These Regulations, which come into force on 1st November 2001, implement Commission Directive 1999/21/EC on dietary foods for special medical purposes (O.J. No. L91, 7.4.1999, p.29) and extend to Scotland only.

Article 1(2) of the Directive classifies such foods as foods specially processed or formulated for the dietary management of specified types of patients under medical supervision whose treatment calls for a special diet, and regulation 2 of these Regulations defines dietary 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, and regulation 3(1) of these Regulations prohibits the sale of dietary food unless those criteria 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, or imported from outside the European Community. Regulation 3(2) of these Regulations imposes that notification requirement, and regulation 3(3) specifies which authorities are to be recipients of the notification. For dietary foods manufactured in Scotland, or imported into Scotland 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 (c. 16) 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 (O.J. No. L186, 30.6.89, p.23) on the Official Control of Foodstuffs (regulation 6).