food contact & food additives_laura wang

China Food Additives regulatory

developments

REACH24H CONSULTING GROUP

LAURA WANG

REACH24H CONSULTING GROUP LAURA WANG

Content 1. An introduction of China Food Additives Regulation System

2. The updates of China Food Additives Regulation

• Updates in Food Safety Law

• Updates in GB 2760-2014

1. Some practical tips


• Leading compliance solution provider in China and AP

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• Registration services on new food additives, food contact

materials and food raw materials

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• Practical tools such as regulatory database, inventory tool

box, etc.

• Webinars of development of regulations

Regulation system in China


Which direction

Basic Law

Food Safety Law

How to do

Measures

• Administrative Measures on New

Varieties of Food Additives;

• Provisions on Application and

Acceptance of New Varieties of

Food Additives;

• Provisions on Supervision and

Administration of Production of

Food Additives;

• General Rules on Examination for

Food Additive Production

License

• etc.

What’s the details

Standards

• GB 2760 Standard for Uses of

Food Additives;

• GB 31624 Standard for Beta –

carotene;

• GB 8273 D-isoascorbate;

• GB 4578 Saccharin sodium;

• GB 3861 Vanillin;

• GB 1976 Sodium alginate;

• GB 22216 Hydrogen peroxide

• GB 1976 Sodium alginate

• 200+ GB standards

Definition and scope of Food Additives


US EU China

Direct food additives ● ● ●

Flavor ● - ●

Enzyme ● - ●

Food fortifiers ● - ●

Food processing aid ● - ●

Food contact additives ● - -

Food ingredients ● - -

How food additives are managed in China


Assessing Safety

NHFPC

• Draft and publish

relevant standards;

• Assess safety of food

additives

• Approve new food

additives

Manufacture/Importation

CFDA, AQSIQ

• Manage the manufacturing of

food additives

• Monitor the circulation of food

additives in the market

• AQSIQ is in charge of the

importation of food additives

and food additives used in the

food

Monitoring & Inspection

Local FDA

• Monitor and inspect time to time

about the trade and

manufacturing of food additives

• Publish the results to the public


Fo

od

Ad

ditiv

es stand

ards

Application standard

Product standards

Labelling standards

Manufacturing Practice

GB29924 General rules on food additives labelling

Manufacturing regulations of food additives

200+ product standards

GB26687 General rules of Compound Food Additives

GB25594 Enzyme used in food industry

GB30616 Food flavor

GB29983 General rules on Food flavor

GB29987 Chewing gum bases and their ingredients

GB2760 Standard for Uses of Food Additives

GB14880 Standard for Nutritional Fortifiers

Updates in China Food

Additives Regulations


1. Updates in Food Safety Law

2. Updates in GB 2760 - 2014

Updates in Food Safety Law 2015


2 National standards

3 Production

Food Safety Risk Surveillance and Assessment

1

4 Imported food

5 Legal liabilities




3 Production


1

4 Imported food

5 Legal liabilities

I Article 21 Food safety risk assessment results shall be the

scientific basis for developing and modifying food safety

standards, as well as food safety regulatory work.

In case the food safety risk assessment conclusion shows a

food, a food additive, or a food related product is unsafe,

CFDA and AQSIQ shall immediately inform consumers to stop

consumption or usage of the product, and take actions to

terminate product and trading of the food, food additive

and food-related products; if necessary, NHFPC shall

immediately formulate or modify the relevant food safety

national standards in conjunction with CFDA.

“

”Chapter 2 Food Safety Risk Surveillance and

Assessment




3 Production


1

4 Imported food

5 Legal liabilities

Article 26 Food safety standards shall include the following standards

1) Limits of pathogenic microorganisms, pesticide residues,

veterinary drug residues, heavy metals, biotoxins,

contaminants, and other substances hazardous to human

health in food, food additives and food-related products;

2) Varieties, scope of application, and dose of food

additive use;

3) …..

“

” Chapter 3 Food Safety Standards




3 Production


1

4 Imported food

5 Legal liabilities

Article 39 The State adopts a licensing system for the production of food

additives. Food additives production shall have venue,

equipment/facilities, professionals and management system that match

the produced food additive variety, the producer shall, in accordance

with the procedure of Article 35.2 of this law, obtain the food additive

producing license. The production of food additives should be in

accordance with laws, regulations and food safety national standards.

“

”

Article 59 Food additives manufacturers shall establish delivery inspection

record system to check the compliance certificates and safety status of

outgoing products. They shall truly record information such as name,

specification, quantity, production date or batch number, shelf life,

compliance certificate number, date of selling, as well as name, address

and contact information of the purchaser. The records and documents

shall be kept in compliance with provisions in Article 50.2 of the Law.

Chapter 4 Food Production and Trading




3 Production


1

4 Imported food

5 Legal liabilities

“

”Chapter 6 Food Import and Export

Article 92 Imported foods, food additives and food-related products

shall comply with China’s national food safety standards. Imported

foods and food additives shall pass inspection by the exit-entry

inspection and quarantine agencies (CIQ) pursuant to laws and

administrative regulations.

Imported foods and food additives shall be accompanied by inspection certificates, as required by AQSIQ.




