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Table of Contents
Intro
Chinese food law: A legal-systematic analysis
Copyright
Table of contents
List of abbreviations
About the authors
Preface
1. Introduction
1.1 The dragon awakens!
1.2 Chinese food law
1.3 Legal-systematic approach
1.4 What is food law?
1.5 Development of Chinese Food Law
1.5.1 The first food-related measures
1.5.2 Patchwork of food-related legislation
1.5.3 From food hygiene to the Food Safety Law
1.5.4 Deregulation
1.5.5 Framework for analysis
2. Institutional framework
2.1 Political, legal and legislative specifics of the PRC
2.2 National and regional
2.3 Food safety governance
2.4 Public actors
2.4.1 Institutional framework as from March 2018
2.4.2 Administrative departments before March 2018
3. General principles and rules of Chinese Food Law
3.1 The Food Safety Law
3.2 Aim and scope of the Food Safety Law
3.3 General principles
3.3.1 Prevention principle
3.3.2 Risk management
3.3.3 Full-process control
3.3.4 Social governance
3.4 Key definitions
3.4.1 Food
3.4.2 Food additives
3.4.3 Food-related products
3.4.4 Food safety
3.4.5 Food producers and distributors
3.5 Food Law and science
3.5.1 Risk assessment
3.5.2 Risk management
3.5.3 Risk communication
3.6 Food safety standards
3.6.1 The PRC's standardisation system
3.6.2 Food safety standards under the Food Safety law
3.6.3 Other food-related standards
3.7 Obligations for food producers and distributors
3.7.1 Licensing system
3.7.2 Hygiene requirements
3.7.3 Prohibited activities: the core of Chinese food safety law
3.7.4 Small food workshops and food vendors
3.7.5 Self-regulatory rules
3.7.6 Food labelling
3.7.7 Special foods
3.8 International trade
3.8.1 Import
3.8.2 Export
3.8.3 International standards.
3.9 Enforcement
3.9.1 Supervision, administration and credit
3.9.2 Incident management and emergency response
3.9.3 Risk, warning and other communication on enforcement activities
3.10 Liability
3.10.1 Liable actors
3.10.2 Types of liability
3.10.3 Legal consequences for authorities
3.11 Discussion
3.11.1 Actors addressed under the Food Safety Law
3.11.2 Issues covered under the Food Safety Law
3.11.3 How China's food legal system deals with food safety
4. Homology of medicine and food
4.1 Introduction
4.2 Food as well as medicine
4.3 Regulation of the homology
4.4 Discussion
5. Edible agricultural products and the Agri-Product Quality and Safety Law
5.1 Introduction
5.2 History
5.3 The Agri-Product Quality and Safety Law
5.4 Agriculture in the food chain
5.4.1 Governance at the source
5.4.2 Environmental governance
5.4.3 Commitment to compliance certification
5.5 Edible agricultural products
5.6 Relation between APQSL and FSL
5.7 Standard setting
5.7.1 Farm Product Quality and Safety Standards
5.7.2 System for risk monitoring and risk assessment
5.8 Product requirements
5.9 Process requirements
5.9.1 Pre-farmgate
5.9.2 Licensing
5.9.3 Licensed agricultural inputs
5.9.4 Safety self-assessment
5.9.5 Traceability, trade and recall
5.10 Presentation requirements
5.10.1 Mandatory labelling
5.10.2 Quality marks
5.10.3 GMO labelling
5.11 Enforcement
5.12 Monitoring and inspection
5.12.1 Monitoring systems
5.12.2 Inspection
5.12.3 Inspection at the market
5.12.4 Re-inspection
5.12.5 Inspector liability
5.12.6 Social governance and complaints
5.13 Control measures and sanctions
5.13.1 Identification
5.13.2 Control measures
5.13.3 Sanctions
5.14 Discussion.
6. Pre-market authorisation of food ingredients and products
6.1 Introduction
6.2 New food additives
6.2.1 Definition and scope of food additives
6.2.2 Requirements for market access
6.2.3 Authorisation procedure for new food additives
6.2.4 Post-authorisation requirements
6.2.5 Authorisation procedure for imported food additives
6.2.6 Labelling requirements
6.2.7 Supervision, inspection and liability
6.2.8 Overview of the authorisation procedure for food additives
6.3 Novel food materials
6.3.1 Definition and scope of novel food materials
6.3.2 Requirements for market access
6.3.3 Authorisation procedure for novel food materials
6.3.4 Post-authorisation requirements
6.3.5 Authorisation procedure for imported novel food materials
6.3.6 Labelling requirements
6.3.7 Supervision, inspection and liability
6.3.8 Overview of the authorisation procedure for novel food materials
