Global Foundation for the Care of Newborn Infants
GFCNI
The GFCNI is the first global organization and network to unite patients, families, healthcare professionals, medical staff, and scientists from different disciplines, fields, and countries – all with the joint goal of advancing the health and quality of care for newborns and their families across the globe.
ID: 33597655264-22
Lobbying Activity
Response to Revision of the Union legislation on blood, tissues and cells
8 Sept 2022
In July 2022, the European Commission adopted the proposal for a regulation on standards of quality and safety for substances of human origin (SoHo) intended for human application. Previously unregulated at EU level, this new proposal has extended its scope of SoHo to “human breast milk”. We, the European Foundation for the Care of Newborn Infants, welcome and support the aims of ensuring safety and protection for recipients and donors by clarifying regulatory aspects of donor human milk.
In Europe and worldwide, preterm birth, low birthweight, asphyxia, congenital abnormalities, infections and birth trauma are the main causes of neonatal death. Mother’s own milk is the preferred option for infant nutrition of these vulnerable newborns to achieve optimal growth, development, and health. When mother’s own milk is not available, donor human milk is the next best alternative.
In light of the draft regulation and in order to guarantee that the highest level of safety for these infants and their nutritional needs are met, we request European policy makers to ensure that this proposal:
1. Recognises human milk as the best option for preterm, sick and low birthweight infants and has, at its core, the theme of ensuring a safe, secure supply for all mothers in need of donor human milk for their infants.
2. Notes that human milk is produced and expressed by the lactating mother with the sole purpose of feeding her own baby. Therefore, mother’s own milk must be excluded from the definition of SoHo as set out in this proposal and should emphasize donor human milk.
3. Ensures equitable access to safe donor human milk for preterm, sick and low birthweight infants as a key theme and accounts for the practical specifics of human milk and its donation.
4. Endorses recognition, support and regulation of human milk banks in Europe.
5. Ensures that the regulation does not endanger the functioning of already well-established donor human milk services across the European Union, particularly with regards to potential financial costs and perceived legal and administrative obstacles.
6. Includes the need for EU-wide research and data collection of human milk donation and use.
Making sure that preterm, sick and low birthweight infant conditions and consequent needs are recognized and best care is provided will save lives and improve quality of life. Human milk-based nutrition must be considered a European public health issue and a human right for all these infants.
Signatories on behalf of the European Foundation for the Care of Newborn Infants (EFCNI)
Silke Mader, Chairwoman of the Directors Board and Founder
Prof. Dr. Luc Zimmermann, Senior Medical Director
Dr. Johanna Kostenzer, Head of Scientific Affairs
Read full responseResponse to Revision of the Union legislation on blood, tissues and cells
8 Dec 2020
Response by the European Foundation for the Care of Newborn Infants (EFCNI)
The European Foundation for the Care of Newborn Infants (EFCNI) welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation and its planned revision for the fourth Quarter of 2021. The focus of the Impact Assessment will be on the quality and safety aspects of Substances of Human Origin (SoHO). We understand that the focus is on the origin of the substances used and not on the use of the final product.
EFCNI is the first pan-European organisation which represents the interests of preterm and newborn infants and their families. We bring together parents, interdisciplinary healthcare experts, and scientists with the common goal of improving long-term health of newborns, especially of preterm, sick, and low birthweight infants.
The scientific community unanimously agrees that mother’s own milk is the first choice in infant feeding. When mother’s own milk is not available, donor human milk is the preferred option, mostly supplied through human milk banks. This applies especially to preterm, sick and low birthweight infants who have special nutritional needs. However, today, donor human milk and milk banking are not regulated at EU level leading to legal uncertainty and lacking safety and quality standards.
In this regard, the Inception Impact Assessment contains several statements that are very relevant to us:
Page 1: “…while new therapies have emerged since the BTC legislation was adopted, it is not always clear whether, and if so which, of the BTC Directives apply, leaving these substances unregulated or regulated in divergent ways (e.g. breast milk and faecal microbiota transplants)”
Page 3: “…the scope of the BTC legislation will be clarified to include novel substances of human origin currently used but not regulated at the EU level”
Page 5: “…possibly extending the scope of the BTC legislation to include other substances of human origin would increase the oversight workload. This will be mitigated by a risk-based inspection scheduling to increase oversight efficiency”
We are very pleased to see that human milk is identified as one of the substances that should be considered for inclusion in the new EU legislation.
