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Is Holle Formula Safe?

📅 Updated February 2026⏱️ 5 min readNEW

TL;DR

Holle formula is exceptionally clean and holds the ultra-strict Demeter organic certification. Recent 2024 independent lab tests found zero detectable heavy metals in their infant formulas. However, parents should be aware that Stage 2 and 3 formulas contain maltodextrin, and buying through third-party importers carries temperature control risks.

🔑 Key Findings

1

October 2024 independent lab tests showed "non-detect" levels for lead, arsenic, cadmium, and mercury in Holle Goat formula down to 1.5 ppb.

2

Stage 1 uses 100% lactose, but Stages 2 and 3 introduce organic maltodextrin and starch.

3

Holle recently updated its Goat formulas to remove palm oil, though the Cow milk lines still contain it.

4

DHA is sourced from plant-based algae rather than fish oil, avoiding hexane extraction concerns.

The Short Answer

Holle formula is clean and exceptionally safe for most infants. It carries the Demeter certification, which is arguably the strictest organic farming standard in the world. Independent lab testing in late 2024 found non-detectable levels of all heavy metals in Holle's infant formula, clearing up fears from a 2022 controversy involving their baby food purees.

However, safety isn't just about ingredients—it's about how you get the product. Because Holle isn't FDA-approved for US retail, you have to buy it through third-party importers. This introduces gray-market risks regarding temperature control and shipping delays.

Why This Matters

European formulas operate by completely different rules than American brands. The EU strictly regulates carbohydrate sources, bans corn syrup in infant formula, and requires the inclusion of DHA. These rigorous standards are why so many parents seek out imports. European Vs American Formula

Heavy metal contamination is a massive concern in baby food. In 2022, the New York Attorney General flagged Holle's fruit purees for containing trace amounts of lead. But independent testing of their infant formula in late 2024 showed a completely different story—testing negative for lead, arsenic, cadmium, and mercury down to an incredibly low 1.5 parts per billion. Heavy Metals Baby Formula

Not all stages of Holle are created equal. While Stage 1 formulas mirror breast milk closely with 100% lactose, Stages 2 and 3 introduce starches and maltodextrin. Many parents prefer to stick to Stage 1 for the entire first year to avoid these processed carbohydrates. Hipp Vs Holle

What's Actually In Holle Formula

  • Demeter-Certified Milk — Sourced from biodynamic farms that exceed standard organic requirements for animal welfare, soil health, and chemical restrictions. Best Organic Formula
  • Algae-Sourced DHA — Holle uses plant-based algae oil rather than fish oil. This avoids fish allergens and potential solvent contamination from marine oils. Dha Source Formula
  • Palm Oil — Present in the cow's milk formulas as a fat source to mimic palmitic acid in breast milk. It can occasionally cause firmer stools or reduced calcium absorption in some babies. Palm Oil Baby Formula
  • Organic Maltodextrin — Used in Stage 2 and 3 formulas as a carbohydrate thickener. It digests quickly but helps keep older babies full longer.

What to Look For

Green Flags:

  • Demeter Certification — The absolute gold standard for biodynamic, chemical-free farming.
  • Non-Detect Heavy Metals — Recent third-party lab testing confirms the infant formula is incredibly pure.
  • 100% Lactose in Stage 1 — The primary carbohydrate exactly mimics human breast milk. Closest To Breast Milk

Red Flags:

  • Gray Market Shipping — Buying imported formula means risking temperature fluctuations during transit that can degrade delicate nutrients. Why European Formula Expensive
  • Maltodextrin in Later Stages — An easily digestible but processed carbohydrate used as a filler in Stages 2 and 3.
  • Palm Oil in Cow Formulas — Can cause constipation or harder stools in sensitive babies. Best Formula Constipation

The Best Options

Holle makes several different lines, but the ingredient quality shifts slightly depending on the milk source and the stage.

BrandProductVerdictWhy
HolleGoat Milk Stage 1Palm oil-free, 100% lactose, and tested non-detect for heavy metals.
HolleCow Milk Stage 1Exceptionally clean Demeter milk, though it does contain palm oil.
HolleCow Milk Stage 2⚠️High-quality base, but relies on maltodextrin and starch as carbs.

The Bottom Line

1. Stick to Stage 1 if you want 100% lactose. It's the closest to breast milk and avoids the maltodextrin found in later stages.

