Frequently Asked Questions on Nutrition Labelling Scheme
- Definition and Coverage of the Amendment Regulation "Updated in March 2018"
- Information Presentation on Nutrition Labelling "Updated in November 2010"
- Nutrition Claims Updated
- Laboratory Analysis "Updated in June 2010"
- Indirect Nutrient Analysis
- Exemption (excluding Small Volume Exemption Scheme)
- Small Volume Exemption Scheme (SVE) "Updated in June 2011"
- Sampling and Enforcement"Updated in January 2017"
- Nutrition Label Calculator (NLC)
1. Definition and Coverage of the Amendment Regulation
2. Information Presentation on Nutrition Labelling
3. Nutrition Claims
4. Laboratory Analysis
5. Indirect Nutrient Analysis
6. Exemption (excluding Small Volume Exemption Scheme)
7. Small Volume Exemption Scheme (SVE)
8. Sampling and Enforcement
9. Nutrition Label Calculator (NLC)
1. Definition and Coverage of the Amendment Regulation
1.1 | What is prepackaged food? |
Under the Food and Drugs (Composition and Labelling) Regulations, "prepackaged food" means any food packaged, whether completely or partially, in such a way that (a) the contents cannot be altered without opening or changing the packaging; and (b) the food is ready for presentation to the ultimate consumer or a catering establishment as a single food item. Such definition also applies to the Amendment Regulation. The following are not considered as prepackaged food and general labelling and nutrition labelling is not required: Products that are not packed beforehand and are just put in packaging for customers at the point of sale (e.g. cream cake and bread displayed for sale without packaging); Products put in packaging that the opening is not tied up nor sealed e.g. eggs that are put in paper tray which can be opened without force. However, for example, for bakery products packed in a plastic bag fastened up with a metal wire, a plastic wire or a date hook, they are considered as prepackaged food. |
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1.2 | Are drinks considered as food? |
Under the Public Health and Municipal Services Ordinance (Cap 132), "food" includes drink and articles and substances used as ingredients in the preparation of food or drink or of such products and "drink" does not include water other than (a) aerated water; (b) distilled water; (c) water from natural springs, either in its natural state or with added mineral substances; and (d) water placed in a sealed container for sale for human consumption. The above also applies to the Amendment Regulation. | |
1.3 | (Deleted in August 2016) |
1.4 | Is the Nutrition Labelling Scheme applicable to health products? How can I confirm if my product needs to fulfill nutrition labelling requirements or is eligible for applying Small Volume Exemption? "updated in March 2018" |
In general, products which fall within the definition of "Food" under the Public Health and Municipal Services Ordinance (Cap 132) are regulated under the Ordinance. Whether an individual product is to be defined as "Food" under the Ordinance would be considered on a case-by-case basis. For the definitions of "pharmaceutical products" and "medicine", “Chinese herbal medicine” and “proprietary Chinese medicine”, they are laid down under the Pharmacy and Poisons Ordinance (Cap. 138) and the Chinese Medicine Ordinance (Cap. 549). In addition, the Undesirable Medical Advertisements Ordinance (Cap. 231) prohibits advertisements claiming that a product has curative or preventive effects on any of the diseases listed in a schedule to the Ordinance. The authority of these Ordinances lies with the Department of Health. Details of these Ordinances are available at the website http://www.elegislation.gov.hk. For "pharmaceutical products", the trade can also refer to the "Guidance Notes on Classification of Products as Pharmaceutical Products" issued by the Department of Health which is available at the website http://www.drugoffice.gov.hk. For Chinese medicines, the trade can browse the website of the Chinese Medicine Council of Hong Kong at http://www.cmchk.org.hk. Like other commodities, the claims of "health products" are also regulated under the Trade Descriptions Ordinance (Cap 362). The Small Volume Exemption Scheme is only applicable to prepackaged food regulated under the Public Health and Municipal Services Ordinance (Cap. 132). It is the responsibility of the trade to verify from the Department of Health whether their health products should be classified as Chinese medicine or western medicine before applying for the exemption. |
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1.5 | What is food for special dietary use? "Updated in December 2011" |
Food for special dietary use is those specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific disease and disorders and which are presented as such. The composition of these food stuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist. It should be noted that the presentation of the product as a food for special dietary use needs to observe relevant provisions in existing law of Hong Kong, including the Undesirable Medical Advertisements Ordinance (Cap. 231) and general food labeling requirements. | |
1.6 | What are the examples of "food for special dietary uses"? "Updated in October 2011" |
Without contravening the principles mentioned in Q1.5, the following products are generally considered as food for special dietary uses- (i) products that must always be used under medical supervision and is presented as such (if medical supervision is only required under certain circumstances, e.g., product with statements such as " for children under age of 3, use under medical supervision only" or "use under medical supervision if use as sole source of nutrition", the product does not fall into this category ); (ii) products solely for tube feeding; and (iii) products that are specially formulated for certain patients or physical conditions and is clearly presented as such, e.g., with statement "specially formulated for cancer patients" (products only marked with "suitable for xx patients" may not fall into this category). For example, milk specially formulated for pregnant women and lactating mothers and presented as such are considered as food for special dietary uses. On the other hand, protein powder products that are for general population are not considered as food for special dietary uses. More examples on food for special dietary uses are provided in Q1.12 and 1.13. |
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1.7
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If a milk product states that it is intended for babies learning to self-feed or for toddlers, is it covered by the Amendment Regulation which is not applicable to formula intended to be consumed by children under the age of 36 months and food intended to be consumed principally by children under the age of 36 months? |
For products with labels specifying that they are "for babies learning to self-feed" or "for toddlers", they are not covered by the Amendment Regulation. However, it is recommended to the parties concerned of the aforesaid food products to provide specific information on their labels such as "food intended to be consumed principally by children under the age of 36 months" or "formula intended to be consumed by children under the age of 36 months". For other food products with labels without specifying consumption by children under the age of 36 months, relevant information for each case will be considered to see whether such products are covered by the Amendment Regulation. | |
1.8 | If nutrition claims are made on infant formula, will they contravene the Amendment Regulation? |
The Amendment Regulation does not cover infant formula. However, as a general rule, all information provided on food labels should be true and not misleading. | |
1.9 | If the product is not for sale, what are the controls on nutrition labelling and nutrition claims? |
Under the Amendment Regulation, any person who advertises for sale, sells or manufactures for sale any prepackaged food which is not marked with the required nutrition information or contains nutrition claims that do not conform with the law commits an offence. This offence will be committed not only when the prepackaged food concerned is for sale, or is sold. For certain food products which are not for sale but constitute an advertisement itself, it is an offence if any person advertises for sale any prepackaged food and the advertisement contains any nutrition claim that does not conform with the law. | |
1.10 | Are "canola oil", "olive oil", and "hydrogenated oil" considered as nutrients? |
They are not considered as nutrients in the Amendment Regulation. | |
1.11
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Are trans fatty acids from natural source excluded from the labelling requirements? |
