LABELLING OF TOBACCO PRODUCTS [ S.L.315.01 1
SUBSIDIARY LEGISLATION 315.01
HEALTH WARNINGS ON SMOKING 
REGULATIONS
25th March, 1987
LEGAL NOTICE 28 of 1987.
Title.
Smoking Regulations.
Interpretation.
Cap. 315.
"cigarette" does not include cigars or other forms of tobacco or
tobacco products.
Health warnings to 
be according to 
schedule.
3. (1) The health warnings required to be shown, affixed,
displayed or broadcast under the Act shall be one of the warnings
set out in the Schedule.
(2) The health warning shall be shown, affixed or displayed in
one of the official languages of Malta and, unless otherwise
prescribed in these regulations, shall be of a reasonable size as to
be prominently legible and capture the attention of the person
reading it, taking into consideration the size and colour background
on which it is shown, affixed or displayed, to the satisfaction of the
Superintendent.
(3) Each warning in the Schedule shall be preceded by the
words "DANGER: Dept. of Health WARNING".
Health warnings in 
cinemas.
4. (1) It shall be the duty of every person so required under
the Act in respect of a cinema to ensure that the warning shown on
the screen at the beginning of the film is different from the one
shown immediately on the resumption of the show after the
interval.
(2) The health warning which is displayed in a cinema shall be
substituted every three months by another warning from the
Schedule in such a way that all the warnings in the Schedule appear
with the same frequency during a year.
(3) The health warning shown as aforesaid shall be displayed
for a minimum period of thirty seconds.
Health warnings 
during broadcasts.
5. The provisions of regulation 4(2) and (3) shall apply
mutatis   mutandis  to visual warnings required to be broadcast under
the Act in respect of broadcasting stations.
Health warnings in 
advertisements.
6. (1) The health warning in respect of adverts for any
particular brand of an item to which the Act applies, appearing in
any newspaper or magazine shall, where applicable, be changed at
least every three months in such a way that all the warnings in the
Schedule shall as far as possible appear with the same frequency
during a year.
(2) The Superintendent may require that the warning on any
2 [ S.L.315.01 LABELLING OF TOBACCO PRODUCTS
other advert as is referred to in article 6 of the Act other than in the
case of an illuminated sign, be changed or rotated as may in his
opinion be practicable and reasonably necessary but in any case not
more frequently than once every twelve months.
(3) Notwithstanding the provisions of regulation 3(1), the
following warning (in one of the official languages of Malta) may
be used in respect of adverts to which the provisions of sub-
regulation (2) apply -
"TAKE CARE OF YOUR HEALTH - DO NOT SMOKE"
Health warnings on 
packages of 
cigarettes.
7. (1) The health warning on a package of cigarettes shall be
enclosed in a rectangle which shall be of a size approximately 15
millimetres by 50 millimetres or equivalent area. The letters for the
health warning shall be block letters and their size shall be uniform
throughout and shall be such as to reasonably occupy as fully as
possible the space in the rectangle, to the satisfaction of the
Superintendent.
(2) It shall not be lawful to place such warning only on the
transparent foil or outer wrapping of a cigarette package.
(3) In every batch or consignment manufactured or produced
all the different health warnings from the Schedule shall be used
equally on each brand.
(4) Without prejudice to the requirements of the Act in respect
of health warnings, the provisions of this regulation shall apply
mutatis   mutandis  to imported cigarettes in so far as such
compliance is in the opinion of the Superintendent reasonable or
practicable.
(5) It shall be lawful to include the declaration of tar and
nicotine content within the space bordered by the rectangle referred
to in subregulation (1).
Health warning on 
premises.
8. The health warning to be displayed at or in any premises
from which cigarettes, cigars, tobacco or tobacco products or
smoking requisites are sold shall be prominently displayed as near
as is reasonably practicable to the place where such items are
displayed or sold and in such a way as to attract the attention of
customers or other persons on the premises and so as to be easily
seen and read by them. No article shall be put in such a way as to
hinder such persons from easily reading such warning.
Information 
required by 
Superintendent.
9. The Superintendent may require any person responsible for
ensuring compliance with the provisions of these regulations to
provide such information as may be reasonably necessary to ensure
that the provisions of these regulations are complied with and it
shall be the duty of such person to comply with any such request
from the Superintendent.
LABELLING OF TOBACCO PRODUCTS [ S.L.315.01 3
SCHEDULE
(Regulation 3(1))
Health warnings which may be used in accordance with the
requirements of the Tobacco Smoking Control Act:
1. Cigarettes can cause lung cancer and heart disease.
2. Smoking during pregnancy endangers the health of mother
and baby.
3. If you stop smoking you improve your health and live
longer.
4. The more you smoke the more you risk your health.
4 [ S.L.315.01 LABELLING OF TOBACCO PRODUCTS
SUBSIDIARY LEGISLATION 315.01
LABELLING OF TOBACCO PRODUCTS 
REGULATIONS
5th April, 2004
LEGAL NOTICE 243 of 2003.
Title ans 
commencement.
