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Food for infants and young children

To ensure appropriate nutritional composition and safety of foods specifically manufactured for infants and young children, as well as appropriate consumer information, the Commission has defined specific rules for such foodstuffs. The rules concern infant and follow-on formulae, processed-cereal based foods and baby foods and additives in foods for infants and young children.

Glossary

Infants

Children under the age of 12 months

Young children

Children aged between 1 and 3 years

Infant formulae

Foodstuffs 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

Foodstuffs used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants

Processed cereal baby-food and baby foods

Foodstuffs intended for use by infants when they are weaned and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food

 

Formulae

Infant formula and follow-on formula are products designed to satisfy the specific nutritional requirements of healthy infants (children under the age of 12 months). These products are specifically covered by Commission Directive 2006/141/EC.

The Directive lays down the requirements for the composition and labelling of infant formula and follow-on formula. The annexes of the Directive give criteria for the composition (protein, carbohydrate, fat, mineral substances, vitamins and certain other ingredients) of infant formulae and follow-on formulae including, where necessary, minimum and maximum levels.

Commission Regulation (EC) No 1609/2006 authorised the placing on the market of infant formulae based on hydrolysates of cow's milk in accordance with specifications for the protein content source, processing and quality set out in the Annex thereto for a period of two years.

Further to the expiry of such Regulation, these specifications concerning protein quality were added to Directive 2006/141/EC by adopting Commission Regulation (EC) No 1243/2008.

Commission Directive 2013/46/EU extended these specifications to follow-on formulae based on hydrolysates of cow's milk and also authorised the placing on the market in the EU of infant formulae and follow-on formulae manufactured from goats' milk protein.

Certain of the rules on composition and labelling of infant and follow-on formulae also apply to exports of the products to third countries ( Council Directive 92/52/EEC). In addition, Council Resolution of 18 June 1992pdf(6 MB) Choose translations of the previous link  on the marketing of breastmilk substitutes in third countries by Community-based manufactures foresees measures to support appropriate marketing practices for breast-milk substitutes in third countries.

Directive 2006/141/EC also encompasses the specific rules on the presence of pesticides residues in infant and follow-on formulae, previously set out in Commission Directive 1999/50/EC. It requires that infant formula and follow-on formula contain no detectable levels of pesticide residues, meaning not more than 0.01 milligrams of pesticide residues per kilogram. The Directive also prohibits the use of certain very toxic pesticides in the production of infant and follow-on formulae and establishes levels lower than the general maximum level of 0.01 milligrams per kilogram for a few other very toxic pesticides.

In addition to the requirements relating to infant formulae and follow-on formulae in Directive 2006/141/EC, there are also specific provisions on hygiene, on the use of food additives, on the presence of contaminants in the products and on the use of materials intended to come into contact with foodstuffs.

What will the new Regulation on Food for Specific Groups do for infant formulae and follow-on formulae from 20 July 2016?

  • Set general compositional and labelling rules. In addition, the new Regulation extends to the labelling of follow-on formula the existing restriction of use of pictures or text which may idealize the use of products (currently only applicable to infant formula)

  • Require the Commission to adopt, through delegated act, specific compositional and information rules for infant and follow-on formulae, which will replace Directive 2006/141/EC.

 

Scientific advice on the composition of infant formulae and follow-on formulae
  • Scientific Opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae

  • Scientific Opinion related to the safety and suitability for particular nutritional use by infants of formulae based on whey protein partial hydrolysates with a protein content of at least 1.9 g protein/100 kcal (2005)

  • Scientific Opinion related to the safety and suitability for particular nutritional use by infants of fructooligosaccharides in infant formulae and follow-on formulae (2004)

  • Scientific Opinion related to the evaluation of goats' milk protein as a protein source for infant formulae and follow-on formulae (2004)

  • Statement replying to applicant's comment on the Panel's Opinion relating to the evaluation of goat's milk protein as a protein source for infant formulae and follow-on formulae (2005)

  • Reportpdf(3 MB) Choose translations of the previous link  on the revision of essential requirements of infant formulae and follow-on formulae (2003)

  • Statementpdf(28 kB) Choose translations of the previous link  on the use of resistant short chain carbohydrates (oligofructose and oligogalactose) in infant formulae and in follow-on formulae (2001)