In the Amendment Regulation, trans fatty acids mean the sum of all unsaturated fatty acids which contain at least one non-conjugated and trans double bond. Basically, it follows the definition of trans fatty acids as stated in the Codex Guidelines on Nutrition Labelling. Conjugated trans fatty acids from natural and industrial sources are excluded from the definition. However, if a food contains non-conjugated trans fatty acids, no matter of its source, their contents should be declared according to the requirements of the Amendment Regulation. | |
1.12 | A product is targeted to a particular group of consumers. Is it considered as food for special dietary uses? "Updated in October 2011" |
If a product is targeted to a particular group of consumers (e.g., the elderly population) only as marketing strategy, but the composition is not significantly different from ordinary food, or if the product is added with nutrients which is of interest to a particular group of consumers who actually do not have special requirement on these nutrients as compared to the general population, the product is not considered as a food for special dietary use. In any case, a product is considered as a food for special dietary uses only when the principles mentioned in Q1.5 are satisfied. Q1.13 below provides further example on the classification of food for special dietary uses. | |
1.13 | What other products are not considered as food for special dietary uses? "Updated in October 2011" |
In addition to the products mentioned in Q1.6 and 1.12, it should be noted that products to be classified as food for special dietary uses should not have any information or advertisement suggesting or implying that the product is also recommended or suitable for the general population or other population subgroups which do not have that specific disease or condition (e.g., "for health-conscious people", "for maintaining well-being and help you stay energetic", "for picky-eaters"). In any cases, products would be classified as food for special dietary uses only if the principles mentioned in Q1.5 are satisfied. In case of uncertainty, relevant information for individual products will be considered to see whether such products are considered as food for special dietary uses. | |
2. Information Presentation on Nutrition Labelling
3. Nutrition Claims
3.1 | How to determine if a nutrition claim can be made on a certain substance? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The trade can use the following three criteria as a guide to determine if a nutrition claim can be made on a certain substance. If the substance fulfils all criteria, then a nutrition claim can be made:
In other words, if relevant nutrition claim conditions have not been stipulated in the Amendment Regulation for a specific nutrient or a specific claim, it would not be acceptable to make such claim on the nutrient. If the substance is not a nutrient, it is not covered by the Amendment Regulation; however the information provided must be correct and not misleading. |
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3.2 | Are products with their claims covered with a sticker or blacked out considered as products with no nutrition claim? "updated in April 2010" | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
If any product provides a nutrition claim on the label, but such a claim is properly and completely covered up with a firmly attached sticker or blacked out rendering it invisible, the product is considered as a product with no nutrition claim. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.3 | If a nutrient is specially highlighted on the package, is it considered as a nutrition claim? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Under the Amendment Regulation, a nutrition claim means any representation which states, suggests or implies that a food has particular nutritional properties. The whole presentation has to be considered on a case-by-case basis as to determine whether it is a nutrition claim. If the presentation suggests or implies that the food contains, does not contain, is rich or low in energy or certain nutrient, it is considered as a nutrition claim. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.4 | Conditions for nutrient content claims are different for solid and liquid food for certain nutrients. How to classify semi-solid food and mixed solid and liquid food? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
For classification of food as to follow conditions of either solid or liquid food, it should be determined basing on its status as sold. For example, ice cream is in the status of solid when it is sold. Nutrient content claims for ice-cream should follow conditions set for solid food. Nutrient content claims for semi-solid food (e.g. yogurt, custard) and mixed solid and liquid food (e.g. borsch, porridge, congee) shall follow the conditions set for solid food. However, for products like milk powder that have to be reconstituted before consumption, conditions for nutrient content claims are applicable to its status after reconstitution following instructions provided on the package. The preparation instructions should be clearly stated. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.5 | Some beverages contain solid ingredients such as fruit pulps. Should these beverages meet conditions for solid food or liquid food when making nutrient content claims? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Beverages containing solid ingredients shall be considered on a case-by-case basis. Foods commonly sold and consumed as beverages would generally be considered as liquid food. As such, beverages such as orange juice with pulp are considered as liquid food in general. These beverages only contain very small amount of solid which are not the major constituent of the beverage and could be swallowed easily without chewing. However, if the solid part is one of the major constituents of the beverage, the beverage may need to comply with requirement for solid food when making nutrient content claims. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.6 | Can nutrition claim be made on soluble fibre? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Soluble fibre is a dietary fibre. According to Amendment Regulation, "dietary fibre" means any fibre analysed by means of any official method adopted by AOAC and soluble fibre is one of those. Therefore, nutrient content claim for soluble fibre should meet the claim conditions for dietary fibre. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.7 | Is nutrition claim made on an ingredient of a product e.g. "Oat contains high level of dietary fibre" allowed? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
If the ingredient concerned is the sole ingredient of the product, it should meet the relevant claim conditions. However, if the claimed ingredient is not the sole ingredient and the presentation implies the nutritional property of the whole product as containing high level of fibre but which is not the fact, the claim may be considered misleading. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.8 | Is the statement "calcium content equivalent to a cup of milk" a nutrition claim? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Whether a statement is a nutrition claim shall be considered on a case-by-case basis. For example, the statement " Rich in calcium- calcium content in one package equivalent to a cup of milk" is considered a nutrient content claim ("High calcium"), but the statement " A pack of biscuit (100g) contains 400mg calcium, calcium content equivalent to a cup of milk" is considered a quantitative declaration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.9 | Is "0 g trans fat" defined as "quantitative declaration or "nutrient content claim"? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The statement "0 g trans fat" on its own without referring the nutrient content to either per package, per serving or per 100g/mL should be considered as a nutrient content claim (i.e. "trans fat free"). However, if the statement is accompanied by the information on the amount of food which is relevant to the labelling format of nutrition information of the product (e.g. "0 g of trans fat per 100g", "0 g of trans fat per serving"), the statement would be considered as an acceptable quantitative declaration. The same principle is applicable to energy and other nutrients. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.10 | Are the conditions for "free" claims different from definition of "0" on nutrition label? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The definition of "0" for absolute amount expression on nutrition label in Table 2 of the Technical Guidance Notes should not be confused with the conditions of "free" for nutrient content claims. Concerning absolute amount expression on nutrition label, for energy and nutrients (protein, carbohydrates, total fat, saturated fat, trans fat, sodium, sugars, dietary fibre and cholesterol), there are definitions of "0" set out in the Technical Guidance Notes. Those with levels not greater than the specified amount can be labelled as "0" as the absolute amount expression in the nutrition label. While a nutrient content claim e.g. "trans fat free", "sugar free" are to be made, conditions set out in Schedule 8 of the Amendment Regulation need to be fulfilled. They are compared in the following table:
