Baby formula safety standards and how to choose a formula

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

If breastfeeding is not possible, not sufficient, or not the right choice for your family, infant formula is a safe and nutritionally complete way to feed your baby. The decision of which formula to use can feel overwhelming given the number of products on supermarket shelves, each marketed with a different set of claims. Understanding what the regulatory framework actually requires, and what that means for the safety of any formula your baby drinks, makes the choice significantly less daunting.

This article explains how infant formula is regulated, what the different formula types are, how to prepare and store formula safely, and when it is worth talking to a health professional rather than deciding alone. All guidance is drawn from the Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ) Standard 2.9.1, and the Raising Children Network.

How infant formula is regulated

Infant formula sold in Australia is subject to some of the most detailed food regulation in the country. The primary legislative instrument is FSANZ Food Standard 2.9.1, which sits within the Australia New Zealand Food Standards Code and sets mandatory compositional requirements for all infant formula products. This standard defines minimum and maximum levels for more than 30 nutrients, including protein, fat, carbohydrates, vitamins, and minerals. Any formula sold legally as suitable from birth must meet all of these requirements.

The standard distinguishes between infant formula (from birth) and follow-on formula (from six months), and sets different compositional rules for each. It also covers formulas made for particular medical purposes, such as products designed for premature infants or babies with specific metabolic conditions. Those specialised products may additionally fall under the TGA's regulatory scope, where they are treated as therapeutic goods rather than general foods and must meet additional safety and quality requirements before they can be supplied.

For most families using standard cow's milk or goat's milk formula bought from a supermarket or pharmacy, FSANZ Standard 2.9.1 is the relevant benchmark. When a product is lawfully on the shelf and clearly labelled as infant formula, it has been formulated to meet every nutrient minimum and maximum in that standard. Advertising claims about added ingredients or proprietary blends are layered on top of a compliant baseline, not in place of it.

The Raising Children Network, a parenting resource funded by the Australian Government, notes that all formula sold in Australia must meet these standards and that parents do not need to worry that a formula approved for sale here is nutritionally inadequate. The question for most families is therefore not "is this formula safe?" but "which formula is the best practical fit for my baby?"

Types of formula and what they are made from

Most infant formulas share the same regulatory baseline, but they differ considerably in their protein source and processing. Understanding these categories helps you make a more informed choice and know when specialist advice is needed.

Cow's milk-based formula

The large majority of infant formulas are based on modified cow's milk. The proteins in cow's milk (whey and casein) are present in different proportions to those found in human breast milk, so manufacturers adjust the ratio and add other nutrients to bring the profile closer to the standard set by FSANZ 2.9.1. Cow's milk formula is the default starting point for most healthy full-term babies and is widely available. It is not suitable for babies with a confirmed cow's milk protein allergy, but it is well tolerated by the vast majority of infants.

Goat's milk-based formula

Goat's milk formula has been available in Australia for many years and must meet the same FSANZ compositional standard as cow's milk formula when labelled as suitable from birth. The proteins in goat's milk have a slightly different structure to those in cow's milk, but goat's milk formula is not considered hypoallergenic and is not appropriate for babies with a diagnosed cow's milk protein allergy - the proteins are similar enough that cross-reactivity is a real risk. Some families choose goat's milk formula based on digestive tolerance, though the evidence that it is meaningfully easier to digest than cow's milk formula is not conclusive. If your reason for considering it is a suspected allergy, speak to a GP or paediatric allergist first.

Partially hydrolysed formula

Partially hydrolysed (or "comfort") formulas contain cow's milk proteins that have been partially broken down into smaller fragments. They are marketed for babies with mild feeding difficulties such as colic, wind, or unsettled behaviour. They are not suitable for managing cow's milk protein allergy, because the proteins are not broken down sufficiently to prevent an allergic reaction. The evidence supporting their use for colic is modest. If your baby is genuinely unsettled and you are considering a hydrolysed formula, a health professional can help you decide whether the formula or something else is likely to be the cause.

