China Food Additive Regulation

The illegal use of food additives can be blamed for the occurrence of numerous food safety issues in China. These issues has negatively influenced the reputation of Chinese products both domestically and in foreign markets. Food additives when used correctly are indispensable for improvemen of the sensory characteristics of foods along with ensuring physiochemical stability and microbiological safety. The alarming lack of social conscience demonstrated by certain producers looking to turn a quick profit at the expense of the public’s health and the existing legal loopholes and regulatory gaps jointly are major problems facing efficient regulation of food additives in China. As a developing country China is on the way of optimizing its regulatory framework for food and learning important lessons from inadequacies in the past.

1. Competent Authorities of Food Additives

Under the current food supervisory system, the State Administration for Market Regulation takes comprehensive control over production, circulation and catering service of food additives; the National Health Commission (NHC, former NHFPC) undertakes the work the NHFPC did.

The current main competent authorities for supervision of food additives in China

2. National Food Safety Standards (NFSSs) for Food Additives

There are three main types of NFSSs for food additives, use standards, specification standards and labelling standard. The standards in the first type mainly include lists of allowable food additives and specify application scopes and maximum levels. The standards in the second type mainly detail requirements for raw materials used to make food additives, sensory requirements, physical and chemical indicators, microbiological indicators and test methods. There are more than 2400 allowable food additives in China but it is almost impossible for every food additive to have its own specification standard now so the NHC formulates general rules for the quality and specification of food additives, compound food additives and flavorings as a temporary measures to seal up the regulatory gap.

Main types of NFSSs for food additives

Use Standard	GB 2760-2014 National Food Safety Standard Standard for Uses of Food Additives
	GB 14880-2012 Standards for Uses of Nutritional Fortification Substances in Foods
Specification Standard	GB 26687-2011 General Rules for Compound Food Additives
	GB 29938-2020 General Rules for Flavorings
	Over 200 specification standards for food additive, such as GB 6783 NFSS Food Additive Gelatin (Find those National food additive standards in ChemLinked Food Regulatory Database)
Labeling Standard	GB 29924-2013 General Rules for Labeling of Food Additives
	GB 7718-2011 General Rules for the Labeling of Prepackaged Foods

GB 2760-2014 National Food Safety Standard Standard for Uses of Food Additives

GB 2760-2014 is a very basic standard for food additives in China, which gives out the definition, sets down general application principles for use, lists allowable food additives and also stipulates the application scope and maximum levels or residue limits. It includes the following parts:

Scope
Terms and definitions
Use principle of food additives
Food classification system
Provisions for use of food additives
Flavorings
Food processing acids

Appendix A provisions for use of food additives
Appendix B provisions for use of flavorings
Appendix C provisions for use of food processing aids
Appendix D Function classification of food additives
Appendix E Food Classification system
Appendix F Index of food additives in Appendix A

According to GB 2760-2014, food additive refers to an artificially chemosynthetic or natural substance to be added to foods in order to improve food quality, colour, fragrance and taste, and for the purpose of preservation and processing technology. The scope of food additive in China also includes flavorings, gum-based substances in chewing gum and processing aids. Permitted food additives are classified into 22 varieties according to their functions. Over 2400 permitted food additives are listed in GB 2760-2014.

The 22 categories of food additives

1. acidity regulator	7. gum-based substances in chewing gum	13. flour treatment agent	19. thickener
2. anticaking agent	8. coloring	14. glazing agent	20. flavoring
3. antifoaming agent	9. color retention agent	15. humectant	21. processing aids
4. antioxidant	10. emulsifier	16. preservative	22. other
5. bleaching agent	11. enzyme	17. stabilizer/gelling agent	/
6. bulking agent	12. flavor enhancer	18. sweetener	/

Lists of allowable food additives in GB 2760-2014

List Name

A.1: List of permitted varieties, scope of application and maximum dosage or residue level of food additives

A.2: List of food additives that can be used in all kinds of food properly according to the needs of production

B.2: Allowable natural flavorings

B.3: Allowable synthetic flavorings

C.1: Processing aids without restrictions on their residue levels (exclduing enzyme preparations)

C.2: Processing aids with designated function and scope of application (exclduing enzyme preparations)

C.3: Food enzyme preparations

In generally, Food additives should not be intended to cover up food rancidness, quality defects (in the food itself or during processing) or be used for adulteration or falsification, or reduce the nutritional value of food. Levels of food additives should be as low as possible. Unless a residue level is specified, food processing aids used in the course of food processing should be removed.

