No one would be surprised to know that the European Union has regulations for blood banks or even sperm banks. But milk banks? Not yet, though Brussels wants to add human breast milk to the bloc’s regulation of human substances.
The proposed regulations will not place the EU bureaucracy between a mother and her breastfed child but would apply to mother’s milk donated to breast milk banks around the bloc as part of the commission’s rewritten directive covering safety rules around substances of human origin (SoHO) intended for human use. The revamping of the regulation started in 2020 and is slowly making its way through the EU legislative process.
Critics consider including breast milk in the regulation another example of EU overreach, while experts say bloc-wide regulations could save infant lives.
In October 2022, German MEP Christine Anderson with the ID Group, who is also a mother of three, ironised:
To put it in terms the EU technocrats can understand: Breast milk is a product that is consumed almost exclusively in the vicinity of the place of production by one or at most two infants. Unless there were a cross-border market for human breast milk, which the EU wants to legalize. However, I haven’t noticed anything about that yet. Or do the EU officials mean to put breast milk smugglers in a row with gasoline, alcohol, tobacco and weapons smugglers?
The medical establishment currently recommends exclusive breastfeeding for babies up to six months of age, and breast milk is particularly important for premature and underdeveloped newborns.
When babies can not be fed with their mother’s milk, human milk banks are the main source of breast milk for babies in need of it. Women with excess milk can donate it to these milk banks, which safely store and distribute it.
Including Russia, Georgia, and Turkey, Europe has 282 active milk banks, plus 18 under development, according to the European Milk Bank Association, though the distribution is very uneven. While France has a well-organised network of 36 milk banks and Italy 39, Spain has only 16, and Portugal and Romania each have just one. Regulations regarding everything from the screening of donors to safety protocols also vary.
Breast milk does cross borders, too.
Politico reports that Germany, for example, despite having 31 milk banks, buys breast milk from Belgium and the U.S. to feed very premature infants still in hospital.
“There are children dying in Germany because they didn’t have, or didn’t have enough, human milk,” Elien Rouw, a breastfeeding specialist in Germany and president-elect of the Academy of Breastfeeding Medicine, told Politico.
For this reason, many experts welcome bloc-wide regulations. But they caution the commission not to ruin what is already working.
Women sharing breast milk to keep babies happy and healthy is as “old as mankind,” the Hamburg-based Human Milk Bank Initiative (FMBI) said in a 2020 position statement on the EU proposal.
It sees no need to regulate what it calls “peer-to-peer” sharing—small circles of women who know each other supplying breast milk among themselves when needed. The regulation of wider breast milk sharing has advantages and disadvantages.
“Human milk has developed into a profitable commodity which is processed on an industrial scale and traded worldwide,” which causes potential problems, according to (FMBI). One of the problems is trade occurring increasingly over the internet. The European Milk Bank Association recently warned of the increase in the informal selling of breast milk online where its quality and safety is not guaranteed. Human milk is susceptible to bacteria if not properly collected and stored, among other potential dangers to infants who consume it.
FMBI also warned that commercialization has at times led to the exploitation of poor women:
The commodification of human milk has in the past resulted in ethically questionable approaches to acquire human milk from lactating mothers in resource-limited regions or from socio-economically disadvantaged populations … This has raised the issue of vulnerability to exploitation and the limits of self-determination of women of economic uncertainty when faced with the opportunity to market their breast milk.
Politico reports that European countries vary in compensating women for donating breast milk. France, for example, offers no compensation, while in Sweden, women receive about 22 euros for a litre of breast milk. The draft regulation currently allows for compensating women for their expenses when donating breast milk but it leaves the detail up to member states.
FMBI also noted that, as regulations currently stand, milk banks have been able to provide high-quality milk for a relatively low cost, making it available to infants in need at the same time that the banks have the added social benefit of encouraging breastfeeding. Overregulation could disrupt the workings of this system if compliance prices non-profit milk banks out of existence, the statement said:
It is the urgent recommendation of the Human Milk Bank Initiative that any legal framework must avoid disadvantaging donor human milk from institutionalized human milk banks in favour of commercially processed products. This may create a situation where the utilization rate of human milk for preterm infants might actually decrease across Europe and other positive effects from human milk banks promoting lactation are lost.
The current draft regulation sets the requirement as an EU-wide standard but leaves spelling out the details up to the experts, namely the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).
The regulation is still in parallel discussion and approval processes in the EU Parliament and the Council.