2. Opt for the Goat line to avoid palm oil. Holle reformulated their goat milk formulas to exclude palm oil, making them easier to digest. Goat Vs Cow Milk Formula

3. Vet your importer carefully. Since Holle isn't officially sold on US shelves, only buy from reputable European formula distributors with fast, temperature-controlled shipping.

FAQ

Does Holle formula have heavy metals?

Recent 2024 independent tests found zero detectable heavy metals in Holle formula. While their baby food purees were flagged in 2022 for trace amounts of lead, the infant formulas are stringently tested and pass with flying colors. Lead In Baby Formula

Why is Holle not FDA approved?

Holle doesn't meet specific FDA labeling and nutritional ratio requirements. The European Union has different, often stricter, standards for infant formula. Because Holle hasn't paid to go through the expensive US approval process, it remains an unapproved import. Is Formula Fda Regulated

Does Holle use corn syrup?

No, Holle does not use corn syrup in any of its formulas. Stage 1 relies entirely on organic lactose, while Stages 2 and 3 use organic maltodextrin and starch to provide longer-lasting energy for older babies. Formula No Corn Syrup


References (10)
  1. 1. organicformulashop.com
  2. 2. organicformulastore.com
  3. 3. tamararubin.com
  4. 4. holle-babyfood.com
  5. 5. euromallusa.com
  6. 6. euromallusa.com
  7. 7. euromallusa.com
  8. 8. organicformulashop.com
  9. 9. ny.gov
  10. 10. organicsbestshop.com

🛒 Product Recommendations

Holle Goat Stage 1

Holle

Palm oil-free, 100% lactose, and non-detect for heavy metals.

Recommended
👌
Holle Cow Stage 1

Holle

Excellent Demeter-certified milk, but contains organic palm oil.

Acceptable
👌
Holle Cow Stage 2 & 3

Holle

Clean ingredients, but uses maltodextrin as a carbohydrate source.

Acceptable
Bobbie Organic Infant Formula

Bobbie

A US-manufactured formula that closely mimics European standards with a simple recipe of organic lactose and grass-fed milk. It recently earned a 'Top Choice' rating in Consumer Reports' 2025 heavy metal testing and holds the Clean Label Project Purity Award.

Recommended

Kendamil Classic Infant Formula

Kendamil

This British brand uses whole milk fats (MFGM) rather than skim, providing a creamier texture without palm oil. It tested cleaner for heavy metals than its own Organic version in recent 2025 independent analysis.

Recommended
Baby's Only Organic Premium Infant Formula

Baby's Only

Recently reformulated as an FDA-approved infant formula, this product uses organic lactose as its sole carbohydrate and contains no palm oil. It was rated a 'Top Choice' for low heavy metals by Consumer Reports in 2025, distinguishing it from the brand's older rice-based toddler drinks.

Recommended
Kirkland Signature ProCare

Costco

An exceptional budget option that uses lactose as the primary carbohydrate and contains zero palm oil. Recent independent testing confirmed it has low to non-detectable levels of heavy metals, outperforming many premium brands.

Recommended

Lebenswert Bio Stage 1

Lebenswert (Holle)

A subsidiary of Holle that holds the strict Bioland organic certification. Unlike Holle's Cow Milk Stage 1, Lebenswert Stage 1 is completely free of maltodextrin, relying 100% on organic lactose for sweetness.

Recommended
HiPP Dutch Stage 1

HiPP

Ideally formulated with both prebiotics (GOS) and probiotics (Lactobacillus fermentum) to support infant gut health. It is starch-free and uses lactose as the only carbohydrate, testing consistently low for contaminants.

Recommended
ByHeart Whole Nutrition Infant Formula

ByHeart

The first new US formula manufacturer in decades to own their entire supply chain. Their recipe uses organic, grass-fed whole milk and a proprietary protein blend, with no corn syrup, soy, or palm oil.

Recommended
Aussie Bubs Grass Fed Infant Formula

Bubs

An Australian import now officially sold in the US, featuring milk from grass-fed cows and a clean oil blend free of palm oil. It holds a Clean Label Project Purity Award and offers a high-quality whole milk base.

Recommended

Jovie Goat Milk Formula

Jovie

A Dutch goat milk formula that uses full-cream goat milk, meaning less vegetable oil is needed to reach fat requirements. It is free from palm oil and soy, making it a gentle alternative for babies sensitive to cow milk proteins.

