Summary and Analysis of Food Additives Permitted to be Used in FSMP

It was mentioned in our last article A Brief Discussion on Raw Materials of FSMP in China that, FSMP are essentially the combination of the nutrients (required by the target population) and food additives (necessary for manufacturing, maintaining product characteristics and facilitating preparation). This time we are going to talk about food additives permitted to be used in FSMP (product for the population over 1 year old).

GB 29922 3.8.1: “The use of food additives in the products (for the population between 1-10 years old) can refer to GB 2760 –food additives permitted to be used in infant formula; for the population over 10 years old, refer to the use of food additives for the products’ analogues categorized in GB 2760.”

1. Food additives applicable for the products for 1-10 years old population

The state has made the above requirements for additives applicable to children aged 1 to 10, because the tolerance of children within this age group is closer to that of infants and young children. The above requirements can ensure the safety of the product. That is to say, 18 additives and 3 flavors are permitted to be used. Detailed information is as following:

Table 1. Food additives applicable to FSMP for 1-10 years old

S .N.	Food additive	Fun ction	Food cod e	Food categ ory	Max applying dosage
1	Mono-and diglycerides of fatty acids	Emulsifier	13.01	Infant formula	Use as needed
2	Guar gum	Thickener	13.01.02	Older infants and young children formula	1.0g/L (measured in ready-to-eat state)
3	Carob bean gum	Thickener	13.01	Infant formula	7.0g/kg
4	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)
5	Carrageenan	Emulsifier, Stabilizer, Thickener	13.01	Infant formula	0.3g/L (measured in ready-to-eat state)
6	Ascorbyl palmitate	Antioxidant	13.01	Infant formula	0.05g/kg (measured by ascorbic acid in fat)
7	Sodium caseinate	Other	13.01.02	Older infants and young children formula	1.0g/kg (measured in ready-to-eat state, as the carrier of DHA and ARA)
8	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-)
9	Phospholipid	Antioxidant, Emulsifier	13.01	Infant formula	Use as needed
10	Citric acid, trisodium citrate, tripotassium citrate	Acidity regulator	13.01	Infant formula	Use as needed
11	Citric and fatty acid esters of glycerol	Emulsifier	13.01	Infant formula	24.0g/kg
12	Calcium hydroxide	Acidity regulator	13.01	Infant formula	Use as needed
13	Potassium hydroxide	Acidity regulator	13.01	Infant formula	Use as needed
14	Lactic acid	Acidity regulator	13.01	Infant formula	Use as needed
15	Potassium carbonate	Acidity regulator	13.01	Infant formula	Use as needed
16	Potassium hydrogen carbonate	Acidity regulator	13.01	Infant formula	Use as needed
17	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)
18	Isomerized lactose syrup	Other	13.01	Infant formula	15.0g/kg

What’s more, GB 2760 requires that Vanillin, ethyl vanillin and vanilla bean extract (extract) can be used in older infants and young children formula, with the maximum dosage of 5mg/100mL, 5mg/100mL and use as needed, in which the 100mL is calculated as ready-to-eat state. Therefore, these three flavors can be applied to FSMP for 1-10 years old people as well.

2. Food additives applicable to the products for over 10 years old population

FSMP for people over 10 years old are more complicated, and the manufacturing techniques are similar to common food. Food additives used in the products, therefore, are required to be more diverse, and the state has made the above requirements for additives applicable to this age group. The “analogues” of the products means that the main raw materials, product state and manufacturing techniques of them are similar. More significantly, these three factors shall be considered together, but not emphasize one of them. If not, there would be mistakes on selecting food categories, resulting in mistakes on using additives.

For example: sucralose is added as a sweetener in a liquid product. If this product is considered as a beverage product (except packaged drinking water), the maximum applying amount of sucralose is 0.25g/kg. But if it is considered as modified milk, then the maximum applying amount of sucralose is 0.3g/kg otherwise.

The above are analysis and summary of the requirement on food additives applying for FSMP. Due to the particularity of the target population of such products, enterprises should minimize or prudently use food additives on the premise of ensuring the necessity of manufacturing and take clinical use of products into account.

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