Labelling Guidelines On Food Allergens, Food Additives And Date Format

Food and Drugs (Composition and Labelling)
(Amendment) Regulation 2004
Labelling Guidelines on Food Allergens,
Food Additives and Date Format

INTRODUCTION

The Food and Drugs (Composition and Labelling) (Amendment) Regulation 2004 (the Amendment Regulation) was enacted on 9 July 2004. In order to assist the trade to adapt to the changes brought forward by the Amendment Regulation in particular on the following aspects -

  1. Labelling of allergenic substances;
  2. Labelling of food additives; and
  3. Labelling of date format,

the Food and Environmental Hygiene Department has prepared these labelling guidelines in consultation with the trade.

2. Entities engaged in the manufacturing, wholesale and retail business of prepackaged food are encouraged to get acquainted with the new requirements laid down in the Amendment Regulation and ensure that their products adhere to these requirements on or before 9 July 2007.

DISCLAIMER

3. These guidelines are intended for use as general reference for labelling purpose only. Information contained in these guidelines is not exhaustive. Specific issues should be considered on a case by case basis. For detailed legal provisions governing the labelling of prepackaged food, please refer to the Food and Drugs (Composition and Labelling) Regulations, Cap. 132 W.

ALLERGENS

Objective of Legislative Amendment

4. Allergies affect the lives of millions of people around the world. Food allergy is a reaction of the body's immune system to some substances or ingredients in food. For this reason, the labelling of allergenic substances in food is important and essential for susceptible individuals. For them, the presence of allergens in food is potentially life-threatening. Currently, there is no cure for food allergy. The only successful method to manage food allergy is avoidance of foods containing the allergen. In such cases, individuals must rely on accurate food labelling.

5. It is considered that adhering to Good Manufacturing Practice (GMP) is essential for effective reduction of food contamination by substances including allergens. In addition to providing correct and complete food labelling, food manufacturers also need to evaluate all aspects of their operations to formulate and develop plans to control unidentified allergens. Detailed information on allergenic substances present in final food products should be recorded for future reference.

6. As part of the public health mission to ensure food safety, the Government has brought the requirements for labelling of allergens in line with those of the Codex Alimentarius Commission so as to keep abreast of the worldwide trend and provide informed choices for consumers.

Legal Requirements

7. A new provision as laid down in paragraph 2(4E) of Schedule 3 to the Food and Drugs (Composition and Labelling) Regulations, (Cap. 132) (Regulations) requires declaration of the presence of substances which are known to cause allergy on food labels. It states that-

  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.

8. The eight substances listed above have been identified to be responsible for 90% of the food allergic reactions. In order to comply fully with the statutory provision, the name of the substances as prescribed in the Regulations shall be specified in the list of ingredients. Some of these items such as milk and eggs, are often used as food ingredients in formulated products. For food safety purpose, they are required to be indicated in the list of ingredients if present in the final food products under the Regulations.

Examples

9. The following examples are considered acceptable

"Wheat"; "Rye"; "Flour (cereals containing gluten)"; "Egg";

"Shrimp (Crustacean)"; "Crab meat (Crustacean products)"; "Fish";

"Mackerel (fish)"; "Fish meat"; "Peanuts"; "Soy sauce (contains soybeans)";

"Flavour and flavouring (contains peanut)"; "Milk"; "Whey protein (milk product)";

LABELLING OF FOOD ADDITIVES

Objective of Legislative Amendment

10. Before the amendments made on 9 July 2004, paragraph 2(5) of Schedule 3 to the Regulations required an additive constituting one of the ingredients of a food to be listed by its specific name or by the appropriate category or by both name and category. In some cases, the specific names of the food additives added to the food are not included in the labels. In order to provide more information to consumer and to align with those standards promulgated by the Codex Alimentarius Commission, the paragraph 2(5) of Schedule 3 to the Regulations was amended.

