Presentation from a webinar, held on 18 August 2016, by CIRS

1. www.cirs-reach.com
One Stop Service of China
Food Regulatory
Compliance
Interpretation of Administrative Measure on Health Food
Registration and Filing
cathy.yu@cirs-group.com
18 August 2016

2. 目录CONTENTS
www.cirs-reach.com
 Introduction of Health Food in China
 Overview of China Health Food Regulations
 Introduction of Administrative Measure on Health
Food Registration and Filing
 Health Food Raw Material Directory
 Process of Health Food Registration and Filing
 Document Requirements of Health Food Registration
and Filing
 Testing Scope of Health Food Registration and Filing
 The Difference Between Health Food Registration and
Filing

3. www.cirs-reach.com
Introduction of Health Food in China
What is health food in China?
• has specific health function or supply vitamins and (or) minerals
• is suitable for specific groups of people
• regulates body's function, but cannot treat disease
• has no acute, sub-acute or chronic health effect to human body
• different from general(common) foods or medicines

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Introduction of Health Food in China
How do we judge the difference of health food from general food or drug?
I. Compared with drug:
a. cannot prevent or treat disease
b. non-toxic
c. for oral use only
d. food or health food raw material (cannot use poisonous or harmful substance)
II. Compared with general food:
a. has health function claim
b. can use health food raw material
c. are suitable for specific groups of people

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Introduction of Health Food in China
The names of health food in different countries
China:
EU:
USA:
Canada:
Australia:
Korea:
Japan:
Health Food
Food Supplement
Dietary Supplement
Natural Health Product
Complementary Medicines
Health Functional Food
Food with Health Claims (FHC)

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Overview of China Health Food Regulations
Name Released Date Implemented Date
Food Safety Law of the People‘s Republic of China (2015 version) 2015.04.24 2015.10.01
Administrative Measure on Health Food Registration and Filing 2016.03.01 2016.07.01
Administrative Measure on Health Food Function Directory and
Food Raw Material Directory (Draft)
2015.07.28 -
Administrative Measure on the Labeling of Health Food (Draft) 2015.07.28 -
Name List of Excipients available for Health Food Filing (the first
batch) (Draft) &Name List of Health Food Filing Excipients Need
Further Argument
2016.05.30 -
Health Food Raw Materials Directory (the first batch) –Nutrition
Supplement Raw Materials (Vitamins and Minerals) Directory
(Revised Draft)
2016.06.02 -
Detailed Rules on Health Food Registration Technical Evaluation
(Draft)
2016.06.08 -
Requirements for Health Food Registration Dossier (Draft) 2016.06.08 -
......(updated regulations)

7. www.cirs-reach.com
Overview of China Health Food Regulations
In accordance with Food Safety Law of the People’s Republic of
China (2015 version), companies who plan to place health food
in Chinese market shall apply and obtain the health food
registration certificate or filing certificate.
For domestic health foods produced in China, the registration
shall be conducted with CFDA, whereas, the filing shall be
carried out with Provincial Food and Drug Administration (FDA).
For imported health foods produced in oversea factories, both
the registration and filing shall be applied with CFDA.
PS. Oversea companies shall have a permanent Chinese representative
office or appoint a Chinese agent to deal with registration or filing and
obtain such certificates.

8. www.cirs-reach.com
Introduction of Administrative Measure on Health Food
Registration and Filing
Classification of Health Food in China
I. Nutrition supplement:
Food that provides the vitamins and (or) minerals but without
providing energy or other active ingredients.
II. Functional health food:
Food that labeled with health function claim has physiological
effects on the human body.

9. www.cirs-reach.com
Introduction of Administrative Measure on Health Food
Registration and Filing
The biggest change is the new policy- Filing
What health food could do the filing?
For imported health food, first, it shall be a
nutrition supplement, second, it shall meet the
requirements in the Health Food Raw Materials
Directory.
For domestic health food, it shall meet the
requirements in the Health Food Raw Materials
Directory.

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Introduction of Administrative Measure on Health Food
Registration and Filing
Applicant's qualification should be noticed that
For imported health food, both the registration
and filing applicant shall be the oversea
manufacturer of the marketed health food
(oversea manufacturer refers to the legal person
or other organization).
For domestic health food, the registration
applicant shall be the registered legal person or
other organization. However, the filing applicant
shall be the factory that has the production
qualification.