6.4 Functional ingredients and health foods
6.4.1 Definition and scope of health foods
6.4.2 Requirements for market access
6.4.3 Authorisation procedure for health foods
6.4.4 Post-authorisation requirements
6.4.5 Authorisation procedure for imported health foods
6.4.6 Labelling requirements
6.4.7 Supervision, inspection and liability
6.4.8 Overview of the authorisation procedure for health foods
6.5 Foods for special medical purposes
6.5.1 Definition and scope of foods for special medical purposes
6.5.2 Requirements for market access
6.5.3 Authorisation procedure for foods for special medical purposes
6.5.4 Post-authorisation requirements
6.5.5 Authorisation procedure for imported foods for special medical purposes
6.5.6 Labelling requirements
6.5.7 Supervision, inspection and liability
6.5.8 Overview of the authorisation procedure for FSMP
6.6 Infant formula.
6.6.1 Definition and scope of infant formula
6.6.2 Requirements for market access
6.6.3 Authorisation procedure for infant formula recipe
6.6.4 Post-authorisation requirements
6.6.5 Authorisation procedure for imported infant formula
6.6.6 Labelling requirements
6.6.7 Supervision, inspection and liability
6.6.8 Overview of the authorisation procedure for infant formula
6.7 Discussion
6.7.1 Health foods
6.7.2 Foods for special medical purposes
6.7.3 Infant formula
7. Genetically modified food
7.1 Introduction
7.2 Institutional aspects
7.3 Concept
7.3.1 Definition
7.3.2 Gene editing
7.4 Safety classification
7.5 Application, scope and requirements
7.5.1 Deadline
7.5.2 Initial research
7.5.3 Approval of next testing stage
7.5.4 Safety certificate
7.5.5 Production license
7.5.6 Processing license
7.5.7 Marketing license
7.5.8 Import
7.6 Procedure
7.6.1 Application
7.6.2 Safety assessment
7.7 Traceability
7.8 Incident management
7.9 Labelling and advertisement
7.9.1 Catalogue of Ag GMOs subject to labelling administration
7.9.2 GMO labelling responsibility
7.9.3 GMO labelling phrasing
7.9.4 No GM-free labelling
7.9.5 Advertisement
7.10 Enforcement
7.10.1 Penalty provisions
7.10.2 Import
7.10.3 Labelling
8. Food safety limits
8.1 Contamination
8.2 Chemical contaminants
8.3 Pesticide residues
8.4 Residues of veterinary drugs
8.5 Pathogens
8.6 Mycotoxins
8.7 Other limits
8.8 Discussion
9. Process requirements
9.1 Introduction
9.2 Legal framework of process requirements
9.2.1 Process requirements under the FSL
9.2.2 Implementation of the FSL through Administrative Regulations and Rules
9.2.3 Hygiene standards as technical guidance
9.2.4 Voluntary management schemes for safety assurance.
9.3 Licensing
9.3.1 Licensing procedure
9.3.2 Principles of the licensing system
9.3.3 Enforcement and liability
9.3.4 Small businesses
9.3.5 Overseas businesses
9.4 Self-regulatory rules for food safety management
9.4.1 Control of incoming materials
9.4.2 Control of contamination during processing
9.4.3 Packaging
9.4.4 Control measures for food storage and transportation
9.4.5 Health management of employees
9.4.6 HACCP
9.4.7 Self-inspection, enforcement and liability
9.5 Traceability
9.5.1 Establishment and implementation of traceability systems by food businesses
9.5.2 Involvement of the (local) government
9.5.3 Traceability of imported food products
9.5.4 Liability
9.6 Recall
9.6.1 Recall procedure
9.6.2 Liability
9.7 Discussion
9.7.1 Prevention
9.7.2 Risk management
9.7.3 Full-process control
9.7.4 Social governance
Supplementary material
10. Food information
10.1 Introduction
10.2 Legal framework of food presentation rules
10.2.1 Pre-packaged Product Labelling Standard
10.2.2 Nutrition Labelling of Pre-packaged Foods Standard
10.2.3 Standard on Pre-packaged Special Dietary Food Labels
10.2.4 Advertisement Law
10.2.5 Competent authorities
10.3 Responsibilities, general principles and liability
10.3.1 Responsibilities of food businesses
10.3.2 General principles
10.3.3 Legal liability and other consequences in case of non-compliance
10.4 Mandatory particulars for food labelling
10.4.1 Name of the food
10.4.2 Contact details of the food producer
10.4.3 Production date, expiry date, and storage requirements
10.4.4 Net quantity
10.4.5 List of ingredients
10.4.6 Code of product standard(s)
10.4.7 Production license number
10.4.8 Nutrition information
10.4.9 Other requirements.
