[Customs Knowledge] How much do you know about infant formul
How much do you know about infant formula for special medical purposes
Every year, a portion of newly born babies are unable to feed breast milk or regular infant formula due to various diseases. The most common cases include milk protein allergy, lactose intolerance, premature birth, and low birth weight, which prevent breastfeeding or regular formula feeding. For this group of newborns, special medical purpose infant formula foods are the main source of food that they rely on for survival in the early stages or for a considerable period of time.
1、 What is special medical infant formula food?
Special medical infant formula refers to powdered or liquid formula designed to meet the nutritional needs of infants with special medical conditions such as disorders, diseases, or medical conditions. Under the guidance of a doctor or clinical nutritionist, when consumed alone or in combination with other foods, its energy and nutritional composition can meet the growth and development needs of infants with special medical conditions aged 0-6 months.
The formula of infant formula for special medical purposes should be based on research results in medicine and nutrition, and its safety, nutritional adequacy, and clinical efficacy need to be scientifically proven
2、 How does the customs supervise the import of infant formula food for special medical purposes
01 Registration of Overseas Production Enterprises
Overseas production enterprises of infant formula food for special medical purposes shall be recommended for registration by the competent authorities of their respective countries (regions) to the General Administration of Customs.
02 Importer and exporter registration and qualification assurance
Importers, overseas exporters or agents of infant formula food for special medical purposes shall file with customs.
Conformity assurance refers to the submission by importers or their agents to customs of proof materials or written commitments indicating that the imported food complies with relevant provisions such as Chinese laws and regulations and national food safety standards.
03 Product registration number verification
Imported infant formula food for special medical purposes should be registered with the food and drug regulatory department of the State Council. When customs declaration is made, the product registration number needs to be declared, and customs and the State Administration for Market Regulation conduct online verification.
04 Inspection with attached certificate of conformity
The importer shall submit the qualification certification materials accompanying the batch of products (such as official certificates issued by the competent authorities of the exporting country/region, product testing reports, or self qualification statements, etc.) as required during customs declaration, and the customs shall verify and inspect the relevant certification materials.
05 on-site inspection
The customs will conduct on-site inspections on whether imported special medical infant formula food meets the requirements of food safety laws, regulations, and national food safety standards.
06 Supervision and sampling inspection
According to the imported food safety supervision and sampling plan and the special imported food safety supervision and sampling plan, the customs implements sampling, inspection, disposal and other management behaviors for imported special medical purpose infant formula food.
07 Label inspection
The label of infant formula food for special medical purposes should comply with the requirements of Chinese laws, regulations and standards. The product registration number and the registration number of overseas production enterprises (registered in China or approved by the competent authorities of the country/region) should be marked on the label, and the Chinese label must be printed on the minimum sales packaging and cannot be added.
08 Import and Sales Record Inspection
Importers shall establish a food import and sales record system in accordance with Article 98 of the Food Safety Law

3、 How should infant formula foods for special medical purposes be selected?
01 Lactose free formula or low lactose formula
Lactose free or low lactose formulas are suitable for infants with primary or secondary lactose intolerance.
Due to the fact that lactose is the main component of carbohydrates in milk, newborns and infants may experience congenital lactose intolerance or various other causes (such as diarrhea), leading to a decrease in lactase activity in the infant's intestines and even complete cessation of secretion. As a result, lactose intolerance may occur, and the unhydrolyzed lactose is broken down by bacteria in the large intestine to produce acid and gas, leading to symptoms such as bloating and abdominal pain. This type of product formula should completely or partially replace lactose in regular infant formula with other carbohydrates.
02 Formula for partial hydrolysis of milk protein
The partially hydrolyzed formula of milk protein is suitable for high-risk infants with milk protein allergy.
High risk infants with allergies refer to infants whose parents or first degree relatives have a history of milk protein allergy, therefore these infants also have a risk of milk protein allergy. The use of partially hydrolyzed milk protein formulas can reduce the likelihood of infants consuming allergen milk protein. This type of food involves heating and/or enzymatic hydrolysis of milk proteins in products to easily digestible small molecule proteins, peptides, and amino acids, in order to reduce the allergenicity of large molecule milk proteins and help establish tolerance and improve digestion rate.
03 Milk protein deep hydrolysis formula or amino acid formula
Milk protein deep hydrolysis formula or amino acid formula is suitable for infants with food protein allergy.
Food protein allergy is an adverse reaction caused by an inappropriate immune response of infants to protein in food. Milk protein deep hydrolysis formula food hydrolyzes large molecule milk proteins that are prone to allergic reactions into short peptides and free amino acids through certain processes. Amino acid formula foods use monomeric amino acids as the source of protein.
04 Premature/Low Birth Weight Infant Formula
Premature/low birth weight infant formula is suitable for premature/low birth weight infants.
In clinical practice, infants born before 37 weeks of pregnancy are referred to as premature infants, and infants born with a birth weight below 2500g are referred to as low birth weight infants. There are significant differences in physiological conditions, nutritional needs, and nutrient digestion and absorption between premature/low birth weight infants and term infants. To meet the nutritional needs of catching up with growth, the content of energy, protein, and some vitamins and minerals in premature/low birth weight infant formula should be significantly higher than that in term infant formula.
05 Breast milk nutritional supplements
Breast milk nutritional supplements are suitable for premature/low birth weight infants.
Breast milk nutritional supplements are liquid or powdered special medical infant formulas specifically designed to supplement the insufficient energy, protein, vitamins, and minerals in the breast milk of premature/low birth weight infants, which need to be added to breast milk for use. Breast milk nutritional supplements are not full nutrient formula foods, but supplements for breastfeeding premature/low birth weight infants. The energy and nutrient content when used with breast milk formula should meet the upper and lower limits of energy and nutrients in premature/low birth weight infant formula.
06
Formula for amino acid metabolism disorders
The formula for amino acid metabolism disorders is suitable for infants with amino acid metabolism disorders.
Amino acid metabolism disorder refers to a condition caused by genetic factors
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