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1. Background introduction in China

1.1 Introduction of China health food market
Ø With the strengthened awareness of health caused by aging and environmental pollution in China, health food market will grow at an average annual rate of 10-15%, from RMB260 billion in 2016 to RMB400 billion in 2021. Moreover, consumers’ mind-set about health food is gradually shifting from being seen as luxury goods to ordinary consumer products.
Ø Besides, implementation of Outline of "healthy China 2030" and National Nutrition Program (2017 - 2030) indicated that the state will actively raise the nutrient intake of its people, and will make the development of health food and nutrient fortified food one of its priorities. This will help boost the development of China’s health food market.
Ø From regulatory point of view, after 30 years development, China has set up a complete regulatory system from health food, “Administrative Measures for Registration and Filing of Health Food” that has been implemented since 2016 opened the registration admittance and filing double-track system of health food products, and the relevant supporting regulations have been promulgated in succession.
Ø With the positive policy background as well as increasing demand, China health food industry will continue to grow steadily. In this report, Foodmate, as the leading food regulation consulting company in China, reviews the development process of market and management of health food, analyzes the opportunities and challenges faced by the imported health food enterprises, and interprets the relevant laws and regulations of health food registration and filing in details.

1.2 Booming opportunity for foreign companies in China health food market
1) Booming demands
Booming demand for health food and imported health food is more preferred:
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2) Booming demands drivers
Urbanization & aging are key drivers for the demand, policy & e-commerce are playing key enabling role:
Urbanization
Consumers’ disposable income increased which can afford more health food consumption
Environmental pollution which makes people become much care about their health and demand for health food
Ageing of population
 
Population above 60 will take 17% of the total population
Aging of the population causes the management demand of slow disease like Strengthen immunity, regulation of blood glucose and blood lipid ,etc. which will bring vast opportunities for health food industry
Policy and regulatory perspective
 
Outline of "healthy China 2030" , National Nutrition Program (2017 - 2030) provides an unprecedented opportunity for health food industry
Registration and filing system shorten and simplified duration and process
Booming of e-commerce
Much easier
More convenient
Lower cost
1.3 Regulatory compliance - the biggest challenge for foreign health food entering to China 
                                                                     
Year
Development
1987
First health food regulation “Regulation for Administration for Traditional Chinese Medicine Health Care Drugs” was issued
1996
Health food management steps into legislative track. “Administrative Measures for Health Food” was implemented, and the auxiliary documents of registration, production, and operation, etc. Of health food were issued
2003
Examination & approval and administration of health food was in jurisdiction of CFDA in the function adjustment
2005
Health food registration management system in China was increasingly complete Administrative of Health Food” was implemented
2013
China Food and Drug Administration was established Strengthen health food management in market like carry out “Striking four illegal behaviors” action for health food to purify market.
2015
Historically defined the legal status of health food. The “Food Safety Law of the People’s Republic of China” was revised.
2016
only registration system to registration & filing dual-track system the “Administrative Measures for Registration and Filing of Health Food” was implemented.

Ø Health food definition has been clarified
Ø 28 health food functions has been defined
Ø Approval ingredients/raw materials scope for health food has been established
Ø From only registration system to registration and filing dual systems
Ø Comprehensive regulatory structure and strict supervision system have been refined

2) Challenges for foreign health food companies to enter China market
Ø Unfamiliar with complicated registration requirement and process
Ø Unfamiliar with approval 28 function in China health food
Ø Unfamiliar with the allowed ingredient/raw material can be used in health food
Ø Lack of support for lots of detections which must be conducted in China
 
2. What are health food?

Health food refer to food products which are claimed to have certain specific health functions or can supplement certain vitamins and/or minerals, and have been legitimately licensed for the same. In other words, the foods are suitable for certain people to help them improve body functions without the purpose of therapy, and will bring no acute, sub-acute or chronic harm to human body.

2.1 Classification of Health Food in China:
Ø Nutrition supplement:
Food that provides the vitamins and /or minerals but without providing energy or other active ingredients.
Ø Functional health food:
Food that labeled with health function claim has physiological effects on the human body.

