MANUFACTURE, PRESENTATION AND SALE OF TOBACCO AND RELATED PRODUCTS REGULATIONS

SUBSIDIARY LEGISLATION 315.10

MANUFACTURE, PRESENTATION AND SALE OF

TOBACCO AND RELATED PRODUCTS

REGULATIONS

20th May, 2016 *

LEGAL NOTICE 67 of 2016, as amended by Legal Notices 229 of 2023

and 178 of 2025.

(1) The title of these regulations is the Manufacture,

P r e s e n t a t i o n a n d S a l e o f To b a c c o a n d R e l a t e d P r o d u c t s

Regulations.

(2) The scope of these regulations is to implement Directive

2014/40/EU of the European Parliament and of the Council of 3

April 2014 on the approximation of the laws, regulations and

administrative provisions of the Member States concerning the

manufacture, presentation and sale of tobacco and related products

and repealing Directive 2001/37/EC, as may be amended, from time

to time.

(3) The competent authority responsible for the implementation

and enforcement of the obligations provided for in these

regulations shall be the Superintendent of Public Health.

Graphical health warning library

(Regulation 10)

PART 1

MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS

MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS

PART 2

MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS

PART 3

MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS

The photographs, images and textual illustrations contained in this Schedule have

been developed for use on tobacco product packages in accordance with the

Commission Delegated Directive 2014/109/EU of 10 October 2014 amending

Annex II to Directive 2014/40/EU of the European Parliament and of the Council

by establishing the library of picture warnings to be used on tobacco products.

All other uses are subject to the permission of the European Commission.

For the purposes of these regulations, the following

definitions shall apply

"addictiveness" means the pharmacological potential of a

substance to cause addiction, a state which affects an individual’s

ability to control his or her behaviour, typically by instilling a

reward or a relief from withdrawal symptoms, or both;

"additive" means a substance, other than tobacco, that is added to

a tobacco product, a unit packet or to any outside packaging;

"age verification system" means a computing system that

unambiguously confirms the consumer ’s age electronically in

accordance with national requirements;

"Directive" means Directive 2014/40/EU of the European

Parliament and of the Council of 3 April 2014 on the approximation

of the laws, regulations and administrative provisions of the

Member States concerning the manufacture, presentation and sale

of tobacco and related products and repealing Directive 2001/37/

EC;

"characterising flavour" means a clearly noticeable smell or taste

o t h er t h a n o n e o f t o b a c c o , r e s u l t i n g f r o m a n a d d i t i v e o r a

combination of additives, including, but not limited to, fruit, spice,

herbs, alcohol, candy, menthol or vanilla, which is noticeable

before or during the consumption of the tobacco product;

"chewing tobacco" means a smokeless tobacco product

*see regulation 1(4) of these regulations, as originally promulgated.

exclusively intended for the purpose of chewing;

"cigar" means a roll of tobacco that can be consumed via a

combustion process and is further defined in Article 4(1) of

Directive 2011/64/EU;

"cigarette" means a roll of tobacco that can be consumed via a

combustion process and is further defined in Article 3(1) of

Council Directive 2011/64/EU;

"cigarillo" means a small type of cigar and is further defined in

Article 8(1) of Council Directive 2007/74/EC;

"combined health warning" means a health warning consisting of

a combination of a text warning and a corresponding photograph or

illustration, as provided for in these regulations;

"Commission" means the European Commission;

"consumer" means a natural person who is acting for purposes

which are outside his or her trade, business, craft or profession;

"cross-border distance sales" means distance sales to consumers

where, at the time the consumer orders the product from a retail

outlet, the consumer is located in a Member State other than the

Member State or the third country where that retail outlet is

established; a retail outlet is deemed to be established in a Member

State

(a) in the case of a natural person: if he or she has his or

her place of business in that Member State;

(b) in other cases: if the retail outlet has its statutory seat,

central administration or place of business, including a

branch, agency or any other establishment, in that

Member State;

"electronic cigarette" means a product that can be used for

consumption of nicotine-containing vapour via a mouth piece, or

any component of that product, including a cartridge, a tank and the

device without cartridge or tank. Electronic cigarettes can be

disposable or refillable by means of a refill container and a tank, or

rechargeable with single use cartridges;

"heated tobacco product" means a novel tobacco product that is

heated to produce an emission containing nicotine and other

chemicals, which is then inhaled by the user, and that, depending on its

characteristics, is a smokeless tobacco product or a tobacco product for

smoking.

"emissions" means substances that are released when a tobacco

or related product is consumed as intended, such as substances

found in smoke, or substances released during the process of using

smokeless tobacco products;

"flavouring" means an additive that imparts smell and, or taste;

"health warning" means a warning concerning the adverse effects

on human health of a product or other undesired consequences of

its consum ption, including text warnings, com bined health

warnings, general warnings and information messages, as provided

for in these regulations;

"herbal product for smoking" means a product based on plants,

herbs or fruits which contains no tobacco and that can be consumed

via a combustion process;

"import of tobacco or related products" means the entry into the

territory of the European Union, hereinafter referred to as "the

Union", of such products unless the products are placed under a

customs suspensive procedure or arrangement upon their entry into

the Union, as well as their release from a customs suspensive

procedure or arrangement;

"importer of tobacco or related products" means the owner of, or

a person having the right of disposal over, tobacco or related

products that have been brought into the territory of the Union;

"information society services’ means any service normally

provided for remuneration, at a distance, by electronic means and at

the individual request of a recipient of services;

"ingredient" means tobacco, an additive, as well as any substance

or element present in a finished tobacco product or related

products, including paper, filter, ink, capsules and adhesives;

"manufacturer" means any natural or legal person who

manufactures a product or has a product designed or manufactured,

and markets that product under their name or trademark;

"maximum level" or "maximum emission level" means the

maximum content or emission, including zero, of a substance in a

tobacco product measured in milligrams;

"nasal tobacco" means a smokeless tobacco product that can be

consumed via the nose;

"nicotine" means nicotinic alkaloids;

"novel tobacco product" means a tobacco product which

(a) does not fall into any of the following categories

cigarettes, roll-your-own tobacco, pipe tobacco,

waterpipe tobacco, cigars, cigarillos, chewing tobacco,

nasal tobacco or tobacco for oral use; and

(b) is placed on the market after 19 May 2014;

"outside packaging" means any packaging in which tobacco or

related products are placed on the market and which includes a unit

packet or an aggregation of unit packets; transparent wrappers are

not regarded as outside packaging;

