Infant formula regulation and options: an overview

0-6 months · Feeding · Reviewed 20 June 2026 · All articles

Infant formula is one of the most tightly regulated food products in the world, and for good reason: for some babies it is the sole source of every nutrient needed to grow and develop in the first months of life. Whether you are exclusively formula-feeding from birth, supplementing breastfeeding, or transitioning from breast to bottle, understanding what goes into formula, how it is regulated, and how to prepare it safely can give you confidence and peace of mind.

This guide covers the regulatory framework that governs formula composition, the different types of formula available, how to choose the right one for your baby, safe preparation and storage practices, and when to speak to a healthcare provider.

How infant formula is regulated

The starting point for formula regulation globally is the Codex Alimentarius, a collection of internationally agreed food standards developed jointly by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). The Codex Standard for Infant Formula (CXS 72-1981, last revised 2019) sets minimum and maximum nutrient levels across protein, fat, carbohydrate, vitamins, and minerals. It also prohibits certain harmful substances and sets hygiene requirements for manufacture.

National governments then translate these Codex standards into domestic law. In Japan, infant formula is regulated under the Ministry of Health, Labour and Welfare (MHLW) framework for special-use foods (tokutei hoken yo shokuhin). The MHLW publishes composition standards that align closely with Codex while incorporating additional national requirements on labelling, manufacturing hygiene, and permissible ingredients. Formula sold on the Japanese market must be certified compliant before it reaches store shelves. Similar frameworks exist in the European Union under Commission Delegated Regulation (EU) 2016/127, and in Australia and New Zealand under Food Standard 2.9.1.

What this means for you as a parent: any formula bought through a legitimate retailer in a country with a robust food-safety framework has already been independently verified to meet strict nutritional standards. The differences between brands within the same regulatory market are largely about ingredient sourcing, optional add-ins (such as prebiotics, long-chain polyunsaturated fatty acids, and nucleotides), and texture or taste rather than fundamental safety or nutritional adequacy.

Types of infant formula and when each is used

Not all formula is the same. Manufacturers produce a range of formulations designed for different ages and clinical needs. Understanding the categories helps you find the right match for your baby's situation.

Standard cow's milk-based formula

This is the most widely used type and the default starting point for healthy, full-term infants who are not breastfed. Cow's milk protein is modified to make it easier for an infant to digest: the casein-to-whey ratio is adjusted, lactose is used as the primary carbohydrate, and fat is partially or fully replaced with plant-based oils to approximate the fatty acid profile of breast milk. The result is a nutritionally complete food for babies from birth to around 6 months (stage 1) or up to 12 months (stage 2, sometimes called follow-on formula).

Partially hydrolysed formula

In partially hydrolysed (HA) formula, the cow's milk proteins are broken down into smaller peptides using enzymes. This is sometimes described as "gentle" formula. It may suit babies who seem uncomfortable after feeds on standard formula, though the evidence for its superiority over standard formula for healthy, non-allergic infants remains limited. It is not suitable for babies with a confirmed cow's milk protein allergy (CMPA), where extensively hydrolysed or amino-acid-based formula is needed.

Extensively hydrolysed formula

Extensively hydrolysed formula (EHF) breaks proteins into very small fragments, most of which are individual amino acids or very short peptides. It is the first-line treatment recommended by paediatric allergy guidelines for infants with confirmed CMPA. Because the protein fragments are too small to trigger an immune response in most affected infants, EHF is tolerated by around 90 percent of babies with CMPA. It requires a prescription or a recommendation from a doctor in many healthcare systems, including in Japan, and is typically more expensive than standard formula.

Amino-acid-based formula

For the roughly 10 percent of infants with CMPA who do not tolerate EHF, amino-acid-based (elemental) formula contains protein only in its simplest building-block form. It is also used for babies with multiple food protein intolerances. This formula type is always prescribed by a specialist.

Soy-based formula

Soy formula replaces cow's milk protein with soy protein isolate. It is sometimes chosen by families with religious or cultural objections to dairy, or for rare conditions such as galactosaemia. Paediatric allergy guidelines generally do not recommend soy formula as the primary alternative for CMPA, because approximately 10 to 14 percent of infants with CMPA also react to soy protein. If soy is being considered, discuss it with your doctor first.

Goat's milk formula

Goat's milk-based formula is available in several markets and has become more widely available in Japan in recent years. Goat's milk protein has a different structure to cow's milk protein, and some parents find it is better tolerated. However, it is not suitable for infants with CMPA because the proteins share allergenic epitopes with cow's milk proteins and cross-reactivity is common. Goat's milk formula must meet the same regulatory standards as cow's milk formula in any market where it is sold.

