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Tobacco (Smoking Control) Act (Cap. 315) 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>-

Title and commencement.

1. (1) The title of these regulations is the Labelling of Tobacco
Products Regulations, 2003.
2004.
(2) These regulations shall come into force on the 5th April,

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 15th 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.
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 2997

Tar, carbon monoxide

and nicotine yields.

B 2998

General warning.

Warning on cigarette packets.

Warning on unit packets of tobacco products other than cigarettes.

(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.
4. (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.
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 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%.
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 75cm2 then the warning taken from the list in Schedule 1 to these regulations shall be spread over an area of at least 24cm2< 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.
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
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 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.
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.
10. To ensure product identification and traceability, the 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 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>-
B 2999

Source of warning.

Area to be covered on cigarette packets.

Printing style.

Batch numbers.

List of ingredients

B 3000

Superintendent to inform public.

Tobacco for oral use prohibited.

Qualificative labelling of tobacco products.

Repeals L.N. 28 of

1987.

(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.
12. It shall be the duty of the Superintendent to inform the public as to the tar, nicotine and carbon monoxide yields of cigarettes.
13. It shall be an offence to place on the market tobacco for oral use.
14. It shall be an offence to label any tobacco packet as “light”
or “mild”.
15. The Health Warning (On Smoking) Regulations, 1987 are hereby repealed.
SCHEDULE 1
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
B 3001
B 3002
SCHEDULE 2
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

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

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

Prezz 14ç – Price 14c