 
2.2 Health food functions approved in China:
No.
Approved functions
1
Strengthen immunity
2
Nutrition supplement
3
Relieve physical fatigue
4
Assist to reduce blood fat
5
Anti-oxidative
6
Facilitate feces excretion
7
Assist to regulate blood sugar level
8
Increase bone mineral density
9
Improve sleep
10
protect function for the chemical liver injury
11
Lose weight
12
Enhance anoxia endurance
13
Remove chloasma
14
Assist to improve memory
15
Clear heat from throat
16
Improve alimentary anemia
17
Protect function for radiation hazards
18
Relieve asthenopia
19
Adjust intestinal flora
20
Assist to reduce blood press
21
Protect function for gastric mucosal damage
22
Promote digestion
23
Improve skin moisture
24
Improve growth & development
25
Remove acne
26
Promote lead detoxification
27
Accelerate lactation
28
Improve oil in skin
2.3 Ingredients and raw materials allowed to be used in health food:
No.
Raw materials allowed to be used in health food
1
“Health Food Raw Materials Contents” (I) (2016)
2
“Compilation of guidelines for technical requirements of raw materials and auxiliary materials for health food registration” (First batch) (2014)
3
“List of articles that are both food and medicine” (2002)
4
“List of articles that can be used for health food” (2002)
5
“List of strains that can be used for food” (2010)
6
“List of strains for infants and young children” (2011)
7
Raw materials of common food (“China Food Composition” 2002, 2004)
8
Raw materials of novel food (refer to the website of National Health
and Family Planning Commission)
9
Nutritional fortification substances in foods (GB 14880)
10
Food additives (GB 2760)
11
Other available lists published by Ministry of Health and National Health and Family Planning Commission
12
Other available lists published by CFDA
13
Available lists acquiesced
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Raw materials in the “List of articles prohibited in health food” (2002) shall not be used in health food products

3. Regulatory framework for health food

Regulatory framework
Name
Administrative Department
China Food and Drug Administration (CFDA)
Health Food Registration & Filing Regulations
Food Safe Law of The People’s Republic of China (2015)
Administrative Measures of Health Food Registration And Filing(2016
Guidance for Health Food Registration (2016)
Detailed Guidance for Health Food Registration Approval (2016 Version) (2016
List of Approved Health Food Raw Materials Directory (The 1st Batch) (2017
List of Auxiliary Materials for Health Food Filing and Terms of Use (Trial) (2017)
Directory of Health Function Available to Claim for Health Food (The 1st Batch) (2017)
Guideline for Health Food Filing Application (Trial) (2017
Main Production Process of Health Food Filing Products (Trial) (2017)
Production & Operation Regulations
Food production license management measures (Revised 2015,2017)
Health Food Production License Review Rules (2016
Food Business License Review General Rules (Trial)2015
Management Measures for Daily Supervision And Inspection of Food Production And Operation2016
Food Safety Sampling Inspection Management Measures2014
Internet Food Safety Violations Investigation Measure2016
Food Recall Management Measures2015
Measures for the Supervision and Administration of the Quality and Safety of the Marketing of Edible Agricultural Products2016
import & Export Regulations
import and Export Food Safety Management Measures 2011
import and Export Pre-Packaged Food Label Inspection Supervision and Management Regulations (2012)
Regulations on the Registration of Foreign Producers of imported Foods2012
imported Food importers and Exporters Filing Management Regulations (2012)
import and Export Commodities Random Inspection Management Measures (2002)
import and Export Goods Exemption Inspection Measures (2002)
Product Standard
GB 16740-2014 National Standard for Health Food

4. Health food registration 

4.1 The Procedure of health food registration
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NOTE: yr means year; wd means working days
4.2 Materials submitted for health food registration
materials submitted
Registration application form and the legal liability commitment of the applicant for the authenticity of the application materials
Scanning copy for supporting document of subject registration of the applicant
Product R&D report,
documents related to product formulation
The production process materials of product
The materials for evaluation on safety and healthcare function test
Type, name and standards of packaging materials directly contacting health food
Manuscript of product label and specification and the searching information certifying that the common name in product name is not the same as the registered drug, and that certifying that the product name is not the same as the healthcare food name which has been approved or filed
3 minimum packaged samples for sale
10 Other materials related to appraisal on product registration
Additional materials submitted for initial import
Ø The qualification certificate whose registration applier is overseas manufacture of health food on sale issued by the competent government department or law service institution of the producing country (region) of product
Ø The certificate issued by the government competent department or law service institutions of the producing country (region) certifying that the health food had put on the market for more than one year, or the safety report on overseas sale of product and population consumption situation
Ø The text of technical regulations or standards related to health food of producing country (region) or international organizations
Ø The packing, label and instruction sample of product which has been put on market in producing country (region);

