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CAP 132W FOOD AND DRUGS (COMPOSITION AND LABELLING) REGULATIONS


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  (Cap 132, section 55) [11 November 1960] G.N.A. 132 of 1960 (G.N.A. 74 of 1960) Cap 132W reg 1 Citation These regulations may be cited as the Food and Drugs (Composition and Labelling) Regulations. Cap 132W reg 2 Interpretation (1) In these regulations, unless the context otherwise requires- "additive" (添加剂) means any substance, not commonly regarded or used as food, which is added to, or used in or on, food at any stage to affect its keeping qualities, texture, consistency, appearance, taste, odour, alkalinity or acidity, or to serve any other technological function in relation to food, and includes processing aids in so far as they are added to, or used in or on, food as aforesaid, but does not include- (a) vitamins, minerals or other nutrients in so far as they are used solely for the purpose of fortifying or enriching food or of restoring the constituents of food; (b) herbs or spices when used as seasoning; (c) hops; (d) salt; (e) yeast or yeast extracts; (f) the total products of any hydrolysis or autolysis of food protein; (g) starter cultures; (h) malt or malt extract; (i) any substance which is present in food solely as a result of its addition to animal, bird or fish feedingstuffs or its use in a process or treatment carried out in crop husbandry, animal husbandry, veterinary medicine or storage (including any pesticide, fumigant, sprout depressant or veterinary medicine); or (j) air or water; (L.N. 222 of 1985) "Authority" (主管当局) means the Director of Food and Environmental Hygiene; (78 of 1999 s. 7) "catering establishment" (饮食供应机构) means a restaurant, canteen, club, public house, school, hospital or other 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 for immediate consumption; (L.N. 222 of 1985) "Codex Alimentarius Commission" (食品法典委员会) means the body created in 1963 by the World Health Organization and the Food and Agriculture Organization to develop food standards, guidelines and related texts; (L.N. 85 of 2004) "container" (容器) includes every kind of box, bottle, tin, carton, package or wrapping enclosing an article or substance, but does not include an outer cover or wrapping superimposed for the purpose of consignment or delivery; "frozen confection" (冰冻甜点) means any confection commonly sold for human consumption in a frozen or chilled state; (L.N. 163 of 1969) "ingredient" (配料) means any substance, including any additive and any constituent of a compound ingredient, which is used in the manufacture or preparation of a food and which is still present in the finished product, even if in altered form; (L.N. 222 of 1985) "International Numbering System for Food Additives" (食物添加剂国际编码系统) means the numbering system adopted by the Codex Alimentarius Commission for identifying food additives in a list of ingredients of prepackaged food; (L.N. 85 of 2004) "ionizing radiation" (电离辐射) 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 are emitted- (a) by measuring or inspection devices; and (b) at an energy level no higher than the appropriate maximum level; (L.N. 80 of 1996) "irradiated food" (辐照食物) means any food which has been subjected to treatment by ionizing radiation; (L.N. 80 of 1996) "labelling" (标签、加上标签), in relation to a food, includes any words, particulars, trade mark, brand name, pictorial matter or symbol relating to the food and appearing on the packaging of the food or on any document, notice, label, ring or collar accompanying the food; (L.N. 222 of 1985) "meat" (肉类) means the flesh or other edible part of- (a) any animal; or (b) any bird, intended for human consumption; (L.N. 116 of 1970; L.N. 222 of 1985) "milk" (奶类) means cows milk and includes cream and separated milk but does not include dried milk, condensed milk or reconstituted milk or buffaloes milk or goats milk; (32 of 1963 s. 20) "milk beverage" (奶类饮品) means any beverage resulting from the combining with a liquid of milk fat and other solids derived from milk, whether exclusive of any food additive or otherwise; (L.N. 217 of 1977) "permitted colouring matter" (准许染色料) means any colouring matter specified in the First Schedule to the Colouring Matter in Food Regulations (Cap. 132 sub. leg. H), or any combination of such colouring matters; "prepackaged food" (预先包装食物) means any food packaged, whether completely or partially, in such a way that- (a) the contents cannot be altered without opening or changing the packaging; and (b) the food is ready for presentation to the ultimate consumer or a catering establishment as a single food item; (L.N. 222 of 1985) "reconstituted milk" (再造奶) means products resulting from the recombining with water of milk constituents, namely, milk fat and other solids derived from milk exclusive of any other substance, and includes the products resulting from the melting of frozen concentrated milk and "to reconstitute milk" (再造奶) shall be construed accordingly; (L.N. 30 of 1967) "sell" (售卖) includes offer or expose for sale and have in possession for sale, and "sale" (出售) and "sold" (售出) shall be construed accordingly; (L.N. 222 of 1985) "tenderized meat" (加工制嫩肉类) means meat which has been treated with proteolytic enzymes or meat derived from live animals or birds which have been so treated; (L.N. 116 of 1970) "ultimate consumer" (最后消费者) means any person in Hong Kong who buys 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. (L.N. 222 of 1985) (2) For the purposes of these regulations, the supply of food, otherwise than by sale, at, in or from any place where food is supplied in the course of a business shall be deemed to be a sale of that food, and references to purchasers shall be construed accordingly. (L.N. 222 of 1985) (L.N. 222 of 1985) Cap 132W reg 3 Standards of composition The standards of composition of the foods and drugs specified in Schedule 1 shall be the standard prescribed in respect thereof in that Schedule. (L.N. 80 of 1996) Cap 132W reg 4 Marking and labelling The foods and drugs specified in Schedule 2 shall be marked and labelled