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Functional foods

Health food refers to foods that claim to have specific health functions or for the purpose of supplementing vitamins and minerals, that is, suitable for consumption by specific groups of people, regulating body functions, not for the purpose of treating diseases, and do not cause any acute, subacute or chronic harm to the human body food.

"Health food" are generally called in mainland China, and other countries or regions are called: Dietary Supplements. In Europe and the United States, it is called "nutritional food".It is included in the category of "specific nutritional food". If a health food category is exported to China for the first time, GACC must first conduct a conformity assessment on the official regulatory system of the country of origin.

GACC registration conditions for overseas manufacturers of imported foods are as follows: 

1. The food safety management system of the country/region where the manufacturer is located has passed GACC's equivalence assessment and/or review; 

2. The manufacturer was established with approval by the competent authority of the country/region, and the manufacturer is under effective regulation by the competent authority; 

3. The manufacturer has an established, effective food safety and sanitation management system and protection system, legally produces and exports food in the country/region, and ensures that foods exported to China comply with relevant Chinese laws, regulations, and national food safety standards; 

4. Food exporting to China conforms with relevant inspection and quarantine requirements that have been agreed upon after discussion by the GACC and the competent authorities of the country/region.

The Chinese national standards and regulations that GACC is required to comply with include but are not limited to:
1. National Food Safety Standard  Good manufacture practice for Health Food  GB17405-1998
2. National Food Safety Standard  Health Food GB 16740-2014
3. National Standard for Food Safety General Rules for Labeling of Prepackaged Foods GB 7718-2011
4. National Standard for Food Safety Food Additive Use Standard GB 2760-2014
5. National Food Safety Standard General Hygienic Specification for Food Production GB 14881-2013
6. Food defense plan and its application guide  for food production enterprises GB T 27320-2010
7. Hazard Analysis and Critical Control Points (HACCP) System General Requirements for Food Manufacturers GB/T 27341
(If you need to obtain the English version of the above regulations or technical standards, or the official language version of your country, feel free to contact us)

The General Administration of Chinese Customs, overseas official regulatory agencies and production enterprises will jointly promote:

  • 01

    Confirm the HS code and the applicable access method.

  • 02

    Obtain the account and password officially granted by the supervisor or account re-authentication.

  • 03

    Prepare documents in strict accordance with Conditions and Key Points of Control Inspection for Registration of Overseas Manufacturers of Imported Health Food, conduct self-assessment, and fill in the registration application.

  • 04

    Submit an electronic application, fill in the enterprise elements and upload relevant materials as required; if necessary, include but not limited to floor plan of factory and workshop, process flow chart, etc.

  • 05

    The competent authority reviews the summary and forwards the electronic application with other support materials required by GACC.

  • 06

    The GACC office will review whether the materials are complete and in compliance with the legal form, and decide whether to accept it or issue a correction notice to the competent authority.

  • 07

    The expert group evaluates and reviews, including a combination of document review and on-site review or other reasonable review methods, and forms a review report.

  • 08

    Review by the General Administration of Chinese Customs whether it meets the statutory requirements and standards.

  • 09

    GACC approve or disapprove the registration, and feedback the information to the competent authority and Enterprise (enterprise applicants can receive the registration feedback in Cifer system).

  • 10

    The enterprises approved for registration, China Customs will publish them online in due course.

Our assistance includes but is not limited to:

1. Assist in product classification, determine the corresponding registration method and the best implementation plan; confirm the applicable official competent authority approval number, enterprise type, precise customs code and inspection and quarantine code details.