Legal Requirements

11. The amended paragraph 2(5) of Schedule 3 in the Amendment Regulation requires that an additive constituting one of the ingredients of a prepackaged food shall be listed by both its functional class and its specific name or its identification number under the International Numbering System (INS) for Food Additives. The trade is also at liberty to use the prefix "E" or "e" with the INS number as adopted by the European Union under the E-numbering system.

12. As regards the nomenclature of the INS, it means the numbering system being adopted by the Codex Alimentarious Commission for identifying food additives in a list of ingredients of prepackaged food. Relevant information on the INS for food additives can be accessed at CFS's webpage at ( http://www.cfs.gov.hk/english/whatsnew/whatsnew_fstr/whatsnew_fstr_13_ins.html ).

Examples

13. If a food contains an additive, namely benzoic acid to be used as a preservative which constitutes one of the ingredients, it shall be indicated in the list of ingredients by its functional class and either its specific name or its INS number or its "E" number, i.e. Preservative (Benzoic acid) or Preservative (E 210) or Preservative (210).

LABELLING OF DATE FORMAT

Objective of Legislative Amendment

14. The Amendment Regulation provides more flexibility in labelling the durability by removing the requirement for the dates to be listed in the strict order of the day, the month and the year. Besides, it facilitates consumers in understanding the expiry date as it will now be indicated in both English letterings and Chinese characters.

Legal Requirements

15. According to the amended paragraph 4 of Schedule 3 to the Regulations, indication of durability in Arabic numerals is no longer required to be expressed in the strict order of a day, a month and a year. Instead, the day, month and year can appear in any order. The day shall be indicated by the words "DD", "dd", "D" or "d" in English lettering and "日" in Chinese character; the month shall be indicated by the words "MM", "mm", "M" or "m" in English lettering and "月" in Chinese character; and the year shall be indicated by the words "YY", "yy", "Y" or "y" in English lettering and "年" in Chinese character.

Examples

16. As far as the requirements for the indication of durability is concerned, the following examples are considered acceptable:

  1. 年Y 月M 日D ;
  2. Y年 D日 M月 ;
  3. 日dd 月mm 年yy;
  4. y年 m月 d日；
  5. Y年 M月 D日；
  6. DD日 MM月 YY年.

GRACE PERIOD

17. In order to allow sufficient time for the trade to change the labels of their prepackaged food products where necessary, a grace period of 36 months from 9 July 2004 is provided. The Government will take enforcement action when the grace period expires on 9 July 2007.

Appendix I

Frequently Asked Questions

(A) Labelling of Food Allergens

1. Is there any tolerance limit for allergenic substances?

There is at present no tolerance limit for allergenic substances in food as it is generally considered that the amount of allergenic protein necessary to elicit an allergenic reaction can be very small.

2. Can I use a disclaimer "may contain allergens" on food labels?

There is at present no international agreement on the use of allergen warning statement on food label. Having considered the views from the trade, we tend to accept the trade's proposal to allow a warning statement for specific food allergen on food label. The statement should be marked at the end or in immediate proximity to the ingredients list if allergens are not used as an ingredient in the food product but produced on a production line shared with allergen containing products or in a factory where specified allergens are also handled. The warning should be in one of the following formats:

  1. "May contain traces of (NAME OF ALLERGEN)";
  2. "Contains traces of (NAME OF ALLERGEN)"; or
  3. "Produced in a factory where (NAME OF ALLERGEN)" is also handled.

However, the use of the allergen warning statement cannot be emphasised too strongly, and must not be used as a way of evading the responsibility to exercise "all reasonable precautions and all due diligence" to prevent cross-contamination. Besides, "May contain" is a two edged sword. Whereas when used responsibly, it is intended to warn those allergic to the substance referred to of a possible risk, some of the same sufferers tend to regard it as unfairly robbing them of choice.

3. Any examples of actions which are considered "reasonably", "in good faith", and "best endeavours" as prescribed in the Amendment Regulation?