Recommended

Nara Organic Whole Milk Formula

Nara

A newer US option that uses organic whole milk from grass-fed cows and contains no palm oil or soy. It relies entirely on lactose for carbohydrates, avoiding the fillers often found in other boutique organic brands.

Recommended
👌

Aptamil Gold+ Infant Formula

Aptamil

A widely available European-style formula now sold in the US that includes both prebiotics and probiotics. While it contains a complex ingredient list, it avoids corn syrup and provides a solid science-backed nutrient profile.

Acceptable
👌
Earth's Best Organic Dairy Infant Formula

Earth's Best

Rated a 'Top Choice' for safety in 2025 Consumer Reports testing with low heavy metal levels. However, it contains organic palm oil, which may cause firmer stools in some infants compared to palm-free options.

Acceptable

Pepticate

Nutricia

An extensively hydrolyzed whey formula for cows' milk protein allergy (CMPA) that is now available in the US. It offers a cleaner ingredient profile than traditional American hypoallergenic options, avoiding corn syrup solids in favor of lactose.

Recommended
🚫
EleCare Hypoallergenic

Abbott

Consumer Reports' 2025 testing found this formula had the highest levels of inorganic arsenic (19.7 ppb) among all products tested. Parents requiring amino acid formula should consult a doctor for safer alternatives like Neocate.

Avoid
🚫

Similac Alimentum

Abbott

This hypoallergenic formula tested for concerning levels of arsenic (15.1 ppb) in recent independent investigations. It also relies heavily on corn maltodextrin and sugar (sucrose) rather than lactose.

Avoid
🚫

Enfamil Nutramigen

Enfamil

While effective for allergies, this formula had the highest detectable lead levels (4.2 ppb) in Consumer Reports' 2025 study. It also lists corn syrup solids as the primary ingredient.

Avoid
⚠️

Enfamil NeuroPro

Enfamil

Contains palm olein oil as a primary fat source, which clinical studies have linked to reduced calcium absorption and constipation in infants. While low in heavy metals, the fat blend is less optimal than palm-free competitors.

Use Caution
⚠️

Kabrita Goat Milk-Based Toddler Formula

Kabrita

Despite its Clean Label Project certification, Consumer Reports listed this product as a 'Worse Choice' in 2025 due to heavy metal test results. The discrepancy between certification and independent testing warrants caution.

Use Caution
🚫

Similac Sensitive

Similac

The first ingredient is corn syrup, and it contains added sugar (sucrose). Marketing claims about 'sensitivity' often mask a formulation that is simply lactose-reduced and filled with cheap processed sugars.

Avoid
🚫

Dr. Brown’s SoothePro

Dr. Brown’s

Flagged as a 'Worse Choice' in 2025 safety testing by Consumer Reports due to elevated heavy metal levels. It is marketed for digestive relief but fails to meet the safety benchmarks of cleaner gentle formulas.

Avoid
🚫

Similac NeoSure

Similac

Designed for premature babies, but identified as a 'Worse Choice' for heavy metals in recent independent testing. Parents of preemies should ask their pediatrician about safer high-calorie alternatives.

Avoid
⚠️

Kendamil Organic Infant Formula

Kendamil

Surprisingly, the Organic version of this formula tested for higher lead levels than the 'Classic' version in 2025 analysis. The Classic line is currently the safer choice regarding heavy metal exposure.

Use Caution
🚫

Enfamil ProSobee Simply Plant-Based

Enfamil

A soy-based formula that was listed as a 'Worse Choice' by Consumer Reports. Soy formulas are generally not recommended for healthy term infants due to high aluminum content and phytoestrogen concerns.

Avoid
🚫

Similac Soy Isomil

Similac

Combines the potential risks of soy protein (aluminum, phytoestrogens) with a carbohydrate profile of corn syrup and sucrose. Unless medically necessary for galactosemia, soy formulas like this should be avoided.

Avoid
🚫
Parent's Choice Gentle

Walmart

A budget generic that mimics the 'Gentle' formulation by using corn syrup solids as the very first ingredient. While cheap, it lacks the high-quality lactose base found in other budget options like Costco's ProCare.

Avoid
⚠️

Serenity Kids Toddler Formula

Serenity Kids

While the company holds a Purity Award, independent testing by lead-safety advocates in 2024 flagged a batch for containing detectable lead and cadmium. As a 'Toddler' labeled product, it is also not FDA-regulated as strictly as infant formula.

Use Caution

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