2. Assist enterprises to obtain account numbers and passwords.
3. Assist manufacturer to review the registration elements according to the "Conditions and Key Points of Control Inspection for Registration of Overseas Manufacturers of Imported Health Food", complete the self-assessment, and provide continuous improvement solution based on the assessment results, so that they meet the registration conditions and check points and China's national food production and product standards. Assist in sorting, screening, editing, and translating the required materials, so that the application materials meet the integrity, authenticity and validity.
4. Assist to fill in the Registration Application of Overseas Health Food Imported Manufactures Recommended by Competent Authority and submit the application.
5. Follow up the application submitted by the competent authority, the basic status report on animal and plant epidemics, veterinary hygiene, public health, plant protection, pesticide and veterinary drug residues related to the exporting country (region), the registration management of food production enterprises and the requirements of enterprise hygiene standards, etc. The laws, regulations and standards of the exporting country (region), the organization and personnel of the competent authority of the exporting country (region), the quarantine of the exporting country (region) competent authority of its recommended enterprises, the assessment answer sheet of the actual situation of sanitation control, the exporting country (regional) competent authority's assessment of the actual situation. A statement that the companies that are recommends comply with Chinese laws and regulations.

6. Materials correction, when the written materials do not meet the registration requirements, assist the enterprise to complete the interpretation, sorting, screening, editing, translation, calibration and other standards and laws and regulations of the required materials within the specified time.

7. Acceptance by Chinese Customs and follow-up and communication of technical review by expert group, preparation and coordination before on-site review or video review.

8. Assist in successful access and follow up on the use of registration data for customs clearance, and respond immediately if there are any problems.

9. According to the change of the enterprise, assist the change application.

10. Other enterprise access and follow-up related support.

The remedy here is a self-definition or appellation of the institution for the following business conditions, and does not mean that the official expression and is not related to any other third-party and economic remedy.

GACC Access Remedy

According to GACC Decree No. 248 from January 1 2022, overseas manufacturers of imported food will be admitted in accordance with new policies, regulations and procedures. We provide all-round consultation and analysis. After adjustment and verification, the enterprises meet China's food production safety and hygiene standards, product pesticide and veterinary drug residues and other laws and regulations, but also according to the country (region) and product, free assistance to check the conformity assessment and give non-binding and pragmatic market access feasibility suggestions for reference.

Product Filing Relief

       When importing "health food" as common food, it is often hindered by the applicability of dosage forms and food national standards. Based on professional and rich experience in filing, feasible suggestions are given, trying to implement the filing of imported health food in a relatively short period of time.

Agent Remedy

The original agent caused unacceptable losses due to lack of technical level and experience; the original agent voluntarily canceled the entrustment or lost contact, resulting in application interruption and economic losses. According to the specific situation, we can continue to register and application service or give free reference suggestions.

Data remedy

In October 2021, GACC arranged to open a "green channel" for registration of 18 categories of food for one month. Some overseas competent authorities submitted incomplete or confusing enterprise elements, such as the address of the enterprise, the country name as the business license number, and the type of product as Names of people, etc., so that the corresponding overseas producers are still unable to use valid GACC codes to assist in customs declaration. Our agency has reasonably relieved many cases.

Remedy for overseas competent authority's administrative account

Due to the different organizational structure and supervision system of each country, some countries cannot effectively transmit the new GACC regulations and practical guidelines, some are completely unaware of the new GACC regulations, and some have heard of them but they do not know how to obtain the management account granted by GACC and which ones in their own countries. The institution should obtain a management account and conduct classified management; for this reason, our institution will participate in the assistance of embassy personnel when necessary through email, telephone, video conference, etc., fully publicize and implement the essentials of the laws and regulations, understand and discuss the country's governance and supervision system, and successfully implement remedy for multiple cases. Provide in-depth explanations on the use of training and operation guidelines for the management terminal of overseas competent authorities, so that they can fully understand the positive significance of the human-friendly architecture GACC Cifer system as a supporting measure for GACC Decree No.248. more+

Training, translating and Consultants

When there is no knowledge or understanding of China's regulatory system, food safety laws and regulations, and access procedures, we can provide paid training translation services to enterprises, so that enterprises can fully understand China's regulatory system, laws and regulations, and can complete the work independently. Enterprise access registration and product labeling compliance work, or become the annual partner of regulatory consulting and product compliance. The team is well established, familiar with the evolution of all regulations, rich in technical reserves, smooth in multilingual communication, convenient in handling affairs, mastering key points of compliance, and understanding of trade customs clearance and quarantine matters. The appointment of consultants is not an open business, and the invitation system is adopted. After evaluation and analysis, those who meet the conditions will be actively invited by our institution. more+