* A nutrient content claim can be made only for energy and those nutrients specified in Schedule 8 of the Amendment Regulation and must meet the conditions set out in the Schedule. Since "free" claims for these categories are not included in Schedule 8, and there are no respective conditions set for such claims, as such, they are not allowed. |
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3.11 | Are claims of "95% fat free" or "contains 5% fat" allowed? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The expression of "X% fat free" is considered as a synonym of "low fat" claims. Therefore, in order to use these expressions, the claim conditions for "low fat" must be met, i.e., the food should contain not more than 3g of total fat per 100g if it is a solid food, or the food should contain not more than 1.5g of total fat per 100mL if it is a liquid food. Since the expression of "95% fat free" or "contain 5% fat" implies that the food contains 5g of total fat per 100g or 100ml of food, it does not fulfill the requirements of a "low fat" claim and therefore is not allowed. If the expression is "100% fat free", it has to meet the condition of "fat free" claim, i.e. the food should contain not more than 0.5g of total fat per 100g or per 100mL of food. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.12 | Are claims such as "no oil", "low oil" or "less oil" considered as nutrient content claims on fat? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total fat normally refers to the sum of triglycerides, phospholipids, wax ester, sterols and minor amount of non-fatty material. Edible oils, such as corn oil, peanut oil, etc., contain mainly (normally over 97%) triglycerides. Hence, "oil" can, in general, means fat, and claims such as "no oil", "low oil" or "less oil" must also satisfy the respective claim conditions for "no fat", "low fat" or "less fat". | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.13 | Are "no MSG", "no hydrogenated oil", "caffeine-free", "with electrolytes", "less sweet", "unsweetened", "sweetened", "not a significant source of", "no added" and claims on glycaemic index considered as nutrient content claim? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The above are not considered as nutrient content claim. The one "not a significant source of" is also not considered as a synonym of "low", "free" or as equivalent to "zero gram". In addition, "contains phenylalanine" and "casein free" are allowed. As a general rule, they need to be factually correct and not misleading. For claims "with vitamins" or "with minerals", all listed vitamins or minerals need to meet the conditions of respective claims. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.14 | Are claims like "with amino acids", "with glucose" or "with omega-3" allowed? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
A nutrient content claim can be made only for energy and those nutrients specified in Schedule 8 of the Amendment Regulation and must meet the conditions set out in the Schedule. Since the above nutrients are not included in Schedule 8, and there are no respective conditions set for their content, as such, nutrient content claims cannot be made on them. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.15 | Are "100% Natural/Organic/Fresh", "100% Oat", "non GMO", "Wheat free", "Dairy Free", "Soy free", "Yeast free", "with probiotics", "with prebiotics", "with antioxidants", "contains enzymes", "contains co-enzymes" and "no hormones" considered as nutrition claims? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The above are not considered as nutrition claims as long as they are not referring to any nutrients. In addition, claims of "no galactose" or "galactose free" are allowed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.16 | Can claims like "no starch" or "low starch" be made? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
A nutrient content claim can be made only for energy and those nutrients specified in Schedule 8 of the Amendment Regulation and must meet the conditions set out in the Schedule. As starch was not included in the Schedule and there is no respective condition set for its content, nutrient content claims on starch such as "no starch" or "low starch" cannot be made. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.17 | If the ingredient list contains "low fat milk" or "low sodium salt", are they considered as nutrition claims? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Mentioning of any nutrient content in a list of ingredients as required by the Food and Drugs (Composition and Labelling) Regulations are not considered as nutrition claim. However, if the overall presentation of the product states, suggests, or implies that the product has particular nutritional properties, it will be considered as nutrition claims. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.18 | Is the statement "This is not a sodium free product" acceptable? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The statement would be acceptable if it is factually correct, i.e., the food does not meet the claim condition of "sodium free" as stipulated in the Amendment Regulation. The statement is not considered as a nutrition claim on sodium provided that the whole presentation does not imply the product has particular nutritional properties related to sodium. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.19 | Is the statement "not a low calorie food" acceptable? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The statement "not a low calorie food" is acceptable provided that it is factually correct (i.e., the food does not meet "low energy" requirement as stipulated in the Amendment Regulation). It is not considered as a nutrition claim on energy provided that the whole presentation does not imply whether the product is high or low in energy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.20 | How should reference food for nutrient comparative claims be described? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
When making comparative claims, it is mandatorily required to include (1) a description of the foods being compared and (2) the difference in the energy value or the content level of the nutrient between the foods being compared expressed as an absolute value, a percentage or a fraction. In addition to these mandatory requirements, it is also recommended to include the absolute value of the content of the energy or nutrient in the reference food in order to facilitate comparison of nutrient contents in different products. |
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3.21 | What does the word "similar" mean with respect to nutrient comparative claim? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Examples of similar foods include same food of different brands (e.g. Brand A cookies and Brand B cookies), or different versions of the same food (e.g. Brand A regular cookies and Brand A fat-reduced cookies), or food of the same category/food group (e.g. prawn crackers and potato chips; milk and cheese). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3.22 | How to determine if a nutrient function claim can be made on a certain substance? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The trade can use the following three criteria as a guide to determine if a nutrient function claim can be made on a certain substance. If the substance fulfils all criteria, then a nutrition claim which contains information on the physiological role of the claimed nutrient can be made: (i) The targeted nutrient has nutrient content claim conditions or Chinese NRV as set out in Scehdule 7 of the Amendment Regulation; (ii) The claim is based on scientific substantiation and scientific consensus (if there is currently no consensus, e.g. if research result had only been published on individual journals but there is no international consensus on the function, this requirement is not fulfilled); and (iii) If the claim is made on protein, dietary fibre, vitamins or minerals, the content of claimed nutrient in the product should meet conditions of nutrient content claim for "source". |