"pipe tobacco" means tobacco that can be consumed via a

combustion process and exclusively intended for use in a pipe;

"placing on the market" means to make products, irrespective of

their place of manufacture, available to consumers located in the

Union, with or without payment, including by means of distance

sale; in the case of cross-border distance sales the product is

deemed to be placed on the market in the Member State where the

consumer is located;

"pouch" means a unit packet of roll-your own tobacco, either in

the form of a rectangular pocket with a flap that covers the opening

or in the form of a standing pouch;

"refill container" means a receptacle that contains a nicotine-

containing liquid, which can be used to refill an electronic

cigarette;

"roll-your-own tobacco" means tobacco which can be used for

making cigarettes by consumers or retail outlets;

"retail outlet" means any outlet where tobacco products are

placed on the market including by a natural person;

"smokeless tobacco product" means a tobacco product not

involving a combustion process, including chewing tobacco, nasal

tobacco and tobacco for oral use;

"substantial change of circumstances" means an increase of the

sales volumes by product category by at least 10% in at least five

Member States based on sales data transmitted in accordance with

regulation 5(6) or an increase of the level of prevalence of use in

the under twenty-five (25) years of age consumer group by at least

five percentage points in at least five Member States for the

respective product category based on the Special Eurobarometer

385 Report of May 2012 or equivalent prevalence studies; in any

case, a substantial change of circumstances is deemed not to have

occurred if the sales volume of the product category at retail level

does not exceed 2.5% of total sales of tobacco products at Union

level;

"Superintendent" means the Superintendent of Public Health and,

to the extent of any delegation or authority given, includes an

authorised officer;

"tar" means the raw anhydrous nicotine-free condensate of

smoke;

"tobacco" means leaves and other natural processed or

unprocessed parts of tobacco plants, including expanded and

reconstituted tobacco;

"tobacco for oral use" means all tobacco products for oral use,

except those intended to be inhaled or chewed, made wholly or

partly of tobacco, in powder or in particulate form or in any

combination of those forms, particularly those presented in sachet

portions or porous sachets;

"tobacco products for smoking" means tobacco products other

than a smokeless tobacco product;

"tobacco products" means products that can be consumed and

consist, even partly, of tobacco, whether genetically modified or

not;

"toxicity" means the degree to which a substance can cause

harmful effects in the human organism, including effects occurring

over time, usually through repeated or continuous consumption or

exposure;

"unit packet" means the smallest individual packaging of a

tobacco or related product that is placed on the market;

"waterpipe tobacco" means a tobacco product that can be

consumed via a waterpipe. For the purpose of these regulations,

waterpipe tobacco is deemed to be a tobacco product for smoking.

If a product can be used both via waterpipes and as roll-your-own

tobacco, it shall be deemed to be roll-your-own tobacco.

LIST OF TEXT WARNINGS

(Regulation 11)

(1)

Smoking causes 9 out of 10 lung cancers

It-tipjip jikkawża 9 minn 10 każijiet ta’ kanċer fil-pulmun

(2)

Smoking causes mouth and throat cancer

It-tipjip jikkawża kanċer fil-ħalq u fil-gerżuma

(3)

Smoking damages your lungs

It-tipjip jagħmel ħsara fil-pulmuni

(4)

Smoking causes heart attacks

It-tipjip jikkawża l-attakki tal-qalb

(5)

Smoking causes strokes and disability

It-tipjip jikkawża attakki ta’ puplesija u diżabilità

(6)

Smoking clogs your arteries

It-tipjip isoddlok l-arterji

(7)

Smoking increases the risk of blindness

It-tipjip iżidlek ir-riskju li tgħama

(8)

Smoking damages your teeth and gums

It-tipjip iħassarlek snienek u l-ħanek

MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS

(9)

Smoking can kill your unborn child

It-tipjip jista’ joqtol it-tarbija tiegħek qabel it-twelid

(10) Your smoke harms your children, family and friends

It-tipjip tiegħek jagħmel ħsara lil uliedek, familtek u ħbiebek

(11) Smokers’ children are more likely to start smoking

It-tfal ta’ min ipejjep għandhom possibilità akbar li jibdew ipejpu wkoll

(12) Quit smoking - stay alive for those close to you

Aqta’ t-tipjip issa - ibqa’ ħaj għal dawk li tħobb

(13) Smoking reduces fertility

It-tipjip inaqqas il-fertilità

(14) Smoking increases the risk of impotence

It-tipjip iżid ir-riskju ta’ impotenza.

The emission levels from cigarettes placed on the market

or manufactured in Malta ("maximum emission levels") shall not be

greater than

(a) 10 mg of tar per cigarette;

(b) 1 mg of nicotine per cigarette;

(c) 10 mg of carbon monoxide per cigarette.

(1) The tar, nicotine and carbon monoxide emissions from

cigarettes shall be measured on the basis of ISO standard 4387 for

tar, ISO standard 10315 for nicotine, and ISO standard 8454 for

carbon monoxide.

The accuracy of the tar, nicotine and carbon monoxide

measurements shall be determined in accordance with ISO standard

8243. (2) The measurements referred to in sub-regulation (1) shall be

verified by laboratories accredited on the basis of ISO standard

17025 and which are approved by the Superintendent.

These laboratories shall not be owned or controlled directly

or indirectly by the tobacco industry.

(3) The Superintendent shall communicate to the Commission a

list of approved laboratories, specifying the criteria used for

approval and the methods of monitoring applied, and shall update

that list whenever any change is made.

(4) The Superintendent shall notify the Commission of any

measurement methods used at a national level for emissions from

cigarettes other than the emissions referred to in sub-regulation (3)

and for emissions from tobacco products other than cigarettes.

(5) The Superintendent shall charge manufacturers and

importers of tobacco products, at such times and intervals as the

Superintendent may reasonably require, proportionate fees as the

Minister may by regulations prescribe, for the verification of the

measurements referred to sub-regulation (1).

(1) Manufacturers and importers are to submit to the

Superintendent the following information by brand name and type

(a) a list of all ingredients, and quantities thereof, used in

the manufacture of the tobacco products, in

descending order of the weight of each ingredient

included in the tobacco products;

(b) the emission levels referred to in regulation 3;

(c) where available, information on other emissions and

their levels.

For products already placed on the market that information

shall be provided by 20 November 2016.

Manufacturers and importers shall also inform the

Superintendent if the composition of a product is modified in a way

that affects the information provided under these regulations.

