Selling infant formula and baby food: the rules by market
The rules infant formula and baby food must meet before going on sale in the EU, the UK, Switzerland, the US, Canada, Mexico, Brazil, Australia, New Zealand, Japan, South Korea, Singapore, India, the UAE and Saudi Arabia: who writes them, who enforces them, and what has to be registered, tested and labelled, with the official source for each. Compliant Always shows which of them apply to your product.
Europe
- European UnionIn the EU, food for infants and young children falls under Regulation (EU) No 609/2013. Infant and follow-on formula follow Delegated Regulation (EU) 2016/127; processed cereal-based food and other baby food follow Directive 2006/125/EC. Both set composition, labelling and pesticide limits, and infant formula is notified in each member state where it is sold.Selling infant formula and baby food in the EU
- United KingdomIn Great Britain, infant formula, follow-on formula, and processed cereal-based food and baby food fall under assimilated Regulation (EU) No 609/2013 on food for specific groups. Formula follows detailed composition, labelling and advertising rules, and infant formula is notified before sale. Northern Ireland follows EU nutrition law directly.Selling infant formula and baby food in the UK
- SwitzerlandIn Switzerland, infant formula, follow-on formula and cereal-based and other baby food are covered by the FDHA Ordinance on Food for Persons with Special Nutritional Needs (VLBP). Infant formula is notified to the FSVO before first sale and on each recipe or label change. Advertising infant formula is limited to scientific and baby-care publications.Selling infant formula and baby food in Switzerland
The Americas
- United StatesIn the US, the FDA does not approve infant formulas, but a manufacturer registers and notifies the FDA at least 90 days before marketing a new formula. Formula meets nutrient, quality and manufacturing rules in 21 CFR 106 and 107. Baby food follows the food rules, with its own nutrition labelling and FDA lead action levels.Selling infant formula and baby food in the US
- CanadaIn Canada, infant formula (a "human milk substitute" in the Food and Drug Regulations) and baby food are covered by Division 25 of the Food and Drug Regulations and by the Safe Food for Canadians Regulations. A new formula is notified to Health Canada at least 90 days before sale. Labels follow Division 25, and the CFIA enforces.Selling infant formula and baby food in Canada
- MexicoIn Mexico, infant formula, follow-on formula and food for infants and young children follow NOM-131-SSA1-2012 and the Reglamento de Control Sanitario de Productos y Servicios. Formula labels may make no nutrition or health claims, must state that breast milk is the best food for babies, and may not suggest the formula equals or betters it.Selling infant formula and baby food in Mexico
- BrazilIn Brazil, infant formula, follow-on formula, transition foods and cereal-based foods for young children follow ANVISA's RDC 976/2025. Formulas are registered with ANVISA before sale; transition and cereal foods are notified. Law 11.265/2006 bans promotion of infant formula and sets the label warnings, and no functional or health claims are allowed.Selling infant formula and baby food in Brazil
Asia and the Pacific
- AustraliaIn Australia, infant formula and follow-on formula are regulated by Standard 2.9.1 and Schedule 29 of the Food Standards Code, revised under Proposal P1028 with a transition to 13 September 2029. Labels carry prescribed names, the protein source and set warnings, and must not show a picture of an infant. Food for infants follows Standard 2.9.2.Selling infant formula and baby food in Australia
- New ZealandNew Zealand opted out of the joint infant formula standard, Standard 2.9.1, and that joint standard does not govern infant formula or follow-on formula sold in New Zealand. Food for infants follows Standard 2.9.2, with limits on sodium, sugars and honey, and age statements. Formulated supplementary foods for children aged 1 to 3 follow Standard 2.9.3.Selling infant formula and baby food in New Zealand
- JapanIn Japan, infant formula meets the Ministerial Ordinance on Milk as powdered or liquid infant formula, and labelling it as a breast-milk alternative needs permission from the Consumer Affairs Agency as a Food for Special Dietary Uses. It must meet a nutrient table and carry set statements. Other baby food follows the general food rules.Selling infant formula and baby food in Japan
- South KoreaIn South Korea, baby food is regulated by the Ministry of Food and Drug Safety (MFDS). The Livestock Products Sanitary Control Act lists milk formula among processed milk products, and the Food Sanitation Act covers food generally. Baby food makers, larger formula sellers and infant formula importers register traceability.Selling infant formula and baby food in South Korea
- SingaporeIn Singapore, infants' food and infant formula are special purpose foods under the Food Regulations, administered by the Singapore Food Agency. Regulations 251 to 254 set their labelling, health claims are prohibited on infant formula, and imports need health certificates and periodic laboratory reports. Marketing follows a code administered through the Health Promotion Board.Selling infant formula and baby food in Singapore
- IndiaIn India, infant milk substitutes and infant foods meet FSSAI's standards under the Food Safety and Standards Act, 2006, and the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992 adds its own rules. That Act bars advertising and promotion, and requires an "IMPORTANT NOTICE" on each container stating that mother's milk is best.Selling infant formula and baby food in India
The Middle East
- United Arab EmiratesIn the UAE, infant formula and baby food are food under Federal Law No. 10 of 2015: they are registered in ZAD before they are traded, carry an Arabic label meeting the mandatory food standards, and need ministry approval on first import. Feeding bottles, teats and soothers fall under MoIAT's child care articles scheme.Selling infant formula and baby food in the UAE
- Saudi ArabiaIn Saudi Arabia, food for infants and children needs the consent of the Saudi Food and Drug Authority (SFDA) and goes through pre-registration evaluation. SFDA's guide for breastmilk substitutes, applied since 1 March 2020, adds licensed warehouses, listed exporting establishments, a statutory agent and recall duties, alongside the Ministry of Health's marketing regulation.Selling infant formula and baby food in Saudi Arabia
Other products
- Food
- Supplements
- Beverages
- Alcohol
- Pet food
- Cosmetics and beauty
- Cleaning products and detergents
- Toys
- Electrical and electronics
- Clothing, footwear and textiles
- Kitchenware and food contact articles
- Consumer goods
Selling infant formula and baby food somewhere not listed here? Tell us the product and the market, and we will come back to you with the rules that apply.
Tell us where you sellCompliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.