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3.23 | Can nutrient function claim made for a nutrient with a NRV established by other recognised international food/health authorities but not Chinese NRV nor conditions included in Schedule 8? | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No. Nutrient function claim can only be made on a nutrient with a Chinese NRV set out in Schedule 7 of the Amendment Regulation, or with conditions for making nutrient content claims set out in Schedule 8 of the Amendment Regulation. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
4. Laboratory Analysis
4.1 | General | |||||||||||||||||||||||||
4.1.1 | How can I know the content of the nutrients in a prepackaged food? Which method will the Government adopt for testing the nutrients? | |||||||||||||||||||||||||
Testing the nutrients by a laboratory is one of the most straightforward ways to know the content of the nutrients in a prepackaged food. Testing services are commercially available for analyzing the nutrients in prepackaged foods. CFS will consider the latest development of the testing methods when deciding the methods to use. At the moment, AOAC Official Methods will be adopted by CFS for testing nutrient content. Nutrition information may also be calculated based on the nutrition information of the raw materials and their cooking method (i.e. indirect nutrient analysis). However, the trade needs to ensure that the nutrition information is correct. More information on indirect nutrient analysis is provided in the "Technical Guidance Notes on Nutrition Labelling and Nutrition Claims". | ||||||||||||||||||||||||||
4.1.2 | Can I use methods other than AOAC official methods to test the nutrient content? | |||||||||||||||||||||||||
Every AOAC official method specifies the applicable food matrices. A number of AOAC official methods are found to be acceptable to test the same nutrient, but in different matrices. Hence, the selection of an appropriate method is crucial to obtain the correct result. For those food matrices that suitable AOAC official method cannot be found, alternative or modified method can be employed. For the testing of dietary fibre, however, only AOAC official methods are acceptable. | ||||||||||||||||||||||||||
4.1.3 | What are the detection limits for the nutrients in foods? | |||||||||||||||||||||||||
A reasonably practicable low detection limit by the best available technology should be adopted for detecting nutrients in a food sample. For each nutrient with definition of "0" provided in the "Technical Guidance Notes on Nutrition Labelling and Nutrition Claims", the detection limit provided by the commercial testing laboratory should be lower than the corresponding definition of "0". However, for testing saturated fat and trans fat of a food sample with the claim of "Free of saturated fat", the detection limits for saturated and trans fat should not be higher than 0.05g per 100g, as the relevant standard is that the food can contain not more than 0.1g of saturated fat and trans fat combined. | ||||||||||||||||||||||||||
4.1.4 | Can the specified method in the Annex of the ‘Method Guidance Notes on Nutrition Labelling and Nutrition Claims' be used to test dairy products? | |||||||||||||||||||||||||
The methods specified in the Annex are currently used by CFS for determining nutrients contents in indigenous mixed foods, but some of them are not suitable for dairy products. Analytical laboratories should use the most appropriate methods published by the AOAC International or other international/nationally recognized standard methods. For example, ISO 8851-1/IDF 191-1:2004 is considered suitable for the determination of fat content in butter. | ||||||||||||||||||||||||||
4.1.5 | Do the tolerance limits of nutrients take into account the measurement uncertainty? | |||||||||||||||||||||||||
Measurement uncertainty is a quantitative indicator of the analytical variability of a test result and has not been taken into consideration when corresponding tolerance limits were set. Since measurement uncertainty and tolerance limit are independent of each other, the measurement uncertainty will be dealt with separately in the event of compliance checking. | ||||||||||||||||||||||||||
4.2 | Sample Preparation | |||||||||||||||||||||||||
4.2.1 | For health foods packed in the form of ‘capsule', should the "shell" of the capsule be analyzed together with the content? | |||||||||||||||||||||||||
As the "shell" of the capsule is usually consumed together with the content inside the capsule, the whole capsule (including the "shell" and the content) should be analysed for nutrient content. If the instruction clearly specifies the "shell" of the capsule should be removed before consumption, the "shell" of the capsule can then be removed before the analysis. | ||||||||||||||||||||||||||
4.2.2 | How to blend soft gelatin capsules into homogeneous fine powder? | |||||||||||||||||||||||||
After mixing the soft gelatin capsules with liquid nitrogen, it will be solidified and become brittle. Grind the mixture with a mill and it will be reduced to fine powder. | ||||||||||||||||||||||||||
4.3 | Energy | |||||||||||||||||||||||||
4.3.1 | How can I measure the energy content of a food sample? | |||||||||||||||||||||||||
Energy is obtained by the summation of the energy contributed by available carbohydrates, protein, total fat, ethanol, and organic acids, multiplied by corresponding conversion factors. It is calculated by the following formula: (weight in grams [4 x available carbohydrates + 4 x protein + 9 x total fat + 7 x ethanol(alcohol) + 3 x organic acids] kcal in 100 g of food) | ||||||||||||||||||||||||||
4.3.2 | When do I need to include ethanol (alcohol) in the energy calculation? | |||||||||||||||||||||||||
Energy calculation includes energy contribution from ethanol. However, not all food contains ethanol. When ethanol is a significant energy contributor, its level must be determined and included in energy calculation, especially for alcoholic beverages, confectionery and desserts containing alcohol. Measurement of ethanol by gas chromatographic method is a common, valid and precise approach. | ||||||||||||||||||||||||||
4.3.3 | Can I determine the "organic acids" content by titration? | |||||||||||||||||||||||||
For "organic acids", the Codex's guidelines have not provided a definition. Different types of food would contain different organic acids. For "milk", "meat", "vegetable and fruit", the predominant organic acid(s) are citric acid, lactic acid, and malic acid and citric acid respectively. However, some prepackaged foods would have significant amount of organic acids, such as fruits, fruit products (including juices), a few vegetables (particularly those preserved in acetic acid), and other manufactured products (including vinegar, salad dressings, soft drinks and yoghurt). Liquid chromatographic method similar to AOAC official method 986.13 for determining the content of different organic acids is preferred. | ||||||||||||||||||||||||||
4.3.4 | Some countries have provided specific energy conversion factor for individual sugar alcohols. Can I use these factors to calculate the energy content? | |||||||||||||||||||||||||
According to Codex's "Guidelines on Nutrition Labelling, CAC/GL 2-1985 (Rev. 1 – 1993, Amend. 2 - 2003)" and the nutrition labelling requirements proposed by Mainland China, no specific energy contributors are assigned for sugar alcohols. Since the content of sugar alcohols in a prepackaged food would be included in the available carbohydrates content if it is calculated by the difference (refer to question 4.3.1), the energy conversion factor for carbohydrates would also be applied to sugar alcohols. |
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4.3.5 | What is the temperature for the determination of moisture and ash since different methods use different temperature and it varies from 100℃ to 110℃ and 500℃ to 600℃ respectively? | |||||||||||||||||||||||||
Though different national or international standard methods use different temperature to test for moisture and ash content, 105℃ and 550℃ are the most commonly used temperature for the determination of moisture and ash respectively. Therefore, it is advised that 105℃ and 550℃ be used for the analysis of moisture and ash respectively. | ||||||||||||||||||||||||||
4.3.6 | How to calculate the energy content of a food sample in terms of kJ? "updated in April 2010" | |||||||||||||||||||||||||
If the energy value of a food sample in terms of kcal per 100g is available, then simply multiply it by the conversion factor of 4.184. Otherwise, the energy value is calculated by the formula as follows. Both approaches are acceptable.
(weight in grams [17 x available carbohydrates + 17 x protein + 37 x total fat + 29 x ethanol(alcohol) + 13 x organic acids] kJ in 100 g of food) |
