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Special Dietary Foods

Categories of foods for special dietary purposes:

1. Formula foods for infants and young children

a. Formula foods for infants

b. Formula foods for older baby and young children

c. Formula infants foods for special medical purposes

2. Supplementary foods for infants and young children

a. Cereal supplementary food for infants and young children

b. Canned supplementary food for infants and young children

3. Food for Special Medical Purpose,FSMP (Food for Special Medical Purpose,FSMP(Excluding Infants Formula foods for special medical purposes)

4. Other foods for special dietary use other than the above categories (including nutritional supplements, sports nutrition foods, and other special dietary foods with corresponding national standards)

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.

• GACC registration process (text description)

• The flow chart for the GACC registration of imported food of overseas producers

• Conditions and Key Points of Control Inspection for Registration of Overseas Production Enterprises of Imported foods for special dietary purposes

• Registration Application of Overseas foods for special dietary purposes Imported Manufactures Recommended by Competent Authority

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
Preparing documents in strict accordance with the Conditions and Key Points of Control Inspection for Registration of Overseas Production Enterprises of Imported foods for special dietary purposes and conduct self-assessment and fill in the registration application form.
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 enterprises to check the registration elements according to the "Conditions and Key Points of Control Inspection for Registration of Overseas Production Enterprises of Imported foods for special dietary purposes", complete the self-assessment, and provide continuous improvement plans based on the assessment results, so that they meet the registration conditions 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 in filling out the "Application for Registration of Overseas Competent Authority Recommendation for Manufacturers of Imported Foods", submit an electronic application and upload relevant certification materials.

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 Chinese national standards and regulations that is required to comply with include but are not limited to:

14. National Standard for Food Safety Food Additive Use Standard GB 2760-2014

15. National Standard for Food Safety General Rules for Labeling of Prepackaged Foods GB 7718-2011

16. National Food Safety Standard Food Nutrition Enhancer Use Standard GB 14880-2012

17. National Food Safety Standard General Hygienic Specification for Food Production GB 14881-2013

18. Hazard Analysis and Critical Control Points (HACCP) System General Requirements for Food Manufacturers GB/T 27341

19. National Food Safety Standard General Rules for Nutrition Labeling of Prepackaged Foods GB 28050-2011

20. National Food Safety Standard for the Use of Additives for Food Contact Materials and ProductsGB 9685-2016

(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)

Regulatory Measures

1. Overseas manufacturing enterprises exporting foods for special dietary uses to China may be recommended and registered by the competent authorities of the country (region) where they are located to the GACC, and can export their products to China after passing the registration procedures of the GACC.

2. Overseas exporters or agents and domestic importers shall record their information through the record-keeping system for importers and exporters of imported food and cosmetics of the General Administration of Customs of China.

3. Formula Registration Certificate of Infant Formula Milk Powder (Import)

4. Registration Certificate of Formula Food for Special Medical Purposes (Import)

5. Chinese labels of imported foods for special dietary uses shall be printed on the minimum sales package and no additional labels shall be added. The registration number of the overseas manufacturer in China or the registration number approved by the competent authority of the country (region) where the manufacturer is located shall be marked on the inner and outer packaging.

Solutions for Meeting the Regulatory Measures:

1. Solution: Overseas manufacturing enterprises shall fill out the application form through the CIFER registration system after the official recommendation, and the applicant enterprise shall meet the standards and requirements stipulated in the Compliance Checklist for Registration of Overseas Manufacturers of Imported Foods for Special Dietary Uses; After the GACC receives the application, the expert panel shall evaluate and examine the applicant through written inspection, video inspection, on-site inspection and other forms of inspection or any combination of the above, and register the overseas manufacturers of imported food that meet the requirements and give them the registration number in China.

Solution: Submit the application through “Internet + Customs” - “Record System for Importers and Exporters of Imported Food”.

3. Formula Registration Certificate of Infant Formula Milk Powder (Import)

Solution: Declare to the Center for Food Evaluation of the State Administration for Market Regulation according to the Administrative Measures for Product Formula Registration of Infants and Young Children Formula Milk Powder and other relevant laws and regulations.