Extensively hydrolysed formula

Extensively hydrolysed formulas break the cow's milk proteins down much further, to the point where most babies with cow's milk protein allergy can tolerate them. These are prescribed rather than bought over the counter in most cases, and they are used under the supervision of a paediatric dietitian or allergist. They taste noticeably different from standard formula and some babies need time to adjust. They are significantly more expensive than standard products.

Amino acid-based (elemental) formula

For babies with the most severe cow's milk protein allergy, or with other conditions causing very poor gut function, amino acid-based formulas contain no intact proteins at all. Nutrition is delivered entirely as free amino acids. These formulas are always managed with specialist medical input and are not available as an over-the-counter purchase.

Soy-based formula

Soy formula uses protein derived from soya beans rather than dairy. FSANZ Standard 2.9.1 sets separate compositional requirements for soy-based formula. Soy formula is not recommended as a first choice for managing cow's milk protein allergy because a significant proportion of babies with cow's milk allergy also react to soy. It is also not recommended for premature babies or babies under six months without specialist guidance because of concerns about phytoestrogen content. There are limited circumstances in which soy formula is the appropriate choice (for example, in some cases of galactosaemia), but these situations are managed medically. The Raising Children Network advises checking with a GP before choosing soy formula.

Stage 1 and stage 2: what the difference actually means

Walk past any formula display and you will see products labelled Stage 1, Stage 2, and sometimes Stage 3. These stage labels correspond to different age ranges and different compositional profiles set under FSANZ 2.9.1.

Stage 1 (infant formula) is the only product suitable as a sole source of nutrition from birth. It is the formulation that has been specifically designed and regulated to meet all the nutritional needs of a healthy full-term infant who is not receiving breast milk.

Stage 2 (follow-on formula) is formulated for babies over six months who are also eating solid foods. Because solid foods now contribute some nutrients, follow-on formula is not required to serve as a sole nutrition source and its composition can differ. It typically contains more iron and protein than stage 1, reflecting the assumption that it is one part of a mixed diet. The Raising Children Network is clear that follow-on formula is not nutritionally necessary: breast milk or stage 1 formula alongside solid foods continues to meet a baby's needs after six months. The promotion of follow-on formula is regulated in Australia specifically because there was concern that marketing would lead parents to switch unnecessarily.

Stage 3 products, sometimes called toddler milk or growing-up milk, are not regulated as infant formula under FSANZ 2.9.1. They are ordinary foods. There is no evidence they are beneficial compared with regular cow's milk and a varied diet for children over twelve months. Health authorities do not recommend them.

For the purposes of most parents reading this: stage 1 formula is what you need for a healthy newborn or young baby. If your baby is over six months and eating solids, you can continue with stage 1 formula if you prefer, or switch to stage 2, but there is no nutritional requirement to change.

Preparing formula safely

Formula preparation is the area where parents can most directly affect the safety of what their baby drinks. The formula powder itself is not sterile, and the preparation process is what makes it safe for a newborn's still-developing immune system.

Water temperature

The most important step in safe preparation is using water that has been freshly boiled and then cooled to no lower than 70 degrees Celsius. At this temperature, the water will kill the bacteria Cronobacter sakazakii, which can be present in powdered formula and which causes serious illness in young infants. Water that has been boiled and left to cool for no more than 30 minutes will typically be around this temperature. Do not use water that has been sitting since the previous boil, and do not use water from a water cooler, as these may not reach the required temperature.

Sterilising equipment

All bottles, teats, caps, and any utensils used to measure or mix formula must be sterilised before each use. This applies until your baby is 12 months old. You can sterilise by boiling, by using a cold-water sterilising solution, or by using a steam steriliser. Wash equipment thoroughly in hot soapy water before sterilising, as sterilisation does not remove residue left by milk.

Measuring and mixing

Always use the scoop provided with the formula tin, levelled off without packing down. Adding more powder than recommended to make feeds more concentrated is dangerous and can cause serious harm. Adding too little produces a feed that does not meet your baby's nutritional needs. Shake or swirl the bottle until the powder is fully dissolved, then cool it under running cold water until it is comfortable on the inside of your wrist before feeding.