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4.3.7 | What energy conversion factor should be used for polyols? For the polyol "erythritol"(E968), can I consider it as an energy free food additive? "updated in June 2010" | |||||||||||||||||||||||||
Polyols are commonly known as sugar alcohol, that can be used as sugar substitute to provide bulk and sweetness. Polyols are slowly and incompletely metabolized and provide less energy than sucrose. Erythritol is a kind of polyol, which is present in sugar-free chewing gum, confectionery and bakery products. For simplicity, polyols are classified as carbohydrate constituent when deriving the energy content of the prepackaged product (see FAQ 9 of the Method Guidance Notes). Therefore, energy conversion factor of "4 kcal per gram" or "17 kJ per gram" for carbohydrates as adopted by Codex is also applicable to polyols. On the other hand, it is understood that the use of other conversion factors ranging from 0 to 0.2 kcal per gram and 1.6 to3.8 kcal per gram has been adopted/recommended by different jurisdictions for erythritol and other polyols respectively. CFS has recently reviewed the scientific literature on metabolisable energy provided by polyols and concluded it is also reasonable to accept the use of other energy conversion factors for polyols which are accepted by recognized international/national food/health authorities. When discrepancies are detected during enforcement, CFS would require the manufacturer, importer or vendor to provide relevant details such as types and amounts of ingredients of the product concerned and the conversion factors applied for consideration. |
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4.4 | Carbohydrates (Including Sugars) | |||||||||||||||||||||||||
4.4.1 | Why do I need to test for water and ash content of the food samples? | |||||||||||||||||||||||||
The available carbohydrate content of foods has, for many years, been calculated by difference, rather than analyzed directly. Under such approach, the relevant constituents in foods (protein, fat, water, alcohol, ash, dietary fibre) are determined individually, summed and subtracted from the total weight of the food. This is referred to as available carbohydrates by difference and is calculated by the following formula: 100 – (weight in grams [protein + fat + water + ash + alcohol(ethanol) + dietary fibre] in 100 g of food) |
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4.4.2 | What is the difference between total carbohydrates and available carbohydrates? | |||||||||||||||||||||||||
Total carbohydrates refers to the sum of available carbohydrates and dietary fibre. | ||||||||||||||||||||||||||
4.4.3 | For some prepackaged food that contains indigestible material, such as chewing gum, can the carbohydrate content be calculated by difference? | |||||||||||||||||||||||||
If you get the content of the indigestible material in the prepackaged food, the calculation of available carbohydrates by difference still could be applied with the additional factor of indigestible material. Otherwise, the content of available carbohydrates could be calculated by the summation of the contents of starch and total available sugars, and if quantified or added to the food, any available oligosaccharides, glycogen and maltodextrins. | ||||||||||||||||||||||||||
4.4.4 | Do sugar alcohols belong to carbohydrates? | |||||||||||||||||||||||||
Sugar alcohol (also known as polyol) is a hydrogenated form of carbohydrates, whose carbonyl group (aldehyde or ketone) has been reduced to a primary or secondary hydroxyl group. In general, sugar alcohol is classified as a carbohydrates constituent. | ||||||||||||||||||||||||||
4.4.5 | How to calculate the "available carbohydrate" for a product containing functional fibre? | |||||||||||||||||||||||||
According to the definition of "dietary fibre" in our regulation, functional fibre is a component of "dietary fibre". Hence, dietary fibre, including functional fibre, should be excluded when calculating 'available carbohydrate'. | ||||||||||||||||||||||||||
4.4.6 | How to calculate the amount of "available carbohydrate" in a product of vinegar correctly? | |||||||||||||||||||||||||
For general foodstuff, the small amount of organic acids present would not affect the calculation of the amounts of energy and available carbohydrate significantly. However, the acetic acid content in vinegar cannot be neglected and will affect the calculation of both energy and available carbohydrate. Since organic acids have not been mentioned in the formula for the calculation of available carbohydrate, an additional term for organic acids should be inserted as alcohol does. The formula is as follows: Gram weight of available carbohydrates in 100g of food = 100 - (weight in grams [protein + fat + water + ash + alcohol (ethanol) + dietary fibre + organic acids] in 100g of food |
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4.4.7 | How many monosaccharides and disaccharides should be tested for sugars? | |||||||||||||||||||||||||
According to international trend, fructose, galactose, glucose, lactose, maltose and sucrose are the commonly tested parameters. | ||||||||||||||||||||||||||
4.4.8 | Can I test reducing sugars instead of monosaccharides and disaccharides for sugars? | |||||||||||||||||||||||||
Sugars means all mono-saccharides and di-saccharides present in food. If the food sample contains one single form of reducing sugar, then the reducing sugar test result would be comparable to the result analyzed by high performance liquid chromatography. However, if the sample contains more than one form of sugars, the reducing sugar test result could not truly reflect the content of sugars in the sample, as defined in the law. | ||||||||||||||||||||||||||
4.5 | Dietary Fibre | |||||||||||||||||||||||||
4.5.1 | Since "dietary fibre" is a method dependent test parameter, the change of the definition of dietary fibre would affect the labelling and claims significantly. Which AOAC official method should be used to determine the dietary fibre content? | |||||||||||||||||||||||||
According to the Amendment Regulation, any appropriate AOAC official method is acceptable. In general, CFS would use the AOAC official methods 985.29 and/or 2001.03 to measure the content of dietary fibre of a prepackaged food. If necessary, CFS would require the manufacturer, importer or vendor to provide the method used for follow up. | ||||||||||||||||||||||||||
4.5.2 | Can I use Englyst method to determine the dietary fibre content of a prepackaged food? | |||||||||||||||||||||||||
The Englyst method, which is not used world-wide, is complicated and may therefore be less suitable for routine analysis. Furthermore, Englyst method generally gives lower values than AOAC official method 985.29 or 2001.03. Therefore, the Administration only accepts AOAC official methods. In general, CFS would use the AOAC official methods 985.29 and/or 2001.03 to measure the content of dietary fibre of a prepackaged food. If the result does not match with the labelled content, CFS would require the manufacturer, importer or vendor to provide the method used for further follow up. | ||||||||||||||||||||||||||
4.5.3 | Can I use AOAC official method 2001.03 to determine the content of dietary fibre? What is the difference between the AOAC official methods 985.29 and 2001.03? | |||||||||||||||||||||||||
The AOAC official method 985.29 or 991.43 determines the total dietary fibre - the sum of insoluble dietary fibre (IDF) and soluble dietary fibre (SDF) in foods. The total dietary fibre content is the sum of IDF and SDF with respect to AOAC official method 985.29. However, the AOAC official method 2001.03 determines the IDF, high molecular weight (HMW) SDF and low molecular weight resistant maltodextrin (LMWRMD) in foods. According to the AOAC official method 2001.03, the total dietary fibre is defined as the sum of IDF, HMWSDF and LMWRMD. Hence, the total dietary fibre results obtained by AOAC official methods 985.29 and 2001.03 may be different. The difference would depend on whether the food sample contains resistant maltodextrin or other carbohydrates polymers that give positive result on testing. | ||||||||||||||||||||||||||
4.5.4 | Would AOAC official method 985.29 underestimate the dietary fibre content when the prepackaged food product contains functional fibre? | |||||||||||||||||||||||||
In many countries, synthetically manufactured or naturally occurring isolated oligosaccharides and manufactured resistant starch that have beneficial physiological effects in humans are found in prepackaged food and serve as fibre. AOAC official method 985.29 is not suitable to test for these substances. Specific test methods are required for testing these carbohydrate polymers, including AOAC official method 997.08, 2001.03, 2000.11, etc. In summary, the Administration accepts a set of test methods, listed below, for the analysis of functional fibre -.