11. www.cirs-reach.com
Health Food Raw Material Directory
February 17, 2016: Health Food Raw Materials Directory (the first batch) –Nutrition Supplement
Raw Materials (Vitamins and Minerals) Directory (Draft)
June 2, 2016: Revised Health Food Raw Materials Directory (the first batch) –Nutrition
Supplement Raw Materials (Vitamins and Minerals) Directory (Draft)
Revised version contains
• 22 kinds of vitamins and minerals
• 68 compounds

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Health Food Raw Material Directory
Take the mineral-Magnesium as an example:
Nutrition
name
Compound
name
Functional
components
Suitable
crowds
Minimum
daily
intake
Maximum
daily
intake
Magnesium
Magnesium
carbonate
Mg (account
as Mg, mg)
1-3 years / /
4-6 years 30 200
Magnesium
phosphates
7-10 years 45 250
11-13 years 60 300
Magnesium
chloride
14-17 years 65 300
Adult 65 350
Magnesium
oxide
Pregnant
women
70 350
Wet nurse 70 400

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Health Food Raw Material Directory
If the vitamin and mineral nutrition supplements are not complying with requirements
of Health Food Raw Material Directory, then the products cannot be filed and shall get
registered. In the following circumstances, vitamin and mineral nutrition supplements are
considered as not complying with the requirements of Health Food Raw
Material Directory:
• The daily intake of vitamins and minerals is not in compliance with that listed in
the Health Food Raw Material Directory;
• Compounds of the vitamins or minerals that are not listed in the Health Food Raw
Material Directory;
• The supplemented vitamins and minerals are not listed in the Health Food Raw
Material Directory; and
• Vitamins and minerals that are extracted from edible part of the food.

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Health Food Raw Material Directory
Key Points when using the raw materials:
I. Both the content of the nutrient supplements claimed on the label for filing and the
scope of nutrient contents listed in the technical requirements shall not exceed the
recruitment amount for target users;
II. If the compound is not in the list but the health food manufacturer still hopes to put
the compound into its filing health food, the manufacturer shall, in accordance with
relevant requirements of Administrative Measures on Health Food Function Directory
and Food Raw Material Directory, apply for the approval to list the compound in the
Health Food Raw Materials Directory. (PS. Another choice: If the compound is not in
the list, the health food manufacturer could do the registration.)
III. Dosage form of nutrient supplements for filing shall not be: sustained release
preparation, controlled release preparation, sublingual absorption preparation,
enteric-coated preparation, spray preparation and so on. As a result, it is
recommended that enterprises should not apply for filing for the above mentioned
dosages.

15. www.cirs-reach.com
Health Food Raw Material Directory
Latest Health Food Raw Material Directory: Revised Health Food Raw
Materials Directory (the first batch) –Nutrition Supplement Raw Materials
(Vitamins and Minerals) Directory (Draft)
PS. The Draft only could be a reference.
Subsequent Health Food Raw Material Directory:
1. Health Food Raw Materials Directory (the first batch) –Nutrition
Supplement Raw Materials (Vitamins and Minerals) Directory (Formal)
2. Health Food Raw Materials Directory (the second batch) –Functional
Health Food Raw Materials Directory (Only available for domestic)
3. The third batch
4. The fourth batch
5. …..

16. www.cirs-reach.com
Process of Health Food Registration and Filing
Registration process Timeline
1 Feasibility analysis by CIRS 7 workdays
2 Dossier compose by CIRS 1 month
3 Sample test by laboratory 7-14 months
4 Dossier preparation and submission by CIRS 1 month
5 Technical evaluation by CFDA with 60 workdays
6 Additional documents preparation and
submission if necessary by CIRS
within 3 months
7 On-site verification if necessary by CFDA with 30 workdays
8 Re-test if necessary by CFDA with 60 workdays
9 Registration approval by CFDA with 20 workdays
10 Send registration certificate by CFDA with 10 workdays

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Process of Health Food Registration and Filing
Filing process Timeline
1 Feasibility analysis by CIRS 5 workdays
2 Dossier compose by CIRS 20 workdays
3 Sample test by laboratory 1-3 months
4 Dossier preparation and submission by CIRS 10 workdays
5 Additional documents preparation and
submission if necessary
Case by case
6 Filing approval and certificate issued by CFDA
1 workday according to the
regulation.
(30 workdays according to
CFDA suggestion)

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Document Requirements of Health Food Registration and Filing
Document requirements of registration
• Health food registration application form; Letter of commitment for authenticity of the
materials;
• Copies of legally registered certificates of the applicant;
• Product development report including the product technical requirements;
• Product formulation materials (APIs and excipients);
• Product production process materials;
• Safety and function assessment material; and tests reports of functional
components/characteristic ingredients, stability, hygiene health and others if necessary;
• Information of packaging materials in direct contact with the product;
• Samples of product label and package insert;
• 3 samples with the minimum sales packaging;
• Other materials pertaining to the product registration technical evaluation.

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Document Requirements of Health Food Registration and Filing
Document requirements of filing
• Health food filing application form; Letter of commitment for authenticity of the materials;
• Copies of legally registered certificates of the applicant;
• Product formulation materials (APIs and excipients);
• Product production process materials;
• Information of packaging materials in direct contact with the product;
• Samples of product label and package insert;
• Product technical requirements;
• Test according to product technical requirements;
• Other materials proving product safety and health function.

