regulations, the
    health food approval certificate should be cancelled;

3)  Other cases where the certificate should be cancelled by laws.

　

**Article 95** In the process of health food registration, if personnel
of the State Food and Drug Administration and drug (food) administrative
departments in provinces, autonomous regions and municipalities violate
the regulations, in cases below, the administrative departments can, in
accordance with Article 72, 73, 74 and 75 of Law of Administrative
Permission, take actions:

1)  Refusal to process health food registration application which meets
    the legal requirements;

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1)  Refusal to make public materials for health food registration
    application;

2)  Unable to inform applicants according to laws when the health food
    registration application processed;

3)  In cases where the application materials are incomplete and not
    standard, unable to inform applicants of what are further required
    at one time;

4)  Unable to explain reasons why the application is refused to be
    processed or rejected;

5)  Granting registration to health food that does not comply with the
    Measures, or exceed one's statutory authority to grant registration;

6)  Refusal to grant registration to health food that comply with the
    Measures or unable to grant registration in due time;

7)  Charging an applicant individually or charging an applicant not in
    compliance with legal stipulations;

8)  Asking for or taking bribery, or for other interests.

**Article 96** During the process of health food registration, the State
Food and Drug Administration should provide compensation according to
the national compensation law if the Administration violates the
regulation and harms the legal rights and benefits of applicants.

**Article 97** An applicant hides relevant information or provides fake
material or sample products to apply for registration. Over this, the
State Food and Drug Administration should refuse to process that
application or grant registration, and issue warnings to the applicant.
The applicant is not allowed file that particular health food
application within a year.

**Article 98** In cases where an applicant gets the health food approval
certificate by cheating and bribery, the State Food and Drug
Administration should cancel his or her health food approval
certificate, and health food approval serial number. The applicant is
not allowed to file registration application for that particular health
food within three years.

**Article 99** In cases where designated testing agencies violate the
article 75 of the Measures, the State Food and Drug Administration
should ask it to make corrections in due time. As for wrongly charged
fees, the State Food and Drug Administration or other relevant
government departments should ask the agency to return that to the
applicant. In serious cases, the health food testing certificate will be
cancelled.

**Article 100** In cases where designated testing agencies violate the
Measures to conduct examination or make errors during the test and
examination, the State Food and Drug Administration should issue
warnings and ask it to make corrections. In serious cases, its health
food examination certificate will be cancelled.

**Article 101** In cases where the designated testing agencies issue
fake test reports or examination reports, its health food examination
certificate will be cancelled. Illegal earnings will be confiscated. In
cases of crimes, agencies must bear the criminal responsibilities.

In cases where designated testing agencies issue test reports or
examination reports that are unauthentic and brings about loss, the
agencies should bear the legal liabilities.

## Chapter IX Supplementary Provisions

**Article 102** Working periods mentioned in the Measures are working
days, excluding statutory holidays.

**Article 103** Packaging materials and containers that have direct
contact with health food must comply with national eating or medical
requirements ensure the safety of human health and safety standards.

**Article 104** The rights to explain the regulation rests with the
State Food and Drug Administration.

**Article 105** The Measures shall go into effect as of July 1, 2005.

Prior to the Measures, other measures on health food registration that
are incompatible with the Measures will be terminated.

## Appendix I Application Items for Product Registration

1\. Application Items for Domestic Health Food Registration

1\) Application Form for a Health Food Registration.

> 2\) Photocopies of an applicant's identity card, operation certificate
> or other legal registration certificates issued by other sectors.
>
> 3\) An applicant is required to supply proof that the intended name
> must be different from drugs that have been registered (which can be
> generated from the online database of the State Food and Drug
> Administration).

4\) Certificate to show the applicant do not infringe others' patent
right.

5\) Certificate of trademark registration (except unregistered
trademark).