To determine whether the defendant has acted "reasonably" and "in good faith", or used "best endeavours", production of certificate or laboratory testing reports obtained from the importer or manufacturer and demonstration of the means carried out by the defendant to verify the accuracy of such documents could be taken into account to establish the defence.

4. There are studies which state that refined peanut oil does not cause any allergenic reactions even in patients with known peanut allergy. Would refined peanut oil or other products of similar nature be exempted from allergen declaration?

Such products are not exempted from allergen declaration. If the refined peanut oil is a single ingredient product and its food name has clearly indicated the presence of peanut, it is deemed to be complied with the current labelling regulation. However, if the refined peanut oil contains more than one ingredient, the name of the allergenic protein should be in compliance with the allergen declaration requirement.

5. To avoid a long list of ingredients, is it acceptable to declare the allergens somewhere else?

No. The allergenic substances shall be specified in the list of ingredients as required by law. However, additional statements such as "this food contains (name of food allergens)" may be printed on other part of the food label to alert consumer with hypersensitivity.

6. Is it necessary to declare the allergenic substance in the ingredients list if the food name of the product itself has already declared the presence of the allergen?

For single ingredient product e.g. peanut oil, it is exempted from the labelling of ingredient list under Schedule 4 to the Food and Drugs (Composition and Labelling) Regulations, Cap. 132W. Therefore, if the name of the single ingredient food has clearly declared the presence of the allergen i.e. peanut, there is no need to declare the allergen in the ingredient list. On the other hand, if the food product contains more than one ingredient, it is necessary to specify the name of the allergenic substances in the ingredients list in accordance with paragraph 2 (4E) of Schedule 3 to the aforesaid Regulations.

7. Is it necessary to specify the allergenic substance if the ingredient itself already tells the nature?

It is not necessary to specify the allergenic substance in the ingredients list if the name of the food source from which the major food allergen is derived appears in the name of the ingredient e.g. milk solids has clearly indicated that the ingredient is come from milk, there is no need to label it to read as "Milk solids (contain milk). Similarly, the use of "Egg white powder" instead of "Egg white powder (egg product)" is also acceptable.

8. How can I detect the presence of allergens in a food? Which method the Government will adopt for testing the allergens?

Running through the ingredient list is the most straightforward way to know the presence of an allergen in a food. Test kits are also commercially available for detecting the allergens in foods. Information may be obtained from AOAC International as well as the ELISA test kit suppliers. The Government will consider the latest development of the testing methods when deciding the methods to use. At the moment, ELISA test kit will be adopted by the Government as a test method for food allergens.

9. Most prepackaged food in Hong Kong come from China and South East Asia which do not have allergen management system (AMS) and it is hard for local importer/retailer to comply with the allergen labelling regulation?

Though the countries in question may not have AMS system, the manufacturer should have the knowledge of the presence of known food allergens when they are an intentional part of the food, regardless of source.

10. What are the detection limits for the allergens in foods?

A reasonably practicable low detection limit by the best available technology will be adopted for detecting an allergen in a food sample. Reference will be made to the detection limits provided by the commercially available test kits.

11. Is it acceptable to label Salmon and Mackerel instead of Salmon (fish) and Mackerel (fish)?

The purpose of allergen labelling is to alert susceptible consumer to avoid from food containing allergens. Therefore, the ingredients in foods must be listed by their "common or usual name" which is familiar to consumer. According to the Amendment Regulation, the name of the allergenic substances shall be specified in the ingredients list. In this example, the name of the allergenic substance i.e. fish is not indicated in the ingredient name Salmon and Mackerel and therefore is considered not acceptable under the Amendment Regulations.

12. Cross contaminant is not an intended ingredient added to the food, it does not fall within the definition of "ingredient" and hence should not be taken as part of the ingredient in the ingredients list?