For a new or modified tobacco product, the information

required under these regulations shall be submitted prior to the

placing on the market of those products.

(2) The list of ingredients referred to in sub-regulation (1)(a)

shall be accompanied by a statement setting out the reasons for the

inclusion of such ingredients in the tobacco products concerned.

That list shall also indicate the status of the ingredients, including

whether they have been registered under Regulation (EC) No 1907/

2006 of the European Parliament and of the Council as well as their

classification under Regulation (EC) No 1272/2008 of the

European Parliament and of the Council.

(3) The list referred to in sub-regulation (1)(a) shall also be

accompanied by the relevant toxicological data regarding the

ingredients in burnt or unburnt form, as appropriate, referring in

particular to their effects on the health of consumers and taking into

account, inter alia, any addictive effects.

Furthermore, for cigarettes and roll-your-own tobacco, a

technical document setting out a general description of the

additives used and their properties shall be submitted by the

manufacturer or importer.

Other than for tar, nicotine and carbon monoxide and for

emissions referred to in regulation 4(4), manufacturers and

importers shall indicate the methods of measurement of emissions

used. Manufacturers and importers of tobacco products into Malta

may also be required to provide detailed studies assessing the

effects of ingredients on health taking into account, inter alia, their

addictiveness and toxicity.

(4) The Superintendent shall ensure that the information

submitted in accordance with sub-regulation (1) and regulation 6 is

made publicly available on a website. The Superintendent shall

take the need to protect trade secrets duly into account when

making that information publicly available and shall require

manufacturers and importers to specify, when submitting the

information pursuant to sub-regulation (1) and regulation 6, the

information which they consider to constitute trade secrets.

(5) The format for the submission and the making available of

information referred to in sub-regulations (1) and (6) and

regulation 6 shall be in compliance with Commission Implementing

Decision (EU) 2015/2186 of 25 November 2015 establishing a

format for the submission and making available of information on

tobacco products.

(6) Manufacturers and importers shall submit to the

Superintendent internal and external studies available to them on

market research and preferences of various consumer groups,

including young people and current smokers, relating to ingredients

and emissions, as well as executive summaries of any market

surveys they carry out when launching new products.

Manufacturers and importers shall also report to the Superintendent

their sales volumes in Malta per brand and type, reported in sticks

or kilograms, on a yearly basis starting from 1 January 2015.

(7) All data and information provided to and by the

Superintendent under this regulation and under regulation 6 shall

be provided in electronic form. The Superintendent shall store all

the information electronically and shall ensure that the Commission

and other Member States have access to that information for the

purpose of applying these regulations. The Superintendent shall

ensure that trade secrets and other confidential information are

treated in a confidential manner.

(8) The Superintendent may charge manufacturers and

importers of tobacco products proportionate fees as the Minister

may by regulations prescribe, for receiving, storing, handling,

analysing and publishing the information submitted to them

pursuant to this regulation.

(1) In addition to the reporting obligations laid down in

regulation 5, enhanced reporting obligations shall apply to certain

additives contained in cigarettes and roll-your-own tobacco that are

included in a priority list. The priority list of additives shall be laid

down and subsequently updated in accordance with Commission

Implementing Acts. This list shall contain additives

(a) for which initial indications, research, or regulation in

other jurisdictions exist suggesting that they have one

of the properties set out in sub-regulation (2)(a) to (d);

and

(b) which are amongst the most commonly used additives

by weight or number according to the reporting of

ingredients pursuant to regulation 5(1) and (3).

(2) Manufacturers and importers of cigarettes and roll-your-

own-tobacco containing an additive that is included in the priority

list provided for in sub-regulation (1) shall carry out

comprehensive studies, which shall examine for each additive

whether it

(a) contributes to the toxicity or addictiveness of the

products concerned, and whether this has the effect of

increasing the toxicity or addictiveness of any of the

products concerned to a significant or measurable

degree;

(b) results in a characterising flavour;

(c) facilitates inhalation or nicotine uptake; or

(d) leads to the formation of substances that have

carcinogenic, mutagenic and toxic for reproduction

(hereinafter "CMR") properties, the quantities thereof,

and whether this has the effect of increasing the CMR

properties in any of the products concerned to a

significant or measurable degree.

(3)

Those studies shall take into account the intended use of the

products concerned and examine in particular the emissions

resulting from the combustion process involving the additive

concerned. The studies shall also examine the interaction of that

additive with other ingredients contained in the products

concerned. Manufacturers or importers using the same additive in

their tobacco products may carry out a joint study when using that

additive in a comparable product composition.

(4) Manufacturers and importers shall establish a report on the

results of these studies. That report shall include an executive

summary, and a comprehensive overview compiling the available

scientific literature on that additive and summarising internal data

on the effects of the additive.

Manufacturers and importers shall submit these reports to

the Commission and to the Superintendent if the tobacco product

containing this additive is placed on the Maltese market at the latest

eighteen (18) months after the additive concerned has been

included in the priority list pursuant to sub-regulation (1). The

Commission and the Superintendent may also request

supplementary information from manufacturers or importers

regarding the additive concerned. This supplementary information

shall form part of the report.

The Commission and the Superintendent may require these

reports to be peer reviewed by an independent scientific body, in

particular as regards their comprehensiveness, methodology and

conclusions. The information received shall assist the Commission

an d the Superin ten den t i n taki ng th e d ecisi ons pu rsuan t to

regulation 7.

The Superintendent may charge manufacturers and

importers of tobacco products proportionate fees as the Minister

may by regulations prescribe, for such peer reviews.

(5) Small and medium-sized enterprises as defined in

Commission Recommendation 2003/361/EC shall be exempted

from the obligations pursuant to this regulation, if a report on that

additive is prepared by another manufacturer or importer.

(1) The placing on the market of tobacco products with a

characterising flavour is prohibited.

The use of additives which are essential for the manufacture

of tobacco products, for example sugar to replace sugar that is lost

during the curing process, provided those additives do not result in

a product with a characterising flavour and do not increase to a

significant or measurable degree the addictiveness, toxicity or the

CMR properties of the tobacco product, shall not be prohibited.

(2) Uniform rules for the procedures for determining whether a

tobacco product falls within the scope of sub-regulation (1) shall be

laid down by a Commission Implementing Act.

(3) The placing on the market of tobacco products containing

the following additives shall be prohibited

(a) vitamins or other additives that create the impression

that a tobacco product has a health benefit or presents

reduced health risks;

(b) caffeine or taurine or other additives and stimulant

compounds that are associated with energy and

vitality;

(c) additives having colouring properties for emissions;

(d) for tobacco products for smoking, additives that

facilitate inhalation or nicotine uptake; and

(e) additives that have CMR properties.

