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Infant formulae and follow-on formulae

See our update on Changes to Infant Formula Composition (October 2019)

Infant formulae and follow-on formulae

Infant formulae and follow-on formulae are products designed to satisfy the specific nutritional requirements of healthy infants.

  • Glossary
    Infants Children under the age of 12 months
    Young children Children aged between 1 and 3 years
    Infant formulae Food used by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding
    Follow-on formulae Food used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants

     

  • EU Legislation

    The Commission Delegated Regulation (EU) 2016/127 (OJ L 25, 2.2.2016, p. 1–29) of 25 September 2015 came into force on the 22nd February 2020, except for the rules on infant formula and follow-on formula manufactured from protein hydrolysates, to which have applied since 22 February 2021. This Regulation replaced the previous Directive 2006/141/EC. The Commission Delegated Regulation (EU) 2016/127 supplemented Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding.

    Amended by:

    •    Commission Delegated Regulation (EU) 2023/589 of 10 January 2023 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates.
    •    Commission Delegated Regulation (EU) 2022/519 of 14 January 2022 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates.
    •    Commission Delegated Regulation (EU) 2021/1041 of 16 April 2021 amending Delegated Regulation (EU) 2016/127 as regards the requirements on pesticides in infant formula and follow-on formula.
    •    Commission Delegated Regulation (EU) 2021/572 of 20 January 2021 amending Delegated Regulation (EU) 2016/127 as regards the date of application of certain of its provisions.
    •    Commission Delegated Regulation (EU) 2019/828 of 14 March 2019 amending Delegated Regulation (EU) 2016/127 with regard to vitamin D requirements for infant formula and erucic acid requirements for infant formula and follow-on formula.
    •    Commission Delegated Regulation (EU) 2018/561 of 29 January 2018 amending Delegated Regulation (EU) 2016/127 with regard to protein requirements for follow-on formula.

  • National Legislation

    European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) Regulations 2023 (S.I. No. 490/2023)

    These Regulations give further effect to Regulation (EU) No. 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control as amended by Commission Delegated Regulation (EU) 2023/439 of 16 December 2022. These Regulations also give effect to Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding, as amended by Commission Delegated Regulation (EU) 2018/561 of 29 January 2018, Commission Delegated Regulation (EU) 2019/828 of 14 March 2019, Commission Delegated Regulation (EU) 2021/572 of 20 January 2021, Commission Delegated Regulation (EU) 2021/1041 of 16 April 2021, Commission Delegated Regulation (EU) 2022/519 of 14 January 2022 and Commission Delegated Regulation (EU) 2023/589 of 10 January 2023.

    These Regulations amend the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) Regulations 2019 (S.I. No. 425 of 2019) in the manner specified in these Regulations.

  • Labelling

    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 galactosaemia*’. The statement ‘contains Docosahexaenoic acid (DHA)*’ 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.

    * Galactosaemia. A condition where an infant cannot consume galactose, one of the components of lactose, the sugar found in milk.
    *Docosahexaenoic acid (DHA). Fatty acid naturally found in breast milk and important in early brain and eye development.
  • Advertising and Marketing

    Article 10 of Commission Delegated Regulation (EU) 2016/127 sets out the rules in relation to the advertising of infant formula. The advertising and promotion of infant formula is strictly regulated. Advertising of infant formulae is restricted to publications specialising in baby care and scientific publications.

    Point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders, and tie-in sales, are prohibited.

    Manufacturers and distributors of infant formula must not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers. Donations or low-price sales of supplies of infant formulae to institutions or organisations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formulae and only for as long as required by such infants.

    However, the rules allow for some latitude in addressing health professionals. The FSAI has guidance for the infant formula industry on compliance with food law governing commercial communications to health professionals in relation to infant formula products  in Ireland. The FSAI has also created an assessment tool which allows industry to assess their compliance with current food law in this area.

  • Notifications

    When a food business operator places an infant formula on the market, they must notify the competent authority of the Member States where the product is being marketed by sending a model of the label used for the product. This requirement also applies to follow-on formula manufactured from protein hydrolysates or including certain substances.

    In Ireland, the competent authority is the Food Safety Authority of Ireland. The obligation to notify falls on the manufacturer if the product is manufactured in Ireland and on the importer if the product is imported into Ireland. Please notify your products online through the FSAI Food Notification System.

    Link to Bottle Feeding Safely - Expressed Breast Milk or Formula.

    Link to Guidance for Foods governed under Regulation (EU) No 609/2013 Foods for Specific Groups for the attention of competent authorities, manufacturers and retailers of infant formula, follow-on formula and food for special medical purposes (FSMPs).