ISO publishes new standards for testing infant formula: ISO 20636:2018

SWITZERLAND – The international standard-setting body, International Organization for Standardization (ISO) has developed and published new standards for testing infant formulas and adult nutritionals.

The standards adjudged ISO 20635; Infant formula and adult nutritionals involves determination of vitamin C by (ultra) high performance liquid chromatography with ultraviolet detection ((U)HPLC-UV), while ISO 20636; Infant formula and adult nutritionals covers determination of vitamin D by liquid chromatography-mass spectrometry.

ISO reiterates the test methods reinforces standards and regulations developed by Codex Alimentarius in line with infant formula and formulas for special medical purposes intended for infants.

Codex Alimentarius, also referred to as the Food Code is the Joint Food Standards Programme established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

It is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety.

According to ISO, if the standards were accepted on a global scale and recommended for use in various applications, they could be used as reference methods for dispute resolutions.

Infant formula and formulas for special medical purposes are some of the most heavily regulated and tested products in the world, accompanied with rigorously checked nutritional labelling to ensure they comply to standard requirements.

The standards will be useful to regulators and commercial laboratories, as well as manufacturers of infant formula and milk products.

“These standards provide an effective way of demonstrating compliance with national and international regulations as they represent a globally harmonized method of testing, in line with other standards-developing organizations in the sector, such as AOAC INTERNATIONAL and the International Dairy Federation (IDF),” said Erik Konings, Convenor of the working group that developed the standards.

“They were developed as there were no completely internationally agreed and harmonized standards of this kind, and will thus help to ensure the safety and quality of products for consumers as well as facilitating their trade on the global market.”

ISO 20635 and ISO 20636 were developed as part of the SPIFAN project (Stakeholder Panel on Infant Formula and Adult Nutritionals), managed by AOAC INTERNATIONAL in cooperation with ISO and the IDF.

The project seeks to develop standard method performance requirements and methods of analysis for 20 or more priority nutrients in infant formula and adult nutritionals.

Food and Drug Administration (FDA) on 9 June 2014 made a final step on infant formula protections by publishing an interim rule that sets standards for manufacturers of infant formula.

The final rule provided some modifications and clarifications including testing for nutrient content in the final product stage, good manufacturing practices specifically designed for infant formula as well as a requirement for manufacturers to demonstrate that their products support normal physical growth.

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