Nowadays, a lot of food safety accidents involve the abuse of food additives. Food manufacturers are to blame for addition of add unwanted substances into food while in some cases these substances are naturally occurring byproducts of food ingredients. For instance, the food additive, benzoic acid, is banned in meat products but allowed in soy sauce. During the production of meat products, the benzoic acid contained in the soy sauce migrates into meat products rather than being deliberately added by food manufacturers.

If the following carry-over principles are satisfied, it is acceptable a food additive can be introduced into foods through ingredients (including food additives).

The food additive is allowed to be used in food ingredients;
The level of the additive in food ingredients should not exceed the permitted maximum level;
These ingredients must be used in the normal production process. The content of this additive in food should not exceed the level that is carried over by ingredients;
The content of this additive introduced into food by ingredients shall be notably lower than the required level of such additive through being directly added into food

GB 14880-2012 Standards for Uses of Nutritional Fortification Substances in Foods

GB 14880-2012 specifies the main purposes of the use of nutritional fortification substances in foods, application requirements, selection principles for fortification food categories and provisions for use of nutritional enhancers. Its four appendixes are shown as below:

Appendix A Provisions for use of nutritional fortification substances in Foods

Table A.1 List of allowable nutritional fortification substances, scope of application and dosage

Appendix B List of compound sources of allowable nutritional fortification substances
Appendix C List of allowable nutritional fortification substances in foods for special dietary use and their compound sources

Table C.1 List of allowable nutritional fortification substances in foods for special dietary use and their compound sources
Table C.2 Other allowable nutritional components only for part of foods for special dietary use and their dosages

Appendix D Food Classification System

Food companies can refer to the flowchart shown below to use the above four appendixes:

Food additives can only be used if they are covered in the national food safety standards (GB 2760+GB14480), within the list of allowable food additives and within the allowed scope of applications and dosage levels.

GB 26687-2011 is a general standard for all compound food additives except for flavorings and chewing gum base. It mainly contains the following information, the definition of compound food additive; naming principles; basic requirements; sensory requirements; limit of harmful substances; control of pathogenic microorganisms; and labeling requirements. Imported compound food additives should have Chinese labels and instructions.

GB 29938-2013 is the generally recognized standard regarding quality specifications and safety requirements for more than 1600 types of flavorings. GB 2760-2014 includes around 2000 types of natural and synthetic flavorings. Prior to the enactment GB 29938-2013, there were only specification standards for approximately 200 types of flavorings so most of flavorings have no corresponding quality and specification standards. However, the government requires food additive manufacturers to apply for production licenses for food additives which must comply with related national standards, industrial standards or international and other countries’ rules. The huge gap makes a number of food additive manufacturers unable to produce those food additives without any reference standards. GB 29938-2013 is hereby formulated to alleviate the conflict.

The labeling, instructions and packaging of food additives should be in line with requirements in GB 29924-2013. Labels of food additives provided for food manufacturers/ dealers and directly for retail purpose are different.

3. Regulation on production and Operation of Food Additives

A production licensing system is implemented for food additives. Before the governmental reorganization in Mar 2013, the production of food additives was managed by AQSIQ (now SAMR) and food additive producers needed to apply for food additive production licenses to provincial Administrations of Quality and Technology Supervision. The reference regulations include Provisions on Supervision and Administration of Production of Food Additives (AQSIQ Order 127, 2010) and General Rules on Examination for Food Additive Production License (AQSIQ Order 81, 2010) and MOH Circular 89, 2009 on Strengthening Supervision and Administration of Food Additives.

Under the new supervisory system, both production and operation of food additives must be licensed and SAMR is in charge of this area. A new set of rules will be formulated by SAMR.

4. Registration of New Food Additives

All food additives used in China should comply with the basic principle that they are technically necessary and proven to be safe. New food additives are required to be registered with NHC before marketing and applied into foods according to Administrative Measures on New Varieties of Food Additives (MOH Order 73, 2010) and its supporting Provisions on Application and Acceptance of New Varieties of Food Additives.

Food additives that do not meet the following criteria will be regarded as “new” and need risk assessment and registration:

Not included in national food safety standards (GB 2760+GB 14480)
Not new additives approved by NHC
Need expansion of the scope of use or increase of dosage

Through analysis of data gap, applicants need to prepare the following documents for domestic or imported new food additives and submit them to the National Center for Health Inspection and Supervision (NCHIS) under NHC for technical review.

