Draft nutrition for healthy term infants - Recommendations from birth to six months: Use of human milk substitutes

Recommendations on the use of human milk substitutes

When feeding at the breast is not possible, the first choice is to feed expressed human milk from the infant's own mother or birthing parent. For situations when the infant is partially breastfed, it is important to support the mother or birthing parent to maintain or improve lactation (PHAC, 2019).

If an infant cannot or should not be fed their mother's or birthing parent's human milk, another option is to provide appropriately screened, pasteurized, donor human milk (Pound et al., 2020). Human milk banks operating in Canada abide by strict operating procedures, which include donor screening, medical supervision, bacteriological testing, pasteurisation, storage, and distribution. Access to pasteurised human milk from appropriately screened donors is currently limited in Canada. Donor human milk from the milk banks in Canada is only available to infants according to specified needs.

This statement does not recommend the sharing or use of unprocessed and unscreened donor human milk obtained from private sources such as the Internet or from private individuals (Health Canada, 2014). The safe use of donor human milk requires it to be properly collected from screened donors, pasteurized, and stored.

Commercial infant formula may be the most feasible alternative if it is not possible for an infant to be exclusively fed their mother's or birthing parent's expressed milk. If an infant needs commercial infant formula, give parents and caregivers information and support. The commercial infant formula chosen should be appropriate for the infant, and prepared and stored safely to reduce the risk of illness from bacterial growth.

Background

The Food and Drug Regulations set the nutritional composition and labelling of commercial infant formula sold in Canada. Commercial infant formula is designed to meet the known nutritional requirements for the growth and development of healthy term infants. The regulations also restrict the food additives that may be used in commercial infant formulas. Commercial infant formula may contain optional ingredients, such as nucleotides, live microorganisms, and oligosaccharides. However, there is limited evidence of the benefits of adding these ingredients to commercial infant formula.

Health Canada conducts a premarket assessment for all new commercial infant formulas and commercial infant formulas that undergo a change in formulation, processing, or packaging. Health Canada requires the manufacturer to submit details of the formulation, ingredients, processing, packaging, and labelling for review. Manufacturers must also submit evidence that the infant formula is nutritionally adequate to support growth and development. Claims about the health benefits of the ingredients must be substantiated by acceptable scientific evidence.

Dairy-based infant formula

For healthy term infants who are not exclusively breastfed or fed human milk, dairy-based commercial infant formula such as cow's milk-based formula is the standard product. The protein in these formulas may be whole milk protein, a combination of casein and whey proteins, or just one of these proteins. The protein may be partially or extensively hydrolyzed (broken down to smaller peptides).

Lactose-free cow's milk-based formula

For healthy term infants, lactose-free infant formula has no advantage compared to the standard cow's milk-based infant formula. Even in the case of acute gastroenteritis, enough lactose digestion and absorption are usually preserved to continue to use standard cow's milk-based infant formula (Heyman & AAP, 2012).

Lactose is a disaccharide containing glucose and galactose. In lactose-free cow's milk-based infant formula, glucose polymers – usually from corn-syrup solids – replace lactose in this formula. However, these formulas still contain a small amount of residual lactose. For this reason, they are contraindicated for infants with galactosemia. Furthermore, they are not recommended for infants with congenital lactase deficiency. This is a rare disorder that presents with intractable diarrhea when human milk or lactose-containing formula is consumed. The only formula indicated for infants with galactosemia or congenital lactase deficiency is a plant-based (e.g., soy-based) commercial infant formula, which contains no lactose.

Lactose-free dairy-based infant formula, made from cow's milk, goat's milk or any other mammal's milk, is also unsuitable for infants with confirmed cow's milk protein allergy. Furthermore, it is ineffective in the dietary management of infantile colic.

Partially hydrolyzed cow's milk protein formula

A number of commercial infant formulas contain protein that has been partially hydrolyzed. Some infant formulas contain a combination of partially hydrolyzed and intact proteins. Currently, there is little evidence to support any benefit of protein hydrolysates to the digestive system compared to standard cow's milk-based formula (Greer et al., 2019).

Advise parents and caregivers that formulas with partially hydrolyzed protein are not recommended for infants with cow's milk protein allergy.

Thickened infant formula

There are some commercial infant formulas available that have been slightly thickened with a food thickener, such as rice starch. They may be labelled as suitable for infants who spit up frequently. However, spitting up is normal in infancy and only very rarely leads to health problems, such as failure to thrive.

Thickened formula may reduce the frequency of regurgitation and vomiting in some formula-fed infants with reflux (Kwok et al., 2017; Rosen et al., 2018). However, other therapeutic approaches may be needed, especially in cases of severe reflux (Rosen et al., 2018). Further assessment is warranted if spitting up persists or increases in severity.

