European Union: Proposal to Recast and Amend Directive 91/321/EEC on Infant Formulae and Follow-on Formulae

Last Updated: 17 August 2004
Article by Kevin O'Connor

Originally published June 2004

On 6 April 2004 the European Commission released a working document for a proposal to amend and recast Directive 91/321/EEC of 14 May 1991 on infant formulae ("IF") and follow-on formulae ("FOF").1 The amendments are primarily a response to ongoing discussions at an international level within the Codex Alimentarius and the report of the Scientific Committee for Food ("SCF") on the Revision of Essential Requirements of Infant Formulae and Follow-on Formulae which was adopted by the Commission on 4 April 2003.2 On 7 May 2004 Member States' experts met in Brussels to discuss the proposal and the views of industry. Many welcomed the working document but have requested more time to consider the changes proposed.


The definitions of IF and FOF would be revised to ensure consistency between the two definitions and to take into account the latest definitions in the Draft Revised Codex Alimentarius Formulae.3 IF would mean foods for use by infants "up to the introduction of complimentary feeding" and FOF would mean food for use "when appropriate complimentary feeding is introduced". Unlike the previous definitions, there is no mention made of specific ages of application. The UK has suggested that a reference to use by infants over 6 months should be included in the definition for FOF.

Inclusion of new ingredients

The proposal would require manufacturers to take into account specific factors when considering the inclusion of new ingredients and to systematically review the available data relating to the expected benefits and safety considerations, including as necessary, appropriate preclinical and clinical studies, performed following expert guidance on the design and conduct of such studies. This represents a step beyond the current requirement that the suitability of ingredients need only be established by generally accepted scientific data.

However, the industry is unhappy that the current text places the onus on industry to ensure the use of new ingredients is safe but the assessment of supporting data falls to the Member States if they request such data. Although this is essentially the same text as appears in the existing Directive, the implication of this is that verification of product safety can occur only after a product is already on the market. The Commission has expressed its willingness to consider this point further.


The essential composition specified in Annexes I and II of Directive 91/321 would be amended in light of the conclusions of the SCF on the Revision of Essential Requirements of Infant Formulae and Follow-on Formulae. Important proposed changes include:

• The SCF recommended that the maximum energy content of both IF and FOF should be reduced from 315kJ (75kcal) per 100ml to 295kJ (70 kcal) per 100ml.

• All formulae should be compared to breast milk as the reference protein, and all formulae should match the amino acid profile of breast milk.

• The SCF proposed that the maximum fat level should be reduced to 6.0g/100kcal. Levels for new ingredients including phospholipids, taurine, oligosaccharides, and inositol have also been proposed.

• Glucose and sucrose may be added to IF but only to help camouflage the taste of certain types of formulae.

• Revised maximum vitamin and mineral levels have been recommended by the SCF based on current evidence of safe maximum intakes or, if such evidence did not exist, a maximum level was proposed for guidance purposes.

• Purity criteria would also be adopted in respect of vitamins, minerals and other nutritional substances.

In addition, several Member States raised industry concerns at the meeting in Brussels on 7 May concerning the proposed change in the protein conversion factor for cows' milk proteins from 6.38 to 6.25. Industry concerns centre on the apparent lack of public health need for such changes and the burden to industry with the concurrent increase in 2% protein content of formulae. Concern has been expressed about the inclusion of honey as a permitted carbohydrate source and the risk of infant botulism. The Commission has agreed to look into this. However a request to include a reference to GMOs being prohibited was considered by the Commission to be inappropriate as legislation already covers this issue.


The Directive restricts claims on IF to those listed in Annex IV of the Directive. The Commission is considering a request put forward by the UK, that the restrictions on advertising currently imposed in respect of IF be extended to FOF on the grounds that they too are breast milk substitutes. Currently the proposal amends the list of permitted claims and where appropriate extends the list to permit claims concerning ingredients for which conditions of use are to be specified in the future Directive following review of the essential composition described above. In addition, the proposal is to permit statements on formulae that reflect ethical or religious considerations which might influence dietary choices. The Commission has asked for examples of ethical or religious considerations (for example vegetarian, vegan) that could be included to improve the wording of the current draft.


As the currently drafted proposal would incorporate new reference values (for example recommended daily intakes) for labelling purposes. They accord with the SCF opinion of March 2003 on the revision of reference values for nutrition labelling.4 The Commission is to give further consideration to the reference values for chromium and molybdenum further due to the lack of biological and nutritional data in relation to these substances.




3. Appendix V


The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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