Evaluation of Nutrient Claims and Potential Health Risks of Follow-up Formulas Based on Label Declarations

Year 2025, Volume: 10 Issue: 3, 188 - 198, 31.12.2025

Betül Karapınar , Tuğba Demir

Abstract

Infant formulas and follow-up milks play a critical role in supporting growth and development during early childhood; however, excessive fortification or inaccurate labeling can lead to nutrient imbalances and safety concerns. This study evaluated the nutritional composition of sixteen commercially available products in Türkiye, including nine follow-up formulas and seven infant formulas, based on manufacturer-declared label information. All nutrient values were standardized to a 200 mL serving and compared with age-specific Recommended Dietary Allowance (RDA), Adequate Intake (AI), and Tolerable Upper Intake Level (UL) values established by the European Food Safety Authority (EFSA) and the Institute of Medicine (IOM). Descriptive analyses and box plot visualizations were used to assess inter-product variability, with a focus on zinc, copper, and vitamin K due to their potential toxicity risks. Overall, most products contained nutrient levels well below UL thresholds, indicating a broad safety margin. However, notable variability was observed: zinc levels reached up to 91.7% of the infant RDA per 200 mL, suggesting that multiple servings could approach UL limits; one product reported copper levels equivalent to 636% of the infant RDA, likely representing a labeling error or formulation inconsistency; and vitamin K values exceeded 500% of AI in several brands, though no UL has been defined. These findings highlight inconsistencies in fortification strategies, nutrient content claims, and labeling accuracy, emphasizing the importance of regulatory harmonization, routine laboratory verification, and transparent reporting to ensure product safety and consumer trust.

Keywords

Follow-up milk , Food safety , Infant formula , Nutrient fortification , Public health

