Provisions for Health Food Registration (interim)

Chapter I General Provisions

Article 1 With a view to standardizing the registration of health food, guaranteeing the quality of health food,

ensuring food safety for people s consumption, the Provisions are formulated in accordance with Food

Hygiene Law of the People’s Republic of China and Administrative Reconsideration Law of the People s

Republic of China.

Article 2 The health food mentioned in the Provisions refers to those foods which claim to have certain

health functions or aim at supplementing vitamins and minerals, namely, those foods which are used for

certain groups of people with the aim to adjust organic function instead of curing diseases and will not cause

any acute, sub-acute or chronic damages to human body.

Article 3 The Provisions apply to the registration of both domestic and imported health food in the territory

of the People s Republic of China.

Article 4 the registration of health food refers to the application and approval procedures of the State Food

and Drug Administration to systematically assess and review the safety, effectiveness and quality control of

the health food applying for registration, as well as their labels, package insert and other contents, and then
determine whether to approve of the registration according to legal procedures, qualifications and

requirements, depending on the application of the applicant. The procedures include the review and approval

of registration application, application for alteration and registration application of technical transfer product.

Article 5 The State Food and Drug Administration is in charge of the registration administration work of the

health food nationwide and responsible for the review and approval of health food.

The (food) and drug Administration departments of the provincial, autonomous and municipal regions

directly under the Central Government are entrusted by the State Food and Drug Administration and are

responsible for the acceptance and format review of registration application dossiers for domestic health food,
checking the site for the testing and sample trial production of the health food in the registration application,

and organize the inspection of the samples.

The inspection institution designated by the State Food and Drug Administration is responsible for the safety

toxicology test, function test (including both animal testing and/or pre-eat test on human body, active
ingredients or badge element test, hygiene test, stability test; and conducts the specific inspection and recheck

of the samples.

Article 6 The registration and administration of health food should adhere to the principles of being scientific,

open,just, efficient and convenient.

Chapter II Application and Approval

Section I General Requirements
Article 7 The applicant for health food registration refers to the person who applies for health food

registration, is able to assume the relevant legal liabilities and holds the approval certificate for the health

food after the application is authorized.

The applicant in Chinese territory should be the citizen, legal person or other organizations legally registered

in the territory of China.

The foreign applicant should be a legal health food manufacturer in foreign countries. The imported heath

food registration of foreign applicants should be conducted by its representative office in China or the agency

in China who is entrusted by the foreign manufacturer.

Article 8 The registration of health food includes the product registration application, the application of

alteration and registration and the application of technical transfer product.

Article 9 The State Food and Drug Administration and the (food) and drug administration departments on the

provincial, autonomous, municipal level under the Central Government, should publicize the dossiers needed

for health food registration application and the relevant registration application model text at the department

location where health food registration application is accepted.

Article 10 The health food registration applicant should submit complete and standard dossiers and provide
actual conditions according to the provisions and should be responsible for the authenticity of the application

dossiers.

Article 11 The applicant should be permitted to alter mistakes outright in the application dossiers submitted

if any mistakes in the application dossiers is found outright.

Article 12 If the application Articles of the applicant are incomplete and do not conform to the legal formats,
the State Food and Drug Administration and the (food) and drug administration departments on the provincial,

autonomous, municipal level under the Central Government should inform the applicant of the dossiers

needed outright or in 5 days; if they do not inform the applicant within the time limit, the application is
namely accepted the day when the application dossiers are submitted. A written statement should be given to

the applicant if the application is not accepted.

Article 13 In the review process, the State Food and Drug Administration should inform the applicant at one

time of any other supplement dossiers needed. The applicant should submit the supplement dossiers within 5
months after they receive the notice. The application should be rejected if the supplement dossiers can not be

submitted at due time. The applicant must submit a written application and state the reason for the delay if the

supplement dossiers are overdue in special cases. The State Food and Drug Administration should respond

within 20 days.

Article 14 In the event of supplement dossiers needed in the registration application, the review period

should be prolonged by 30 days on the basis of the original review period and the period for the alteration of

the application should be prolonged by 10 days.