1. (1) The title of these regulations is the Labelling of
Tobacco Products Regulations.
(2) These regulations shall come into force on the 5th April,
2004.
Interpretation. 2. In these regulations:
''ingredient'' means any substance or any constituent except for
tobacco leaf and other natural or unprocessed tobacco plant parts
used in the manufacture or preparation of a tobacco product and
still present in the finished product, even if in altered form,
including paper, filter, inks and adhesives;
''ISO 4387'' means the latest edition of the International Standard
entitled Cigarettes Determination of total and dry particulate matter
using a routine analytical cigarette-smoking machine-Glass fibre
filter-smoking trap method ISO 4387: 1987 (E) first edition
published by the International Organisation for Standardisation on
15 th April 1987;
''most visible surface'', in relation to a rectangular cigarette
packet, means that surface of the packet which is, or is equal in area
to, the largest surface and either -
( a ) faces a person opening that packet, or
(b) where no such surface faces a person opening the
packet, carries most prominently the name, trademark
or other distinguishing mark of the brand of cigarettes;
and in relation to other cigarette packets means the most
conspicuous surface;
''packet'', in relation to a tobacco product, means any box,
package, container or other receptacle which contains the product,
and in which the product is, or is intended to be, presented for
retail, excluding any additional outer wrapping (whether or not
transparent) which may be discarded on opening, and where any
such receptacle is or is to be contained in another such receptacle
(excluding such outer wrapping), includes each such receptacle;
''nicotine'' means nicotinic alkaloids;
''Superintendent'' means the Superintendent of Public Health;
''tar'' means the raw anhydrous nicotine-free condensate of
smoke;
''warning'' means a message set out in the First and Second
Schedules.
LABELLING OF TOBACCO PRODUCTS [ S.L.315.01 5
Tar, carbon 
monoxide and 
nicotine yields.
3. (1) The tar, nicotine and carbon monoxide yields must be
indicated on cigarette packets.
(2) The accuracy of the indications on packets shall be verified
in accordance with ISO standard 8243.
(3) The statement relating to -
( a ) the tar yield shall be shown as a figure rounded to the
nearest whole number and expressed in milligrams in
the form ''x mg tar/qatran'';
( b ) the nicotine yield shall be shown as a figure rounded to
one decimal place and expressed in milligrams in the
form ''y.z mg nicotine/nikotina'';
( c ) the carbon monoxide shall be shown as a figure
rounded to the nearest whole number and expressed in
milligrams in the form ''x mg carbon monoxide''.
(4) The following indications shall also be printed on one side
of cigarette packets, in English and Maltese:
( a ) at least 12% of the corresponding surface is covered,
such area to be defined by a right-angled polygon
drawn closely round the periphery of the printed
letters;
( b ) in clearly legible print (in bold letters in the type face
known as Helvetica in type that is in a colour that
contrasts with that of the background);
( c ) on a background of contrasting colour, within a
rectangular or square border (in the same colour as the
text) of which the lines are no wider than an upper-
case letter ''l'' in the type size used for the text of the
message; and
( d ) the batch number.
General warning.
most visible surface and on any outside packaging with
the exception of additional transparent wrappers, used
in the retail sale of the product, the following general
warning in English and Maltese:
Tobacco seriously harms you and others around
you
It-Tabakk jag]mel ]sara serja lilek u ta’
madwarek
( b ) This general warning shall be rotated in such a way as
to guarantee the regular appearance of the warning
indicated in paragraph ( a ).
Warning on 
cigarette packets.
5. With regard to cigarette packets, each packet shall carry, in
English and Maltese, specific warnings alternating as follows:
( a ) the warnings shall be selected from the list of warnings
in the First Schedule; and
( b ) the specific warnings selected shall be printed on the
unit packets so as to guarantee the appearance of each
6 [ S.L.315.01 LABELLING OF TOBACCO PRODUCTS
warning on an equal quantity of unit packets, with a
tolerance of around 5%.
Warning on unit 
packets of tobacco 
products other than 
cigarettes.
6. In addition to the general warning referred to in regulation
4, unit packets of tobacco products other than cigarettes shall carry
specific warnings as follows:
( a ) if the most visible surface exceeds 75cm 2  then the
warning taken from the list in the First Schedule shall
be spread over an area of at least 24cm 2 ; and
( b ) unit packets of cigars, cigarillos, pipe tobacco or other
smoking tobacco products with the exception of
cigarettes and rolling tobacco, shall carry a specific
warning from among those in the Second Schedule, in
such a way as to ensure that they are in actual fact
rotated.
The specific warnings shall be printed on, or irremovably
affixed to, the unit packets in English and Maltese.
Source of warning. 7. The warnings referred to in regulations 4, 5 and 6 are to be
combined with the following indications of authority:
Danger - Health Department WARNING
TWISSIJA mid-Dipartiment tas-Sa]]a - Periklu
Area to be covered 
on cigarette 
packets.