in the manner prescribed in that Schedule. (L.N. 80 of 1996) Cap 132W reg 4A Labelling of prepackaged food (1) Without prejudice to regulation 4 but subject to paragraph (2), prepackaged food shall be marked and labelled in the manner prescribed in Schedule 3. (2) The items listed in Schedule 4 shall be exempt from the requirements of this regulation to the extent specified in that Schedule. (3) The Authority may by notice in the Gazette amend Schedule 4. (L.N. 222 of 1985; L.N. 80 of 1996) Cap 132W reg 5 Offences and penalties *(1) Any person who advertises for sale, sells or manufactures for sale any food or drug which does not conform to the relevant requirements as to composition prescribed in Schedule 1 or which is not marked and labelled in the manner prescribed in Schedule 2 or Schedule 3 commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months. (L.N. 222 of 1985; L.N. 330 of 1987; L.N. 80 of 1996; L.N. 177 of 1996) (1A) Any person who sells any food after the date shown as the "use by" date on food marked or labelled for the purposes of Schedule 3 commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months. (L.N. 80 of 1996; L.N. 177 of 1996) (1B) Any person who, not being the manufacturer or packer originally responsible for so marking or labelling the food, alters, removes or obliterates the labelling of any food or drug marked or labelled for the purposes of Schedule 2 or Schedule 3 commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months. (L.N. 80 of 1996; L.N. 177 of 1996) (2) In any proceedings for an offence against paragraph (1) in relation to the publication of an advertisement, it shall be a defence for the defendant to prove that, being a person whose business it is to publish, or arrange for the publication of, advertisements, he received the advertisement for publication in the ordinary course of business. (3) In any proceedings for an offence against paragraph (1) in relation to the possession for sale of any prepackaged food which is not marked or labelled in the manner prescribed in Schedule 2 or Schedule 3, it shall be a defence for the defendant to show that before offering the food for sale he would have taken all reasonable steps to ensure that the food was so marked or labelled. (L.N. 222 of 1985; L.N. 80 of 1996) (3A) Without affecting paragraph (3), in any proceedings for an offence against paragraph (1) in relation to any prepackaged food which is not marked or labelled in accordance with paragraph 2(4E) of Schedule 3, it shall be a defence for the defendant to show that he- (a) reasonably and in good faith relied on information provided by the importer or manufacturer as to whether the food consisted of or contained any substance referred to in that sub-paragraph; or (b) (i) has used his best endeavours to obtain such information from the importer or manufacturer but such information is not available; and (ii) has in good faith marked on the food that he does not know whether the food consists of or contains any such substance. (L.N. 139 of 2004)(4) In any proceedings for an offence against paragraph (1B), it shall be a defence for the defendant to prove that each alteration, removal or obliteration in respect of which the offence is alleged was effected under the written authorization of a person capable of effecting that alteration, removal or obliteration without contravention of that provision. (L.N. 80 of 1996) _______________________________________________________________________________ Note: * The operation of this regulation is affected by the transitional provision in section 3 of the Food and Drugs (Composition and Labelling) (Amendment) Regulation 2003 (L.N. 226 of 2003) & the transitional provision in section 6 of the Food and Drugs (Composition and Labelling) (Amendment) Regulation 2004 (L.N. 85 of 2004). The text of section 3 of L.N. 226 of 2003 is reproduced below-- "3. Transitional provision It shall not be an offence under regulation 5(1) of the Food and Drugs (Composition and Labelling ) Regulations (Cap 132 sub. leg. W) ("the principal Regulations") to advertise for sale, sell or manufacture for sale on or before 18 June 2005 any prepackaged food containing any additive which is listed otherwise than by the appropriate category as specified in paragraph 2(6) of Schedule 3 to the principle Regulations as amended by this Regulation in circumstances where that additive is listed by the appropriate category as specified in what would have been paragraph 2(6) of Schedule 3 to the principal Regulations had this Regulation not come into operation." The text of section 6 of L.N. 85 of 2004 is reproduced below-- "6. Transitional provision It shall not be an offence under regulation 5(1) of the Food and Drugs (Composition and Labelling ) Regulations (Cap 132 sub. leg. W) ("principal Regulations") to advertise for sale, sell or manufacture for sale on or before 9 July 2007 any prepackaged food which is not labelled in accordance with paragraphs 2 and 4 of Schedule 3 to the principle Regulations as amended by this Regulation, if that prepackaged food is labelled in accordance with what would have been the requirements of paragraphs 2 and 4 of Schedule 3 to the principle Regulations had this Regulation not come into operation. (L.N. 139 of 2004)". Cap 132W reg 6 Name in which proceedings may be brought Without prejudice to the provisions of any other enactment relating to the prosecution of criminal offences, and without prejudice to the powers of the Secretary for Justice in relation to the prosecution of criminal offences, prosecutions for an offence under any of the provisions of these regulations may- (L.N. 362 of 1997) (a) where the offence was committed in respect of drugs, be brought in the name of the Director of Health; (L.N. 76 of 1989) (b) where the offence was committed in respect of food, in the name of the Director of Food and Environmental Hygiene. (78 of 1999 s. 7) (c) (Repealed 78 of 1999 s. 7) (L.N. 30 of 1967) Cap 132W reg 7 Compliance with other labelling requirements Nothing in these regulations shall be construed as exempting any person from compliance with any other provisions of the Ordinance which relate to the labelling of food. (L.N. 222 of 1985) Cap 132W Sched 1 [regulation 3] (L.N. 80 of 1996) (In this Schedule reference to proportion or percentage means proportion or percentage by weight) PART I COMPOSITION OF FOODS AND DRUGS OTHER THAN MILK AND MILK PRODUCTS 1. Drugs and ingredients and component parts of drugs shall conform to the standards specified therefor respectively in the British Pharmacopoeia or British Pharmacopoeia Codex. 