GB 25596-2025National food safety standard - General rules for infant formula food for special medical purposes (English PDF)

1 Scope

1 This standard applies to infant formula food for special medical purposes intended for infants aged 0 to 12 months.

2 Terms and definitions

2.1 Infant formula food for special medical purposes is formula food specially processed and compounded to meet the particular need for nutrients or for a diet of infants whose intake is restricted, whose digestion or absorption is impaired, whose metabolism is disturbed or who are in a specific disease state. Products of this kind shall be used under the guidance of a physician or a clinical nutritionist, either alone or together with other foods.

3 Technical requirements

3.1.1 The formula of an infant formula food for special medical purposes shall be based on the findings of medical and nutritional research, and its safety, nutritional adequacy and clinical effect shall have been scientifically demonstrated.

3.1.1.1 The categories of the common infant formula foods for special medical purposes, the groups in the particular medical conditions for which they are intended and the main technical requirements of the formula shall comply with Annex A.

3.1.1.2 The formula of any other infant formula food for special medical purposes for which there is a genuine clinical need shall comply with 3.1.1.

3.1.2 The processing of infant formula food for special medical purposes shall comply with the relevant national rules.

3.2.1 The raw materials used in the product shall comply with the corresponding safety standards or relevant rules, and no substance that harms the nutrition or the health of the infant shall be used.

3.2.2 The raw materials and the food additives used shall not contain gluten.

3.2.3 Hydrogenated fats and oils shall not be used.

3.2.4 Raw materials that have been irradiated shall not be used.

3.3 The colour, taste, smell, texture and reconstitution behaviour of an infant formula food for special medical purposes shall match the character of the product concerned. The product shall be free of foreign matter visible to the naked eye.

3.4.1 The energy, the nutrients and their amounts shall be based on the required ingredients laid down in this standard and shall be adjusted as Annex A requires, according to the particular nutritional needs of infants with a particular disorder, disease or medical condition, so that the nutritional needs of infants in that particular medical condition are met.

3.4.2 The energy contained in 100 mL of the product ready to eat shall lie between 250 kJ, that is 60 kcal, and 314 kJ, that is 75 kcal. The energy is calculated by multiplying the protein, fat and carbohydrate content of 100 mL of the product by the energy factors 17 kJ/g, 37 kJ/g and 17 kJ/g respectively, the energy factor of dietary fibre being 8 kJ/g; the sum is the value in kilojoules per 100 mL, and dividing it by 4.184 gives the value in kilocalories per 100 mL.

3.4.3 The amounts of protein, fat and carbohydrate per 100 kJ and per 100 kcal shall comply with Table 1, which gives a minimum and a maximum for each on both bases together with the method of determination. The rows of the table are protein, fat with linoleic acid, alpha-linolenic acid and the ratio of linoleic acid to alpha-linolenic acid beneath it, and carbohydrate. The footnotes state that the protein content is calculated as nitrogen multiplied by 6.25 and that single L-form amino acids may be added as the particular nutritional needs of the infant require, in which case they shall comply with Annex B; that in the finished product the total of lauric acid and myristic acid shall not exceed 20 % of the total fatty acids, the trans fatty acids shall not exceed 3 % of the total fatty acids and the erucic acid shall not exceed 1 % of the total fatty acids, the total fatty acids being the sum of the C4 to C24 fatty acids; that N.S. means not specified; and that the carbohydrate content is obtained by formula (1) as 100 less the sum of the protein, fat, moisture, ash and dietary fibre contents, all in grams per 100 g, the dietary fibre being reckoned from the amount of oligosaccharide or polysaccharide added.

3.4.4 Except where there is a particular need, such as lactose intolerance, the carbohydrate of an infant formula food for special medical purposes shall come first of all from lactose; glucose polymers may be added in a suitable amount, starch being added only after pre-gelatinization, and fructose and sucrose shall not be used as a source of carbohydrate.

3.4.5 The vitamins shall comply with Table 2, which gives a minimum and a maximum per 100 kJ and per 100 kcal, together with the method of determination, for vitamin A, vitamin D, vitamin E, vitamin K1, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin as nicotinamide, folic acid, pantothenic acid, vitamin C, biotin and choline. The footnotes explain the retinol equivalent and its relation to international units, state that vitamin A covers only preformed retinol and excludes any carotenoid component when the vitamin A activity is calculated or claimed, give the conversion for calciferol and for the tocopherol equivalents, and state that niacin excludes the precursor forms.

