Labelling, Presentation and Advertising of Foodstuffs Regulations, 2004 (L.N. 483 of 2004)

L.N. 483 of 2004 FOOD SAFETY ACT (CAP. 449) Labelling, Presentation and Advertising of Foodstuffs Regulations, 2004 IN exercise of the powers conferred by article 10 of the Food Safety Act, the Minister of Health, the Elderly and Community Care has made the following regulations: B 7725 1.1 The title of these regulations is the Labelling, Presentation Citation and d Ad · · f d ff 1 · 2004 d h 11 h commencement. an vert1smg o Foo stu. s Regu at10ns, an s a t ey enter into force on the 25th November, 2004, provided that: 1.1.1 products which do not comply with the provisions of these regulations, but which comply with the provisions of the Labelling, Presentation and Advertising of Foodstuffs Regulations, 2002, and which have been placed on the market or labelled prior to the 2S1h November, 2005 may continue to be sold while stocks last; 1.1.2 the provisions of subregulation 1.1.1 shall not apply to the provisions of regulation 17 .1; 1.1.3 the provisions of regulation 17.1 shall apply as from the 201h May, 2006, however products which do not comply with regulation 17.1 but which were labelled before the 201h May, 2006 may be sold while stocks last. 1.2 regulations implement the provisions of: (a) Directive 2000/13/EC of the European Parliament and of the Council of the 201h March, 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and adve1iising of foodstuffs, as amended by: Commission Directive 2001/101/EC of the 26th November, 2001, Commission Directive 2002/67 /EC of the 18th July, 2002, B 7726 Scope and applicability. Definitions and interpretation. Directive 2003/89/EC of the European Parliament and of the Council of the 10th November, 2003; (b) Council Directive 89/398/EEC of 3rd May, 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, as amended by: Directive 96/84/EC of the European Parliament and of the Council of the 19th December, 1996, Directive 1999/41/EC of the European Parliament and of the Council of the 71h June, 1999; (c) Commission Directive 87/250/EEC of the 15th April, 1987 on the indication of alcoholic strength by volume in the labelling of alcoholic beverages for sale to the ultimate consumer; ( d) Commission 94/54/EC of the 181h November, 1994 concerning compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC, as amended by: Council Directive 96/2 l/EC of the 29th March, 1996, Commission Directive 2004/77 /EC of the 29th April, 2004; (e) Commission Directive 2001/15/EC of the 151h February, 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses, as amended by: Commission Directive 2004/5/EC of the 201h January, 2004. These regulations concern the labelling of foodstuffs to be delivered as such to the ultimate consumer and certain aspects relating to the presentation and advertising thereof. These regulations shall apply also to foodstuffs intended for supply to hotels, restaurants, hospitals, canteens and other similar mass caterers (thereinafter referred to as 'mass caterers'). 3.1 In these regulations, unless the context otherwise requires, the following definitions shall apply: (a) "labelling" means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff; (b) "pre-packaged foodstuff' shall mean any single item for presentation as such to the ultimate consumer and to mass caterers, consisting of a foodstuff and the packaging into which it was put before being offered for sale, whether such packaging encloses the foodstuff completely or only partially, but in any case in such a way that the contents cannot be altered without opening or changing the packaging; (c) "ingredient" shall mean any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in finished product, even if in altered form; ( d) "edible ice" includes ice cream, water and fruit whether alone or in combination, and any similar food; (e) "confectionery product'' means any item of chocolate confectionery or sugar confectionery; (f) "fancy confectionery product" means any confectionery product in the fo1m of a figure, animal, cigarette or egg or in any other fancy form; (g) "biscuits" includes wafers, rnsks, oatcakes and matzos; (h) "catering establishment" means any restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation; (i) "cheese" means the fresh or matured product intended for sale for human consumption, which is obtained as follows: (i) in the case of any cheese other than whey cheese, by the combining, by coagulation or by any technique involving coagulation, of any of the following substances: milk, cream, skimmed milk, partly skimmed milk, concentrated skimmed milk, reconstituted dried milk, butter milk, materials obtained from milk, other ingredients necessary for the manufacture of cheese provided that those are not used for replacing, in whole or in part, any milk B 7727 B 7728 constituent, with or without partially draining the whey resulting from coagulation; (ii) in the case of whey cheese by concentrating whey with or without the addition of milk and milk fat, and moulding such concentrated whey, or by coagulating whey with or without the addition of milk and milk fat; (j) "cream" means that part of milk rich in fat which has been separated by skimming or otherwise and which is intended for human consumption; (k) "disease" includes any injury, ailment or adverse condition, whether of body or mind; (l) "flour confectionery" means any cooked food which is ready for consumption without further preparation (other than reheating), of which a characterising ingredient is ground 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, extmded 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; (m) "ionising radiation" means any gamma rays, X-rays or corpuscular radiations which are capable of producing ions either directly or indirectly other than those rays or radiations which arc emitted by measuring or inspection devices, provided that the dose absorbed is not greater than ().01 Gy for inspection devices which utilise neutrons and 0.5 Gy in other cases, at a maximum radiation energy level of 10 MeV in the case of X-rays, 14 MeV in the case of neutrons and 5 McV in other cases; (n) "irradiated" means subjected to treatment by ionising radiation; ( o) "lot" means a batch of sales units of food produced, manufactured or packaged under similar conditions; (p) "lot marking indication" means an indication that allows identification of the lot to which a sales unit of food belongs; ( q) "milk" means human consumption of milk intended for sale, or sold, for (i) one or more cows, and includes skimmed milk, semi-skimmed milk and whole milk, or (ii) one or more ewes, goats or buffaloes; (r) "prepacked for direct sale" means (i) 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 (ii) in relation to flour confectionery, bread and edible ices, prepacked by a retailer for sale as in sub-paragraph (i) 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; ( s) "preparation", in relation to food, includes manufacture and any form of processing or treatment, and "prepared" shall be constmed accordingly; (t) "seasonal selection pack" means a pack consisting of two or more different items of food which are wholly or partly enclosed in outer packaging decorated with seasonal designs; (u) "treating", in relation to disease, includes doing or providing anything for alleviating ~++,v,+n of the disease, whether it is done or provided by way of cure or not. (v) "food for particular nutritional intended for human consumption which means a food (i) owing to its special composition or process of manufacture, is dearly distinguishable from food intended for normal human consumption is suitable for its claimed particular nutritional purpose, and B 7729 B 7730 Misleading claims. (ii) is sold in such a way as to indicate that suitability; (w) "community" means the European Community; (x) "Member State" shall mean a Member State of the European Community; (y) "Directive" 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; (z) "Foodstuffs Directorate" shall mean the Directorate responsible for foodstuffs within the Malta Standards Authority. 