Food and Drugs (Composition and Labelling) Regulations

Regulation 2　　　Interpretation

1. In these regulations, unless the context otherwise requires-

"additive" (添加劑) 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-

1. 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;
2. herbs or spices when used as seasoning;
3. hops;
4. salt;
5. yeast or yeast extracts;
6. the total products of any hydrolysis or autolysis of food protein;
7. starter cultures;
8. malt or malt extract;
9. 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
10. air or water; (L.N. 222 of 1985)

"advertisement" (宣傳品) means any form of advertising intended for the general public which is published by any means including-

1. newspaper or other publication;
2. television or radio broadcast;
3. electronic messages;
4. display of notices, signs, labels, showcards or goods;
5. distribution of samples, circulars, catalogues, price lists or other materials; or
6. exhibition of pictures, models or films,
   and "advertise" (宣傳) shall be construed accordingly; (L.N. 69 of 2008)

"Authority" (主管當局) means the Director of Food and Environmental Hygiene; (78 of 1999 s. 7)

"available carbohydrates" (可獲得的碳水化合物) means total carbohydrates excluding dietary fibre; (L.N. 69 of 2008)

"catering establishment" (飲食供應機構) 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" (食品法典委員會) 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;

"dietary fibre" (膳食纖維) means any fibre analyzed by means of any official methods adopted by the independent organization internationally recognized as regards validating and approving analytical methods for foods and agriculture known as AOAC INTERNATIONAL; (L.N. 69 of 2008)

"energy" (能量), in relation to any food, means the energy provided by the food which is-

1. calculated as the total amount of energy contributed by available carbohydrates (or, if the food is infant formula, total carbohydrates), protein, total fat, ethanol and organic acids contained in the food; and
2. calculated according to the Guidelines on Nutrition Labelling adopted by the Codex Alimentarius Commission; (L.N. 69 of 2008)

"folic acid" (葉酸) , in relation to any infant formula or follow-up formula, means N-pteroyl-L-glumatic acid;

"follow-up formula" (較大嬰兒及幼兒配方產品) means—

1. a product that, according to its descriptions or instructions for use, is—
   1. represented as a replacement for human breast milk or infant formula; and
   2. intended for consumption as a liquid element in a progressively diversified diet by persons of any age from 6 months to under 36 months (even if it is also claimed in the descriptions or instructions, if applicable, to be suitable for consumption by persons of any other age); or
2. a product marked or labelled as "follow-up formula" or "較大嬰兒及幼兒配方產品", or with any other words of similar meaning;

"formula for special medical purposes for infants and young children" (特殊醫用嬰幼兒配方產品) means a product that—

1. according to its descriptions or instructions for use, is specially processed or formulated for the dietary management for, and intended for the exclusive or partial feeding of, persons of any age under 36 months (even if it is also claimed in the descriptions or instructions, if applicable, to be suitable for consumption by persons of any age from 36 months onwards)—
   1. who have limited or impaired capacity to take, digest, absorb or metabolize ordinary food or certain nutrients in it;
   2. who have special nutrient requirements that are determined medically; or
   3. whose dietary management cannot be achieved only by consumption of other food for special dietary uses or modification of normal diet; and
2. may only be used under medical supervision;

"frozen confection" (冰凍甜點) means any confection commonly sold for human consumption in a frozen or chilled state; (L.N. 163 of 1969)

"infant formula" (嬰兒配方產品) means—

1. a product that, according to its descriptions or instructions for use, is intended for consumption as a substitute for human breast milk that is specially manufactured to satisfy, by itself, the nutritional requirements of persons of any age up to and including 12 months until the introduction of appropriate complementary feeding (even if it is also claimed in the descriptions or instructions, if applicable, to be suitable for consumption by persons of any age over 12 months); or
2. a product marked or labelled as "infant formula" or "嬰兒配方產品", or with any other words of similar meaning;

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" (食物添加劑國際編碼系統) 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" (電離輻射) 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-

1. by measuring or inspection devices; and
2. at an energy level no higher than the appropriate maximum level; (L.N. 80 of 1996)

"irradiated food" (輻照食物) means any food which has been subjected to treatment by ionizing radiation; (L.N. 80 of 1996)

"labelling" (標籤、加上標籤), 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)

"list of nutrients" (營養素表) —

1. in relation to any prepackaged food to which regulation 4B applies, means a list of nutrients required by section 1 of Schedule 5; and
2. in relation to any infant formula, follow-up formula or prepackaged food for infants and young children, means a list of nutrients required by section 1 of Schedule 6A; (L.N. 69 of 2008)

"meat" (肉類) means the flesh or other edible part of-

1. any animal; or
2. any bird,

intended for human consumption; (L.N. 116 of 1970; L.N. 222 of 1985)

"milk" (奶類) 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" (奶類飲品) 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)

"niacin" (煙酸)—

1. in relation to any infant formula, means nicotinamide together with nicotinic acid; and
2. in relation to any follow-up formula, means nicotinamide;

"nutrient" (營養素) —

1. means any substance present in food which—
   1. belongs to, or is a component of, one of the following categories—
      1. protein;
      2. carbohydrates;
      3. fat;
      4. dietary fibre;
      5. vitamins;
      6. minerals; and
   2. satisfies any of the following conditions—
      1. the substance provides energy;
      2. the substance is needed for growth, development and normal functions of the body;
      3. a deficit of the substance will cause characteristic bio-chemical or physiological changes to occur; and
2. in Part IV of Schedule 1 and Schedule 6A, includes myo-inositol, L-carnitine and taurine; (L.N. 69 of 2008)

"nutrient comparative claim" (營養素比較聲稱) means a nutrition claim that compares the energy value or the content level of a nutrient in different versions of the same food or similar foods; (L.N. 69 of 2008)

"nutrient content claim" (營養素含量聲稱) means a nutrition claim that describes the energy value or the content level of a nutrient contained in a food; (L.N. 69 of 2008)

"nutrient function claim" (營養素功能聲稱) means a nutrition claim that describes the physiological role of a nutrient in growth, development and normal functions of the body; (L.N. 69 of 2008)

"nutrient reference value" (營養素參考值) means any reference value set out in Schedule 7; (L.N. 69 of 2008)

"nutrition claim" (營養聲稱)-

1. means any representation which states, suggests or implies that a food has particular nutritional properties including-
   1. the energy value;
   2. the content of protein, available carbohydrates, total fat, saturated fatty acids, trans fatty acids, sodium and sugars; or
   3. the content of vitamins and minerals; and
2. includes nutrient content claim, nutrient comparative claim and nutrient function claim; (L.N. 69 of 2008)

"permitted colouring matter" (准許染色料) 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" (預先包裝食物) means any food packaged, whether completely or partially, in such a way that-

