WRITTEN QUESTION E-2149/99

by Glenys Kinnock (PSE) to the Commission

(24 November 1999)

Subject: Dietary Foods Directive

What measures will the Commission take to ensure that the Dietary Food Directive meets the requirements of the international code for the marketing of breast milk and subsequent WHA resolutions?

Joint answer to Written Questions E-2149/99 and E-2150/99 given by Mr Liikanen on behalf of the Commission

(16 December 1999)

The World health organisation (WHO) code for the marketing of breastmilk substitutes, adopted by the World health assembly as a recommendation, concerns the quality, labelling, marketing and distribution of breast-milk substitutes. Such products are infant formulae and are considered as foods for particular nutritional uses (dietary foods) under Community legislation. Infant formulae intended for infants in good health are covered by Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae(1).

Directive 91/321/EC includes provisions inspired by the WHO code and gives effect to the aims of the code as appropriate to the legal, socio-economic and cultural situations existing in the Community. This directive was based on a report of the scientific committee for food (SCF) and was extensively discussed with experts from the Member States. The Parliament also made a significant contribution to its contents.

Infant formulae intended for infants not in good health are considered as dietary foods for special medical purposes and are covered by Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes(2). This directive was also based on a report of the SCF and was extensively discussed with experts of the Member States. The Parliament was informed and raised no objections.

Labelling provisions and marketing restrictions were not imposed for infant formulae for special medical purposes. Such rules would have meant restrictions on the labelling and the provision of information for these products that were considered, for the reasons given below, neither necessary nor appropriate.

Foods for special medical purposes are defined in the Directive as mldr A category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two.

It is clear from this definition that these products are necessary for the normal growth of the patients (infants) and even life saving for them because the dietary management of their condition or disease cannot be achieved otherwise. Such diseases or conditions may be rare metabolic diseases or failing vital organs. It is vital that information on the existence of the products should be able to reach those that are responsible for the feeding of these infants without undue restrictions. Any measures to restrict the diffusion of such information through advertising or distribution of relevant informational material would therefore not be appropriate.

It should also be noted that, fortunately, the incidence of these conditions or metabolic diseases is low. Consequently the number of products and the quantities concerned are very limited. In addition these products are only to be given to infants under medical supervision. For these reasons advertising to the public at large would be unsustainable as a marketing tool.

The labelling of infant formula is required to bear a statement concerning the superiority of breastfeeding, in order to protect and promote this practice. Imposing such a statement for foods for special medical purposes would not be appropriate. Breastfeeding is or may be contraindicated in certain metabolic diseases; therefore such a statement could be detrimental for the health of the infants concerned. It would also be, in such cases, contradictory to medical advice and thus confusing for those responsible for the feeding of these infants.

(1) OJ L 175, 4.7.1991.

(2) OJ L 91, 7.4.1999.