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Document 32016R0127

Infant and follow-on formula – composition and information

Date of last review:
30/03/2023
Initial creation date:
27/01/2020
Summarised document(s):
Author:
Publications Office of the European Union
Responsible entity(ies):
Directorate-General for Health and Food Safety

Infant and follow-on formula – composition and information

 

SUMMARY OF:

Delegated Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 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

WHAT IS THE AIM OF THE REGULATION?

  • It supplements Regulation (EU) No 609/2013 on foods for specific groups, which requires the European Commission to adopt composition and labelling rules for infant formula* and follow-on formula*, through a delegated act, and based on the latest scientific advice.
  • It bans nutritional and health claims on infant formula to protect and encourage breastfeeding.
  • It helps national authorities to better monitor the infant formula market through additional notification rules.

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 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:

  • 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.

FROM WHEN DOES THE REGULATION APPLY?

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.

BACKGROUND

For further information, see:

KEY TERMS

Infant formula. Food used by infants (children under 12 months of age) 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 formula. Food used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants.
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.

MAIN DOCUMENT

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.

RELATED DOCUMENTS

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

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