"Official Release" new food raw materials, new varieties of food additives, new varieties of food-related products approval licensing matters implementation norms and guidelines

On September 26, 2023, the Food Safety Standards and Monitoring and Evaluation Department issued the implementation specifications and guidelines for the approval and licensing of new food raw materials, new varieties of food additives, and new varieties of food-related products.

Please visit the following link

http://www.nhc.gov.cn/sps/s3584/202309/b1d53d3a8e554ef39f37ee8ccf72d126.shtml

Among them, the implementation norms for the administrative licensing of new varieties of food additives are as follows:

Implementation norms for administrative licensing matters (basic elements)

Name of 1. Administrative Licensing Matters: Examination and Approval of New Varieties of Food Additives

2. Central Authority: National Health Commission

3. implementing agency: National Health Commission

4. Setting and Implementation Basis: the People's Republic of China Food Safety Law

5. children: None

Approval of new varieties of food additives

000123102000

1. basic elements

1. Name and code of administrative licensing matters

Approval of new varieties of food additives [000123102000]]

2. Name and code of sub-items of administrative licensing matters

None

3. Name and code of business handling items for administrative licensing matters

1. Approval of new varieties of food additives (00012310200001)(approved)

4. Setting basis

(1) Article 37 of the the People's Republic of China Food Safety Law

5. Basis of implementation

(1) Article 37 of the the People's Republic of China Food Safety Law

(2) "new varieties of food additives management approach" first, 2. 3. 4. 5. 6. seven

6. Regulatory Basis

(1) Articles 5, 6, 7, 19, 21, 22 and 23 of the the People's Republic of China Food Safety Law

7. Implementing agency: National Health Commission

8. Approval level: National level

9. Level of Exercise: National/Bureau (Department, Council)

10. Whether to be accepted by the examination and approval authority: Yes

11. Acceptance level: National level

12. Whether there is a preliminary examination link: No

13. Level of preliminary examination: none

14. Corresponding to the national basic directory of government services. Name: Approval of new varieties of food additives

15. Harmonization of elements: national harmonization of all elements

Types of 2. administrative licensing matters

Inspection type

3. administrative licensing conditions

1. Conditions for granting an administrative license

The definition of new varieties of food additives: (1) varieties of food additives that are not included in the national food safety standards; (II) varieties of food additives that are not included in the announcement of the National Health and Family Planning Commission; varieties of food additives that are (III) to expand the scope of use or dosage.

It is technically necessary and has been proven safe and reliable through risk assessment.

Meet the requirements of food additives: (1) should not cover up food spoilage; (II) should not cover up food itself or quality defects in the processing process; (III) should not use food additives for the purpose of doping, adulteration, or forgery; (IV) should not Reduce the nutritional value of the food itself; (V) reduce the amount of food used in the food as much as possible while achieving the expected effect; (VI) processing aids for the food industry should be removed before they are made into final products, except where the amount of residues is permitted.

2. Basis for stipulating the conditions for administrative licensing

(1) Article 37 of the the People's Republic of China Food Safety Law using new food raw materials to produce food, or producing new varieties of food additives or new varieties of food-related products, the safety assessment materials of the relevant products shall be submitted to the health administrative department of the State Council. The health administrative department of the State Council shall organize the review within 60 days from the date of receipt of the application; grant permission and publish it for those that meet the food safety requirements; and deny permission and explain the reasons in writing for those that do not meet the food safety requirements.

(2) Articles 2, 3 and 4 of the Measures for the Administration of New Varieties of Food Additives refer:

(I) food additives not listed in the national food safety standards;

(II) is not included in the National Health and Family Planning Commission announcement allows the use of food additives varieties;

(III) expand the scope of use or the amount of food additives.

Food additives should be technically necessary and proven safe and reliable through risk assessment.

The use of food additives shall meet the following requirements:

(I) should not cover up food spoilage;

(II) should not cover up quality defects in the food itself or during processing;

(III) do not use food additives for the purpose of adulteration, adulteration or forgery;

(IV) should not reduce the nutritional value of the food itself;

(V) reduce the amount of food used as much as possible under the expected effect;

(VI) processing aids for the food industry should be removed before they are made into final products, except where the amount of residues is permitted.

4. Administrative Licensing Service Object Types and Reform Measures

1. Type of service object: natural person, enterprise legal person, institution legal person, social organization legal person, unincorporated enterprise

2. Whether it is an enterprise-related licensing matter: No

3. Name of business license related matters: none

4. License name: None

5. Mode of reform: none

Specific reform initiatives

Reform initiatives that do not involve business licensing matters involving enterprises.

7. Strengthening post-event regulatory measures

Organize and carry out food safety risk monitoring and risk assessment, and formulate and publish national food safety standards in conjunction with the food safety supervision and administration department of the State Council.

Listen to the suggestions of food safety risk assessment put forward by the food safety supervision and management departments of the State Council and agricultural administration in the supervision and management work, and provide information and materials such as risk sources, relevant inspection data and conclusions.

And the administrative department of agriculture in a timely manner to inform each other food, edible agricultural products safety risk monitoring and risk assessment results and other information.

If it is necessary to formulate and revise relevant national food safety standards, it shall be formulated and revised immediately in conjunction with the food safety supervision and administration department of the State Council.

Work with the Food Safety Supervision and Administration Department of the State Council and relevant departments of the State Council to conduct a comprehensive analysis of the food safety status based on the results of food safety risk assessment and food safety supervision and management information.