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4.5.5 | Can I use AOAC official method 2009.01 to determine the dietary fibre content?"updated in March 2010" | |||||||||||||||||||||||||
According to the Amendment Regulation, any appropriate AOAC official method is acceptable. | ||||||||||||||||||||||||||
4.5.6 | What is the difference between the AOAC official method 2001.03 and 2009.01?"updated in March 2010" | |||||||||||||||||||||||||
The AOAC official method 2001.03 determines the insoluble dietary fibre, high molecular weight soluble dietary fibre and low molecular weight resistant maltodextrin, but not all of resistant starch and non-digestible oligosaccharides. However, the AOAC official method 2009.01 determines the sum of total dietary fibre (analyzed by AOAC official method 985.29), resistant starch and non-digestible oligosaccharides from 3 to 9 monomeric units. It takes the advantage of AOAC official methods 985.29, 2001.03 and 2002.02. Hence, the total dietary fibre results obtained by AOAC official methods 2001.03 and 200.9.01 may be different. The difference would depend on whether the prepackaged food sample contains resistant starch and/or some non-digestible oligosaccharides that gives poor recovery on AOAC official method 2001.03. | ||||||||||||||||||||||||||
4.5.7 | Can I sum up the results obtained from AOAC official method 985.29 and 2002.02 as total dietary fibre for a prepackaged food containing resistant starch?"updated in March 2010" | |||||||||||||||||||||||||
Since the enzymatic-gravimetric AOAC official method 985.29 recovers some but not all resistant starch, the summing up approach would create a double accounting problem. Thus, the AOAC official method 2009.01 is recommended as the method of testing. | ||||||||||||||||||||||||||
4.5.8 | Does fermented fish found to contain dietary fibre reasonable? | |||||||||||||||||||||||||
According to the ASEAN Food Composition Tables, 'Fermented fish (Pla-ra)' was found to contain 0.5g dietary fibre per 100 gram. Therefore, the presence of dietary fibre in fermented fish is possible. | ||||||||||||||||||||||||||
4.6 | Fat | |||||||||||||||||||||||||
4.6.1 | Can I use the sum of individual triglyceride, converted from individual fatty acid, for total fat? | |||||||||||||||||||||||||
Total fat normally refers to the sum of triglycerides, phospholipids, wax ester, sterols and minor amount of non-fatty material. These non-triglyceride components may play an important role in metabolism. Therefore, AOAC gravimetric methods are accepted for the determination of total fat. | ||||||||||||||||||||||||||
4.6.2 | What is saturated fat? | |||||||||||||||||||||||||
Saturated fat refers to the total of fatty acids containing no double bonds and commonly the sum of 13 saturated fatty acids including C 4:0, C 6:0, C 8:0, C 10:0, C 12:0, C 14:0, C 15:0, C 16:0, C 17:0, C 18:0, C 20:0, C 22:0, and C 24:0. | ||||||||||||||||||||||||||
4.6.3 | What is trans fat? | |||||||||||||||||||||||||
Trans fat is defined as the sum of all unsaturated fatty acids which contains at least one nonconjugated and trans double bond. More specifically, it means all the geometrical isomers of monounsaturated and polyunsaturated fatty acids having non-conjugated, interrupted by at least one methylene group, carbon-carbon double bonds in the trans configuration; and commonly refers to the sum of C 14:1T(9-trans), C 16:1T(9-trans), C 18:1T(total), C 18:2TT(9,12-trans), C 18:2T(9-cis,12-trans), C 18:2T(9-trans, 12-cis), C 20:1T(11-trans) and C 22:1T(13-trans). | ||||||||||||||||||||||||||
4.6.4 | I learnt that corn oil contained significant amount of C18:3t fatty acids. Do I need to determine the trans-C18:3 content in other prepackaged foods? | |||||||||||||||||||||||||
Most prepackaged foods do not contain measurable amount of C18:3t fatty acids. Refined edible oils, margarines, table spreads and fried foods with high fat content might contain measurable amount of C18:3t fatty acids. Owing to lack of individual standard for these C18:3t fatty acids, quantification can take the response factor of linolenic acid methyl ester in accordance to the AOAC official method 996.06 or equivalent national/international method. | ||||||||||||||||||||||||||
4.7 | Protein | |||||||||||||||||||||||||
4.7.1 | Can I test for protein by testing the Kjeldahl nitrogen content? | |||||||||||||||||||||||||
The protein content can be determined based on the nitrogen content in the food sample while the nitrogen content can be determined by Kjeldahl method or combustion method. CFS has compared the two methods and found that they give comparable results. Unless a different nitrogen conversion factor is given in a Codex standard or in the Codex method of analysis for that food, the nitrogen content is multiplied by a factor of 6.25 to arrive at protein content. For selected raw foods, the nitrogen conversion factor could vary from 6.38 (whey powders or milk) to 5.70 (pearl millet grain or soybean). Because proteins are made of chains of amino acids joined by peptide bonds, they can be hydrolysed to their component amino acids, which can then be measured. The sum of the amino acids then represents the protein of the food. This method has an advantage of removing the use of nitrogen conversion factor, but is much more expensive. |
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4.8 | Vitamins and Minerals | |||||||||||||||||||||||||
4.8.1 | Does alpha-carotene belong to vitamin A? | |||||||||||||||||||||||||
Carotenoids with provitamin A activity include α-carotene, β-carotene, γ-carotene and β-cryptoxanthin. With reference to the Codex Guidelines, according to which the conversion factor is 6 μg β-carotene to 1μg Retinol Equivalent (RE), the Amendment Regulation recognizes only beta-carotene, amongst the carotenoids, in the calculation of RE for vitamin A, and apply the same conversion factor. BS EN 12823:2000 Part 1 and 2 are appropriate methods for measuring retinol and β-carotene in foods respectively. | ||||||||||||||||||||||||||
4.8.2 | How many different forms of vitamin D are there in food? | |||||||||||||||||||||||||
Two common forms of vitamin D are found in foods, namely cholecalciferol (D 3) and ergocalciferol (D 2). Vitamin D 3 is more widely distributed (e.g. in fish oils, many fatty fish tissues, eggs, butter and cream cheese) and D 2 occurs naturally in low concentrations in fish oils and mushrooms. Some meats contain 25-hydroxy-cholecalciferol in concentrations that contribute to vitamin D activity and thus is considered as vitamin D as well. BS EN 12821:2000 could be used for measuring vitamin D in foods. | ||||||||||||||||||||||||||
4.8.3 | Is α-tocopherol equivalent to vitamin E? | |||||||||||||||||||||||||
Vitamin E activity is exhibited naturally by eight substances structurally based on tocopherols and tocotrienols. Each vitamer has a different vitamin activity compared with α-tocopherol, which is seen as the primary structure. The preferred analytical method is therefore the one that separates and measures all the different vitamers. BS EN 12822:2000 is a suitable method for measuring tocopherols in foods. According to FAO, α-tocopherol equivalents of mixed diet containing natural forms of vitamin E could be estimated as the sum of the number of milligrams of alpha-tocopherol, beta-tocopherol multiplied by 0.5, gamma-tocopherol multiplied by 0.1, delta-tocopherol multiplied by 0.01 and alpha-tocotrienol multiplied by 0.3. | ||||||||||||||||||||||||||
4.8.4 | Can erythorbic acid count as vitamin C? | |||||||||||||||||||||||||
There are two substances showing vitamin C activity, L-ascorbic acid and the first product of its oxidation – L-dehydroascorbic acid. The D-isomer (erythorbic acid), which is used as an antioxidant food additive, is not active. Hence, vitamin C refers to the sum of the number of milligrams of L-ascorbic acid and L-dehydroascorbic acid. | ||||||||||||||||||||||||||
4.8.5 | Does niacin equal to nicotinamide? | |||||||||||||||||||||||||
"Niacin" (Vitamin B3) refers to nicotinamide, nicotinic acid, and derivatives that have biological activity of nicotinamide. |
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4.8.6 | Can the content of folate in food be expressed in terms of Dietary Folate Equivalent (DFE)? | |||||||||||||||||||||||||