References

• Agostoni, C., Braegger, C., Decsi, T., Kolacek, S., Koletzko, B., Michaelsen, K. F., Mihatsch, W., Moreno, L. A., Puntis, J., Shamir, R., Szajewska, H., Turck, D., and van Goudoever, J. (2009). Breast-feeding: A commentary by the ESPGHAN Committee on Nutrition. Journal of Pediatric Gastroenterology and Nutrition, 49, 112-125. https://doi.org/10.1097/MPG.0b013e31819f1e05
• Bjørklund, G., Chartrand, M. S., and Aaseth, J. (2017). Manganese exposure and neurotoxic effects in children. Environmental research, 155, 380-384. https://doi.org/10.1016/j.envres.2017.03.003
• Cancalon, M., Hemery, Y. M., Barouh, N., Thomopoulos, R., Baréa, B., Durand, E., Villeneuve, P., and Bourlieu Lacanal, C. (2023). Dataset of the nutritional composition of follow-on infant formulas commercialized worldwide in 2021. Data in Brief. https://doi.org/10.1016/j.dib.2023.109649
• Codex Alimentarius Commission. (2007). Standard for infant formula and formulas for special medical purposes intended for infants (Codex Stan 72-1981, Revised 2007). Food and Agriculture Organization/World Health Organization. Codex Alimentarius Commission. (2007). Standard for... - Google Akademik
• Biniş, A. B., and Demir, T. (2023). Açık ve Ambalajlı Dondurmalarda Aflatoksin M1 Varlığının Araştırılması. Instıtute of Health Sciences Journal, 8(3), 418-427. https://doi.org/10.51754/cusbed.1326151
• Demir, T., and Ağaoğlu, S. (2023a). Exposure assessment of aflatoxin M1 through ingestion of infant formula in Türkiye. Türk Tarım-Gıda Bilim ve Teknoloji dergisi, 11(2). http://doi.org/10.24925/turjaf.v11i2.396-402.5805
• Demir, T., and Ağaoğlu, S. (2023b). Estimated daily intake and health risk assessment of toxic elements in infant formulas. British Journal of Nutrition, 130(10), 1732-1742. https://doi.org/10.1017/S0007114523000971
• Demir, T., Tutun, S., & Karapınar, B. (2025). A Systematic Review and Meta-Analysis of Lead Concentrations in Fish: Implications for Dietary Exposure and Risk Assessment. MEMBA Su Bilimleri Dergisi, 11(3), 375-387. https://doi.org/10.58626/memba.1758457
• Dobrzyńska, M., Drzymała-Czyż, S., Jakubowski, K., Kurek, S., Walkowiak, J., and Przysławski, J. (2021). Copper and zinc content in infant milk formulae available on the Polish market and contribution to dietary intake. Nutrients, 13(8), 2542. https://doi.org/10.3390/nu13082542
• Dobrzyńska, M., Wojciechowska, Z., Jakubowski, K., Markowska, H., Przysławski, J., Niedzielski, P., and Drzymała Czyż, S. (2025). Analysis of the Elemental Composition of Milk Formulae: Impact on the Nutritional Status of Infants From Birth to 1 Year of Age. Biological Trace Element Research. https://doi.org/10.1007/s12011-025-04687-x
• EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). (2014). Scientific Opinion on the essential composition of infant and follow-on formulae. EFSA Journal, 12(7), 3760. https://doi.org/10.2903/j.efsa.2014.3760
• EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). (2013). Scientific Opinion on nutrient requirements and dietary intakes of infants and young children in the European Union. EFSA Journal, 11(10), 3333. https://doi.org/10.2903/j.efsa.2013.3333
• EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). (2012). Scientific opinion on the tolerable upper intake level of vitamin D. EFSA Journal, 10(7), 2813. https://doi.org/10.2903/j.efsa.2012.2813
• EFSA Panel on Contaminants in the Food Chain (CONTAM). (2020). Update of the risk assessment of nickel in food and drinking water. EFSA Journal, 18(3), 6268. https://doi.org/10.2903/j.efsa.2020.6268
• European Commission. (2023). Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006. Official Journal of the European Union, L119, 103-142. https://doi.org/10.2903/sp.efsa.2024.EN-8596
• Fox, M. K., Pac, S., Devaney, B., and Jankowski, L. (2004). Feeding infants and toddlers study: what foods are infants and toddlers eating?. Journal of the American Dietetic Association, 104, 22-30. https://doi.org/10.1016/j.jada.2003.10.026
• Han, J., Kang, L., Liang, D., Li, H., Su, Y., Zhang, Y., and Yang, Y. (2019). Composition requirements of follow-up formula for 6-12-month-old infants: Recommendations of a Chinese expert group. Asia Pacific Journal of Clinical Nutrition, 28(2), 321-331. https://doi.org/10.6133/apjcn.201906_28(2).0017
• Hörnell, A., Lagström, H., Lande, B., and Thorsdottir, I. (2013). Protein intake from 0 to 18 years of age and its relation to health: a systematic literature review for the 5th Nordic Nutrition Recommendations. Food and Nutrition Research, 57, 21083. https://doi.org/10.3402/fnr.v57i0.21083
• Islam, M. M., Khatun, M., Peerson, J. M., Ahmed, T., Mollah, M. A., Dewey, K. G., et al. (2008). Effects of energy density and feeding frequency of complementary foods on total daily energy intakes and consumption of breast milk by healthy breastfed Bangladeshi children. American Journal of Clinical Nutrition, 88(1), 84-94. https://doi.org/10.1093/ajcn/88.1.84
• Koletzko, B., Baker, S., Cleghorn, G., Neto, U. F., Gopalan, S., Hernell, O., Hock, Q. S., Jirapinyo, P., Lonnerdal, B., Pencharz, P., Pzyrembel, H., Ramirez-Mayans, J., Shamir, R., Turck, D., Yamashiro, Y., and Zong-Yi, D. (2005). Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group. Journal of Pediatric Gastroenterology and Nutrition, 41(5), 584-599. https://doi.org/10.1097/01.mpg.0000187817.38836.42
• Kramer, M. S., and Kakuma, R. (2012). Optimal duration of exclusive breastfeeding. Cochrane Database of Systematic Reviews, 8, CD003517. https://doi.org/10.1002/14651858.CD003517