Customs Clearance reject and early warning remedy

Misjudgment caused by enterprise qualification problems, product technology non-compliance, label non-compliance or self-perceived compliance or misclassification in the process of food trade. Sanctions such as return request of shipments, suspension of imports, and revocation of qualifications caused by triggering risk warnings. We can try to assist producer and companies in product compliance, corporate rectification, training, re-certification, re-communication and other measures to promote the process of removing sanctions.

Related Laws and Regulation of Imported Health Food are including but not limited to:
Measures for the Administration of the Registration and Recordation of Dietary Supplements

Health Food Record Filing Guidelines (Trial)

Health Food Raw Material Catalog  Nutrient Supplements (2020 Version)

List of Health Functions Allowed for Health Food Claims  Nutrient Supplements (2020 Version)

Health food Record filing product dosage form and technical requirements (2021 Version)

Coenzyme Q10 and other five health food raw materials record product dosage form and technical requirements 2021[NO.4]

Complementary Interpretation of "Formulations and Technical Requirements for Recorded Products of Five Health Food Raw Materials including Coenzyme Q10"

Health food products available for record excipients and their use regulations(2021 Version)

Q10 Health Food Raw Material Catalog -Coenzyme Q10

Health Food Raw Material Catalog- Spirulina

Health Food Raw Material Catalog-Broken Ganoderma lucidum spore powder

Health Food Raw Material Catalog-Melatonin

Health Food Raw Material Catalog - Fishoil

Imported health food record filling registration form
(If you need to obtain the English version of the above regulations or technical standards, or the official language version of your country, feel free to contact us)
 

Imported health food need to apply record filling:

(1) Health food whose raw materials have been listed in the health food raw material catalog;

(2) Imported health food that is supplemented with vitamins, minerals and other nutrients (listed in the health food raw material catalog);

Imported health food that requires registration and approval:

(1) Health food using raw materials other than the health food raw material catalog (hereinafter referred to as the raw materials outside the catalog);

(2) Imported health food (except health food supplemented with nutrients such as vitamins and minerals);

Test that may be involved in the filing or registration process:

(1) Functional ingredients or iconic ingredients, hygiene self-inspection;

(2) Functional ingredients or iconic ingredients, hygiene, and stability tests;

· Toxicology test;

· Animal testing;

· Human consumption evaluation test;

(3) Other tests (such as strain identification, strain virulence, stimulants, illegal drug test reports, etc.) are carried out when necessary;

 

Imported health food recordation process:

Provide samples for filing inspection--Organize filing materials--Apply for the username and password of the filing information system--Fill in the filing information system--Submit the filing materials--Review and obtain the filing certificate
 

Imported health food filing application materials (depending on the product):

1. Imported health food registration form, and the legal responsibility commitment letter of the filing person responsible for the authenticity of the submitted materials

2. A copy of the main registration certificate of the enterprise

3. Product formula material: product formula information

(The original registrant who has changed the formula needs to submit the adjusted formula and the description of the change of the formula)

4. Product production process materials, including production flowchart and descriptions

5. Safety and health function evaluation materials

5.1 Three batches of product efficacy ingredients or iconic ingredients, hygiene and stability inspection reports produced by the pilot scale process and above

(If the product formula of the original registrant has not changed, this item does not need to be provided)

5.2 Instructions on the rational use of raw materials and auxiliary materials, as well as instructions on label instructions and product technical requirements that comply with relevant regulations

6. Types, names and relevant standards of packaging materials

7. Sample draft of product label

8. Product technical requirements materials

9. A full-item inspection report issued by a legally qualified inspection agency that meets the technical requirements of the product

9.1 Qualification document of food inspection agency

9.2 Three batches of whole-item inspection reports that meet product technical requirements

10. Product name related search materials

11. Other materials indicating product safety and health functions

12. Qualification document issued by the competent government department or legal service agency of the country (region) where the product is produced, certifying that the filer is an overseas manufacturer of the listed health food