2. Margarine shall be any article of food, whether mixed with butter or not, which resembles butter and is not milk-blended butter. It shall be free from rancidity and shall contain neither more than 16% moisture nor more than 10% butter fat. 3. Coffee shall be the seed of Coffea arabica and other species of the genus Coffea and shall contain no foreign substances. 4. Lard shall be the clean fat rendered from the meat of the hog. It shall contain not more than 1% of substances other than hog fat unavoidably incorporated with it in the process of rendering, and not more than 1% of water. It shall not contain any foreign substance. 5. Vinegar shall be a liquid derived wholly from alcoholic and acetous fermentations without any intermediate distillation. It shall contain not less than 4.0 grammes of acetic acid in 100 cubic centimetres of the vinegar, and shall not contain any other foreign substance, except caramel. 6. Malt vinegar shall be vinegar as prescribed in item 5, but it shall be derived wholly from malted barley, with or without addition of cereals, the starch of which has been saccharified by the diastase of malt. Nothing prescribed in this item or in item 5 shall apply to Chinese native vinegar sold as such under the names of Chit Ts'o (浙醋), Pak Ts'o (白醋) or Hak Ts'o (黑醋). (L.N. 45 of 1975) 7. Honey shall contain not more than 5% of sucrose. 8. Baking powder shall yield not more than 1.5% of its weight of residual carbon dioxide and not less than 8% of its weight of available carbon dioxide, the weight of residual and available carbon dioxide, respectively, being determined in the following manner- (a) Residual carbon dioxide- A sample of 2 grammes of baking powder shall be treated with 25 millilitres of water and evaporated to dryness on a boiling water bath and subsequently treated with a further 25 millilitres of water and evaporated in like manner. The weight of the residual carbon dioxide is the weight evolved when the sample so treated is further treated with excess of dilute sulphuric acid at room temperature, the evolution being completed either by boiling or by means of reduced pressure. (b) Available carbon dioxide- The weight of available carbon dioxide is the difference between the total weight of carbon dioxide and the weight of the residual carbon dioxide obtained when the sample is treated in the manner prescribed in paragraph (a), the total weight of carbon dioxide being determined by ascertaining the weight evolved when a similar sample of the baking powder is treated with excess of dilute sulphuric acid at room temperature, the evolution being completed either by boiling for minutes or by means of reduced pressure. PART II COMPOSITION OF MILK AND MILK PRODUCTS 9. Milk and reconstituted milk shall contain not less than 3.25% of milk fat, and the quantity of milk solids, other than milk fat, present in milk and reconstituted milk shall not be less than 8.5%. 9A. A milk beverage shall contain not less than 0.1% of milk fat. (L.N. 217 of 1977) 9B. Skimmed milk shall contain not more than 0.3% of milk fat, and the quantity of milk solids, other than milk fat, present in skimmed milk shall not be less than 8.5%. (L.N. 80 of 1996) 9C. Semi-skimmed milk shall contain not less than 1.5% and not more than 1.8% of milk fat, and the quantity of milk solids, other than milk fat, present in semi-skimmed milk shall not be less than 8.5%. (L.N. 80 of 1996) 10. Cream shall consist of that part of milk rich in fat which has been- (a) in the case of clotted cream, produced and separated by scalding, cooling and skimming; and (b) in every other case, separated by skimming or otherwise. (L.N. 217 of 1977) 11. (1) Subject to paragraphs (2) to (6), cream, howsoever described as cream, including such descriptions as single cream, pouring cream, coffee cream, fruit cream, or reconstituted cream, shall contain not less than 18% milk fat. (2) Sterilized cream shall contain not less than 23% milk fat. (3) Half cream and sterilized half cream shall contain not less than 12% milk fat. (4) Whipping cream and whipped cream shall contain not less than 35% milk fat. (5) Double cream and thick cream shall contain not less than 48% milk fat. (6) Clotted cream shall contain not less than 55% milk fat. (L.N. 217 of 1977) 12. (1) No sterilized cream or ultra heat treated cream shall contain more than 0.2% of any one or, as the case may be, more than 0.2% of any combination of the following ingredients- (a) calcium chloride; (b) sodium or potassium salts of- (i) carbonic acid; (ii) citric acid; (iii) orthophosphoric acid. (2) No cream which is sold or delivered to a manufacturer for the purpose of his manufacturing business or to a caterer for the purpose of his catering business shall contain more than 13% sugar. (3) No whipping cream which is sold or delivered to a manufacturer for the purpose of his manufacturing business or to a caterer for the purpose of his catering business, whipped cream and cream in an aerosol container shall contain- (a) more than 13% sugar; and (b) more than 0.3% of any one or, as the case may be, more than 0.3% of any combination of the following ingredients- (i) sodium alginate or a mixture of sodium bicarbonate, tetrasodium pyrophosphate and alginic acid; (ii) sodium carboxymethyl cellulose; (iii) carrageenan; (iv) gelatin. (4) Whipped cream and cream in an aerosol container may contain nitrous oxide. (5) No cream in an aerosol container shall contain more than 0.5% of glyceryl monostearate. (6) Clotted cream may contain nisin. (L.N. 217 of 1977) 13. The product known as "half and half" consisting of a mixture of milk and cream shall contain