Infant and follow-on formula – composition and information

KEY POINTS

Infant formula or follow-on formula not manufactured entirely from cows’ milk or goats’ milk proteins must carry the names as set out for each official language of the European Union (EU). In English, they are respectively ‘infant formula’ and ‘follow-on formula’.

Ingredients

Infant formula and follow-on formula must:

• comply with this regulation, and with other relevant rules of EU food law, including Regulation (EU) No 1169/2011 on providing food information to consumers;
• follow the compositional requirements of the regulation that are applicable to products ready for use, marketed as such or to products ready for use after preparation as instructed by the manufacturers;
• require nothing more than the addition of water for preparation in accordance with the manufacturer’s instructions;
• be manufactured from protein sources as set out in the regulation and other food ingredients whose suitability for infants from birth (for infant formula) or for infants aged over 6 months (for follow-on formula) is recognised by generally accepted scientific data;
• not contain pesticide residues exceeding 0.01 mg/kg per active substance, with certain exceptions;
• not be made from agricultural products using pesticides containing the banned substances listed in the regulation, subject to a maximum residue value for the purposes of checking.

No product other than infant formula may be marketed or represented as suitable to satisfy the nutritional requirements of normal healthy infants during the first months of life.

Food information

Formula must comply with Regulation (EU) No 1169/2011 on providing food information to consumers, with the following additional information:

• for infant formula:
  • a statement that the product is suitable for infants from birth when they are not breastfed,
  • an ‘important notice’ (also included in any advertising) about the superiority of breastfeeding and a statement recommending that the product be used only on professional advice;
• for follow-on formula:
  • a statement that the product is suitable only for infants over 6 months, only as part of a diversified diet, not to be used as a substitute for breast milk during the first 6 months and that the decision to begin complementary feeding should be made only on professional advice based on the individual infant’s specific growth and development needs;
• instructions for the preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage.

The labelling, presentation and advertising of infant formula and follow-on formula must provide the necessary information about the appropriate use of the products. This is so as not to discourage breastfeeding, and the information provided must avoid any risk of confusion between infant formula and follow-on formula.

In addition to the information referred to in Regulation (EU) No 1169/2011, the mandatory nutrition declaration for infant formula and follow-on formula must include the amount of each mineral substance and of each vitamin listed in annexes to this regulation, respectively, and present in the product, with the exception of molybdenum and the amount of salt.

The mandatory nutrition declaration may be supplemented with the amounts of components of protein, carbohydrate or fat and the whey protein / casein ratio, and other substances listed in the annexes to this regulation or Regulation (EU) No 609/2013.

Nutrition and health claims must not be made on infant formula.

The statement ‘lactose only’ may only be used where lactose is the only carbohydrate present in the product. The statement ‘lactose free’ is for use only where the lactose content is not greater than 2.5 mg/100 kJ (10 mg/100 kcal).

When the statement ‘lactose free’ is used for formula manufactured from protein sources other than soya protein isolates, it must be accompanied by the statement ‘not suitable for infants with galactosaemia³’. The statement ‘contains Docosahexaenoic acid (DHA)⁴’ or ‘contains DHA’ (as required by the legislation for all infant formula) may only be used for infant formula placed on the market before 22 February 2025.

Advertising and promotion

Advertising of infant formula, which must only contain information of a scientific and factual nature, is restricted to publications specialising in baby care and scientific publications. EU Member States can apply stricter rules such as banning such advertising. Advertising must not imply or create a belief that bottle feeding is equivalent or superior to breastfeeding.

There must be no point-of-sale advertising, free samples or any other promotional device to induce sales of infant formula directly to the consumer.

Feeding information

Member States must ensure that objective information is provided on infant and young child feeding. Informational and educational materials must include clear information on the following:

• the benefits and superiority of breastfeeding;
• maternal nutrition and the preparation for, and maintenance of, breastfeeding;
• the possible negative effect on breastfeeding of introducing partial bottle feeding;
• the difficulty of reversing the decision not to breastfeed;
• where needed, the proper use of infant formula.

Such information must include the social and financial implications of the use of infant formula, the health hazards of inappropriate foods or feeding methods, and the health hazards of improper use of infant formula. It must not contain any pictures that could idealise the use of infant formula.

Notification

When infant formula is placed on the market, the food business operator must notify national authorities of the information on the label by sending a model of the label used and all relevant information considered necessary to demonstrate compliance with the regulation. This also applies to follow-on formula manufactured from protein hydrolysates or including certain substances.