1. the contents cannot be altered without opening or changing the packaging; and
2. the food is ready for presentation to the ultimate consumer or a catering establishment as a single food item; (L.N. 222 of 1985)

"prepackaged food for infants and young children" (預先包裝嬰幼兒食物) means any prepackaged food that, according to its descriptions or instructions for use, is intended for consumption by persons of any age under 36 months (even if it is also claimed in the descriptions or instructions, if applicable, to be suitable for consumption by persons of any age from 36 months onwards), but does not include any infant formula or follow-up formula;

"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" (售賣) 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)

"sugars" (糖) means all mono-saccharides and di-saccharides present in food; (L.N. 69 of 2008)

"tenderized meat" (加工製嫩肉類) 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)

"trans fatty acids" (反式脂肪酸) means the sum of all unsaturated fatty acids which contains at least one nonconjugated and trans double bond; (L.N. 69 of 2008)

"ultimate consumer" (最後消費者) means any person in Hong Kong who buys otherwise than-

1. for the purpose of resale;
2. for the purposes of a catering establishment; or
3. for the purposes of a manufacturing business; (L.N. 222 of 1985; L.N. 69 of 2008)

"vitamin A" (維他命A) —

1. in Part IV of Schedule 1 and section 1(1) and (3) of Schedule 6A, means all-trans retinol, calculated in terms of Retinol Equivalent (RE) or International Unit (IU) (with 1 μg RE as being equivalent to 3.33 IU); and
2. in any other case, means the sum of retinol and beta-carotene contained in the food, calculated in terms of RE (with 6 μg of beta-carotene as being equivalent to 1 μg RE); (L.N. 69 of 2008)

"vitamin C" (維他命C)—

1. in relation to any infant formula, means ascorbic acid together with dehydroascorbic acid; and
2. in relation to any follow-up formula, means ascorbic acid;

"vitamin E" (維他命E)—

1. in relation to any infant formula, means d-alpha-tocopherol, calculated in terms of alpha-Tocopherol Equivalent (α-TE) or International Unit (IU) (with 1 IU as being equivalent to 0.67 mg α-TE); and
2. in relation to any follow-up formula, means alpha-tocopherol compounds, calculated in terms of α-TE or IU—
   1. (for alpha-tocopherol compounds from any natural source) with 1 IU as being equivalent to 0.67 mg α-TE; or
   2. (for alpha-tocopherol compounds from any synthetic source) with 1 IU as being equivalent to 0.45 mg α-TE;

"vitamin K" (維他命K), in relation to any infant formula or follow-up formula, means vitamin K1."

(1A) In the definition of follow-up formula in paragraph (1), a reference to replacement for human breast milk or infant formula (replacing formula) includes a reference to any product that is a replacement of the replacing formula or any of its subsequent replacements.

(1B) To avoid doubt, if any product falls within both the definitions of infant formula and follow-up formula in paragraph (1), it is to be treated for the purposes of these regulations as an infant formula but not a follow-up formula.

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)

Regulation 3　　　Standards of composition

1. Subject to paragraph (2), the standards of composition of the foods and drugs specified in Schedule 1 shall be the standard prescribed in respect thereof in that Schedule.
2. The item listed in Schedule 1A is exempt from the standards in Part IV of Schedule 1.

(L.N. 80 of 1996)

Regulation 4A　　　Labelling of prepackaged food

1. Without affecting regulations 4, 4B and 4C, but subject to paragraph (2), prepackaged food shall be marked and labelled in the manner prescribed in Schedule 3. (L.N. 69 of 2008)
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)

Regulation 4B　　　Nutrition labelling of prepackaged food and nutrition claim

1. Without affecting regulations 4, 4A and 4C but subject to paragraphs (2), (6) and (7), prepackaged food shall be marked or labelled with its energy value and nutrient content in compliance with Part 1 of Schedule 5.
2. Subject to paragraphs (3) and (4), the following items shall be exempt from the requirement of paragraph (1)-
   1. any item prescribed in Part 1 of Schedule 6; or
   2. any item in respect of which an exemption has been granted under Part 2 of Schedule 6.
3. If-
   1. any item prescribed in Part 1 of Schedule 6 is marked or labelled with its energy value or any nutrient content; or
   2. any nutrition claim is made on the label of, or in any advertisement for, any item prescribed in Part 1 of Schedule 6, paragraph (1) shall apply in relation to such item.
4. If-
   1. any item in respect of which an exemption has been granted under Part 2 of Schedule 6 is labelled or displayed for sale otherwise than in the manner required by the Authority; or
   2. any nutrition claim is made on the label of, or in any advertisement for, any item in respect of which an exemption has been granted under Part 2 of Schedule 6, paragraph (1) shall apply in relation to such item.
5. Subject to paragraphs (6) and (7), any nutrition claim made on the label of, or in any advertisement for, a prepackaged food shall conform to Part 2 of Schedule 5.
6. This regulation does not apply to food for special dietary uses.
7. Without affecting paragraph (6), if a prepackaged food (the food) is infant formula, follow-up formula or prepackaged food for infants and young children, this regulation applies to the food only if it is claimed in its descriptions or instructions for use to be suitable for consumption by persons of any age from 36 months onwards.

(L.N. 69 of 2008)

Regulation 4C　　　Nutrition labelling of infant formulae, follow-up formulae and prepackaged food for infants and young children

1. Without affecting regulations 4, 4A and 4B but subject to paragraph (2), any infant formula, follow-up formula or prepackaged food for infants and young children must be marked or labelled with its energy value and nutrient content in compliance with Schedule 6A.
2. The items listed in Schedule 6B are exempt from the requirement of paragraph (1).

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Regulation 5　　　Offences and penalties

*(1) Any person who advertises for sale, sells or manufactures for sale any food or drug which, subject to regulation 3(2), 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 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; L.N. 69 of 2008)

(1AA) Any person who advertises for sale, sells or manufactures for sale any prepackaged food which-

1. is not marked or labelled in compliance with regulation 4A(1) or 4B(1); or
2. has on its label any nutrition claim that does not conform to regulation 4B(5),

commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months. (L.N. 69 of 2008)

(1AB) If-

1. any person advertises for sale any prepackaged food; and
2. the advertisement contains any nutrition claim that does not conform to regulation 4B(5),
   the person commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months. (L.N. 69 of 2008)

(1AC) Any person who advertises for sale, sells or manufactures for sale any infant formula, follow-up formula or prepackaged food for infants and young children that is not marked or labelled in compliance with regulation 4C(1) commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months.