> 6\) A report on the research and development of the product (including
> basic concept of the research and development, function screening
> process and expected effects).
>
> 7\) The formula producing health food (raw materials and supplementary
> materials) and its justification; sources of raw materials and
> supplementary materials and their usage justification.
>
> 8\) Functional ingredients/marker ingredients and the contents, and
> testing methods for functional ingredients/marker ingredients.
>
> 9\) Sketch of the producing technique, its detailed explanation and
> relevant research materials.
>
> 10\) Product quality standards and its formulation explanation
> (including quality standards for raw material and supplementary
> materials).
>
> 11\) Category, name, quality standards and selection basis of
> materials that have direct contact with the package.
>
> 12\) Test reports and other relevant materials issued by testing
> agencies, as follows:
>
> A. Test Application Form;
>
> B. Notification of testing request accepted by testing agencies;
>
> C. Security toxicology test report;
>
> D. Function test report;
>
> E. Test reports on dopes, illegal drugs, etc. (Registration
> application for functions including alleviation of physical fatigue,
> losing weight, and improving growing functions);
>
> F. Effective ingredient test report;
>
> G. Stability test report;
>
> H. Hygiene test report;
>
> I. Other test reports (including examination reports on raw material,
> test reports on virulence of bacterial categories).

13\) Samples of labels and instructions.

14\) Other materials helpful to product assessment and review.

15\) Two sealed samples in the sale package of minimal degree.

Note:

> a\. In terms of registration application of products made from
> epiphyte, beneficial bacterium, nucleic acid, enzyme preparation,
> amino acid chelate, applicants are required to supply above materials,
> but also to provide applications in accordance with relevant
> regulations
>
> b\. In terms of registration application of products made from
> nationally protected wildlife, applicants are required not only to
> supply above materials, but also to present the certificate issued by
> relevant government departments to show that an applicant is allowed
> to use that particular raw materials, and the trade contact signed by
> the raw materials provider and applicant.
>
> c\. In terms of registration application of the health food for adding
> to vitamins or minerals, an applicant is not required to provide test
> report on animal test reports or human trial test reports and function
> research and development reports and function research and development
> report.
>
> d\. In terms of registration application of health food whose
> functions are outside the list published by the State Food and Drug
> Administration, applicants are required not only to supply materials
> above on raw materials, but also to provide materials below on newly
> added functions: (1) Function research and development reports
> including information on function's name, application reasons and
> justification, the process of function testing and testing methods,
> research process and relevant data, function assessment procedures and
> justification of testing methods, and scientific literatures. (2) An
> applicant's self-test report on product function evaluation in
> accordance with the function evaluated process and test methods. (3)
> The test report issued by designated testing agencies on product
> function assessment in accordance with the function evaluation process
> and the test methods, and test report on testing assessment.
>
> e\. In terms of one single applicant applying for different forms of
> the same health food, if one form of that health food has undergone
> all the tests required and been issued testing reports, other forms of
> that health food can be waived of function and safety toxicology
> tests. But, the applicant is required to supply photocopies of those
> test reports. Essential change in the manufacturing techniques and
> changes affecting the security and functions are not covered.

2\. Application Items for Imported Health Food Registration

In terms of imported health food registration application, applicants
are required not only to supply application materials on raw materials
and functions declared as did with domestic health food, but also to
supply materials below:

> 1\) The certificate to prove that the producer of the health food
> meets quality management standards where the manufacturer is based,
> and the certificate should be issued by a relevant department where
> the manufacturer is based.
>
> 2\) If foreign enterprises' representative offices in China handle
> registration, they are required to present photocopies of Registration
> Certificate of Foreign Enterprises' Representative Offices in China.
>
> If agents in China are entrusted by foreign enterprises to handle
> registration, they are required to present a copy of notarized entrust
> letter and the photocopy of the operation license of entrusted agents.
>
> 3\) Certificate to show that the product has been produced and sold
> where the manufacturer is based for more than one year. That
> certificate must be attested by the notary agency where the health
> food is produced and confirmed by the Chinese embassy or consulate in
> the residing country.
>
> 4\) Relevant product standards of the country or region where the
> manufacturer is based or stipulated by certain international
> organizations.
>
> 5\) Samples of packages, labels and instruction to be used where that
> product goes to market.
>
> 6\) Samples of three continuous batch numbers, three times of what is
> needed for being tested.
>
> Application materials above must be in Chinese and attached with the
> original language. Materials in languages other than Chinese can be
> taken as reference. The Chinese translation must be notarized by
> Chinese notary agencies to ensure the translated parts are coherent
> with original meanings. Quality standards to be registered (in
> Chinese) must be in compliance with quality standards of Chinese
> health food in format.

