Looks like labeling laws. Not written in English and also some reports of adverse events they are trying to figure out.

https://www.nytimes.com/2020/04/18/parenting/baby/european-f...

When we purchased it (it was still legal several years ago), the instructions were in English. We followed the mixing guide, we knew what the ingredients were (because we researched) including the milk proteins.

The formulas available on the American market were all loaded with sweetener and caused colic. This is an anecdote, but so is what's presented in that article.

> loaded with sweetener and caused colic

Interesting. Sucrose, glucose, fructose have same amount of calories as lactose, just different sweetness (apparently evolutionary trait so that babies don’t get too addicted to milk).

That's the thing, they claimed it didn't meet the standard because it hadn't gone through the approval process.