not less than 11.5% milk fat. 13A. The product known as recombined or reconstituted "half and half" consisting of recombined or reconstituted cream and recombined or reconstituted milk shall contain not less than 11.5% milk fat. 14. Sweetened condensed or evaporated milk hall be milk which has been condensed by the evaporation of a portion of its water content, and to which sugar has been added, and shall contain not less than 28% of total milk solids and not less than 8 % of milk fat. It shall not contain any foreign substance except sugar, salt (sodium chloride) and any additive specified in column 2 of Division 1 of Part III of this Schedule not exceeding the level specified opposite to the additive in column 3 of that Division. (L.N. 85 of 2004) 15. Sweetened condensed skimmed or separated milk shall be skimmed or separated milk which has been condensed by the evaporation of a portion f its water content, and to which sugar has been added, and shall contain not less than 24% of total milk solids including fat. It shall contain no foreign substance other than sugar, salt (sodium chloride) and any additive specified in column 2 of Division 1 of Part III of this Schedule not exceeding the level specified opposite to the additive in column 3 of that Division. (G.N.A. 48 of 1961. L.N. 85 of 2004) 16. Unsweetened condensed or evaporated milk shall be milk which has been condensed by evaporation of a portion of its water content, and heat-treated, and shall contain not less than 25.5% of total milk solids and not less than 7.8% of milk fat. It shall contain no foreign substance except salt (sodium chloride) and any additive specified in column 2 of Division 1 of Part III of this Schedule not exceeding the level specified opposite to the additive in column 3 of that Division. (L.N. 85 of 2004) 17. Unsweetened condensed or evaporated skimmed or separated milk shall be skimmed or separated milk which has been condensed by the evaporation of a portion of its water content, and heat-treated, and shall contain not less than 20% of total milk solids including fat. (G.N.A. 48 of 1961) 18. Butter shall be the clean, non-rancid fatty substance obtained by churning milk or cream. It shall contain not less than 80% of milk fat, not more than 16% of water and not more than 4% of salt (sodium chloride). It shall not be mixed with any foreign fat or oil, and it shall not contain any foreign substance except salt (sodium chloride), permitted colouring matter and any additive specified in column 2 of Division 2 of Part III of this Schedule not exceeding the level specified opposite to the additive in column 3 of that Division. (L.N. 85 of 2004) 19. Cheese shall be the solid or semi-solid product obtained by coagulating milk with rennet or acid, with or without the addition of ripening ferments, seasonings, salt (sodium chloride) and permitted colouring matter. It shall contain not less than 30% of milk fat in its water-free substance, and it shall not contain any foreign fat. 20. Cream cheese shall be cheese made from milk and cream. It shall contain not less than 60% of milk fat in its water-free substance. 21. Whole-milk cheese shall be cheese made from milk. It shall contain not less than 50 % of milk fat in its water-free substance. 22. Skim-milk cheese shall be cheese made from milk from which part of the fat has been removed. It shall contain not less than 10% of milk fat in its water-free substance. 23. Ghee shall be made from milk (including buffalo milk) and shall contain no fat other than that derived from such milk. 24. Ice cream shall contain not less than 5% fat, 10% sugar and 7 1/2% milk solids other than fat: Provided that ice cream containing any fruit, fruit pulp or fruit puree shall either conform to the aforesaid standard or, alternatively, the total content of fat, sugar and milk solids other than fat shall not be less than 25% of the ice cream including the fruit, fruit pulp or fruit puree, as the case may be, and such total content of fat, sugar and milk solids other than fat shall include not less than 7 1/2% fat, 10% sugar and 2% milk solids other than fat. For the purpose of the aforesaid standards relating to ice cream, "sugar" (糖) means sucrose, sugar or the solids of any sweetening material derived from starch, provided that no ice cream shall contain less than 7 1/2% sucrose. PART III ADDITIVES IN CERTAIN MILK PRODUCTS Division 1 Additives in sweetened condensed or evaporated milk, sweetened condensed skimmed or separated milk and unsweetened condensed or evaporated milk Item Additive Maximum Level Firming Agents 1. Potassium chloride 2 grams per kilogram singly or 3 grams per kilogram in combination, expressed as anhydrous substances 2. Calcium chloride Stabilizers 3. Sodium citrates 2 grams per kilogram singly or 3 grams per kilogram in combination, expressed as anhydrous substances 4. Potassium citrates 5. Calcium citrates Acidity Regulators 6. Calcium carbonates 2 grams per kilogram singly or 3 grams per kilogram in combination, expressed as anhydrous substances 7. Sodium phosphates 8. Potassium phosphates 9. Calcium phosphates 10. Diphosphates 11. Triphosphates 12. Polyphosphates 13. Sodium carbonates 14. Potassium carbonates Thickener 15. Carrageenan 150 milligrams per kilogram Emulsifier 16. Lecithins Limited by good manufacturing practice Division 2 Additives in butter Item Additive Maximum Level Acidity Regulators 1. Sodium phosphates } 2 grams per kilogram 2. Sodium carbonate 3. Sodium hydrogen carbonate Limited by good manufacturing practice 4. Sodium hydroxide 5. Calcium hydroxide For the purposes of this Part, "good manufacturing practice" (优良制造规范) includes a manufacturing practice which complies with the following requirements- (a) the quantity of the additive added to food is limited to the lowest possible level necessary to accomplish its desired effect; (b) the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technical effect in the food itself, is reduced to the extent reasonably possible; and (c) the additive is prepared and handled in the same way as a food ingredient. (L.N. 85 of 2004) Cap 132W Sched 2 MARKING