Labelling of Tobacco Products Regulations, 2003

L.N. 243 of 2003

TOBACCO (SMOKING CONTROL) ACT

(CAP. 315)

Labelling of Tobacco Products Regulations, 2003

IN exercise of the powers conferred by article 9 of the Tobacco

(Smoking Control) Act, the Minister of Health has made the following

regulations>-

(1) The title of these regulations is the Labelling of Tobacco

Products Regulations, 2003.

(2) These regulations shall come into force on the 5th April,

2004.

List of health warnings referred to in regulations 5 and 6 (a)>

1. Smoking causes cancer

It-tipjip i[ib il-kançer

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

It-tipjip jikka;una dipendenza qerrieda

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 Schedules 1 and 2 to

these regulations.

(1) The tar, nicotine and carbon monoxide yields must Tar, carbon

List of health warnings referred to in regulation 6 (b)>

1. Smoking causes cancer

It-tipjip i;ib il-kançer

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

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 iç-çirkulazzjoni tad-demm u jista’ jwassal ghal infertilit·

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 infertilit·

15. Smoking contains benzene, nitrosamines, formaldehyde and hydrogen cyanide

Is-sigarretti fihom benzene, formaldehyde u hydrogen cyanide

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

monoxide

be indicated on cigarette packets.

and nicotine yields.

(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.

(a) Each unit packet of tobacco products shall carry, on the

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) hereof.

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 Schedule 1 to these regulations< and

(b) the specific warnings selected shall be printed on the

unit packets so as to guarantee the appearance of each warning on

an equal quantity of unit packets, with a tolerance of around 5%.

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 Schedule 1 to these regulations 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 Schedule 2 to these regulations, 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.

The warnings referred to in regulations 4, 5 and 6 are to be Source of warning.

combined with the following indications of authority>-

Danger - Health Department WARNING

TWISSIJA mid-Dipartiment tas-Sa]]a - Periklu

The text of the warnings on cigarette packets provided for in Area to be covered

on cigarette packets.

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 Schedule 1 to these

regulations, 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.

The required warnings and yield indications shall be>-

Printing style.

(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.

To ensure product identification and traceability, the Batch numbers.

tobacco product shall bear a batch number or equivalent thereby enabling

the time and place of manufacture to be identified.

.11. Manufacturers and importers shall at the end of each year 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.

Il-manifatturi u l-importaturi g[andhom fi tmiem kull sena Lista ta’ ingredjenti.

jippre]entaw lis-Suprintendent lista ta’ l-ingredjenti kollha, f’ordni

dixxendenti skond il-pi], u]ati fil-manifattura ta’ dawk il-prodotti tat-

tabakk skond ma jkun jisimhom u t-tip tag[hom. Dik il-lista>-

(a) g[andu jkollha mag[ha dikjarazzjoni li tag[ti r-ra;unijiet

g[aliex dawk l-ingredjenti jkunu ;ew inklu]i f’dawk l-prodotti

tat-tabakk<

(b) g[andha tindika l-funzjoni u l-kategorija tag[hom<

(ç) g[andu jkollha mag[ha kull tag[rif tossikolo;iku li l-

manifattur jew l-importatur ikollu dwar dawk l-ingredjenti f’g[amla

ma[ruqa jew mhix, skond ma jkun adatt, b’riferenza partikolari

g[all-effetti tag[hom fuq is-sa[[a u kull effett ta’ vizzju possibbli.

It shall be the duty of the Superintendent to inform the public

as to the tar, nicotine and carbon monoxide yields of cigarettes.

It shall be an offence to place on the market tobacco for

13. oral use.

Huwa reat li titqieg[ed fis-suq in-niskata, jew tabakk li

projbita.

jittie[ed mill-fomm.

It shall be an offence to label any tobacco packet as “light”

or “mild”.

The Health Warning (On Smoking) Regulations, 1987 are

1987. hereby repealed.