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Selling infant formula and baby food in the UK

In 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.

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

Framework
Assimilated Regulation (EU) No 609/2013
Formula rules
Assimilated Delegated Regulation (EU) 2016/127
Baby food in England
Processed Cereal-based Foods and Baby Foods Regulations 2003
Before sale
Notification of infant formula to the competent authority
Claims
Nutrition and health claims prohibited on infant formula
Who enforces
Trading standards or environmental health, and port health

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, or processed cereal-based food or baby food? Read more
  2. 2Does the formula meet the composition rules, including the mandatory DHA? Read more
  3. 3Does the label carry the mandatory statements, and keep infant and follow-on formula distinct? Read more
  4. 4Has the infant formula been notified with a model of the label? Read more
  5. 5Do the advertising and promotion stay within the limits? Read more
  6. 6Does the baby food label give the age, gluten status and nutrition values? Read more

The rules, by area

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

Food for specific groups

Which products the rules cover, and how they are defined.

  • The food for specific groups Regulation covers infant and follow-on formula, processed cereal-based food and baby food, food for special medical purposes, and total diet replacement for weight control.
  • An infant is a child under 12 months; a young child is aged between one and 3 years.
  • Infant formula satisfies by itself the nutritional needs of infants in the first months of life; follow-on formula is the principal liquid once appropriate complementary feeding is introduced.
  • The legislation is devolved: England, Scotland and Wales each have their own enforcement regulations, and DHSC guidance says the principles are similar across GB.

How we help: Compliant Always records which category each product falls in, and the rules that follow from it. Ask about this

Formula composition and labelling

What infant and follow-on formula contain, and what their labels say.

  • Delegated Regulation (EU) 2016/127 sets composition, labelling and advertising rules, including the mandatory addition of docosahexaenoic acid (DHA).
  • Infant formula states it is "suitable for infants from birth when they are not breast fed" and carries an "Important Notice" on the superiority of breast feeding.
  • Labels give preparation, storage and disposal instructions with a warning about the risks of inappropriate preparation, and must not use "humanised", "maternalised" or "adapted".
  • Infant and follow-on formula labels differ in text, images and colours. Labelling must not include a picture of an infant or anything that idealises the product.
  • The nutrition declaration is per 100 ml prepared, includes the listed vitamins and minerals, and omits salt. Nutrition and health claims are prohibited on infant formula.
  • Formula also meets the food information rules of Regulation (EU) No 1169/2011 unless the Delegated Regulation says otherwise.

How we help: Compliant Always sets the mandatory formula statements beside your label and flags images or wording the guidance lists as idealising. Ask about this

Notification

What the authority is told before formula goes on sale.

  • No food business operator may place infant formula on the market without prior notice to the competent authority where it is marketed; in England, that is the Secretary of State for Health and Social Care.
  • The notification includes a model of the label and other information the authority reasonably requests.
  • DHSC coordinates notification forms for England, Scotland and Wales.
  • Follow-on formula is notified where it is made from protein hydrolysates or contains substances not listed in Annex II.

How we help: Compliant Always keeps each notification and the label model sent with it, so a changed label is matched to what was notified. Ask about this

Advertising and promotion

The limits on how infant formula is promoted.

  • Advertising of infant formula is restricted to publications specialising in baby care and scientific publications, and contains only scientific and factual information.
  • Point-of-sale advertising, samples and other promotional devices to induce sales of infant formula directly to the consumer at retail level are prohibited.
  • DHSC guidance lists discount coupons, price reductions, multi-buys, loyalty schemes and gifts as covered by the prohibition.
  • Labelling, presentation and advertising of infant and follow-on formula must not discourage breastfeeding.

How we help: Compliant Always keeps promotional material for formula with the product, so it can be checked against the advertising limits before use. Ask about this

Processed cereal-based food and baby food

Weaning foods for infants and young children.

  • Processed cereal-based food covers simple cereals, cereals with added high-protein food, pastas, and rusks and biscuits; baby food covers other weaning foods. Milks for young children are not covered.
  • Products must not contain residues of individual pesticides above 0.01 mg/kg, unless a specific level is set.
  • Labels state the age from which the product may be used, which cannot be less than four months, and whether it contains gluten if that age is below six months.
  • Labels give energy, protein, carbohydrate and fat per 100 g or 100 ml, and the listed vitamins and minerals.
  • Voluntary guidelines published in August 2025 for England set sugar and salt targets and labelling actions, to be met by the end of February 2027. They restrict most free sugars in meals, finger foods and drinks aimed at babies up to 12 months.

How we help: Upload a pesticide residue report and Compliant Always reads it against the 0.01 mg/kg default limit, and keeps it with the batch. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Food business operatorComposition, labelling, notification of infant formula, and promotion within the limits.Specifications, notifications and label versions kept together and dated.
ManufacturerComposition, pesticide residues and the clinical evaluation of protein hydrolysate formula.Test reports and specifications kept with each batch.
RetailerNot running point-of-sale promotions, samples or price promotions on infant formula.The product facts a retailer needs, shown from the record.
UK importerThe address on the label where the business is outside the UK, and the paperwork behind imported formula.Overseas suppliers' certificates read and dated before the goods arrive.

Great Britain and Northern Ireland

EU nutrition legislation listed in the Windsor Framework continues to apply directly in Northern Ireland, with NI's own enforcement regulations. Northern Ireland takes part in GB risk assessment and risk management under a UK-wide common framework.

Scotland and Wales have their own enforcement regulations for food for specific groups. The 2025 voluntary baby food guidelines apply to England.

Questions businesses ask

Which rules apply to infant formula in Great Britain?
Assimilated Regulation (EU) No 609/2013 on food for specific groups and Delegated Regulation (EU) 2016/127, which set composition, labelling and advertising rules for infant and follow-on formula.
Do I need to notify infant formula before selling it in the UK?
Yes. Infant formula cannot be placed on the market without prior notice to the competent authority, with a model of the label. DHSC coordinates the forms for England, Scotland and Wales.
Can infant formula make health claims?
No. Nutrition and health claims are prohibited on infant formula, and DHSC considers this to include its advertising.
Can a formula label show a picture of a baby?
No. The labelling of infant and follow-on formula must not include a picture of an infant or any other picture or text that may idealise its use.
Is DHA required in infant formula?
Yes. Delegated Regulation (EU) 2016/127 makes the addition of docosahexaenoic acid (DHA) mandatory in infant and follow-on formula.
Can infant formula be discounted or promoted in shops?
No. Point-of-sale advertising, samples and promotional devices for infant formula at retail are prohibited; DHSC guidance includes price reductions, coupons and multi-buys.
What must a follow-on formula label say?
That it is suitable only for infants over 6 months, forms part of a diversified diet, and is not a substitute for breast milk in the first 6 months.
What age can baby food be labelled from?
The stated age cannot be less than four months. If it is below six months, the label says whether the product contains gluten.
What is the pesticide limit for baby food?
Individual pesticide residues must not exceed 0.01 mg/kg in processed cereal-based food and baby food, unless a specific level is set.
Are there sugar and salt limits for baby food in England?
Voluntary guidelines from August 2025 set sugar and salt reduction targets and labelling actions for products for children up to 36 months, to be met by the end of February 2027.
Do the same formula rules apply in Northern Ireland?
EU nutrition legislation applies directly in Northern Ireland under the Windsor Framework, with NI's own enforcement regulations.
How does Compliant Always help with selling in the UK?
Our team reads the rules for the markets you sell in, including the split between Great Britain and Northern Ireland. Compliant Always shows which apply to your product and keeps the documents behind each one ready. 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.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the UK and what your paperwork needs to show.

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