Raw Materials and Food Additives Permitted to be Used in FSMP for Infants in China

CIRS has analyzed the essence of FSMP and the question of “what raw materials and food additives are permitted to be used in FSMP for the population over 1 year old”. In this article, CIRS will focus on the raw materials and food additives that are permitted to be used in FSMP for infants.

1. Raw materials

It shall be noticed that, under GB25596, 3 kinds of substances cannot be used in FSMP for infants: 1) gluten; 2) hydrogenated fats; 3) irradiated raw materials. Below are the discussions for what raw materials can be used in infant FSMP based on different nutrients.

1) Protein and amino acid:

There are no general requirements on what kind of proteins should be used in the products, but in different product categories, there are. For instance, it is required that for lactose free or low lactose formula, the protein source shall be milk protein. And the formula for the infants with food protein allergy shall not contain food protein, but use amino acids. The source and quality of amino acids should meet the relevant requirements in appendix B of GB25596 and GB14880.

2) Fat (fatty acid)

The same with FSMP for over 1 year old population, the common edible vegetable oils such as sunflower seed oil and soybean oil can be used as the sources of fats (fatty acids). Meanwhile, it could be noticed that in practical, the applications of palm oil and coconut oil in infant FSMP are more than the applications of them in the FSMP for over 1 year old population, which is because of the better digestion and absorption characteristics resulting from higher proportion of medium chain fat (MCT). While it shall be determined by enterprises themselves for how much they shall be used in the products, based on the applicable population and on GB25596. For example, MCT shall be the partial source of fats in preterm/low birth weight infant formula, but it shall not be more than 40% of the total fats. Besides, as linoleic acid and alpha-linolenic acid are the unsaturated fatty acids necessary for the growth and development of infants, the content of them in products are mandatory in GB25596, so enterprises should take this into account when choosing edible vegetable oil as the source of fat (fatty acid).

3) Carbohydrate

GB25596 stipulates that lactose can be completely or partially replaced by other carbohydrates in lactose free or low lactose formula and milk protein partially hydrolyzed formula, otherwise the main carbohydrate source should be lactose or glucose polymer, and fructose should not be used. What’s more, due to the need of formula adjustment or manufacturing technique, starch may be used in the product, but only pre-gelatinized starch is permitted for infant FSMP, to ensure good digestion and absorption characteristics. For dietary fibers, enterprises can choose the related substances allowed in GB14880 to be used for infant FSMP, including galactooligosaccharides (GOS), fructooligosaccharides (FOS), fructosaccharides, and raffinose etc.

4) Vitamin and mineral

There are 13 vitamins and 12 minerals being mandatory to be present in infant FSMP, and it is described for the lower and upper limits of them in GB25596, when necessary, their adding amount can be adjusted according to GB25596 and its Question and Answer.

5) Optional ingredients

Although the optional ingredients listed in GB25596 and the nutritional enhancers listed in GB14880 are not mandatory for human body, they have been scientifically proved to be beneficial to the growth and development of infants, so they can also be used for infant FSMP. In addition, some common food raw materials without special restrictions and without active ingredients other than those specified in GB25596 and the relevant standards, can also be used as the sources of optional ingredients, such as caseinate.

6) Probiotics

Up to now, 6 kinds of 8 strains of probiotics approved by the National Health Commission (the former National Health and Family Planning Commission, the former Ministry of Health) can be used for infant FSMP. The specific information are shown in the following table.

Table 1. Available probiotics in infant FSMP

S.N.	Latin name	Strain no.	Issue date and source
1	Bifidobacterium animalis	Bb-12	2011/10/24, Notice no.25, 2011 from MOH
2	Bifidobacterium lactis	HN019
2	Bifidobacterium lactis	Bi-07
3	Lactobacillus rhamnosus	LGG
3	Lactobacillus rhamnosus	HN001
4	Lactobacillus reuteri	DSM17938	2014/5/30, Notice no.10, 2014, from NHFPC
5	Lactobacillus fermentum	CECT5716	2016/6/8, Notice on Lactobacillus fermentum CECT5716 and other 3 strains
6	Bifidobacterium breve	M-16V

2. Food additive

All food additives in GB2760 that can be used in 13.01 infant formula and 13.01.03 infant formula for special medical purposes are permitted to be used in infant FSMP. Please refer to the following table for details.

Table 2. Available food additives for infant FSMP

S.N.	Food additive	Function	Food code	Food category	Max applying dosage
1	Mono-and diglycerides of fatty acids	Emulsifier	13.01	Infant formula	Use as needed
2	Carob bean gum	Thickener	13.01	Infant formula	7.0g/kg
3	Xanthan gum	Stabilizer, Thickener	13.01.03	Infant formula for special medical purposes	9.0g/kg（only applicable to powder product, recalculate for liquid product based on dilution factor）
4	Carrageenan	Emulsifier, Stabilizer, Thickener	13.01	Infant formula	0.3g/L（measured in ready-to-eat state）
5	Ascorbyl palmitate	Antioxidant	13.01	Infant formula	0.05g/kg（measured by ascorbic acid in fat）
6	Calcium hydrogen phosphate, sodium dihydrogen phosphate	Moisture holding agent, Bulking agent, Acidity regulator, Stabilizer, Firming agent, Anti-caking agent	13.01	Infant formula	1.0g/kg（can be used individually or together, maximum applying amount is measured by PO43-）
7	Phospholipid	Antioxidant, Emulsifier	13.01	Infant formula	Use as needed
8	Citric acid, trisodium citrate, tripotassium citrate	Acidity regulator	13.01	Infant formula	Use as needed
9	Citric and fatty acid esters of glycerol	Emulsifier	13.01	Infant formula	24.0g/kg
10	Calcium hydroxide	Acidity regulator	13.01	Infant formula	Use as needed
11	Potassium hydroxide	Acidity regulator	13.01	Infant formula	Use as needed
12	Lactic acid	Acidity regulator	13.01	Infant formula	Use as needed
13	Potassium carbonate	Acidity regulator	13.01	Infant formula	Use as needed
14	Potassium hydrogen carbonate	Acidity regulator	13.01	Infant formula	Use as needed
15	Starch sodium octenyl succinate (sodium starch octenyl succinate)	Emulsifier, other	13.01.03	Infant formula for special medical purposes	150.0g/kg（only applicable to powder product, recalculate for liquid product based on dilution factor）
16	Isomerized lactose syrup	Other	13.01	Infant formula	15.0g/kg

It could be realized from the above information that, the available raw materials and food additives are basically covered by GB25596, GB14880, GB2760 and relevant notices from NHC (former NHFPC and former MOH). Therefore, the formula shall not only meet the nutritional requirements of the applicable population, but fully comply with the above regulations and standards as well as the relevant requirements in the notices.

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