AND LABELLING OF FOODS AND DRUGS [regulation 4] (L.N. 80 of 1996) 1. (Repealed L.N. 80 of 1996) 2. Separated milk, skimmed milk, partly skimmed milk, condensed or evaporated skimmed milk and condensed or evaporated partly skimmed milk. (1) Every container containing separated milk, skimmed milk, partly skimmed milk, condensed or evaporated skimmed milk or condensed or evaporated partly skimmed milk shall bear a label upon which is printed such one of the following declarations as may be applicable- (a) in the case of separated milk- SEPARATED MILK (离脂奶) Children under one year of age should not be fed on this milk except under medical advice. (除由医生指导外不应用以喂哺一岁以下之婴儿) (b) in the case of skimmed milk- SKIMMED MILK (脱脂奶) Children under one year of age should not be fed on this milk except under medical advice. (除由医生指导外不应用以喂哺一岁以下之婴儿) (c) in the case of partly skimmed milk- PARTLY SKIMMED MILK (部分脱脂奶) Children under one year of age should not be fed on this milk except under medical advice. (除由医生指导外不应用以喂哺一岁以下之婴儿) (d) in the case of condensed or evaporated skimmed milk and condensed or evaporated partly skimmed milk, whichever of the following is appropriate- CONDENSED SKIMMED MILK (脱脂炼奶) Children under one year of age should not be fed on this milk except under medical advice. (除由医生指导外不应用以喂哺一岁以下之婴儿) CONDENSED PARTLY SKIMMED MILK (部分脱脂炼奶) Children under one year of age should not be fed on this milk except under medical advice. (除由医生指导外不应用以喂哺一岁以下之婴儿) Provided that in any such declaration- (i) the words "EVAPORATED" and "(蒸发)" or the words "EVAPORATED" and "(淡)" may be substituted for the words "CONDENSED" and "(炼)" respectively; (L.N. 80 of 1996) (ii) the words "MACHINE-SKIMMED" and "(机械脱脂)" may be substituted for the words "SKIMMED" and "(脱脂)" respectively; (iia) the words "SEMI-" and "(半)" may be substituted for the words "PARTLY" and "(部分)" respectively; (L.N. 80 of 1996) (iii) if sugar has not been added to the milk, the words "UNSWEETENED" and "(未加糖)" may be added to the English lettering and Chinese characters respectively, which constitute the description of the milk; and (iv) if sugar has been added to the milk, the words "SWEETENED" and "(加糖)" (shall be added to the English lettering and Chinese characters respectively, which constitute the description of the milk. (2) Each declaration prescribed in paragraph (1) shall- (a) be marked distinctly and legibly, in English lettering and Chinese characters; (b) be printed in dark block type upon a light-coloured ground or in light block type upon a dark-coloured ground; (c) be enclosed by a surrounding line; (d) include within the surrounding line no matter other than that prescribed in paragraph (1). (3) Every label prescribed in paragraph (1) shall be securely affixed to or form part of the container, and shall be so placed on the side or top of the container as to be clearly visible. (4) No comment on or explanation of the prescribed declaration shall be placed on the label or container. 3. Reconstituted milk and cream. (1) Subject to the provisions of paragraph (2), every container containing reconstituted milk or reconstituted cream shall be clearly and legibly marked- (a) with the words "RECONSTITUTED MILK (再造奶)" or "RECONSTITUTED CREAM (再造忌廉)", as the case may be, in English capital lettering and Chinese characters of equal size and prominence and of greater prominence than any other lettering or characters respectively appearing upon such container; (b) in either the English or the Chinese language or in both languages, with the name and address of the person by whom the contents were processed; and (c) in either the English or the Chinese language or in both languages, with a declaration of the method of heat-treatment by which the contents were processed. (L.N. 80 of 1996) (2) (a) Every container containing reconstituted skimmed milk shall bear such label as may be approved by the Authority. (L.N. 222 of 1985) (b) The Authority shall not approve a label unless he is satisfied that there has been substantial compliance with- (L.N. 222 of 1985) (i) the provisions of paragraph (1) relating to reconstituted milk, and (ii) the provisions of item 2 relating to skimmed milk. 3A. Pasteurized cream and ultra heat treated cream. (1) Subject to paragraph (2), every container containing pasteurized cream or ultra heat treated cream shall be clearly and legibly marked as follows- (a) "PASTEURIZED" in English capital lettering and "巴士德消毒" in Chinese characters; (b) "ULTRA HEAT TREATED" in English capital lettering and "超高温处理" in Chinese characters; or (c) "U.H.T." in English capital lettering and "超高温处理" in Chinese characters,or with any one of the words or expressions in these subparagraphs. (2) Paragraph (1) shall not apply to containers containing clotted cream. (L.N. 80 of 1996) 4. Milk. Every container containing milk shall be clearly and legibly marked- (a) in either the English or the Chinese language or in both languages, with the name and address of the person by whom the contents were processed; and (b) in either the English or the Chinese language or in both languages, with a declaration of the method of heat-treatment by which the contents were processed. (L.N. 80 of 1996) 5. Beverages containing milk or reconstituted milk. (1) Every container containing a beverage which includes milk or reconstituted milk and which conforms to the standard of composition specified in Part II of Schedule 1, shall be clearly and legibly marked- (a) in either the English or the Chinese language or in both languages, with the name and address of the person by whom the contents were processed; (b) in either the English or the Chinese language or in both languages, with a declaration of the method of heat-treatment by which the contents were processed. (L.N. 80 of 1996) (2) The Authority may in any case dispense with or relax the requirements of paragraph (1)(b). (L.N. 222 of 1985) 6. Beverages described as milk or cream or resembling milk. Every container containing- (a) a beverage which includes milk or reconstituted milk but which does not conform to the standards of composition specified in Part II of Schedule 1; or (L.N. 80 of 1996) (b) a beverage which is described for the purpose of sale by any name, trade mark or trade description which includes the words "milk" or "cream" or the Chinese characters "奶" or "忌廉" or any word or character implying that such beverage is or contains milk or cream; or (c) any soya bean juice or coconut juice (except in whole coconuts) or any other beverage which resembles milk either in colour, taste, appearance or consistency,shall be marked in a conspicuous and easily legible manner in the English and Chinese languages with an accurate description of the principal ingredients. 