| 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 - (a) Labelling of allergenic substances;
(b) Labelling of food additives; and
(c) 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-
(a) If a food consists of or contains any of the following substances-
(i) cereals containing gluten (namely wheat, rye, barley, oats, spelt,
their hybridized strains and their products);
(ii) crustacea and crustacean products;
(iii) eggs and egg products;
(iv) fish and fish products;
(v) peanuts, soyabeans and their products;
(vi) milk and milk products (including lactose);
(vii) tree nuts and nut products,
the name of the substance shall be specified in the list of ingredients.
(b) If a food consists of or contains sulphite in a concentration of
10 parts per million or more, the functional class of the sulphite and
its name shall be specified in the list of ingredients.
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:
(a) 年Y 月M 日D ;
(b) Y年 D日 M月 ;
(c) 日dd 月mm 年yy;
(d) y年 m月 d日；
(e) Y年 M月 D日；
(f) 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:
(a) "May contain traces of (NAME OF ALLERGEN)";
(b) "Contains traces of (NAME OF ALLERGEN)"; or
(c) "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:
(a) 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.
(b) 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).
(c) 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".
(d) 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 |
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