Article 15 If the registration is approved after a legal review process, the State Food and Drug

Administration should issue a health food approval certificate to the registration applicant in a stipulated time

and deliver it in 10 days; if the registration is rejected, it should inform the applicant in a written form in a

stipulated time, state the reason and inform the applicant of his right to apply for re-examination,

administrative reconsideration or lodge administrative litigation.

Article 16 The State Food and Drug Administration and the (food) and drug administration departments on

the  provincial,  autonomous,  municipal  level  under  the  Central  Government  should  inform  the  interested

person if they find that there are application dossiers directly related to maj or benefits of other people in the

review  process  of health  food registration  application. The applicant  and the interested person  can  submit

their statement and defense in written form or apply for a hearing according to the law.

Article 17 The State Food and Drug Administration should publicize the acceptance, review process of the

health food registration application information and relevant information of approved health foods at their

government website.

Article 18 The State Food and Drug Administration should duly adjust the function ranges of health foods,

assessment and inspection methods of health foods, as well as the technical standard in the review accord to

the development and need of science and technology and publish the information.

Section II the Product Registration Application and Approval

Article 19 The product registration application includes the domestic health food registration application and

imported health food registration application.

The domestic health food registration application refers to the application of the applicant who registers to

produce and sell health food in China.

The imported health food registration application refers to the registration application of health food which

has been produced and sold in foreign territory and will be sold in Chinese market.

Article 20 The applicant should conduct relevant research work before he applies for the health food
registration.

After the research work is completed, the applicant should submit the samples and relevant testing materials

to an inspection institution designated by the State Food and Drug Administration for the relevant test and

inspection.

If the applied health function is included the range published by the State Food and Drug Administration, the

applicant should provide the product research report by an designated inspection institution; if the applied

health function is not included in the range published, the applicant should conduct the animal test and
pre-eating test on human body independently and provide the function research and development report to the

inspection institution.

A product research and development report should include the research and development ideas, function

screening process and expected effects. A function research and development report should include the name
of functions, application reasons, function testing, assessment method and testing results. If the animal test

and pre-eating test on human body can not be done, the reason should be stated in the function research and

development report and the relevant data should be submitted.

Article 21 After receiving the samples and relevant data submitted by the applicant, the inspection institution

should conduct the safety toxicology test, function test, active ingredient test or badge substance test, hygiene

test and stability test according to the  health food inspection and assessment technology standard published

by the State Food and Drug Administration, as well as the inspection methods published by other relevant

departments and provided by the relevant industry. If the function is not included in the range published by

the State Food and Drug Administration, the applicant should validate the function test and the methods of

assessment and the test results, and submit the testing report.

Article 22 The applicant can apply for the health food registration only after the test report is issued by the

inspection institution.

Article 23 When applying for the domestic health food registration, the applicant should fill in Application

Form for Registration of Domestic Health Food according to the provisions and submit the application

dossiers and samples to the (food) and drug administration departments on the provincial, autonomous,

municipal level under the Central Government, where the sample trial production is located.

Article 24 The (food) and drug administration departments on the provincial, autonomous, municipal level
under the Central Government should review the application dossiers on their standard and integrality forms

and samples and send an acceptance or rejection notice to the applicant within 5 days after receiving the

application dossiers

Article 25 Concerning those qualified registration applications, within 15 days after the acceptance of the
application, the (food) and drug administration departments on the provincial , autonomous, municipal level

under the Central Government should inspect the site of test and sample trial production, select samples for

inspection, provide a review conclusion and submit the conclusion and application dossiers to the State Food
and Drug Administration and at the same time send an inspection notice to the designated inspection

institution and provide samples for inspection.

Article 26 The samples needed for health food registration application should be produced in the workshop

which meets the Good Manufacturing Practice for Health Food and the processing must conform to the

provisions in the Good Manufacturing Practice for Health Food.

Article 27 After receiving the inspection notice and samples, the inspection institution should inspect and

recheck the samples and submit the inspection report to the State Food and Drug Administration and at the

same time send the copies of the inspection report back to the (food) and drug administration department on
the provincial, autonomous, municipal level under the Central Government and the applicant. In special cases,

when the inspection institution cannot complete the inspection task within the stipulated time, it should

inform the State Food and Drug Administration and the (food) and drug administration departments on the
provincial, autonomous, municipal level under the Central Government in written form to state the reason in

time.