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

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.

DEFINITIONS OF "INFANT FORMULAE" AND "FOLLOW-ON FORMULAE"

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.

ESSENTIAL COMPOSITION

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