Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States (2024)

Chapter: Appendix F: Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex

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Appendix F

Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex

This appendix contains the following:

Table F-1: Infant Formula Macronutrient Content Standards

Table F-2: Infant Formula Vitamin Content Standards

Table F-3: Infant Formula Minerals and Trace Elements Content Standards

Table F-4: Regulation Requirements for Protein Quality, Growth, and Tolerance Studies, by Country

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TABLE F-1 Infant Formula Macronutrient Content Standards

CODEXUSAU/NZCanadaEU
MacronutrientUnit of MeasurementMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum Level
CalorieskJ/100 mL250295N/AN/A250315aN/AN/A250293
kcal/100 mL6070N/AN/AN/AN/A66.4686070
Proteing/100 kcal1.831.84.5N/AN/A1.841.82.5
g/100 kJ0.450.7N/AN/A0.450.7N/AN/A0.430.6
Total fatg/100 kcal4.463.36N/AN/A3.364.46
g/100 kJ1.051.4N/AN/A1.051.5N/AN/A1.11.4
Linoleic acidmg/100 kcal300N/A300N/AN/AN/A500bN/A5001200
mg/100 kJ70N/AN/AN/AN/AN/AN/AN/A120300
α-Linolenic acidmg/100 kcal50N.S.N/AN/AN/AN/AN/AN/A50100
mg/100 kJ12N.S.N/AN/AN/AN/AN/AN/A1224
Ratio linoleic/α-linolenic acidN/A5:115:1N/AN/A5:115:1N/AN/AN/AN/A
Carbohydratesg/100 kcal914N/AN/AN.S.N.S.N/AN/A914
g/100 kJ2.23.3N/AN/AN.S.N.S.N/AN/A2.23.3

NOTES: N.S. = not specified, RE = retinol equivalents, mg = milligrams, g = grams, kcal = kilocalories, kJ = kilojoules.

a The units were converted to kJ/100 mL from the reported kJ/L in the AU/NZ standards.

b Canadian infant formula nutrient requirements for linoleic acid must be in glyceride form.

SOURCES: EU, 2015; FAO/WHO, 2020; FDA, 2023a; FSANZ, 2023a; Government of Canada, 2023; Health Canada, 2021a.

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TABLE F-2 Infant Formula Vitamin Content Standards

CODEXUSAU/NZCanadaEU
VitaminUnit of MeasurementMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum Level
Vitamin Aµg RE/100 kcal
µg RE/100 kJ		60
14		180
43		250a
N/A		750
N/A		N/A
14		N/A
43		250b
N/A		500
N/A		70
16.7		114
27.2
Vitamin Dµg/100 kcal
µg/100 kJ		1
0.25		2.5
0.6		40c
N/A		100
N/A		N/A
0.25		N/A
0.63		40d802
0.48		3
0.72
Vitamin EVaried0.5 mg α-TE/100 kcal
0.12 mg α-TE/100 kJ		N/A
N/A		0.7
IUs/100 kcal		N/A0.11 mg/100 kJ1.1 mg/100 kJ0.6 IU/100 kcalN/A0.6 mg α-TE/100 kcal
0.14 mg α-TE/100 kJ		5 mg α-TE/100 kcal
1.2 mg α-TE/100 kJ
Vitamin Kµg/100 kcal
µg/100 kJ		4
1		N/A
N/A		4
N/A		N/A
N/A		N/A
1		N/A
N/A		8
N/A		N/A
N/A		1
0.24		25
6
Thiamin (B1)µg/100 kcal
µg/100 kJ		60
14		N/A
N/A		40
N/A		N/A
N/A		N/A
10		N/A
N/A		40
N/A		N/A
N/A		40
9.6		300
72
Riboflavin (B2)µg/100 kcal
µg/100 kJ		80
19		N/A
N/A		60
N/A		N/A
N/A		N/A
14		N/A
N/A		60
N/A		N/A
N/A		60
14.3		400
95.6
Vitamin B6µg/100 kcal
µg/100 kJ		35
8.5		N/A
N/A		35
N/A		N/A
N/A		N/A
9		N/A
36		35
N/A		N/A
N/A		20
4.8		175
41.8
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Vitamin B12µg/100 kcal
µg/100 kJ		0.1
0.025		N/A
N/A		0.15
N/A		N/A
N/A		N/A
0.025		N/A
N/A		0.15
N/A		N/A
N/A		0.1
0.02		0.5
0.12
Niacinµg/100 kcal
µg/100 kJ		300 70N/A
N/A		250
N/A		N/A
N/A		N/A
130i		N/A
N/A		250
N/A		N/A
N/A		400e mg/100 kcal
100f mg/100 kJ		1500 mg/100 kcal
360 mg/100 kJ
Folic acid (Folacin)µg/100 kcal
µg/100 kJ		10
2.5		N/A
N/A		4
N/A		N/A
N/A		N/A
2		N/A
N/A		4 N/AN/A
N/A		15 µgDFE
3.6 µgDFE		47.6 µgDFE
11.4 µgDFE
Pantothenic acidµg/100 kcal
µg/100 kJ		400
96		N/A
N/A		300
N/A		N/A
N/A		N/A
70		N/A
N/A		300
N/A		N/A
N/A		400
100		2000
480
Biotinµg/100 kcal
µg/100 kJ		1.5
0.4		N/A
N/A		1.5
N/A		N/A
N/A		N/A
0.36		N/A
N/A		2
N/A		N/A
N/A		1
0.24		7.5
1.8
Vitamin C (ascorbic acid)mg/100kcal
mg/100 kJ		10
2.5		N/A
N/A		8
N/A		N/A
N/A		N/A
1.7		N/A
N/A		8
N/A		N/A
N/A		4
0.96		30
7.2
Cholinemg/100 kcal
mg/100 kJ		7
1.7		N/A
N/A		7
N/A		N/A
N/A		N/A
1.7		N/A
7.1		12
N/A		N/A
N/A		25
6		50
12
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NOTES: a-TE = alpha-tocopherol; DFE = dietary folate equivalent; g = grams; IU = international units; kcal = kilocalories, kJ = kilojoules; mg = milligrams; RE = retinol equivalents; µg = micrograms.

