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Selling infant formula and baby food in the EU

In 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.

Updated · Each section links to the official source it comes from

Framework
Regulation (EU) No 609/2013, applying from 20 July 2016
Formula
Delegated Regulation (EU) 2016/127
Cereal-based and other baby food
Directive 2006/125/EC
Pesticide residues
No more than 0.01 mg/kg per pesticide, lower for some
Before sale
Infant formula label notified in each member state of sale
Claims
No nutrition or health claims on infant formula

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it infant formula, follow-on formula, processed cereal-based food or other baby food? Read more
  2. 2Does the composition meet the rules for that category, including pesticide limits? Read more
  3. 3Does the label carry the additional mandatory particulars for its category? Read more
  4. 4Do the claims, pictures and advertising stay within the limits? Read more
  5. 5Has the label been notified to each member state where it is needed? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Food for infants and young children

Which products the specific rules cover, and which text applies to each.

  • Regulation (EU) No 609/2013 was adopted on 12 June 2013 and applies from 20 July 2016. It regulates the content and marketing of food made for and marketed to vulnerable groups, including infants and young children.
  • It sets general composition and labelling rules, and requires the Commission to adopt specific rules for infant and follow-on formula and for processed cereal-based food and other baby food.
  • Infants are children under 12 months; young children are aged between 1 and 3 years.
  • It establishes a single Union list of substances, including minerals and vitamins, that may be added to these foods.
  • Young-child formulae ('growing-up milks') have no specific rules: since 20 July 2016 they are covered by the horizontal rules of EU food law.

How we help: Compliant Always records which category each product falls in, and reads its specification against the rules for that category. Ask about this

Composition, pesticides and contaminants

What the products may contain, and the limits that apply.

  • The composition must be appropriate for the nutritional requirements of the persons it is intended for, and the food may not contain any substance in a quantity that endangers their health (Article 9, Regulation (EU) No 609/2013).
  • Delegated Regulation (EU) 2016/127 sets the composition of infant and follow-on formula. It has applied since 22 February 2020, and since 22 February 2022 to formula manufactured from protein hydrolysates.
  • Directive 2006/125/EC sets criteria for protein, carbohydrate, fat, minerals and vitamins in processed cereal-based food and baby food, and remains applicable until a delegated act replaces it.
  • Formula and baby food may contain no more than 0.01 mg/kg of any individual pesticide residue; certain very toxic pesticides may not be used in their production, and lower levels apply to a few others.
  • They must also meet EU rules on hygiene, food additives, contaminants and materials in contact with the products.
  • Dossiers for formula manufactured from protein hydrolysates are submitted for evaluation via the E-submission Food Chain Platform.

How we help: Compliant Always keeps each product's specification, certificates of analysis and pesticide results with the batch they cover, dated. Ask about this

Labelling

What the label adds to the general food information rules.

  • Infant and follow-on formula follow Regulation (EU) No 1169/2011 unless Delegated Regulation (EU) 2016/127 provides otherwise, and their mandatory particulars appear in a language easily understood by consumers.
  • Infant formula adds: that it is suitable from birth when infants are not breast fed; instructions for preparation, storage and disposal, with a warning on the hazards of getting them wrong; and, under the words 'important notice', a statement on the superiority of breast feeding.
  • Follow-on formula adds that it is suitable only for infants over six months, should form only part of a diversified diet and is not a substitute for breast milk during the first six months, with preparation and storage instructions.
  • Formula labels may not use the terms 'humanised', 'maternalised' or 'adapted', and are designed to avoid confusion between infant formula and follow-on formula in text, images and colours.
  • Processed cereal-based food and baby food state the age from which they may be used (not less than four months), whether gluten is present if that age is under six months, energy value and protein, carbohydrate and lipid content, and preparation instructions where needed (Article 8, Directive 2006/125/EC).

How we help: Compliant Always reads each label against the particulars for its category and shows what is missing, with the article it comes from. Ask about this

Claims, images and advertising

Limits on how formula and baby food are presented and promoted.