(4) The placing on the market of tobacco products containing

flavourings in any of their components such as filters, papers,

packages, capsules or any technical features allowing modification

of the smell or taste of the tobacco products concerned or their

smoke intensity shall be prohibited. Filters, papers and capsules

shall not contain tobacco or nicotine.

(5) The Superintendent shall ensure that the provisions and

conditions laid down in Regulation (EC) No 1907/2006 are applied

to tobacco products as appropriate.

(6) On the basis of scientific evidence, the Superintendent may

prohibit the placing on the market of tobacco products containing

additives in quantities that increase the toxic or addictive effect or

the CMR properties of a tobacco product at the stage of

consumption to a significant or measurable degree. The

Superintendent shall inform the Commission on such measures

taken.

(7) Tobacco products other than cigarettes, roll-your-own

tobacco and heated tobacco products shall be exempted from the

prohibitions laid down in sub-regulations (1) and (4)

(8) The Superintendent may charge manufacturers and

importers of tobacco products proportionate fees which the

Minister may by regulations prescribe, for assessing whether a

tobacco product has a characterising flavour, whether prohibited

additives or flavourings are used and whether a tobacco product

contains additives in quantities that increase to a significant and

measurable degree the toxic or addictive effect or the CMR

properties of the tobacco product concerned.

(9) In the case of tobacco products with a characterising

flavour whose Union-wide sales volumes represent 3% or more in a

particular product category, the provisions of this regulation shall

apply from 20 May 2020.

(1) Each unit packet of a tobacco product and any outside

packaging shall carry the health warnings provided for in these

regulations in both Maltese and English.

(2) Health warnings shall cover the entire surface of the unit

packet or outside packaging that is reserved for them and they shall

not be commented on, paraphrased or referred to in any form.

(3) Health warning on a unit packet and any outside packaging

shall be irremovably printed, indelible and fully visible, including

not being partially or totally hidden or interrupted by tax stamps,

items, when tobacco products are placed on the market. On unit

packets of tobacco products other than cigarettes and roll-your-own

tobacco in pouches, the health warnings may be affixed by means

of stickers, provided that such stickers are irremovable. The health

warnings shall remain intact when opening the unit packet other

than packets with a flip-top lid, where the health warnings may be

split when opening the packet, but only in a manner that ensures the

graphical integrity and visibility of the text, photographs and

cessation information.

(4) The health warnings shall in no way hide or interrupt the

tax stamps, price marks, tracking and tracing marks, or security

features on unit packets.

(5) The dimensions of the health warnings provided for in

regulations 9, 10, 11 and 12 shall be calculated in relation to the

surface concerned when the packet is closed.

(6) Health warnings shall be surrounded by a black border of a

width of 1 mm inside the surface area that is reserved for these

warnings, except for health warnings pursuant to regulation 11.

(7) Images of unit packets and any outside packaging targeting

consumers in the Union shall comply with the provisions of these

regulations.

(1) Each unit packet and any outside packaging of tobacco

products for smoking shall carry the general warning: ‘Smoking

kills’ and ‘It-tipjip joqtol’.

(2) Each unit packet and any outside packaging of tobacco

products for smoking shall carry the following information

message: ‘Tobacco smoke contains over 70 substances known to

cause cancer’ and ‘Id-duħħan tat-tabakk fih aktar minn 70 sustanza

magħrufa li jikkawżaw il-kanċer’.

(3) For cigarette packets and roll-your-own tobacco in cuboid

packets the general warning shall appear on the bottom part of one

of the lateral surfaces of the unit packets, and the information

message shall appear on the bottom part of the other lateral surface.

These health warnings shall have a width of not less than 20 mm.

For packets in the form of a shoulder box with a hinged lid

that result in the lateral surfaces being split into two when the

packet is open, the general warning and the information message

shall appear in their entirety on the larger parts of those split

surfaces. The general warning shall also appear on the inside of the

top surface that is visible when the packet is open.

The lateral surfaces of this type of packet shall have a

height of not less than 16 mm.

For roll-your-own tobacco marketed in pouches, the general

warning and the information message shall appear on the surfaces

that ensure the full visibility of those health warnings. For roll-

your-own tobacco in cylindrical packets the general warning shall

appear on the outside surface of the lid and the information

message on the inside surface of the lid.

Both the general warning and the information message shall

cover 50% of the surfaces on which they are printed.

(4) The general warning and information message referred to in

sub-regulations (1) and (2) shall be

(a) printed on a white background in Black Helvetica bold

type, in a font size which ensures that the text occupies

the greatest possible proportion of the surface area

reserved for it;

(b) at the centre of the surface reserved for them, and on

cuboid packets and any outside packaging they shall

be parallel to the lateral edge of the unit packet or of

the outside packaging.

(5) The precise position of the general warning and the

information message on roll-your-own tobacco marketed in

pouches, taking into account the different shapes of pouches, shall

be in compliance with Commission Implementing Decision (EU)

2015/1735 of 24 September 2015 on the precise position of the

general warning and the information message on roll-your-own

tobacco marketed in pouches.

(1) Each unit packet and any outside packaging of tobacco

products for smoking shall carry combined health warnings. The

combined health warnings shall

(a) contain one graphic chosen from the set of graphical

warnings contained in Schedule 1 specified for the

production year during which the pack is produced.

For the purpose of these regulations

(i)

the set of graphic contained in Part 1 of

Schedule 1 is specified for the production year

2016-2017 and every third production year

thereafter;

(ii) the set of graphic contained in Part 2 of

Schedule 1 is specified for the production year

2017-2018 and every third production year

thereafter;

(iii) the set of graphic contained in Part 3 of

Schedule 1 is specified for the production year

2018-2019 and every third production year

thereafter;

(iv) "Production year" means a period of twelve (12)

months beginning on 20th May and ending on

19th May;

(b) include the following smoking cessation information

"Tobacco

Stop

Line

80073333;

Website

health.gov.mt";

(c) cover 65% of both the external front and back surface

of the unit packet and any outside packaging.

