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Infant formulae


Infant formulae and follow-on formulae for young children have to follow very strict rules regarding composition, maximum pesticide residues, labelling, advertising and marketing.


Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formula. [See amending acts].


Directive 91/321/EEC - Repealed as from 1 January 2008.

Directive 91/321/EEC is a specific Directive deriving from Directive 89/398/EEC.

It lays down rules for the marketing of infant formulae and follow-on formulae intended for use by infants in good health in the Community. It also provides for Member States to give effect to the principles and aims of the International Code of Marketing of Breast-milk Substitutes.

These marketing rules include the stipulation of authorised food ingredients, compositional criteria, substances which may be used in the manufacture of the formulae concerned, sales names, compulsory label information additional to that required under Council Directive 79/112/EEC on the labelling of foodstuffs, etc.

Advertising of infant formulae is restricted to publications specialising in baby care and scientific publications. Member States are required to ensure that objective and consistent information is provided on the feeding of infants and young children.


Directive 1999/50/EC

Directive 1999/50/EC reduces the maximum level of pesticide residues in infant formulae and follow-on formulae to 0.01 mg/kg. This level represents the minimum level detectable when using multi-residue methods for screening levels of more than a hundred substances at a time.

Directive 91/321/EC

Annex IX to the Directive lists those pesticides which are prohibited from use in agricultural products intended for the production of infant formulae and follow-on formulae. However, this prohibition does not necessarily guarantee that products are free from such pesticides, since some pesticides degrade slowly and still contaminate the environment, causing their residues to be present in the products concerned.

Directive 2006/141/EC

This Directive repeals Directive 91/321/EEC as from 1 January 2008.

Directive 2006/82/EC

This adapts Directive 91/321/EEC and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania.

Regulation (EC) No 1609/2006

This authorises the placing on the market of infant formulae based on hydrolysates of whey protein derived from cows' milk protein for a two-year period.

ActEntry into force - Date of expiryDeadline for transposition in the Member StatesOfficial Journal
Directive 91/321/EEC30.05.1991 - 01.01.2008-OJ L 175, 4.07.1991; corrigendum: OJ L 101, 4.05.1995

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal
Directive 1999/50/EC22.06.199930.06.2000OJ L 139 of 2.06.1999
Directive 2003/14/EC6.03.20036.03.2004OJ L 41 of 14.02.03
Acts of accession of the Czech Republic, Slovak Republic and the Republics of Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland and Slovenia to the European Union.1.05.2004-OJ L 236 of 23.09.2003
Directive 2006/141/EC--OJ L 401 of 30.12.2006
Directive 2006/82/EC---
Regulation (EC) No 1609/2006--OJ L 299 of 28.10.2006


Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [Official Journal L 364 of 20.12.2006].

Council Directive 92/52/EEC of 18 June 1992 on infant formulae and follow-on formulae intended for export to third countries [Official Journal L 179 of 1.07.1992].
The purpose of this Directive is to make sure that certain regulations of Commission Directive 91/321/EEC are applicable to the same products exported to third countries.

Last updated: 09.04.2008

See also

Further information on infant and young child nutrition is provided by the SCADplus factsheet on processed cereal-based baby foods.

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