5. application materials

1. Name of application materials

An entity or individual applying for the production, operation, use or import of new varieties of food additives (hereinafter referred to as the applicant) shall file an application for the license of new varieties of food additives and submit the following materials:

Common name, functional classification, amount and scope of use of (I) additives;

Information or documents (II) to prove the technical necessity and effectiveness of use;

(III) the quality specifications, production processes and inspection methods of food additives, and the inspection methods or relevant information of the additives in food;

(IV) safety assessment materials, including production raw materials or sources, chemical structure and physical characteristics, production process, toxicological safety evaluation data or inspection reports, quality specification inspection reports;

(V) labels, instructions and food additive product samples;

(VI) other countries (regions), international organizations allow the production and use of information to help safety assessment.

Those who apply for expanding the scope of use or dosage of food additives may be exempted from submitting the materials mentioned in Item 4 of the preceding paragraph, except for those required to be supplemented in the technical review.

To apply for the first import of new varieties of food additives, in addition to the materials specified in Article 6, the following materials shall be submitted:

The certification materials issued by the relevant departments or institutions of the (I) exporting country (region) allowing the additive to be produced or sold in the country (region);

(II) the certification materials for the examination or certification of the production enterprise issued by the relevant institutions or organizations of the country (region) where the production enterprise is located.

2. The basis of the prescribed application materials.

(1) Article 6 of the Measures for the Administration of New Varieties of Food Additives and Article 7 Article 6 An entity or individual applying for the production, operation, use or import of new varieties of food additives (hereinafter referred to as the applicant) shall file an application for the license of new varieties of food additives and submit the following materials:

Common name, functional classification, amount and scope of use of (I) additives;

Information or documents (II) to prove the technical necessity and effectiveness of use;

(III) the quality specifications, production processes and inspection methods of food additives, and the inspection methods or relevant information of the additives in food;

(IV) safety assessment materials, including production raw materials or sources, chemical structure and physical characteristics, production process, toxicological safety evaluation data or inspection reports, quality specification inspection reports;

(V) labels, instructions and food additive product samples;

(VI) other countries (regions), international organizations allow the production and use of information to help safety assessment.

Those who apply for expanding the scope of use or dosage of food additives may be exempted from submitting the materials mentioned in Item 4 of the preceding paragraph, except for those required to be supplemented in the technical review.

Article 7 To apply for importing new varieties of food additives for the first time, in addition to the materials specified in Article 6, the following materials shall be submitted:

The certification materials issued by the relevant departments or institutions of the (I) exporting country (region) allowing the additive to be produced or sold in the country (region);

(II) the certification materials for the examination or certification of the production enterprise issued by the relevant institutions or organizations of the country (region) where the production enterprise is located.

6. intermediary services

1. Whether there are statutory intermediary services: none

2. Intermediary Service Item Name: None

3. Basis for setting up intermediary service matters

None

4. Institutions providing intermediary services: none

5. Nature of charges for intermediary services: None

7. Approval Procedure

1. Procedures for administrative licensing

The applicant applies online, submits materials on site, and the government affairs hall issues an acceptance certificate, and gives a reply within 5 working days (acceptance, rejection, and correction).

The government affairs hall will hand over the application materials to the National Food Safety risk Assessment Center, and organize experts in medicine, agriculture, food, nutrition, technology and other fields to conduct technical review on the technical necessity and safety assessment data of new varieties of food additives within 60 working days, and make technical review conclusions (recommended approval, recommended disapproval, postponed retrial).

If the retrial is postponed, the National Food Safety Risk Assessment Center shall make a technical review notice and hand it over to the government affairs hall, and the government affairs hall shall make a technical review notice and serve it to the applicant. After applying for supplementary materials online, the applicant will submit the materials to the government affairs hall on site, which will be handed over to the national food safety risk assessment center for expert technical review.

If the proposal is not approved, a notice shall be issued. If the proposal is not approved without application for review or application for compound, it shall be reported to the National Health and Health Commission.

If it is recommended to be approved, the National Food Safety Risk Assessment Center will write interpretation materials, solicit opinions from departments, industries and society, form a social risk assessment report and report it to the National Health Commission. The National Health Commission makes a decision on whether to approve or not according to the technical review conclusion, and issues a public announcement on the approved products.

The National Food Safety Risk Assessment Center produces a technical review notice to hand over to the government affairs hall, and the government affairs hall delivers the review conclusion to the applicant.

The varieties, scope of use and dosage of the approved food additives shall be formulated and published as national food safety standards in accordance with the procedures of national food safety standards.

The specific procedures for the review and licensing of new food additive safety assessment materials shall be implemented in accordance with the "Administrative Licensing Law", "Administrative Measures for Health Administrative Licensing" and other relevant laws and regulations.

2. Basis for stipulating administrative licensing procedures

(1) Article 9, 10. 11, 12, 13 and 14 of the Measures for the Administration of New Varieties of Food Additives The applicant shall indicate in the materials submitted in Items 1, 2 and 3 of Paragraph 1 of Article 6 of these Measures that do not involve trade secrets and can be disclosed to the public.

The technical necessity and use effect of new varieties of food additives shall be openly solicited from the public, and the opinions of relevant departments and relevant industry organizations such as quality supervision, industrial and commercial administration, food and drug supervision and management, industry and information technology, commerce, etc.

If there is a major difference of opinion or a major interest relationship is involved, a hearing may be held to hear the opinions.

The relevant opinions reflected shall be used as the reference basis for the technical review.

Article 10 The National Health and Family Planning Commission shall organize experts in medicine, agriculture, food, nutrition, technology, etc. within 60 days after acceptance to conduct a technical review of the technical necessity and safety assessment data of new varieties of food additives, and make Technical review conclusions. If it is necessary to supplement relevant materials in the technical review, the applicant shall be notified in a timely manner, and the applicant shall timely supplement relevant materials as required.

When necessary, experts can be organized to verify and evaluate the development and production of new varieties of food additives.