(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 or drug, alters, removes or obliterates the marking or labelling of any food or drug marked or labelled for the purposes of regulation 4, 4A, 4B or 4C 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; L.N. 69 of 2008)

(2) In any proceedings for an offence against paragraph (1), (1AA) or (1AB) in relation to the publication of an advertisement, it shall be a defence for the defendant to prove- (L.N. 69 of 2008)

1. that before publishing, or arranging for the publication of, the advertisement, the defendant had taken all reasonable steps to ensure that all nutrition claims in the advertisement conform to regulation 4B(5); or
2. that, being a person whose business is to publish, or arrange for the publication of, advertisements, the defendant received the advertisement for publication in the ordinary course of business. (L.N. 69 of 2008)

(2A) In any proceedings for an offence against paragraph (1AC) in relation to the publication of an advertisement, it is a defence for the defendant to prove that, being a person whose business is to publish, or arrange for the publication of, advertisements, the defendant received the advertisement for publication in the ordinary course of business.

(3) In any proceedings for an offence against paragraph (1) or (1AA) in relation to the sale of any prepackaged food which is not marked or labelled in compliance with regulation 4, 4A(1) or 4B(1), it shall be a defence for the defendant to show that before offering the food for sale he had taken all reasonable steps to ensure that the food was so marked or labelled. (L.N. 222 of 1985; L.N. 80 of 1996; L.N. 69 of 2008)

(3A) Without affecting paragraph (3), in any proceedings for an offence against paragraph (1AA) in relation to any prepackaged food which is not marked or labelled in accordance with section 2(4E) of Schedule 3, it shall be a defence for the defendant to show that he- (L.N. 69 of 2008)

1. 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 section; or; (L.N. 69 of 2008)
2. 1. has used his best endeavours to obtain such information from the importer or manufacturer but such information is not available; and
   2. 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. 85 of 2004 and L.N. 139 of 2004)

(3B) In any proceedings for an offence against paragraph (1AC) in relation to the sale of any infant formula, follow-up formula or prepackaged food for infants and young children that is not marked or labelled in compliance with regulation 4C(1), it is a defence for the defendant to show that, before offering the formula or food for sale, the defendant had taken all reasonable steps to ensure that the formula or food was so marked or labelled.

(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 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 principal 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 principal 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)".

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Schedule 1　　　FOOD AND DRUGS (COMPOSITION AND LABELLING) REGULATIONS

[regulations 2, 3 & 5 & Schedule 1A & 2]
(L.N. 80 of 1996; L.N. 69 of 2008)

(In this Schedule reference to proportion or percentage means proportion or percentage by weight)

PART IA

GOOD MANUFACTURING PRACTICE

For the purposes of this Schedule, ''good manufacturing practice'' (優良製造規範) includes a manufacturing practice which complies with the following requirements-

1. the quantity of the additive added to food is limited to the lowest possible level necessary to accomplish its desired effect;
2. 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
3. the additive is prepared and handled in the same way as a food ingredient.

(L.N. 207 of 2004)

PART I

COMPOSITION OF FOODS AND DRUGS OTHER THAN MILK, MILK PRODUCTS AND INFANT FORMULAE

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 grams of acetic acid in 100 cubic centimetres of the vinegar, and shall not contain any other foreign substance, except caramel. (L.N. 207 of 2004)
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-
   1. Residual carbon dioxide-
      A sample of 2 grams 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. (L.N. 207 of 2004)
   2. 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-
    1. in the case of clotted cream, produced and separated by scalding, cooling and skimming; and
    2. 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) Subject to paragraphs (1A), (1B), (1C), (1D), (1E), (3) and (6), cream shall not contain any ingredient except any additive specified in column 2 of Division 3 of Part III of this Schedule not exceeding the level specified in respect of the additive in column 3 of that Division. (L.N. 207 of 2004)
    (1A) There may be added into cream to serve as stabilizers or thickeners-
    1. ingredients derived exclusively from milk or whey and containing 35% or more of any type of milk protein; and
    2. milk powder.

    The total quantity of the ingredients and milk powder shall not exceed 20 grams per kilogram of cream. (L.N. 207 of 2004)
    (1B) Gelatin and starch may be added into cream to serve as stabilizers in amounts governed by good manufacturing practice. (L.N. 207 of 2004)
    (1C) Whipped cream and cream in an aerosol container may contain carbon dioxide, nitrogen or nitrous oxide as packing gases or propellants. (L.N. 207 of 2004)
    (1D) Fermented cream may contain starter cultures of harmless micro-organisms. (L.N. 207 of 2004)
    (1E) Fermented cream and acidified cream may contain-

    1. sodium chloride;
    2. rennet; or
    3. other coagulating enzymes which are safe for human consumption. (L.N. 207 of 2004)

    (2) (Repealed L.N. 207 of 2005)
    (3) 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 may contain not more than 13% sugar. (L.N. 207 of 2004)
    (4)-(5) (Repealed L.N. 207 of 2005)
    (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 shall 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

Division 2

Additives in butter

Division 3

Additives in cream

(L.N. 85 of 2004; L.N. 207 of 2004)

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PART IV

ENERGY AND NUTRITIONAL COMPOSITION OF INFANT FORMULAE

Division 1

Energy value

Division 2

Nutrient content

1. the words "formula for special medical purposes" or "特殊醫用配方產品", or any other words of similar meaning, in the name of the formula or in a conspicuous place of the package that is not in close proximity to other information on the package;
2. the words "USE UNDER MEDICAL SUPERVISION" or "在醫生指示下使用", or any other words of similar meaning, in bold and in a conspicuous place of the package that is not in close proximity to other information on the package;
3. a statement stating "For the dietary management of (fill in the disease, disorder or medical condition for which the formula is intended to be used or known to be effective)", or showing any other words of similar meaning; and
4. (if the formula poses a health hazard when consumed by a person who does not have the disease, disorder or medical condition stated in the statement) a warning statement and explanation on the hazard in bold and in a conspicuous place of the package that is not in close proximity to other information on the package.

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Schedule 2　　　Marking and Labelling of Foods and Drugs

[regulations 4 & 5]
(L.N. 80 of 1996; L.N. 69 of 2008)

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-
      1. in the case of separated milk-

         SEPARATED MILK (離脂奶) Children under one year of age should not be fed on this milk except under medical advice. (除由醫生指導外不應用以餵哺一歲以下之嬰兒)

      2. in the case of skimmed milk-

         SKIMMED MILK (脫脂奶) Children under one year of age should not be fed on this milk except under medical advice. (除由醫生指導外不應用以餵哺一歲以下之嬰兒)

      3. in the case of partly skimmed milk-

         PARTLY SKIMMED MILK (部分脫脂奶) Children under one year of age should not be fed on this milk except under medical advice. (除由醫生指導外不應用以餵哺一歲以下之嬰兒)

      4. 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 (脫脂煉奶） Children under one year of age should not be fed on this milk except under medical advice. (除由醫生指導外不應用以餵哺一歲以下之嬰兒)

          

         CONDENSED PARTLY SKIMMED MILK (部分脫脂煉奶) Children under one year of age should not be fed on this milk except under medical advice. (除由醫生指導外不應用以餵哺一歲以下之嬰兒)