According to para. 2 (4E) of the Food and Drugs (Composition and Labelling) Regulations, Cap. 132W, if a food consists of or contains a food allergen, the name of the substance shall be specified in the list of ingredients. Therefore, although the allergen unintentionally introduced is not an intended ingredient in food, its presence shall be disclosed in the list of ingredients or in immediate proximity to the ingredients list. It would not confuse or mislead consumer so long as it is actually present in the finished product. The manufacturer has the responsibility to determine whether cross contaminated food allergens have been introduced into the finished food product during processing and packing; and to indicate its presence on the food label accordingly. If every possible step have been taken by the manufacturer to prevent cross-contamination and yet still cannot rule out the possibility of the presence of cross-contaminated food allergens in food, he or she may consider using the warning statement stated in Question 2 above.

13. If a product contains a peanut paste, is it possible to label it as "peanut paste" instead of "peanut paste (contain peanut)"?

Similar to question 7 above, the answer to this question is yes.

14. According to Codex, processing aids are exempted from labelling in ingredients list, is this exemption also applied to allergen labelling?

A very low level of allergenic substance may cause allergy reaction to susceptible consumers. Therefore, all ingredients including processing aids that constitute part of the food and contain an allergenic substance must be declared in the ingredients list in accordance with paragraph 2(4E) of Schedule 3 to the Food and Drugs (Composition and Labelling) Regulations, Cap. 132W.

15. Are there any labelling formats or methods for the labelling of food allergens recommended by CFS?

We recommend using one or more of the following methods to disclose the presence of allergens in a product:

  1. The use of a statement, such as "Contains_____________ " with the blank filled in with the specified food allergens (e.g. Contains soy and milk). This statement should be placed at the end of, or in immediate proximity to, the ingredient declaration.
  2. The use within the ingredient declaration of a parenthetical statement following the ingredient name or class name that identifies allergens that are present in the ingredient (e.g. natural flavour (peanuts and soybeans), whey (milk), mackerel (fish).
  3. The use within the ingredient declaration of a name that identifies the presence of the allergen such as "natural peanut flavour", "egg white powder", "peanut paste".
  4. The use of bolding or other highlighting within the ingredient declaration or in allergy information statements in immediate proximity to the ingredient declaration.

(B) Food Additive

1. How should an additive be labelled if there is no INS number?

The additive shall be labelled with its functional class and its specific name if it has no INS number.

2. Will the declaration of functional class be optional (e.g. citric acid instead of acid (citric acid)?

The declaration of functional class for an additive is mandatory. For the example as quoted, it shall be listed as "acid (citric acid)" if the citric acid functions as an acid in the food concerned.

3. Is there any need to declare vitamins and minerals?

Under the Regulations, those vitamins and minerals that are added solely for the purpose of fortifying or enriching food or of restoring the constituents of food are not classified as food additives and are not required to be labelled in the same manner as for additives. These vitamins and minerals are however required to be indicated as ingredients in the list of ingredients. However, if vitamins are added to food to achieve certain technical functions, they should be indicated in the same manner as the additives.

4. Can we use the Chinese names for additives being adopted by the Mainland? If not, where can we find the Chinese names for the additives as there is no Chinese version for the Codex's INS list?

One may browse the CFS's website at ( http://www.cfs.gov.hk/english/whatsnew/whatsnew_fstr/whatsnew_fstr_13_ins.html )to obtain relevant information. In the case where there is no legal Chinese translation of the additives in local legislation, it should use a Chinese name commonly adopted by the trade and the authority, such as the Chinese translation adopted by the Mainland.

5. Is there any exemption on ingredient declaration if the supplier does not provide information regarding formulation of blended additives due to trade secret?

No. It is the responsibility of the trade to list the ingredients for the information of consumers. Provision of such information will not lead to leakage of trade secret as no formulation is required.

6. Is it acceptable to declare the functional class followed by both the specific name and INS number of the food additive added to the food?

Yes, it is acceptable to declare the functional class followed by both the specific name and INS number of the food additive added to the food.