Article 11 The specific procedures for the administrative licensing of new varieties of food additives shall be implemented in accordance with the relevant provisions of the Administrative Licensing Law and the Measures for the Administration of Health Administrative Licensing.

Article 12 The comprehensive review conclusions proposed by the review body shall include the results of safety, technical necessity review and social stability risk assessment.

Article 13 According to the conclusions of the technical review, the National Health and Family Planning Commission has decided to approve new varieties of food additives that are technically necessary and meet the food safety requirements and are included in the list of food additives allowed to be published.

For the lack of technical necessity and does not meet the food safety requirements, not permit and explain the reasons in writing.

The discovery of non-edible chemical substances or other substances harmful to human health that may be added to food shall be implemented in accordance with Article 49 of the Regulations on the Implementation of the Food Safety Law.

Article 14 The National Health and Family Planning Commission shall, in accordance with the technical necessity and the results of the food safety risk assessment, formulate and publish the varieties, scope of use, and dosage of the food additives that are allowed to be used in the announcement in accordance with the procedures of the national food safety standards.

3. Whether on-site inspection is required: in some cases

4. Need to organize a hearing: No

5. Whether bidding, auction and listing are required: No

6. Whether inspection, testing and quarantine are required: No

7. Whether identification is required: No

8. Need for expert review: Yes

9. Whether it is necessary to publicize to the society: Yes

10. Whether to implement the notification commitment: No.

11. Whether the examination and approval authority entrusts the service organization to carry out technical services: No

8. acceptance and approval time limit

1. Commitment acceptance time limit: 5 working days

2. Legal approval time limit: 20 working days

3. Basis for stipulating statutory time limits for examination and approval

(1) Article 42 of the Administrative Licensing Law of the People's Republic of the People's Republic of China, except for those who can make an administrative licensing decision on the spot, the administrative organ shall make an administrative licensing decision within 20 days from the date of accepting the application for administrative licensing. If a decision cannot be made within 20 days, it may be extended for 10 days with the approval of the person in charge of the administrative organ, and the applicant shall be informed of the reasons for the extension. However, if there are other provisions in laws and regulations, such provisions shall prevail.

In accordance with the provisions of Article 26 of this Law, if the administrative license is handled uniformly, jointly or centrally, the time for handling shall not exceed 45 days; if it cannot be completed within 45 days, it may be extended for 15 days with the approval of the person in charge of the people's government at the corresponding level, and the applicant shall be informed of the reasons for the extension.

(2) Article 45 of the Administrative Licensing Law of the the People's Republic of China. If an administrative organ makes an administrative licensing decision and needs hearing, bidding, auction, inspection, testing, quarantine, appraisal and expert review according to law, the time required shall not be counted within the time limit specified in this section. The administrative organ shall inform the applicant of the required time in writing.

(The approval of "Three New Foods" is different from general administrative licenses. It has a relatively complex background and coordination difficulties. It involves key and difficult issues such as national food safety, people's food safety and health assurance, and the process of strict control is extremely cumbersome. And meticulous, it needs to be fully coordinated by experts, society, people, relevant departments, and organizations, the final judgment and decision can only be made after reaching a consensus (if there is no consensus, it will have to be coordinated repeatedly), otherwise the serious impact and consequences will be very passive, even affect the image of the government, lead to instability, etc.)

4. Commitment approval time limit: 20 working days

The additional time required for expert review, inspection and inspection in accordance with the law is not counted in this time limit.

9. charge

1. Whether to charge for administrative licensing: No

2. The name of the charging item, the standard of the charging item, the basis for setting the charging item, and the basis for stipulating the charging standard.

None

10. administrative license

1. Approval Result Type: Other

2. Name of Approval Result: Notice of Conclusion of Administrative License Examination

3. The validity period of the approval result: no time limit

4. The basis for stipulating the validity period of the approval results.

(1) Article 50 of the Administrative License Law of the People's the People's Republic of China of China, where a licensee needs to extend the validity period of an administrative license obtained in accordance with the law, it shall apply to the administrative organ that made the decision on the administrative license 30 days before the expiration of the validity period of the administrative license. However, if there are other provisions in laws, regulations and rules, such provisions shall prevail.

The administrative organ shall, on the basis of the application of the licensee, make a decision on whether to grant the renewal of the administrative license before the expiration of the term of validity of the administrative license; if no decision is made within the time limit, the renewal shall be deemed to be granted.

5. Whether it is necessary to go through the formalities for approval result change: No

6. Requirements for the approval of the results of the change procedures

None

7. Whether it is necessary to go through the formalities for the renewal of the approval results: No

8. Requirements for the renewal of approval results

None

9. Effective geographical scope of approval results

Nationwide

10. The basis for stipulating the effective geographical scope of the examination and approval results.

(1) Article 41 of the Administrative Licensing Law of the People's the People's Republic of China of China, where there is no geographical restriction on the scope of application of an administrative license established by a law or administrative regulation, the administrative license obtained by the applicant shall be valid nationwide.

