(This note is not part of the Regulations)
1These Regulations implement in England Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements.2The Regulations concern the sale (as defined in regulation 2(1)) of food supplements which are sold as food and presented as such (regulation 3). A food supplement is defined as a food sold in dose form whose purpose is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination (regulation 2(1)).3With effect from 1st August 2005 the Regulations—aprohibit the sale of a food supplement to the ultimate consumer unless it is prepacked (regulations 4 and 2(2)),bprohibit the sale of a food supplement in the manufacture of which a vitamin or mineral has been used, unless certain compositional requirements are met, subject to a transitional provision (regulation 5 and Schedules),cprohibit the sale of a food supplement which is ready for delivery to the ultimate consumer or a catering establishment unless certain requirements as to labelling, presentation and advertising of the product are met (regulations 6 and 7).4Article 6(2) of the Directive (labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties) is already implemented in the Food Labelling Regulations 1996 (regulation 40(1) and Schedule 6, Part I, paragraph 2).5The Regulations make provision as to responsibilities for enforcement (regulation 8); create offences and penalties (regulation 9) and apply certain provisions of the Food Safety Act 1990 (regulation 11). The Regulations provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive (OJ No. L186, 30.6.89, p.23) on the official control of foodstuffs (regulation 10).6A regulatory impact assessment has been prepared and placed in the Library of each House of Parliament together with a Transposition Note setting out how the main elements of Directive 2002/46/EC are transposed in these Regulations. Copies may be obtained from the Food Labelling and Standards Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.