The Difference Between American And European Baby Formula: Ingredients, Quality, And Regulations

European Baby Formula
European baby formula is far superior to American formula.

First-time mommy, first-time daddy, first child, first baby formula choice… All these “firsts” need so much effort, time, and devotion. We know how to make your formula choice easier (and your day longer).

Choosing first baby formula 1

Newborns are much more vulnerable to non-organic food and GMOs, toxins, heavy metals, and harmful chemicals than we are. It’s crucially important to give your kid high-quality food from the first days of life. If it’s not breast milk, then it should be premium infant formula.

Thankfully, it is now the 21st century, and baby food manufacturers have succeeded in creating a baby formula that mimics mommy’s breast milk as much as possible. This is a great invention, isn’t it? 

We have spent months researching the baby formula world – to save time for you to sleep. We dived deeply into US and EU food safety regulations, read scientific articles and governmental reports, carefully gathered insights into organic farming, biodynamic manufacturing, and harm from toxic heavy metals, and here we are! So, we have no general phrases like “European formula is better regulated”, “Cleaner” or that it “Doesn’t include hidden ingredients” that are so popular on the internet.

This article explains the differences between American and European baby formulas in terms of regulation, quality, and formula composition. 

To make a long story short – yes, European baby formula is far superior to American formula. Why? Here you’ll find the answer. 

Article Content:

This article is a guide that will help you to make a preliminary formula choice. Always consult your pediatrician to make the final choice, considering all the specific nutrient needs of your baby. 

American Vs. European Baby Formula

(Comparison In A Table)

Looking for the best alternative to breastfeeding, more and more American parents are switching to European formula brands. Although these products are not registered with the FDA and don’t have official distribution channels in the United States, demand is growing.

So, what makes them so attractive for millions of young parents? Is it a trend or a conscious decision? Let’s see the table below [2,3,4].

American Vs. European Baby Formula

Ingredients and quality
Often contains corn syrup and sucrose as a sweetenerNever contains corn, may contain sucrose for a special type of formula
Often contains sugarNever contains sugar
May contain brown rice syrupNever contains “empty” carbohydrates, like rice syrup
Milk is not always organicOrganic milk only
May contain soy oil, soy lecithinMostly soy-free
Often contains palm oilMostly palm oil-free
No requirements regarding lactose minimum level30% of lactose as must-have minimum
May contain carrageenan as a stabilizerThe law prohibits carrageenan
Often contain guar gum and preservatives (pectins, fructans)Locust gum, guar gum, pectins, and fructans are prohibited by the law
May contain sesame seed oil, cottonseed oil, and saltSesame seed oil, cottonseed oil, and salt are totally prohibited
Taurine is often among the ingredients listTaurine isn't used in leading brands; if added, must be minimized to a safe level – not more than 12 mg/100 kcal
There is no requirement for trans fatty acidsThe trans fatty acid content shall not exceed 3% of the total fat content
Farming practices
Cows are mostly raised on corn, fed with grain, soy, or corn. This makes them sick and in need of antibioticsCows are raised on grass, fed primarily with natural grass and hay. They can roam freely, which makes them happier and healthier
Only some brands follow organic farmingFarming is based on sustainable and organic biodynamic agriculture.
Labels and instructions
Easy to understand which formula is suitable for your baby's age (0-6 months, 0-12 months, etc.)Classification by stages (1,2,3)
More time to get to the right stage for your baby's age
Labels and all the information about a product are in EnglishPackaging and documentation sometimes lacks English translation
Regulatory authority and their requirements
FDA (Food and Drug Administration)EC (European Commission)
The general food laws and regulations apply to infant formula as wellSpecific rules for baby formula define laws for infant and follow-on formulas more accurately and in more detail than in the US
Requires 11 obligatory minerals in infant formula and 15 vitaminsRequires 14 mandatory minerals in infant formula (+Selenium, Molybdenum, Fluoride vs. the US) and 12 vitamins (-B2, Choline, Inositol)
Sets only minimum necessary amount for each mineral and vitamin and no limits for maximum level (max level only for 5 nutrients out of 26)Defines minimum and maximum necessary amount for each mineral and vitamin
Carnitine’s amount isn’t mentioned in the product declarationCarnitine’s amount must be mentioned in the obligatory nutrition declaration
Allows significantly higher concentrations of iron than EC (as there is no maximum level)Sets the lower and higher acceptable level of iron concentrations
Does not regulate the level of sucrose/lactoseDoes not allow sucrose for most infant formula types and sets mandatory lactose levels
Doesn't require adding DHA (docosahexaenoic acid), although most brands add itRequires addition of DHA
Doesn't set requirements for the level of pesticide residuesRequires no detectable levels of pesticide residues in baby formula (< 0.01 milligrams per kilogram)
Doesn’t ask manufacturers to test for heavy metalsDefines strict standards and limits for heavy metals in infant nutrition and asks manufacturers to follow them
May contain a dangerous level of lead, cadmium, and other heavy metals as no regulations existEU has defined regulatory standards for a maximum level of lead, cadmium, and arsenic in infant formulas

