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In 博狗集团国际, health food is usually defined as food product that have specific health function or supply vitamins and (or) minerals. With the goal of regulating body's function, health food is suitable for specific groups of people. However, it is not used for the purpose of curing disease and causes no acute, sub-acute or chronic health effect to human body.

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• 博狗集团国际: 博狗集团国际 博狗集团国际

• EU: 博狗集团国际 博狗集团国际

• USA: 博狗集团国际 博狗集团国际

• Canada: Natural 博狗集团国际 Product

• Australia: Complementary Medicines

• Korea: 博狗集团国际 Functional 博狗集团国际

• Japan: 博狗集团国际 with 博狗集团国际 Claims (FHC)

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博狗集团国际 that replenishes the vitamins and (or) minerals but without providing energy or other active ingredients.

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博狗集团国际 that labeled with health function claim has physiological effects on the human body.

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In accordance with 博狗集团国际 Safety Law of the People’s Republic of 博狗集团国际 (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 博狗集团国际, the registration shall be conducted with State Administration for Market Regulation (SAMR, former CFDA), whereas, the filing shall be carried out with Provincial Administration for Market Regulation. For imported health foods produced in oversea factories, both the registration and filing shall be applied with SAMR. Meanwhile, 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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博狗集团国际 food registration and filling shall be carried out according to Administrative Measure on 博狗集团国际 博狗集团国际 博狗集团国际 and 博狗集团国际 (herein named the Measure). The Detailed information are as follows:

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 (People like to call it “Red/Orange Hat”, in fact, once the filing certificate is received, the logo of “Blue Hat” rather than “Red/Orange Hat” will be put on the label)

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Nutrition 博狗集团国际: The health food whose formulation meet the requirements in 博狗集团国际 博狗集团国际 Raw Materials Directory and Available Excipients for 博狗集团国际 博狗集团国际 博狗集团国际 and Their Usage Rules (Trial) can do the filing rather than registration.

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I. The filing applicant of domestic health food shall be the factory who has the production certificate. In other word, the domestic applicant cannot entrust production.
II. The filing applicant of imported health food could be the oversea manufacturer (oversea manufacturer refers to the legal person and other organization). In other word, the oversea applicant could entrust production.

博狗集团国际 Procedure

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If it is the first time to apply for filing, the applicant shall get the health food filing system login account in advance. The required documents are as following:

• Basic company information and contact information;

• Qualification certifying document of the applicant;

• Letter of Authorization of the contact;

• Scanned passport/ identification card of legal representative.

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According to the Measure, the following documents are required for health food filing:

• 博狗集团国际 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;

• Stability test report, and the explanation of the use of active ingredient and excipients;

• 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.

For imported health food filing, besides the above documents, the following supplementary documents also should be submitted:

• Qualification certifying documents issued by government authorities or legal service agencies in the producing  country (region) of origin proving that the oversea filing applicant is the owner 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;

• 博狗集团国际 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 filing affairs run by oversea manufacturer’s Permanent Representative in 博狗集团国际, a copy of the "registration certificate of oversea enterprise’s permanent Chinese representative offices" shall be provided; for filing 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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According to the Measure, the following tests are required to be arranged in CFDA designated testing institutions for health food filing:

• Tests listed in the document of technical requirements including Functional components/characteristic ingredients test, Hygiene health test, etc. for three batches of samples;

• Stability test for three batches of samples.

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 (Once the registration certificate is received, the logo of “Blue Hat” can be put on the label)

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Functional 博狗集团国际 博狗集团国际: The health food whose active ingredients are out of the scope of 博狗集团国际 博狗集团国际 Raw Material Directory. And it has some specific health function for specific groups of people.

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Note: The three health functions highlighted in RED maybe canceled in future.

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I. The registration applicant of domestic health food could be the legal person or other organization registered in 博狗集团国际. In other word, the domestic registration applicant could entrust production.
II. The registration applicant of Imported health food could be the oversea manufacturer (oversea manufacturer refers to the legal person and other organization). In other word, the oversea registration applicant could entrust production.

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According to the Measure, the following documents are required for health food registration:

• 博狗集团国际 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.

For imported health food registration, besides the above documents, the following supplementary documents also should be submitted:

• Qualification certifying documents issued by government authorities or legal service agencies in the producing country (region) of origin proving that the oversea registration applicant is the owner 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;

• 博狗集团国际 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 博狗集团国际, 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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According to the Measure, the following tests are required to be arranged in CFDA designated testing institutions for health food registration:

• Safety and toxicology test;

• Animal and (or) human function test;

• Functional components/characteristic ingredients test, Hygiene health test;

• Stability test;

• Strain identification and strain virulence test for Probiotics-based 博狗集团国际 博狗集团国际;

• Stimulants, illicit drugs test for 博狗集团国际 博狗集团国际 with Relieving physical fatigue, Weight loss or Improving growth and development function;

• Other tests if necessary

Our Services

CIRS is providing one-stop services of 博狗集团国际 food regulatory compliance. We also deliver the most up-to-date regulatory information about food safety control in 博狗集团国际. For health food, we offer the following services:

I. Training on 博狗集团国际 博狗集团国际 Regulation

II. 博狗集团国际 博狗集团国际 Regulation Update Monitoring

III. 博狗集团国际 博狗集团国际 博狗集团国际

IV. 博狗集团国际 博狗集团国际 博狗集团国际

V. Single Technology Services

1. Pre-market Investigation

2. Classification Analysis and Formula Review

3. Chinese Label and Package Insert Design

4. Dossier Preparation

5. Translation

6. Test Arrange and Monitoring