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standards & regulations

National Health and Family Planning Commission of the People’s Republic of China has issued a lot of national standards to standardize the production and marketing of Formula foods for special medical purpose(FSMP), such as GB 29922—2013, GB 29923 - 2013, GB 14880-2012, GB 2760-2014, etc。

Terms and Definitions
Formula foods for special medical purpose(FSMP)

The formula food specifically processed and formulated to meet special demand of the population for nutrient or foods having food restriction, digestive and absorptive disorder, metabolic disturbance or specific disease status。 Such products shall be singly used or used in combination with other foods under the guidance of the doctors or clinical dietitian。

1 Formula food with complete nutrition

The formula food for special medical purpose that can be used as single nutrition source to meet the nutritional demand of the target population.

1.1 Formula food with complete nutrition for the population at 1-10 years old

1。1。1 Energy in every 100ml (liquid product or the product that can be diluted into liquid in edible status) or every 100g (non-liquid product for direct use) formula food with complete nutrition for the population at 1-10 years old shall be no less than 250 kJ (60 kcal)。 The calculation of energy shall be based on the content of protein, fat and carbohydrate every 100 mL or every 100 g product, multiplied by their respective energy coefficients 17 kJ/g, 37 kJ/g and 17 kJ/g (energy coefficient of dietary fiber, calculated with 50% of the energy coefficient of carbohydrate), the sum is the value in kJ/100mL or kJ/100g, divided by 4。184 to obtain the value in kcal/100mL or kcal/100g。

1.1.2 In formula food with complete nutrition for the population at 1-10 years old, the content of protein shall not be less than 0.5g/100kJ (2g/100kcal), in which the high-quality protein shall account for no less than 50%. Refer to GB 5009.5 for the test method of protein.

1.1.3 In formula food with complete nutrition for the population at 1-10 years old, the content of linoleic acid shall be no less than 2.5%; the energy supply of α-linolenic acid shall be no less than 0.4%. Refer to GB 5413.27 for the test method of fatty acid.

1.1.4 In formula food with complete nutrition for the population at 1-10 years old, the content of vitamin and minerals shall comply with the regulations in Table 1.

1.1.5 Except for the ingredients as specified in Table 1, if one or more ingredients in Table 2 are added or labeled in the product, their contents shall comply with the regulations in Table 2.

1.2 Formula food with complete nutrition for the population above 10 years old

1.2.1 Energy in every 100ml (liquid product or the product that can be diluted into liquid in edible status) or every 100g (non-liquid product for direct use) formula food with complete nutrition for the population above 10 years old shall be no less than 295 kJ (70 kcal). The calculation of energy shall be based on the content of protein, fat and carbohydrate every 100 mL or every 100 g product, multiplied by their respective energy coefficients 17 kJ/g, 37 kJ/g and 17 kJ/g (energy coefficient of dietary fiber, calculated with 50% of the energy coefficient of carbohydrate), the sum is the value in kJ/100mL or kJ/100g, divided by 4.184 to obtain the value in kcal/100mL or kcal/100g.

1.2.2 In formula food with complete nutrition for the population above 10 years old, the content of protein shall not be less than 0.7g/100kJ (3g/100kcal), in which the high-quality protein shall account for no less than 50%. Refer to GB 5009.5 for the test method of protein.

1。2。3 In formula food with complete nutrition for the population above 10 years old, the content of linoleic acid shall be no less than 2。0%; the energy supply of α-linolenic acid shall be no less than 0。5%。 Refer to GB 5413。27 for the test method of fatty acid。

1.2.4 In formula food with complete nutrition for the population above 10 years old, the content of vitamin and minerals shall comply with the regulations in Table 3.

1.2.5 Except for the ingredients as specified in Table 3, if one or more ingredients in Table 4 are added or labeled in the product, their contents shall comply with the regulations in Table 4.

2 Specific formula food with complete nutrition

The formula food for special medical purpose that can be used as single nutrition source to meet the nutritional demand of the target population under specific disease or medical conditions.

The content of energy and nutritive ingredients in specific formula food with complete nutrition shall be based on the formula foods with complete nutrition in 1。1 or 1。2, but may be adjusted according to special requirements for nutrients because of the disease or medical conditions, to meet the nutritional demand of the target population。 See Appendix A for formula foods with incomplete nutrition。

3 Formula food with incomplete nutrition

The formula food for special medical purpose that can meet some nutritional demand of the target population but cannot be used as single nutrition source。

Common formula foods with incomplete nutrition mainly include nutrient module, electrolyte formula, thickening module, liquid formula and amino acid metabolic disorder formula and so on. Technical indexes of the products shall comply with the requirements in Table 5. Since such products cannot be used as the single nutrition source to meet the nutritional demand of the target population and shall be used in combination with other foods, there is no requirement on the content of the nutrients. Formula foods with incomplete nutrition for special medical purpose shall be used under the guidance of the doctor or clinical dietitian according to the specific conditions or demand of the individual patients.

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