Explanatory Note
(This note is not part of the Regulations)
1. These 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.E+W
2. The 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)).E+W
3. With effect from 1st August 2005 the Regulations—E+W
(a)prohibit the sale of a food supplement to the ultimate consumer unless it is prepacked (regulations 4 and 2(2)),
(b)prohibit 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),
(c)prohibit 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).
4. Article 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).E+W
5. The 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 89/397/EEC (OJ No. L186, 30.6.89, p.23) on the official control of foodstuffs (regulation 10).E+W
6. A 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.E+W