## Appendix II Application Items for Alteration

1\. Application Items for Domestic Health Food Alteration

> 1\) Application Form of Domestic Health Food Alteration or Memo Form
> for Domestic Health Food Alteration.

2\) Names of altered items, reasons and proof.

> 3\) Photocopies of the applicant's identity card, business license or
> other legal registration certificates issued by other agencies.

4\) Photocopies of health food approval documents and its appendix.

> 5\) Newly proposed label of health food, draft specifications,
> attached by detailed alteration note.

Notes:

> a\. In terms of application for narrowing down applicable population,
> enlarging inapplicable population and alteration of important and
> notes, an applicant is required not only to supply information on the
> above items, but also to supply the product manufacturing and selling
> certificate issued by provincial health food administrative
> departments where the applicant are based.
>
> b\. In terms of application for altering intake, an applicant is
> required not only to supply materials on above item, but also to
> supply:
>
> 1\) The product manufacturing and selling certificate issued by
> provincial health food administrative departments where the applicants
> are based;
>
> 2\) Regarding application for decreasing intake, it is required to
> submit the test report that designated testing agencies produce after
> conducting function tests over the intended dose;
>
> 3\) Regarding application for increasing intake, it is required to
> submit the test report that designated testing agencies produce after
> conducting toxicological safety tests over the intended dose and
> function tests to compare the original intake with the intended
> intake.
>
> c\. In terms of application for altering Product specification, best
> before date and quality standards, an applicant is required to not
> only supply materials on above items, but also supply:
>
> 1\) The product manufacturing and selling certificate issued by
> provincial health food administrative departments where the applicants
> are based;
>
> 2\) Reports able to prove alteration will not change product safety
> and function, relevant research materials, scientific literature or
> test reports. In terms of application for altering quality standard,
> an applicant is required to supply relevant testing materials and
> literature review on quality standard research;
>
> 3\) Revised quality standard;
>
> 4\) Effective and marker ingredients, hygiene and stability self-test
> reports of samples with three continuous batch numbers;
>
> 5\) Samples with three continuous batch numbers, which should be three
> times of what is needed for the test (except application for altering
> best before date).
>
> d\. In terms of application for adding functions of health food, an
> applicant is required not only to supply materials above, but also to
> supply:
>
> 1\) The product manufacturing and selling certificate issued by
> provincial health food administrative departments where the applicants
> are based;
>
> 2\) Revised quality standard;
>
> 3\) Function test report of newly added functions of health food.
>
> e\. In terms of application for altering the name of health food, an
> applicant is required not only to supply materials above, but also to
> supply proof that the intended new name must be different from drugs
> that has been registered (which can be generated from the online
> database of the State Food and Drug Administration).
>
> f\. In terms of application for altering applicants' own names or
> addresses, applicants are required not only to supply materials above,
> but also to present applicant's name alteration or address alteration
> documents issued by local industry and commerce administrative
> departments.

2\. Application Items for Imported Health Food Alteration

> 1\) Application Form of Imported Health Food Alteration or Memo Form
> for Imported Health Food Alteration.

2\) Names of altered items, reasons and proof.

> 3\) If foreign enterprises' representative offices in China handle
> alteration, they are required to present photocopies of Registration
> Certificate of Foreign Enterprises' Representative Offices in China.
>
> If an agent in China is entrusted by foreign enterprises to handle
> alteration, they are required to present original copy of notarized
> entrust letter and the photocopy of the operation license of entrusted
> agents.

4\) Photocopies of health food approval documents and its appendix.