13. The certification document issued by the competent government department or legal service institution of the country (region) where the product is produced has been on the market for more than one year, or the safety report on the overseas sales of the product and the consumption of the population

14. The original text of technical regulations or standards related to health food in the country (region) of product production or international organization

15. The actual sample, Chinese translation and notarial certificate of the packaging, label, instruction manual listed in the country (region) where the product is produced

16. If the filing affairs are handled by the resident representative office of the overseas filing person in China, the "Registration Certificate of the Resident Representative Office of Foreign Enterprises in China" and its photocopy shall be submitted. If an overseas filing person entrusts a domestic agency to handle filing matters, it shall submit the original notarized power of attorney and a photocopy of the business license of the entrusted agency.

 

Import Health Food Blue-hat registration

Application for health food registration requires a long time for professional review (usually 5-10 years), and has comprehensive requirements for product formula, preparation process, method demonstration, equivalence study, test report and clinical data, according to the specific situation of the product Contact us for the best registration solution.

Health food labels and instructions must comply with relevant national standards and requirements, and indicate the following:

(1) Health care function and suitable population;

(2) Edible methods and dosage;

(3) Storage method;

(4) The name and content of the functional ingredients;

(5) Health food approval number;

(6) Health food labels;

(7) Other label contents stipulated by relevant standards or requirements;

Additional instructions:

(1) The names of health food should be accurate and scientific, and should not use personal names, place names, code names and exaggerated names that are easy to misunderstand.

(2) The contents of labels, instructions and advertisements of health food must be true and meet the quality requirements of their products, and no propaganda suggesting that the disease can be cured.

Imported health food with the following customs codes is monitored under Decree No. 248:

HS Codes Prodcut Name CIQ Codes Inspection and quarantine name Product Category
1504100010 Endangered fish liver oil and its isolates 101 Endangered fish cod liver oil and its isolates (edible health food) Healthy food
1504100090 Other fish liver oil and its fractions 201 Other fish liver oil and its separated products (health food) Healthy food
1504200011 Endangered fish oil soft capsules 101 Endangered fish oil soft capsules (except cod liver oil) (health food) Healthy food
1504200019 Endangered fish other fish oils, fats and their fractions 107 Endangered fish other fish oils, fats and their fractions (except cod liver oil) (health food) Healthy food
1504200091 Other fish oil soft capsules 101 Other fish oil soft capsules (except cod liver oil) (health food) Healthy food
1504200099 Other fish oils, fats and their fractions 107 Other fish oils, fats and their fractions (except cod liver oil) (health food) Healthy food
2104200000 Homogenized mixed food 104 Homogenized mixed food (with health food approval number) Healthy food
2106100000 Concentrated protein and artificial protein material 102 Concentrated protein and artificial protein substances (with health food approval number) Healthy food
2106903010 Royal jelly formulation containing endangered plant components 101 Royal jelly preparation containing endangered plant ingredients (with health food approval number) Healthy food
2106903090 Other royal jelly preparations 101 Other royal jelly preparations (with health food approval number) Healthy food
2106905010 Endangered Seal Oil Capsules 999 Endangered seal oil capsules (edible health food) Healthy food
2106905090 Other seal oil capsules 999 Other seal oil capsules (edible health food) Healthy food
2106909019 Other numbered unlisted foods containing endangered animal and plant ingredients 107 Other numbered unlisted foods containing endangered animal and plant ingredients (with health food approval number) Healthy food
2106909090 Food not listed in other numbers 140 Other foods whose numbers are not listed (with health food approval number) Healthy food
2202100010 Flavored, sweetened or other sweetened water containing endangered animal and plant ingredients (including mineral water and soft drinks) 108 Flavored, sweetened or other sweetened water containing endangered animal and plant ingredients (including mineral water and soft drinks) (with health food approval number) Healthy food
2202100090 Other flavored, sweetened or other sweetened water (including mineral water and soda) 108 Other flavored, sweetened or other sweetened water (including mineral water and soft drinks) (with health food approval number) Healthy food
2202990011 Other bulk non-alcoholic beverages containing endangered animal and plant ingredients (excluding fruit juice or vegetable juice of item 20.09) 108 Other bulk non-alcoholic beverages containing endangered animal and plant ingredients (excluding fruit juice or vegetable juice of item 20.09) (with health food approval number) Healthy food
2202990019 Other bulk non-alcoholic beverages (excluding fruit or vegetable juices of item 20.09) 999 Other bulk non-alcoholic beverages (excluding fruit juice or vegetable juice of heading 2009) (health food) Healthy food
2202990091 Other packaged non-alcoholic beverages containing endangered animal and plant ingredients (excluding fruit juice or vegetable juice of item 20.09) 108 Other non-alcoholic beverages in other packages containing endangered animal and plant ingredients (excluding fruit juice or vegetable juice of item 20.09) (with health food approval number) Healthy food
2208909021 Potato distilled liquor containing endangered wild animals and plants 105 Potato distilled spirits containing endangered wild animals and plants (with health food approval number) Healthy food
2208909091 Other distilled spirits and alcoholic beverages containing endangered wild animals and plants 106 Other distilled spirits and alcoholic beverages containing endangered wild animals and plants (with health food approval number) Healthy food
2209000000 Vinegar and substitutes for vinegar made with acetic acid 104 Vinegar and vinegar substitutes made with acetic acid (with health food approval number) Healthy food
2936280000 Unmixed vitamin E and its derivatives 102 Unmixed vitamin E and its derivatives (whether soluble in solvent or not) (with health food approval number) Healthy food
2936901000 Vitamin AD3 102 Vitamin AD3 (including natural concentrates, whether soluble in solvents or not) (with health food approval number) Healthy food
2936909000 Provitamins, mixed provitamins, other mixed vitamins and their derivatives (including natural concentrates, whether or not dissolved in solvents) 102 Provitamins, mixed provitamins, other mixed vitamins and their derivatives (including natural concentrates, whether soluble in solvents or not) (with health food approval number) Healthy food
3004905110 Chinese medicinal wine containing endangered animal and plant ingredients (already prescribed dose or retail packaging) 102 Chinese medicinal wine containing endangered animal and plant ingredients (prescribed dose or retail packaging) (with health food approval number (health food)) Healthy food
3004905190 Chinese medicinal wine containing other ingredients (already prescribed dose or retail packaging) 102 Chinese medicinal wine containing other ingredients (already prescribed dose or retail packaging) (with health food approval number) Healthy food
3504001000 Peptone 101 Peptone (with health food approval number) Healthy food
3504009000 Other proteins and their derivatives (including peptone derivatives and skin powder (whether or not chrome alum is added)) 101 Other proteins and their derivatives (including peptone derivatives and skin powder (whether or not added with chrome alum)) (with health food approval number) Healthy food
7116100000 Natural or cultured pearl products 101 Natural or cultured pearl products (with health food approval number) Healthy food
HS Codes of Imported Health food to China(download)

1. What are the common mistakes in registration?

(1) The product was classified incorrectly, and the wrong access method and procedure were applied.
(2) Failure to strictly follow the "Registration Conditions for Overseas Manufacturers of Imported Health Foods and Key Points for Comparative Inspection" to inspect the elements of the enterprise and conduct feasibility assessments.

(3) Electronic application has not been submitted. "Application for Registration of Overseas Officially Recommended Manufacturers of Imported Health Foods"

(4) Registration application materials or attachments submitted are not in English or Chinese.

(5) The file format is incorrect and cannot be opened.

(6) There is a vacancy in the application materials where the signature and seal of the competent authority is required.

(7) The necessary parts of the application form are incomplete.

(8) The attachments of the application form are incomplete or do not correspond to the description of the content of the application form, which cannot prove the validity of the content of the application form.

(9) There are descriptions in the application form and attached materials that are obviously inconsistent with Chinese regulations.