Follow-on formula (stage 2 and beyond)

Follow-on formula is marketed for infants from 6 months onward. Regulatory bodies, including the WHO and the European Food Safety Authority, have concluded that follow-on formula offers no advantage over stage 1 formula for healthy infants who are also receiving solid foods. Stage 1 formula can be used from birth to 12 months. The distinction is primarily commercial. If you are happy with what you are using, there is no nutritional reason to switch at 6 months.

How to choose a formula for your baby

For a healthy, full-term infant with no known allergies or intolerances, any stage 1 cow's milk-based formula sold in a regulated market is nutritionally adequate. There is no convincing evidence that premium-priced formulas with added ingredients such as beta-palmitate, HMOs (human milk oligosaccharides), or specific probiotic strains produce clinically meaningful better outcomes compared to standard formula in healthy infants.

Practical factors to consider include the following:

In Japan, major brands include Meiji Hohoemi, Morinaga Hagukumi, Glico Icreo, and Snow Brand (Yuki-no-megumi), all of which comply with MHLW standards. All are available in powder form and in varying tin sizes. Many pharmacies and baby goods shops also carry imported formulas from Europe and Australia for families who prefer them.

Safe preparation of powdered infant formula

Powdered infant formula is not sterile. It is manufactured under stringent hygiene conditions, but Cronobacter sakazakii and, rarely, Salmonella have been detected in powdered formula. The WHO and MHLW both recommend using water at or above 70 degrees Celsius to prepare powdered formula because this temperature kills these pathogens.

The correct preparation steps are as follows:

  1. Clean all surfaces and wash hands thoroughly with soap and water before starting.
  2. Sterilise the bottle, teat, and any other feeding equipment you will use.
  3. Bring fresh, cold tap water to a full rolling boil. Do not re-boil previously boiled water.
  4. Allow the water to cool to at least 70 degrees Celsius. This takes approximately 30 minutes in an open container. A kettle with a temperature-hold function set to 70 degrees is a convenient alternative.
  5. Pour the required amount of water into the sterilised bottle first.
  6. Using only the scoop provided with the tin, add the correct number of level scoops of powder as specified on the label. Do not pack the powder or add extra scoops.
  7. Seal the bottle and shake until the powder is fully dissolved.
  8. Cool the formula to a safe feeding temperature by holding the bottle under cold running water or placing it in a bowl of cold water. Test the temperature on the inside of your wrist before feeding.
  9. Feed immediately if possible. If not, store in the back of the refrigerator (not the door) and use within 24 hours.
  10. Discard any formula left in the bottle after a feed, and never re-use it.

Formula prepared in advance and stored in the fridge should be reheated by standing the bottle in warm water. Do not use a microwave: microwaves heat unevenly and can create hot spots that burn your baby's mouth.

Storage guidelines for formula

Opened tins of powdered formula should be stored in a cool, dry place with the lid tightly closed. Most manufacturers recommend using the contents within four weeks of opening, regardless of the printed best-before date, because exposure to air and moisture can degrade the powder and create conditions for bacterial growth. Do not store opened tins in the fridge.

Prepared formula that has not been used should be refrigerated immediately and discarded after 24 hours. Formula that has been warmed once should never be re-refrigerated or rewarmed: use it or discard it. When you are out of the house, carry boiled water in a vacuum flask (at 70 degrees or above) and carry measured powder in a clean, dry container, combining them just before the feed.

Signs a formula may not be suiting your baby

Some degree of unsettledness, wind, and spitting up is normal in the early weeks regardless of what your baby is fed. However, the following signs suggest the formula may not be suiting your baby and warrant a conversation with your doctor or paediatrician:

These symptoms can have multiple causes, and not all of them are formula-related. Do not switch formula without medical guidance, as choosing the wrong alternative can delay proper diagnosis or expose your baby to unnecessary costs and disruption. Your doctor may refer you to a paediatric dietitian or allergist for evaluation.

When to consult a healthcare provider

Always consult your doctor, midwife, or child health nurse if you are uncertain which formula to use, if your baby is premature or was born with a health condition, if symptoms of intolerance or allergy appear, or if your baby is not gaining weight as expected. In Japan, the maternal and child health booklet (boshi kenko techo) system means you have regular scheduled check-ups at one, three, and six months where feeding can be discussed. Many city health centres and paediatric clinics also offer feeding consultations.

If you are considering switching from breast milk to formula, or combination feeding, a lactation consultant or breastfeeding support service can help you make the transition in a way that preserves your milk supply if you wish to maintain it.

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