Application documents	domestic	imported
Application form	√	√
Common name, function category, dosage and scope of use	√	√
Supporting documents to prove its technical necessity and intended using effects	√	√
Quality and specification requirements, production techniques and testing method as well as the method or instructions to test the additive in food	√	√
Safety evaluation data, including raw materials or sources, chemical structure and physical properties, production techniques, toxicological safety evaluation data or testing reports and quality and specification testing report	√	√
Samples of label, instructions and food additive product	√	√
The supporting document of its production and use issued by other countries (region) or international organizations that are conducive to the safety evaluation	√	√
The certificate to allow the production or sale of the food additive in exporting country		√
The supporting document of examination or accreditation of the manufacturer in the country where the manufacturer is located		√
Power of attorney		√

The NCHIS organizes experts in the fields of medicine, agriculture, food, nutrition and processing techniques to carry out technical review on the technical necessity and safety evaluation data of the new varieties of food additive and form a technical review conclusion within 60 days upon receipt of the application. If additional information is required for the technical review, the applicant shall be informed in a timely manner to provide the supplementary documentation as soon as possible. It is recommended that information submitted for the first time should be as complete as possible since requirements to supplement data prolongs the registration time. According to an official from NCHIS, it is almost a mission impossible for new additives that have no history of domestic and foreign use to be approved.

5. Food Additives Liable to be Illegally Added in Foods

To crack down on illegal addition of non-edible substances in foods and abuse of food additives, the NHC released 6 batches of “black list” in succession, which are summarized below:

Table 1. List of non-edible substances liable to be illegally added into foods

No.	Non-edible substance	May be added to	Test method
1	Rongalite	dried bean curd, silk noodles, flour, bamboo shoots	GB/T 21126-2007;
2	Sudan red	chili powder, chili-containing food (chili sauce, spicy condiments)	GB/T 19681-2005
3	Basic Orang II	beancurd sheet
4	Melamine	milk and dairy products	GB/T 22388-2008 GB/T 22400-2008
5	Boric acid and borax	Yoda, meat balls, cold noodles, dumpling wrapper	/
6	Sodium thiocyanate	milk and dairy products	/
7	Rhodamine B	condiment	/
8	Pigment green	tea	/
9	Auramine O	bean products	/
10	industrial formaldehyde	sea cucumber, dried squid, blood curd	SC/T 3025-2006
11	industrial caustic soda	sea cucumber, dried squid, fresh and raw milk	/
12	carbon monoxide	tuna, salmon	/
13	sodium sulphide	MSG	/
14	industrial sulphuer	white sugar, pepper, candied fruit, white fungus, longan, carrots, ginger, etc.	/
15	industrial dte	millet, corn flour, cooked meat, etc.	/
16	Pericarpium Papaveris	hotpot condiments and snacks	refer to methods developed by Shanghai Institute of Food and Drug
17	leather hydrolysate	milk and dairy products, milk drinks
18	Potassium bromate	wheat flour	GB/T 20188-2006
19	β-lactamase	milk and dairy products	LC
20	Dimethyl fumarate	pastry	GC
21	waste edible oil	edible oil	/
22	industrial mineral oil	aging rice	/
23	industrial gelatine	ice crean, pig skin aspic	/
24	Industrial alcohol	adulterated wine	/
25	DDVP	ham, dried fish, salted fish	GB/T 5009.20-2003
26	hair water	soy bean sauce	/
27	industrial acetic acid	adulterated edible vinegar	GB/T5009.41-2003
28	clenbuterol hydrochloride, ractopamine	port, beef, mutton, liver	GB/T22286-2008
29	Nitrofurans	pork, poultry, animal aquatic products	GB/T 21311-2007
30	zeranol	beef, mutton and liver, milk	GB/T 21982-2008
31	antibiotic residue	pork	/
32	palliative	pork	refer to GB/T 20763-2006
33	fluorescent whitening substance	agaricus bisporus, enoki mushroom, Pleurotus nebrodensis, flour
34	Industrial magnesium chloride	fungus	/
35	aluminium phosphide	fungus	/
36	Filling raw materials bleaching agent	baked food	/
37	Orange II sodium salt	yellow croaker, Abalone sauce, pickled and stewed meat products, thick broad-bean sauce, etc.	/
38	chloroamphenicol	uncooked aquatic products, meat, hog casing, honey	GB/T 22338-2008
39	quinolones	Malatang	/
40	Sodium silicate	flour products
41	malachite green	fish	GB20361-2006
42	urotropine	dried bean curd, rice noodles	/
43	Sodium pentachlorophenol	crab	SC/T 3030-2006
44	olaquindox	aquaculture feed	SC/T 3019-2004
45	Basic Yellow	large yellow croaker	/
46	sulfadimidine	roast meat	GB20759-2006
47	dipterex	pickled food	GB/T5009.20-2003