  • Nutrition and health claims shall not be made on infant formula (Article 8, Delegated Regulation (EU) 2016/127).
  • The labelling, presentation and advertising of infant and follow-on formula may not discourage breast feeding, and may not include pictures of infants or other pictures or text that may idealise their use; graphics for identification and preparation are allowed (Article 10, Regulation (EU) No 609/2013).
  • These foods may not be presented as preventing, treating or curing a human disease.
  • 'Lactose free' may be used on formula only where lactose is no more than 2.5 mg/100 kJ (10 mg/100 kcal), with 'not suitable for infants with galactosaemia' where the protein source is not soya protein isolate.
  • Advertising of infant formula is restricted to publications specialising in baby care and scientific publications, and member states may restrict it further.
  • There may be no point-of-sale advertising, samples or other promotional devices for infant formula at retail, such as special displays, discount coupons and tie-in sales.

How we help: Compliant Always sets your label, claims and promotional copy beside these limits, with the source for each, so a retailer's question is answered from the record. Ask about this

Notification

Telling national authorities when formula goes on sale.

  • When infant formula is placed on the market, the food business operator notifies the competent authority of each member state where it is marketed, by sending a model of the label and any other information the authority reasonably requests (Article 12).
  • Follow-on formula manufactured from protein hydrolysates, or containing substances other than those listed in Annex II, is notified in the same way, unless a member state exempts the operator under a national monitoring system.
  • The Commission notes that the delegated Regulation extended notification to many follow-on formulae, in addition to infant formula.

How we help: Compliant Always records each notification by member state with the label version sent, so a label change shows which notifications it touches. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Food business operatorComposition, labelling and notification of the formula or baby food it places on the market.Notifications, labels and specifications kept together by product and member state.
ManufacturerMaking the product to the composition, pesticide, hygiene and contaminant rules, and the evidence that it did.Certificates of analysis and test results kept with each batch.
Brand and marketingLabels, claims, images and promotion within the limits for formula.Copy checked against the rules, with the source for each limit.
ImporterProducts made outside the EU that it places on the EU market.Suppliers' documents read and dated before the goods arrive.

Member states

The Regulations apply directly in each member state. Infant formula is notified to the competent authority of each member state where it is sold, and member states may further restrict or prohibit advertising of infant formula.

Questions businesses ask

Which EU law covers infant formula and baby food?
Regulation (EU) No 609/2013 on food for specific groups. Delegated Regulation (EU) 2016/127 sets the rules for infant and follow-on formula, and Directive 2006/125/EC still covers processed cereal-based food and other baby food.
What is the difference between infant formula and follow-on formula?
Infant formula is used in the first months of life and meets infants' nutritional needs by itself. Follow-on formula is used once complementary feeding begins, as the main liquid in a progressively diversified diet.
Do I need to notify infant formula before selling it in the EU?
Yes. The food business operator notifies the competent authority of each member state where it is sold, sending a model of the label. Some follow-on formulae must be notified too, unless the member state exempts them.
Can infant formula carry nutrition or health claims in the EU?
No. Delegated Regulation (EU) 2016/127 says nutrition and health claims shall not be made on infant formula.
Can a formula label show a picture of a baby?
No. The labelling of infant and follow-on formula may not include pictures of infants, or other pictures or text that may idealise their use. Graphics that identify the product or show how to prepare it are allowed.
What must a baby food label show in the EU?
The age from which it may be used, not less than four months; whether it contains gluten if that age is under six months; energy, protein, carbohydrate and lipid content; and preparation instructions where needed.
What is the pesticide limit for baby food in the EU?
No more than 0.01 mg/kg of any individual pesticide residue in formula and baby food. Certain very toxic pesticides may not be used at all, and lower levels apply to a few others.
Are growing-up milks regulated as infant formula?
No. The Commission concluded that young-child formulae need no specific rules, and since 20 July 2016 they are covered by the horizontal rules of EU food law.
Can infant formula be advertised in the EU?
Only in publications specialising in baby care and in scientific publications, with scientific and factual information. There may be no point-of-sale advertising or samples at retail, and member states may restrict advertising further.
When can a formula say 'lactose free'?
When lactose is no more than 2.5 mg/100 kJ (10 mg/100 kcal). Unless the protein source is soya protein isolate, it is accompanied by 'not suitable for infants with galactosaemia', in the same size and close to it.
Which language must a formula label be in?
The mandatory particulars appear in a language easily understood by consumers. The general food information rules also let a member state require its own official languages.
How does Compliant Always help with selling in the EU?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant 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.

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