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Infant formulae

The compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health are laid down in this Directive.

ACT

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC.

SUMMARY

Directive 2006/141/EC is a specific directive adopted pursuant to the Framework Directive concerning foodstuffs intended for particular nutritional uses.

Scope

This Directive lays down the compositional and labelling requirements for infant formulae * and follow-on formulae * intended for use by Community infants * in good health.

Composition

Infant formulae and follow-on formulae shall be manufactured from cows’ milk proteins or soya proteins and other food substances (minerals, vitamins, amino acids, etc.) set out in the Annex to the Directive.

Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children *.

Placing on the market

When infant formulae or follow-on formulae are placed on the market, the manufacturer or importer of the said formulae shall forward a model of the label used to the competent authority of the Member State where the product is to be marketed. This measure will facilitate official monitoring of the formulae being marketed.

Pesticide residues

The maximum pesticide residue level in infant formulae and follow-on formulae is set at 0.01 mg/kg of the product proposed ready for consumption.

The use of the pesticides listed in Annex VIII is prohibited in agricultural products intended for the production of infant formulae and follow-on formulae.

Labelling

The name under which infant formulae and follow-on formulae are sold, shall be respectively: “infant formulae” and “follow-on formulae”, unless they are entirely manufactured from cows' milk proteins. In this case their name shall be, respectively: "infant milk" and "follow-on milk".

Mandatory particulars are added to the general rules for the labelling, presentation and advertising of foodstuffs. These particulars state:

  • in the case of infant formulae:
    • that the product is suitable for particular nutritional use by infants from birth when they are not breast fed;
    • the superiority of breast feeding;
    • that the product is only to be used on the advice of independent persons qualified in this field.
  • in the case of follow-on formulae:
    • that the product is suitable for particular nutritional use by infants aged over six months,
    • that it should form only part of a diversified diet,
    • that it is not to be used as a substitute for breast milk during the first six months of life,
    • that the decision to begin complementary feeding should be made only on the advice of professionals responsible for maternal and child care;
  • in the case of infant formulae and follow-on formulae:
    • the energy value and protein, carbohydrate and fat content,
    • the average quantity of each mineral substance and vitamin (see Annexes I and II),
    • instructions concerning the preparation, storage and disposal of the product.

The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product.

Advertising

Advertising of infant formulae shall be restricted to publications specialising in baby care and scientific publications.

Member States shall ensure that advertising does not favour bottle-feeding over breast feeding. In any case, Member States may further restrict or prohibit the advertising of infant formulae.

Key terms of the Act
  • Infants: children under the age of 12 months.
  • Young children: children aged between one and three years.
  • Infant formulae: foodstuffs intended for particular nutritional use 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 intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal
Directive 2006/141/EC

19.1.2007

31.12.2007

OJ L 401 of 30.12.2006

Successive amendments and corrections to Directive 2006/141/CE have been incorporated in the basic text. This consolidated version  is for reference purpose only.
Last updated: 14.09.2010
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