4.1 labelling and methods used must not: (a) be such as could mislead degree, paiiicularly: purchaser to a material (i) as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production; (ii) by attributing to the foodstuff effects or properties which it docs not possess; (iii) by suggesting that the foodstuff possesses special characteristics when in fact all similar foodstuffs possess such characteristics; (b) subject to other provisions applicable to natural mineral waters and foodstuffs for particular nutritional uses, attribute to any foodstuff the propc1iy of preventing, treating or curing a human disease, or to such properties. 4.1 The prohibitions or restrictions referred to in paragraph 4.1 shall also apply to: ( a) presentation of foodstuffs, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are ananged and the setting in which they are displayed; (b) advertising. In accordance with paragraphs 6 to 18 and subject to exceptions contained therein, indication of the following particulars shall be compulsory on the labelling of foodstuffs: (a) the name under which the product is sold; (b) the list of ingredients; ( c) the quantity of certain ingredients or categories of ingredients as provided for in regulation 9; (d) the date of minimum durability or, in the case of foodstuffs which, from the microbiological point of view, arc highly perishable, the "use by" date; (c) any special storage conditions or conditions of use; (f) the name or business name and address of the manufacturer or packager, or of a seller established in Malta or within the European Community, provided that a post office box shall not be considered to be a valid address for the purposes of these regulations;. (g) particulars of the place of origin or provenance where failure to give such particulars might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff; (h) instructions for use when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions; (i) with respect to beverages containing more than 1.2 by volume of alcohol, the actual alcoholic strength by volume. 5.2 provisions of paragraph 5.1 shall be without prejudice to other provisions regarding weights and measures. B 7731 Compulsory particulars. 6.1 Other provisions applicable to specified foodstuffs and not Other provisions f d ff . l "d f d . . . l applicable lo to oo stu. s rn genera may prov1 c or crogat1ons, m cxccpt10na specificd cases, from the requirements laid down in Article 5.1 points (b) and (d), fo0dstuffs. provided that this docs not result in the purchaser being inadequately informed. 6.2 Other provisions applicable to specified foodstuffs and not to foodstuffs in general may provide that other particulars in addition to those listed in paragraph 5.1 must appear on the labelling. B 7732 Name under which the product is sold. 7.1 name under which a foodstuff is sold shall be the name provided for in the specific Community provisions applicable to provided that, (a) In the absence of Community provisions, the name under which a product is sold shall be the name provided for in the laws, regulations and administrative provisions applicable in Malta. (b) Failing this, the name under which a product is sold shall be the name customary in Malta, or a description of the foodstuff, and if necessary of its use, which is clear enough to let the purchaser know its true nature and distinguish it from other products with which it might be confused. ( c) The use in Malta of the sales name under which the product is legally manufactured and marketed in the Member State of production shall also be allowed. However, where the application of the other provisions of these regulations, in particular those set out in paragraph 5 .1, would not enable consumers in Malta to know true nature of the foodstuff and to distinguish it from foodstuffs with which they could confuse it, the sales name shall accompanied by other descriptive information which shall appear in proximity to the sales name. ( d) In exceptional cases, the sales name of the Member State of production shall not be used in Malta when the foodstuff which it designates is so different, as regards its composition or manufacture, from the foodstuff known under that name that the provisions of point ( c) are not sufficient to ensure correct information for consumers in Malta 7 .2 No trade mark, brand name or fancy name may be substituted for the name under which the product is sold. 7 .3 name under which the product is sold shall include or be accompanied by particulars as to the physical condition of the foodstuff or the specific treatment which it has undergone ( e.g. powdered, freeze dried, deep-frozen, tenderized, concentrated, smoked) in all cases where omission of such information could create confusion in the mind of the purchaser. 7.4 Any foodstuff which has been treated with ionising radiation must bear one of the following indications: in Maltese: "ittrattat bir-radjazzjoni'' or "trattat permezz ta' radjazzjoni ionizzanti" in English: "ilrndiated" or "treated with ionising radiation", in Italian: "ilrndiato" or "trattato con radiazioni ionizzanti". B 7733 8.1 Ingredients shall be listed in accordance with this regulation Listing of and the First, Second and Third (Parts A and B) Schedules to these ingredients. regulations. 8 .2 Ingredients need not be listed in the case of: (a) - fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated, carbonated water, description of which indicates that it has been carbonated and to which no other ingredient has been added, any drink with an alcoholic strength by volume of more than 1.2%, fermentation vinegars derived exclusively from a single basic product, provided that no other ingredient has been added; (b) - cheese, butter, fermented milk and cream, provided that no ingredient has been added other than lactic products, enzymes and micro-organism cultures essential to manufacture, or the salt needed for the manufacture of cheese than fresh cheese and processed cheese; ( c) products comprising a single ingredient, where: B 7734 the trade name is identical with the ingredient name, or the trade name enables the nature of the ingredient to be clearly identified. Provided that, Any ingredient, as defined in subregulation 3.l(c) and listed in Part B of the Third Schedule, shall be indicated on the labelling where it is present in beverages referred to in subregulation 8.2(a). This indication shall comprise the word 'contains' followed by the name of the ingredient(s) concerned. However, an indication is not necessary when the ingredient is already included under its specific name in the list of ingredients or in the name under which the beverage is sold. 8.3 Where an ingredient of the foodstuff is itself the product of several ingredients, the latter shall be regarded as ingredients of the foodstuff in question. 8.4 The following shall not be regarded as ingredients: (i) the constituents an ingredient which have been temporarily separated during the manufacturing process and later reintroduced but not in excess of their original proportions; (ii) additives: whose presence in a given foodstuff is solely due to the fact that they were contained in one or more ingredients of that foodstuff, provided that they serve no technological function in the finished product, which are used as processing aids; (iii) substances used in the quantities strictly necessary as solvents or media for additives or flavouring; (iv) substances which are not additives but are used in the same way and with the same purpose as processing aids and are still present in the finished product, even if in altered form. 8 .5 The list of ingredients shall include all the ingredients of the foodstuff, in descending order of weight, as recorded at the time of their use in the manufacture of the foodstuff. It shall appear preceded by a suitable heading which includes the word "ingredients". However: added water and volatile products shall be listed in of their weight in the finished product; the amount of water added as an ingredient in a foodstuff shall be calculated by deducting from the total amount of the finished product the total amount of the other ingredients used. This amount need not be taken into consideration if it does not exceed 5 by weight of the finished product, ingredients used in concentrated or dehydrated fo1m and reconstituted at the time of manufacture may be listed in order of weight as recorded before their