Since folic acid taken with food is 85 percent bio-available but food folate is only about 50 percent bio-available, folic acid taken with food is 85/50 (i.e., 1.7) times more available. Thus, when calculating the folic acid equivalents of mixed diet containing natural and synthetic forms of folic acid, it could be estimated as the sum of the number of micrograms of food folate and synthetic folic acid multiplied by 1.7 in the units of μg DFE. | ||||||||||||||||||||||||||
4.8.7 | Can I use other AOAC official method instead of AOAC official method 985.35 to determine the content of calcium and sodium in food? | |||||||||||||||||||||||||
For calcium analysis, it is well known that anionic chemical interferences, such as phosphate, sulfate and aluminum interferences, would be present if lanthanum is not used in samples and standards. Therefore, other methods that employ lanthanum to reduce the anionic chemical interferences would be suitable for analysis. In the analysis of sodium by flame absorption spectrometry or inductively coupled plasma – optical emission spectrometry, sodium can experience partial ionization which indirectly affects absorption sensitivity. The presence of other alkali salts in the sample can reduce this ionization and thereby enhance analytical results. The ionization suppressive effect of sodium is small if the ratio of sodium to potassium is under 10. Any enhancement due to other alkali salts in food can be stabilized by adding excess cesium to both sample and standard solutions. As such, other methods that employ cesium to reduce the ionization suppressive effect would be suitable for the analysis of sodium. Furthermore, reagent blanks should be analyzed to correct for sodium impurities in the buffer stock. |
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5. Indirect Nutrient Analysis
5.1 | What kind of food products is more suitable for using indirect nutrient analysis in estimating the nutrient contents? |
Indirect nutrient analysis is more suitable for food products that have simple food processing steps such as boiling, steaming, mixing, and roasting (e.g. dumpling, dim sum). It is less suitable for food products that have undergone complicated procedures that may have changed the nutrient profiles of the food, such as a combination of the processing procedures listed above, baking, and fermenting (e.g. cookies, bread). | |
5.2 | When using indirect nutrient analysis in making a nutrition label, can the information come from different sources? |
There are 2 ways that the trade can obtain the nutrient content of a food: (i) laboratory analysis of representative food samples, and (ii) calculation based on the nutrition information of the food ingredients and their cooking method (i.e. indirect nutrient analysis). Before conducting indirect nutrient analysis, the trade must ensure that the method is appropriate for the product and suitable data for each ingredient is available for use in the calculation. When calculating nutrient content of food products by using information from food composition databases, it should be noted that different databases may have their own definition of nutrients in foods. Discrepancy in food nutrient values may therefore be observed between individual databases. The selection of databases and food data would depend on the actual situation and must be considered case-by-case. In any case, the trade must satisfy themselves that the calculated nutrient values for nutrition labelling are accurate and representative of their particular product. It is the trade's responsibility to ensure the appropriateness of the data used in making the nutrition label which meets the requirements of the Amendment Regulation. | |
6. Exemption (excluding Small Volume Exemption Scheme)
6.1 | Do all exempted items need application and approval? |
Items exempted under the Amendment Regulation are listed in Schedule 6 of the Amendment Regulation and Annex I of the Technical Guidance Notes. Application and approval are required only for the last item in Annex I of the Technical Guidance Notes, which is prepackaged food with annual sales volume not exceeding 30 000 units. One may refer to details in Part 2 of Schedule 6 of the Amendment Regulation or Annex V of the Technical Guidance Notes. | |
6.2 | Are prepackaged foods such as red chilli peppers, spring onion, garlic in their fresh, dried, and diced/mashed/powdered form exempted from nutrition labelling? |
According to item 6 in Part 1 of Schedule 6 to the Amendment Regulation, vegetables (whether fresh, chilled, frozen or dried) packed in a container which contains no other ingredient and to which no other ingredient has been added are exempted from nutrition labelling. There is no definition of "vegetables" in the said Regulation or in the main Ordinance, Cap.132. Nevertheless, vegetables are usually referred to food items traditionally classified as such food group. In general, vegetables include legumes (e.g. green peas, soybeans), mushrooms, seaweeds and fungi but do not include nuts, seeds, rice or other cereal grains. As for red chilli peppers, spring onion, garlic in their fresh or dried form, they are considered as vegetables and so can be exempted. However, if they have been subject to other treatment or processing resulting in a substantial change in the natural state of the food, such as dicing, mashing, powdering, etc, they are generally not consumed as vegetables and cannot be exempted. | |
6.3 | Are ingredients of common Chinese soups (e.g. Chinese yam 淮山, red date 紅棗, Chinese wolfberry 杞子) exempted from nutrition labelling? |
Whether an ingredient can be exempted shall be considered on a case-by-case basis. For example, Chinese yam is a tuber and can be consumed as vegetables in its fresh state. Red date is a kind of fruit and can be consumed in its dried state. Chinese wolfberry in its dried state can be consumed as dried fruit and is used as soup ingredient. If a soup ingredient is considered as a fruit or a vegetable and if it is packaged in a container which contains no other ingredient and to which no other ingredient has been added, it can be exempted under item 6 in Schedule 6 to the Amendment Regulation. | |
6.4 | Under the exemption list in Schedule 6 of the Amendment Regulation, what is "catering establishment" referring to? Does it cover school lunchbox providers? |
Under the Food and Drugs (Composition and Labelling) Regulations, "catering establishment" 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. Such definition also applies to the Amendment Regulation. If a school lunchbox provider runs the business as a food factory where the lunchboxes are prepared and delivered to some other places for sale for human consumption, it is not classified as a "catering establishment". | |
6.5 | One item under exemption list in Schedule 6 of the Amendment Regulation is "Prepackaged food (a) processed and sold to an ultimate consumer at the same premises; or (b) 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 (a) or (b)." If the product is processed (e.g. baked) in one premise and sold in another premise outside (a) or (b), are the same products sold in (a) or (b) exempted? |
No. If the same products are also sold in other premises, all of them are not exempted. | |
7. Small Volume Exemption Scheme (SVE)
7.1 | For products exempted under Small Volume Exemption Scheme, presence of existing nutrition label without any nutrition claims will not remove its exemption status. However, does the existing nutrition label need to meet labelling requirements of the Amendment Regulation? | ||||||
The labelling requirements of the Amendment Regulation are not applicable to items exempted under the Small Volume Exemption Scheme. However, as a general rule, all information provided should be accurate, true and not misleading. | |||||||
7.2 | Specific labels are needed to indicate certain products are exempted under the Small Volume Exemption Scheme. Can that label incorporate other information e.g. ingredients, expiry dates, etc? Furthermore, is it acceptable for not providing a surrounding line to the label, if it is a separate sticker? "updated in April 2010" | ||||||
Label requirements for prepackaged food exempted from nutrition labelling under Small Volume Exemption Scheme are listed out in the Appendix I of the "Guide to Application for Small Volume Exemption from Nutrition Labelling". The label should be enclosed by a surrounding line in the shape of a rectangle, a square or a circle and shall include no matter other than the wordings required. However, outside the surrounding line, other information can be provided.