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Document Requirements of Health Food Registration and Filing
Additional document requirements of imported health food
• Qualification certifying documents issued by government authorities or legal service
agencies in the producing country (region) of origin proving that the registration applicant
is the oversea manufacturer of the health food marketed;
• Certifying documents issued by government authorities or legal service agencies in the
producing country (region) of origin proving that the product has been marketed more
than a year, or safety report of oversea sales and consumer’s feedback;
• Health food-associated standards issued by the product producing country (region) of
origin or international organizations;
• Packaging, labels, package inserts for products marketed in the producing country
(region)of origin;
• For registration affairs run by oversea manufacturer’s Permanent Representative in China,
a copy of the "registration certificate of oversea enterprise’s permanent Chinese
representative offices" shall be provided; for registration affairs run by domestic agencies
entrusted by oversea manufacturers, the applicant shall provide the original notarized
certificate of entrustment and copies of business license of the agencies entrusted.

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Document Requirements of Health Food Registration and Filing
Registration dossier requirements for product containing extracts
• The manufacturing technique of extract
shall be submitted;
• The technical requirements of extract
shall be submitted;
• The total items self-test report of extract
according to the technical requirements
shall be submitted.
Technical requirements for extracts are including: source,
manufacturing technique, extract rate and sense
requirements, general quality control index (such as
moisture, ash content and particle size), pollutant index
(such as lead, total arsenic, total mercury, residue of
extraction solvent), pesticide residue, characteristic
ingredients index, microbiological indicator (including total
bacterial count, coli group, molds and yeasts, staphylococcus
aureus as well as salmonella), etc.

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Testing Scope of Health Food Registration and Filing
Testing scope of registration
• Functional components test,
hygiene test, and stability
test;
• Toxicology test;
• Animals function test;
• Human function test；
• Other tests if necessary.

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Testing Scope of Health Food Registration and Filing
Testing scope of registration- Functional components test, hygiene test,
and stability test
In order to make the test result more reliable, the functional components test,
hygiene test, and stability test shall be carried out for 3 batches of samples.
What is stability test? if the shelf time of the product is 2 years, accelerated test (For
accelerated test, the samples shall be stored at temperature 37±2℃, relative
humidity RH75±5%, away from direct sunlight for 3 months) will be used. Then the
laboratory will test the functional components and hygiene items four times
(1.before stability test, 2. after 1 month, 3. after 2 months, 4. after 3 months)

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Testing Scope of Health Food Registration and Filing
Testing scope of registration- Function test

25. www.cirs-reach.com
Testing Scope of Health Food Registration and Filing
Testing scope of registration- Function test

26. www.cirs-reach.com
Testing Scope of Health Food Registration and Filing
Testing scope of registration- Other tests if necessary
1 Stimulants, illicit drugs test (for functions Alleviating physical fatigue,
Weight control, improving child growth).
2 Strain identification and virulence test (if add probiotics)
3 Strain identification test (if add some special ingredients, eg. Rhodiola
rosea, spirulina)

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Testing Scope of Health Food Registration and Filing
Testing scope of filing
• Functional components test
& hygiene test;
• Stability test (for the
moment, not sure if
needed);

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Testing Scope of Health Food Registration and Filing
Authorized laboratories
1. http://www.sfda.gov.cn/WS01/CL1158/90881.html
2. http://www.sfda.gov.cn/WS01/CL1158/90880.html
3. http://www.sfda.gov.cn/WS01/CL1158/109561.html
4. http://www.sfda.gov.cn/WS01/CL1158/109613.html
5. http://www.sfda.gov.cn/WS01/CL0847/124180.html
PS. All the registration and filing tests shall be carried out in the above 58
laboratories authorized by CFDA

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The Difference Between Health Food Registration and Filing
• Functional components test
& hygiene test;
• Stability test (for the
moment, not sure if
needed);
Registration Filing
Dossier
R&D report and Safety and function assessment materials shall be
submitted for registration but not required for filing.
Test
Toxicology test and function test are needed for registration but
not necessary for filing.
Cost 400,000RMB-800,000RMB 100,000RMB-200,000RMB
Duration 2-3years 3-6months
Format of the
registration No. and
filing No. for
imported health food
国食健注J+4 numbers of the
year code +4 sequence
numbers (eg.国食健注
J20170001)
食健备J+4 numbers of the year
code +00+6 sequence numbers (eg.
食健备J201700000001)
Format of the
registration No. and
filing No. for domestic
health food
国食健注G+4 numbers of
the year code +4 sequence
numbers (eg.国食健注
G20170001)
食健备G+4 numbers of the year
code +2 numbers of the provincial
code+6 sequence numbers (eg.食
健备G201701000001)
PS. Please click here to find more difference between the registration and filing.

30. Thank You!
Add：11/F., Bldg 1, Dongguan Hi-Tech Park, 288 Qiuyi Rd, Binjiang
District, Hangzhou, China
Zip：310052
Tel：+86 571 87206538
E-mail：cathy.yu@cirs-group.com
More information regarding food import can be found here:
Link: www.cirs-reach.com

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