FOOD, ENGLAND Title, commencement and application 1 These Regulations may be cited as the Food with Added Phytosterols or Phytostanols (Labelling) (England) Regulations 2004; they come into force on 12th January 2005 and apply in relation to England only. Interpretation 2 1 In these Regulations — “ the Act ” means the Food Safety Act 1990; “biscuits” includes wafers, rusks, oatcakes and matzos; “confectionery product” means any item of chocolate confectionery or sugar confectionery; “Directive 2000/13” means Directive 2000/13/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, as amended by amendments up to and including those effected by Directive 2003/89/EC of the European Parliament and of the Council ; “edible ice” includes ice–cream, water ice and fruit ice, whether alone or in combination, and any similar food; “fancy confectionery product” means any confectionery product in the form of a figure, animal, cigarette or egg or in any other fancy form; “flour confectionery” means any cooked food which is ready for consumption without further preparation (other than reheating), of which a characterising ingredient is ground cereal, including shortbread, sponges, crumpets, muffins, macaroons, ratafias, pastry and pastry cases, and also includes meringues, petits fours and uncooked pastry and pastry cases, but does not include bread, pizzas, biscuits, crispbread, extruded flat bread or any food containing a filling which has as an ingredient any cheese, meat, offal, fish, shellfish, vegetable protein material or microbial protein material; “the key particulars” means those particulars specified in items 1 and 5 in the second paragraph of Article 2 of Regulation 608/2004; “prepacked for direct sale” means — in relation to a food other than flour confectionery, bread and edible ices, prepacked by a retailer for sale by him on the premises where the food is packed or from a vehicle or stall used by him, and in relation to flour confectionery, bread and edible ices, prepacked by a retailer for sale as in paragraph (a) of this definition, or prepacked by the producer of the food for sale by him either on the premises where the food is produced or on other premises from which he conducts business under the same name as the business conducted on the premises where the food is produced; “preparation”, in relation to food, includes manufacture and any form of processing or treatment; “Regulation 608/2004” means Commission Regulation (EC) No. 608/2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phyostanols and/or phytostanol esters; “sell” includes offer or expose for sale and have in possession for sale, and “sale” shall be construed accordingly; “the specified particulars” means the particulars required by Article 2 of Regulation 608/2004. 2 Food 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 mass caterer, and b it is — i put into packaging before being offered for sale in such a way that the food, whether wholly or only partly enclosed, cannot be altered without opening or changing the packaging, or ii wholly enclosed in packaging before being offered for sale and the food is intended to be cooked without opening the packaging, but food shall not be regarded as prepacked for the purposes of these Regulations if it comprises an individually wrapped sweet or chocolate which is not enclosed in any further packaging and which is not intended for sale as an individual item. 3 Other expressions used both in these Regulations and in Directive 2000/13 have the same meaning in these Regulations as they have in that Directive. Offences and penalty 3 Subject to regulation 4, if any person — a sells any food in respect of which the labelling requirements of Regulation 608/2004 apply and which is not labelled with the specified particulars, or b sells any food which is not labelled in accordance with regulation 5, 6 or 7, he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale. Exemption 4 In the case of — a food which is not prepacked, b food which is prepacked for direct sale or c individually wrapped fancy confectionery products which are not enclosed in any further packaging and which are intended for sale as single items, such food need not be labelled with any of the specified particulars other than the key particulars. Manner of labelling: general requirement 5 When any food other than food to which regulation 6 applies is sold, any particulars with which it is required to be labelled by Regulation 608/2004 shall appear — a on the packaging, b on a label attached to the packaging, or c on a label which is clearly visible through the packaging, save that, where the sale is otherwise than to the ultimate consumer, such particulars may, alternatively, appear only on the commercial documents relating to the food where it can be guaranteed that such documents, containing all such particulars, either accompany the food to which they relate or were sent before, or at the same time as, delivery of the food. Manner of labelling: special rules 6 1 This regulation applies to — a food which is not prepacked; b food which is prepacked for direct sale; and c any individually wrapped fancy confectionery product which is not enclosed in any further packaging and which is intended for sale as a single item. 2 When any food to which this regulation applies is sold to the ultimate consumer, the key particulars with which that food is required to be labelled by Regulation 608/2004 as read with regulation 4 shall appear — a on a label attached to the food, or b on a menu, notice, ticket or label which is readily discernible by an intending purchaser at the place where he chooses that food. 3 When any food to which this regulation applies is sold otherwise than to the ultimate consumer, the key particulars with which that food is required to be labelled by Regulation 608/2004 as read with regulation 4 shall appear — a on a label attached to the food, or b on a ticket or notice which is readily discernible by the intending purchaser at the place where he chooses the food, or c in commercial documents relating to the food where it can be guaranteed that such documents either accompany the food to which they relate or were sent before, or at the same time as, delivery of the food. Intelligibility of labelling 7 1 The particulars with which a food is required to be labelled as referred to in regulations 5 and 6, or which appear on a menu, notice, ticket or label pursuant to regulation 6, shall be easy to understand, clearly legible and indelible and, when a food is sold to the ultimate consumer, such particulars shall be marked in a conspicuous place in such a way as to be easily visible. 2 Such particulars shall not in any way be hidden, obscured or interrupted by any other written or pictorial matter. 3 Paragraph (1) shall not be taken to preclude the giving of such particulars at mass caterers, in respect of foods the variety and type of which are changed regularly, by means of temporary media (including the use of chalk on a blackboard). Enforcement 8 1 Subject to paragraph (2), each food authority shall enforce and execute these Regulations in its area. 2 Each port health authority shall enforce and execute these Regulations in its district in relation to imported food. 3 In this regulation “food authority” does not include — a the council of a district in a non–metropolitan county except where the county functions have been transferred to that council pursuant to a structural change; b the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple). Defence in relation to exports 9 In any proceedings for an offence under these Regulations, it shall be a defence for the person charged to prove that the food in respect of which the offence is alleged to have been committed — a was intended for export to a country, other than a Member State, which has legislation analogous to Regulation 608/2004 and that the food complies with that legislation; or b was intended for export to a Member State, is food to which Regulation 608/2004 applies and the food complies with the provisions of that Regulation as read with Directive 2000/13 as applied in that State. Application of various provisions of the Act 10 1 The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations — a section 2 (extended meaning of “sale” etc. ); b section 3 (presumption that food is intended for human consumption); c section 20 (offences due to fault of another person); d section 21 (defence of due diligence) as it applies for the purposes of section 14 or 15; e section 30(8) (which relates to documentary evidence); f section 35(1) (punishment of offences) in so far as it relates to offences under section 33(1) as applied by paragraph (3) below; g section 35(2) and (3) in so far as it relates to offences under section 33(2) as applied by paragraph (3) below; h section 36 (offences by bodies corporate). 2 In the application of section 32 of the Act (powers of entry) for the purposes of these Regulations, the references in subsection (1) to the Act shall be construed as including references to Regulation 608/2004. 3 The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act shall be construed as including a reference to these Regulations as read with Regulation 608/2004 — a section 33(1) (obstruction etc. of officers); b section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by sub–paragraph (a) above; c section 44 (protection of officers acting in good faith). Signed by authority of the Secretary of State for Health Melanie Johnson Parliamentary Under Secretary of State, Department of Health 15th December 2004