Cylindrical packets shall display two combined health

warnings, equidistant from each other, each covering

65% of their respective half of the curved surface;

(d) show the same graphic on both sides of the unit

packets and any outside packaging;

(e) appear at the top edge of a unit packet and any outside

packaging, and be positioned in the same direction as

any other information appearing on that surface of the

packaging. Transitional exemptions apply as follows

(i)

in those cases where the tax stamp or national

identification mark used for fiscal purposes is

affixed at the top edge of a unit packet made of

carton material, the combined health warning

that is to appear on the back surface may be

positioned directly below the tax stamp or

national identification mark;

(ii) where a unit packet is made of soft material, a

rectangular area is to be reserved for the tax

stamp of a height not exceeding 13 mm between

the top edge of the packet and the top end of the

combined health warnings.

The exemptions referred to in sub-paragraphs (i) and

(ii) shall apply for a period of three years from 20 May

2016. Brand names or logos shall not be positioned

above the health warnings;

(f)

be reproduced in accordance with the format, layout,

design and proportions specified by the Commission

pursuant to sub-regulation (3);

(g) in the case of unit packets of cigarettes, respect the

following dimensions

(i) height: not less than 44 mm;

(ii) width: not less than 52 mm.

(2) The combined health warnings are grouped into three sets

as set out in Schedule 1. Each of the 14 graphics in the set of

graphical warnings specified for the production year must be

displayed to the extent possible in equal numbers on each brand of

tobacco products.

(3) The layout, design and shape of the combined health

warnings, taking into account the different packet shapes, shall be

in compliance with Commission Implementing Decision (EU)

2015/1842 of 9 October 2015 on the technical specifications for the

layout, design and shape of the combined health warnings.

(1) (a) Tobacco products for smoking other than cigarettes,

roll-your-own tobacco, waterpipe tobacco and heated tobacco

products are exempt from the obligations to carry the information

message laid down in regulation 9(2) and the combined health

warnings laid down in regulation 10. In addition to the general

warning provided for in regulation 9(1), each unit packet and any

outside packaging of such products shall carry one of the text

warnings listed in Schedule 2. The general warning specified in

regulation 9(1) shall include a reference to the cessation from

smoking services referred to in regulation 10(1)(b);

(b) the general warning shall appear on the most visible

surface of the unit packet and any outside packaging;

(c) each text warning listed in Schedule 2 shall be

displayed to the extent possible in equal numbers on

each brand of these products. The text warnings shall

appear on the next most visible surface of the unit

packet and any outside packaging;

(d) for unit packets with a hinged lid, the next most visible

surface is the one that becomes visible when the

packet is open;

(e) Deleted by Legal Notice 178 of 2025.

Provided that heated tobacco products that depending on their

characteristics are smokeless tobacco products shall be regulated in

accordance with Article 12 of Directive 2014/40/EU.

(2) The general warning referred to in sub-regulation (1) shall

cover 32% of the relevant surface of the unit packet and any outside

packaging.

(3) The text warning referred to in sub-regulation (1) shall

cover 45% of the relevant surface of the unit packet and any outside

packaging.

(4) Where the health warnings referred to in sub-regulation (1)

are to appear on a surface exceeding 150 cm 2 , the warnings shall

cover an area of 48 cm 2 .

(5) The health warnings referred to in sub-regulation (1) shall

comply with the requirements specified in regulation 9(4). The text

of the health warnings shall be parallel to the main text on the

surface reserved for these warnings.

The health warnings shall be surrounded by a black border

of a width of not less than 3 mm and not more than 4 mm. This

border shall appear outside the surface reserved for the health

warnings.

(1) The labelling of unit packets and any outside

packaging and the tobacco product itself shall not include any

element or feature that -

(a) promotes a tobacco product or encourages its

consumption by creating an erroneous impression

about its characteristics, health effects, risks or

emissions; labels shall not include any information

about the nicotine, tar or carbon monoxide content of

the tobacco product;

(b) suggests that a particular tobacco product is less

harmful than others or aims to reduce the effect of

some harmful components of smoke or has vitalising,

energetic, healing, rejuvenating, natural, organic

properties or has other health or lifestyle benefits;

(c) refers to taste, smell, any flavourings or other

additives or the absence thereof;

(d) resembles a food or a cosmetic product;

(e) suggests that a certain tobacco product has improved

biodegradability or other environmental advantages.

(2) The unit packets and any outside packaging shall not

suggest economic advantages by including printed vouchers,

offering discounts, free distribution, two-for-one or other similar

offers.

(3) The elements and features that are prohibited pursuant to

sub-regulations (1) and (2) may include, but are not limited to,

texts, symbols, names, trademarks, figurative or other signs.

(1) Unit packets of cigarettes shall have a cuboid shape.

Unit packets of roll-your-own tobacco shall have a cuboid or

cylindrical shape, or the form of a pouch. A unit packet of

cigarettes shall include at least 20 (twenty) cigarettes. A unit packet

of roll-your-own tobacco shall contain tobacco weighing not less

than 30 g.

(2) A unit packet of cigarettes may consist of carton or soft

material and shall not have an opening that can be re-closed or re-

sealed after it is first opened, other than the flip-top lid and

shoulder box with a hinged lid. For packets with a flip-top lid and

hinged lid, the lid shall be hinged only at the back of the unit

packet.

(1) The manufacturer and the importer shall ensure that

all unit packets of tobacco products are marked with a unique

identifier. In order to ensure the integrity of the unique identifier, it

shall be irremovably printed or affixed, indelible and not hidden or

interrupted in any form, including through tax stamps or price

marks, or by the opening of the unit packet. In the case of tobacco

products that are manufactured outside of the Union, the

obligations laid down in these regulations apply only to those that

are destined for, or placed on, the Union market.

(2) The unique identifier shall allow the following to be

determined

(a) the date and place of manufacturing;

(b) the manufacturing facility;

(c) the machine used to manufacture the tobacco products;

(d) the production shift or time of manufacture;

(e) the product description;

(f)

the intended market of retail sale;

(g) the intended shipment route;

(h) where applicable, the importer into the Union;

(i)

the actual shipment route from manufacturing to the

first retail outlet, including all warehouses used as

well as the shipment date, shipment destination, point

of departure and consignee;

(j)

the identity of all purchasers from manufacturing to

the first retail outlet; and

(k) the invoice, order number and payment records of all

purchasers from manufacturing to the first retail outlet.

(3) The information referred to in sub-regulation (2)(a), (b),

(c), (d), (e), (f), (g) and, where applicable, (h) shall form part of the

unique identifier.

(4) The information mentioned in sub-regulation (2)(i), (j) and

(k) shall be electronically accessible by means of a link to the

unique identifier.

