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  Foods for Infants & Young Children - Infant Formulae and Follow-on Formulaeslide
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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 updates 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.

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 1992 pdf 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 baby food contains no detectable levels of pesticide residues, meaning not more than 0.01 milligrams of pesticide residues per kilogramme. 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 kilogramme 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.

Further information on the legislation in these areas is available on the specific webpages: food hygiene, food additives, food contaminants and food contact materials.

What will the new Regulation 609/2013 on Food for Specific Groups (FSG) do for infant and follow-on formulae from 20 July 2016?

  • Set general compositional and labelling rules. In addition the new Regulation extends the restriction of use of pictures or text which may idealise the use, beside of the already existing provisions to infant, also to follow-on formulae;
  • Require the Commission to adopt through delegated act specific compositional and labelling rules for infant and follow-on formulae, which will replace Directive 2006/141/EC.

Scientific advice

- 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 formula 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)

Report on the revision of essential requirements of infant formulae and follow-on formulae (2003)

Statement on the use of resistant short chain carbohydrates (oligofructose and oligogalactose) in infant formulae and in follow-on formulae (2001)

Additional statement on the use of resistant short chain carbohydrates (oligofructosyl-saccharose and oligogalactosyl-lactose) in infant formulae and in follow-on formulae (2001)

Scientific Opinion on the calculation of vitamin E content of infant formulae and follow-on formulae (1996)

Scientific Opinion on phthalates in infant formulae (1996)

Report on essential requirements for infant formulae and follow-on formulae (1993)

Report on infant formulae claimed to be 'hypoallergenic' or 'hypoantigenic' (1991)

Report on the minimum requirements for soya-based infant formulae and follow-up milks (1988)

First report on the essential requirements of infant formulae and follow-up milks based on cows' milk proteins (1983)

First Addendum to the Report concerning the essential requirements of infant formulae and follow-up milks based on cows' milk (1989)

First Addendum to the Report concerning the minimum requirements for soya-based infant formulae and follow-up milks (1989)

Second Addendum 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

- Pesticide residues in foods for infants and young children

Scientific Opinion on a maximum residue limit (MRL) of 0.01 mg/kg for pesticides in foods intended for infants and young children (1997)

Further advice on the Scientific Opinion on a maximum residue limit (MRL) of 0.01 mg/Kg for pesticides in foods intended for infants and young children (1998)

Scientific Opinion on lindane in foods intended for infants and young children (1998)

Scientific Opinion on lindane in baby foods (1994)

 
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