Labelling

The labelling of infant formulae and follow on formulae shall present:

  • the mandatory food information referred to in the Food Information Regulation (EU) No 1169/2011, and
  • the mandatory additional labelling referred to in Delegated Regulation (EU) 2016/127

Mandatory food information

The mandatory food information (EU) No 1169/2011 shall be provided on infant formulae and follow on formulae:

  • the name of the food (infant formula or follow on formula)
  • the list of ingredients
  • any ingredients causing allergies or intolerances
  • the quantity of certain ingredients or categories of ingredients (if applicable)
  • the quantity of content
  • the name, business name or auxiliary business name and address of the responsible food business operator
  • the country of origin or place of provenance (if applicable)
  • a nutrition declaration
  • instructions for preparation, storage and disposal, and a warning against the health hazards of inappropriate preparation and storage.
  • correct information about the appropriate use of the product so as not to discourage breast feeding

Mandatory additional information on infant formulae

In addition to the mandatory food information, the following shall be provided on infant formulae (Delegated Regulation (EU) 2016/127):

  • the name of the product "infant formula" or "milk-based infant formula" (if manufactured solely from cow's milk protein)
  • a statement that the product is suitable for infants from birth when they are not breast fed
  • instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage
  • preceded by the words ‘important notice’ or their equivalent 
    • a statement concerning the superiority of breast feeding
    • a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for
      maternal and child care

Mandatory additional information on follow-on formulae

  • the name of the product "follow on formula" or "milk-based follow on formula" (if manufactured solely from cow's milk protein)
  • the following statements:
    • the product is suitable only for infants over the age of six months
    • it should form only part of a diversified diet
    • it is not to be used as a substitute for breast milk during the first six months of life
    • the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, based on the individual infant's specific growth and development needs
  • instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage

Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between the products. The labelling of infant formulae and follow on formulae shall provide necessary information about the appropriate use of the products so as not to discourage breast feeding. The use of the terms "humanised", "maternalised", "adapted", or similar terms shall be prohibited.

Nutrition declaration

Infant formulae and follow on formulae shall bear a nutrition declaration. The mandatory nutrition declaration shall include the information referred to in the Food Information Regulation (EU) 1169/2011 (salt excluded) and the mandatory additional information defined in the Delegated Regulation (EU) 2016/127.

The energy value and the amounts of nutrients of infant formula and follow-on formula shall be expressed per 100 ml of the food ready for use after preparation in accordance with the manufacturer's instructions. Where appropriate, the information may in addition refer to 100 g of the food as sold.

Mandatory nutrient declaration

The mandatory nutrition declaration for infant formula and follow-on formula must include the following information in 100 ml of the product ready for use:

  • energy
  • fat
  • saturates
  • carbohydrate
  • sugars
  • protein
  • the amount of each mineral substance and of each vitamin listed in Annex I or Annex II and present in the product, with the exception of molybdenum.

The mandatory nutrition declaration for infant formula shall also include the amounts of

  • choline,
  • inositol and
  • carnitine.

Voluntary nutrition declaration

In addition, the content of the mandatory nutrition declaration for infant formula and follow-on formula may be supplemented with one or more of the following statements of the Delegated Regulation (EU) 2016/127:

  • the amounts of components of protein, carbohydrate or fat
  • the whey protein/casein ratio
  • the amount of any of the substances listed in Annex I or Annex II or in the Annex to Regulation (EU) No 609/2013
  • the amount of any of the substances added to the product pursuant to Article 3

The percentage of vitamins and minerals expressed as reference intake values, presented in Annex VII to the Delegated Regulation (EU) 2016/127, can be indicated in the labelling of follow on formula, in addition to their amounts.

The information included in the mandatory nutrition declaration for infant formula and follow-on formula shall not be repeated on the labelling.

Page last updated 7/2/2026