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Infant and follow-on formula – composition and information
Infant and follow-on formula – composition and information
Infant and follow-on formula – composition and information
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:
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:
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.
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:
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.
It has applied since 22 February 2020, except for the rules about infant formula and follow-on formula manufactured from protein hydrolysates, which have applied since 22 February 2022.
For further information, see:
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 (OJ L 25, 2.2.2016, pp. 1–29).
Successive amendments to Regulation (EU) 2016/127 have been incorporated into the original text. This consolidated version is of documentary value only.
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 and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35–56).
See consolidated version.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp. 18–63).
See consolidated version.
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9–25).
See consolidated version.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1–24).
See consolidated version.
last update 30.03.2023