Making formula in advance

The Raising Children Network and food safety guidelines recommend making formula fresh for each feed where possible. If you need to prepare feeds in advance, they can be stored in a sterilised bottle at the back of the refrigerator (at or below 5 degrees Celsius) for up to 24 hours. Transport cold formula in a cool bag with an ice pack if you are going out. Warm individual bottles just before feeding rather than warming a batch ahead of time.

Storage, reuse, and handling

Opened tins of formula powder should be stored with the lid firmly closed in a cool, dry place - not in the fridge or freezer, and not in direct sunlight. Use the contents within the time specified on the tin after opening, which is typically four weeks. Avoid storing formula near the stove or in humid areas such as near a sink.

Never reuse formula left in a bottle after a feed. Once your baby's saliva has entered the teat or bottle, bacteria multiply rapidly in the remaining milk. Even if there is formula left, it should be discarded. This is one of the most common sources of formula-related illness in young babies and it is entirely preventable.

Warming formula before a feed is a matter of preference, as babies can drink formula at room temperature or even cold from the fridge without any nutritional disadvantage. If you do warm it, use a bowl of warm water or a bottle warmer. Never use a microwave - it creates hot spots that can burn a baby's mouth even when the bottle feels only warm from the outside.

When to talk to a health professional

There are situations where selecting a formula should not be done based on shelf browsing alone. These include:

Suspected cow's milk protein allergy: symptoms include persistent eczema, blood in the stools, significant vomiting or reflux, or a rash following feeding. A GP or paediatric allergist should assess your baby before you switch to an alternative formula.
Premature or low birth weight babies: these infants often need specialised formula with a different nutrient profile, usually managed in hospital initially and then with community dietitian support.
Switching formulas for reflux: anti-reflux formulas are widely available but work best as part of a broader management plan. If reflux is severe enough to consider changing formula, a GP or paediatric nurse should be involved.
Any formula marketed for a medical purpose: products labelled for specific conditions such as lactose intolerance, metabolic disorders, or very severe allergy are medical foods and should only be used on professional advice.
Your baby is not gaining weight as expected: if your baby's growth is not tracking normally on their growth chart, the feeding situation needs professional review regardless of which formula you are using.

Your GP, child and family health nurse, or a paediatric dietitian are all appropriate first points of contact. In many areas a child health nurse is available via a free community service and can answer formula questions without requiring a GP appointment.

Frequently asked questions

Is infant formula regulated in Australia?

Yes. Infant formula sold in Australia is regulated by two overlapping bodies. The Therapeutic Goods Administration (TGA) oversees the safety and quality of infant formula as a food for special medical purposes where applicable, and Food Standards Australia New Zealand (FSANZ) sets mandatory compositional requirements under Food Standard 2.9.1. Every formula sold legally must meet the nutrient minimums and maximums set out in that standard, ensuring it can serve as a sole source of nutrition for a healthy infant from birth.

What is the difference between stage 1 and stage 2 formula?

Stage 1 (infant formula) is formulated for babies from birth and is suitable as the sole source of nutrition for the first six months and beyond. Stage 2 (follow-on formula) is marketed for babies over six months who have started solids. Follow-on formula is not nutritionally necessary - breast milk or stage 1 formula alongside solid foods meets a baby's needs after six months. FSANZ Standard 2.9.1 sets separate compositional rules for each stage, but health authorities including the Raising Children Network note that follow-on formula offers no proven advantage over continuing with infant formula.

How long can prepared formula be stored in the fridge?

Prepared formula can be stored in a clean, sealed container in the refrigerator for up to 24 hours. It should be placed in the fridge as quickly as possible and never left at room temperature for more than one hour. Discard any formula left in a bottle after a feed, as saliva from the teat introduces bacteria that can multiply rapidly. Never reuse or reheat formula that has already been partially drunk.

Can I use goat's milk formula from birth?

Yes, provided the product meets FSANZ Standard 2.9.1, which applies equally to goat's milk-based and cow's milk-based infant formulas. Any formula labelled as suitable from birth and sold legally in Australia must satisfy the same minimum nutrient requirements regardless of its protein source. However, it is worth discussing the choice with your GP, child health nurse, or lactation consultant, particularly if your baby has any feeding difficulties or you are switching formulas for allergy-related reasons.

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