XI. Limitations on the Quantity of Administrative Licenses

1. There is no administrative license quantity limit: none

2. How to publish quantitative restrictions: None

3. Periods for publication of quantity limits: None

4. Ways of implementing administrative licensing under quantitative restrictions: none

5. The basis for stipulating the implementation of administrative licensing methods under quantitative restrictions.

None

XII. Annual inspection after administrative licensing

1. Annual inspection requirements: none

2. Basis for setting annual inspection requirements

None

3. Annual inspection cycle: none

4. Does the annual inspection require submission of materials: None

5. Name of materials submitted for annual inspection: none

6. Whether the annual inspection is charged: none

7. The name of the annual inspection fee items, the standard of the annual inspection fee items, the basis for setting the annual inspection fee items, and the basis for stipulating the annual inspection fee standards

None

8. Certificate or mark of passing annual inspection: None

XIII. Annual Report after Administrative Licensing

1. With or without annual report requirements: none

2. Name of materials submitted in the annual report: None

3. Basis for setting annual report requirements

None

4. Annual report cycle: None

XIV. Regulatory Subjects

Food safety supervision and administration department of the State Council, local people's governments at or above the county level

XV. Remarks

Among them, the implementation specifications for the administrative licensing of new varieties of food-related products are as follows:

New varieties of food-related products approval

[111000007178369727100012310300001]]

1. basic elements

1. Name of administrative licensing matters

New varieties of food-related products approval

2. Code of service guide

[111000007178369727100012310300001]]

3. Name of the corresponding government service implementation list

Approval of new varieties of food-related products

4. Setting basis

(1) Article 37 of the the People's Republic of China Food Safety Law

5. Basis of implementation

(1) Article 37 of the the People's Republic of China Food Safety Law

(2) Article 4 of the Provisions on the Administration of Administrative Licensing of New Varieties of Food-related Products 3. Article 1 and 2.

6. Regulatory Basis

(1) Articles 5, 6, 7, 19, 21, 22 and 23

7. Source of power: statutory level exercise

8. Implementing agency: National Health Commission

9. Main body of implementation: National Health Commission of the People's Republic of China

10. Nature of the subject of implementation: statutory authorities

11. Code of implementation subject: 111000007178369727

12. Approval level: National level

13. Level of exercise: national level

14. Whether to be accepted by the examination and approval authority: Yes

15. Acceptance level: National level

16. Whether there is a preliminary examination link: No

17. Preliminary Examination Level: None

Types of 2. administrative licensing matters

Inspection type

3. administrative licensing conditions

1. Conditions for granting an administrative license

(1) Meet the definition of new varieties of food-related products: (1) Food packaging materials, containers and their additives that have not been included in the national food safety standards or the announcement of the Ministry of Health; food packaging materials that have (II) expanded the scope or amount of use, Containers and their additives; (III) new raw materials that have not been included in the list of food disinfectants and detergent raw materials; (IV) new materials and new additives that directly contact food in tools and equipment for food production and operation.

(2) Meet the relevant requirements of new varieties of food-related products: (1) The purpose is clear and technically necessary; the (II) does not cause harm to human health under normal and reasonable use; the (III) does not cause food composition, structure, color, flavor and other properties Change; (IV) reduce the amount of use as much as possible when the expected effect is achieved.

2. Basis for stipulating the conditions for administrative licensing

(1) Article 37 of the the People's Republic of China Food Safety Law using new food raw materials to produce food, or producing new varieties of food additives or new varieties of food-related products, the safety assessment materials of the relevant products shall be submitted to the health administrative department of the State Council. The health administrative department of the State Council shall organize the review within 60 days from the date of receipt of the application; grant permission and publish it for those that meet the food safety requirements; and deny permission and explain the reasons in writing for those that do not meet the food safety requirements.

(2) Articles 2, 3 and 4 of the Administrative Provisions on the Administration of New Varieties of Food-related Products The term "new varieties of food-related products" refers to new materials, new raw materials or new additives used in food packaging materials, containers, detergents, disinfectants and tools and equipment used in food production and operation, including:

(I) the food packaging materials, containers and their additives that have not been listed in the national food safety standards or the announcement of the Ministry of Health;

(II) food packaging materials, containers and additives for which the scope of use or the amount of use is expanded;

(III) new raw materials that have not been included in the list of food disinfectants and detergent raw materials;

New materials and new additives in direct contact with food in tools and equipment for (IV) food production and operation.

Food-related products shall meet the following requirements:

The purpose of the (I) is clear and technically necessary;

The (II) does not cause harm to human health under normal and reasonable use;

(III) does not cause changes in the composition, structure or color, aroma and other properties of the food;

(IV) reduce the amount of use as much as possible to achieve the desired effect.

The Ministry of Health is responsible for the licensing of new varieties of food-related products, formulating technical specifications for safety assessment, and designating the Health Supervision Center of the Ministry of Health as the technical review agency for new varieties of food-related products (hereinafter referred to as the review agency) to be responsible for new varieties of food-related products. Application acceptance, organization of safety assessment, technical review and approval.

3. Acceptance conditions

(I) Applicant Conditions

enterprises or individual citizens.

Approval is granted if the (II) has or meets the following conditions:

Where the food safety requirements are met, approval shall be granted.

The (III) shall not be approved under any of the following circumstances:

(A) does not meet the scope of the definition of new varieties of food-related products;

2. The declared information or samples are not true;

3. The test results do not meet the relevant standards and regulations;

4. Toxicological evaluation or safety assessment results have potential safety problems;

5. The security basis is insufficient and the supplementary information still does not meet the security requirements, and the safety judgment cannot be made;

Problems exist in other technical links that affect product safety;

7. Other non-compliance with the relevant laws and regulations of China.

The (III) shall not be approved under any of the following circumstances:

(A) does not meet the scope of the definition of new varieties of food-related products;

2. The declared information or samples are not true;

3. The test results do not meet the relevant standards and regulations;

4. Toxicological evaluation or safety assessment results have potential safety problems;

5. The security basis is insufficient and the supplementary information still does not meet the security requirements, and the safety judgment cannot be made;

Problems exist in other technical links that affect product safety;

7. Other non-compliance with the relevant laws and regulations of China.

4. Administrative Licensing Service Object Types and Reform Measures

1. Type of service object: natural person, enterprise legal person, institution legal person, social organization legal person, unincorporated enterprise

2. Subject classification for natural persons: health

3. Subject classification for legal person matters: health care

4. Classification of themes with local characteristics for natural persons:

5. Subject classification for local characteristics of legal persons:

6. Whether it is an enterprise-related licensing matter: No

7. Name of Business License Matters Involving Enterprises: None

8. License name: None

9. Mode of reform: none

10. Specific reform initiatives

Reform initiatives that do not involve business licensing matters involving enterprises.

