These Regulations, which come into force on 1st November 2001, implement Commission Directive 1999/21/EC on dietary foods for special medical purposes 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. 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/EC on the Official Control of Foodstuffs (reg. 6).