         Provided that in any such declaration-

         (i) the words "EVAPORATED" and "(蒸發)" or the words "EVAPORATED" and "(淡)" may be substituted for the words "CONDENSED" and "(煉)" respectively;

         (ii) the words "MACHINE-SKIMMED" and "(機械脫脂)" may be substituted for the words "SKIMMED" and "(脫脂)" respectively;

         (iia) the words "SEMI-" and "(半)" may be substituted for the words "PARTLY" and "(部分)" respectively;

         (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-
      1. be marked distinctly and legibly, in English lettering and Chinese characters;
      2. be printed in dark block type upon a light-coloured ground or in light block type upon a dark-coloured ground;
      3. be enclosed by a surrounding line;
      4. 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-
      1. 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;
      2. 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
      3. 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.
   2. 1. Every container containing reconstituted skimmed milk shall bear such label as may be approved by the Authority.
      2. The Authority shall not approve a label unless he is satisfied that there has been substantial compliance with-
         1. the provisions of paragraph (1) relating to reconstituted milk, and
         2. 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-
      1. "PASTEURIZED" in English capital lettering and "巴士德消毒" in Chinese characters;
      2. "ULTRA HEAT TREATED" in English capital lettering and "超高溫處理" in Chinese characters; or
      3. "U.H.T." in English capital lettering and "超高溫處理" 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.
4. Milk.

   Every container containing milk shall be clearly and legibly marked-

   1. 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
   2. 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.
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-
      1. 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;
      2. 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.
   2. The Authority may in any case dispense with or relax the requirements of paragraph (1)(b).
6. Beverages described as milk or cream or resembling milk.

   Every container containing-

   1. 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
   2. 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
   3. 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.

   6A. Follow-up formula.

   Any container containing follow-up formula must not be marked or labelled to the effect that the formula is suitable for consumption by persons of any age under 6 months.

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.

8. (Repealed L.N. 222 of 1985)
9. Tenderized meat.
   1. Every container containing tenderized meat shall be clearly and legibly marked with the words "TENDERIZED MEAT" in capital letters and the Chinese characters (加工製嫩肉類).
   2. 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 (加工製嫩肉類) shall be affixed or attached to that meat.
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 "輻照食品" in Chinese characters.

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Schedule 3　　　Marking and Labelling of Prepackaged Foods

[regulations 4A & 5 & Schedules 4 & 5]
(L.N. 80 of 1996; L.N. 69 of 2008)

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"(商標), 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-
      1. that a food is powdered or is in any other physical condition; or
      2. 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" (成分組合), "contents" (內含物質) 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" (恢復水分產品的配料) or "ingredients of the ready to use product" (即食產品的配料) 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-
      1. 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
      2. 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" (可變比例) or other words indicating the nature of the order in which those ingredients are listed. (L.N. 80 of 1996)
      
      (4B) Subject to subsection (4D), where a food is characterized by- (L.N. 69 of 2008)
      1. 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;
      2. 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)
      1. Any declaration required by subsection (4B) shall appear either- (L.N. 69 of 2008)
         1. next to the name of the food; or
         2. in the list of ingredients in close proximity to the name of the ingredient in question.
      2. 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 subsection (4B)- (L.N. 69 of 2008)
      1. 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;
      2. 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)
      3. "ingredient" (配料) does not include a nutrient. (L.N. 69 of 2008)
      
      (4E)
      1. If a food consists of or contains any of the following substances-
         1. cereals containing gluten (namely wheat, rye, barley, oats, spelt, their hybridized strains and their products);
         2. crustacea and crustacean products;
         3. eggs and egg products;
         4. fish and fish products;
         5. peanuts, soyabeans and their products;
         6. milk and milk products (including lactose);
         7. tree nuts and nut products,
         the name of the substance shall be specified in the list of ingredients.
      2. 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)
      
      (4F) If a food consists of or contains hydrogenated oil—
      1. the list of ingredients must contain a reference to "hydrogenated oil"; or
      2. the name of the oil, as appearing in the list of ingredients, must be qualified by the word "hydrogenated".
   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; L.N. 69 of 2008)
      1. its specific name; or
      2. its identification number under the International Numbering System for Food Additives; or
      3. 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; L.N. 69 of 2008)

      Acid (酸味劑)
      Acidity regulator (酸度調節劑)
      Anti-caking agent (抗結劑)
      Anti-foaming agent (消泡劑)
      Antioxidant (抗氧化劑)
      Bulking agent (增體劑)
      Colour retention agent (護色劑)
      Colour (色素)
      Emulsifier (乳化劑)
      Emulsifying salt (乳化鹽)
      Firming agent (固化劑)
      Flavour enhancer (增味劑)
      Flour treatment agent (麵粉處理劑)
      Foaming agent (發泡劑)
      Gelling agent (膠凝劑)
      Glazing agent (上光劑)
      Humectant (水分保持劑)
      Preservative (防腐劑)
      Propellant (推進劑)
      Raising agent (膨脹劑)
      Stabilizer (穩定劑)
      Sweetener (甜味劑)
      Thickener (增稠劑) (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-
      1. flavour and flavouring (調味料及調味劑);
      2. modified starch (改性澱粉),

      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-
      1. except where paragraph (b) applies, a "best before" (此日期前最佳) date; and
      2. 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" (此日期或之前食用) date.
   2. The "best before" (此日期前最佳) date shall be indicated by-
      1. 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
      2. 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" (此日期或之前食用) date shall be indicated by-
      1. the words "use by" in English lettering and "此日期或之前食用" in Chinese characters followed by the date up to and including which the food, if properly stored, is recommended for use; and
      2. 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 subsection (7), shall be expressed in terms of a day, a month and a year except that- (L.N. 85 of 2004; L.N. 69 of 2008)
      1. 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;
      2. 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
      3. 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" (此日期或之前食用) date shall be shown either in Arabic numerals or in both the English and Chinese languages and, subject to subsection (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; L.N. 69 of 2008)
   6. The "best before" (此日期前最佳) date or the "use by" (此日期或之前食用) 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" (此日期或之前食用) date is shown in Arabic numerals-
      1. the day shall be indicated by the words "DD", "dd", "D" or "d" in English lettering and "日" in Chinese character;
      2. the month shall be indicated by the words "MM", "mm", "M" or "m" in English lettering and "月" in Chinese character; and
      3. 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-
      1. it is marked or labelled with-
         1. an indication of its country of origin;
         2. the name of the distributor or brand owner in Hong Kong; and
         3. the address of the registered or principal office of the distributor or brand owner in Hong Kong; and
      2. 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-
      1. 1. 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
         2. 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
      2. 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; L.N. 69 of 2008)
   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)

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Schedule 4　　　Items exempt from Schedules 3

[regulation 4A]
(L.N. 80 of 1996)