11. Strengthening post-event regulatory measures

The food safety supervision and administration department of the State Council shall, in accordance with this Law and the duties prescribed by the State Council, supervise and administer food production and marketing activities.

The health administrative department of the State Council shall, in accordance with this Law and the duties prescribed by the State Council, organize and carry out food safety risk monitoring and risk assessment, and, in conjunction with the food safety supervision and administration department of the State Council, formulate and publish national food safety standards.

Local people's governments at or above the county level shall be responsible for the supervision and administration of food safety in their respective administrative regions, uniformly lead, organize and coordinate the supervision and administration of food safety in their respective administrative regions and the response to food safety emergencies, and establish and improve the working mechanism and information sharing mechanism for the whole process of supervision and administration of food safety.

Local people's governments at or above the county level shall, in accordance with this Law and the provisions of the State Council, determine the duties of the food safety supervision and administration, health administration and other relevant departments at the same level. The relevant departments shall be responsible for the supervision and administration of food safety within their respective administrative areas.

Local people's governments at or above the county level shall implement the food safety supervision and management responsibility system. The people's government at a higher level is responsible for the evaluation and assessment of the food safety supervision and management work of the people's government at the next level. The local people's governments at or above the county level shall be responsible for the evaluation and assessment of the food safety supervision and administration departments at the same level and other relevant departments.

If the food safety supervision and administration and agricultural administrative departments of the State Council find it necessary to carry out food safety risk assessment in the course of supervision and administration, they shall put forward suggestions on food safety risk assessment to the health administrative department of the State Council, and provide information and materials such as risk sources, relevant inspection data and conclusions. Under the circumstances specified in Article 18 of this Law, the health administrative department of the State Council shall conduct food safety risk assessment in a timely manner and notify the relevant departments of the State Council of the assessment results.

The administrative departments of health and agriculture of the people's governments at or above the provincial level shall timely inform each other of the monitoring information on the safety risks of food and edible agricultural products. The administrative departments of health and agriculture under the State Council shall timely inform each other of the safety risk assessment results of food and edible agricultural products and other information.

The results of food safety risk assessment are the scientific basis for the formulation and revision of food safety standards and the implementation of food safety supervision and management. After the food safety risk assessment, it is concluded that food, food additives, and food-related products are unsafe, the food safety supervision and administration department of the State Council shall immediately announce to the public in accordance with their respective duties, inform consumers to stop eating or using, and take corresponding measures to ensure The production and operation of the food, food additives, and food-related products; where relevant national food safety standards need to be formulated or revised, the administrative department of health under the State Council shall, in conjunction with the food safety supervision and administration department under the State Council, formulate and revise the same immediately.

The food safety supervision and administration department of the State Council shall, in conjunction with the relevant departments of the State Council, conduct a comprehensive analysis of the food safety situation based on the results of food safety risk assessment and food safety supervision and administration information. For foods that may have a high degree of safety risk after comprehensive analysis, the food safety supervision and administration department of the State Council shall promptly put forward food safety risk warnings and announce them to the public.

5. application materials

1. Name of application materials

An entity or individual applying for a license for a new variety of food-related product (hereinafter referred to as the applicant) shall apply to the review agency and submit the following materials:

(I) application form;

Physical and chemical properties of (II);

Necessity, purpose and conditions of use of (III) technology;

(IV) production process;

(V) quality specifications, inspection methods and inspection reports;

(VI) toxicological safety assessment data;

(VII) migration and/or residues, estimated dietary exposure and methods for their assessment;

Information or supporting documents (VIII) the permitted use at home and abroad;

(IX) other information to assist in the assessment.

Application for new raw materials for food disinfectants and detergents may be exempted from submitting the seventh information.

Application for food packaging materials, containers, tools, equipment with new additives, should also submit the scope of use, the amount of use and other information.

Where an application is made for the expansion of the scope or amount of use of additives for food packaging materials, containers, tools and equipment, the first, third, sixth and seventh items and the scope of use shall be submitted,

Those who apply for importing new varieties of food-related products for the first time shall, in addition to the materials specified in Article 5, submit the following materials:

The certification materials issued by the relevant department or institution of the (I) exporting country (region) allowing the product to be produced or sold in the country (region);

(II) certification materials for the examination or certification of the production enterprise issued by the relevant institutions or organizations of the country (region) where the production enterprise is located;

(III) the entrusted applicant shall submit a power of attorney for the entrustment declaration;

The Chinese translation of the (IV) shall be notarized by a Chinese notary office.

2. The basis of the prescribed application materials.

(1) Article 5 of the Administrative Provisions on the Administration of New Varieties of Food-related Products and Article 5 of the Provisions on the Administration of Administrative Licensing of New Varieties of Food-related Products and the units or individuals applying for the license of new varieties of food-related products (hereinafter referred to as the applicant) shall apply to the review institution and submit the following materials:

(I) application form;

Physical and chemical properties of (II);

Necessity, purpose and conditions of use of (III) technology;

(IV) production process;

(V) quality specifications, inspection methods and inspection reports;

(VI) toxicological safety assessment data;

(VII) migration and/or residues, estimated dietary exposure and methods for their assessment;

Information or supporting documents (VIII) the permitted use at home and abroad;

(IX) other information to assist in the assessment.

Application for new raw materials for food disinfectants and detergents may be exempted from submitting the seventh information.

Application for food packaging materials, containers, tools, equipment with new additives, should also submit the scope of use, the amount of use and other information.

