Beyond the pale? Why the EU is regulating breast milk – POLITICO

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The European Union regulates all kinds of banks: cash banks, blood banks, sperm banks

Its subsequent goal? Breast milk banks.


Brussels bureaucrats need to homogenize the guidelines overseeing the donation and use of donor breast milk throughout the bloc. 

It is a part of the European Fee’s proposed revamp of the legal guidelines masking security and high quality requirements for substances of human origin (SoHO) supposed for human use. At present, the legal guidelines cowl blood, tissues and cells, however the EU needs to increase protection to all SoHO — together with donor breast milk.

Whereas, at first look, it would appear to be the EU is making an attempt to milk its regulatory powers, specialists are largely in favor of the plan to set EU-wide requirements, saying it’s going to enhance its availability and security.

With lawmakers and EU nations debating the revamp, POLITICO walks you thru the subject.

What are breast milk banks?

Ladies who make extra breast milk than their infants want can donate it to a breast milk financial institution.

These banks display donors and accumulate, course of and distribute the milk to infants in want — these whose mom’s personal milk is not obtainable or ample.

Whereas unique breastfeeding is recommended for all infants in the first six months of their life, it’s particularly vital for untimely or sick newborns, specialists say.

Amongst many different advantages, breast milk incorporates antibodies which might be vital for newborns’ immune techniques. Infants born earlier than 30 weeks of being pregnant are particularly inclined to infections, notably from necrotizing enterocolitis, a kind of intestine irritation that may be deadly. Their survival charges enhance after they get human milk as in contrast with components, mentioned Elien Rouw, a breastfeeding medication specialist in Germany and president-elect of the Academy of Breastfeeding Drugs.

There are at present 282 breast milk banks in Europe, together with Turkey and Ukraine, in line with the European Milk Financial institution Affiliation.

Aren’t they already regulated?

Donor breast milk is regulated otherwise in several nations. For instance, it’s thought of a well being product in France, a meals in Germany, and is uncategorized and unregulated in Romania. And whereas the security requirements are set at the nationwide stage in France, for example, they’re set at the regional stage in Belgium.

The Fee needs to harmonize breast milk security requirements throughout the EU | Kenzo Tribouillard/AFP through Getty Pictures

There is some stage of convergence although. For instance, most nationwide pointers in the world recommend donor breast milk ought to be pasteurized, in line with the European Milk Financial institution Affiliation.


In France, for instance, the milk is first examined for micro organism and extremely contaminated milk is thrown out, explains Jean-Charles Picaud, professor of pediatrics specialised in neonatology at Hôpital de la Croix-Rousse in Lyon, and president of the French Human Milk Financial institution Affiliation. The remaining is then pasteurized at exactly 62.5 levels Celsius for precisely half-hour after which retested earlier than being made obtainable for infants.

What does the Fee need to do?

The Fee needs to harmonize security requirements throughout the EU, not solely to make sure the security of the infants that eat breast milk, but additionally to make it simpler for donor breast milk — and different SoHO — to cross borders. 

Donor milk banks are erratically unfold out throughout the Continent. There are over 30 in France, for instance, however solely 4 in Belgium and one in Romania. And components of Europe are dealing with a scarcity of donor breast milk, whereas it stays in restricted provide elsewhere. 

“There are kids dying in Germany as a result of they didn’t have, or didn’t have sufficient, human milk,” Rouw, the breastfeeding medication specialist in Germany, mentioned. Facilities in Germany caring for terribly untimely infants with out direct entry to a milk financial institution are shopping for it partially from Belgium and the United States, she added.

Consultants agree that having harmonized security requirements would make the cross-border trade of breast milk simpler, bettering infants’ entry to it. These embrace issues like donor choice standards, maternal blood checks for infections, hygiene requirements throughout assortment, chilly chain circumstances throughout transport, and testing the milk for micro organism, mentioned Picaud, president of the French Human Milk Financial institution Affiliation.

Nonetheless, whereas the Fee is setting out the precept of bloc-wide requirements in its regulation, it goals to depart it to knowledgeable our bodies — the European Centre for Illness Prevention and Management (ECDC) and the European Directorate for the High quality of Medicines & HealthCare (EDQM) — to hammer out the exact scientific and technical particulars in order that these will be extra simply up to date ought to the want come up.

Ought to donors receives a commission?

The controversy over paying for substances of human origin is a divisive one. Germany’s Human Milk Financial institution Initiative, a nongovernmental group that promotes nonprofit donor milk banks, warned ready statement to the Fee in 2020 that “ethically questionable approaches” have been used globally to accumulate human milk from “lactating moms in resource-limited areas or from socio-economically deprived populations.”

EU nations take various approaches with regards to donor compensation for breast milk. Donors in France, for example, obtain no monetary compensation. In Sweden, donating moms obtain a nominal 250 Swedish krona (€22.56) per liter of donated milk.

The Fee’s proposed revision consists of steering on compensation for all SoHO donors, to permit any monetary losses to be coated — however leaves it to EU nations to find out whether or not to permit it and if that’s the case, the circumstances for it, guaranteeing they continue to be “financially impartial.”

In addition to human milk banks, the new legislation would additionally apply to any firm trying to commercialize breast milk as an ingredient.

GettyImages 1241500767A nurse checks reserves of breast milk in the Sant’Anna hospital in Turin, Italy | Diana Bagnoli/Getty Pictures

Given the rising physique of analysis displaying the scientific advantages of donor breast milk for untimely infants, hospital-affiliated milk banks round the world are increasing their actions — and there is additionally rising industrial curiosity, a Fee spokesperson instructed POLITICO.

At the very least one firm is utilizing breast milk to make fortifiers for sick and untimely infants in the neonatal intensive care unit, that are then added to both a mom’s milk or donor milk.

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