On the other hand, it is acceptable for not providing a surrounding line for the exemption label, if it is in the form of a separate sticker, as the rim of the sticker is considered as a surrounding line for the label. |
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7.3 | Prepackaged food with annual sales volume not exceeding 30000 units can apply for exemption under the Small Volume Exemption Scheme. How to count as one unit? | ||||||
Upon application, exemption from nutrition labelling requirements of a prepackaged food may be granted if the annual sales volume of food of the same version in Hong Kong would not exceed 30000 units. Eligible applicants are manufacturers (for local products) or importers (for imported products) and sales volume refer to those at the manufacturer or importer level. In determining whether certain prepackaged foods are of the same version, ingredients, packing size, flavour, manufacturer/packer, container and other features of the foods will be taken into consideration. Traders should submit separate applications in respect of products of different versions. For products identical in all the factors mentioned above but with different packaging design or artwork, whether they are considered as different versions will be determined on a case-by-case basis and traders should submit the details and the package for consideration. |
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7.4 | How to count the sales volume of products exempted under the Small Volume Exemption Scheme? | ||||||
Sales volume refers to products sold at the manufacturer or importer level (i.e. number of units that are sold to the retailers or distributors), not to those actually sold out by the retailers to the ultimate consumers, unless the products are sold directly to the ultimate consumers. The selling unit refers to the unit of the pack size that is to be sold to the ultimate consumers. For products selling in bulk to the ultimate consumer (e.g. 6 bottles of 250 mL beverages packed together and being sold as one unit), the whole package would be considered a single selling unit. Traders should specify such in the application form when applying for exemption. When counting the sales volume for a product granted with exemption, it refers to the sum of the number of units sold by all the exemption grantees in respect of the product. It does not cover the sales volume for the same product being sold by other manufacturers or importers not granted with exemption. |
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7.5 | If an additional pack is attached to a "6-pack product" as a bonus item (i.e. free of charge), will this additional pack be counted into the sales volume of the "6-pack product" granted with exemption under the Small Volume Exemption Scheme? | ||||||
In determining whether certain products are of the same version, one of the characteristics will be taken into consideration is the packing size of the product. If the additional pack is securely attached to the "6-pack product", this "6 plus 1" pack may be counted as a "selling unit" different from the "6-pack" version. If the additional pack is not attached to the "6-pack product" and can be sold to customers as a single unit, this additional pack is regarded as another different version of the product. Traders should submit separate applications for products of different versions. For the "buy one get one free" scenario, the two products of the same version will be counted as 2 units instead of 1 unit. In any case, traders are required to specify clearly the selling unit of the product in the application form when applying for exemption. | |||||||
7.6 | Under the Small Volume Exemption Scheme, in case some products distributed by a food importer to its retailers were subsequently returned from the retailers due to whatever reasons, will these returned products be deducted from the sales volume already reported to CFS? | ||||||
The importer should provide documentary proof such as sales invoice, records or account showing the movement of the products for CFS's consideration on a case-by-case basis. | |||||||
7.7 | Some food products such as cheese, sausage and ham that are manufactured in bulk and require cutting and repacking before sale have the problem of cutting into exact weight and will even be cut into various sizes to meet customer demand. Can these repacked non-fixed weight products be regarded as same version when applying for Small Volume Exemption? "Updated in April 2010" | ||||||
Considering the operational difficulty encountered by the trade, CFS accepts such kind of non-fixed weight food products be regarded as same version when applying for Small Volume Exemption. This is applicable to products with cutting and repacking being done either at local retail shops or in overseas countries before importation.
Similarly, food products sold under "catch weight" such as dried fruits, nuts, pickles, bean curd, tofu puffs, "siu mai" and processed meat, etc that are packed and sold in a package or container of same size and design but with variable weight, would also be regarded as same version when applying for Small Volume Exemption. |
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7.8 | What parameters are used to determine if "catch weight" products applying for Small Volume Exemption are the "same version"? "Updated in June 2010" | ||||||
We will consider the following parameters to determine if the "catch weight" products under application for Small Volume Exemption are the "same version":
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7.9 | What will be the consequence for those food products approved under the Small Volume Exemption Scheme with annual sales volume exceeding 30 000 units? "Updated in June 2011" | ||||||
A revocation letter will be issued to the grantee requiring him/her to cease the sale of the food product approved under the Small Volume Exemption Scheme one month after the notification of the revocation of the approval, i.e., the product should no longer be sold unless a proper nutrition label is provided as required by the regulation. After the revocation, application for approval under the Small Volume Exemption Scheme for the same product will not be granted in the following two years. |
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7.10 | What will be the consequence if the grantee has violated the conditions to be observed by him/her in connection with the Small Volume Exemption Scheme? "Updated in June 2011" | ||||||
A letter will be issued to the grantee upon detection of the violation of the conditions to be observed, requiring him/her to account for this irregularity within 21 days. Should the explanation provided is not accepted, a revocation letter will be issued to the grantee requiring him/her to cease the sale of the food product approved under the Small Volume Exemption Scheme one month after the notification of the revocation of the approval, i.e., the product should no longer be sold unless a proper nutrition label is provided as required by the regulation. After the revocation, application for approval under the Small Volume Exemption Scheme for the same product will not be granted in the following two years. |
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8. Sampling and Enforcement
8.1 | Are the tolerance limits applicable to absolute and relative nutrient declaration and claims? |
The tolerance limits are only applicable to declared values on nutrition label but not to claims. For nutrients which are voluntarily labelled, if only relative values are provided on the label, the declared relative value will be converted to absolute value before applying the tolerance limits. Tolerance limits also apply to factual statements and rounding rule of round to zero. |
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8.2 | I have made a nutrition label for a product basing on the information given in the food composition databases recommended by CFS using the NLC. Do I have any legal responsibility if the calculated label values are different from the values being tested by CFS? |
As the suitability of using specific food composition data highly depends on the characteristics of the product and its ingredients, the CFS does not recommend the use of particular food composition databases in indirect nutrient analysis. However, a list of food composition databases and sources of relevant information was provided for the trade's convenient reference. During enforcement, the accuracy of the energy and nutrient contents on the nutrition labels will be checked against results of laboratory testing, in which tolerance limits (as stated in Table 3 of the Technical Guidance Notes) and rounding rules (as set out in Table 2 of the Technical Guidance Notes) would be taken into account. The trade should keep documents and records that support their calculations when using indirect nutrient analysis, and produce for scrutiny by CFS when discrepancy of values is found between the label and the test done by CFS. Depending on the severity of discrepancy, CFS will consider issuing a warning letter to the trade to correct the values on the label, or else prosecution action will be taken. | |
8.3 | If the nutrient content of a food product does not tally with the declared value on its nutrition label, does it involve food safety concern? "Updated in January 2017" |
In general, food product with nutrient content that does not tally with the declared value on its nutrition label has no food safety concern. However, according to Section 61 of the Public Health and Municipal Services Ordinance (Cap 132), if any person falsely describes food or misleads as to the nature, substance or quality of the food on a label of the food sold by him, he shall be guilty of an offence and be liable to a maximum fine of $50,000 and six months' imprisonment upon conviction. | |
9. Nutrition Label Calculator (NLC)
9.1 | Who are more suitable to use the NLC to make a nutrition label? | ||||||||||
The NLC is suitable for use by the trade or their representatives who know their food product's nutrient content and processing well. Furthermore, they should have read and understood the Amendment Regulation, the Technical Guidance Notes, the Method Guidance Notes and User Guide of the NLC. In addition, they should agree with the User Agreement of the NLC before getting access to it. | |||||||||||
9.2 | What kind of information is needed before using the NLC? | ||||||||||
Before commencing on making a nutrition label using NLC, the below information shall be available:
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9.3 | How can the Nutrition Label Calculator facilitate the trade in making nutrition labels which comply with the Amendment Regulation? | ||||||||||
The NLC is a web-based, free of charge tool, which is easily accessible at the Centre for Food Safety website to facilitate the trade to make nutrition labels. Provided that the user has the information about the ingredients' nutrient contents and cooking methods, or the nutrient profiles of the product, the NLC can help the trade to formulate a nutrition label that complies with the Amendment Regulation in the following ways:
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