  • Additional statementpdf(27 kB) Choose translations of the previous link  on the use of resistant short chain carbohydrates (oligofructosyl-saccharose and oligogalactosyl-lactose) in infant formulae and in follow-on formulae (2001)

  • Scientific Opinionpdf(6 MB) on the calculation of vitamin E content of infant formulae and follow-on formulae (1996)

  • Scientific Opinionpdf(6 MB) on phthalates in infant formulae (1996)

  • Reportpdf(4 MB) Choose translations of the previous link  on essential requirements for infant formulae and follow-on formulae (1993)

  • Reportpdf(6 MB) Choose translations of the previous link  on infant formulae claimed to be 'hypoallergenic' or 'hypoantigenic' (1991)

  • Reportpdf(3 MB) Choose translations of the previous link  on the minimum requirements for soya-based infant formulae and follow-up milks (1988)

  • First reportpdf(6 MB) Choose translations of the previous link  on the essential requirements of infant formulae and follow-up milks based on cows' milk proteins (1983)

  • First Addendumpdf(4 MB) Choose translations of the previous link  to the Report concerning the essential requirements of infant formulae and follow-up milks based on cows' milk (1989)

  • First Addendumpdf(4 MB) Choose translations of the previous link  to the Report concerning the minimum requirements for soya-based infant formulae and follow-up milks (1989)

  • Second Addendumpdf(6 MB) Choose translations of the previous link  concerning the essential requirements of infant formulae and follow-up milks based on cows' milk proteins and the minimal requirements for soya-based infant formulae and follow-up milks (1991)

Additional Scientific Advice

 

Cereals and other baby foods

Processed-cereal based foods and other baby foods (weaning foods) are specifically intended for infants (children under the age of 12 months) and young children (between one and three years) as they progress onto a mixed family diet.

Processed cereal-based foods and baby foods for infants and young children are covered by Commission Directive 2006/125/EC. It sets out rules on the composition and labelling of processed-cereal based foods and other baby foods. It gives criteria for the composition (protein, carbohydrate, fat, mineral substances and vitamins) of weaning foods including, where necessary, minimum and maximum levels.

The Directive encompasses the specific rules on the presence of pesticides residues in processed cereal-based baby foods and baby foods set out in Commission Directive 99/39/EC and requires that this type of food contains no detectable levels of pesticide residues, meaning not more than 0.01 milligrams of pesticide residues per kilogram. In addition, the Directive prohibits the use of certain very toxic pesticides in the production of processed cereal-based baby foods and baby foods and establishes levels lower than the general maximum level of 0,01 milligrams per kilogram for a few other very toxic pesticides.

In addition to the requirements relating to processed-cereal based foods and other baby foods in Directive 2006/125/EC there are also specific provisions on hygiene, on the use of food additives, on the presence of contaminants in the products and on the use of materials intended to come into contact with foodstuffs.

What will the new Regulation on Food for Specific Groups do for processed cereal-based foods and other baby foods from 20 July 2016?

  • Set general compositional and labelling rules

  • Require the Commission to adopt, through delegated act, specific compositional and labelling rules for processed cereal-based foods and baby foods, which will replace Directive 2006/125/EC

 

Scientific advice on the composition of processed cereal-based foods and baby foods

Additional scientific advicepdf(119 kB) Choose translations of the previous link  on pesticide residues in foods for infants and young children

 

Additives

When an application is submitted for the use of a food additive in food for infants or young children, the European Commission may ask the European Food Safety Authority (EFSA) to consider its safety aspects. EFSA then draws up an opinion, on the basis of which the Commission would work closely with Member States' experts to consider whether or not to authorise the food additive, taking into account the technological need of the requested use. Only if the use of the additive is deemed safe and justified, can it be authorised for use in food for infants and young children.

The use of additives in foods for infants and young children in good health and in foods for special medical purposes for the same age group is regulated by European Parliament and Council Regulation (EC) No 1333/2008 on food additives. The authorised additives and their specific conditions of use are listed in Annex VI of European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners. Neither colours nor sweeteners are authorised in these foodstuffs.

 

Scientific advice on the composition of additives