Where an application is made for the expansion of the scope or amount of use of additives for food packaging materials, containers, tools and equipment, the first, third, sixth and seventh items and the scope of use shall be submitted,

Article 6 To apply for the first import of new varieties of food-related products, in addition to the materials specified in Article 5, the following materials shall be submitted:

The certification materials issued by the relevant department or institution of the (I) exporting country (region) allowing the product to be produced or sold in the country (region);

(II) certification materials for the examination or certification of the production enterprise issued by the relevant institutions or organizations of the country (region) where the production enterprise is located;

(III) the entrusted applicant shall submit a power of attorney for the entrustment declaration;

The Chinese translation of the (IV) shall be notarized by a Chinese notary office.

3. Material Information

（a）

(1) Name of application materials: application materials

(2) Material type: paper and electronic

(3) Material form: original and copy

(4) Material need: required

(5) Source channels:

(6) Source channel description:

(7) Number of copies of paper materials: 5

(8) Paper material specifications:

(9) Instructions for filling:

(10) Acceptance criteria: 1. The applicant shall submit 1 original and 4 copies of the application materials, 1 CD-ROM of the electronic documents of the application materials and necessary samples. The application materials shall be complete and clear, and the contents before and after shall be consistent. Foreign languages should be translated into standard Chinese, and the literature can provide Chinese abstracts, and the translation should be attached to the corresponding foreign language materials.

2. The application materials for new varieties of food-related products shall include the following contents, and shall be arranged in a book in the following order, with page numbers indicated page by page, and there shall be distinguishing marks between each item:

(1) the application form;

(2) physical and chemical properties;

(3) Technical necessity, purpose and conditions of use;

(4) the production process;

(5) Quality specification requirements, inspection methods and inspection reports;

(6) Toxicological safety assessment data;

(7) Migration and/or residues, estimated dietary exposure and methods of assessment;

(8) Information or supporting documents of permitted use at home and abroad;

(9) Other information useful for evaluation.

Applications for new raw materials for food disinfectants and detergents may be exempted from submitting migration and/or residues, estimated dietary exposure and evaluation methods.

Where an application is made for new additives for food packaging materials, containers, tools and equipment, the scope of use and the amount of use shall also be submitted.

The entrusted applicant shall also submit a power of attorney.

3. The application for food packaging materials, containers, tools, equipment additives to expand the scope of use or use, shall submit the following materials:

(1) the application form;

(2) Technical necessity, purpose and conditions of use;

(3) the scope of use, the amount of use;

(4) Toxicological safety assessment data;

(5) Migration and/or residues, estimated dietary exposure and methods of assessment;

The entrusted applicant shall also submit a power of attorney.

4. Those who apply for importing new varieties of food-related products for the first time shall also submit the following materials:

(1) The certification materials issued by the relevant departments or institutions of the exporting country (region) allowing the product to be produced or sold in the country (region);

(2) The certification materials for the examination or certification of the production enterprise issued by the relevant institutions or organizations of the country (region) where the production enterprise is located.

5.1 original and 4 copies of the above information, 1 electronic CD and necessary samples.

(1) Name of application materials: An entity or individual applying for a new variety license for food-related products (hereinafter referred to as the applicant) shall apply to the review agency and submit the following materials: (1) Application form; (II) physical and chemical characteristics; (III) technology Necessity, use and conditions of use; (IV) production process; (V) quality specifications, inspection methods and inspection reports; (VI) toxicological safety assessment data; (VII) migration and/or residues, estimated dietary exposure and methods for their assessment; information or documentation (VIII) permitted use at home and abroad; (IX) other information useful for the assessment. Application for food

(2) Material type:

(3) Material form:

(4) Material need: required

(5) Source channels:

(6) Source channel description:

(7) Copies of paper materials:

(8) Paper material specifications:

(9) Instructions for filling:

(10) Acceptance criteria:

6. intermediary services

1. Whether there are statutory intermediary services: none

2. Intermediary Service Item Name: None

3. Basis for setting up intermediary service matters

None

4. Institutions providing intermediary services: none

5. Nature of charges for intermediary services: None

7. Approval Procedure

1. Procedures for administrative licensing

(1) The review agency shall organize experts in medicine, food, chemicals, materials, etc. within 60 days after acceptance to conduct technical reviews on the safety of new varieties of food-related products and make technical review conclusions. If additional information is needed in the process of technical review, the review institution shall timely inform the applicant in writing at one time, and the applicant shall timely supplement the relevant information as required.

According to the needs of technical evaluation, the evaluation institution may require the applicant to answer relevant technical questions on the spot, and the applicant shall cooperate. When necessary, experts can be organized to verify and evaluate the development and production of new varieties of food-related products.

If it is necessary to carry out verification tests on relevant materials and inspection results, the review institution shall inform the applicant of the requirements such as inspection items, inspection batches and inspection methods. The verification test shall be conducted in the inspection institution that has obtained the qualification. If there is no national standard inspection method for food safety, the inspection method shall be verified first.

The specific procedures for administrative licensing of new varieties of food-related products shall be implemented in accordance with the relevant provisions of the Administrative Licensing Law and the Administrative Measures for Health Administrative Licensing.

The review institution shall solicit opinions from the public during the review process.

According to the conclusion of the technical review, the Ministry of Health approves and announces the new varieties of food-related products that meet the food safety requirements. For those who do not meet the requirements, no permission shall be granted and the reasons shall be given in writing. Food-related products (including imported food-related products) that meet the requirements of the Ministry of Health's announcement do not need to apply for a license again.

According to the safety assessment results of food-related products, the Ministry of Health formulates and publishes corresponding national food safety standards in accordance with the relevant provisions on the management of national food safety standards.