7. Frozen confections. Every container containing a frozen confection shall be clearly and legibly marked, in English lettering, with the name and address of the person by whom the contents were manufactured. (L.N. 163 of 1969) 8. (Repealed L.N. 222 of 1985) 9. Tenderized meat. (a) Every container containing tenderized meat shall be clearly and legibly marked with the words "TENDERIZED MEAT" in capital letters and the Chinese characters (加工制嫩肉类). (b) In the case of tenderized meat which is not made up in or on a container, a label or ticket clearly and legibly marked with the words "TENDERIZED MEAT" in capital letters and the Chinese characters (加工制嫩肉类) shall be affixed or attached to that meat. (L.N. 116 of 1970) 10. Irradiated foods. Every container containing irradiated food shall be clearly and legibly marked with the words "IRRADIATED" or "TREATED WITH IONIZING RADIATION" in English capital lettering and "辐照食品" in Chinese characters. (L.N. 80 of 1996) (L.N. 30 of 1967) Cap 132W Sched 3 MARKING AND LABELLING OF PREPACKAGED FOODS [regulation 4A] (L.N. 80 of 1996)1. Name or designation (1) Prepackaged food shall be legibly marked or labelled with its food name or designation. (L.N. 80 of 1996) (2) The food name or designation shall not be false, misleading or deceptive in any respect as to the nature of the food. (L.N. 80 of 1996) (3) If any brand name, including any fancy name, or any trade mark would be likely to mislead a purchaser in any respect as to the nature of the food, such name or mark shall be immediately followed by the word "Brand" (牌子) or the letters "TM"(商标), as appropriate, printed in legible letters or characters of not less than 3 mm in height. (4) Any customary or traditional name in use in Hong Kong before the commencement of these regulations and indicative of a particular food may continue to be used as the name of that food, unless and until the Authority by notice in the Gazette prohibits such use. (5) Where a purchaser could be misled by the omission of an indication- (a) that a food is powdered or is in any other physical condition; or (b) that a food has been dried, freeze-dried, frozen, concentrated or smoked, or has been subjected to any other treatment, the name of the food shall include or be accompanied by such an indication. 2. List of ingredients (1) Prepackaged food shall be legibly marked or labelled with a list of ingredients, headed or preceded by an appropriate heading consisting of or including any of the words "ingredients" (配料), "composition" (成分组合), "contents" (内含物质) or words of similar meaning. (L.N. 80 of 1996) (2) Subject to sub-paragraphs (3), (4), (4A) and (4B), the ingredients (other than water if it constitutes less than 5% by volume of the food) shall be listed in descending order of weight or volume determined as at the time of their use when the food was packaged. (L.N. 80 of 1996) (3) In the case of an ingredient which is used in a food in concentrated or dehydrated form and which is reconstituted during preparation of the food for consumption, the weight or volume used in determining the order of the list of ingredients may be the weight or volume of the ingredient before concentration or dehydration. (4) Without prejudice to sub-paragraph (3), where a food is in concentrated or dehydrated form and is intended to be reconstituted by the addition of water, its ingredients may be listed in descending order of their weight or volume in the food when reconstituted as directed, if the heading of the list of ingredients includes or is accompanied by the words "ingredients of the reconstituted product" (恢复水分产品的配料) or "ingredients of the ready to use product" (即食产品的配料) or by some other indication to similar effect. (4A) Without prejudice to sub-paragraph (4B), where a food consists of, or contains, mixed fruits, nuts, vegetables, spices or herbs and no particular fruit, nut, vegetable, spice or herb predominates significantly by weight, those ingredients may be listed otherwise than in descending order of weight if- (a) in the case of a food which consists entirely of such a mixture, the heading of the list of ingredients includes or is accompanied by the words "in variable proportion" or other words indicating the nature of the order in which the ingredients are listed; or (b) in the case of a food which contains such a mixture, that part of the list where the names of those ingredients appear is accompanied by the words "in variable proportion" (可变比例) or other words indicating the nature of the order in which those ingredients are listed. (L.N. 80 of 1996)(4B) Subject to sub-paragraph (4D), where a food is characterized by- (a) the presence of a particular ingredient, the labelling of the food shall not place special emphasis on the presence of that ingredient, unless the labelling includes a declaration of either the minimum percentage by weight of that ingredient in the food or the actual amount of that ingredient in the food, determined as at the time of its use in the preparation of the food; (b) the low content of a particular ingredient, the labelling of the food shall not place special emphasis on the low content of that ingredient, unless the labelling includes a declaration of either the maximum percentage by weight of that ingredient in the food or the actual amount of that ingredient in the food, determined as at the time of its use in the preparation of the food. (L.N. 80 of 1996)(4C) (a) Any declaration required by sub-paragraph (4B) shall appear either- (i) next to the name of