Products Regulations, 2016

L.N. 67 of 2016

TOBACCO (SMOKING CONTROL) ACT

(CAP. 315)

Manufacture, Presentation and Sale of Tobacco and Related

Products Regulations, 2016

IN exercise of the powers conferred by article 9(f) of the

Tobacco (Smoking Control) Act, the Parliamentary Secretary for

Health has made the following regulations:-

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

Presentation and Sale of Tobacco and Related Products Regulations, and

commencement.

2016. (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.

(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.

(4) These regulations shall come into force on 20th May, 2016.

Graphical health warning library

(Regulation 10)

PART 1

PART 2

PART 3

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 Interpretation.

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 other than one of tobacco, resulting from an additive or 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

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;

"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 consumption, including text warnings, combined 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

(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.

B

€3.24

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 and the

Superintendent in taking the decisions pursuant 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 and roll-your-own

tobacco 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 Labelling and

outside packaging shall carry the health warnings provided for in packaging

general

these regulations in both Maltese and English.

provisions.

(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, price

marks, security features, wrappers, jackets, boxes, or other 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 in Black Helvetica bold type, Font size 20 on

a white background;

(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 Labelling and

tobacco products for smoking shall carry combined health warnings. packaging

combined health

The combined health warnings shall

warnings for

tobacco

products for

(a)

contain one graphic chosen from the set of graphical smoking.

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) Tobacco products for smoking other than cigarettes, Labelling and

roll-your-own tobacco and waterpipe tobacco are exempt from the packaging

labelling of

obligations to carry the information message laid down in regulation tobacco

products for

9(2) and the combined health warnings laid down in regulation 10. In smoking other

addition to the general warning provided for in regulation 9(1), each than

roll-your-own

unit packet and any outside packaging of such products shall carry tobacco and

waterpipe

one of the text warnings listed in Schedule 2. The general warning tobacco.

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

services referred to in regulation 10(1)(b).

The general warning shall appear on the most visible

surface of the unit packet and any outside packaging.

Each text warning listed in Schedule 2 must 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.

For unit packets with a hinged lid, the next most visible

surface is the one that becomes visible when the packet is open.

(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. Labelling and

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

appearance and

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

packets.

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 Labelling and

all unit packets of tobacco products are marked with a unique packaging

traceability.

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

external auditor, who is proposed and paid by the tobacco

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 Labelling and

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

security feature.

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) Retail outlets engaging in cross-border distance

sales of tobacco products may not supply such products to consumers

in Member States where such sales have been prohibited.

Retail outlets intending to engage in cross-border distance

sales to consumers located in the Union must register with the

Superintendent and with the competent authority in the Member State

where the actual or potential consumers are located. Retail outlets

established outside the Union shall be required to register with the

competent authorities in the Member State where the actual or

potential consumers are located. All retail outlets intending to engage

in cross-border distance sales shall submit the following information

to the competent authorities when registering

(a)

name or corporate name and permanent address of

the place of activity from where the tobacco products will 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 website or websites used for that

purpose and all relevant information necessary to identify the

website.

(2) The Superintendent shall ensure that consumers have

access to the list of all retail outlets registered with them. Retail

outlets may only start placing tobacco products on the market via

cross-border distance sales when they have received confirmation of

their registration with the Superintendent.

(3) The retail outlet supplying tobacco products sold via cross-

border distance sales shall nominate, to the Superintendent, a natural

person to be responsible for verifying, before the tobacco products

reach the consumer, that they comply with the national provisions

adopted pursuant to these regulations, if such verification is necessary

in order to ensure compliance and facilitate enforcement.

(4) Retail outlets engaged 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 Tobacco (Smoking Control) Act. Cap. 315.

The retail outlet or natural person nominated pursuant to sub-

regulation (3) shall provide to the Superintendent a description of the

details and functioning of the age verification system.

(5) Retail outlets shall only process personal data of the

consumer in accordance with Directive 95/46/EC and those 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 Notification of

products shall submit a notification to the Superintendent of any such novel

products.

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 sub-regulation (2)(b)(ii) are

only present in the nicotine-containing liquid in trace levels, if

such traces are technically unavoidable during manufacture;

(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 include a leaflet with information 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;

(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) health warnings comply with the requirements

specified in regulation 9(4).

(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.

(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.

(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

Member States, duly ensuring that trade secrets and other 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

herbal products for smoking shall carry the following health for smoking.

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.

(1) Manufacturers and importers of herbal products for Reporting of

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

herbal products

and quantities thereof that are used in the manufacture of such for smoking.

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.

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 information shall lie

primarily with the importer, if the 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 hundred

euro (€200) and not exceeding one thousand euro (€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.

The following regulations -

Revocation.

(a)

the Labelling of Tobacco Products Regulations -

S.L.315.01;

(b) the Ban on Smokeless Tobacco Regulations -

S.L.315.02;

(c)

the Tobacco Products (Cigarette Composition)

Regulations - S.L.315.05; and

(d) the Use of Colour Photographs or other Illustrations

as Health Warnings on Tobacco Products Regulations -

S.L.315.08,

are hereby revoked without prejudice to anything done or omitted to

be done thereunder.