Baby food and infant formula

• Regulation (EU) No 609/2013 — food for specific groups
• Delegated Regulation (EU) 2016/127 — infant and follow-on formula
• Regulation (EU) No 1169/2011 — food information
• Regulation (EC) No 178/2002 — general food law

Who has to appoint one

Anyone placing infant formula, follow-on formula or processed cereal-based baby food on the EU market. Infant formula additionally requires notification to the competent authority of each member state where it is marketed, with the label as it will appear.

Thresholds and exemptions

None. The compositional and labelling rules are among the most prescriptive in EU food law, and there is no small-producer exemption.

What must appear on the label

Compositional declarations per 100 ml or 100 g, preparation and storage instructions with hygiene warnings, age of introduction, and for infant formula a statement on the superiority of breastfeeding, no images idealising use, and no nutrition or health claims except those expressly permitted.

Marketplace fields

Marketplaces require the EU operator details and remove listings using imagery or claims prohibited for infant formula. Cross-border sales of formula are additionally sensitive because of diversion and counterfeiting.

Documentation you must hold

Food business registration, notification per member state for formula, HACCP documentation, traceability, compositional analysis against the delegated Regulation, and pesticide residue compliance which for baby food is set at the limit of determination.

Standards and testing

Compositional verification of every regulated nutrient, contaminant testing including heavy metals and mycotoxins, microbiological testing with particular attention to Cronobacter for powdered formula, and pesticide residue analysis at the stricter baby food limits.

Language requirements

The complete label in the official language of each member state of sale, with no exceptions.

When it applies

Notification before the first sale of formula in each member state.

How long records are kept

Batch and traceability records per national law, generally shelf life plus a defined period.

What happens if you do not comply

Withdrawal, recall and prosecution. This is the most heavily enforced food category in the Union because the consumers are infants, and marketing infringements on formula are pursued as vigorously as safety ones.

Who enforces it

National food safety authorities and health ministries.

Where the boundary lies

Advertising restrictions on infant formula are stricter than for any other food, extending to social media, influencer content and free samples. A product marketed for infants that is not compositionally compliant cannot be sold at all.

Questions we are asked

Can we advertise infant formula online?

Advertising of infant formula is restricted or prohibited in most member states, including through social media and influencers. Follow-on formula rules differ but remain restrictive.

Do we need to notify every market?

For infant formula, yes, with the label as it will appear in that member state.