Food and Environmental
Hygiene Department
August 2005
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) crustacean and crustacean products;
(iii) eggs and egg products;
(iv) fish and fish products;
(v) peanuts, soybeans 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
“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 has been uploaded to the FEHD’s webpage. It can be
accessed by browsing the FEHD’s website at http://www.fehd.gov.hk.
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:
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 FEHD?
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 FEHD’s website at http://www.fehd.gov.hk
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?
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Last
revision date: 15-09-2005