International Infant Formula Regulations - Japan, Australia, New Zealand, China, and the WHO Codex Baseline — The Infant Formula Atlas

By María López Botín · Mother of 2, researching infant formula and infant nutrition since 2018

The US FDA 21 CFR 107 and EU Regulation 2016/127 frameworks get most of the attention in English-language infant formula discussion, but infant formula is manufactured and regulated in dozens of countries under a patchwork of national standards. Japan, Australia/New Zealand, China, and other major markets each have their own compositional rules, labeling requirements, and enforcement mechanisms, many derived from the international Codex Alimentarius baseline but with meaningful national variations. This guide walks through the major non-US, non-EU frameworks, what they require, where they diverge from FDA and EU rules, and why this matters for parents encountering international brands.

International infant formula regulation varies by country but most frameworks reference the Codex Alimentarius Stan 72-1981 baseline. Japan's MHLW framework requires pre-market notification with nutrient specifications similar to EU. Australia/New Zealand's FSANZ standards align closely with Codex and EU. China's GB 10765 is stricter than many frameworks post-2008 melamine scandal, requiring separate registrations for each product formulation. The FDA and EU frameworks are both stricter than Codex in most respects; most international frameworks are in between or aligned with Codex.

Codex Alimentarius: the international baseline

The Codex Alimentarius is a joint WHO/FAO food standards body that publishes voluntary international standards. For infant formula:

Codex Stan 72-1981: Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
Adopted 1981, amended 2007 and 2011
Reference framework used or adapted by many national regulators
Sets nutrient minimums, labeling requirements, and safety baselines

Key Codex nutrient ranges

Nutrient	Codex minimum	Codex maximum
Energy	60 kcal/100 ml	70 kcal/100 ml
Protein	1.8 g/100 kcal	3.0 g/100 kcal
Fat	4.4 g/100 kcal	6.0 g/100 kcal
Carbohydrate	9.0 g/100 kcal	14.0 g/100 kcal
Iron (cow-milk)	0.45 mg/100 kcal	1.3 mg/100 kcal
DHA	Not mandatory	,

How Codex relates to FDA and EU

FDA, stricter than Codex on iron minimum (higher), on many vitamins (narrower ranges); DHA optional in both
EU, stricter than Codex on DHA (mandatory since 2020), protein maximum (lower), iodine maximum (lower)
Other countries, range from slightly below Codex to significantly above, depending on national priorities

For our detailed FDA/EU comparison, see:

Japan: MHLW framework

Regulatory body

Japan's infant formula regulation is administered by the Ministry of Health, Labour and Welfare (MHLW) under the Food Sanitation Act and the Health Promotion Act.

Key features

Pre-market notification required with detailed nutrient analysis
Compositional standards largely aligned with Codex but with some Japan-specific requirements
"Medical Dietary Food for Special Uses": Japan's regulatory category for infant formula, requiring specific clinical documentation
Label requirements: Japanese-language labeling with standardized nutrient disclosure format

Distinctive elements

Emphasis on 100% Japanese sourcing for many domestic products (Meiji Hohoemi, Morinaga Hagukumi, both promote Japan-sourced dairy)
Nucleotide supplementation is common and has been standard in Japanese formulas longer than in US or EU mass-market
Lactoferrin additions at commercially-meaningful levels in some premium Japanese formulas
Smaller retail packaging, 800g tins common like EU, but also smaller on-the-go single-serve sachets

Major Japanese brands

Meiji: Hohoemi (follow-on formula leader), Stepup (growing-up milk)
Morinaga: Hagukumi, Chilmil (follow-on)
Wakodo: Haihai, Lebens (smaller-share Japanese brand)
Beanstalk: Snow Brand Megmilk's premium baby formula line
Bean Stalk Snow, specialty variants

See the Meiji and Morinaga brand hubs for product-level documentation.

US access to Japanese formulas

Not FDA-registered. Personal-use imports legal under FDA enforcement discretion, but Japanese formulas have limited US importer infrastructure. Some specialty channels import for Japanese expat families; Amazon sometimes carries individual cans at premium pricing.

Australia and New Zealand: FSANZ framework

Regulatory body

Food Standards Australia New Zealand (FSANZ) administers the Food Standards Code, which includes Standards 2.9.1 (Infant Formula Products) and 2.9.2 (Follow-on Formula).

