InterpretationS

2.—(1) In these Regulations–

“the Act” means the Food Safety Act 1990;

“catering establishment” means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation;

F1...

[F2“Directive 2001/83” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as last amended by Directive 2009/53/EC of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products;]

[F2“Directive 2002/46” means 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 as last amended by Commission Regulation (EC) No. 1170/2009 amending Directive 2002/46/EC and Regulation (EC) No. 1925/2006 as regards the lists of vitamins and minerals and their forms that can be added to foods, including food supplements;]

“dose form” means a form such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids or powders designed to be taken in measured small unit quantities;

“food supplement” means any food the purpose of which is to supplement the normal diet and which–

(a)

is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and

(b)

is sold in dose form;

“preparation” includes manufacture and any form of processing or treatment and “prepared” shall be construed accordingly;

[F3“Regulation (EU) No 1169/2011” means Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004;]

“sell” includes possess for sale and offer, expose or advertise for sale, and “sold” shall be construed accordingly; and

“ultimate consumer” means any person who purchases otherwise than–

(a)

for the purpose of resale;

(b)

for the purposes of a catering establishment; or

(c)

for the purposes of a manufacturing business.

(2) A food supplement shall be regarded as prepacked for the purposes of these Regulations if–

(a)it is ready for sale to the ultimate consumer or to a catering establishment; and

(b)it is put into packaging before being offered for sale in such a way that the food supplement cannot be altered without opening or changing the packaging.

(3) Other expressions used both in these Regulations and in Directive 2002/46 have the same meaning in these Regulations as they have in that Directive.

[F4(4) In these Regulations any reference to an Annex to Directive 2002/46 is a reference to that Annex as amended from time to time.]

Textual Amendments