Parents and caregivers should not thicken infant formula during home preparation, for example, by adding rice cereal. This will increase the caloric density of the formula and can lead to inappropriate weight gain (Levy et al., 2018).

Iron

Dairy-based commercial infant formulas for term infants typically contain iron in the range of 0.65 mg to 1.3 mg per 100 mL (Unger et al., 2019). Infants at risk of iron deficiency may need a formula containing iron at the higher end of the range (Unger et al., 2019).

Soy-based commercial infant formulas contain a higher level of iron. This is because the phytic acid in soy can interfere with iron absorption (Health Canada, 2023).

Live microorganisms

Live microorganisms may be added to commercial infant formula if the microorganism has been assessed as safe for infant use. More evidence is needed to substantiate the clinical benefits from infant formula supplemented with live microorganisms (Indrio et al., 2022). Infant formulas containing live microorganisms are not suitable for vulnerable infants, such as those with immune deficiencies.

Plant-based infant formula

Soy-based infant formula

Dairy-based commercial infant formula, such as cow's milk-based formula, is recommended for an infant who is not exclusively breastfed or fed human milk. Soy-based commercial infant formula is indicated only for infants who have galactosemia or who cannot consume dairy-based products for cultural or religious reasons. The use of soy-based infant formula may be considered in infants with cow's milk allergy after non-IgE-mediated cow's milk allergy has been ruled out (Vandenplas et al., 2021).

The soy-based commercial infant formulas currently available have been shown to support normal growth and nutritional status in infants. No overt toxicities have been observed in healthy infants fed these formulas as their sole source of nutrition (Vandenplas et al., 2014). The National Toxicology Program Board of Scientific Counsellors concluded that there is minimal concern about adverse developmental effects in humans due to the presence of estrogenic isoflavones (phytoestrogens) in soy infant formula, but found that there was insufficient information from studies in humans to reach a conclusion on potential risk (McCarver et al., 2011).

Other plant-based infant formula

Additional plant-based infant formulas, such as those based on rice protein, are now available. Such commercial infant formulas could provide plant-based alternatives to soy-based infant formulas for some infants.

Formulas for special medical purposes

Extensively hydrolyzed protein formula

Extensively hydrolyzed protein formula is available at the retail level. The protein in this formula has been extensively broken down to the small peptide level. It is intended for infants who have physician-confirmed food allergies or malabsorption syndromes and cannot tolerate formula based on intact cow's milk protein or soy protein. For most of these infants, extensively hydrolyzed formula is recommended (CPS, 2024). It is noted that extensively hydrolyzed formula has provoked allergic reactions in some highly allergic infants. For these infants, an amino acid-based formula is recommended (Meyer et al., 2018).

Extensively hydrolysed formula is also sometimes used for infants with reflux, along with other therapeutic interventions (Rosen et al., 2018).

There is little evidence that formula with extensively hydrolyzed protein, in comparison to formula with intact cow's milk protein, could delay or prevent atopic dermatitis in early childhood for infants who are at high risk of developing atopic disease (Greer et al., 2019).

Other infant formulas for special medical purposes

Some infant formulas are only intended for use under medical supervision. They include formulas for the dietary management of conditions such as aminoaciduria and severe malabsorption syndrome. There are also formulas for preterm infants. These products are not generally available at the retail level, although they may be available for preterm infants on discharge from hospital.

Such formulas are not for healthy term infants and are beyond the scope of this document. Advise parents and caregivers that they are not appropriate for healthy term infants.

Safe preparation and storage

Young infants are vulnerable to food-borne illness. Proper preparation and storage of commercial infant formula is very important to reduce the risk. Recommend sterilization of all infant feeding equipment after every feed. Instruct parents and caregivers to follow the manufacturer's preparation and storage directions, and to always do the following:

• Clean kitchen surfaces.
• Wash hands thoroughly with soap and warm water.
• Thoroughly wash bottles, nipples, caps, tongs, measuring cups, or other equipment.
• Sterilize the washed equipment by boiling in an open pot of clean water for two minutes. Allow the equipment to air dry and cool (Health Canada, 2022a).
• Avoid cross-contamination from other foods prepared in the kitchen.

Liquid formula

Liquid infant formula is heat-treated by the manufacturer to be sterile. It is available in ready-to-feed formats or as a liquid concentrate. Ready-to-feed infant formula is the safest choice for higher-risk infants who are formula fed, including low birth weight and immuno-compromised infants.

Although the liquid formula is sterile, parents and caregivers should still follow the manufacturer's directions for preparation and storage, and avoid cross-contamination. Liquid concentrate infant formula must be prepared by adding safe drinking water to dilute the concentrated formula according to the manufacturer's instructions. The water must be boiled and then cooled to between room temperature and body temperature.