> 5\) Health food alteration certificates issued by relevant agencies
> where that particular health food is produced and relevant materials.
> That certificate must be attested by the notary agencies where the
> health food is produced and confirmed by the Chinese embassy or
> consulate in the residing country.

Notes:

> a\. In terms of application for narrowing down applicable population,
> enlarging inapplicable population and altering warnings, an applicant
> is required not only to supply information above, but also to supply
> samples of changed label and SP after alteration.
>
> b\. In terms of application for altering intake (product specification
> unchanged), an applicant is required not only to supply materials
> above, but also to supply:
>
> 1\) As for application for decreasing intake, it is required to submit
> the test report that designated testing agencies produce after
> conducting function tests over the intended intake;
>
> 2\) It is required to submit the test report that designated testing
> agencies produce after conducting toxicological safety tests over the
> intended and function tests to compare the original intake with the
> intended dose;
>
> 3\) Samples of labels and specifications after alteration.
>
> c\. In terms of application for altering Product specification, best
> before date and quality standards, an applicant is required to not
> only supply materials on above items, but also to supply:
>
> 1\) Reports able to prove that alteration will not change product
> safety and function, relevant research materials, scientific
> literature and or test reports. In terms of application for altering
> product specification, the applicant is required to supply relevant
> research materials and scientific literature on quality standard
> research;
>
> 2\) Effective and marker ingredients, hygiene and stability self-test
> reports of samples with three continuous batch numbers;
>
> 3\) Samples with three continuous batch numbers, which should be three
> times of what is needed for the test (except application for altering
> best before date);
>
> 4\) Samples of labels and instructions after alteration.
>
> d\. In terms of application for adding functions of health food,
> applicants are required not only to supply materials above, but also
> to supply:
>
> 1\) Function test report of newly added functions of health food;
>
> 2\) Samples of labels and instructions and quality standards.
>
> e\. In terms of application for altering the manufacturing site
> outside China, applicants are required not only to supply materials
> above, but also to supply:
>
> 1\) The certificate to prove that new manufacturing site meets quality
> management standards where the new side is based, the certificate
> should be issued by relevant departments where the new site is based;
>
> 2\) The certificate to prove that the health food is allowed to be
> sold where the new site is based;
>
> 3\) Effective and marker ingredients, hygiene and stability self-test
> reports of samples with consecutively three continuous batch numbers
> which should be produced in the new site;
>
> 4\) Samples with three different batch numbers that should be produced
> in the new site;
>
> 5\) Samples of labels and specifications after alteration.
>
> 6\) In terms of application for altering the name of health food, an
> applicant is required not only to supply materials above, but also to
> supply proof that the intended name must be different from the drug
> that has been registered (which can be generated from the online
> database of the State Food and Drug Administration). It is also
> required to supply samples of labels and instructions after
> alteration.
>
> 7\) In terms of application for altering applicants' own names or
> addresses, an applicant is required not only to supply materials
> above, but also to the certificate issued by relevant departments in
> the country or region where the health food is produced to prove that
> manufacturing site is unchanged. It is also required to supply samples
> of labels and specifications after alteration.
>
> 8\) In terms of application for altering agents in China, an applicant
> is required to supply materials above, but also to supply entrust
> letter and notarizations to prove that foreign health food
> manufacturers entrust new agents in China while canceling the entrust
> relations with previous agents.
>
> Application materials above must be in Chinese and attached with
> original language. Materials in languages other than Chinese can be
> taken as reference. The Chinese translation must be notarized by
> Chinese notary agencies to ensure the translated parts are coherent
> with original meanings. Quality standards to be registered (in
> Chinese) must be in compliance with quality standards of Chinese
> health food in format.

## Appendix III Application Items for Technical-Transfer Product Registration

1\. Application Items for Domestic Health Food Technology Transfer
Product Registration

1\) The Application Form for Health Food Technology Transfer
Registration.

> 2\) Photocopies of applicant's identity card, operation license or
> other legal registration certificates issued by other sectors.

3\) Effective transfer contract signed by both sides and notarized.