In our Digital Policy Workshop on November 18, chaired by MEP Professor Dr Angelika Niebler and MEP Radka Maxová, international experts addressed this particular topic and provided information why it is important to include donor human milk in the directive. Our policy recommendations “Making Human Milk Matter – The need for regulation in the European Union” are available here: www.efcni.org/human-milk-regulation
The policy recommendations have been independently developed by the EFCNI Working Group on Human Milk Regulation in close collaboration with representatives of EMBA, ESPR, ESPGHAN, UENPS, and parent organisations.
We therefore respectfully request the European Commission to be included as relevant stakeholder in the meetings to come.
On behalf of the EFCNI Working Group on Human Milk Regulation
Silke Mader, Founder and Chairwoman of the Executive Board
Johanna Kostenzer PhD, Head of Scientific Affairs
Professor Luc Zimmermann, Senior Medical Director
European Foundation for the Care of Newborn Infants (EFCNI)
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www.efcni.org
Read full responseResponse to Farm to Fork Strategy
16 Mar 2020
We welcome the Commission’s Farm to Fork Strategy initiative for sustainable food. In particular, we welcome the emphasis on a healthy nutrition as a tool to prevent the onset of debilitating or fatal diseases in the future.
As a non-profit European organisation and network representing the interests of preterm and newborn infants and their families, we believe that this Strategy should take into account also the nutritional needs of newborn infants, including preterm and sick ones.
The scientific community, e.g. World Health Organization, European Society for Paediatric Gastroenterology Hepatology and Nutrition, European Society on Pediatric Research, agrees on the benefits of breast milk for preterm and sick newborns and as alternative donor human milk.
Breastfeeding, or when it is not possible, donated human milk, is proven to:
• Lowers risk of intestinal disease (NEC)* in infants by 6-7 times ,
• Improves prevention of later hypertension by 34% ,
• Increase sepsis prevention by 20%
• Improve defence against chronic lung disease (BPD)* by 22% ,
• Increase prevention against potentially blinding disease (ROP)* by 40-45% .
As underlined in Commission’s communication on the Farm to Fork Strategy, consumers should be provided with better information on what they eat so to help them to choose a healthy diet. As such, we urge the Commission to explore new ways to give parents and carers of newborns better information on the ingredients and the nutritional value of the products intended to infant nutrition.
Stringent requirements on the ingredients contained in baby milk products, as well as clear front-of pack nutrition labelling should apply. This is also important for any kind of baby and toddler nutrition products.
Misleading labelling or advertising which may lead the parent or carer of a newborn to prefer infant formulas over breastfeeding or human milk-based products should be prohibited. Mothers should be able to to make a health-conscious nutrition choice. The recommendation of the World Health Organization on the importance of breastfeeding and donor milk needs to be followed to protect the health or our infants. Preterm and sick infants need parenteral nutrition or supplementation to ensure a healthy growth. Each of these infants need a safe and optimal nutrition and needs to be provided on their individual needs to ensure a healthy growth, but also to prevent further health complications.
1. Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013. doi:10.1016/j.jpeds.2013.07.011
2. Singhal A, Cole TJ, Lucas A. Early nutrition in preterm infants and later blood pressure: Two cohorts after randomised trials. Lancet. 2001. doi:10.1016/S0140-6736(00)04004-6
3. Furman L, Taylor G, Minich N, Hack M. The effect of maternal milk on neonatal morbidity of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2003. doi:10.1001/archpedi.157.1.66
4. Kreissl A, Sauerzapf E, Repa A, et al. Starting enteral nutrition with preterm single donor milk instead of formula affects time to full enter
5. Villamor-Martínez E, Pierro M, Cavallaro G, Mosca F, Kramer BW, Villamor E. Donor human milk protects against bronchopulmonary dysplasia: A systematic review and meta-analysis. Nutrients. 2018. doi:10.3390/nu10020238
6.. Kreissl A, Sauerzapf E, Repa A, et al. Starting enteral nutrition with preterm single donor milk instead of formula affects time to full enteral feeding in very low birthweight infants. Acta Paediatr Int J Paediatr. 2017. doi:10.1111/apa.13914 and Manzoni P, Stolfi I, Pedicino R, et al. Human milk feeding prevents retinopathy of prematurity (ROP) in preterm VLBW neonates. Early Hum Dev. 2013. doi:10.1016/S0378-3782(13)70019-7
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