The Medical Food (England) Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which come into force on 1st November 2001, 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.

Enforcement responsibilities, offences and penalties, and application of provisions of the Food Safety Act 1990 are set out in regulations 4, 5 and 7 of these Regulations. The Regulations also provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (OJ No. L186, 30.6.89, p. 23) on the official control of foodstuffs (regulation 6).

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect that these Regulations would have on business costs, has been prepared and placed in the Library of each House of Parliament. Copies may be obtained from the library of the Ministry of Agriculture, Fisheries and Food, at Nobel House, 17 Smith Square, London SW1P 3JR.