7. What are the detection limits for the additives in foods?

A reasonably practicable low detection limit by the best available technology will be adopted for detecting an additive in a food sample. Appropriate allowance will be made for those additives that may be naturally present in the food or in the raw material and present in the final product.
If the ingredient is naturally present in the raw material and is not intended to be added to food, it is not necessary to declare it in the ingredients list.

(C) Date Format

1. Can the expiry date [d日/m月/y年] be indicated with either the upper case or lower case letters?

Yes. Both upper case and lower case letters are acceptable.

2. Can Chinese characters be permitted to precede or follow the English lettering?

Yes. Chinese characters may precede the English lettering or vice versa.

3. Can the Arabic numerals be put on top or under the expiry date?

Yes. The numerals can be put on top, under or beside the expiry date.

4. Is it legally acceptable to indicate the durability to read as DD,MM,YYYY and 日，月，年?

Yes, the above date format is acceptable though it is preferable to adhere to the specified format.

(D) Others

1. If the prepackaged food items are solely supplied to catering establishment for further cooking and processing, is it still necessary to comply with the Amendment Regulations to provide both the functional class and specific name or E. No. of the food additives added to the food?

Yes. All prepackaged foods except those granted with exemption are required to provide both the functional class and specific name or E. No. of the food additives added to the food.

2. Is it acceptable to use a sticker label to provide the information such as "May contain…..(name of allergens)" and "specific name for additives" instead of printed it on food label?

Yes. The use of sticker label is acceptable. However, a written authorization from the manufacturer of the food item concerned is required before you can affix a sticker label on the original packing.

3. For commercial blend of additives, the suppliers would only disclose the information of "emulsifier and stabilizer" and will not provide the trade with the percentage of the additive added. As such, can we only declare it as "emulsifier and stabilizer (E XXX , E XXX)?

According to the existing labelling legislation, there is no need to disclose the % of the food additives added to food. Only the functional use and specific name or E. No. of the food additive added is required.

4. What if the existing classification classes laid down in the labelling legislation does not cover the technological function of some food additives, how should it be labelled?

The 23 functional classes of food additives as listed in para. 2(6) of Schedule 3 to the Food and Drugs (Composition and Labelling) Regulations, Cap. 132W have covered the functional classes of common food additives. For example, the functional use of cellulose can be labelled as "stabilizer".

5. Is it acceptable to label the Arabic numerals to read as 08.08.2006 if the English lettering printed in the label is written as "DD, MM, YY" only?

Yes, but it is preferable to follow the specified format.

6. Since the testing or detecting system differs among HK, China and Asia, it is difficult for local traders to detect those allergens/ingredients other than the one listed in Government's website. What should the trade do?

It is the vendor's or importer's responsibility to obtain the relevant information from the manufacturers regarding the food allergens/food additives present in the food product.

7. In order to comply with the statutory requirements on the subject of presence of allergens, please confirm whether a beer manufacturer in HK, with cereals (i.e. malt and maize grits) as one of its ingredients is or is not exempted from such labelling requirements?

According to Schedule 4 of the Food and Drugs (Composition and Labelling) Regulations, Cap. 132W, drinks with an alcoholic strength by volume of more than 1.2% but less than 10% are exempted from the provision of food labelling information required in Schedule 3 except paragraph 3 and 4 of the aforesaid Regulations. In this connection, if the beer in question has an alcoholic strength by volume of more than 1.2 %, it is also exempted from allergen labelling. However, if a list of ingredients is indicated, it shall have to comply with the provision on allergen labelling.

8. If the food allergen can only be detected at ppb level and not at ppm level, is it necessary to declare the presence of food allergen in food label?

The detection level of ELISA testing kits which is currently adopted by the Government Laboratory is at ppm level.

9. If the food label declares both the functional class, specific name and INS No. at the same time, is it legally acceptable of not using the terms or description of the functional classes and food additives listed in the relevant food regulations?

No, it should follow the legislation.

Updated June 2007