After the corresponding national food safety standards are published, the original announcement will be automatically abolished.

2. Basis for stipulating administrative licensing procedures

(1) Article 9, 10. 11, and 12 of the "Administrative Regulations on Administrative Licensing of New Varieties of Food-related Products" Article 9 The review agency shall organize experts in medicine, food, chemicals, materials, etc. within 60 days after acceptance. The safety of new varieties of food-related products conducts technical review and makes technical review conclusions. If additional information is needed in the process of technical review, the review institution shall timely inform the applicant in writing at one time, and the applicant shall timely supplement the relevant information as required.

According to the needs of technical evaluation, the evaluation institution may require the applicant to answer relevant technical questions on the spot, and the applicant shall cooperate. When necessary, experts can be organized to verify and evaluate the development and production of new varieties of food-related products.

If it is necessary to carry out verification tests on relevant materials and inspection results, the review institution shall inform the applicant of the requirements such as inspection items, inspection batches and inspection methods. The verification test shall be conducted in the inspection institution that has obtained the qualification. If there is no national standard inspection method for food safety, the inspection method shall be verified first.

Article 10 The specific procedures for the administrative licensing of new varieties of food-related products shall be implemented in accordance with the Administrative Licensing Law, the Administrative Measures for Health Administrative Licensing and other relevant provisions.

Article 11 The review body shall solicit opinions from the public during the review process.

According to the conclusion of the technical review, the Ministry of Health approves and announces the new varieties of food-related products that meet the food safety requirements. For those who do not meet the requirements, no permission shall be granted and the reasons shall be given in writing. Food-related products (including imported food-related products) that meet the requirements of the Ministry of Health's announcement do not need to apply for a license again.

Article 12 The Ministry of Health shall, in accordance with the safety assessment results of food-related products and in accordance with the relevant provisions on the administration of national food safety standards, formulate and publish corresponding national food safety standards.

After the corresponding national food safety standards are published, the original announcement will be automatically abolished.

3. Whether on-site inspection is required: in some cases

4. Need to organize a hearing: No

5. Whether bidding, auction and listing are required: No

6. Whether inspection, testing and quarantine are required: No

7. Whether identification is required: No

8. Need for expert review: Yes

9. Whether it is necessary to publicize to the society: Yes

10. Whether to implement the notification commitment: No.

11. Whether the examination and approval authority entrusts the service organization to carry out technical services: No

8. acceptance and approval time limit

1. Commitment acceptance time limit: 5 working days

2. Legal time limit for approval: 20 working days

3. Basis for stipulating statutory time limits for examination and approval

(1) Article 42 of the Administrative Licensing Law of the the People's Republic of China, except for those who can make an administrative licensing decision on the spot, the administrative organ shall make an administrative licensing decision within 20 days from the date of accepting the application for administrative licensing. If a decision cannot be made within 20 days, it may be extended for 10 days with the approval of the person in charge of the administrative organ, and the applicant shall be informed of the reasons for the extension. However, if there are other provisions in laws and regulations, such provisions shall prevail.

In accordance with the provisions of Article 26 of this Law, if the administrative license is handled uniformly, jointly or centrally, the time for handling shall not exceed 45 days; if it cannot be completed within 45 days, it may be extended for 15 days with the approval of the person in charge of the people's government at the corresponding level, and the applicant shall be informed of the reasons for the extension.

(2) Article 45 of the Administrative Licensing Law of the the People's Republic of China If an administrative organ makes an administrative licensing decision and needs hearing, bidding, auction, inspection, testing, quarantine, appraisal and expert review according to law, the time required shall not be counted in the time limit specified in this section. The administrative organ shall inform the applicant of the required time in writing.

(The approval of "Three New Foods" is different from general administrative licenses. It has a relatively complex background and coordination difficulties. It involves key and difficult issues such as national food safety, people's food safety and health assurance, and the process of strict control is extremely cumbersome. And meticulous, it needs to be fully coordinated by experts, society, people, relevant departments, and organizations, the final judgment and decision can only be made after reaching a consensus (if there is no consensus, it will have to be coordinated repeatedly), otherwise the serious impact and consequences will be very passive, even affect the image of the government, lead to instability, etc.)

4. Commitment approval time limit: 20 working days

(1) The additional time required for expert review, inspection and testing in accordance with the law is not calculated within the time limit.

5. Type of parts: commitment parts

9. charge

1. Whether to charge for administrative licensing: No

2. The name of the charging item, the standard of the charging item, the basis for setting the charging item, and the basis for stipulating the charging standard.

None

3. Whether relief is allowed: No

4. The basis for allowing relief:

10. administrative license

1. Approval Result Type: Other

2. Name of administrative license certificate: Notice of conclusion of administrative license examination

3. The validity period of the administrative license: no time limit

4. The basis for stipulating the validity period of the administrative license:

(1) Article 50 of the Administrative License Law of the the People's Republic of China Where a licensee needs to extend the validity period of an administrative license obtained in accordance with the law, it shall apply to the administrative organ that made the administrative license decision 30 days before the expiration of the validity period of the administrative license. However, if there are other provisions in laws, regulations and rules, such provisions shall prevail.

The administrative organ shall, on the basis of the application of the licensee, make a decision on whether to grant the renewal of the administrative license before the expiration of the term of validity of the administrative license; if no decision is made within the time limit, the renewal shall be deemed to be granted.

5. Whether it is necessary to go through the formalities for approval result change: No

6. Requirements for the approval of the results of the change procedures

None

7. Whether it is necessary to go through the formalities for the renewal of the approval results: No

8. Requirements for the renewal of approval results

None

9. Effective geographical scope of approval results

Nationwide

10. The basis for stipulating the effective geographical scope of the examination and approval results.

(1) Article 41 of the Administrative Licensing Law of the People's the People's Republic of China of China, where there is no geographical restriction on the scope of application of an administrative license established by a law or administrative regulation, the administrative license obtained by the applicant shall be valid nationwide.