(L.N. 222 of 1985; L.N. 80 of 1996; L.N. 69 of 2008)

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Schedule 5　　　NUTRITION LABELLING AND NUTRITION CLAIM

(L.N. 69 of 2008 01/07/2010)
[regulations 2 & 4B & Schedule 6]

PART 1
NUTRITION LABELLING

1. List of nutrients
   1. Prepackaged food shall be legibly marked or labelled with a list of nutrients setting out-
      1. the energy value of the food;
      2. the content of the following nutrients contained in the food-
         1. protein;
         2. available carbohydrates;
         3. total fat;
         4. saturated fatty acids;
         5. trans fatty acids;
         6. sodium; and
         7. sugars; and
      3. if applicable, the content of any other nutrient contained in the food for which a nutrition claim is made on the label of, or in any advertisement for, the food.
   2. Without prejudice to subsection (1), the content of any other nutrient contained in the food may also be set out in the list of nutrients.
   3. Without prejudice to subsection (1), if a prepackaged food has on its label, or in its advertisement, a nutrition claim which is made in relation to any type of fat contained in the food, the content of cholesterol contained in the food shall also be set out in the list of nutrients.
   4. For the purposes of subsection (1)(b)(ii)-
      1. available carbohydrates may be marked or labelled on a list of nutrients as "carbohydrates" or "碳水化合物";
      2. the content of total carbohydrates contained in a prepackaged food may be set out in a list of nutrients in substitution of the content of available carbohydrates provided that the content of dietary fibre contained in the food is also set out in the list of nutrients.
   5. Other information may be set out in a list of nutrients provided that such information is not false, misleading or deceptive in any respect as to the nutritional or dietary value of the food.
2. Energy value expression
   1. Subject to subsection (2), the energy value to be set out in a list of nutrients shall be expressed-
      1. in kilocalorie (kcal) per 100 g or 100 mL of food; or
      2. in kilojoule (kJ) per 100 g or 100 mL of food.
   2. The energy value to be set out in a list of nutrients may be expressed-
      1. where the package contains a single serving, in kilocalorie (kcal) or kilojoule (kJ) per package;
      2. where the package contains a single serving, in kilocalorie (kcal) or kilojoule (kJ) per serving if-
         1. the single serving is quantified in gram (g) or millilitre (mL) and is specified to be so on the package; and
         2. it is specified on the package that the package contains one serving;
      3. where the package contains more than one serving, in kilocalorie (kcal) or kilojoule (kJ) per serving if-
         1. a single serving is quantified in gram (g) or millilitre (mL) and is specified to be so on the package; and
         2. the number of servings contained in the package is specified on the package.
   3. Without prejudice to subsections (1) and (2), the energy value may further be expressed as the ratio (as a percentage) of the energy value to-
      1. the nutrient reference value of energy; or
      2. any other reference value of energy adopted by any national or international health authority.
3. Nutrient content expression
   1. Subject to subsection (2), the content of nutrients referred to in section 1(1)(b) and (c) and (3) to be set out in a list of nutrients shall be expressed-
      1. in gram (g) per 100 g or 100 mL of food;
      2. in milligram (mg) per 100 g or 100 mL of food; or
      3. in microgram (μg) per 100 g or 100 mL of food.
   2. The content of nutrients referred to in section 1(1)(b) and (c) and (3) to be set out in a list of nutrients may be expressed-
      1. where the package contains a single serving, in gram (g), milligram (mg) or microgram (μg) per package;
      2. where the package contains a single serving, in gram (g), milligram (mg) or microgram (μg) per serving if-
         1. the single serving is quantified in gram (g) or millilitre (mL) and is specified to be so on the package; and
         2. it is specified on the package that the package contains one serving;
      3. where the package contains more than one serving, in gram (g), milligram (mg) or microgram (μg) per serving if-
         1. a single serving is quantified in gram (g) or millilitre (mL) and is specified to be so on the package; and
         2. the number of servings contained in the package is specified on the package.
   3. Without prejudice to subsections (1) and (2), the content of a nutrient may further be expressed as the ratio (as a percentage) of the content of that nutrient to-
      1. the nutrient reference value of that nutrient; or
      2. any other reference value of that nutrient adopted by any national or international health authority.
   4. If the content of any other nutrient is expressed as a percentage in a list of nutrients, the content of that nutrient shall be expressed in the manner specified in subsection (3).
4. Format of list of nutrients
   1. Subject to subsection (2), a list of nutrients shall be presented in tabular form in a conspicuous place of the package with an appropriate heading.
   2. A list of nutrients may be presented in linear form if the total surface area of the package is smaller than 200 cm².
   3. The marking or labelling of prepackaged food for the purposes of this Schedule shall be in-
      1. the English language;
      2. the Chinese language; or
      3. both languages,

      but numbers may be expressed in Arabic numerals.

   4. Without prejudice to section 8(2) of Schedule 3, a list of nutrients shall be in both the English and Chinese languages if both languages are used in the marking or labelling of prepackaged food.
   5. 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 or labelled in accordance with this Schedule in the language of the country of its manufacture.

PART 2
NUTRITION CLAIM

5. Nutrition claim

   For the purposes of these regulations, the following do not constitute a nutrition claim-

   1. mention of any nutrient content in a list of ingredients required by section 2 of Schedule 3;
   2. any quantitative or qualitative declaration of any nutrient content specified in section 2(4E)(a) of Schedule 3;
   3. other quantitative or qualitative declaration of energy value or any nutrient content required by law;
   4. any quantitative or qualitative declaration of change in nutritional value due to genetically modified process;
   5. any claim forming part of the name, brand name or trade mark of a prepackaged food; and
   6. any quantitative declaration of energy value or any nutrient content contained in a prepackaged food which-
      1. is expressed-
         1. as an actual amount; or
         2. in any manner specified in section 2 or 3; and
      2. does not place any special emphasis on the high content, low content, presence or absence of energy or that nutrient contained in the food.
6. Nutrient content claim

   A nutrient content claim shall not be made on the label of, or in any advertisement for, a prepackaged food unless-