a The U.S. nutrient requirements for infant formula measure vitamin A in International Units/100 kcal.

b The Canadian nutrient requirements for infant formula measure vitamin A in International Units/100 kcal.

c The U.S. nutrient requirements for infant formula measure vitamin D in International Units/100 kcal.

d The Canadian nutrient requirements for infant formula measure vitamin D in International Units/100 kcal.

e The units for niacin were converted to µg/100 kcal from the reported mg/100 kcal in the EU standards.

f The units for niacin were converted to µg/100 kJ from the reported mg/100 kJ in the EU standards.

g The units for pantothenic acid were converted to µg/100 k cal from the reported mg/100 kcal in the EU standards.

h The units for pantothenic acid were converted to µg/100 kJ from the reported mg/100 kJ in the EU standards.

i AU/NZ standards are for preformed niacin.

SOURCES: EU, 2015; FAO/WHO, 2020; FDA, 2023a; FSANZ, 2023b; Government of Canada, 2023; Health Canada, 2021.

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Suggested Citation: "Appendix F: Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press. doi: 10.17226/27765.
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TABLE F-3 Infant Formula Minerals and Trace Elements Content Standards

CODEXUSAU/NZCanadaEU
Minerals and Trace ElementsUnit of MeasurementMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum LevelMinimum LevelMaximum Level
Calciummg/100 kcal
mg/100 kJ		50
12		N/A
N/A		60
N/A		N/A
N/A		N/A
12		N/A
N/A		50
N/A		N/A
N/A		50
12		140
33.5
Phosphorusmg/100 kcal
mg/100 kJ		25
6		N/A
N/A		30
N/A		N/A
N/A		N/A
6		N/A
25		25
N/A		N/A
N/A		25
6		90
21.5
Calcium/Phosphorus RatioN/A1:12:11.1:12:11.2:12:11.2:12:11:12:1
Magnesiummg/100 kcal
mg/100 kJ		5
1.2		N/A
N/A		6
N/A		N/A
N/A		N/A
1.2		N/A
4		6
N/A		N/A
N/A		5
1.2		15
3.6
Ironmg/100 kcal
mg/100 kJ		0.45
0.1		N/A
N/A		0.15
N/A		3
N/A		N/A
0.2		N/A
0.5		0.15
N/A		N/A
N/A		0.3
0.07		1.3
0.31
Zincmg/100 kcal
mg/100 kJ		0.5
0.12		N/A
N/A		0.5
N/A		N/A
N/A		N/A
0.12		N/A
0.43		0.5
N/A		N/A
N/A		0.5
0.12		1
0.24
Manganeseµg/100 kcal
µg/100 kJ		1
0.25		N/A
N/A		5
N/A		N/A
N/A		N/A
0.24		N/A
24		5
N/A		N/A
N/A		1
0.24		100
24
Copperµg/100 kcal
µg/100 kJ		35
8.5		N/A
N/A		60
N/A		N/A
N/A		N/A
14		N/A
43		60
N/A		N/A
N/A		60
14.3		100
24
Iodineµg/100 kcal
µg/100 kJ		10
2.5		N/A
N/A		5
N/A		75
N/A		N/A
1.2		N/A
10		5
N/A		N/A
N/A		15
3.6		29
6.9
Seleniumµg/100 kcal
µg/100 kJ		1
0.24		N/A
N/A		2
N/A		7
N/A		N/A
0.25		N/A
1.19		N/A
N/A		N/A
N/A		3 0.728.6 2
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Suggested Citation: "Appendix F: Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press. doi: 10.17226/27765.
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Sodiummg/100 kcal
mg/100 kJ		20
5		60
14		20
N/A		60
N/A		N/A
5		N/A
15		20
N/A		60
N/A		25
6		60
14.3
Potassiummg/100 kcal
mg/100 kJ		60
14		180
43		80
N/A		200
N/A		N/A
20		N/A
50		80
N/A		200
N/A		80
19.1		160
38.2
Chloridemg/100 kcal
mg/100 kJ		50
12		160
38		55
N/A		150
N/A		N/A
12		N/A
35		55
N/A		150
N/A		60
14.3		160
38.2
Myo-inositolamg/100 kcal
mg/100 kJ		4
1		N/A
N/A		4
N/A		N/A
N/A		N/A
1		N/A
9.5		N/A
N/A		N/A
N/A		4
0.96		40
9.6
L-Carnitinemg/100 kcal
mg/100 kJ		1.2
0.3		N.S.
N.S.		N/A
N/A		N/A
N/A		N/A
0.21		N/A
0.8		N/A
N/A		N/A
N/A		N/A
N/A		N/A
N/A