10.5 Voluntary particulars for food labelling.
Chinese food law: A legal-systematic analysis
Copyright
Table of contents
List of abbreviations
About the authors
Preface
1. Introduction
1.1 The dragon awakens!
1.2 Chinese food law
1.3 Legal-systematic approach
1.4 What is food law?
1.5 Development of Chinese Food Law
1.5.1 The first food-related measures
1.5.2 Patchwork of food-related legislation
1.5.3 From food hygiene to the Food Safety Law
1.5.4 Deregulation
1.5.5 Framework for analysis
2. Institutional framework
2.1 Political, legal and legislative specifics of the PRC
2.2 National and regional
2.3 Food safety governance
2.4 Public actors
2.4.1 Institutional framework as from March 2018
2.4.2 Administrative departments before March 2018
3. General principles and rules of Chinese Food Law
3.1 The Food Safety Law
3.2 Aim and scope of the Food Safety Law
3.3 General principles
3.3.1 Prevention principle
3.3.2 Risk management
3.3.3 Full-process control
3.3.4 Social governance
3.4 Key definitions
3.4.1 Food
3.4.2 Food additives
3.4.3 Food-related products
3.4.4 Food safety
3.4.5 Food producers and distributors
3.5 Food Law and science
3.5.1 Risk assessment
3.5.2 Risk management
3.5.3 Risk communication
3.6 Food safety standards
3.6.1 The PRC's standardisation system
3.6.2 Food safety standards under the Food Safety law
3.6.3 Other food-related standards
3.7 Obligations for food producers and distributors
3.7.1 Licensing system
3.7.2 Hygiene requirements
3.7.3 Prohibited activities: the core of Chinese food safety law
3.7.4 Small food workshops and food vendors
3.7.5 Self-regulatory rules
3.7.6 Food labelling
3.7.7 Special foods
3.8 International trade
3.8.1 Import
3.8.2 Export
3.8.3 International standards.
3.9 Enforcement
3.9.1 Supervision, administration and credit
3.9.2 Incident management and emergency response
3.9.3 Risk, warning and other communication on enforcement activities
3.10 Liability
3.10.1 Liable actors
3.10.2 Types of liability
3.10.3 Legal consequences for authorities
3.11 Discussion
3.11.1 Actors addressed under the Food Safety Law
3.11.2 Issues covered under the Food Safety Law
3.11.3 How China's food legal system deals with food safety
4. Homology of medicine and food
4.1 Introduction
4.2 Food as well as medicine
4.3 Regulation of the homology
4.4 Discussion
5. Edible agricultural products and the Agri-Product Quality and Safety Law
5.1 Introduction
5.2 History
5.3 The Agri-Product Quality and Safety Law
5.4 Agriculture in the food chain
5.4.1 Governance at the source
5.4.2 Environmental governance
5.4.3 Commitment to compliance certification
5.5 Edible agricultural products
5.6 Relation between APQSL and FSL
5.7 Standard setting
5.7.1 Farm Product Quality and Safety Standards
5.7.2 System for risk monitoring and risk assessment
5.8 Product requirements
5.9 Process requirements
5.9.1 Pre-farmgate
5.9.2 Licensing
5.9.3 Licensed agricultural inputs
5.9.4 Safety self-assessment
5.9.5 Traceability, trade and recall
5.10 Presentation requirements
5.10.1 Mandatory labelling
5.10.2 Quality marks
5.10.3 GMO labelling
5.11 Enforcement
5.12 Monitoring and inspection
5.12.1 Monitoring systems
5.12.2 Inspection
5.12.3 Inspection at the market
5.12.4 Re-inspection
5.12.5 Inspector liability
5.12.6 Social governance and complaints
5.13 Control measures and sanctions
5.13.1 Identification
5.13.2 Control measures
5.13.3 Sanctions
5.14 Discussion.
6. Pre-market authorisation of food ingredients and products
6.1 Introduction
6.2 New food additives
6.2.1 Definition and scope of food additives
6.2.2 Requirements for market access
6.2.3 Authorisation procedure for new food additives
6.2.4 Post-authorisation requirements
6.2.5 Authorisation procedure for imported food additives
6.2.6 Labelling requirements
6.2.7 Supervision, inspection and liability
6.2.8 Overview of the authorisation procedure for food additives
6.3 Novel food materials
6.3.1 Definition and scope of novel food materials
6.3.2 Requirements for market access
6.3.3 Authorisation procedure for novel food materials
6.3.4 Post-authorisation requirements
6.3.5 Authorisation procedure for imported novel food materials
6.3.6 Labelling requirements
6.3.7 Supervision, inspection and liability
6.3.8 Overview of the authorisation procedure for novel food materials
