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Article

Characterization of Infant Formulae Marketed in Italy and Virulence Potential of Bacillus cereus Isolates

1
Department of Veterinary Medicine and Animal Sciences, University of Milan, Via dell’Università 6, 26900 Lodi, Italy
2
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Via San Zeno 37, 56127 Pisa, Italy
3
Research Center Nutraceuticals and Food for Health-Nutrafood, University of Pisa, 56128 Pisa, Italy
4
Department of Veterinary Medicine, University of Sassari, Via Vienna 2, 07100 Sassari, Italy
*
Authors to whom correspondence should be addressed.
Foods 2026, 15(3), 536; https://doi.org/10.3390/foods15030536
Submission received: 15 December 2025 / Revised: 27 January 2026 / Accepted: 29 January 2026 / Published: 3 February 2026

Abstract

This study aimed to evaluate the microbiological quality and safety of powdered formulae intended for infant consumption on the Italian market. A total of 83 samples, including 23 infant formulae (PIF), 42 follow-on formulae (FOF), and 18 formulae for special medical purposes (SMPs), were taken between 2023 and 2024. Low total viable counts were highlighted with all SMP samples, 87.0% of PIF samples and 97.6% of FOF samples being compliant with the threshold set by the Code of Hygienic Practice for Powdered Formulae for Infants and Young Children (2.70 Log CFU/g). High contamination levels (>4 Log CFU/g) were found exclusively in PIF (8.7%) and FOF samples (2.4%). Considering potential pathogenic bacteria, the presence of Listeria monocytogenes, Yersinia enterocolitica, Salmonella spp., Bacillus cereus, and Cronobacter sakazakii was investigated. Enumeration of Bacillus cereus, Staphylococcus aureus, and Clostridia was also performed. Only presumptive B. cereus was detected (37 samples, and in 3 samples was enumerated with counts equal to 1 Log CFU/g). A total of 42 presumptive B. cereus isolates were tested for the production of hemolysin BL, phosphatidylcholine-specific phospholipase C, proteases, and for the presence of chromosomal toxin-encoding genes, showing a relevant prevalence of virulence factors and highlighting a potential concern for infants. The antimicrobial resistance pattern of the isolates showed high resistance rates to β-lactams and a moderate resistance to erythromycin. A chemical–physical characterization of the formulae was also performed showing high heterogeneity in terms of pH, Aw, and concentration of organic acids. The results obtained provide useful information for monitoring the potential exposition of infants to microbial populations and to evaluate the safety of the products available on the market.
Keywords: microbiota; powdered infant formulae; follow-on formulae; formulae for special medical purposes; contamination microbiota; powdered infant formulae; follow-on formulae; formulae for special medical purposes; contamination

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MDPI and ACS Style

Fusi, V.; Stella, S.; Ghelardi, E.; Celandroni, F.; Bernardi, C.; Addis, M.F.; Locatelli, C.; Scarano, C.; Piras, F.; Siddi, G.; et al. Characterization of Infant Formulae Marketed in Italy and Virulence Potential of Bacillus cereus Isolates. Foods 2026, 15, 536. https://doi.org/10.3390/foods15030536

AMA Style

Fusi V, Stella S, Ghelardi E, Celandroni F, Bernardi C, Addis MF, Locatelli C, Scarano C, Piras F, Siddi G, et al. Characterization of Infant Formulae Marketed in Italy and Virulence Potential of Bacillus cereus Isolates. Foods. 2026; 15(3):536. https://doi.org/10.3390/foods15030536

Chicago/Turabian Style

Fusi, Viviana, Simone Stella, Emilia Ghelardi, Francesco Celandroni, Cristian Bernardi, Maria Filippa Addis, Clara Locatelli, Chistian Scarano, Francesca Piras, Giuliana Siddi, and et al. 2026. "Characterization of Infant Formulae Marketed in Italy and Virulence Potential of Bacillus cereus Isolates" Foods 15, no. 3: 536. https://doi.org/10.3390/foods15030536

APA Style

Fusi, V., Stella, S., Ghelardi, E., Celandroni, F., Bernardi, C., Addis, M. F., Locatelli, C., Scarano, C., Piras, F., Siddi, G., & Tirloni, E. (2026). Characterization of Infant Formulae Marketed in Italy and Virulence Potential of Bacillus cereus Isolates. Foods, 15(3), 536. https://doi.org/10.3390/foods15030536

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