Key features

Pre-market notification required
Compositional standards largely aligned with EU 2016/127 but with Oceania-specific variations
Mandatory DHA in infant formulas (since 2013 update)
Australian/New Zealand dairy sourcing emphasized for domestic products
English-language labeling

Distinctive elements

A2 beta-casein prominence: Australia/New Zealand have the strongest A2-only commercial infant formula market globally (a2 Platinum leads)
Grass-fed dairy is more common in Australia/NZ baby formulas than in US or EU mass-market
Whole milk fat retention occasionally found (similar to Kendamil's UK approach)

Major Australia/NZ brands

a2 Platinum (the a2 Milk Company): A2-only premium global leader
Bubs, goat and organic variants, received US Operation Fly Formula attention in 2022
Bellamy's Organic — Australian organic leader, Tasmania-sourced
Aptamil Australia: Danone's Australian market variant
Karicare (New Zealand) — historically Nutricia-owned, Australia/NZ retail standard
Oli6, goat-milk specialty

Product-level documentation lives on each brand hub; the goat-milk formulas filter consolidates Oli6, Bubs, Karicare, Holle Goat, Kendamil Goat, Jovie, Kabrita, and Nannycare in one list.

US access to Australian/NZ formulas

Some Australian brands (Bubs, a2 Platinum) received enforcement discretion during the 2022 US shortage and have maintained some US retail presence. Others (Karicare, Oli6, Bellamy's) are available via import only.

For the 2022 context, see our Abbott 2022 recall aftermath pillar.

China: GB 10765 framework (post-2008)

Regulatory body

China's infant formula regulation is administered by the State Administration for Market Regulation (SAMR) under GB 10765 (for infant formula, 0-6 months), GB 10766 (follow-on, 6+ months), and GB 10767 (toddler formula).

The 2008 melamine scandal context

In 2008, the Sanlu Group and other Chinese manufacturers were found to have adulterated infant formula with melamine, a nitrogen- rich chemical used to falsely elevate protein test readings. At least 6 infant deaths and 300,000 affected infants resulted. The scandal transformed Chinese infant formula regulation and consumer behavior:

Pre-registration requirements became stricter
Product formula registration, every individual formulation requires separate registration (approximately 400 products approved out of thousands of applications as of 2016 tightening)
Import restrictions and premiums, imported Western formulas (Nutricia, Abbott, Nestlé) gained massive Chinese market share from consumer trust shifts
Chinese domestic brand rebuilding: Feihe, Junlebao, and other Chinese brands have rebuilt trust over 15 and years

Current GB 10765 framework

Compositional standards generally stricter than Codex, comparable to EU in many dimensions
DHA:ARA ratios specified
Registration-per-formulation, unusual globally, creates barriers to rapid product iteration
Domestic manufacturing preferences: Chinese-origin ingredients increasingly emphasized

Major Chinese brands

Feihe (Yili Group), largest Chinese domestic brand, premium positioning
Junlebao, major domestic competitor
Ausnutria: Dutch-Chinese joint ownership (also owns Kabrita)
Biostime, operator of multiple brands including some European imports

US and Western access

Chinese domestic brands are not typically imported to the US or Europe. The Chinese infant formula market operates mostly as a domestic market with significant imports from Western brands rather than exports.

Other regional frameworks (brief overview)

India

FSSAI (Food Safety and Standards Authority of India) administers the Infant Milk Substitutes Act
Prohibits marketing of infant formula directly to consumers (stricter WHO Code implementation than many countries)
Major domestic brands include Nestle Lactogen and Nan

Latin America

Most countries use Codex-derived national standards
Brazil (ANVISA) and Mexico (COFEPRIS) are the major regulatory bodies
Nestlé NAN has dominant market share across most Latin American countries

Middle East and Africa

Varied frameworks, many Codex-based
GCC countries (Gulf Cooperation Council) have harmonized standards for imported formulas
Halal certification prominent for Muslim-majority markets

Russia

GOST (national standards) framework with significant domestic manufacturing
Nutricia and Nestlé have historical presence; recent geopolitical restrictions affect access

Why this matters for parents

Direct relevance: limited

For most parents, international infant formula regulations are not directly relevant because:

US-sold formulas must meet FDA 21 CFR 107 regardless of brand origin
Imported European organic formulas (HiPP, Holle, Kendamil, Lebenswert) operate under FDA enforcement discretion and don't require deep regulatory understanding
Japanese, Australian, and Chinese formulas have minimal US commercial presence

Indirect relevance: context matters

Understanding international frameworks helps when:

Traveling internationally with a formula-fed infant
Returning from overseas with formula (US Customs personal-use exemption applies)
Immigrant families understand their home-country brand in the US market context
Researching brands that have multi-country presence (Nestlé NAN, Aptamil, HiPP) and may have different formulations in different markets

For practical travel and import guidance, see:

The WHO Code of Marketing of Breast-milk Substitutes

All infant formula regulations globally operate against the backdrop of the WHO International Code of Marketing of Breast- milk Substitutes (1981). The Code:

Prohibits direct-to-consumer marketing of infant formula in hospital and clinical settings
Restricts promotional samples and gifts to healthcare workers
Requires labeling acknowledging breast milk's superiority
Prohibits images of infants on packaging

Implementation varies

Stricter implementation: India, Brazil, several European countries
Partial implementation: US (voluntary industry codes rather than binding law)
Looser implementation: some markets with aggressive direct-to-consumer advertising

This is why infant formula packaging and marketing differ dramatically by country even for the same brand. An Aptamil packaging in the UK looks different from Aptamil in Australia or Aptamil in the Middle East, not just language but image choices, claims, and compositional disclosures vary based on local WHO Code implementation.