3.4.6 The minerals shall comply with Table 3, which gives a minimum and a maximum per 100 kJ and per 100 kcal, together with the method of determination, for sodium, potassium, copper, magnesium, iron, zinc, manganese, calcium, phosphorus, the calcium to phosphorus ratio, iodine, chlorine and selenium. A footnote states that N.S. means not specified.

3.5.1 Where, beyond the required ingredients of 3.4, one or more of the ingredients of Table 4 is added to the product or declared on the label, its amount shall comply with Table 4. That table gives a minimum and a maximum per 100 kJ and per 100 kcal, together with the method of determination, for chromium, molybdenum, inositol, taurine, L-carnitine, docosahexaenoic acid and arachidonic acid. A footnote states that where docosahexaenoic acid is added to an infant formula food for special medical purposes, at least the same amount of arachidonic acid shall be added, and that the amount of eicosapentaenoic acid shall not exceed the amount of docosahexaenoic acid; another footnote states that N.S. means not specified.

3.5.2 Where a substance other than those of Table 4 and Annex B is added to the product, the relevant national rules shall be complied with.

3.6 The other indicators shall comply with Table 5, which fixes upper limits and the methods of determination for the moisture of solid products, for the ash of solid products and of liquid products on a total dry matter basis, and for the impurity level of solid and of liquid products. The footnotes state that the moisture requirement applies only to solid products, and that a liquid product formed by mixing a human milk fortifier with human milk shall meet the ash requirement.

3.7 The contaminant limits shall comply with GB 2762.

3.8 The mycotoxin limits shall comply with GB 2761.

3.9.1 The pathogen limits of solid products shall comply with GB 29921 and the other microbiological limits shall comply with Table 6.

3.9.2 Liquid products shall meet the requirement of commercial sterility, tested by the method of GB 4789.26.

3.9 (Table 6) Table 6 gives the sampling plan and the limits for the aerobic plate count and for coliforms, expressed as the number of sample units, the number that may exceed the lower limit and the two limit values, together with the method of determination. Its footnotes state that sampling and sample handling follow GB 4789.1 and GB 4789.18, and that the aerobic plate count does not apply to products to which live cultures, aerobic and facultatively anaerobic, have been added, the live count in such products being required to reach at least 1 000 000 colony forming units per gram or per millilitre.

3.10.1 The use of food additives and nutrient fortifiers shall comply with GB 2760 and GB 14880.

3.10.2 The quality of the food additives and nutrient fortifiers shall comply with the corresponding standards and rules.

3.11 In products whose main protein source is soybean or soy protein products, the urease activity shall comply with Table 7, which requires a negative result in the qualitative determination of urease activity by the method of GB 5009.183; a footnote states that for a liquid product the amount taken for the test is converted according to its dry matter content.

4 Other

4.1.1 The product label shall comply with GB 13432 or the relevant rules, or both. The declaration of the contents of the required and the optional ingredients shall also carry the amount per 100 kilojoules.

4.1.2 The label shall clearly state the category of the product, for example lactose free formula, the group in the particular medical condition for which it is intended, and the osmotic pressure.

4.1.3 The label of an anti-reflux formula food shall state the reconstitution temperature, the standing time and other such parameters, together with the viscosity of the product once made up.

4.1.4 A formula food for special medical purposes that may be given to infants over 6 months of age shall state that when an infant over 6 months of age in a particular medical condition eats this product, complementary foods shall be given alongside it.

4.1.5 The label shall clearly state that the product is to be used under the guidance of a physician or a clinical nutritionist.

4.1.6 The label shall not carry the image of an infant or of a woman, and shall not use the words humanized or breast milk like or any similar term.

4.2.1 Directions for the use and the reconstitution of the product, illustrations of them and the storage conditions shall be clearly stated on the label. Where the largest surface of the pack is smaller than 100 square centimetres or the product weighs less than 100 g, the illustrations may be omitted.

4.2.2 A warning shall be given about the health harm that improper reconstitution and improper use may cause.

4.3 Carbon dioxide or nitrogen, or both, complying with the national food safety standards, may be used as the packaging medium.

