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<p>The availability of commercially manufactured products derived from human milk has increased in recent years. These products include human milk-derived fortifiers, enriched donor milk and other preparations . In response to these developments, the Nutrition Committee of the German Society for Pediatrics and Adolescent Medicine (DGKJ) and the Working Group on Breastfeeding, Nutrition and Prevention of the Austrian Society for Pediatrics and Adolescent Medicine (ÖGKJ) provide instructions for dealing with and evaluation of those&#xa0;products. The current scientific evidence, safety, ethical and economic aspects of this product category are discussed.</p><p>Although human milk is considered the gold standard for infant nutrition, the use of human milk as a&#xa0;raw material does not automatically justify conclusions on the superiority&#xa0;of those&#xa0; products. Manufacturing and processing procedures as well as the duration of storage can alter nutrient composition, bioactive compounds and biological properties. Current evidence does not demonstrate a&#xa0;consistent clinically relevant advantage of human milk-derived commercial products over bovine milk-based alternatives, even in preterm infants. Available randomized controlled trials and meta-analyses show important methodological limitations, heterogeneity and risks of bias, limiting the certainty of conclusions.</p><p>Further concerns relate to product safety, particularly donor selection and screening, hygienic milk collection, transport, processing procedures and contamination risks. Ethical considerations are highly relevant, as financial incentives for milk donation can disproportionately affect socioeconomically disadvantaged mothers and potentially interfere with breastfeeding of their own infants. In addition, the relationship between costs and clinical benefits requires careful evaluation.</p><p>The nutrition committees therefore call for robust evidence regarding efficacy, safety, ethical acceptability and cost-effectiveness as well as an appropriate regulatory framework for the commercial use of human milk, prioritizing breastfeeding protection. Based on the currently available evidence, the routine use of commercially manufactured human milk-derived products cannot be recommended.</p>

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Kommerzielle Produkte aus humaner Milch: Kommentar zu Bewertung und Einsatz

  • 期刊论文

  • 发表日期：

    2026年7月28日

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  • Frank Jochum,
  • Regina Ensenauer,
  • Kai Hensel,
  • Frank Jochum,
  • Hermann Kalhoff,
  • Thomas Kauth,
  • Berthold Koletzko,
  • Thomas Lücke,
  • Carsten Posovszky,
  • Silvia Rudloff,
  • Susann Weihrauch-Blüher,
  • Susanna Wiegand

摘要

The availability of commercially manufactured products derived from human milk has increased in recent years. These products include human milk-derived fortifiers, enriched donor milk and other preparations . In response to these developments, the Nutrition Committee of the German Society for Pediatrics and Adolescent Medicine (DGKJ) and the Working Group on Breastfeeding, Nutrition and Prevention of the Austrian Society for Pediatrics and Adolescent Medicine (ÖGKJ) provide instructions for dealing with and evaluation of those products. The current scientific evidence, safety, ethical and economic aspects of this product category are discussed.

Although human milk is considered the gold standard for infant nutrition, the use of human milk as a raw material does not automatically justify conclusions on the superiority of those  products. Manufacturing and processing procedures as well as the duration of storage can alter nutrient composition, bioactive compounds and biological properties. Current evidence does not demonstrate a consistent clinically relevant advantage of human milk-derived commercial products over bovine milk-based alternatives, even in preterm infants. Available randomized controlled trials and meta-analyses show important methodological limitations, heterogeneity and risks of bias, limiting the certainty of conclusions.

Further concerns relate to product safety, particularly donor selection and screening, hygienic milk collection, transport, processing procedures and contamination risks. Ethical considerations are highly relevant, as financial incentives for milk donation can disproportionately affect socioeconomically disadvantaged mothers and potentially interfere with breastfeeding of their own infants. In addition, the relationship between costs and clinical benefits requires careful evaluation.

The nutrition committees therefore call for robust evidence regarding efficacy, safety, ethical acceptability and cost-effectiveness as well as an appropriate regulatory framework for the commercial use of human milk, prioritizing breastfeeding protection. Based on the currently available evidence, the routine use of commercially manufactured human milk-derived products cannot be recommended.