4. Registration Certificate of Formula Food for Special Medical Purposes (Import)

Solution: Declare to the Center for Food Evaluation of the State Administration for Market Regulation according to the Administrative Measures for Registration of Formula Food for Special Medical Purposes and other relevant laws and regulations.

Information required for Customs declaration:

1. Certificate of Origin

2. Sanitary certificate (Certificate of free sale or health certificate)

3. Invoice, contract, packing list, Bill of Lading

4. Test report

5. List of ingredients

6. Certificate of Formula Registration of Formula Milk Powder for Infants and Young Children (Import) (only applicable to Formula Milk Powder for Infants and Young Children)

7. Registration Certificate of Formula Food for Special Medical Purposes (Import) (Only applicable to Formula Food for Special Medical Purposes)

8. Chinese label, label of foreign languages, and translation

9. Other materials or reports to be submitted

The following imported foods for special dietary purposes are monitored by Decree 248:

HS codes of imported foods for special dietary purposes in GACC system (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 "Conditions and Key Points of Control Inspection for Registration of Overseas Production Enterprises of Imported foods for special dietary purposes" to inspect the elements of the enterprise and conduct feasibility assessments.

(3) Electronic application has not been submitted. "Registration Application of Overseas foods for special dietary purposes Imported Manufactures Recommended by Competent Authority"

(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 foods for special dietary purposes?
Answer: According to Decree No.249 Article 30:The packaging, 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. Can formula foods for special medical purposes be traded online?
Answer: According to the "Market Access Negative List (2018 Edition)", the prohibition of access is stipulated: the specific nutritional formula food in the formula food for special dietary purpose shall not be traded online.

5. What are the changes between food for special dietary purposes application and previous customs record filling for overseas manufacturers?
Answer: Before enforcement of Decree 249, only imported milk powder and FSMP overseas manufacturers are required to make application, now it extends to the categories like formula foods for infants and young children, supplementary foods for infants and young children and sports nutrition foods.

6. 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)

The Chinese national standards and regulations that is required to comply with include but are not limited to:

6. National food safety standards-Labeling of prepackaged foods for special dietary use GB 13432-2013

7. National Food Safety Standard General Standard for Sports Nutrition Food GB 24154-2015

8. National Food Safety Standard Multi-nutrient Supplementary Food for Pregnant and Lactating Women GB 31601-2015
9. National Food Safety Standard Complementary food supplements GB 22570-2014

10. National Standard for Food Safety General Rules for Labeling of Prepackaged Foods GB 7718-2011

11. National Food Safety Standard General Rules for Nutrition Labeling of Prepackaged Foods GB 28050-2011

12. National Standard for Food Safety Food Additive Use Standard GB 2760-2014

13. National Food Safety Standard Food Nutrition Enhancer Use Standard GB 14880-2012
(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 Food Compliance Services

1. Feasibility analysis of food import

2. Regulatory requirements and compliance procedures related to food import

3. Special product pre-license consultation

4. Consultation on other food import problems

Product technical compliance support

Purpose: To determine whether food can be imported into China

1. Determine the product classification and whether it can be imported

2. Check whether the product is illegally added or the dosage and content are not compliant

3. Whether the imported food meets the national food safety standards

4. If there is any non-compliance, propose amendments

Product Label Review

Purpose: To ensure that the Chinese labels of imported products meet the requirements

1. Review the original product standard and give suggestions for revision

2. Review Chinese labels, translate and make Chinese labels

Food for Special Medical Purpose Registration Inquiry

1. Training for FSMP Registration
2. FSMP Registration Documents Review( Formula,Label, Raw materials and research consulting)
3. FSMP Registration Application

New food additives Compliance Application

1. Food additive Inquiry and Training
2. New categories of food additive identification
3. Food additive scope of application or usage expansion
4. New categories of food additive compliance application

New food raw material declaration and consultation

1. New food raw material compliance consultation and training

2. Identification of new food raw materials

3. Substantial Equivalence Argument

4. New food raw material declaration

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.

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.

Product Registration Relief

Imported food for special dietary use is defined in a wide range of products, and different product types are subject to different registration systems.Official reviews are strict in the following aspects such as: enterprise's self-research ability, test ability, clinical trial process, and safety of product formula, etc. It's highly recommended you reach to a professional consulting provider for a better solution.

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.