(5) All economic operators involved in the trade of tobacco

products, from the manufacturer to the last economic operator

before the first retail outlet, must record the entry of all unit

packets into their possession, as well as all intermediate

movements and the final exit of the unit packets from their

possession. This obligation may be complied with by the marking

and recording of aggregated packaging such as cartons,

mastercases or pallets, provided that the tracking and tracing of all

unit packets remains possible.

(6) All natural and legal persons engaged in the supply chain

of tobacco products shall maintain complete and accurate records

of all relevant transactions.

(7) The manufacturers of tobacco products shall provide all

economic operators involved in the trade of tobacco products, from

the manufacturer to the last economic operator before the first retail

outlet, including importers, warehouses and transporting

companies, with the equipment that is necessary for the recording

of the tobacco products purchased, sold, stored, transported or

otherwise handled. That equipment shall be able to read and

transmit the recorded data electronically to a data storage facility

pursuant to sub-regulation (8).

(8) Manufacturers and importers of tobacco products shall

conclude data storage contracts with an independent third party, for

the purpose of hosting the data storage facility for all relevant data.

The data storage facility shall be physically located on the territory

of the Union. The suitability of the third party, in particular its

independence and technical capacities, as well as the data storage

contract, shall be approved by the Commission.

The third party’s activities shall be monitored by an

e x t e r na l au d i t o r, w h o i s p r o p o s e d an d p a i d b y t h e t o b a c c o

manufacturer and approved by the Commission. The external

auditor shall submit an annual report to the Superintendent and to

the Commission, assessing in particular any irregularities in

relation to access.

The Commission, the competent authorities of the Member

States, and the external auditor shall have full access to the data

storage facilities. In duly justified cases, the Commission or the

Member States may grant manufacturers or importers access to the

stored data, provided that commercially sensitive information

remains adequately protected in conformity with the relevant Union

and national law.

(9) Recorded data shall not be modified or deleted by an

economic operator involved in the trade of tobacco products.

(10) All personal data shall only be processed in accordance

with the rules and safeguards of the Data Protection Act.

(11) The technical standards for the establishment and the

operation of the tracking and tracing system as provided for in this

regulation, including the marking with a unique identifier, the

recording, transmitting, processing and storing of data and access

to stored data shall be determined in accordance with a

Commission Implementing Act.

(12) The technical standards for ensuring that the systems used

for the unique identifier and the related functions are fully

compatible with each other across the Union shall be determined in

accordance with a Commission Implementing Act.

(13) The provisions of this regulation shall apply to cigarettes

and roll-your-own tobacco from 20 May 2019 and to tobacco

products other than cigarettes and roll-your-own tobacco from 20

May 2024.

(1) In addition to the unique identifier referred to in

regulation 14, all unit packets of tobacco products, which are

placed on the market, shall carry a tamper proof security feature,

composed of visible and invisible elements. The security feature

shall be irremovably printed or affixed, indelible and not hidden or

interrupted in any form, including through tax stamps and price

marks, or other elements imposed by legislation.

Tax stamps may be used for the security feature provided

that the tax stamps fulfil all of the technical standards and functions

required under this regulation.

(2) The technical standards for the security feature and their

possible rotation and adaptation to scientific, market and technical

developments shall be defined by means of Commission

Implementing Acts.

(3) Sub-regulation (1) shall apply to cigarettes and roll-your-

own tobacco from 20 May 2019 and to tobacco products other than

cigarettes and roll-your-own tobacco from 20 May 2024.

(1) Cross-border distance sales of tobacco products to

consumers located in Malta shall be prohibited.

(2) Retail outlets located in Malta engaging in cross-border

distance sales of tobacco products shall not supply such products to

consumers in Member States where such sales have been

prohibited. Retail outlets located in Malta intending to engage in

cross-border distance sales to consumers located in the Union shall

register with the Superintendent and with the competent authorities

in the Member State where the actual or potential consumers are

located. All retail outlets located in Malta intending to engage in

cross-border distance sales shall submit the following information

to the Superintendent when registering

(a) name or corporate name and permanent address of the

place of activity from where the tobacco products shall

be supplied;

(b) the starting date of the activity of offering tobacco

products for cross-border distance sales to consumers

by means of information society services;

(c) the address of the websites used for that purpose and

all relevant information necessary to identify the

website.

(3)

The Superintendent shall make publicly available the list

of all retail outlets located in Malta and engaging in cross-border

distance sales that are registered in accordance with this regulation.

Retail outlets may only start engaging in cross-border distance sales

when they have received confirmation of their registration with the

Superintendent.

(4)

Retail outlets located in Malta supplying tobacco

products sold by cross-border distance sales shall nominate to the

Superintendent, a natural person who shall be responsible for

verifying, before the tobacco products reach the consumer, that they

comply with the national provisions of the Member State where the

consumer is located at the time that the consumer orders the product.

(5)

Retail outlets located in Malta engaging in cross-border

distance sales shall operate an age verification system, which verifies,

at the time of sale, that the purchasing consumer complies with

minimum age requirements provided for under the national provisions

of the Member State where the consumer is located at the time that the

consumer orders the product. The retail outlet or natural person

nominated pursuant to sub-regulation (4) shall provide to the

Superintendent a description of the details of the age verification

system and how it functions.

(6) Retail outlets located in Malta shall only process personal data

of the consumer in accordance with Regulation (EU) 2016/679 of the

European Parliament and of the Council of 27 April 2016 and that data

shall not be disclosed to the manufacturer of tobacco products or

companies forming part of the same group of companies or to other

third parties. Personal data shall not be used or transferred for

purposes other than the actual purchase. This also applies if the retail

outlet forms part of a manufacturer of tobacco products.

(1) Manufacturers and importers of novel tobacco

products shall submit a notification to the Superintendent of any

such product they intend to place on the national market. The

notification shall be submitted in electronic form six months before

the intended placing on the market. It shall be accompanied by a

detailed description of the novel tobacco product concerned as well

as instructions for its use and information on ingredients and

emissions in accordance with regulation 5. The manufacturers and

importers submitting a notification of a novel tobacco product shall

also provide the Superintendent with

(a) available scientific studies on toxicity, addictiveness

and attractiveness of the novel tobacco product, in

particular as regards its ingredients and emissions;

(b) available studies, executive summaries thereof and

market research on the preferences of various

consumer groups, including young people and current

smokers;

(c) other available and relevant information, including a

risk/benefit analysis of the product, its expected

effects on cessation of tobacco consumption, its

expected effects on initiation of tobacco consumption

and predicted consumer perception.