concentration or dehydration, in the case of concentrated or dehydrated foods which are intended to be reconstituted by the addition of water, the ingredients may be listed in order of proportion in the reconstituted product provided that the list of ingredients is accompanied by an expression such as "ingredients of the reconstituted product", or "ingredients of the ready-to-use product", where fmit, vegetables or mushrooms, none of which significantly predominates in terms of weight and which are used in proportions that are likely to vary, are used in a mixture as ingredients of a foodstuff, they may be grouped together in the list of ingredients under the designation 'fruit', 'vegetables' or 'mushrooms' followed by the phrase 'in varying proportions', immediately followed by a list of the fruit, vegetables or mushrooms present; in such cases, the mixture shall be included in the list of ingredients in accordance with the first subparagraph, on the basis of the total weight of the fruit, vegetables or mushrooms present; in the case of mixtures of spices or herbs, where none significantly predominates in proportion by weight, those ingredients may be listed in another order provided that that list of ingredients is accompanied by an expression such as "in variable propo1iion"; ingredients constituting than 2 % of the finished product may be listed in a different order after other ingredients, where ingredients which are similar or mutually substitutable are likely to be used in the manufacture or preparation of a foodstuff without altering its composition, its nature or its perceived value, and in so far as they constitute less than 2 of the finished product, they may be referred to in the list of ingredients B 7735 B 7736 by means of the phrase "contains .... and/or .... ",whereat least one of no more than two ingredients is present in the finished product. provision shall not apply to additives or to ingredients listed in Part B of the Third Schedule. 8.6 Ingredients shall be designated by their specific name, where applicable, in accordance with the rnles laid down in paragraphs 7 .1 to 7.4. However: ingredients which belong to one of the categories listed in the First Schedule and are constituents of another foodstuff need only be designated by the name of that category; however, the designation "starch" listed in the First Schedule must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten, ingredients belonging to one of the categories listed in Second Schedule must be designated by the name of that category, followed by their specific name or EC number; if an ingredient belongs to more than one of the categories, the category appropriate to the principal function in the case of the foodstuff in question shall be indicated; however, the designation "modified starch" listed in the Second Schedule must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten, flavourings shall be designated in accordance with Part A of the Third Schedule, provided that quinine and/or caffeine used as a flavouring in the production or preparation of a foodstuff must be mentioned by name in the list of ingredients indicated in regulation 5.1, immediately after the term 'flavouring' 8.7 provisions may lay down that the name under which a specific foodstuff is sold is to be accompanied by mention of a particular ingredient or ingredients. 8 .8 In the case "'"'.,,.,.,.,,. to in paragraph 8 .3, a compound ingredient may be included in the list of ingredients, under its own designation in so as this is laid down by law or established by custom, in terms of its overall weight, provided that it is immediately followed by a list of its ingredients. Such a list, however, shall not be compulsory: (a) where the composition of the compound ingredient is defined in current Community legislation, and in so far as the compound ingredient constitutes than 2 of the finished product; however, this provision shall not apply to additives, subject to paragraph 8.4, (b) for compound ingredients consisting of mixtures of spices and/or herbs that constitute less than 2 % of the finished product, with the exception of additives, subject to paragraph 8.4, ( c) where the compound ingredient is a foodstuff for which a list of ingredients is not required under Community legislation. 8.9 Notwithstanding paragraph 8.5 the water content need not be specified: (a) where the water is used during the manufacturing process solely for the reconstitution of an ingredient used in concentrated or dehydrated form; (b) in the case of a liquid medium which is not normally consumed. 8.10 Notwithstanding regulation 8 the second subparagraph of subregulation 8 .6 and the second subparagraph of subregulation 8 .8, any ingredient used in the production of a foodstuff and still present in the finished product, even if in altered form, and listed in Part B of the Third Schedule or originating from an ingredient listed in Part B of the Third Schedule shall be indicated on the label with a clear reference to the name of this ingredient. Provided that, the indication referred to in the first subparagraph shall not be required if the name under which the foodstuff is sold clearly to the ingredient concerned; notwithstanding subregulation 8.4 (ii), (iii) and (iv), any substance used in production of a foodstuff and still present in the finished product, even if in altered form, and originating from ingredients listed in B of the Third Schedule shall be considered as an ingredient and shall be indicated on the label with a clear reference to the name of the ingredient from which it originates; in the case of foodstuffs delivered to the ultimate consumer by mass caterers, the provisions of this subregulation shall be B 7737 B 7738 Quanlily of ingredients. deemed to have been complied with if the mass caterer informs the consumer, upon,..,,.,.,,,,.,. of presence or absence of any ingredient(s) listed in Part B of the Third Schedule. 9.1 The quantity of an ingredient or category of ingredients used in the manufacture or preparation of a foodstuff shall be stated. 9 .2 The indication ref erred to in paragraph 9 .1 shall be compulsory: (a) where the ingredient or category of ingredients concerned appears in the name under which the foodstuff is sold or is usually associated with that name by the consumer; or (b) where the ingredient or category of ingredients concerned is emphasised on the labelling in words, pictures or graphics; or ( c) where the ingredient or category of ingredients concerned is essential to characterise a foodstuff and to distinguish it from products with which it might be confused because of its name or appearance; or ( d) in the cases detern1ined in accordance with the procedure laid down in Article 20(2) of the Directive. 9.3 Paragraph 9.2 shall not apply: (a) to an ingredient or category of ingredients: the drained net weight of which is indicated in accordance with paragraph 10.4, or the quantities of which arc already required to be given on labelling under Community provisions, or which is used in small quantities flavouring, or the purposes of which, while appearing in the name under which food is sold, is not such as to govern the choice of the consumer in Malta because the variation in quantity is not essential to characterise the foodstuff or does not distinguish it from similar foods; where specific Community provisions stipulate precisely the quantity of an ingredient or of a category of ingredients without providing for the indication thereof on the labelling; (b) in the cases referred to in the fourth and fifth indents of Article 8 .5; ( c) in the cases determined in accordance with the procedure laid down in Article 20(2) of the Directive. 9 .4 The quantity indicated, expressed as a percentage, shall correspond to the quantity of the ingredient or ingredients at the time of its/their use. However, other provisions, adopted in accordance with the procedure laid down in Article 20(2) of the Directive, may allow for derogations from this principle for certain foodstuffs. 9 .5 The indication referred to in paragraph 9 .1 shall appear in or immediately next to the name under which the foodstuff is sold or in the list of ingredients in connection with the ingredient or category of ingredients in question. 