   1. the claim is made for energy or a nutrient specified in column 2 of Schedule 8 contained in the food;
   2. the claim uses any of the descriptions specified in column 3 of Schedule 8 that applies to energy or that nutrient; and
   3. the food satisfies the applicable condition set out in column 4 of Schedule 8 opposite to-
      1. the word "Energy" or the name of the nutrient concerned specified in column 2 of that Schedule; and
      2. the relevant description specified in column 3 of that Schedule.
7. Nutrient comparative claim
   1. A nutrient comparative claim shall not be made on the label of, or in any advertisement for, a prepackaged food unless the claim-
      1. compares the energy value or the content level of a nutrient specified in column 2 of Schedule 8;
      2. compares different versions of the same food or similar foods;
      3. compares foods of the same quantity;
      4. conforms to subsection (2); and
      5. satisfies the conditions prescribed in subsection (3), (4), (5), (6), (7), (8) or (9), as applicable.
   2. The following information shall appear in close proximity to a nutrient comparative claim-
      1. a description of the foods being compared;
      2. the difference in the energy value or the content level of a nutrient between the foods being compared expressed-
         1. as an absolute value in the manner specified in (as applicable)-
            1. section 2(1) or (2); or
            2. section 3(1) or (2); or
         2. as a percentage or fraction.
   3. If energy value is compared in a nutrient comparative claim-
      1. the relative value of the difference in the energy value between the foods being compared shall not be less than 25%; and
      2. the absolute value of the difference shall not be less than the maximum amount set out in column 4 of Schedule 8 opposite to the description of "Low" content specified for energy in column 3 of that Schedule.
   4. If the content level of total fat, sugars or sodium is compared in a nutrient comparative claim-
      1. the relative value of the difference in the nutrient content between the foods being compared shall not be less than 25%; and
      2. the absolute value of the difference shall not be less than the maximum amount set out in column 4 of Schedule 8 opposite to-
         1. the name of the nutrient concerned specified in column 2 of that Schedule; and
         2. the description of "Low" content specified for that nutrient in column 3 of that Schedule.
   5. If the content level of saturated fatty acids or cholesterol is compared in a nutrient comparative claim-
      1. the relative value of the difference in the nutrient content between the foods being compared shall not be less than 25%; and
      2. the absolute value of the difference shall not be less than the maximum amount set out in paragraph (a)(i) or (b)(i) of column 4 of Schedule 8 opposite to-
         1. the name of the nutrient concerned specified in column 2 of that Schedule; and
         2. the description of "Low" content specified for that nutrient in column 3 of that Schedule.
   6. If the content level of trans fatty acids is compared in a nutrient comparative claim-
      1. the relative value of the difference in the content of trans fatty acids between the foods being compared shall not be less than 25%; and
      2. the absolute value of the difference shall not be less than the maximum amount set out in paragraph (a)(i) or (b)(i) of column 4 of Schedule 8 opposite to the description of "Free" content specified for trans fatty acids in column 3 of that Schedule.
   7. If the content level of protein is compared in a nutrient comparative claim-
      1. the relative value of the difference in the content of protein between the foods being compared shall not be less than 25%; and
      2. the absolute value of the difference shall not be less than-
         1. in the case of solid food, the minimum amount set out in paragraph (a) or (c) of column 4 of Schedule 8 opposite to the description of "Source" content specified for protein in column 3 of that Schedule;
         2. in the case of liquid food, the minimum amount set out in paragraph (b) or (c) of column 4 of Schedule 8 opposite to the description of "Source" content specified for protein in column 3 of that Schedule.
   8. If the content level of dietary fibre is compared in a nutrient comparative claim-
      1. the relative value of the difference in the content of dietary fibre between the foods being compared shall not be less than 25%; and
      2. the absolute value of the difference shall not be less than the minimum amount set out in column 4 of Schedule 8 opposite to the description of "Source" content specified for dietary fibre in column 3 of that Schedule.
   9. If the content level of any vitamin or mineral provided with a nutrient reference value (except sodium) is compared in a nutrient comparative claim-
      1. the relative value of the difference in the nutrient reference value of such vitamin or mineral between the foods being compared shall not be less than 10%; and
      2. the absolute value of the difference shall not be less than-
         1. in the case of solid food, the minimum amount set out in paragraph (a) or (c) of column 4 of Schedule 8 opposite to the description of "Source" content specified for vitamins and minerals provided with nutrient reference values (except sodium) in column 3 of that Schedule;
         2. in the case of liquid food, the minimum amount set out in paragraph(b) or (c) of column 4 of Schedule 8 opposite to the description of "Source" content specified for vitamins and minerals provided with nutrient reference values (except sodium) in column 3 of that Schedule.
8. Nutrient function claim
   1. A nutrient function claim shall not be made on the label of, or in any advertisement for, a prepackaged food unless-
      1. the claim conforms to subsection (2); and
      2. subject to subsection (3), the content of the nutrient concerned is not less than the minimum amount set out in column 4 of Schedule 8 opposite to-
         1. the name of that nutrient specified in column 2 of that Schedule; and
         2. the description of "Source" content specified for that nutrient in column 3 of that Schedule.
   2. A nutrient function claim shall-
      1. not be made for a nutrient which is not-
         1. provided with a nutrient reference value; or
         2. specified in column 2 of Schedule 8;
      2. be based on scientific substantiation and scientific consensus; and
      3. contain information on the physiological role of the nutrient concerned.
   3. Subsection (1)(b) does not apply to a nutrient function claim made for a nutrient which-
      1. is not specified in column 2 of Schedule 8; or
      2. is specified in column 2 of Schedule 8 but no description of "Source" content has been specified for that nutrient in column 3 of that Schedule.

(Schedule 5 added L.N. 69 of 2008)

Schedule 6　　　ITEMS EXEMPT FROM PART 1 OF SCHEDULE 5

PART 1
ITEMS EXEMPT FROM PART 1 OF SCHEDULE 5 UNDER
REGULATION 4B(2)(a) OF THESE REGULATIONS

1. Prepackaged food with an alcoholic strength by volume of more than 1.2% as determined in the manner described in the definition of "alcoholic strength" in section 53 of the Dutiable Commodities Ordinance (Cap 109).
2. Prepackaged food sold at a catering establishment which is usually bought for immediate consumption.
3. Individually wrapped confectionery products in a fancy form intended for sale as single items.
4. Individually wrapped preserved fruits which are not enclosed in any further packaging and which are intended for sale as single items.
5. Prepackaged food packed in a container which has a total surface area of less than 100 cm².
6. Fruit or vegetable, whether fresh, chilled, frozen or dried-
   1. packed in a container which contains no other ingredient; and
   2. to which no other ingredient has been added.
7. Carbonated water-
   1. to which no ingredient other than carbon dioxide has been added; and
   2. the marking or label of which indicates that it has been carbonated.
8. Spring water and mineral water (including water to which minerals have been artificially added and which is described as mineral water).
9. Prepackaged food which does not have any energy value or contain any content of any nutrient referred to in section 1(1)(b) of Schedule 5.
10. Meat, marine or fresh water fish or any other form of aquatic life commonly used for human consumption-
    1. which is in a raw state;
    2. packed in a container which contains no other ingredient; and
    3. to which no other ingredient has been added.
11. Prepackaged food containing assorted ingredients which is-
    1. prepared and sold to an ultimate consumer at the same premises;
    2. not intended for sale for immediate consumption; and
    3. intended to be subjected to a process of cooking for the purpose of rendering it fit for human consumption.
12. Soup pack containing assorted ingredients-
    1. which has not been subjected to any process of heating in the course of manufacture;
    2. which is not intended for sale for immediate consumption; and
    3. which is intended to be subjected to a process of cooking for the purpose of rendering it fit for human consumption in the form of soup.
13. Prepackaged food sold-
    1. by a charitable institution or trust of a public character which is exempt from tax under section 88 of the Inland Revenue Ordinance (Cap 112); and
    2. in an event held for charitable purposes.
14. Prepackaged food-
    1. processed and sold to an ultimate consumer at the same premises; or
    2. processed at a place which is adjacent to, or in the immediate vicinity of, the premises where the food is sold to an ultimate consumer,

    and not offered for sale outside the premises referred to in paragraph (a) or (b).