(2) Manufacturers and importers of novel tobacco products

shall transmit to the Superintendent any new or updated

information on the studies, research and other information referred

to in sub-regulation (1)(a) to (c). The Superintendent may require

manufacturers or importers of novel tobacco products to carry out

additional tests or submit additional information. All information

received pursuant to this regulation shall be made available to the

Commission.

(3) Novel tobacco products placed on the market shall respect

the requirements of these regulations.

(1) Electronic cigarettes and refill containers shall only be

placed on the market if they comply with these regulations and with

all other relevant national and Union legislation.

This does not apply to electronic cigarettes and refill

containers that are subject to an authorisation requirement under

Directive 2001/83/EC or to the requirements set out in Directive

93/42/EEC.

(2)

(a) Manufacturers and importers of electronic cigarettes

and refill containers shall submit a notification to the

Superintendent of any such products which they intend

to place on the market. The notification shall be

submitted in electronic form six months before the

intended placing on the market. For electronic

cigarettes and refill containers already placed on the

market on 20 May 2016, the notification shall be

submitted within six months of that date. A new

notification shall be submitted for each substantial

modification of the product.

(b) The notification shall, depending on whether the

product is an electronic cigarette or a refill container,

contain the following information

(i)

the name and contact details of the

manufacturer, a responsible legal or natural

person within the Union, and, if applicable, the

importer into the Union;

(ii) a list of all ingredients contained in, and

emissions resulting from the use of, the product,

by brand name and type, including quantities

thereof;

(iii) toxicological data regarding the product’s

ingredients and emissions, including when

heated, referring in particular to their effects on

the health of consumers when inhaled and taking

into account, inter alia, any addictive effect;

(iv) information on the nicotine doses and uptake

when consumed under normal or reasonably

foreseeable conditions;

(v) a description of the components of the product;

including, where applicable, the opening and

refill mechanism of the electronic cigarette or

refill containers;

(vi) a description of the production process,

including whether it involves series production,

and a declaration that the production process

ensures conformity with the requirements of this

regulation;

(vii)

a declaration that the manufacturer and importer

bear full responsibility for the quality and safety

of the product, when placed on the market and

used under normal or reasonably foreseeable

conditions;

(c) Where the Superintendent considers that the

information submitted is incomplete, he shall be

entitled to request the completion of the information

concerned.

(d) The Superintendent may charge manufacturers and

importers of tobacco products proportionate fees

which the Minister may by regulations prescribe, for

receiving, storing, handling and analysing the

information submitted to him.

(3) Electronic cigarettes and refill containers shall only be

placed on the market if they comply with the following

requirements

(a) nicotine-containing liquid is only placed on the market

in dedicated refill containers not exceeding a volume

of 10 ml, in disposable electronic cigarettes or in

single use cartridges and that the cartridges or tanks do

not exceed a volume of 2 ml;

(b) the nicotine-containing liquid

does

not

contain

nicotine in excess of 20 mg/ml;

(c) the nicotine-containing liquid does

not

contain

additives listed in regulation 7(3);

(d) only ingredients of high purity are used in the

manufacture of the nicotine-containing liquid.

Substances other than the ingredients referred to in

MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS

sub-regulation (2)(b)(ii) are only present in the

nicotine-containing liquid in trace levels, if such trac

(e) except for nicotine, only ingredients that do not pose a

risk to human health in heated or unheated form are

used in the nicotine-containing liquid;

(f)

electronic cigarettes deliver the nicotine doses at

consistent levels under normal conditions of use;

(g) electronic cigarettes and refill containers are child-

and tamper-proof, are protected against breakage and

leakage and have a mechanism that ensures refilling

without leakage.

(4) Electronic cigarettes and refill containers shall only be

placed on the market if they comply to these further requirements

(a) unit packets of electronic cigarettes and refill

containers shall include a leaflet with information in

the Maltese or in the English language on

(i)

instructions for use and storage of the product,

including a reference that the product is not

recommended for use by young people and non-

smokers;

(ii) contra-indications;

(iii) warnings for specific risk groups;

(iv) possible adverse effects;

(v) addictiveness and toxicity; and

(vi) contact details of the manufacturer or importer

and a legal or natural contact person within the

Union

Provided that the leaflet containing the information

stipulated in this paragraph may be substituted by a label

affixed to the packaging or a leaflet contained within the

packaging, which includes a Quick Response (QR) code

containing an electronic link with information stipulated

in this paragraph in either the Maltese or the English

language.

(b) unit packets and any outside packaging of electronic

cigarettes and refill containers

(i)

include a list of all ingredients contained in the

product in descending order of the weight, and

an indication of the nicotine content of the

product and the delivery per dose, the batch

number and a recommendation to keep the

product out of reach of children;

(ii) without prejudice to sub-paragraph (i), do not

include elements or features referred to in

regulation 12, with the exception of regulation

12(1)(a) and (c) concerning information on the

nicotine content and on flavourings; and

(iii) carry the following health warning

‘This product contains nicotine which is a

highly addictive substance’ and ‘Dan il-

prodott fih in-nikotina li hija sustanza li

tista’ faċilment twassal għad-dipendenza’.

(c) the health warning shall comply with the requirements

specified in regulation 9(4). The text of the health

warnings shall be parallel to the main text on the

surface reserved for these warnings. In addition, it

shall

(i)

appear on the two largest surfaces of the unit

packet and any outside packaging;

(ii) cover 32% of the surfaces of the unit packet and

any outside packaging.

(5)

The following shall also apply to electronic cigarettes

(a) commercial communications in information society

services, in the press and other printed publications,

with the aim or direct or indirect effect of promoting

electronic cigarettes and refill containers are

prohibited, except for publications that are intended

exclusively for professionals in the trade of electronic

cigarettes or refill containers and for publications

which are printed and published in third countries,

where those publications are not principally intended

for the Union market;

(b) commercial communications on the radio, with the aim

or direct or indirect effect of promoting electronic

cigarettes and refill containers, are prohibited;

(c) any form of public or private contribution to radio

programmes with the aim or direct or indirect effect of

promoting electronic cigarettes and refill containers is

prohibited;

(d) any form of public or private contribution to any

event, activity or individual person with the aim or

direct or indirect effect of promoting electronic

cigarettes and refill containers and involving or taking

place in several Member States or otherwise having

cross-border effects is prohibited;

(e) audiovisual commercial communications, to which

Directive 2010/13/EU of the European Parliament and

of the Council applies, are prohibited for electronic

cigarettes and refill containers.