9 .6 provisions of paragraphs 9 .l to 9 .5 shall apply without prejudice to the Nutrition Labelling for Foodstuffs Regulations, 1998. 10.1 The date of minimum durability of a foodstuff shall be the date until which the foodstuff retains its specific properties when properly stored. It shall be indicated in accordance with paragraphs 10.2 to 10.5. 10.2 The date shall be preceded by the words: "Best before ... " when the date includes an indication of the day, "Best before end ... " in other cases. 10.3 The words referred to in paragraph 10.2 shall be accompanied by: either the date itself, or a reference to where the date is given on the labelling. B 7739 Date of minimum durability. B 7740 If need be, these particulars shall be followed by a description of the storage conditions which must be observed if the product is to keep for the specified period. lO .4 The date shall consist of the day, month and year in uncoded chronological form. However, in the case of foodstuffs: which will not keep for more than three months, an indication of the day and the month will suffice, which will keep for more than three months but not more than 18 months, an indication of the month and year will suffice, which will keep for more than 18 months, an indication of the year will suffice. 10.5 Subject to other provisions imposing other types of date indication, an indication of the durability date shall not required for: fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated. This derogation shall not apply to sprouting seeds and similar products such as legume sprouts, wines, liqueur wines, sparkling wines, aromatiscd wines and similar products obtained from frnits other than grapes, and beverages falling within CN Guidelines 2206 00 91, 2206 00 93 and 2206 00 99 and manufactured from grapes or grape musts, beverages containing 10 % or more by volume of alcohol, soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers of more than five litres, intended for supply to mass caterers, bakers' or pastry cooks' wares which, given the nature of their content, arc normally consumed within 24 hours of their manufacture, vrncgar, cooking salt, solid sugar, confectionery products consisting almost solely of flavoured and/or coloured sugars, chewing gums and similar chewing products, individual portions of ice-cream. B 7741 11.1 In the case of foodstuffs which, from the microbiological "Use By" Dale. point of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability shall be replaced by the "use by" date. 11.2 The date shall be preceded by the words: in Maltese: "uza in English: "use by", in Italian: "da consumare entro'', These words shall be accompanied by: either the date itself, or a reference to where the date is given on the labelling. These particulars shall be followed by a description of the storage conditions which must be observed. 11.3 The date shall consist of the day, the month and, possibly, the year, in that order and in uncoded form. 11.4 The 'use by' date or minimum durability date, as the case may be, shall be determined by the manufacturer or packer of the product. 11.5 No person may sell any food after the date shown in a 'use by' date relating to it. B 7742 Instructions for use. Indication of Alcoholic strength. Indication of particulars on prepackaged products. The instructions for use of a foodstuff shall be indicated in such a way as to enable appropriate use to be made thereof. 1 Other provisions may, in the case of cc1iain foodstuffs, specify the way in which the instructions for use should be indicated. 13.1 The rules concerning indication of the alcoholic strength by volume shall, in the case of products covered by tariff heading Nos 22.04 and 22.05, be those laid down in the specific provisions applicable to such products. 13 .2 In the case of other beverages containing more than 1.2 % by volume of alcohol, these rules shall be those laid down in the Fifth Schedule to these regulations. When the foodstuffs arc prepackaged, the particulars provided for in paragraphs 5 .1 and 6.2 shall appear on the prepackaging or on a label attached thereto. 14.2 Notwithstanding paragraph 14.1 and without prejudice to other provisions on nominal quantities, where prepackaged foodstuffs arc: intended for the ultimate consumer but marketed at a stage prior to sale to the ultimate consumer and where sale to a mass caterer is not involved at that stage, intended for supply to mass caterers for preparation, processing, splitting or cutting up, the particulars required under paragraphs 5 .1 and 6 .2 need appear only on the commercial documents referring to the foodstuffs where it can be guaranteed that such documents, containing an the labelling information, either accompany the foodstuffs to which they or were sent before or at the same time as delivery. 14.3 In the case referred to in paragraph 14.2, the particulars referred to in paragraph 5.1,points (a), (d) and (f) and, where appropriate, that referred to in paragraphs 11.1 to 11 .3, shall al so appear on the external packaging in which the foodstuffs arc presented for marketing. 14.4 The particulars mentioned in paragraphs 5.1 and 6.2 shall be easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible. They shall not in any way be hidden, obscured or interrupted by other written or pictorial matter. 14.5 The particulars listed in paragraph 5.1, points (a), (d) and (i) shall appear in the same field of vision. 14.6 In the case of the glass bottles intended for reuse which arc indelibly marked and which therefore bear no label, ring or collar and packaging or containers the largest smfacc of which has an area of than 10 cm2 only the particulars listed in paragraph 5.1, points (a) and (d) need be given. In this case, paragraph 14.5 shall not apply. 14.7 Where a beverage which is intended for consumption without modification, or after reconstitution of the concentrated or dried product, contains caffeine, from whatever source, in a proportion in excess of 150 mg/1, the following message must appear on the label in the same field of vision as the name under which the product is sold: 'High caffeine content'. This message shall be followed, in brackets and in accordance with regulation 14.4, by the caffeine content expressed in mg/100 ml, provided that, 14.7.1 this regulation shall not apply to beverages based on coffee, tea or coffee or tea extract where the name under which the product is sold includes the term 'coffee' or provided that, products which do not comply with this regulation and which were labelled before 1 July 2004 may be marketed until stocks last. 15.1 The provisions of this regulation shall apply without prejudice to the requirements of subregulation 8.10. 15.2 The following foods need not be marked or labelled with any of the particulars specified in paragraph 5 .1 except the name of the food: (a) food which (i) not prcpackcd, or (ii) prepacked direct other than any such food to which paragraphs 15.13, 15.14 or 15.15 apply; (b) any flour confectionery which is packed in a crimp case only or in wholly transparent packaging which is either unmarked or marked only with an indication of the price of the food and any B 7743 Omission of certain particulars. B 7744 lot marking indication given in accordance with paragraph 16.1, if there is not attached to the flour confectionery or its packaging any document, notice, label, ring or collar ( other than a label or labels on which only the price of the food and any lot marking indications arc marked); and (c) individually wrapped sugar or chocolate confectionery products, including boiled sweets and chocolates weighing less than 50 g per item, which are not enclosed in any further packaging when sold to the ultimate consumer and which are intended for sale as single items or by number. 15.3 Food which has not been ilrndiated and which is: (a) not intended for sale, or (b) white bread or flour confectionery, or ( c) carcasses and parts of carcasses which arc not intended for sale in one piece, need not be marked or labelled with any of the particulars specified in regulation 5 .1. 