Table 2. List of food additives liable to be indiscriminately used in foods

No.	Food additives liable to be abused	Added to	Test methods
1	Colorant (Carmine, tartrazine, allura red, sunset yellow, etc.)	pickles, wines	GB/T 5009.35-2003 GB/T 5009.141-2003
2	Colorant, preservative, acid regulator(Adipic acid, etc)	fruit jelly, protein jelly
3	Colorant, preservative, sweetener (sodium saccharin, sodium cyclamate, etc)	pickled vegetables
4	Emulsifier (sucrose esters of fatty acid, etc.), preservative, colorant, sweetener	pastry, moon cakes
5	Flour treatment agent	noodle, dumpling wrapper
6	Bulking agent (aluminium potassium sulfate, aluminium ammonium sulfate), humectant Phosphates (calcium phosphate, disodium dihydrogen pyrophosphate, etc.), thickener (xanthan gum, ablmoschus manihot gum, etc), sweetener (sodium saccharin, sodium cyclamate, etc. )	Pastry	GB/T 5009.182-2003
7	bleaching agent (sulfur)	steamed bun
8	bulking agent (aluminium potassium sulfate, aluminium ammonium sulfate)	fried bread stick
9	color retention agent (nitrate, nitrite)	meat product, marinated deli, cured meat and meat tenderizer	GB/T 5009.33-2003
10	titanium dioxide, aluminium potassium sulfate	wheatmeal
11	talcum powder	wheatmeal	GB 21913-2008
12	ferrous sulfate	stinky tofu
13	sorbic acid	Dairy products (excluding cheese )	GB/T21703-2008
14	natamycin	Dairy products (excluding cheese )	GB/T 21915-2008
15	copper sulphate	Dried vegetable	/
16	sodium cyclamate	alcohol (excluding fermented wine liquor)
17	acesulfame potassium	alcohol
18	aluminium potassium sulfate, aluminium ammonium sulfate	flour product, puffed food
19	carmine	fresh lean meat	GB/T 5009.35-2003
20	tartrazine	large yellow croaker, little yellow croaker	GB/T 5009.35-2003
21	sodium metabisulfite	mellow rice, rice flour	GB5009.34-2003
22	sodium sulfite	grilled fillet, frozen shrimp, roast shrimp, dried fish, shredded squid, crab meat, minced fillet	GB/T 5009.34-2003
24	17 phthalates, inlcuding Diethylhexyl phthalate (DEHP), Diisononyl phthalate (DINP), Diphenyl phthalate Dimethyl phthalate (DMP) Diethyl phthalate (DEP) Dibutyl phthalate(DBP), Diamyl phthalate (DPP), Dihexyl phthalate (DHXP), Dinonyl phthalate (DNP), Diisobutyl phthalate (DIBP), Dicyclohexyl phthalate (DCHP), Di-n-octyl phthalate (DNOP), Benzyl butyl phthalate (BBP), Dimethylglycol phthalate (DMEP) Diethoxyethyl phthalate (DEEP), Di(butoxyethyl) phthalate (DBEP), Bis(4-methyl-2-pentyl) phthalate (BMPP)	emulsifiers, other food additives or foods using emulsifiers	GB/T 21911

It is prohibited to add substances in the Table 1 into food products, such as melamine. For instance, the sensational and notorious food safety scandal regarding illegal addition of melamine in Sanlu baby milk powder has totally damaged the reputation of Chinese baby formula products. In addition, food companies should attach great importance to consumers’ health and avoid using additives in the Table 2.

Recommened online course: Interpretations on China Food Ingredient Compliance

In order to help users quickly find the regulatory requirements of the use of food additives in China, ChemLinked has launched a China Food Additive Database. Input names of the food addtive, and you'll see the application scope, use limit, etc.