interpretation of administrative measure on health food registration filing, 2016
TRANSCRIPT
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One Stop Service of China Food Regulatory Compliance
Interpretation of Administrative Measure on Health Food
Registration and Filing
[email protected] August 2016
目录CONTENTS
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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
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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 diseaseb. non-toxicc. for oral use onlyd. food or health food raw material (cannot use poisonous or harmful substance)
II. Compared with general food:
a. has health function claimb. can use health food raw materialc. 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)
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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.
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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.
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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.
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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.
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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. …..
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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
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Testing Scope of Health Food Registration and Filing
Testing scope of registration- Function test
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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. Rhodiolarosea, 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 58laboratories 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
DossierR&D report and Safety and function assessment materials shall be submitted for registration but not required for filing.
TestToxicology 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 domestichealth 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.
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