15.4 Any food which (a) by virtue of paragraphs 15.2 or 15.3 alone is not marked or labelled with a list of ingredients, and (b) contains any additive which (i) but for paragraphs 15.2 or 15.3, would be required to be named in the list of ingredients of the food, and (ii) was added to or used in the food or an ingredient of the food to serve the function of an antioxidant, colour, flavouring, flavour enhancer, preservative or sweetener, shall be marked or labelled with an indication of every such category of additive that is contained in the food. 15.5 Any edible ice or flour confectionery which, but for this paragraph, would be required to be marked or labelled in accordance with paragraph 15.4 need not be marked or labelled if there is displayed in a prominent position near the edible ice or flour confectionery a notice stating, subject to paragraph 15 .6, that edible ices or flour confectionery, as the case may be, sold at the establishment where the notice is displayed may contain such categories of additives. 15.6 Where, in the circumstances described in paragraphs 15.4 or 15.5, an additive serves more than one of the functions specified in the said paragraph 15 .4, it shall only be necessary to indicate that category which represents the principal function served by the additive in the food or ingredient to which it was added or in which it was used. 15.7 Paragraphs 15.4, 15.5 and 15.6 do not apply to food which is not intended for sale. 15.8 Subject to paragraph 15.9, any food which (a) by virtue of paragraphs 15.4, 15.5, 15.6 or 15.7 alone is exempted from the requirement to be marked or labelled with a list of ingredients, and (b) contains any ingredient which has been irradiated ( and which comprises a particular with which, had that food not been subject to that exemption, the food would have been required by these regulations to be marked or labelled), shall be marked or labelled with an indication that it contains that ingredient, and in such a case the reference within that indication to that ingredient shall include or be accompanied by the word "irradiated" or the words "treated with ionising radiation". 15 .9 Paragraph 15 .8 does not apply to food which is not intended for sale. 15.10 Subjectto paragraphs 15.11 or 15.12, any pre-packed food, either contained in an indelibly marked glass bottle intended for re-use and having no label, ring or collar, or the of whose packaging has an area of less than ten square centimetres, need not by virtue of regulations be marked or labelled with any of the paiiiculars specified in paragraph 5.1 except the name of the food and, unless food is not required to be marked or labelled with such an indication, the appropriate durability indication. 15 .11 Subject to paragraph 15 .12, any pre-packed food which (a) is sold or supplied as an individual portion, and (b) is intended as a minor accompaniment to either B 7745 B 7746 (i) another food, or (ii) another service, need not be marked or labelled with any of the particulars specified in paragraph 5.1 except the name of the food. Such pre-packed food shall include butter and other fat spreads, milk, cream and cheeses, jams and marmalades, mustards, sauces, tea, coffee and sugar, and such other service shall include the provision of sleeping accommodation at an hotel or other establishment at which such accommodation is provided by way of trade or business. 15.12 Paragraphs 15.10 and 15.11 do not apply to any food to which paragraphs 15.2, 15.3, 15.13, 15.14 or 15.15 apply. 15.13 Subject to paragraphs 15.14 and 15.15, any food which is sold at a catering establishment and is either (a) not pre-packed, or (b) pre-packed for direct sale, need not be marked or labelled with any of the particulars specified in paragraph 5. l. 15.14 In the case of any such food which has been irradiated that food shall be marked or labelled with an indication of such treatment, which indication shall include or be accompanied by the word "ilrndiated" or the words "treated with ionising radiation". 15.15 In the case of any such food which contains an ingredient which has been irradiated, that food shall be marked or labelled with an indication that it contains that ingredient and reference within that indication to that ingredient shall include or be accompanied by the word "irradiated'' or the words "treated with ionising radiation". 15 .16 The outer packaging of a seasonal selection pack need not be marked or labelled with any of the particulars specified by these regulations, provided that each item contained in the pack is individually pre-packed and is marked or labelled in accordance with the provisions of these regulations or any other regulations applying to such items. Subject to the provisions of paragraph 16.6, no person may sell or offer for sale any food which forms part of a lot unless it is accompanied by a lot marking indication. 16.2 The lot to which the food in the sales unit belongs shall determined by the producer, manufacturer, packager or the first seller in Malta of the food. 16.3 A lot marking indication must be determined and affixed under the responsibility of one of the operators specified in paragraph 16.2. 16.4 The lot marking indication must be preceded by the letter 'L', except where the indication is clearly distinguishable from other indications on the packaging of the food or on an attached label. 16.5 In the case of prepacked food, the lot marking indication must appear on the packaging of the food or on a label attached to For non-pre-packaged food the indication must appear on the container of the food or on a commercial document that accompanies the food. The indication must be easily visible, clearly legible and indelible. 16.6 The following foodstuffs need not be marked with a lot marking indication: (a) agricultural products which, on leaving the production holding, are (i) sold or delivered to a temporary storage, preparation or packaging station or to a producer's organisation, or (ii) collected for immediate integration into an operational preparation or processing system; (b) food which is intended to be sold to the ultimate consumer and which is not prepacked, is packed at the r"'"""'" of the purchaser or is prepacked for immediate sale; ( c) food in a container where the area of the largest side is than 10 square centimetres; ( d) prepacked food which is sold as an individual portion for immediate consumption and which is intended as a minor accompaniment to another food or another service; B 7747 Lot marking indication. B 7748 Indication of olher particulars. Permilled languages. (e) individual portions of edible ices supplied to the seller in bulk packaging which contains more than one such portion, provided that the bulk packaging must bear the lot marking indication; (f) food which is marked or labelled with the minimum durability or 'use by' date where this consists of at least an uncoded indication of the day and month in that order, whether or not this is required by these regulations. 17 .1 The labelling of foodstuffs falling within one of the categories given in the Sixth Schedule must contain the additional particulars as set out in that Schedule. 18.1 Subject to the provisions of paragraphs 18.2, 18.3 and 18.6, the particulars given according to the provisions of these Regulations shall appear in at one of the following languages: Maltese, English, Italian. 18.2 Paragraph 18.1 shall not apply in the case of the following products: (a) foodstuffs registered in terms of Council Regulation 2081/92 regarding the protection of origin and geographical indications for agricultural products and foodstuffs; (b) foodstuffs registered in terms of Council Regulation 2082/92 regarding certificates of specific character for agricultural products and foodstuffs; ( c) foodstuffs for which specific permitted languages are prescribed by other provisions. 18.3 The Food Safety Commission may, on the advice of the Malta Standards Authority, exempt specific categories of foodstuffs from the language requirement prescribed by paragraph 18. l, provided that such exemptions may only be given to categories of foodstuffs and not to individual products. 18 .4 Any exemptions issued by vi1iue of paragraph 18 .3 shall ensure that consumers are adequately informed. 18.5 Exemptions issued by virtue of paragraph 18.3 may permit the use of other languages other than the ones prescribed by paragraph 18 .1 as well as the use of other measures as regards one or more labelling particulars. 