NOTES: g = grams; mg = milligrams; kcal = kilocalories; kJ= kilojoules; μg = micrograms.

a Inositol and myo-inositol are used interchangeably among countries.

SOURCES: EU, 2015; FAO/WHO, 2020; FDA, 2023a; FSANZ, 2023a; Government of Canada, 2023; Health Canada, 2021a.

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TABLE F-4 Regulation Requirements for Protein Quality, Growth, and Tolerance Studies, by Country

Country, Regulatory AuthorityProtein QualityGrowth and Tolerance
United States, FDA FDA established draft guidance for manufacturers to conduct PER studies in rat bioassays, as mandated by 21 CFR § 106.96(b). Results of the study must be analyzed to determine the protein quality is sufficient (21 CFR § 106.96(e)-(f)) before testing the infant formula product among infants in the growth monitoring study (FDA, 2023b). Conducted after PER study and must demonstrate that the infant formula product being tested supports normal physical growth. The study must be a minimum of 15 weeks, and infants must not be older than 2 weeks at the time of study enrollment (79 FR 8059). The anthropometric data of the experiment group must be compared to a control group to ensure that proper growth is achieved (FDA, 2023b).
European Union (EU), European Commission The studies depend on the responsibility of food manufacturers and operators to ensure that their product is suitable for infants and that there are studies to support the integrity of the product. The quality of the study is determined separately by case, so there is no one uniform protocol for either protein quality or growth and tolerance studies. The EU defers to other expert science groups (i.e., EFSA, UK Committee, ESPGHAN) to give guidance on the design and conduct of studies (EU, 2015).
Australia and New Zealand, FSANZ FSANZ did not find it necessary to regulate the protein source of infant formula and only regulates the quality and quantity. No guidance documents are established for manufacturers (FSANZ, 2023b). For composition, growth studies are required to demonstrate that there are “no negative impacts on physical growth throughout infancy.” There must be a control and intervention group as well as intervention groups that include a referent breastfeeding group. Study results for the infant formula being tested must prove that it is comparable to breastfed infants in its safety, suitability, and outcome of proper growth and healthy development (FSANZ, 2022).
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Country, Regulatory AuthorityProtein QualityGrowth and Tolerance
Canada, Health Canada Requires a PER study. PER methods may be used, and PDCAAS and DIAAS methods are not sufficient to demonstrate protein quality. Additionally, essential, or conditionally essential, amino acids must align with Codex Standard 72, Annex I, matching the profile of human milk (Health Canada, 2021a). Requires a clinical growth and tolerance study that meets the WHO Growth Standards (2008). Over a 16-week period that starts the first 14 days of life, healthy term newborn infants are fed the infant formula being tested (experiment group) and compared to the weight growth rate of a healthy newborn infant consuming a control infant formula that is on the Canadian market. Health Canada established protocol requirements for infant formula manufacturers (Health Canada, 2021b).