> 4\) Photocopy of technology transferee's health food hygiene license
> issued by provincial level health food administrative departments.
>
> 5\) Certificate that proves technology transferee complies with Good
> Manufacture Practice for Health Food, which is issued by provincial
> level health food administrative departments.
>
> 6\) Original copy of health food certificate (including health food
> certificate and its annexes and health food alteration file).
>
> 7\) Samples with three continuous batch numbers produced by technology
> transferees, which should be three times of what is needed for the
> test.

2\. Application Items for Registration of Imported Health Food
Technology Transfer to Chinese Enterprises

In addition to following Section One, applicants are required to supply:

If foreign enterprises' representative offices in China handle
registration, they are required to present photocopies of Registration
Certificate of Foreign Enterprises' Representative Offices in China.

If agents in China are entrusted by foreign enterprises to handle
registration, they are required to present original copy of notarized
entrust letter and the photocopy of the business license of entrusted
agents.

3\. Application Items for Imported Health Food Technology

1\) The application form for health food technology transfer
registration.

> 2\) Certificate to prove that the country or region where technology
> transferee is based allows that particular health food to be produced
> and sold in that country or region. That certificate should be
> notarized by notary agencies of countries where the technology
> transferee is based and approved by Chinese embassies or consulates of
> that country.
>
> 3\) Certificate issued by relevant agencies of where the technology
> transferee is based to prove that the health food is in compliance
> with the local quality management standards.
>
> 4\) Transfer contract. That contract must be notarized by notary
> sectors of countries where the technology transferee is based and
> approved by Chinese embassies or consulates of that country.
>
> 5\) If foreign enterprises' representative offices in China handle
> registration, they are required to present photocopies of Registration
> Certificate of Foreign Enterprises' Representative Offices in China.
>
> If agents in China are entrusted by foreign enterprises to handle
> registration, they are required to present original copy of notarized
> entrust letter and the photocopy of the operation license of entrusted
> agents.
>
> 6\) Original copy of health food approval certificate (including
> health food approval certificate and its attachments and health food
> alteration file).
>
> 7\) Effective and marker ingredients, hygiene and stability self-test
> reports of samples with three continuous batch numbers which should be
> produced in the new site.
>
> 8\) Samples with three continuous different batch numbers produced by
> technology transferees, which should be three times of what is needed
> for the test.

## Appendix IV Application Items for Re-registration

1\. Application Items for Domestic Health Food Re-registration.

1.  Application form for domestic health food re-registration.

2.  Photocopies of applicant's identity card, business license or other
    legal registration certificates issued by other agencies.

3.  Copy of health food approval certificate (including health food
    approval certificate and its attachments and health food alteration
    file).

4.  Copy of certificate to prove that health food administrative
    departments where that health food is produced allows that health
    food to be manufactured and sold.

5.  Summary of sales over the past 5 years.

6.  Summary of consumer feedbacks over the past 5 years.

7.  Samples of the package of health food of minimal degree, labels and
    specifications.

Notes:

If unable to supply materials above, an applicant must supply a written
explanation when applying for re-registration.

2\. Application Items for Imported Health Food Re-registration

1\) Application form for domestic health food re-registration.

> 2\) If foreign enterprises' representative offices in China handle
> registration, they are required to present photocopies of Registration
> Certificate of Foreign Enterprises' Representative Offices in China.
>
> If agents in China are entrusted by foreign enterprises to handle
> registration, they are required to present copy of notarized entrust
> letter and the copy of the business license of entrusted agents.
>
> 3\) Copy of health food approval certificate (including health food
> approval certificate and its attachments and health food alteration
> file).
>
> 4\) Certificate to prove that the country or region where the health
> food is produced allows that particular health food to be produced and
> sold in that country or region. That certificate should be notarized
> by notary agencies of countries where the health food is produced and
> approved by Chinese embassies or consulates of that country.

5\) Summary of imports and sales in China over the past 5 years.

6\) Summary of Chinese consumer feedbacks over the past 5 years.

> 7\) Samples of the package of health food of minimal degree, labels
> and specifications.

END TRANSLATION