the food; or (ii) in the list of ingredients in close proximity to the name of the ingredient in question. (b) The actual amount of an ingredient in a food referred to in sub-paragraph (4B) shall be indicated by reference to the numerical count of the contents or to the net weight or net volume of that ingredient and such indication shall conform with paragraph 7(2). (L.N. 80 of 1996)(4D) For the purposes of sub-paragraph (4B)- (a) a reference in the name of a food to a particular ingredient shall not of itself constitute the placing of special emphasis on the presence or low content of that ingredient; (b) a reference in the labelling of a food to an ingredient which is used in a small quantity and only as a flavouring shall not of itself constitute the placing of special emphasis on the presence or low content of that ingredient. (L.N. 80 of 1996)(4E) (a) If a food consists of or contains any of the following substances- (i) cereals containing gluten (namely wheat, rye, barley, oats, spelt, their hybridized strains and their products); (ii) crustacea and crustacean products; (iii) eggs and egg products; (iv) fish and fish products; (v) peanuts, soyabeans and their products; (vi) milk and milk products (including lactose); (vii) tree nuts and nut products, the name of the substance shall be specified in the list of ingredients. (b) If a food consists of or contains sulphite in a concentration of 10 parts per million or more, the functional class of the sulphite and its name shall be specified in the list of ingredients. (L.N. 85 of 2004)(5) Subject to section 58 of the Ordinance and unless the Authority otherwise allows in any particular case, an additive (except an additive specified in sub-paragraph (7)) constituting one of the ingredients of a food shall be listed by its functional class and- (L.N. 85 of 2004) (a) its specific name; or (b) its identification number under the International Numbering System for Food Additives; or (c) its identification number under the International Numbering System for Food Additives with the prefix "E" or "e". (L.N. 85 of 2004)(6) The functional classes of additive for the purpose of sub-paragraph (5) are- (L.N. 85 of 2004) Acid (酸味剂) Acidity regulator (酸度调节剂) Anti-caking agent (抗结剂) Anti-foaming agent (消泡剂) Antioxidant (抗氧化剂) Bulking agent (增体剂) Colour retention agent (护色剂) Colour (色素) Emulsifier (乳化剂) Emulsifying salt (乳化盐) Firming agent (固化剂) Flavour enhancer (增味剂) Flour treatment agent (面粉处理剂) Foaming agent (发泡剂) Gelling agent (胶凝剂) Glazing agent (上光剂) Humectant (水分保持剂) Preservative (防腐剂) Propellant (推进剂) Raising agent (膨胀剂) Stabilizer (稳定剂) Sweetener (甜味剂) Thickener (增稠剂) (L.N. 226 of 2003; L.N. 85 of 2004) (7) An additive which constitutes one of the ingredients of a food and falls in any of the following classes shall be listed by the appropriate class title- (a) flavour and flavouring (调味料及调味剂); (b) modified starch (改性淀粉),and the expression "flavour" may be qualified by "natural", "natural identical", "artificial" or a combination of these words as appropriate. (L.N. 85 of 2004) 3. List of ingredients of exempt food If any prepackaged food is marked or labelled with a list of ingredients notwithstanding that it is exempted from the requirements of paragraph 2, such list shall conform in all respects with the requirements of this Schedule. 4. Indication of "best before" or "use by" date (1) Prepackaged food shall be legibly marked or labelled with the appropriate durability indication, that is to say- (a) except where sub-sub-paragraph (b) applies, a "best before" (此日期前最佳) date; and (b) in the case of a prepackaged food which, from the microbiological point of view, is highly perishable and is therefore likely after a short period to constitute an immediate danger to human health, a "use by" (此日期前食用) date.(2) The "best before" (此日期前最佳) date shall be indicated by- (a) the words "best before" in English lettering and "此日期前最佳" in Chinese characters followed by the date up to and including which the food can reasonably be expected to retain its specific properties if properly stored; and (b) a statement of any storage conditions which need to be observed if the food is to retain its specific properties until that date. (3) The "use by" (此日期前食用) date shall be indicated by- (a) the words "use by" in English lettering and "此日期前食用" in Chinese characters followed by the date up to and including which the food, if properly stored, is recommended for use; and (b) a statement of any storage conditions which need to be observed if the food is to retain its quality attributes until that date. (4) The "best before" (此日期前最佳) date shall be shown either in Arabic numerals or in both the English and Chinese languages and, subject to sub-paragraph (7), shall be expressed in terms of a day, a month and a year except that- (L.N. 85 of 2004) (a) in the case of a food which can reasonably be expected to retain its specific properties for not more than 3 months, the date may be expressed in terms of a day and a month; (b) in the case of a food which can reasonably be expected to retain its specific properties for more than 3 but not more than 18 months, the date may be expressed in terms of a month and a year if the date is preceded by the word "end" in English lettering and is followed immediately by the word "底" in Chinese character; or (c) in the case of a food which can reasonably be expected to retain its specific properties for more than 18 months, the date may be expressed either in terms of a month and a year or in terms of a year, if the date is preceded by the word "end" in English lettering and is followed immediately by the word "底" in Chinese character. (L.N. 85 of 2004)(5) The "use by" (此日期前食用) date shall be shown either in Arabic numerals or in both the English and Chinese languages and, subject to sub-paragraph (7), shall be expressed in terms of a day and a month or in terms of a day, a month and a year. (L.N. 85 of 2004) (6) The "best before" (此日期前最佳) date or the "use by" (此日期前食用) date may appear on the labelling of a food separately from the words immediately preceding the date, provided that those words