3 Production


1

4 Imported food

5 Legal liabilities

“

” Chapter 9 Legal liabilities

Article 124 …The producer or trader is also subject to a fine between RMB

50,000 to 100,000 if the total value of the commodity is less than RMB

10,000, or a fine between 10 and 20 times if the total value of the

commodity exceeds RMB 10,000; for severe violation of the law, the

business license of food producers and traders will be revoked:

1) Producing or trading food and food additives which exceed food

safety

standard limits in relation to pathogenic microorganisms, pesticide

residues, vet drugs residues, biotoxins, heavy metals, and other substances

hazardous to human health;

2) Producing or trading foods and food additives with food materials and

food additives that have passed the shelf life;

3) Producing or trading food involved using food additives beyond

allowed scope or excessively use of food additives;

4) Producing or trading foods and food additives which are rotten or

spoiled, have rancid fat, grows with molds or insects, are dirty or

contaminated, contain foreign matter, adulterated with alien substances,

or display abnormal sensory indication;

…

8) Using new food materials to produce food, or producing new varieties

of food additives without a safety assessment;

…


Updates in GB 2760-2014Standard for Uses of Food Additives

1 3

Consolidation of the

public notice from

NHFPC

2

Removes the part of

nutritive fortify and

chewing gum bases

and their ingredients,

which will be

regulated by

another specific

standard

Modify the carry-

over principle

4

Modify the Appendix

A , Appendix B,

Appendix C; Delete

the Appendix D and

Modify the Appendix

F



1

Consolidation of the

public notice from

NHFPC

• Public notices are like the extension of GB 2760

• Adds the announcements that are published since the release of

GB2760 – 2011 that enables better search



• Food nutritive fortifier is no longer regulated as food additives but

regulated under GB 14880

• The chewing gum is no longer regulated by GB 2760, which will

be regulated by another specific standard. But it still belongs to

Food additives.

2

Removes the part of

nutritive fortify and

chewing gum bases

and their ingredients,

which will be

regulated by

another specific

standard



3

Modify the carry-

over principle

3.4.2 Anti-carry-over principleOn the condition that certain food ingredient is served as a raw

material of a specific final product, the food additive which is

applied to the aforementioned specific final product are approved

to be added in the food ingredient, while at the same time the level

of the food additive in the final product shall comply with the

requirements in this standard. It shall be clearly indicated on the

label of the aforementioned food ingredient that it is used for the

production of the aforementioned product.

“

”



• Modify 14 aluminum related food additives

• Modify usage standards of 17 food additives, i.e. Aspartame

• Delete 34 provisions of 28 additives that are not technical

unnecessary

• Some food additives and their provisions for use are deleted,

including octylphenol polyoxyethylene, starch aluminum

octenylsuccinate, and β-naphthol, etc.

4 Appendix A provisions for use of food additives

Modify the Appendix

A , Appendix B,

Appendix C; Delete

the Appendix and

Modify the Appendix

F Food classification

system



• Some food essences are deleted as they are listed in food spices

and classified as food seasonings

• “ Tea, coffee” is added in Appendix B.1 (List of foods not allowed

to be added with flavorings and essences)

• Add the notes regarding “The permitted food use synthetic

flavoring substances” in Appendix B.3

4 Appendix B provisions for use of food flavorings

Modify the Appendix

A , Appendix B,

Appendix C; Delete

the Appendix and

Modify the Appendix


system



• Hydrogen peroxide is included in Appendix C.1 (List of

processing aids that can be used during the course of various

foods processing without residual limits (excluding enzyme

preparations))

• Methanol, palladium, polyglycerol ester of polylinoleic acid and

their provisions for use are removed from Appendix C.2 (List of

processing aids that need stipulated functions and applications

scopes (excluding enzyme preparations)).

4 Appendix C provisions for use of processing aids for food

industry

Modify the Appendix

A , Appendix B,

Appendix C; Delete

the Appendix and

Modify the Appendix


system



• Delete the regulations of chewing gum

• It will be regulated by specific standard (GB29987)

4 Appendix D list of chewing gum bases and their ingredients

Modify the Appendix

A , Appendix B,

Appendix C; Delete

the Appendix and

Modify the Appendix


system



• Parts of food names or classifications are modified

• The classification of food for special dietary uses is deleted

• Food additives in this classification are regulated by GB

29922-2013 Formula foods for special medical uses

• Food additives in this classification are regulated by

products standards

4 Appendix F Food classification system

Modify the Appendix

A , Appendix B,

Appendix C; Delete

the Appendix and

Modify the Appendix


system



Contents

Num.

Appendix A (Food additives)

Appendix B (Food flavoring)

Appendix C (Processing aid

Appendix D (Chewing gum)

Summary

GB 2760-2011 332 1853 162 55 2314

GB 2760-2014 336 1866 169 0 2333

Summary of the Updates in China Food

Additives Regulations


2 Adopts part of

overseas/international way

3 Emphasize the

technical necessity of

food additives

Emphasize the importance

of food additives

1


Some practical tips 1. A working flow for imported food traders/manufacturers

2. A working flow for imported food additives

3. A very brief introduction of new food additives registration


Ingredients review

Food raw materials review

Food additives review

Whether the food additives are included in GB 2760 - 2014

Check the scope and function of the food additives

Check the maximum limits

Label review – GB 7718 - 2011

A working flow for imported food

traders/manufacturers


Ingredients review

Food raw materials review

Food additives review

Whether the food additives are included in GB 2760 - 2014

Check the scope and function of the food additives

Check the maximum limits

Label review – GB 7718 - 2011

A working flow for imported food

additives

Import to China

Register new food additives/Extend the scope (or amount) of use


Register new food additivesor extend the scope/amount of use

1 3

Shall at least used in

other regions of the

world, better if in

US/EU

2

Prove safety and

technical necessity

Timeline lasts at least

12 months;

Cost depends on

the availability of

data and the usage

of the additives in

other regions

Contact

for any further questions

Email: [email protected]

Laura Wang

REACH24H CONSULTING GROUP

Tel: +86 571 8700 7519

mailto:[email protected]

food contact & food additives_laura wang

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