(10) The information of the exported products cannot be accurately listed in the application, so that the customs clearance failure and needs to be urgently added. (Overseas manufacturers generally register according to the actual product strictly corresponding to the HS CODE, but Chinese brokers or freight agencies generally classify HS CODE according to the most preferential tax rate or the lowest supervision conditions or the simplest operation methods. There are cases that different ports and different freight agencies use different HS CODE for the same foods. There is a possibility of different classification, and our agency have to deal with many emergencies caused by the reasonable but misplaced demands of different market entities.)

(11) The application materials provided are contradictory.

(12) The country/origin where the overseas producers is located export firstly some foods has not yet conducted conformity equivalent assessment of the GACC official regulatory system.


2. An example of GACC does not approve review feedback?

3. What's the labeling requirements of imported health food?
Answer: According to Decree No.249 Article 30:The packagings, labels, and marks of import food shall comply with the laws, regulations, national food safety standards of China, and shall be accompanied by an instruction manual in Chinese if the law so requires.The label of an imported dietary supplement or food for special dietary use in Chinese must be printed on the smallest sales package, and shall not be affixed thereto

4. Do overseas manufacturers, exporters and domestic importers need to register for the cross-border e-commerce model?
Answer: According to the "Notice of Improving the Supervision of Cross-border E-commerce Retail Imports" and the "List of Cross-border E-commerce Retail Import Commodities", it is limited to personal use and meets the requirements of cross-border e-commerce. For goods imported from overseas e-commerce retail, the bonded stocking mode "first-line" entry area is regulated according to the goods, and the above-mentioned domestic and overseas enterprises need to register or record with GACC.

5. Are cross-border e-commerce exempt from the regulatory conditions for imported health food?

Answer: According to the "white list" system, the cross-border e-commerce model is exempt from the regulatory conditions for imported health food, that is, the product does not need to be filed or registered, and does not need Chinese labels.


6. Can the so-called "health food" be imported as ordinary food?

Answer: Yes.It can be declared according to ordinary food, but there must be national standards applicable to ordinary food. It is either imported according to the new resource food or according to the approval document of health care products. These two difficulties are similar and then the problem of dosage form. If there is no special publicity on the outer packaging of applicable national standard products, then even special dosage forms can be imported, such as It is said that effervescent tablet is a tablet, and coffee is a granule, all of which can be imported.

7. What kind of health food must be registered?

Answer: In addition to the prescribed filing, other imported products that claim to have health care functions must be registered. The 27 functions are: (1) Strengthening power; (2) Auxiliary lipids; (3) Auxiliary sugars; (4) Antioxidation; (5) ) to help improve memory; (6) to relieve visual fatigue; (7) to clear the throat; (8) to assist in reducing blood pressure; (9) to promote lead excretion; (10) to improve sleep; (11) to promote lactation; (12) to relieve physical fatigue (13) Improve hypoxia tolerance; (14) Have auxiliary protective function against radiation hazards; (15) Lose weight; (16) Improve growth and development; (17) Increase bone density; (18) Improve nutritional anemia; ( 19) Auxiliary protection against chemical liver damage; (20) Acne removal; (21) Melasma removal; (22) Skin moisture improvement; (23) Skin oil improvement; (24) Intestinal flora regulation ; (25) promote digestion; (26) laxative; (27) have auxiliary protective function on gastric mucosal damage.


8. What is the validity period of the health food filing certificate or registration approval document?

Answer: The imported health food filing certificate has no time limit and can be used for a long time without renewal. The registration approval for imported health food is valid for 5 years, and re-registration (ie.renewal) is required upon expiration.

9. Do exporters or shippers need to record?
A: Yes, the exporter of the trade contract or shipper of BL has to do ire (Original AQSIQ) record. After recording will get an 11-digit record number, the record does not issue certificate nor validity limit. It should be noted that this record is very easy, we are obliged to help applicant record free of charge. Watch out for fraudulent websites.
(In China's administrative reform, AQSIQ no longer exist)

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