are followed by a reference to the place where the date appears. (7) Where the "best before" (此日期前最佳) date or the "use by" (此日期前食用) date is shown in Arabic numerals- (a) the day shall be indicated by the words "DD", "dd", "D" or "d" in English lettering and "日" in Chinese character; (b) the month shall be indicated by the words "MM", "mm", "M" or "m" in English lettering and "月" in Chinese character; and (c) the year shall be indicated by the words "YY", "yy", "Y" or "y" in English lettering and "年" in Chinese character,and the day, month and year can appear in any order. (L.N. 85 of 2004) 5. Statement of special conditions for storage or instructions for use (1) Where special conditions are required for the storage of a prepackaged food, a statement of such conditions shall be legibly marked or labelled on the food. (2) Where special instructions are needed in order that appropriate use may be made of a prepackaged food, such instructions shall be legibly marked or labelled on the food. (3) Any statement or instructions marked or labelled on food under this paragraph shall conform so far as possible with other requirements of this Schedule. 6. Name and address of manufacturer or packer (1) Subject to sub-paragraph (2) or (3), prepackaged food shall be legibly marked or labelled with the full name or business name and the full address or details of the registered or principal office of the manufacturer or packer. (2) Sub-paragraph (1) shall not apply to prepackaged food if- (a) it is marked or labelled with- (i) an indication of its country of origin; (ii) the name of the distributor or brand owner in Hong Kong; and (iii) the address of the registered or principal office of the distributor or brand owner in Hong Kong; and (b) the full address of the manufacturer or packer of the food in its country of origin has been notified in writing to the Authority by the distributor or brand owner in Hong Kong.(3) Sub-paragraph (1) shall not apply to prepackaged food if- (a) (i) it is marked or labelled with an indication of its country of origin and with a code marking identifying the manufacturer or packer in that country; and (ii) particulars of the code marking and of the manufacturer or packer to whom it relates have been notified in writing to the Authority by the manufacturer or packer or by the distributor or brand owner in Hong Kong; or(b) the factory or other place where the food was manufactured or packed is owned, run or managed by the government of its country of origin and the food is marked or labelled in such a manner as to indicate that it is a product of that government. 7. Count, weight or volume (1) Prepackaged food shall be clearly marked or labelled with the numerical count of the contents or with the net weight or net volume of the food. (2) The net weight and net volume shall, so far as is practicable, be indicated in accordance with the Weights and Measures Ordinance (Cap. 68) or with the International System of Units set out in the First Schedule to the Metrication Ordinance (Cap. 214). 8. Appropriate language (1) Except as provided in paragraph 4(2), (3), (4) , (5) and (7) and subject to sub-paragraph (3), the marking or labelling of prepackaged food for purposes of this Schedule shall be in either the English or the Chinese language or in both languages. (L.N. 80 of 1996; L.N. 85 of 2004) (2) If both the English and Chinese languages are used in the labelling or marking of prepackaged food, the name of the food and the list of ingredients shall appear in both languages, but otherwise the requirements of this Schedule need only be met in one of those languages. (3) Unless the Authority otherwise requires in any particular case, any prepackaged food may, if it is national or traditional to the country of its manufacture and is not generally manufactured in any other country, be marked and labelled in accordance with this Schedule in the language of the country of its manufacture. (L.N. 222 of 1985) Cap 132W Sched 4 ITEMS EXEMPT FROM SCHEDULE 3 [regulation 4A] (L.N. 80 of 1996) Item Parts of Schedule 3 from which item is exempt Drinks with an alcoholic strength by volume of more than 1.2% but less than 10% as determined under section 53 of the Dutiable Commodities Ordinance (Cap 109) (L.N. 85 of 2004; L.N. 139 of 2004) The whole Schedule except paragraphs 3 and 4 Prepackaged food sold at a catering establishment for immediate consumption The whole Schedule except paragraph 3 Individually wrapped confectionery products in a fancy form intended for sale as single item The whole Schedule Individually wrapped preserved fruits which are not enclosed in any further packaging and which are intended for sale as single items The whole Schedule Prepackaged food packed in a container the largest surface of which has an area of less than 0 cm2 (L.N. 313 of 1985) Paragraphs 2, 5 and 6 Fresh fruit and fresh vegetables Paragraphs 2 and 4 Carbonated water, to which no ingredient other than carbon dioxide has been added and the description of which indicates that it has been carbonated Paragraph 2 Vinegar which is derived by fermentation exclusively from a single basic product and to which no other ingredient has been added Paragraphs 2 and 4 Cheese, butter, fermented milk and fermented cream, to which no ingredient has been added other than- (i) lactic products, enzymes and micro-organism cultures essential to the manufacture of the item; or (ii) the salt needed for the manufacture of mature cheese Paragraph 2 Any food consisting of a single ingredient Paragraph 2 Flavourings Paragraph 2 Cooking salt Paragraph 4 Sugar with no added ingredients other than preservatives Paragraph 4 Chewing gums and other similar products (L.N. 80 of 1996) Paragraph 4 Wines, liqueur wines, sparkling wines, aromatised wines, fruit wines, sparkling fruit wines and other drinks with an alcoholic strength by volume of 10% or more as determined under section 53 of the Dutiable Commodities Ordinance (Cap 109) (L.N. 85 of 2004; L.N. 139 of 2004) The whole Schedule except paragraph 3 (L.N. 222 of 1985; L.N. 80 of 1996)

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