Powdered formula

Powdered infant formula is not sterile. It has been linked to outbreaks of Cronobacter sakazakii and Salmonella enterica, mainly in high-risk infants, which can be potentially fatal or lead to serious disability (WHO, 2012). However, powdered infant formula can be used safely if it is properly prepared.

Advise parents and caregivers as follows:

• If preparing one bottle to be fed immediately, mix the powder with previously boiled safe drinking water, and always ensure the prepared formula is safely cooled before feeding (Health Canada, 2022a).
• If preparing more than one bottle in advance, follow the guidelines for preparation, storage and handling of powdered infant formula (Health Canada, 2022a). These guidelines recommend mixing the powdered infant formula with very hot water (boiled and cooled to 70°C) to kill any potentially harmful bacteria. Infant formula prepared in this manner can be stored in the refrigerator (at 4°C or below) and should be used within 24 hours or as specified by the manufacturer.
• Infant formula should be used within 2 hours from the start of a feeding. Any leftovers should be discarded.
• Powdered infant formula containing added live microorganisms should not be given to vulnerable infants, such as those with immune deficiencies.

Water

Municipal tap water, well water and most types of bottled water are suitable for preparing powdered or concentrated infant formula. The municipal government could be contacted about the safety of the local tap water. Drinking water advisories may be in place in some First Nations communities. Access to safe drinking water may also be impacted by emergency or climate-related events.

Well water, water from other private sources, or water that is disinfected are suitable for preparing infant formula, provided the water is tested. The water must meet the Guidelines for Canadian Drinking Water Quality, including guidelines for microbial water quality as well as those for fluoride, nitrate, nitrite, lead, copper, manganese and strontium. If the available water does not meet the Guidelines, advise parents and caregivers on alternative safe sources of water.

Mineral water and carbonated water are not suitable for preparing infant formula. There is no evidence that distilled water is unsafe for use in preparing infant formula.

Tap water, well water, water from other private sources, and commercially available bottled water are not sterile. Home water treatment equipment does not replace the need to boil water for infants. To ensure water for infants is safe and pathogen-free, give parents and caregivers this advice:

1. Use cold tap water. Hot tap water may contain metal contaminants, such as lead from the pipes.
2. Bring water to a rolling boil.
3. Continue to boil for 2 minutes.
4. Let it cool.

Consult Health Canada's guidelines for preparing and handling powdered infant formula for additional instructions.

Beyond the water used for the preparation of infant formula, there is no need to give infants supplemental water while they are under six months of age. At about six months, when complementary foods are introduced, water can be offered in an open cup.

Other milks

Cow's milk and other animal milks, including goat's milk, are not appropriate alternatives to human milk for young infants (WHO, 2009). Cow's milk and goat's milk differ from human milk because they:

• are low in iron
• are low in essential fatty acids and other essential nutrients
• contain a less digestible form of protein
• have a high renal solute load

In young infants, the use of cow's milk is associated with blood loss in the gastrointestinal tract. This can contribute to iron deficiency anaemia (Christofides et al., 2005; Ehrlich et al., 2022).

Raw or unpasteurized cow's or goat's milk should never be offered. This is due to the risk of food-borne illness from pathogens such as Salmonella, Escherichia coli, Campylobacter, and Listeria monocytogenes (Health Canada, 2013).

Home-made formulas, including those made from canned, evaporated, or whole milk (cow or goat) are not recommended, as they are nutritionally incomplete (WHO, 2009). Home-made formulas should only be considered for emergency, short-term use, when no other options are available. They must be prepared safely, following directions from Infant Feeding in Emergencies (PDF format) (IFE Core Group, 2007, pp. 127-128).

Soy, rice, oat, almond or any other plant-based beverages, even when they are fortified, are not appropriate as human milk substitutes because they are nutritionally incomplete for infants (Merritt et al., 2020).

Supervision of a feeding infant

Breastfeeding allows close, skin-to-skin contact and constant attention to infants during feeding. When an infant is not breastfed, skin-to-skin contact should still be encouraged while feeding. Even older infants who can hold a bottle benefit from being held when feeding.

Cue-based feeding is as important for formula-fed infants as it is for breastfed infants. Teach parents to feed in response to their infant's cues. They should be fed according to their appetite and satiety. Parents and caregivers should respond to fullness cues and not encourage infants to empty the bottle (IOM, 2011).

Feeding must always be supervised. The use of a propped or self-feeding bottle to feed an unattended infant is strongly discouraged. There is a danger of choking or aspiration because the flow of milk into the mouth may be too rapid. This practice also increases the risk of overfeeding, since the infant cannot stop the feeding (IOM, 2011).

The use of a bottle as a pacifier should be discouraged, particularly at bedtime. There is a risk of 'nursing bottle syndrome' and early childhood tooth decay (Health Canada, 2022b).

References

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