• MacLean, W. C., Jr., Van Dael, P., Clemens, R., Davies, J., Underwood, E., O’Risky, L., Rooney, D., and Schrijver, J. (2010). Upper levels of nutrients in infant formulas: Comparison of analytical data with the revised Codex infant formula standard. Journal of Food Composition and Analysis, 23(1), 44-53. https://doi.org/10.1016/j.jfca.2009.07.008
• McCormick, D. B. (1989). Water-soluble vitamins: Bases for suggested upper limits in infant formulas. Journal of Nutrition, 119(Suppl 12S), 1818-1819. https://doi.org/10.1093/jn/119.suppl_12S.1818
• Monteiro, P. O., and Victora, C. G. (2005). Rapid growth in infancy and childhood and obesity in later life—a systematic review. Obesity Reviews, 6(2), 143-154. https://doi.org/10.1111/j.1467-789X.2005.00183.x
• Pandelova, M., Lopez, W. L., Michalke, B., and Schramm, K.-W. (2012). Ca, Cd, Cu, Fe, Hg, Mn, Ni, Pb, Se, and Zn contents in baby foods from the EU market: Comparison of assessed infant intakes with the present safety limits for minerals and trace elements. Journal of Food Composition and Analysis, 27(2), 120-127. https://doi.org/10.1016/j.jfca.2012.04.011
• Peirovi-Minaee, R., Taghavi, M., Harimi, M., and Zarei, A. (2024). Trace elements in commercially available infant formulas in Iran: Determination and estimation of health risks. Food and Chemical Toxicology, 186, 114588. https://doi.org/10.1016/j.fct.2024.114588
• Philippa, P., Ken, K. O., Marieke, H. S., van Tol, E. A. F., Jacques, V., Ieuan, A., Carlo, L. A., and David, B. D. (2016). Breast milk nutrient content and infancy growth. Acta Paediatrica, 105(6), 641-647. https://doi.org/10.1111/apa.13362
• Purkiewicz, A., Mumtaz, W., Tońska, E., and Pietrzak-Fiećko, R. (2024). Mineral content in initial and follow-on infant formulas in Poland: Nutrient adequacy and comparison with breast milk. Applied Sciences, 14(22), 10235. https://doi.org/10.3390/app142210235
• Rips-Goodwin, A. R., Jun, D., Griebel-Thompson, A., Kong, K. L., and Fazzino, T. L. (2025). US infant formulas contain primarily added sugars: An analysis of infant formulas on the US market. Journal of Food Composition and Analysis, 141, 107369. https://doi.org/10.1016/j.jfca.2025.107369
• Scher, D. P., Goeden, H. M., and Klos, K. S. (2021). Potential for manganese-induced neurologic harm to formula-fed infants: a risk assessment of total oral exposure. Environmental health perspectives, 129(4), 047011. https://doi.org/10.1289/EHP7901
• Scientific Committee on Food (SCF). (2002b). Opinion of the Scientific Committee on Food on the tolerable upper intake level of preformed vitamin A (retinol and retinyl esters). Retrieved from https://ec.europa.eu/food/fs/sc/scf/out145_en.pdf
• Scientific Committee on Food (SCF). (2003). Report on the revision of essential requirements of infant formulae and follow-on formulae (SCF/CS/NUT/IF/65 Final). Retrieved from https://ec.europa.eu/food/fs/sc/scf/out199_en.pdf
• Şimşek, T., Güldemir, H. H., and Garipağaoğlu, M. (2022). Bir-iki yaş dönemindeki çocukların beslenme durumu ve besin çeşitliliğinin değerlendirilmesi. Sağlık Bilimleri Dergisi, 31(3), 348-354. https://doi.org/10.34108/eujhs.978480
• Tunçer, E., Bayındır Gümüş, A., & Keser, A. (2021). Evaluation of energy and nutrient content and selected label information of infant and follow-on formulas available in Türkiye. Turkiye Klinikleri Journal of Health Sciences, 6(3), 423–431. https://doi.org/10.5336/healthsci.2020-77808
• Thorisdottir, B., Gunnarsdottir, I., Thorisdottir, A. V., Palsson, G. I., Halldorsson, T. I., and Thorsdottir, I. (2013). Nutrient intake in infancy and body mass index at six years in two population-based cohorts recruited before and after revision of infant dietary recommendations. Annals of Nutrition and Metabolism, 63(2), 145-151. https://doi.org/10.1159/00035443
• Von Kries, R., Koletzko, B., Sauerwald, T., von Mutius, E., Barnert, D., Grunert, V., and von Voss, H. (1999). Breast feeding and obesity: cross sectional study. British Medical Journal (Clinical Research Edition), 319(7189), 147-150. https://doi.org/10.1136/bmj.319.7203.147
• World Health Organization and United Nations Children’s Fund (UNICEF). (2014). Global Nutrition Targets 2025: Breastfeeding Policy Brief. World Health Organization. https://www.who.int/publications/i/item/WHO-NMH-NHD-14.7
• World Health Organization. (2023). WHO guideline for complementary feeding of infants and young children 6-23 months of age. World Health Organization. https://www.who.int/publications/i/item/9789240081864
• Woźniak, D., Podgórski, T., Dobrzyńska, M., Przysławski, J., Drzymała S., and Drzymała-Czyż, S. (2022). The influence of parents’ nutritional education program on their infants’ metabolic health. Nutrients, 14(13), 2671. https://doi.org/10.3390/nu14132671
• Woźniak, D., Podgórski, T., Krzyżanowska-Jankowska, P., Dobrzyńska, M., Wichłacz-Trojanowska, N., Przysławski, J., and Drzymała-Czyż, S. (2022). The influence of intensive nutritional education on the iron status in infants. Nutrients, 14(12), 2453. https://doi.org/10.3390/nu14122453
• Woźniak, D., Przysławski, J., Banaszak, M., and Drzymała-Czyż, S. (2022). Dietary supplements among children ages 0-3 years in Poland—are they necessary? Foods, 12(1), 16. https://doi.org/10.3390/foods12010016
• Yang, T. T., Zhang, Y. M., Ning, Y. B., You, L. L., Ma, D. F., Zheng, Y. D., and Yang, X. G. (2014). Breast milk macronutrient composition and the associated factors in urban Chinese mothers. Chinese Medical Journal, 127, 1721-1725. https://doi.org/10.3760/cma.j.issn.0366-6999.20133260