NOTES: DIAAS = Digestible Indispensable Amino Acid Score; EFSA = European Food Safety Authority; ESPGHAN = European Society for Paediatric Gastroenterology Hepatology and Nutrition; EU = European Union; FDA = U.S. Food and Drug Administration; FSANZ = Food Standards Australia New Zealand; PDCAAS = Protein Digestibility Corrected Amino Acid Score; PER = protein efficiency ratio; UK = United Kingdom.

SOURCES: EU, 2015; FDA, 2023b; FSANZ, 2022/2023; Health Canada, 2021a,b.

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Suggested Citation: "Appendix F: Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press. doi: 10.17226/27765.
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REFERENCES

EU (European Union). 2015. Commission delegated regulation (EU) 2016/127 of 25 September 2015 supplementing regulation (EU) No 609/2013. https://eur-lex.europa.eu/eli/reg_del/2016/127/oj (accessed February 15, 2024).

FAO/WHO (Food and Agriculture Organization and World Health Organization). 2023. Codex Alimentarius international food standards. https://www.fao.org/fao-who-codex-alimentarius/en/ (accessed January 31, 2024).

FDA (U.S. Food and Drug Administration). 2023a. CFR—Code of Federal Regulations Title 21 - food composition, standards, labeling, and economics. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=107&showFR=1 (accessed April 22, 2024).

FDA. 2023b. Protein efficiency ratio (PER) rat bioassay studies to demonstrate that a new infant formula supports the quality factor of sufficient biological quality of protein: Guidance for industry. https://www.fda.gov/media/165173/download (accessed March 13, 2024).

FSANZ (Food Standards Australia New Zealand). 2022. Proposal P1028—infant formula. https://www.foodstandards.gov.au/sites/default/files/food-standards-code/proposals/Documents/SD6%20%20Assessment%20against%20Ministerial%20Policy%20Guidelines.pdf (accessed March 13, 2024).

FSANZ. 2023a. Nutrient composition for infant formula products. https://www.foodstandards.gov.au/sites/default/files/food-standards-code/proposals/SiteAssets/Pages/P1028/Supporting%20Document%202%20-%20Nutrient%20composition.pdf (accessed January 31, 2024).

FSANZ. 2023b. P93 infant formula SOR. https://www.foodstandards.gov.au/food-standards-code/proposals/proposalp93reviewofinfantformula/p93infantformulasor (accessed March 13, 2024).

Government of Canada. 2023. Food and drug regulations. https://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._870.pdf (accessed March 25, 2024).

Health Canada. 2021a. Scientific evidence requirements for nutritional adequacy of a term infant formula: A guidance document for infant formula manufacturers. https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/infant-formula-human-milk-fortifier/scientific-evidence-requirements-nutritional-adequacy-term-infant-formula.html (accessed January 31, 2024).

Health Canada. 2021b. Growth and tolerance clinical trial protocol – healthy term newborn infants: A guidance document for infant formula manufacturers. https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/infant-formula-human-milk-fortifier/growth-tolerance-clinical-trial-protocol-healthy-term-newborn-infants.html#a1 (accessed March 13, 2024).

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Suggested Citation: "Appendix F: Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press. doi: 10.17226/27765.
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Next Chapter: Appendix G: Description of the International Code of Marketing of Breast-Milk Substitutes
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