6.4 Functional ingredients and health foods
6.4.1 Definition and scope of health foods
6.4.2 Requirements for market access
6.4.3 Authorisation procedure for health foods
6.4.4 Post-authorisation requirements
6.4.5 Authorisation procedure for imported health foods
6.4.6 Labelling requirements
6.4.7 Supervision, inspection and liability
6.4.8 Overview of the authorisation procedure for health foods
6.5 Foods for special medical purposes
6.5.1 Definition and scope of foods for special medical purposes
6.5.2 Requirements for market access
6.5.3 Authorisation procedure for foods for special medical purposes
6.5.4 Post-authorisation requirements
6.5.5 Authorisation procedure for imported foods for special medical purposes
6.5.6 Labelling requirements
6.5.7 Supervision, inspection and liability
6.5.8 Overview of the authorisation procedure for FSMP
6.6 Infant formula.
6.6.1 Definition and scope of infant formula
6.6.2 Requirements for market access
6.6.3 Authorisation procedure for infant formula recipe
6.6.4 Post-authorisation requirements
6.6.5 Authorisation procedure for imported infant formula
6.6.6 Labelling requirements
6.6.7 Supervision, inspection and liability
6.6.8 Overview of the authorisation procedure for infant formula
6.7 Discussion
6.7.1 Health foods
6.7.2 Foods for special medical purposes
6.7.3 Infant formula
7. Genetically modified food
7.1 Introduction
7.2 Institutional aspects
7.3 Concept
7.3.1 Definition
7.3.2 Gene editing
7.4 Safety classification
7.5 Application, scope and requirements
7.5.1 Deadline
7.5.2 Initial research
7.5.3 Approval of next testing stage
7.5.4 Safety certificate
7.5.5 Production license
7.5.6 Processing license
7.5.7 Marketing license
7.5.8 Import
7.6 Procedure
7.6.1 Application
7.6.2 Safety assessment
7.7 Traceability
7.8 Incident management
7.9 Labelling and advertisement
7.9.1 Catalogue of Ag GMOs subject to labelling administration
7.9.2 GMO labelling responsibility
7.9.3 GMO labelling phrasing
7.9.4 No GM-free labelling
7.9.5 Advertisement
7.10 Enforcement
7.10.1 Penalty provisions
7.10.2 Import
7.10.3 Labelling
8. Food safety limits
8.1 Contamination
8.2 Chemical contaminants
8.3 Pesticide residues
8.4 Residues of veterinary drugs
8.5 Pathogens
8.6 Mycotoxins
8.7 Other limits
8.8 Discussion
9. Process requirements
9.1 Introduction
9.2 Legal framework of process requirements
9.2.1 Process requirements under the FSL
9.2.2 Implementation of the FSL through Administrative Regulations and Rules
9.2.3 Hygiene standards as technical guidance
9.2.4 Voluntary management schemes for safety assurance.
9.3 Licensing
9.3.1 Licensing procedure
9.3.2 Principles of the licensing system
9.3.3 Enforcement and liability
9.3.4 Small businesses
9.3.5 Overseas businesses
9.4 Self-regulatory rules for food safety management
9.4.1 Control of incoming materials
9.4.2 Control of contamination during processing
9.4.3 Packaging
9.4.4 Control measures for food storage and transportation
9.4.5 Health management of employees
9.4.6 HACCP
9.4.7 Self-inspection, enforcement and liability
9.5 Traceability
9.5.1 Establishment and implementation of traceability systems by food businesses
9.5.2 Involvement of the (local) government
9.5.3 Traceability of imported food products
9.5.4 Liability
9.6 Recall
9.6.1 Recall procedure
9.6.2 Liability
9.7 Discussion
9.7.1 Prevention
9.7.2 Risk management
9.7.3 Full-process control
9.7.4 Social governance
Supplementary material
10. Food information
10.1 Introduction
10.2 Legal framework of food presentation rules
10.2.1 Pre-packaged Product Labelling Standard
10.2.2 Nutrition Labelling of Pre-packaged Foods Standard
10.2.3 Standard on Pre-packaged Special Dietary Food Labels
10.2.4 Advertisement Law
10.2.5 Competent authorities
10.3 Responsibilities, general principles and liability
10.3.1 Responsibilities of food businesses
10.3.2 General principles
10.3.3 Legal liability and other consequences in case of non-compliance
10.4 Mandatory particulars for food labelling
10.4.1 Name of the food
10.4.2 Contact details of the food producer
10.4.3 Production date, expiry date, and storage requirements
10.4.4 Net quantity
10.4.5 List of ingredients
10.4.6 Code of product standard(s)
10.4.7 Production license number
10.4.8 Nutrition information
10.4.9 Other requirements.
10.5 Voluntary particulars for food labelling.