XI. Limitations on the Quantity of Administrative Licenses

1. There is no administrative license quantity limit: none

2. How to publish quantitative restrictions: None

3. Periods for publication of quantity limits: None

4. Ways of implementing administrative licensing under quantitative restrictions: none

5. The basis for stipulating the implementation of administrative licensing methods under quantitative restrictions.

None

XII. Annual inspection after administrative licensing

1. Annual inspection requirements: none

2. Basis for setting annual inspection requirements

None

3. Annual inspection cycle: none

4. Does the annual inspection require submission of materials: None

5. Name of materials submitted for annual inspection:

None

6. Whether the annual inspection is charged: none

7. The name of the annual inspection fee items, the standard of the annual inspection fee items, the basis for setting the annual inspection fee items, and the basis for stipulating the annual inspection fee standards

None

8. Certificate or mark of passing annual inspection: None

XIII. Annual Report after Administrative Licensing

1. With or without annual report requirements: none

2. Name of materials submitted in the annual report:

None

3. Basis for setting annual report requirements

None

4. Annual report cycle: None

XIV. Regulatory Subjects

Food safety supervision and administration department of the State Council, local people's governments at or above the county level

XV. Business Handling Information

1. Whether to do it: No

2. general business model: none

3. Name of inter-provincial service item: None

4. Is it the inter-provincial general service item in article 35: none

5. Application Scenarios:

6. Joint bodies:

7. Handling form: window handling, online handling

8. Whether to run online: Yes

9. Online processing depth: Internet acceptance

10. Network Office Address:https://slps.jdzx.net.cn/

11. Whether it can be handled on the mobile side: No

12. WeChat applet handling address:

13. Address of Alipay applet:

14. Baidu applet handling address:

15.APP handling address:

16. Other handling addresses:

17. Whether the computer side is docked with single sign-on: Yes

18. The computer terminal handles the jump address online: https://slps.jdzx.net.cn/

19. Number of visits to the office site: 1

20. Reasons for on-site handling: the applicant applies online, submits the application materials on site, and the government affairs hall issues the acceptance certificate

21. Service Channels: Entity Hall, Internet Government Service Hall

22. Whether to enter the government hall: Yes

23. Location: Office Address: No.1, Xizhimen Wainan Road, Xicheng District, Beijing (North Skirt Building, Building 2, Xizhimen Office Area, National Health Commission).

24. Handling hours: office hours: Monday to Friday: 8:30-12:00 a.m.; From 13:30 p. m. to 17:00 p.m., legal holidays shall be implemented in accordance with national regulations.

25. Consultation Methods: (1) Window Consultation: Administrative Hall of National Health Commission. Address: No.1, Xizhimen Wainan Road, Xicheng District, Beijing (North Skirt Building, Building 2, Xizhimen Office Area, National Health Commission).

(II) telephone consultation

Tel: 010-68791409

Technical Advisory Tel: 010-52165471

(III) Email Advisory: zwdt_consult@126.com

(IV) Letter Consultation

Acceptance of consultation: No.1, Xizhimen Wainan Road, Xicheng District, Beijing (North Skirt Building, Building 2, Xizhimen Office Area, National Health Commission), zip code: 100044.

Technical Consultation: Building 2, Yard 37, Guangqu Road, Chaoyang District, Beijing 100022.

26. Supervision and Complaint Methods: (1) Window Complaint: Discipline Inspection and Supervision Office of National Food Safety Risk Assessment Center (No.2 Courtyard, No.37 Guangqu Road, Chaoyang District, Beijing).

(II) complaint telephone number: 010-52165512

(III) email complaints: jishenchu@cfsa.net.cn

(IV) letter complaint: discipline inspection and supervision office of the national food safety risk assessment center (no 2, courtyard 37, guangqu road, Chaoyang district, Beijing), zip code 100022.

27. Whether to support appointment processing: No

28. Whether to support online payment: No

29. Whether to support logistics express: No

30. Whether to support self-service terminal processing: No

31. Questions, Answers

(1) Questions: Common Questions on Application Forms

(2) Answer:(1) Attached information (please tick "√" in □ before the information provided): tick "√" should be used for online operation, and "√" should not be filled in manually ".

(2) Legal representative (signature): it shall be signed or signed by the legal representative, and the legal representative's name seal shall be invalid.

(3) Other issues that need to be explained: the name of the production enterprise needs to be filled in, and the Chinese name of the production enterprise should be filled in at the same time for imported products.

(4) Address: It should be consistent with the registered address of the reporting unit.

(1) Question: Modify the contact number at the time of registration

(2) Answer: Telephone 010-68491409 for revision

(1) Problem: Forgot username and password

(2) Answer: Call 010-68791409 for retrieval

(1) Problem: There is a problem in uploading electronic application materials

(2) Answer: Telephone 010-51077100 for consultation

(1) Question: Delivery method of paper application materials

(2) Answer: On-site submission or mail reception

(1) Question: Delivery Method of Approval Results

(2) Answer: Pick it up on site or send it by mail

(1) Question: Understand the progress of the application.

(2) Answer: Visit the website of the National Health Commission's Administrative Hall (http://www.nhc.gov.cn/) "Online Approval Hall" for inquiries, or by telephone 010-68791409.

(1) Question: Understanding the Approval Service Guide

(2) Answer: Log on to the website of the National Health Commission Administration Hall (http://www.nhc.gov.cn/1) In the Permitted Items column, you can query the specific approval guidelines for each type of permitted items.