To learn more about organic farming and ingredients to avoid or pay extra attention to in baby food, read on. 

‘Organic’, ‘Biodynamic’ And ‘EU Organic-certified’…What Do They Mean?

 To stay on the same wavelength, let’s look at the labels and terms you’ll often see on European baby formula products.

What Does The ‘Organic‘ Label On EU Baby Formula Mean? 

It means the product has no artificial colors, flavors, preservatives, or genetically modified ingredients (GMO). ‘Organic farming’ stands for farming practices that focus on animal welfare, sustainability, and harmony with nature.8Oq8w GLiN2Pw5EJZFgnQEql0CYIPk9BpZGS XD8XAsS7KtPG z7e447nR678xY5GddxcTYJYDMCnkgS5 BL1dhmbJXjVGPlM27zoDKOZ77BldwkI1VupK QyszFymES uTObHY

What Does The EU Organic Certification Logo Mean? 

It сonfirms that 95% of a product’s ingredients were grown, processed, transported, and stored in a tightly regulated way to ensure high quality and safety. The organic logo can only be used on products that have been certified as organic by an authorized control body. The control body’s identifier and the product’s agricultural raw materials origin must be placed next to the logo [1].

What Does ‘Biodynamic‘ Stand For? 

Usage of chemical and synthetic pesticides, fertilizers, and GMO technology is strictly prohibited in biodynamic agriculture. The ‘Biodynamic’ motto can be interpreted as ‘Give back to nature more than you take out!’

Ingredients In Baby Formula To Pay Attention To

1. Iron And Zinc

Iron and zinc are essential minerals that kids need from birth for healthy development.

One of the main markers of a healthy child, checked by every pediatrician, is hemoglobin level. Anemia, caused by low levels of iron, is prevalent among infants, especially if they aren’t breastfed, and the most common symptom of zinc deficiency is growth retardation. However, iron and zinc in unnecessary amounts do not help and may be harmful.

Europeans consider that too much iron and zinc could hurt your child and cause tummy problems. While the FDA sets only the minimum level for these nutrients, the EC has a more correct approach as Europeans set both minimum and maximum levels.

And what is more, they divide requirements into two groups – for infant and follow-on formula. The “more the better” approach is not the best option in this case. As an example, we’ll show a difference in approaches for infant formula:

Iron and zinc requirements in infant formula (13, 16)
Iron (mg/100kcal)
Zinc (mg/100kcal)

2. Corn Syrup, Sucrose And Other Sweeteners You Should Avoid

EC allows the following carbohydrates in European baby formulas: lactose, maltose, maltodextrin, and starch.

Sucrose and glucose in minimal amounts (not more than 20%) may only be added to infant formula manufactured from protein hydrolysates.

Corn, corn syrup, and all the rest are strictly prohibited [16].

However, leading European formula manufacturers have stricter internal regulations and no added sugar AT ALL (Kendamil, HIPP). Instead, they use lactose – natural “sugar” from cow’s and goat’s milk – as a carbohydrate. More rarely, they add maltodextrin and starch in small amounts that are considered safe for infant development (Holle, Lebenswert, Loulouka).

But notice that each of these 5 European brands (not only HIPP and Kendamil) have baby formulas with 100% lactose and 0% other sweeteners in their range. 

Unfortunately, the FDA allows sugar, corn, corn syrup, and other “bad” sugars. That’s why you may find them in every second US baby formula.

