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ISO 20636:2018—Infant Formula and Adult Nutritionals

Mother measuring the amount of infant formula, which adheres to ISO 20636:2018, to give to her baby.

Nutrition drinks can have a nourishing mix of protein, fat, and carbohydrates; they may assist people in meeting general dietary needs. Liquid chromatography (i.e., a laboratory technique used to separate and analyze components of a mixture) helps to assure quality control in these products by detecting potential contaminants, verifying the presence and concentration of essential vitamins, minerals, and amino acids. ISO 20636:2018—Infant formula and adult nutritionals – Determination of vitamin D by liquid chromatography-mass spectrometry specifies methods using liquid chromatography to analyze vitamins in infant formula and adult nutritionals.

Why Is Liquid Chromatography Important in Infant Formula and Adult Nutritionals?

Liquid chromatography is a technique used to analyze the contents of infant formula and adult nutritionals, including vitamins, minerals, and contaminants. This method can detect and quantify a variety of substances, such as vitamin B12, vitamin D, vitamin A, Choline, amino acids (like taurine), and other essential components.

The method allows for the precise identification and quantification of individual components within the formula. By analyzing samples with liquid chromatography, manufacturers can assure that infant formula and adult nutritional products meet established quality standards and nutritional claims.

What Is ISO 20636?

ISO 20636:2018 specifies a method for the quantitative determination of vitamin D2 and/or vitamin D3 in infant formula, and adult nutritionals in solid (i.e., powders) or liquid (i.e., ready-to-feed liquids and liquid concentrates) forms using liquid chromatography-mass spectrometry. The standard defines adult nutritionals and infant formula as follows:

  • Adult nutritional: nutritionally complete, specially formulated food, consumed in liquid form, which may constitute the sole source of nourishment, made from any combination of milk, soy, rice, whey, hydrolyzed protein, starch, and amino acids, with and without intact protein
  • Infant formula: breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during the first months of life up to the introduction of appropriate complementary feeding

The use of this method detailed in ISO 20636:2018 can involve hazardous materials, operations, and equipment. This method does not purport to address all the safety problems associated with its use, and as such, it is the responsibility of the user of this method to establish appropriate safety and health practices.

Development of the Regulation of Infant Milk Composition

Infant milk composition has evolved over the decades, with the addition of individual ingredients, which aim to make infant milk closer in composition to breastmilk. For example, taurine was first added in 1984, nucleotides in the late 1990s, and long chain polyunsaturated fatty acids and prebiotics in the early 2000s. Despite these advances in the composition of infant milks, breastmilk contains over 300 components, including nutrients, antibodies, hormones, enzymes, and live cells—making it a complex biological fluid that adapts to a baby’s changing needs throughout their development. Essentially, these components in breastmilk vastly contribute to the health and well-being of infants, compared with only about 75 at most in typical infant formula.

It is therefore difficult to recreate the wide range of immunomodulatory factors in breastmilk. Nonetheless, many infants in the U.S. rely on infant formula for some or all of their nutrition. The U.S. Food and Drug Administration (FDA) notes that assuring that the youngest and most vulnerable individuals have access to safe and nutritionally adequate formula products is a top priority; and as such, the agency regulates the production of infant formulas to help ensure that these products are safe and support healthy growth in infants who consume them.

Moreover, to establish a good market order and assure the healthy growth of infants, it is crucial to monitor the quantity of components in infant formula products.

ISO 20636:2018—Infant formula and adult nutritionals – Determination of vitamin D by liquid chromatography-mass spectrometry is available on the ANSI Webstore.

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