Infant formula and follow-on formula are products that are designed to satisfy the specific nutritional requirements of healthy infants and young children. Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC is the result of the revision of the legislation on infant formulae and follow-on formulae.

This directive replaces Commission Directive 91/321/EEC on infant formulae and follow-on formulae, and its successive amendments, as well as amending Directive 1999/21/EC on dietary foods for special medical purposes:
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, following the Scientific advice of the Scientific Committee on Food.

Pending the transposition into national legislations of Directive 2006/141/EC , Commission Regulation 2006/1609/EC of 27 October 2006 provides for the temporary marketing of infant formulae based on hydrolysates of whey protein derived from cows’ 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 1992 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 and is based on the advice of the Scientific Committee on Food. 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. These rules were initially set out in Directive 2003/14/EC and have also been included in Directive 2006/141/EC.

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: hygiene, food additives, contaminants and food contact materials.

Scientific advice

Composition of infant formulae and follow-on formulae

Opinion of the European Food Safety Authority 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 (Adopted on 5 October 2005)

Report of the Scientific Committee for Food on Food on the Revision of Essential Requirements of Infant Formulae and Follow-on Formulae (adopted on 4 April 2003)

Additional statement of the Scientific Committee for Food on the use of resistant short chain carbohydrates (oligofructosyl-saccharose and oligogalactosyl-lactose) in infant formulae and in follow-on formulae (expressed on 13 December 2001)

Statement of the Scientific Committee for Food on the use of resistant short chain carbohydrates (oligofructose and oligogalactose) in infant formulae and in follow-on formulae (expressed on 26 September 2001)

Opinion of the Scientific Committee for Food on the calculation of vitamin E content of infant formulae and follow-on formulae (expressed on 7 June 1996)

Report of the Scientific Committee for Food on nutrient and energy intakes for the European Community (expressed on 11 December 1992)

Report of the Scientific Committee for Food on essential requirements for infant formulae and follow-on formulae (expressed on 17 September 1993)

Report of the Scientific Committee for Food on infant formulae claimed to be 'hypoallergenic' or 'hypoantigenic' (adopted on 9 December 1991)

Second addendum of the Scientific Committee for Food 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 (adopted on 9 December 1991)

First Addendum to the Report of the Scientific Committee for Food concerning the essential requirements of infant formulae and follow-up milks based on cows' milk (expressed on 27 October 1989)

First Addendum to the Report of the Scientific Committee for Food concerning the minimum requirements for soya-based infant formulae and follow-up milks (expressed on 27 October 1989)

Report of the Scientific Committee for Food on the minimum requirements for soya-based infant formulae and follow-up milks (expressed on 9 December 1988)

First Report of the Scientific Committee for Food on the essential requirements of infant formulae and follow-up milks based on cows' milk proteins (expressed on 27 April 1983)

Pesticide residues in foods for infants and young children

Further advice on the opinion of the Scientific Committee for Food expressed on the 19 September 1997 on a Maximum Residue Limit (MRL) of 0.01 mg/Kg for pesticides in foods intended for infants and young children (adopted by the SCF on 4 June 1998)

Opinion of the Scientific Committee for Food on Lindane in Foods Intended for Infants and Young Children (expressed on 15th January 1998)