Corn is especially harmful to our kids, as it’s hard to find non-genetically modified corn. Be careful, some US brands contain 70% corn maltodextrin and 30% lactose (Gerber Good Start), 80% corn syrup solids, and 20% lactose (Enfamil), 46% maltodextrin, 27% lactose, 27% sugar (Similac). And these formulas don’t seem to be for lactose-intolerant babies. 

You may read more about how sugar affects us, especially our little ones, in our article about sugar here. 

3. Lactose As a Safe “Sugar.”

Lactose is a sugar in human milk which is produced in the breast, and the primary carbohydrate in breast milk and milk-based formulas. So, it’s natural to have it in your formula ingredients list unless your baby has lactose intolerance. So, as a parent, look for lactose at the beginning of the nutrition label of your kid’s formula and try to avoid the other sugars mentioned above [19].

4. Carrageenan – Safe For Health Or Not?

Carrageenan is an additive from red seaweeds, better known as Irish Moss. The food industry uses carrageenan to preserve and thicken products.

For the moment, it is unknown how exactly carrageenan influences human health. Some scientists suggest it is harmful as it may cause intestinal inflammation.

The EU doesn’t allow it in baby foods. For us, this is logical – as shaking the bottle has the same effect, there is no need for this controversial ingredient. 

Keep on reading to clarify all the differences in formula regulations between continents and reveal the truth about toxic heavy metals in kids’ food. 

Differences In European And American Infant And Follow-on Formula Regulation

In the US, the laws and regulations for food apply to infant formula as well. However, you may find brief specific FDA regulations applied to infant formulas in [13].

In Europe, the regulations for baby food are more detailed. There are separate directives for the ingredients and labeling of infant and follow-on formula; separate for the placing on the market; different for protein quality. Plus, relevant EU laws on the use of food additives, hygiene, and on the presence of contaminants apply to baby formula as well. 

The more the better

EC defines the minimum and maximum level for EACH of the 14 minerals and 12 vitamins in formula. An exception is only for 2 minerals (molybdenum and fluoride), where only the maximum required level is set. By the way, these 2 minerals aren’t on the list of obligatory ingredients for infant formula in the US. 

For some nutrients, the difference in required amounts is slight, but for some it is huge. For example, in the US, folate (µg /100kcal) should be a minimum 4, while in Europe it should be a minimum 15 and a maximum 47.6. Another example: iodine (µg /100kcal) in the US should be a minimum 5, while in Europe it should be a minimum 15 and a maximum 29.

The mandatory nutrition declaration in the EU also includes the amount of choline, inositol, and carnitine. The US defines the required minimum only for choline and inositol; carnitine isn’t mentioned. 

Always consult your pediatrician to choose the best nutrient combination for your baby. 

All formula ingredients

In formulas, the ingredients’ suitability should have been demonstrated, where necessary, by appropriate studies [15]. Formula preparation must be as simple as possible – nothing more than adding water should be required [16].

Heavy Metals In Baby Food 

Its a myth.

Unfortunately, baby foods contain significant levels of toxic heavy metals such as inorganic arsenic, lead, cadmium, and mercury. According to the FDA and the World Health Organization, these metals are dangerous to human health, particularly babies’. Even low levels can often cause irreversible damage to a child’s brain development, lowered IQ, and higher rates of antisocial and criminal behavior later in life [4].

Main health concerns from heavy metals in children:

Lead: Damage to brain development (therefore lowering IQs), cardiovascular disease, and cancer.

Inorganic arsenic: Damage to cognitive development, cardiovascular disease, diabetes, and cancer.

Cadmium: Leads to kidney disease, cardiovascular disease, and cancer [17]. 

At the end of 2019, the largest baby food brands in the US were tested for heavy metals: Happy Family Organics, HappyBABY brands, Beech-Nut, Earth’s Best Organic, Gerber. 

According To The Investigation’s Results: 
  • In each brand, there was arsenic, lead, and cadmium. Only one brand tested for mercury (HappyBABY).
  • The levels were multiple times higher than permitted by law. For example, the maximum allowable levels in bottled water are 10 ppb inorganic arsenic, 5 ppb lead, 5 ppb cadmium, and 2 ppb mercury. The test results of baby foods exceeded those levels: up to 91 times the arsenic level, up to 177 times the lead level, up to 69 times the cadmium level, and up to 5 times the mercury level. 
internal standards

For example, the FDA has only finalized one standard—100 ppb inorganic arsenic in infant rice cereal. And Nurture (Happy Family Organics, HappyBABY brands) set its internal standard for that product 15% higher than the FDA limit, at 115 ppb. Another example is Beech-Nut, which set internal arsenic and cadmium standards at 3,000 ppb in additives, such as the vitamin mix.