18.6 The Food Safety Commission may, on the advice of Malta Standards Authority, require that the labelling specific categories of foodstuffs or the provision of specified information must be given in at least one of the official languages of Malta, provided that (a) such requirements shall apply to all products falling within their scope and not to individual products; (b) such requirements are justified by the need to protect human health. 18 .7 Nothing in these regulations shall be construed as precluding the labelling particulars from being indicated in other languages in addition to those prescribed by paragraphs 18.1 and 18.6. 19.1 The nature or composition of products being described as being intended for particular nutritional uses must be such that the products arc appropriate for particular nutritional use intended. 19.2 The products referred to in paragraph 19.1 must also comply with any mandatory provisions applicable to foodstuffs for normal consumption, save as changes made to them to ensure their conformity with the definitions given in paragraph 3.l(v). 19 .3 The specific provisions applicable to the groups of foods for particular nutritional uses appearing in Part A of the Fourth Schedule shall be those laid down by means of the specific regulations given in that Schedule. 19.4 Subject to any derogations given by other provisions, the labelling and the labelling methods used, the presentation and the advertising of the products referred to in paragraph 3.l(v) must not attribute propc1iics for the prevention, treatment or cure of human disease to such products or imply such properties. 19 .5 Nothing in paragraph 19 .4 shall be construed as preventing the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition or pharmacy. 19.6 Only products referred to in paragraph 3.1 (v) may be characterized as "dietetic" or "dietary". 19 .7 In the labelling, presentation and advertising of foodstuffs for nmmal consumption the following shall be prohibited: B 7749 Claims relating to foods for particular nutritional uses. B 7750 (a) the use of the adjectives 'dietetic' or 'dietary' either alone or in conjunction with other words, to designate these foodstuffs; (b) all other markings or any presentation likely to give the impression that one of the products referred to in paragraph 3. l(v) is involved. 19.8 However, in accordance with other provisions which may be adopted, it shall be possible for foodstuffs for normal consumption which are suitable for a particular nutritional use to indicate such suitability. The aforesaid provisions may also lay down the arrangements for indicating this suitability, provided that 19 .8 .1 where no Community provisions have been adopted for the purposes of this subregulation, appropriate provisions may be adopted by the Food Safety Commission. 19.9 The designation under which such a product is sold shall be accompanied by an indication of its particular nutritional characteristics; however, in the case of products intended to fulfil the particular nutritional requirements of infants and young children in good health, this reference shall be replaced by a reference to the purpose for which they are intended. 19 .10 The labelling of products for which no specific provisions have been adopted must also include: ( a) the particular elements of the qualitative and quantitative composition or the special manufacturing process which gives the product its particular nutritional characteristics; (b) the available energy value expressed in kilojoules and kilocalories and the carbohydrate, protein and fat content per 100 grams or 100 millilitres of the product as marketed and, where appropriate, per specified quantity of the product as proposed for consumption, provided that, if, however, the energy value is less than 50 kilojoules (12 kilocalories) per 100 grams or 100 millilitres of the product as marketed, these particulars may be replaced either by the words 'energy value less than 50 kilojoules (12 kilocalories) per 100 grams' or by the words 'energy value less than 50 kilojoules ( 12 kilocalories) per 100 millilitres'. 19 .11 The labelling of products for which specific provisions have been adopted must comply with the requirements laid down in those provisions. 19 .12 Products intended for particular nutritional uses shall only be allowed on the retail market in pre-packaged form, and the packaging shall completely cover the products. 19 .13 To permit efficient official monitoring of foodstuffs intended for a particular nutritional use which do not belong to one of the groups listed in the Fourth Schedule, the following specific provisions shall apply: (a) When a product as referred to above is placed on the market for the first time, the manufacturer or the importer shall notify the Superintendent of Public Health by forwarding a model of the label used the product. (b) In the case of products which have already been placed on the market within the European Community, the manufacturer or importer shall, in addition to the model required by paragraph 19.13 (a), provide the Superintendent of Public Health with an indication of the recipient of the first notification to the competent authorities of a Member State of the European Community. 19 .14 Where necessary, the Superintendent of Public Health may require the manufacturer or the importer to produce the scientific work and the data establishing the product's compliance with the provisions of these regulations relating to foodstuffs for particular nutritional uses as defined in paragraph 3.l(v) together with the information provided for in paragraph 19 .lO(a). If such work is contained in a readily available publication, a mere reference to this publication shall suffice. 19 .15 The Superintendent of Public Health may prohibit, restrict or subject to specified conditions the marketing of products intended for particular nutritional uses if he considers that such products do not comply with paragraph 3 .1 (v) or endanger human health, provided that any such prohibition or restriction shall be notified to the Malta Standards Authority at least three months before being brought into effect, subject to the provisions of paragraph 19 .18. 19 .16 The Foodstuffs Directorate shall, within three months, issue an opinion regarding the proposed measures. B 7751 B 7752 Substances which may be added to foods for particular nutritional uses. 19 .17 In issuing any prohibition or restriction by virtue paragraph 19 .15, the Superintendent of Public Health shall take into account the opinion of the Foodstuffs Directorate. 19 .18 Where the Superintendent of Public Health cons idcrs the imposition of a prohibition or restriction to be an urgent requirement for the protection of public health, he may impose such prohibition or restriction with immediate effect provided the Foodstuffs Directorate is immediately notified of such measures. The Foodstuffs Directorate shall, within three months, issue an opinion regarding the proposed measures. 19.19 For the categories of substances added for specific nutritional purposes in foods for particular nutritional uses listed in the Seventh Schedule to these regulations, only the chemical substances mentioned under each category may be used in the manufacture of foodstuffs for particular nutritional uses covered by this regulation. 19 .20 The use of the substances mentioned in regulation 19 .19 shall be in conformity with any specific provisions concerning those substances that may be laid down in applicable specific provisions. 19 .21 Without prejudice to European Parliament and Council Regulation (EC) No 258/97 (1) or equivalent measures, other substances added for specific nutritional purposes, not belonging to one of the categories listed in the Seventh Schedule, may be used in the manufacture of foods for particular nutritional uses. 19 .22 The use of nutritional substances in foods for particular nutritional uses shall result in the manufacture of safe products that fulfil the particular nutritional requirements of the persons for whom they are intended as established by generally accepted scientific data. 19 .23 The Superintendent of Public Health may require the manufacturer or, where appropriate, the importer to produce the scientific work and the data establishing the use of substances added for specific nutritional purposes in compliance with regulation 19 .22. If such work is contained in a readily available publication, a mere reference to this publication shall suffice. 