Medical Food (England) Regulations 2000 (S.I. No. 845 of 2000).

These Regulations implement in England 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, and 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 placing on the market of products covered by the Directive when manufactured in, or imported from outside, the European Community, and regulation 3(2) and (3) of these Regulations prohibits sale of medical foods by manufacturers and importers covered by a notification requirement unless they have complied with it. In the case of medical foods manufactured in England, or imported into England from outside the United Kingdom, the Food Standards Agency is the relevant authority.