Following consultation with the EC Scientific Committee for Food, the European Commission has developed a proposal for discussion by the EC Working Group on Dietetic Foods on 11 June. Copies have now been circulated.
The Directive would define “foods for special medical purposes” as a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients to be used under the supervision of persons having qualification in medicine, nutrition or pharmacy or of other appropriate health care professionals. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise, or who have other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two. Foods for special purposes are classified in the following 3 categories:
i) nutritionally complete foods with standard nutrient balanced formulation which, used in accordance with the manufacturers instructions, may constitute the sole source of nourishment for the persons for whom they are intended. These foods may also be used as a partial replacement or as a supplement to the patients diet;
ii) nutritionally complete foods with a disease specific nutrient adapted formulation which, used in accordance with the manufacturers instructions, may constitute the sole source of nourishment for the persons for whom they are intended. These foods may also be used as a partial replacement or as a supplement to the patients diet;
iii) nutritionally incomplete foods with standard or disease specific adapted formulation which are not suitable to be used as a sole source of nourishment.
The directive would require that the formulation of foods for special medical purposes shall be based on sound medical and nutritional principles. Their use, in accordance with the manufacturers instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally acceptable scientific data. Products referred to in points i) and ii) above must comply with specified compositional criteria.
The directive would also specify certain labelling conditions.