15. Prepackaged food sold to a catering establishment as a single item.

Note: In this Part-

"prepared" (製備) includes boning, paring, grinding, cutting, cleaning, trimming, flavouring or packaging, but does not include processing;
"processed" (加工處理) includes any treatment or process resulting in a substantial change in the natural state of any food, and "processing" (加工處理) in the definition of "prepared" in this Note shall be construed accordingly.

PART 2
PREPACKAGED FOOD WITH ANNUAL SALES
VOLUME NOT EXCEEDING 30000 UNITS
MAY BE EXEMPT FROM PART 1 OF
SCHEDULE 5 UNDER REGULATION
4B(2)(b) OF THESE REGULATIONS

1. Exemption from Part 1 of Schedule 5
   1. Upon an application made under subsection (2), the Authority may, subject to section 3(1), grant an exemption in respect of any prepackaged food from the requirements of Part 1 of Schedule 5 if the Authority is satisfied that the annual sales volume of food of the same version in Hong Kong would not exceed 30000 units.
   2. Any importer or manufacturer of a prepackaged food may apply to the Authority for exemption under subsection (1) in such manner as the Authority may determine.
   3. On the approval of an application made under subsection (2), the following is payable by the applicant to the Authority—
      1. if the application is made electronically by means of an online communication system provided by the Authority for the purpose, $265; or
      2. if the application is made in any other manner, $345.
   4. The Authority may-
      1. impose such conditions as the Authority may deem fit; and
      2. require the applicant to give an undertaking to comply with such conditions as the Authority may from time to time impose with regard to the prepackaged food to which the exemption applies.
   5. An exemption granted under subsection (1) shall be valid-
      1. (where no other exemption granted under that subsection is for the time being in force in relation to the version of the prepackaged food concerned) for one year;
      2. (where only one other exemption granted under that subsection is for the time being in force in relation to the version of the prepackaged food concerned) until the expiry date of that other exemption; or
      3. (where 2 or more other exemptions granted under that subsection are for the time being in force in relation to the version of the prepackaged food concerned) until the expiry date of the first of such exemptions.
2. Renewal of exemption
   1. Upon an application made under subsection (2), the Authority may, subject to section 3(2), renew an exemption granted under section 1(1) if the Authority is satisfied that-
      1. (where no other exemption granted under section 1(1) is for the time being in force in relation to the version of the prepackaged food concerned) the total sales volume of the version of the prepackaged food in Hong Kong within the validity period of the exemption would not exceed 30000 units;
      2. (where only one other exemption granted under section 1(1) is for the time being in force in relation to the version of the prepackaged food concerned) the total sales volume of the version of the prepackaged food in Hong Kong within the validity period of that other exemption would not exceed 30000 units; or
      3. (where 2 or more other exemptions granted under section 1(1) are for the time being in force in relation to the version of the prepackaged food concerned) the total sales volume of the version of the prepackaged food in Hong Kong within the validity period of the first of such exemptions would not exceed 30000 units.
   2. A person to whom an exemption has been granted may, before the expiration of the exemption, apply to the Authority for renewal of the exemption in such manner as the Authority may determine.
   3. On the approval of an application made under subsection (2), the following is payable by the applicant to the Authority-
      1. if the application is made electronically by means of an online communication system provided by the Authority for the purpose, $250; or
      2. if the application is made in any other manner, $335.
   4. A renewal under subsection (1) takes effect-
      1. on the day following the expiration of the exemption; and
      2. for a period of one year or such lesser period as may be specified by the Authority.
3. Refusal to grant, refusal to renew or revocation of exemption
   1. The Authority may refuse to grant an exemption under section 1(1) if-
      1. the applicant has, in relation to the prepackaged food to which the application relates, failed to comply with any condition imposed under section 1(4) within the past 2 years; or
      2. the annual sales volume of the version of the prepackaged food to which the application relates in Hong Kong exceeded 30000 units in any one of the past 2 years.
   2. The Authority may refuse to renew an exemption under section 2(1) if the applicant has, in relation to the prepackaged food to which the application relates, failed to comply with any condition imposed under section 1(4) within the past 2 years.
   3. The Authority may revoke an exemption granted under section 1(1) or renewed under section 2(1) ("the exemption") if-
      1. the importer or manufacturer to whom the exemption has been granted ("the grantee") has failed to comply with any condition imposed under section 1(4); or
      2. the total sales volume of the version of the prepackaged food to which the exemption applies in Hong Kong within the validity period of the exemption exceeds 30000 units.
   4. The Authority shall not revoke an exemption unless the Authority-
      1. notifies the grantee in writing of-
         1. his intention to revoke the exemption; and
         2. the grounds upon which the Authority proposes to revoke the exemption;
      2. permits the grantee to make representations to the Authority in writing within the period specified in the notice; and
      3. considers the representations, if any, made by the grantee.
   5. If the Authority revokes an exemption, the Authority shall, as soon as practicable, notify the grantee in writing and specify in the notice-
      1. the grounds for the revocation; and
      2. the date on which the revocation is to take effect.
   6. A revocation takes effect on the expiry of 30 days from the date on which the decision to revoke the exemption is made.