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Ø 3: Including R&D person, R&D time, R&D process, the verification data of the medium testing, reports and relevant scientific basis for the raw materials out of the catalog and product safety, health care functions, and quality control, as well as product technical requirements comprehensively determined based on R&D results, etc.
Ø 4: Including the name and amount of raw materials and auxiliary materials, production processes, quality standards, if necessary, should also be provided in accordance with the provisions of the basis for the use of raw materials, the use of parts of the description, inspection certificate, variety identification report.
Ø 5: The production process materials of product; Including production process chart and description, key process control points and instructions
Ø 6: Including the safety of the raw materials and products outside the catalog, testing evaluation materials of health care function, evaluation materials for human consumption, test reports on efficacy ingredients or signature ingredients, hygiene, stability, strain identification, bactericidal virulence, etc., and involving stimulants, illicit drug ingredients and other test reports

5. Health food filing

5.1 The list of nutrient supplements ingredients








According to Administrative measures of health food registration and filing, the filer person shall be an overseas manufacturer of health food on the market. The filer of domestic health food shall be health food manufacturer, the original registrant can serve as a filer.

5.2 Procedure of filing
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5.3 Materials submitted for health food filing
materials submitted
Filing application form and the legal liability commitment of the applicant for the authenticity of the application materials
Scanning copy for supporting document of subject registration of the filing applicant
Materials of product technical requirements
documents related to product formulation
The production process materials of product
The materials for evaluation on safety and healthcare function test
Type, name and standards of packaging materials directly contacting health food
Manuscript of product label and specification and the searching information certifying that the common name in product name is not the same as the registered drug, and that certifying that the product name is not the same as the healthcare food name which has been approved or filed
All-items inspection report issued by the inspection organization entitled with legal qualification and in conformity with the product technical requirements
10 Other materials indicating the safety and healthcare function of products
Additional materials submitted for initial import
Ø The qualification certificate whose registration applier is overseas manufacture of health food on sale issued by the competent government department or law service institution of the producing country (region) of product
Ø The certificate issued by the government competent department or law service institutions of the producing country (region) certifying that the health food had put on the market for more than one year, or the safety report on overseas sale of product and population consumption situation;
Ø The text of technical regulations or standards related to health food of producing country (region) or international organizations
Ø The packing, label and instruction sample of product which has been put on market in producing country (region);

 
6. Special tips about health food

Ø The same company may not use the same formula to register or file health foods of different names; it may not use the same name to register or file health foods of different formulas.
Ø Where the registrant of a health food is transferring technology, the transferee shall re-apply for an application for product registration under the direction of the transferor, and the product technical requirements, etc. shall be consistent with the original application materials.
Ø The label and instructions of health food shall not involve prevention or treatment of diseases; content of the label and instruction shall be true. It shall indicate clearly the suitable and unsuitable groups, functional ingredients or significant ingredients and their content, and shall state “This is not a replacement for medicine”.

7. Our services

Service
Content
 
Required document
review & correction
 
Ø Step by step process guideline
Ø Collect and analyze materials from client
Ø Supplement and revision opinions
Ø Advice on modification in order to meet China statutory requirements
 
Sample inspection
Ø Sample receiving and tracking
Ø Arrange sample inspection
Ø Track inspection progress & handles problems
Ø Inspection report review  
Dossier preparation
Ø Build up dossier storyline structure 
Ø Consolidate draft from English to Chinese
Dossier Submission
online submission
On-site submission
 
Progress following up
Ø Follow up the CFDA review process
Ø Face to face talking with CFDA and supplement required documents accordingly
Contacts

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TEL:010-68869850
Email:global-service@foodmate.net
ADD: W. 4th Ring Road North No.160 Haidian Beijing China

 

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TEL: 0535-2129301
Email:hanking@foodmate.net
ADD: West area, Donghe Technology Park, No. 229 Tongshi South Road, Zhifu District, Yantai City, Shandong Province

 

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Tel: +41 784034643
Email: EUoffice@foodmate.net
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