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Infant and follow-on formulae are subject to stringent legal provisions in the EU. New scientific evidence has made it necessary to revise the existing Regulation regarding the composition of formulae [1]. As of February 2020, all formulae must comply with the new EU Regulation (HA formulae as of 2021).

The most important information at a glance (PDF)

What will change?

The main differences will be in the composition and labelling of infant and follow-on formulae. Here is an overview of the main changes:


  • reduction of the maximum permissible protein levels to 1.8 g – <2.0 g/100 kcal to resemble those in breast milk
  • L-carnitine: mandatory addition to all infant formulae

LCP fatty acids

  • docosahexaenoic acid (DHA): mandatory addition to all infant and follow-on formulae
  • arachidonic acid (ARA): still optional


  • adjustment of minimum and maximum permissible vitamin and mineral levels

Nutritional claims and health claims

  • General ban for infant formulae (except for lactose & DHA)

Protein – less is more

Recent studies have shown that a protein intake that exceeds babies’ and toddlers’ physiological needs increases the risk of obesity later in life. This is why the maximum permissible protein levels in infant and follow-on formulae specified in the new regulation are lower than before. Thanks to reliable scientific data, an underlying safety study is no longer needed for formulae with a reduced protein content (>1.8 g/100 kcal).

Long chain polyunsaturated fatty acids (LCPs) – DHA is mandatory

Breast milk contains both DHA and ARA, which are important for brain and visual development. These fatty acids are particularly important for babies during the first months of life as their bodies cannot yet produce sufficient amounts of LCPs. This is why the new EU Regulation, for the first time, stipulates the mandatory addition of DHA to infant and follow-on formulae. We have, however, been adding DHA and ARA to our HiPP formulae for many years.

ARA is still not a mandatory ingredient, but it can be used as an optional addition. Experts also explicitly support the addition of DHA and ARA to infant formula. Studies have shown that formulae not fortified with these fatty acids may lead to significantly lower fatty acid levels in bottle-fed infants compared to breastfed infants, as breast milk naturally contains ARA [2].

HiPP ORGANIC COMBIOTIC® provides much more than the minimum required by law

All manufacturers must comply with the legal minimum standards. Premium products, however, also contain additional optional ingredients.

  • HiPP infant formulae are fortified with DHA and ARA (omega-6), as recommended by international experts [2]. Breast milk also contains both DHA and ARA, which are important for brain and visual development.
  • A protein content that is tailored to meet age-specific needs for healthy growth.
  • Improved total fat content
  • HiPP ORGANIC COMBIOTIC® formulae contain a tried-and-tested combination of functional ingredients of natural origin:
  • – GOS: derived from organic lactose
  • – L. fermentum: originally isolated from breast milk
  • HiPP’s unique organic Quality

Important notice: Depending on country-specific legislation and recommendation, the ingredients in HiPP COMBIOTIC® formula can differ. Please visit for detail your
local consumer-website.

Why does the formula look, smell and/or taste different?
The adaptation of the recipe may lead to certain changes. HiPP ORGANIC COMBIOTIC® continues to dissolve easily, taste and smell pleasant and be very well tolerated.

Why are certain nutrients not specifically mentioned on the packaging anymore?
Optional ingredients such as the prebiotic GOS may still be present in the product, but they are now only allowed to be mentioned in the list of ingredients.

2 thoughts on “THE NEW EU REGULATION

  1. Hey there. What do you do when/if hospitals challenge using this formula? We will be having a baby soon that will likely need a nicu stay. In Ontario

    1. Hi Marianne,
      This is a great question and one we get the most. The vast majority of the time, hospitals will recommend the ready to feed formula usually made by Enfamil. Reason for this is, since it’s already made, there is little risk of contamination as compared to making powder formula. So a lot of the time, hospitals will say to use liquid formula for the first few months.
      Hospitals aren’t familiar with European brands. From an advice point of view, it is safer for them to recommend brands already in the market.
      We had carried liquid formulas but stopped as international shipping costs have greatly soared and liquids are very heavy, making it expensive to ship. We will certainly be carrying these products again. You should feel confident in using any stage 1 formula we currently offer. Always follow manufacturers instructions on mixing and use proper hygiene.

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