(Schedule 6 added L.N. 69 of 2008)

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Schedule 6A　　　NUTRITION LABELLING OF INFANT FORMULAE, FOLLOW-UP FORMULAE AND PREPACKAGED FOOD FOR INFANTS AND YOUNG CHILDREN

[regulations. 2 & 4C & Sch. 6B]

1. List of nutrients
   1. Any infant formula must be legibly marked or labelled with a list of nutrients setting out—
      1. the energy value of the formula; and
      2. the content of the following nutrients contained in the formula—
         1. protein;
         2. total fat;
         3. total carbohydrates;
         4. vitamin A;
         5. vitamin D3;
         6. vitamin E;
         7. vitamin K;
         8. thiamine;
         9. riboflavin;
         10. niacin;
         11. vitamin B6;
         12. vitamin B12;
         13. pantothenic acid;
         14. folic acid;
         15. vitamin C;
         16. biotin;
         17. iron;
         18. calcium;
         19. phosphorus;
         20. magnesium;
         21. sodium;
         22. chloride;
         23. potassium;
         24. manganese;
         25. iodine;
         26. selenium;
         27. copper;
         28. zinc; and
         29. choline.
   2. If the fluoride content of any infant formula (in a form that is reconstituted or served according to any instructions for use provided) exceeds 100 μg per 100 kcal or 24 μg per 100 kJ, the formula must be marked or labelled with a statement—
      1. indicating that consumption of the formula may cause dental fluorosis; and
      2. recommending that the risk of dental fluorosis should be discussed with a medical practitioner or health professional.
   3. Any follow-up formula must be legibly marked or labelled with a list of nutrients setting out—
      1. the energy value of the formula; and
      2. the content of the following nutrients contained in the formula—
         1. protein;
         2. total fat;
         3. available carbohydrates;
         4. vitamin A;
         5. vitamin D;
         6. vitamin E;
         7. vitamin K;
         8. thiamine;
         9. riboflavin;
         10. niacin;
         11. vitamin B6;
         12. vitamin B12;
         13. pantothenic acid;
         14. folic acid;
         15. vitamin C;
         16. biotin;
         17. iron;
         18. calcium;
         19. phosphorus;
         20. magnesium;
         21. sodium;
         22. chloride;
         23. potassium;
         24. iodine; and
         25. zinc.
   4. Any prepackaged food for infants and young children must be legibly marked or labelled with a list of nutrients setting out—
      1. the energy value of the food; and
      2. the content of the following nutrients contained in the food—
         1. protein;
         2. total fat;
         3. available carbohydrates;
         4. sodium;
         5. vitamin A (if added); and
         6. vitamin D (if added).
   5. Without affecting subsections (1), (3) and (4), the content of any other nutrient contained in the infant formula, follow-up formula or prepackaged food for infants and young children may also be set out in the list of nutrients.
   6. For the purposes of subsections (3)(b)(iii) and (4)(b)(iii)—
      1. available carbohydrates may be marked or labelled on the list of nutrients as "carbohydrates" or "碳水化合物";
      2. the content of total carbohydrates may be set out in the list of nutrients in substitution of the content of available carbohydrates if the content of dietary fibre is also set out in the list of nutrients.
   7. Other information may be set out in a list of nutrients if the information is not false, misleading or deceptive in any respect as to the nutritional or dietary value of the infant formula, follow-up formula or prepackaged food for infants and young children.
2. Energy value expression
   1. The energy value to be set out in a list of nutrients for any infant formula must be expressed in kilocalorie (kcal) or kilojoule (kJ), or both—
      1. per 100 g of the formula (in a form ready for sale); or
      2. per 100 mL of the formula (in a form ready for sale, or in a form that is reconstituted or served according to any instructions for use provided).
   2. The energy value to be set out in a list of nutrients for any follow-up formula or prepackaged food for infants and young children must be expressed in kilocalorie (kcal) or kilojoule (kJ), or both—
      1. per 100 g of the formula or food (in a form ready for sale);
      2. per 100 mL of the formula or food (in a form ready for sale, or in a form that is reconstituted or served according to any instructions for use provided); or
      3. per suggested serving as specified in gram (g) or millilitre (mL).
3. Nutrient content expression
   1. The content of nutrients referred to in section 1(1)(b) of this Schedule to be set out in a list of nutrients for any infant formula must be expressed (for protein, total fat and total carbohydrates) in gram (g) or (for the other nutrients) in an appropriate unit—
      1. per 100 g of the formula (in a form ready for sale); or
      2. per 100 mL of the formula (in a form ready for sale, or in a form that is reconstituted or served according to any instructions for use provided).
   2. The content of nutrients referred to in section 1(3)(b) or (4)(b) of this Schedule to be set out in a list of nutrients for any follow-up formula or prepackaged food for infants and young children must be expressed (for protein, total fat and available carbohydrates) in gram (g) or (for the other nutrients) in an appropriate unit—
      1. per 100 g of the formula or food (in a form ready for sale);
      2. per 100 mL of the formula or food (in a form ready for sale, or in a form that is reconstituted or served according to any instructions for use provided); or
      3. per suggested serving as specified in gram (g) or millilitre (mL).
   3. Without affecting subsections (1) and (2), the content of nutrients referred to in section 1(1)(b) or (3)(b) of this Schedule to be set out in a list of nutrients for any infant formula or follow-up formula may further be expressed (for protein, total fat, total carbohydrates and available carbohydrates) in gram (g) or (for the other nutrients) in an appropriate unit—
      1. per 100 kcal of the formula; or
      2. per 100 kJ of the formula.
4. Format of list of nutrients
   1. Subject to subsection (2), a list of nutrients for any infant formula, follow-up formula or prepackaged food for infants and young children must be presented in tabular form in a conspicuous place of the package with an appropriate heading.
   2. A list of nutrients for prepackaged food for infants and young children may be presented in linear form if the total surface area of the package is less than 200 cm2.
   3. The marking or labelling for the purposes of this Schedule must be in—
      1. the English language;
      2. the Chinese language; or
      3. both languages.
   4. However, numbers may be expressed in Arabic numerals.
   5. A list of nutrients must be in both the English and Chinese languages if both languages are used in the marking or labelling of the infant formula, follow-up formula or prepackaged food for infants and young children.

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Schedule 6B　　　ITEMS EXEMPT FROM SCHEDULE 6A

[regulation 4C]

1. Any formula for special medical purposes for infants and young children that is marked or labelled with—
   1. the words "formula for special medical purposes" or "特殊醫用配方產品", or any other words of similar meaning, in the name of the formula or in a conspicuous place of the package that is not in close proximity to other information on the package;
   2. tthe words "USE UNDER MEDICAL SUPERVISION" or "在醫生指示下使用", or any other words of similar meaning, in bold and in a conspicuous place of the package that is not in close proximity to other information on the package;
   3. a statement stating "For the dietary management of (fill in the disease, disorder or medical condition for which the formula is intended to be used or known to be effective)", or showing any other words of similar meaning; and
   4. (if the formula poses a health hazard when consumed by a person who does not have the disease, disorder or medical condition stated in the statement) a warning statement and explanation on the hazard in bold and in a conspicuous place of the package that is not in close proximity to other information on the package.
2. Any infant formula or follow-up formula packed in a container that has a total surface area of less than 250 cm².
3. Any prepackaged food for infants and young children packed in a container that has a total surface area of less than 100 cm².

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Schedule 7　　　NUTRIENT REFERENCE VALUES FOR DIFFERENT NUTRIENTS FOR PURPOSE OF NUTRITION LABELLING

[regulation 2]

(Schedule 7 added L.N. 69 of 2008)

Schedule 8　　　CONDITIONS FOR NUTRIENT CONTENT CLAIM

[Schedule 5]