FAQ

What is Codex Alimentarius and why does it matter for baby formula?

Codex Alimentarius is a joint WHO/FAO body that publishes voluntary international food standards. Codex Stan 72-1981 sets baseline compositional and safety standards for infant formula that many national regulators reference or adapt. The FDA and EU frameworks are both stricter than Codex in most respects; many other national frameworks (Japan, Australia/NZ, China) are closer to Codex or aligned with one of the two major frameworks.

Are Japanese infant formulas FDA-approved in the US?

No. Japanese infant formulas (Meiji Hohoemi, Morinaga Hagukumi, and others) are not FDA-registered under 21 CFR 107. Personal-use imports are legal under FDA enforcement discretion, but US importer infrastructure is limited. Japanese expat families in the US sometimes self-import; general consumer availability is minimal.

Is a2 Platinum available in the US?

a2 Platinum received FDA enforcement discretion during the 2022 shortage and has maintained some US retail presence since. It is not fully FDA-registered under 21 CFR 107 but is legally available in select US retail channels. The brand's A2-only positioning resonates in the US market where ByHeart and Baby's Only Premium A2 are the US-made A2 alternatives.

What happened with Chinese infant formula in 2008?

The 2008 melamine adulteration scandal involved Sanlu Group and multiple Chinese manufacturers adding melamine (a nitrogen-rich chemical) to infant formula to falsely elevate protein test readings. At least 6 infant deaths and approximately 300,000 affected infants resulted. The scandal transformed Chinese infant formula regulation with stricter registration requirements, and drove Chinese consumers toward Western imported brands for over a decade.

Does Nestlé NAN have different formulations in different countries?

Yes. Nestlé NAN is manufactured and sold in 100 and countries with regional formulations that vary based on local regulations, consumer preferences, and sourcing. NAN OptiPro in Mexico is not identical to NAN 1 in Germany or NAN HA in the UK. Always verify the specific regional label rather than assuming cross-country equivalence. Nestlé's US market is served by Gerber rather than NAN branding.

How does the WHO Code affect infant formula marketing?

The WHO International Code of Marketing of Breast-milk Substitutes (1981) prohibits direct-to-consumer marketing of infant formula in clinical settings, restricts promotional activity, and requires labeling acknowledging breast milk's superiority. Implementation varies dramatically: India enforces strictly; the US implements through voluntary industry codes rather than binding law; some countries minimally enforce. This is why infant formula packaging and advertising look different across countries.

Can I bring Japanese baby formula to the US?

Yes, for personal use. US Customs and Border Protection permits infant formula in personal-use quantities without duty. Bring sealed manufacturer packaging, declare at customs when asked, and be prepared for possible inspection. Commercial quantities trigger different rules. See our traveling with baby formula pillar for the full framework.

Which international regulatory framework is strictest?

EU Regulation 2016/127 is generally considered the strictest among major frameworks, particularly on DHA (mandatory), marketing claims (restrictive), and maximum nutrient levels. FDA 21 CFR 107 is stricter than most frameworks on iron minimums and manufacturing inspection frequency but less restrictive on marketing claims. China's GB 10765 post-2008 is among the strictest on registration requirements but implementation quality varies.

Primary sources

Codex Alimentarius: Stan 72-1981: Standard for Infant Formula and Formulas for Special Medical Purposes. fao.org
Japan Ministry of Health, Labour and Welfare (MHLW) — Infant formula regulation under Food Sanitation Act. mhlw.go.jp
Food Standards Australia New Zealand (FSANZ): Food Standards Code Standards 2.9.1 and 2.9.2. foodstandards.gov.au
State Administration for Market Regulation (China) — GB 10765/10766/10767 infant formula standards. samr.gov.cn
WHO: International Code of Marketing of Breast-milk Substitutes. who.int
FDA: Infant formula regulation framework applicable to US imports of international products. fda.gov
EU Regulation 2016/127. EU comparative reference framework. eur-lex.europa.eu
AAP / PubMed, peer-reviewed literature on international infant nutrition comparative research. pubmed.ncbi.nlm.nih.gov

Non-EU/non-US brand hubs that sit under these frameworks, Karicare brand hub (New Zealand, Nutricia-owned), Bellamy's (Australia organic), Bubs (Australia), A2 Platinum (Australia A2-only)
FDA vs EFSA standards compared
Organic certifications compared

This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.