8. The text of the warnings on cigarette packets provided for
in regulations 4 and 5, excluding the indication of the authority
provided for in regulation 7, shall cover not less than 32% of the
external area of the corresponding surface of the unit packet of
tobacco on which it is printed. In the case of the additional warning
under the First Schedule, such text shall cover not less than 45% of
the external area of the corresponding surface of the unit packet of
tobacco on which it is printed.
Printing style. 9. The required warnings and yield indications shall be -
( a ) clear and legible, irremovably printed, indelible and
shall in no way be hidden, obscured or interrupted by
other written or pictorial manner or destroyed when
the packet is opened. In the case of tobacco products
other than cigarettes, the texts may be affixed by
means of stickers, provided that these are irremovable;
( b ) printed in black Helvetica bold type on a white
background, in lower-case type, except for the first
letter of the message and where required by grammar
usage; and
( c ) centered in the area in which the text is required to be
printed parallel to the top edge of the packet:
Provided that in the case of tobacco products, the general
warning shall be sorrounded by a black border not less than 3mm
and not more than 4mm in width which in no way interferes with
the text of the warning or information given.
Batch numbers. 10. To ensure product identification and traceability, the
tobacco product shall bear a batch number or equivalent thereby
LABELLING OF TOBACCO PRODUCTS [ S.L.315.01 7
enabling the time and place of manufacture to be identified.
List of ingredients.
submit to the Superintendent a list of all ingredients, in descending
order of weight, used in the manufacture of those tobacco products
by brand name and type. Such list shall -
( a ) be accompanied by a statement setting out the reasons
for the inclusion of such ingredients in those tobacco
products;
( b ) indicate their function and category;
( c ) be accompanied by toxicological data available to the
manufacturer or importer regarding those ingredients
in burnt or unburnt form as appropriate, referring in
particular to their effects on health and taking into
account any addictive effects.
Superintendent to 
inform public.
12. It shall be the duty of the Superintendent to inform the
public as to the tar, nicotine and carbon monoxide yields of
cigarettes.
Tobacco for oral 
use prohibited.
13. It shall be an offence to place on the market tobacco for
oral use.
Qualificative 
labelling of 
tobacco products.
14. It shall be an offence to label any tobacco packet as ''light''
or ''mild''.
Repeals L.N. 28 of 
1987.
15. The Health Warning (On Smoking) Regulations, 1987 are
hereby repealed.
8 [ S.L.315.01 LABELLING OF TOBACCO PRODUCTS
FIRST SCHEDULE
List of health warnings referred to in regulations 5 and 6( a ):
1. Smoking causes cancer
It-tipjip i[ib il-kan`er
2. Smoking causes heart disease
It-tipjip i[ib il-mard tal-qalb
3. Smoking kills
It-tipjip joqtol
4. Smoking when pregnant harms your baby
It-tipjip waqt it-tqala jag]mel ]sara lit-tarbija
5. Protect children: don’t make them breathe your smoke
Ipprote[i lit-tfal: tpejjipx ]dejhom
6. Smoking damages the health of those around you
It-tipjip imarrad lil dawk ta’ madwarek
7. Smokers die younger
Jekk tpejjep tmut \g]ir
8. Smoking causes addiction
I t-tipjip jikka[una dipendenza qerrieda
SECOND SCHEDULE
List of health warnings referred to in regulation 6( b ):
1. Smoking causes cancer
It-tipjip i[ib il-kan`er
2. Smoking causes fatal lung cancer
It-tipjip i[ib il-mard qerriedi
3. Smoking damages the health of those around you
It-tipjip imarrad lil dawk ta’ madwarek
4. Smoking causes heart disease
It-tipjip i[ib il-mard tal-qalb
5. Smoking clogs the arteries and causes heart attacks and strokes
It-tipjip isodd l-arterji u jikka[una attakki tal-qalb
6. Protect children: don’t make them breathe your smoke
Ipprote[i t-tfal. T]allihomx jibilg]u d-du]]an tas-sigaretti
7. Your doctor or your pharmacist can help you stop smoking
It-tabib jew l-ispi\jar jg]inuk biex tieqaf tpejjep
LABELLING OF TOBACCO PRODUCTS [ S.L.315.01 9
8. Smoking is highly addictive, don’t start.
It-tipjip huwa vizzju, tibdiex tpejjep
9. Stopping smoking reduces the risk of fatal heart and lung diseases
Jekk tieqaf tpejjep tnaqqas ir-riskju ta’ attakki tal-qalb u mard tal-pulmun
10. Smoking can cause a slow and painful death
It-tipjip jista’ jwassal g]al mewt bil-mod
11. Get help to stop smoking
Itlob l-g]ajnuna biex tieqaf tpejjep
12. Smoking may reduce the blood and causes impotence
It-tipjip inaqqas i`-`irkolazzjoni tad-demm u jista’ jwassal g]al infertilità
13. Smoking causes ageing of the skin
It-tipjip ixejj]ek
14. Smoking can damage the sperm and decreases fertility
It-tipjip jag]mel ]sara lill-isperma u jikka[una infertilità
15. Smoking contains benzene, nitrosamines, formaldehyde and hydrogen
cyanide
Is-sigarretti fihom benzene, formaldehyde u hydrogen cyanide