  • Ingredient testing is not accurate; only final product testing can show the real danger of baby foods.
  • Baby food labels do not warn parents about toxic heavy metals, and manufacturers are not obligated to conduct any testing or are allowed to test only ingredients [4].

Recommendations For Parents: 

  1. Avoid baby foods that contain a high level of toxic heavy metals, such as rice and rice flour.
  2. Be aware that cinnamon, amylase, BAN 800 (a substance used in the bakery), and vitamin premix consistently contain very high levels of toxic heavy metals.
  3. Don’t think that baby food companies would not sell unsafe products even if they’re trusted by the public. There have been cases where these manufacturers knowingly sold baby food containing high levels of toxic heavy metals [4].
  4. Don’t attempt to make homemade infant formula for your baby. It is unlikely to reduce the presence of toxic elements, and it may result in severe nutritional deficiencies and microbial foodborne illness [12].

In April 2021, the FDA announced an action plan to reduce toxic elements to the lowest possible levels in baby foods [12]. However, toxic components, such as arsenic and lead, are present in the environment and cannot be avoided entirely in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals [11]. 

In Europe, heavy metals are strictly regulated by several EU regulations and directives. According to the regular tests of baby formula, very low levels of toxic heavy metals were detected. The reported results were satisfactory even for strict European standards. 

Strict regulations for heavy metals aren’t the only reason why European baby formula brands deserve respect. Find out more about internal quality regulations in the main European baby formula brands in the next paragraph. 

TOP 5 Leading European Baby Formula Brands That Go An Extra Mile In Quality Regulation

Below is essential information about European formula manufacturers from a quality perspective before making your choice.  

C:\Users\vkharkin\Documents\2_VKH_New\Personal\Nataly\Green Baby World\Лулука.pngThe company is certified by independent agencies of the European Organic Association. Loulouka meets EU regulations and more strict Swiss quality standards for organic farming [5]. 
C:\Users\vkharkin\Documents\2_VKH_New\Personal\Nataly\Green Baby World\Holle_Baby-Food_PNG_159_150.pngHolle is one of the leading Demeter-certified baby food manufacturers. Demeter is the trademark for goods produced from biodynamic agriculture. Demeter’s criteria is far superior to the standard organic farming certification. From growing to processing, all production stages are checked. The company strictly follows EC organic regulations and international Demeter regulations [6].
C:\Users\vkharkin\Documents\2_VKH_New\Personal\Nataly\Green Baby World\unnamed.pngLebenswert bio presents baby products which comply with Bioland quality standards. The Bioland guidelines for farmers and manufacturers are even stricter than those of the EC organic regulation and are permanently being developed. For example, Bioland operations are based on a circular economy [7,8].
C:\Users\vkharkin\Documents\2_VKH_New\Personal\Nataly\Green Baby World\HIPP-Logo.svg.pngHiPP has its own HiPP Organic Seal as a sign of high organic farming standards. The company’s own laboratory is one of the best in Europe and can analyze more than 1,200 parameters. Each jar passes up to 260 safety checks, including reviews by independent test institutes. The manufacturer tests products for more than 800 harmful substances – much more than required by legislation. Organic products are produced without genetically modified organisms according to EU regulations [9].
C:\Users\vkharkin\Documents\2_VKH_New\Personal\Nataly\Green Baby World\kendamil-logo-small_1.pngThe company is certified by the EU and the British Soil Association. Milk is from local dairy farms, accredited by Red-Tractor [10]. Red Tractor is a world-leading food safety system that follows the high standards of British food & drink. It’s a quality sign of British food and farming, assuring every stage of the production process, from farm to pack [18].

The Bottom Line

With so many brands, it can be challenging to decide which baby formula to choose and understand the differences between each brand. We hope that the information above provides you with a clearer picture to tackle this often complicated dilemma.

What we suggest you do in any case:
  • Always consult with your pediatrician before starting bottle feeding. 
  • Read accurate labels and check expiration dates. 
  • Always strictly follow the preparation instructions and the dosage ratio, as improper use or storage may cause health problems.
  • Stay calm and positive whatever happens during your parenthood and take care.