(6) Regulation 16 shall apply to cross-border distance sales of

electronic cigarettes and refill containers.For the purpose of this

sub-regulation, the terms "electronic cigarettes" and "refill containers"

shall refer to both nicotine and non-nicotine containing electronic

cigarettes and refill containers.

(7) Manufacturers and importers of electronic cigarettes and

refill containers shall annually submit to the Superintendent

(a) comprehensive data on sales volumes, by brand name

and type of the product;

(b) information on the preferences of various consumer

groups, including young people, non-smokers and the

main types of current users;

(c) the mode of sale of the products; and

(d) executive summaries of any market surveys carried out

in respect of the above, including an English translation

thereof

Provided that the Superintendent shall monitor the market

developments concerning electronic cigarettes and refill containers,

including any evidence that their use is a gateway to nicotine

addiction and ultimately traditional tobacco consumption among

young people and non-smokers.

(8) The information received pursuant to sub-regulation (2)

shall be made publicly available on a website, duly taking into

account the need to protect trade secrets.

All information received pursuant to this regulation shall be

made available, upon request, to the Commission and other

M e m b e r St a t e s, d u l y e n s u r i n g t h a t t r a d e s e c r e t s a n d o t h e r

confidential information are treated in a confidential manner.

(9) Manufacturers, importers and distributors of electronic

cigarettes and refill containers shall establish and maintain a

system for collecting information about all of the suspected adverse

effects on human health of these products.

Should any of these economic operators consider or have

reason to believe that electronic cigarettes or refill containers,

which are in their possession and are intended to be placed on the

market or are placed on the market, are not safe or are not of good

quality or are otherwise not in conformity with these regulations,

that economic operator shall immediately take the corrective action

necessary to bring the product concerned into conformity with

these regulations, to withdraw or to recall it, as appropriate. In such

cases, the economic operator shall also be required to immediately

inform the Superintendent, giving details, in particular, of the risk

to human health and safety and of any corrective action taken, and

of the results of such corrective action.

The Superintendent may also request additional information

from the economic operators, for example on the safety and quality

aspects or any adverse effects of electronic cigarettes or refill

containers.

(10) In the case of electronic cigarettes and refill containers that

comply with the requirements of this regulation, where the

Superintendent ascertains or has reasonable grounds to believe that

specific electronic cigarettes or refill containers, or a type of

electronic cigarette or refill container, could present a serious risk

to human health, he may take appropriate provisional measures.

The Superintendent shall immediately inform the Commission and

the competent authorities of other Member States of the measures

taken and shall communicate any supporting data.

(11) The notification provided for in sub-regulation (2) shall be

in compliance with Commission Implementing Decision (EU)

2015/2183 of 24 November 2015 establishing a common format for

the notification of electronic cigarettes and refill containers

(notified under document C(2015) 8087).

Technical standards for the refill mechanism shall be laid

down and subsequently updated in accordance with Commission

Implementing Acts.

(1) Each unit packet and any outside packaging of herbal

products for smoking shall carry the following health warnings

‘Smoking this product damages your health’ and ‘It-tipjip ta’ dan

il-prodott jagħmel ħsara lil saħħtek’.

(2) The health warning shall be printed on the front and back

external surface of the unit packet and on any outside packaging.

(3) The health warning shall comply with the requirements set

out in regulation 9(4). It shall cover 32% of the area of the

corresponding surface of the unit packet and of any outside

packaging.

(4) Unit packets and any outside packaging of herbal products

for smoking shall not include any of the elements or features set out

in regulation 12(1)(a), (b) and (d) and shall not state that the

product is free of additives or flavourings.

(5) Regulation 16 shall also apply to cross-border distance sales of

herbal products for smoking.

(1) Manufacturers and importers of herbal products for

smoking shall submit to the Superintendent a list of all ingredients,

and quantities thereof that are used in the manufacture of such

products by brand name and type. Manufacturers or importers shall

also inform the Superintendent when the composition of a product

is modified in a way that affects the information submitted pursuant

to this regulation. The information required under this regulation

shall be submitted prior to the placing on the market of a new or

modified herbal product for smoking.

(2) The Superintendent shall make the information submitted in

accordance with sub-regulation (1) publicly available on a website,

duly protecting trade secrets. Economic operators shall specify

exactly which information they consider to constitute a trade secret.

No person may import, manufacture, prepare, store, keep

for sale, sell or supply by way of compensation or otherwise, any

smokeless tobacco product, excluding heated tobacco products as

defined in regulation 2.

The following products, which are not in compliance with

these regulations, may be placed on the market until 20 May 2017

(a) tobacco products manufactured or released for free

circulation and labelled in accordance with Directive

2001/37/EC before 20 May 2016;

(b) electronic cigarettes or refill containers manufactured

or released for free circulation before 20 November

2016;

(c) herbal products for smoking manufactured or released

for free circulation before 20 May 2016.

(1) The Superintendent shall ensure that manufacturers

and importers of tobacco and related products provide his office

and the Commission with complete and correct information

requested pursuant to these regulation and within the time limits set

out herein. The obligation to provide the requested information

shall lie primarily with the manufacturer, if the manufacturer is

established in Malta. The obligation to provide the requested

i n f o r m a t i o n s h a l l l i e p r i m a r i l y w i t h t h e i m p o r t e r, i f t h e

manufacturer is established outside Malta and the importer is

established inside Malta. The obligation to provide the requested

information shall lie jointly with the manufacturer and the importer

if both are established outside Malta.

(2) The Superintendent shall ensure that tobacco and related

products which do not comply with these regulations, including the

implementing and delegated acts provided for in the Directive, are

not placed on the market.

Any person who contravenes or fails to comply with any of

the provisions of these regulations shall be guilty of an offence and

shall, without prejudice to his liability under any other law, be

liable, on a first conviction, to a fine (multa) of not less than two

h u n dr e d e u r o ( € 2 0 0) a nd n o t e xc e e d in g o ne th o u s a n d e u r o

(€1,000), and where the act or omission constituting the offence

subsists for more than a day, the Court shall in addition impose a

fine (multa) of not less than twenty euro (€20) and not more than

one hundred euro (€100) for each day in which such act or omission

subsists, and on a second or subsequently conviction, in addition to

such fines, and, at the request of the prosecution, to imprisonment

for a term not exceeding three months.

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MANUFACTURE, PRESENTATION AND SALE

OF TOBACCO AND RELATED PRODUCTS