Food & Food Contact Materials
CIRS Group
Medical Devices
C&K Testing
Carbon Neutrality

Infant Formula or FSMP for Infant--Which one shall be picked?

from CIRS by

Facing many options in brands of infant formula in the market, mothers often have difficulties in choosing. There is one more option recent years in China, which is FSMP for infants, making the choice even harder. One might wonder whether infant FSMP are safer, more nutritious, and more advanced than the common infant formula.

The good news are, fortunately, China's relevant laws and regulations have been improved, which are more scientific and rigorous, coupled with the strict supervision and management in recent years, contributing to the high passing rate of the products in sampling inspection: in the second half of 2019, the passing rate of infant formula reached 99.8%, and infant FSMP maintained 100%. Therefore, under the premise that the product quality and safety can be assured, how do we make a choice between ordinary infant formula and infant FSMP, or how do we understand these two kinds of products more correctly and clearly?

1. The differences on the labelling

First of all, what are the most distinctive features of the two? The answer is on the labelling:

1) The general name:

  • Infant formula: only the permitted general names shall be used, which are: infant formula milk powder (0-6months, stage 1), elder infant formula milk powder (6-12months, stage 2), young children formula milk powder (12-36months, stage 3).
  • Infant FSMP: must use the classification names or equivalent names specified in Food Safety National Standard General Rules of Infant Formula for Special Medical Purposes (GB 25596), such as “infant lactose free formula for special medical purposes” (this is the general name stipulated after the adjustment of SAMR on May 30, 2019, the products approved and sold before the adjustment can use the old name until the end of shelf life, for details please click here).

2) Registration certificate number:

  • Infant formula: the certificate no. shall be “国食注字YPXXXXXXXX”, such as “国食注字YP20190016”, “YP” is the capitals of Chinese pinyin “Ying Pei” which is the abbreviation of infant formula in Chinese, and the “2019” means that the product was approved for registration in 2019, the first “0” of “0016” means that it is a domestic product, and if is “5”, then it is an overseas manufactured product, and the remainder (016) means that the product was the 16th approved product in 2019.
  • Infant FSMP: the certificate no. shall be “国食注字TYXXXXXXXX”, such as “国食注字TY20180001”, “TY” is the capitals of Chinese pinyin “Te Yi” which is the abbreviation of FSMP in Chinese, and the remaining numbers mean the same with infant formula.

2. The differences on the applicable population

After we can quickly distinguish the two in terms of the appearance (labelling), let’s focus next on the differences of them on the applicable population.

1) The health condition

Infant formula is suitable for term infants and young children who are in good health condition, while infant FSMP shall be used for the infants under specific medical conditions or disorders resulting in intolerance on some food raw materials like protein or lactose, and the decreases or increases on specific nutritional needs compared with the needs of healthy term infants.

At present, GB25596 has already stipulated six categories of infant FSMP, and in the revised plan of it, there would be another six categories to cover more with other medical conditions. The following table lists the existing and planned product categories and the corresponding applicable population.

Existing categories and the applicable population

Planned categories and the applicable population

Lactose free or low lactose formula

Infants with lactose intolerance

Ketogenic formula

Mainly used for infants with intractable epilepsy

Milk protein partially hydrolyzed formula

Infants at high risk for milk protein allergy

Anti-reflux formula

Infants with frequent gastroesophageal reflux

Milk protein extensively hydrolyzed or amino acid formula

Infants with food protein allergy

Abnormal fat metabolism formula

Infants with disorders on fat absorption, metabolism and transport, etc.

Preterm/low birth weight formula

Preterm/low birth weight infants

High energy formula

Infants with high consumption, growth retardation, and fluid restriction due to diseases

Infant nutrition fortifier

Preterm/low birth weight infants

Protein supplement

Preterm/very low birth weight infants and preterm infants who need extra protein

Amino acid metabolism disorder formula

Infants with amino acid metabolism disorders

Medium chain fat components

Infants who need an extra dose of medium chain fat

In the approved FSMP in China, all the 6 categories of infant FSMP have been covered, please click here for specific information of the products.

To sum up, when the infant is in good health, you can choose normal infant formula to feed; and if he/she has some special disorders or diseases or medical conditions, infant FSMP shall be used adeptly. It is important to note that FSMP "should be used under the guidance of a doctor or clinical nutritionist", which is the requirement of GB25596 for the labeling of such products.

2) The ages of the applicable population

In China, infant formula, as mentioned above, include stage 1, stage 2 and stage 3, which cover the population in the ages of 0-36 months; while infant FSMP only aim at the population in the ages of 0-12 months.

For the infants under 6 months of age, feeding alone with breast milk, or infant formula, or some infant FSMP are able to meet the nutritional needs of the growth and development of them. Why is it “some” but not “all” for infant FSMP? Firstly, infant nutrition fortifier (also known as human milk fortifier, HMF), is to supplement the nutrient deficiency in breast milk, which shall be used together with human milk; and secondly, amino acid metabolism disorder formula are asked to be forbidden or only contain a tiny amount on the amino acids related to the metabolic disorders, while these amino acids may be compulsory to the growth of infants, thus, human milk or infant formula may be used together under the guidance of doctors.

And to the infants and young children of 6 months old above, feeding alone with breast milk or infant formula or infant FSMP cannot satisfy the nutritional demands of them, and need to feed together with supplementary food thereby.

3. The last words to say

Apart from the prominent differences, there are probably other confusions when consuming the products, such as:

Q1: Can human milk, infant formula and infant FSMP be fed together?

A: They can be used together under the guidance of doctors or clinical dieticians based on the realistic situations of infants and moms. For example, when there is a lack of human milk, human milk can be fed together with infant formula; and if the infant is preterm or low birth weight, human milk may be used together with HMF or preterm/low birth weight formula.

Q2: Are infant formula more nutritious than human milk?

A: No, they are not. Human milk and infant formula can meet all the nutritional needs of healthy term infants before 6 months of age. It can be proved from Chinses Daily Reference Intakes (DRIs): the Adequate Intake (AI) of 0-6 month infant is set based on the content data of each nutrient in breast milk. Therefore, healthy breast milk can be considered to be the "benchmark" of the nutritional needs of healthy term infants. So there is no such thing that infant formula milk are more nutritious than breast milk.

Q3: Does it matter that how much water is used when preparing the formula?

A: Yes, it matters. Too much water may result in the low nutrient density that is not able to meet the demands of infant growth, and too little water makes hyperosmotic pressure of the preparation, resulting in symptoms of dehydration. Thus, the instruction on the labelling shall be strictly followed when preparing. And specifically, the preparation and consumption of infant FSMP shall be decided according to the instruction, the guidance of doctors and clinical dieticians and the actual situations of the infants.

Last but not least, if you want more information about infant formula, click here to join in the free webinar held by CIRS on April 21 and 22, 2020.

If you have any needs or questions, please contact us at


We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

Contact Us
+353 1 477 3710 (EU)
+44 20 3239 9430 (UK)
+1 703 520 1420 (USA)
+86 571 8720 6574 (CN)
+82 2 6347 8816 (KR)
Contact Us
+353 1 477 3710 (EU)
+44 20 3239 9430 (UK)
+1 703 520 1420 (USA)
+86 571 8720 6574 (CN)
+82 2 6347 8816 (KR)