A Annex A Common infant formula foods for special medical purposes

A Table A.1 lists the common infant formula foods for special medical purposes, giving for each the product category, the group in the particular medical condition for which it is intended, and the main technical requirements of the formula. The categories listed are the lactose free or low lactose formula for lactose intolerant infants; the partially hydrolysed milk protein formula for infants with functional gastrointestinal discomfort, which may also be chosen for infants at high risk of milk protein allergy; the extensively hydrolysed milk protein formula and the amino acid formula for infants with food protein allergy and infants with impaired gastrointestinal function; the formula for amino acid metabolism disorders; the formula for preterm or low birth weight infants; the human milk fortifier for preterm or low birth weight infants; the ketogenic formula for infants with refractory epilepsy; the anti-reflux formula for infants with frequent gastro-oesophageal reflux; the formula for abnormal fat metabolism, for infants with a disorder of fatty acid transport, metabolism or absorption; the high energy formula for infants with high consumption caused by disease, with retarded growth and development or with restricted fluid intake; the protein module for infants who need extra protein; and the medium chain fat module for infants who need extra medium chain fatty acids. Among the technical requirements given are the energy range per 100 mL ready to eat for several categories, the source of the protein, whether the lactose may be replaced wholly or partly by other usable carbohydrates, the limits on lactose content in the lactose free and low lactose formulas, the share of medium chain fat in the total fat for the preterm formula, the formula for abnormal fat metabolism and the medium chain fat module, the mass ratio of fat to protein plus carbohydrate for the ketogenic formula, the amount of starch added to the anti-reflux formula, the protein content of the protein module, and the cross references to Table A.2, Table A.3 and Table A.4 and to Annex B.

A (Table A.2) Table A.2 gives the nutrients whose amounts are to be adjusted in the extensively hydrolysed milk protein formula, the amino acid formula and the formula for amino acid metabolism disorders, with a minimum and a maximum per 100 kJ and per 100 kcal for protein, carbohydrate, vitamin B1, vitamin B2, vitamin B6, niacin as nicotinamide, folic acid, pantothenic acid, vitamin C, biotin, zinc, calcium, manganese, copper, iodine and selenium. A footnote states that for a formula for a rare amino acid metabolism disorder the amounts of some nutrients may be suitably adjusted on the basis of 3.1.1.

A (Table A.3) Table A.3 lists the common amino acid metabolism disorders, the amino acids that are to be restricted in each case and the amount to which they are to be restricted in the formula food, expressed in milligrams per gram of protein equivalent. The disorders listed are phenylketonuria, maple syrup urine disease, propionic acidaemia and methylmalonic acidaemia, tyrosinaemia, homocystinuria, glutaric acidaemia type one, isovaleric acidaemia and urea cycle disorders, and the amino acids restricted are phenylalanine; leucine, isoleucine and valine; methionine, threonine and valine, and isoleucine; phenylalanine and tyrosine; methionine; lysine and tryptophan; leucine; and the non-indispensable amino acids alanine, arginine, aspartic acid, asparagine, glutamic acid, glutamine, glycine, proline and serine. A footnote states that the figure marked applies to a single amino acid.

A (Table A.4) Table A.4 gives the nutrients whose amounts are to be adjusted in the formula for preterm or low birth weight infants, with a minimum and a maximum per 100 kJ and per 100 kcal for protein, fat, carbohydrate, vitamin A, vitamin D, vitamin E, vitamin B2, vitamin B6, niacin as nicotinamide, folic acid, biotin, sodium, copper, magnesium, iron, zinc, calcium, phosphorus, selenium and inositol. A footnote states that N.S. means not specified.

B Annex B Requirements for the single amino acids that may be used in infant formula food for special medical purposes

B Table B.1 lists the single amino acids that may be used in infant formula food for special medical purposes and, for each, the compounds from which it may be sourced. The nineteen entries are aspartic acid, from L-aspartic acid and magnesium L-aspartate; threonine, from L-threonine; serine, from L-serine; glutamic acid, from L-glutamic acid and potassium L-glutamate; glutamine, from L-glutamine; proline, from L-proline; glycine, from glycine; alanine, from L-alanine; cystine, from L-cystine, L-cysteine and L-cysteine hydrochloride monohydrate; valine, from L-valine; methionine, from L-methionine and N-acetyl-L-methionine; leucine, from L-leucine; isoleucine, from L-isoleucine; tyrosine, from L-tyrosine; phenylalanine, from L-phenylalanine; lysine, from L-lysine hydrochloride and L-lysine acetate; arginine, from L-arginine and L-arginine hydrochloride; histidine, from L-histidine and L-histidine hydrochloride monohydrate; and tryptophan, from L-tryptophan. A footnote states that raw materials of animal or plant origin that are not fit for food shall not be used as the source of a single amino acid.