Comparative Analysis of Chinese and International Infant Formula Standards

Codex standards are a series of food standards and guidelines complied by WHO and the Codex Alimentarius Commission of the Food Agriculture Organization, which are acknowledged and adopted by some western countries and also serve as important references for many countries when formulating national regulations. Codex Stan 72-1981(2007 version) is the existing codex standard for infant formula, adopted by EU and Hong Kong. It lays out strict requirements for various aspects of infant formula products, including the essential/optional ingredients and their contents, food additives, contaminants (pesticide residues), packaging, labelling, etc.

China formulated the national standard for infant formula GB 10765-2010 by referring to Codex Stan 72-1981 and also taking into consideration the specific nutritional requirements of Chinese babies, the nutrient content in the breast milk of Chinese mothers as well as Chinese dietary reference intake of nutrients. Therefore there are some small but meaningful discrepancies between the Chinese and Codex standards. Some media hold the incorrect perspective that China’s requirements are either lower or higher than international standards. The truth is that infant formula which is in full compliance with Chinese regulations is designed for Chinese babies. For instances, Codex doesn’t set limit for lactose in infant formula but obviously based on the high prevalence of certain genetic polymorphisms conferring a decreased capacity of the lactase enzyme in the Chinese population, the Chinese standard sets a specific lactose content. In addition saccharose and starch should not be excessively added in infant formula. Moreover, in the Codex, there are no maximum limits for some minerals like Ca and Zn but just GUL (Guidance Upper Level) to advice companies not to add more than the mandatory minimum. Chinese standard sets specific up limits for Ca and Zn.

Comparison of main ingredients of infant formula between international and Chinese standard

Ingredient/ nutrients	Unit	Codex	Remark	Chinese national standard GB 10765-2010	Remark
Energy	kcal/100g	60-70kcal/100mL		60-70kcal/100mL
Protein	g/100kcal	1.8-3.0		1.88-2.93	The content of whey protein in milk-based infant formula should ≥60%
Total fat	g/100kcal	4.4-6.0		4.39-5.86
Linoleic acid	mg/100kcal	300-1400*		0.29-1.38 g/kcal
α-linolenic acid	mg/100kcal	50-N.S.	The linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15.	50-N.S.
Total carbohydrates	g/100kcal	9.0-14.0		9.2-13.8	The content of lactose in total carbohydrate should be less or equal to 90%. For calculation of the proportion of lactose among the total carbohydrates, the added oligosaccharides and polysaccharides should not be included
Vitamin A	µg/100kcal	60-180		59-180
Vitamin D/D3	µg /100kcal	1-2.5		1.05-2.51
Vitamin E	µg /100kcal	0.5-5*		0.5-5.02
Vitamin K/K1	µg /100 kcal	4-27*		4.2-27.2
Vitamin B1	µg /100 kcal	60-300*		59-301
Vitamin B2	µg /100 kcal	80-500*		80-498
Niacin	µg /100 kcal	300-1500*		293-1506
Vitamin B6	µg /100 kcal	35-175*		35.6-188.3
Vitamin B12	µg /100 kcal	0.1-1.5*		0.105-1.506
Pantothenic acid	µg /100 kcal	400-2000		402-2000
Folic acid	µg /100 kcal	10-50*		10.5-50.2
Vitamin C	mg/100 kcal	10-70*	The GUL is calculated according to the content that may lose after a liquid infant formula has expired	10.5-71.1
Biotin	µg /100 kcal	1.5-10*		1.5-10
Iron	mg/100 kcal	0.45-	CAC doesn’t set maximum level; should be specified by each country	0.42-1.51
Calcium	mg/100 kcal	50-140*	The calcium:phosphorus ratio shall not be less than 1 nor greater than 2.	50-146
Phosphorus	mg/100 kcal	25-100*		25-100
Magnesium	mg/100 kcal	5-15*		5.0-15.1
Sodium	gm/100 kcal	20-60		21-59
chloride	mg/100 kcal	50-160		50-159
Potassium	mg/100 kcal	60-180		59-180
Manganese	µg/100 kcal	1-100*		5.0-100.4
Selenium	µg/100 kcal	1-9*		2.01-7.95
Copper	µg/100 kcal	35-120*		35.6-121.3
Zinc	mg/100 kcal	0.5-1.5*		0.5-1.51
Iodine	µg/100 kcal	10-60*		10.5-58.6
Choline	mg/100 kcal	7-50*		7.1-50.2	Optional
Inositol	mg/100 kcal	4-40*		4.2-39.7	Optional
L-Carnitine	mg/100 kcal	1.2-NS		1.3-N.S.	Optional

Comparison of optional ingredients of infant formula between international and Chinese standard

Optional ingredient	Unit	Codex (EU)	Remark	Chinese national standard GB 10765-2010	Remark
taurine	mg/100kcal	No more than 12		N.S.-13
Docosahexaenoic acid	% total fatty acid	0.5*	If docosahexaenoic acid (22:6 n-3) is added to infant formula, arachidonic acid (20:4 n-6) contents should reach at least the same concentration as DHA. The content of eicosapentaenoic acid (20:5 n-3), which can occur in sources of LC-PUFA, should not exceed the content of docosahexaenoic acid. National authorities may deviate from the above conditions, as appropriate for the nutritional needs.	N.S.-0.5
Arachidonic acid	% total fatty acid			N.S.-1	If docosahexaenoic acid (22:6 n-3) is supplemented to the infant formula, at least the same amount of Arachidonic acid (20:4 n-6) should be supplemented.

Comparison of other indexes

Other indexes	Unit	Codex-EU	Chinese national standard GB 10765-2010
water	%	No specific index	5
ash		No specific index	Milk –based powder products 4
Impurity		No specific index	Powder product 12

Comparison of contaminants

contaminants	Unit	Codex-EU	Chinese national standard GB 10765-2010
lead	mg/kg	0.02*	0.15
Nitrate	mg/kg	No specific index	100
Nitrite	mg/kg	No specific index	2
Aflatoxin M1	ug/kg	No specific index	0.5

Note: N.S.: not specified; *: Guidance Upper Level

In general, China’s domestic infant formula products are not inferior to those imported counterparts in terms of formulation design, production technics as well as packaging. However, Chinese manufacturers should recognize the weak links they have, especially the quality of fresh milk and the investment on scientific quality management.