19.24 Any purity criteria for substances listed in the Seventh Schedule, specified by legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this regulation, shall apply. 19.25 For those substances listed in the Seventh Schedule for which purity criteria arc not specified by Maltese or European Community legislation, and until the adoption of such specifications, generally acceptable purity criteria recommended by international bodies shall apply. B 7753 20.1 The Labelling and Presentation of Foodstuffs Regulations Repeal L.N. 5 of ~ ' 2002. 2002 are hereby repealed and any reference to those regulations shall be constrncd as a reference to these regulations. B 7754 FIRST SCHEDULE Categories of Ingredients which may be designated by the Name of the Category rather than the Specific Name Definition Designation Refined oils other than olive oil "Oil", together with either the adjective "vegetable" or "animal", as appropriate, or an indication of their specific vegetable or animal origin The adjective "hydrogenated" must accompany the indication of a hydrogenated oil. Refined fats "Fat", together with either the adjective "vegetable" or "animal", as appropriate, or an indication of their specific vegetable or animal origin The adjective "hydrogenated" must accompany the indication of a hydrogenated fat. Mixtures of flour obtained from two or "Flour", followed by a list of the cereals more cereal species from which it has been obtained, in descending order by weight. Starches, and starches modified by physical "Starch" means or by enzymes All species of fish where the fish constitutes "Fish" an ingredient of another foodstuff and provided that the name and presentation of such foodstuff does not refer to a specific species of fish All types of cheese where the cheese or "Cheese" mixture of cheeses constitutes an ingredient of another foodstuff and provided that the name and presentation of such foodstuff does not refer to a specific type of cheese All spices not exceeding 2 % by weight of "Spice(s)" or "mixed spices" the foodstuff All herbs or parts of herbs not exceeding 2 "Herb(s)" or "mixed herbs" % by weight of the foodstuff All types of gum preparations used in the "Gum base" manufacture of gum base for chewing gum All types of crumbed baked cereal products "Crumbs" or "rusks" as appropriate All types of sucrose "Sugar" Anhydrous dextrose or dextrose "Dextrose" monohydrate Glucose syrup and anhydrous glucose syrup "Glucose syrup" All types of milk protein ( caseins, caseinates and whey proteins) and mixtures thereof Press, expeller or refined cocoa butter All types of wine as defined in Council Regulation (EC) No 149311999 of 17 May 1999 on the common organisation of the market in wine ( 1) Skeletal muscles ;, of mammalian and bird species recognized as fit for human consumption with naturally included or adherent tissue, where the total fat and connective tissue content does not exceed the values indicated below and where the meat constitutes an ingredient of another foodstuff. The products covered by the European Community definition of 'mechanically recovered meat' are excluded from this definition. Maximum fat and connective tissue contents for ingredients designated by the term ' ..... meat'. Species Mammals ( other than rabbits and porcines) and mixtures of species with mammals predominating Porcines Birds and rabbits Fat (%) 25 30 15 Connective tissue 3 (%) 25 25 10 If these maximum limits are exceeded, but all other criteria for the definition of 'meat' are satisfied, the " ... . meat" content must be adjusted downwards accordingly and the list of ingredients must mention, in addition to the term " .... meat", the presence of fat and/or connective tissue. 1 OJL 179, 14.7.1999,p.1. B 7755 "Milk proteins" "Cocoa butter" "Wine" " .... meat" and the name(s) 4 of the animal species from which it comes.". 2 The diaphragm and the masseters are part of the skeletal muscles, while the heart, tongue, the muscles of the head ( other than the masseters ), the muscles of the carpus, the tarsus and the tail are excluded. 3 The connective tissue content is calculated on the basis of the ratio between collagen content and meat protein content. The collagen content means the hydroxyproline content multiplied by a factor of 8. 4 For labeling in English, this designation may be replaced by the generic name of the ingredient for the animal species concerned. B 7756 SECOND SCHEDULE Categories Of Ingredients Which Must Be Designated By The Naine Of Their Category Followed By Their Specific Name Or EC Number Colour Preservative Antioxidant Emulsifier Thickener Gelling agent Stabiliser Flavour enhancer Acid Acidity regulator Anti-caking agent Modified starch(5) Sweetener Raising agent Anti-foaming agent Glazing agent Emulsifying salts(6) Flour treatment agent Firming agent Hurnectant Bulking agent Propellent gas 5 The specific name or EC number need not be indicated. 6 Only for processed cheeses and products based on processed cheeses. THIRD SCHEDULE PART A Designation Of Flavourings In The List Of Ingredients B 7757 1. Flavourings shall be designated either by the word "flavouring(s )" or by a more specific name or description of the flavouring. 2. The word "natural" or any other word having substantially the same meaning may be used only for flavourings in which the flavouring component contains exclusively flavouring substances as defined in Article 1(2)(b)(i) of Council Directive 88/388/EEC of the 22nd June, 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production() and/or flavouring preparations as defined in Article 1(2)(c) of the said Directive. 3. If the name of the flavouring contains a reference to the vegetable or animal nature or origin of the incorporated substances, the word "natural" or any other word having substantially the same meaning may not be used unless the flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned. PARTB Ingredients referred to regulation 8 Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof Crustaceans and products thereof Eggs and products thereof Fish and products thereof Peanuts and products thereof Soybeans and products thereof Milk and products thereof Nuts, i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof Celery and products thereof Mustard and products thereof Sesame seeds and products thereof Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as S02. 7 OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25). B 7758 FOURTH SCHEDULE Categories of Foodstuffs for Particular Nutritional Uses Part A Groups of foodstuffs for particular nutritional uses for which specific provisions are or will be laid down Group Relevant Provisions 1. Infant Formulae and Follow-on Infant Formulae and Follow-on Formulae Formulae Regulations, 1998 (L.N. 249/98) 2. Processed Cereal-based Foods and Baby Processed Cereal-based Foods and Other Foods for Infants and Young Children Foods for Infants and Young Children Regulations, 1998 (L.N. 258/98) 3. Food intended for Use m Energy- Foods Intended for Use m Energy Restricted Diets for Weight Reduction Restricted Diets for Weight Reduction Regulations, 1999 (L.N. 1/99) 4. Dietary Foods for Special Medical Dietary Foods for Special Medical Purposes Purposes Regulations, 2001 (L.N. 309/2001) 5. Foods intended to meet the Expenditure To be adopted of Intense Muscular Effort, especially for Sportsmen ************************ Part B Groups of foodstuffs for particular nutritional uses for which no specific provisions will be adopted and in respect of which the notification procedure prescribed by paragraph 19.13 is not required 1. Foods with a reduced or negligible content of sodium or salt (sodium chloride, table salt) 2. Gluten-free foods ************************ B 7759 FIFTH SCHEDULE Rules for the Indication of Alcoholic Strength by Volume in the Labelling of Alcoholic Beverages for Sale to the Ultimate Consumer 1. Alcoholic strength shall be determined at 20 °C. 2. The figure for alcoholic strength shall be given to not more than one decimal place. It shall be followed by the symbol " % vol." and may be preceded by the word "alcohol" or the abbreviation "ale.". 