Infant formulae and follow-on formulae
See our update on Changes to Infant Formula Composition (October 2019)
Commission Directive 2006/141/EC (OJ L401, p1, 30/12/2006 ) of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC
- Commission Regulation (EC) No 1243/2008 (OJ L335, p25, 13/12/2008) of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae
- Commission Directive 2013/46/EU (OJ L230, p16, 29/08/2013) of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae
Consolidated version of Directive 2006/141/EC as at 18 September 2013
Council Directive 92/52/EEC (OJ L179, 01/07/1992, p129) of 18 June 1992 on infant formulae and follow-on formula intended for export to third countries
Council Resolution (OJ C172, p1, 08/07/1992) of 18 June 1992 on the marketing of breast-milk substitutes in third countries by Community- based manufacturers
Legislation change in 2020
The Regulation below will apply in place of Directive 2006/141/EC from 22 February 2020, except in respect of infant formula and follow-on formula manufactured from protein hydrolysates, to which it will apply from 22 February 2021.
Commission Delegated Regulation (EU) 2016/127 (OJ L 25, 2.2.2016, p. 1–29) 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
European Communities (Infant Formulae and Follow-on Formulae) Regulations 2007 (S.I. No. 852 of 2007)
- European Communities (Infant Formulae and Follow on Formulae) (Amendment) Regulations 2009 (SI No 209 of 2009)
- European Communities (Infant Formulae and Follow-on Formulae)(Amendment)Regulations 2013 (S.I. No. 384 of 2013)
- European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2014 (S.I. No. 92 of 2014)
Commission Directive 2006/141/EC is a ‘specific Directive’ within the meaning of Article 4(1) of Directive 2009/39/EC and it lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health. For the purpose of this legislation, infants are defined as children under the age of 12 months; and ‘young children’ means children aged between one and three years.
Infant formulae and follow-on formulae may only be marketed within the European Community if they comply with Directive 2006/141/EC. The Directive defines ‘infant formulae’ as meaning "foodstuffs intended for particular nutritional use 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"; and ‘follow-on formulae’ as meaning "foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants";
The legislation prescribe the protein sources for the manufacture of formulae and also set out the compositional criteria for both infant formulae and follow-on formulae. Restrictions on advertising and provision of information on infant and young child feeding intended to reach pregnant women and mothers of infants and young children are laid down and detailed labelling requirements for infant formulae and follow-on formulae are prescribed.
In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.
Infant formulae and follow-on formulae must not contain residues of individual pesticides at levels exceeding 0.01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.
The pesticides listed in Annex VIII to Directive 2006/141/EC must not be used in agricultural products intended for the production of infant formulae and follow-on formulae. However, for the purpose of controls:
- pesticides listed in Table 1 of Annex VIII are considered not to have been used if their residues do not exceed a level of 0.003 mg/kg
- pesticides listed in Table 2 of Annex VIII are considered not to have been used if their residues do not exceed a level of 0.003 mg/kg.
Both of the above levels are kept under regular review by the EU in the light of of technical progress and data on environmental contamination.
Infant formulae and follow-on formulae must 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 infant formulae and follow-on formulae.
The labelling must bear, in addition to those indications provided for in Article 9 (1) of Regulation (EU) 1169/2011 on the provision of food information to consumers, the following mandatory particulars:
(a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast fed;
(b) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of six months, that it should form only part of a diversified diet, that it is not to be used as a substitute for breast milk during the first six months of life and that 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;
(c) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use;
(d) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol and carnitine, expressed in numerical form, per 100 ml of the product ready for use
(e) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage.
The labelling may bear the following particulars:
(a) for infant formulae and follow-on formulae the average quantity of nutrients mentioned in Annex III to Directive 2006/141/EC when such declaration is not covered by paragraph 1(d) of Article 13, expressed in numerical form, per 100 ml of the product ready for use;
(b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in Annex VII to Directive 2006/141/EC expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use.
The labelling of infant formulae and follow-on formulae must be designed to provide the 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 are prohibited.
The labelling of infant formulae must bear the following mandatory particulars, 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.
The labelling of infant formulae may not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation.
The labelling of infant formulae may bear nutrition and health claims only in the cases listed in Annex IV to Directive 2006/141/EC and in accordance with the conditions set out therein.
The requirements, prohibitions and restrictions referred to above also apply to:
(a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;
The advertising and promotion of infant formula is strictly regulated. However, the rules allow for some latitude in addressing health professionals. The FSAI has drafted 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.
Advertising of infant formulae is restricted to publications specialising in baby care and scientific publications. Such advertisements for infant formulae are subject to the conditions laid down in Article 13(3) to (7) and Article 13(8)(b) of Directive 2006/141/EC and contain only information of a scientific and factual nature. Such information must not imply or create a belief that bottle-feeding is equivalent or superior to breast feeding.
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 formulae 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 of informational or educational equipment or materials by manufacturers or distributors may be made only on request and with the written approval of the
appropriate national authority or within guidelines given by that authority for this purpose. Such equipment or materials may bear the donating company’s name or logo, but may not refer to a proprietary brand of infant formulae and can only be distributed through the health care system.
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.
When a food business operator places an infant formula on the market he must notify the competent authority of the Member States where the product is being marketed by forwarding to it a model of the label used for the product. In Ireland, the competent authority is the Food Safety Authority of Ireland.
Food businesses must notify us when an infant formula is first placed on the market. Also, changes such as reformulations or the addition of new ingredients to a product already on the market will require notification. 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.
(Note: For future reference, the system can also be easily accessed on the FSAI homepage under Quick Links> Food Notifications.)
Council Directive 92/52/EEC specifies that some of the rules on composition and labelling of infant and follow-on formulae within the EU also apply to exports of the products to third countries. In addition, Council Resolution of 18 June 1992 on the marketing of breastmilk substitutes in third countries by Community-based manufactures sets out measures to support appropriate marketing practices for breast-milk substitutes in third countries
Last reviewed: 9/4/2020