New ISO standard pegged as “big win” for the infant formula industry

10 Jul 2020 --- Motivated to amend “outdated and unvalidated” methods of determining nutrients in infant formula, the International Organization for Standardization (ISO) has introduced a new standard. ISO 23443, Infant formula and adult nutritionals – Determination of β-carotene, lycopene and lutein by reversed-phase ultra-high performance liquid chromatography (RP-UHPLC), is pegged by ISO as a “big win for the infant formula industry,” demonstrating “true international cooperation to protect consumer health and facilitate trade.”

“The infant formula industry fully supports the development and publication of this standard. Infant formulas containing both beta carotene and lycopene are being traded globally without a harmonized method in place to verify compliance with regulations and labeling. So there is the possibility of regulatory disputes regarding the level of beta carotene or lycopene in a particular product. To address potential regulatory disputes, it is beneficial for all stakeholders to have this new standard available,” Erik Konings, convenor of the ISO working group that developed the standards, tells NutritionInsight.

Companies active in the infant formula industry are very careful to ensure end-consumers that their products are safe for consumption. In the past few weeks alone, probiotic manufacturer Lallemand Health Solutions received approval from the Chinese National Health Commission to use three of its probiotic strains in infant formula. Its Bifidobacterium lactis Lafti B94 strain also received a No Questions Letter regarding the Generally Recognized as Safe (GRAS) notification from the US Food and Drug Administration (FDA) in March. 

Konings adds that this cooperation has also been much appreciated by Codex Alimentarius, a key ISO partner, as it is essential for global consistency and improved quality overall. The Codex Alimentarius was established by the UN Food and Agriculture Organization (FAO) and the World Health Organization (WHO) in 1963 to develop harmonized international food standards that protect consumer health and promote fair practices in the food trade.

Detailing the new standard 
The new standard document specifies a method for the quantitative determination of beta-carotene and lycopene in infant formula and adult nutritionals in solids, such as powders, or ready-to-feed liquids and liquid concentrates, using RP-UHPLC and UV-visible detection. 

The application range runs from 

• 1 μg per 100 g to 1,500 μg per 100 g for lycopene.

• 1 μg per 100 g to 2,250 μg per 100 g for beta-carotene. 

Based on the single-laboratory validation, the limit of detection was 0.1 μg per 100 g and the limit of quantification was 0.3 μg per 100 g for each carotenoid.

“Lutein, beta-carotene and lycopene are among the carotenoids present in human milk and are added to infant formula and adult nutritionals. Lutein may play a role in vision and cognitive function and beta-carotene has provitamin A activity. Accurate and precise measurements of these added ingredients are important for ensuring their presence in the allowable ranges,” the standard introduction outlines. 

“Since 2015, new methods of analysis for nutrients in infant formula, which were validated by AOAC International, ISO and IDF through the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) project, have been adopted and published in the Journal of AOAC International. ISO 23443 is one of the last completed in this series of methods,” Konings concludes.

By Anni Schleicher