3. The positive and negative tolerances allowed in respect of the indication of the alcoholic strength by volume shall be as follows expressed in absolute values: (a) Beverages not specified below: 0.3 % vol.; (b) Beers having an alcoholic strength not exceeding 5.5 % vol.; beverages classified under subheading 22. 07 B II of the Common Customs Tariff and made from grapes: 0.5 % vol.; (c) Beers having an alcoholic strength exceeding 5.5 % vol.; beverages classified under subheading 22. 07 B I of the Common Customs Tariff and made from grapes; ciders, perries, fruit wines and the like, obtained from fruits other than grapes, whether or not semi-sparkling or sparkling; beverages based on fermented honey: 1 % vol.; (d) Beverages containing macerated fruit or parts of plants: 1.5 % vol. 4. The tolerances set out in paragraph 3 shall apply without prejudice to the tolerances deriving from the method of analysis used for determining the alcoholic strength. B 7760 1. 2. 3. 4. 5. 6. 7. SIXTH SCHEDULE Compulsory Indication on the Labelling of Certain Foodstuffs of Particulars as required by Paragraph 17.1 Type or catezorv of foodstuff Particulars Foodstuffs whose durability has been "Packaged m a protective extended by means of packaging gases atmosphere" authorized pursuant to the Additives in Food Regulations, 1994 (L.N. 89/94) Foodstuffs containing a sweetener or "with sweetener/s" sweeteners as authorized by the Sweeteners for Use in Foodstuffs Regulations, 2004 (L.N. This particular shall accompany the 254/2004) name under which the product IS sold. Foodstuffs containing both an added sugar or "with sugar/s and sweetener/s" sugars and a sweetener or sweeteners as authorized by the Sweeteners for Use in This particular shall accompany the Foodstuffs Regulations, 2004 (L.N. 254/2004) name under which the product is sold. Foodstuffs containing aspartame "contains a source of phenylalanine" Foodstuffs containing more than 10 % added "excessive consumption may polyols produce laxative effects" Confectionery beverages .. The terms 'contains liquorice' shall or contammg glycyrrhizinic acid or its ammonium salt due be added immediately after the list of to the addition of the substance(s) as such or ingredients, unless the term the liquorice plant Glycyrrhiza glabra, at 'liquorice' is already included in the concentration of 100 mg/kg or 10 mg/1 or list of ingredients or in the name above under which the product is sold. In the absence of a list of ingredients, the particular shall take place nearby the name under which the product is sold. Confectionery containing glycyrrhizinic acid The following message must be or its ammonium salt due to the addition of added after the list of ingredients: the substance(s) as such or the liquorice plant 'contains liquorice - people Glycyrrhiza glabra, at concentrations of 4 suffering from hypertension should g/kg or above avoid excessive consumption'. In the absence of a list of ingredients, the particular shall take place nearby the name under which the product is sold. B 7761 Type or cate~ory of foodstuff Particulars 8. Beverages containing glycyrrhizinic acid or The following message must be its ammonium salt due to the addition of the added after the list of ingredients: substance(s) as such or the liquorice plant 'contains liquorice - people Glycyrrhiza glabra, at concentrations of 50 suffering from hypertension should mg/1 or above, or of 300 mg/1 or above in the avoid excessive consumption'. In the case of beverages containing more than 1.2 % absence of a list of ingredients, the by volume of alcohol (8). particular shall take place nearby the name under which the product is sold. 8 The level shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers. B 7762 SEVENTH SCHEDULE Substances that may be added for specific nutritional purposes in foods for particular nutritional uses For the purposes of this table: "FSMP" means foods for particular nutritional uses intended for special medical purposes, "All FPNU" means dietary foods for particular nutritional uses including FSMPs but excluding infant formulae, follow-on formulae, processed cereal based foods and baby foods intended for infants and young children. Substance Condition of use All FPNU FSMP Cate2orv 1 - Vitamins VITAMIN A retinol X retiny 1 acetate X retinyl palmitate X beta-carotene X VITAMIND cholecalciferol X ergocalciferol X VITAMINE D-alpha-tocopherol X DL-alpha-tocopherol X D-alpha-tocopheryl acetate X DL-alpha-tocopheryl acetate X D-alpha-tocopheryl acid succinate X VITAMINK phylloquinone (phytomenadione) X VITAMINB1 thiamin hydrochloride X thiamin mononitrate X VITAMINB2 riboflavin X riboflavin 5' -phosphate, sodium X NIACIN nicotinic acid X nicotinamide X P ANTOTHENIC ACID B 7763 Substance Condition of use All FPNU FSMP D-pantothenate, calcium X D-pantothenate, sodium X dexpanthenol X VITAMINB6 pyridoxine hydrochloride X pyridoxine 5' -phosphate X pyridoxine dipalmitate X FOLICACID pteroylmonoglutamic acid X VITAMINB12 cyanocobalamin X hy droxoco balamin X BIOTIN D-biotin X VITAMINC L-ascorbic acid X sodium L-ascorbate X calcium L-ascorbate X potassium L-ascorbate X L-ascorbyl 6-palmitate X Cate2ory 2- Minerals CALCIUM carbonate X chloride X salts of citric acid X gluconate X glycerophosphate X lactate X salts of orthophosphoric acid X hydroxide X oxide X sulphate X MAGNESIUM acetate X carbonate X chloride X salts of citric acid X gluconate X glycerophosphate X salts of orthophosphoric acid X B 7764 Substance Condition of use All FPNU FSMP lactate X hydroxide X oxide X sulphate X IRON ferrous carbonate X ferrous citrate X ferric ammonium citrate X ferrous gluconate X ferrous fumarate X ferric sodium diphosphate X ferrous lactate X ferrous sulphate X ferric diphosphate (ferric pyrophosphate) X ferric saccharate X elemental iron (carbonyl + electrolytic + X hydrogen reduced) COPPER cupric carbonate X cupric citrate X cupric gluconate X cupric sulphate X copper lysine complex X IODINE potassium iodide X potassium iodate X sodium iodide X sodium iodate X ZINC acetate X chloride X citrate X gluconate X lactate X oxide X carbonate X sulphate X MANGANESE carbonate X chloride X citrate X gluconate X B 7765 Substance Condition of use All FPNU FSMP glycerophosphate X sulphate X SODIUM bicarbonate X carbonate X chloride X citrate X gluconate X lactate X hydroxide X salts of orthophosphoric acid X POTASSIUM bicarbonate X carbonate X chloride X citrate X gluconate X glycerophosphate X lactate X hydroxide X salts of orthophosphoric acid X SELENIUM sodium selenate X sodium hydrogen selenate X sodium selenite X CHROMIUM (III) and their hexahydrates chloride X sulphate X MOLYBDENUM (VI) ammonium molybdate X sodium molybdate X FLUORINE potassium fluoride X sodium fluoride X Cate2ory 3-Amino acids L-alanine X L-arginine X L-aspartic acid X L-citrulline X L-cysteine X B 7766 Substance Condition of use All FPNU FSMP Cystine X L-histidine X L-glutamic acid X L-glutamine X glycine X L-isoleucine X L-leucine X L-lysine X L-lysine acetate X L-methionine X L-omithine X L-phenylalanine X L-proline X L-threonine X L-tryptophan X L-tyrosine X L-valine X L-serine X L-arginine-L-aspartate X L-lysine-L-aspartate X L-lysine-L-glutamate X N-acety 1-L-cysteine X N-acetyl-L-methionine x in products intended for persons over 1 year of age For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used Cate2ory 4- Carnitine and taurine L-camitine X L-camitine hydrochloride X taurine X L-camitine-L-tartrate X Cate2ory 5- Nucleotides adenosine 5' -phosphoric acid (AMP) X sodium salts of AMP X cytidine 5' -monophosphoric acid (CMP) X sodium salts of CMP X guanosine 5' -phosphoric acid (GMP) X sodium salts of GMP X inosine 5' -phosphoric acid (IMP) X sodium salts ofIMP X B 7767 Substance Condition of use All FPNU FSMP uridine 5' -phosphoric acid (UMP) X sodium salts of UMP X Cate2ory 6- Choline and inositol choline X choline chloride X choline bitartrate X choline citrate X inositol X lppubblikat mid Dipartimenl ta· 1 lnforrnazzjoni (doi.gov.mt) Valletta Published hy the Department oflnfrmnarion (doi.gov.mt) Valletta !v1itbugh tl-lstamperija tal-Gvern - Printed at the Govenunent Printing Pre.~.-,· Prezz Lm l .72i: Price Lm 1. 72c