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 produce both domestically and in foreign markets, while food additives when used correctly are indispensable for improve the sensory characteristics of foods along with ensuring physiochemical stability and microbiological safety. The alarming lack of social conscience demonstrated by certain producers looking into turn a quick profit at the expense of the public’s health and the existing legal loopholes and regulatory gaps jointly lead to the food additive problems. 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.
Contents |
Part 1.Competent Authorities of Food Additives
The overarching Food Safety Law, which has been implemented since 1 June 2009, introduced a system managed by various ministries and institutions whereby supervision and management for food additives is divided between amongst numerous departments. Specifically, the Ministry of Health (MOH) was responsible for formulating food national safety standards for food additives and registration of new food additives; the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) was in charge of supervising production and import & export of food additives, including the administrative licensing of food additive production; the State Food and Drug Administration (SFDA) oversaw the use of food additives in catering service segment; the State Administration for Industry & Commerce (SAIC) regulated the quality of food additives during circulation. In theory, this multi-department management system should ensure efficient management of each sector of the food industry, but in fact the system ensured there were regulatory oversights and a high degree of redundancy. It was thus a major priority to overhaul Food Safety Law 2009 and reallocate power among those departments.
March 2013 saw the Chinese government made its first major move to address the unsatisfactory food supervision system. A major institutional reshuffle ensued whereby regulatory power was consolidated to fewer institutions and their respective roles were clearly delineated thereby reducing the buck-passing that has plagued the previous system.
Under the current food supervisory system, the China Food and Drug Administration (CFDA, former SFDA) takes comprehensive control over production, circulation and catering service of food additives; AQSIQ is no longer responsible for supervising food additives production but focuses on inspection and quarantine of food import and export; SAIC no longer monitors food additives distribution now and the National Health and Family Planning Commission (NHFPC, former MOH) undertakes the work the MOH did. CFDA is amending the Food Safety Law 2009 and released in Oct 2013 the revised draft for public comments, which incorporates these regulatory changes.
The current main competent authorities for supervision of food additives in China
Part 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 NHFPC 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 2760-2011 Standards 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 29938-2013 General Rules for Flavorings |
|
|
Over 200 specification standards for food additive, such as GB 6783 NFSS Food Additive Gelatin |
|
|
Labeling Standard |
GB 29924-2013 General Rules for Labeling of Food Additives |
|
GB 7718-2011 General Rules for the Labeling of Prepackaged Foods |
GB 2760-2011 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.
According to GB 2760-2011, 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. Nutrition enhancers, gum-based substances in chewing gum, flavourings, and processing aids in the food industry are also within the scope of food additives. Permitted food additives are classified into 23 varieties according to their functions. Over 2400 permitted food additives are listed in GB 2760-2011.
The 23 categories of food additives
|
1. acidity regulator |
7. gum-based substances in chewing gum |
13. flour treatment agent |
19. sweetener |
|
2. anticaking agent |
8. coloring |
14. glazing agent |
20. thickener |
|
3. antifoaming agent |
9. color retention agent |
15. humectant |
21. flavoring |
|
4. antioxidant |
10. emulsifier |
16. nutrition enhances |
22. processing aids |
|
5. bleaching agent |
11. enzyme |
17. preservative |
23. others |
|
6. bulking agent |
12. flavor enhancer |
18. stabilizer/gelling agent |
/ |
Lists of allowable food additives in GB 2760-2011
|
List Name |
Number |
|
A.1: List of permitted varieties, scope of application and maximum dosage or residue level of food additives |
280 |
|
A.2: List of food additives that can be used in all kinds of food properly according to the needs of products |
77 |
|
B.2: Allowable natural flavorings |
400 |
|
B.3: Allowable synthetic flavorings |
1453 |
|
C.1: Processing aids without restrictions on their residue levels |
37 |
|
C.2: Processing aids with designated function and scope of application |
70 |
|
C.3: Food enzyme preparations |
52 |
|
D.1: Chewing gum base and its ingredients |
55 |
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 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 2760-2011 includes 1,853 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.
Part 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 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 CFDA is in charge of this area. A new set of rules will be formulated by CFDA to replace those old rules released by AQSIQ.
Part 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 NHFPC (former MOH) 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:
1. Not included in national food safety standards (GB 2760+GB 14480)
2. Not new additives approved by NHFPC (or MOH before)
3. 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 NHFPC 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.
Part 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 NHFPC (former MOH) 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.
