These Regulations, which come into force on 1st November 2001, implement in Wales Commission Directive 1999/21/EC on dietary foods for special medical purposes.

Article 1(2) of the Directive classifies such foods as foods specially processed or formulated for the dietary management, under medical supervision, of patients who require a special diet, and regulation 2 of these Regulations defines medical food as food within that classification.

Article 2 of the Directive calls for Member States to ensure that such food may only be marketed if it complies with the Directive. Articles 3 and 4 of the Directive lay down requirements for formulation, composition and instructions for use of such food, and for its naming and labelling. Regulation 3(1) of these Regulations prohibits the sale of medical food unless those requirements are met.

Article 5 of the Directive requires notification to competent authorities of the placing on the market of products covered by the Directive whether manufactured within, or imported from outside the European Community. Regulation 3(2) and (3) prohibits sale of medical foods by manufacturers and importers covered by this notification requirement unless they have complied with it. In the case of medical foods manufactured in Wales, or imported into Wales from outside the United Kingdom, the Food Standards Agency is the relevant authority.

Regulations 4, 5 and 7 set out enforcement responsibilities, offences and penalties, and application of provisions of the Food Safety Act 1990.

The Regulations also provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive 89/397/EC (OJ No.L186, 30.6.89, p.23) on the official control of foodstuffs (regulation 6).