1

Proposal for Law No 322 /XII

Exhibition of Motives

Tobacco consumption is today the first preventable cause of illness and premature death,

contributing to six of the eight major causes of death verified annually in all

the world. According to the World Health Organization they die, per year, about 6 million

of people as a result of consumption and exposure to tobacco smoke, of which about

700000 in the European Union.

In Portugal, the consumption of tobacco is, too, the first cause of morbidity and

preventable mortality, estimating that it contributes to the deaths of more than 10000 people

per year.

In the sense of creating global conditions to prevent and control tobacco consumption, the

World Health Organization promoted the negotiation of a Framework Convention for the

Tobacco Control, which came to be approved at the 56 th World Health Assembly, in 21

of May 2003 (Table Convention). This Convention was signed by Portugal in 9 of

January 2004, having been approved by the Decree No. 25-A/2005 of November 8.

Law No. 37/2007 of August 14, gave implementation to various provisions of the Convention-

Framework, and transposed Directive No 2001 /37/CE, of the European Parliament and of the Council, of

June 5, 2001, passing standards for the protection of the citizens of the exhibition

involuntary to tobacco smoke and demand reduction measures related to the

dependence and the cessation of its consumption. Pursuant to the provisions of Article 24 of the Law

n ° 37/2007 of August 14 and in order to allow the appropriate amendments to the

prevention and control of tobacco use, the Directorate General of Health has drawn up a

assessment report of the first three years of the application of the said law.

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This report evidenced the good social acceptance of this law, lost by the majority of the

population as a measure of health protection, as well as their positive impact on the

reduction of tobacco use and reduction of exposure to tobacco smoke from environmental tobacco.

It evidenced, however, the existence of places where the protection of smoke exposure

environmental is not properly acautelated, as well as the difficulty of scrutinizing the

compliance with the ventilation requirements in the spaces where smoking is allowed.

Workplaces and other indoor public spaces where smoking is allowed

constitute an important source of exposure to tobacco environmental smoke, main

preventable pollutant from indoor air, currently considered by the World Organisation of the

Health and other international entities as a human carcinogen of group 1, for the

which there is no safe threshold of exposure.

Exposure to tobacco environmental smoke in some places of work may take place from

repeated and continued form throughout the active life, which aggravates the consequences of this

exposure, and may also be a factor of potentiation of other risk factors for the

health and occupational safety. The workers in restaurants, bars, discos and

casinos where you allow to smoke are particularly exposed, and may

present levels of exposure quite higher than those of the general population.

In accordance with Article 8 of the Framework Convention, the Parties " acknowledge being

scientifically proven, unambiguously, that exposure to tobacco smoke causes

diseases, disability and death "and that" Each Party will adopt and implement, in areas of the

state competence in the terms of its domestic law, and will actively encourage, in the

areas in which other skills, adoption and implementation of measures are exercised

legislative, executive, administrative and or other effective, with a view to protecting against the

exposure to tobacco smoke in indoor workplaces, public transport, local

public closed and, where appropriate, in other public places. "

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According to the World Health Organization and the American Society of Heating and Air Conditioning

Engineers , banning the act of smoking in the interior spaces is the only fully effective medium

to control the health risks associated with exposure to tobacco environmental smoke.

The ban on smoking in all catering and beverage establishments contributes

to decrease expenses in ventilation equipment, maintenance expenses of these

equipment and expenditure on energy required for its operation, as well as

to decrease carbon emissions and promote the health of the environment. The option by the

total ban on smoking in these establishments is thus the healthiest option,

ensuring the protection of the health of workers and customers, with lower costs for this

sector.

In order to safeguard investments already carried out, a transitional period is established for the

entry into force of the total ban on smoking, specifically in the establishments of

restoration or beverage that, at the date of the coming into force of the law that results from the present

proposed law, have spaces intended for smokers or are intended solely for

smokers, provided that the requirements set out in Article 5 (5) of the Law have been met

n. 37/2007 of August 14 in its original essay. The maintenance of the permission of

smoking is valid until December 31, 2020.

Considering that exposure to environmental smoke is particularly harmful during the

period of childhood and adolescence, as well as the fact that children do not have any

legal capacity to give your consent to the systematic and prolonged exposure to the

saturated smoke environments, it is necessary to maintain and reinforce effective protection measures,

specifically in schools and other places that welcome children and young people.

In that sense, it promotes a ban on smoking in indoor locations more

comprehensive, decreasing the number of exceptions currently provided for in the law.

There are, however, exceptions to the ban on smoking in certain workplaces

which serve as both a residence or extended accommodation, specifically,

prisons, mental health institutions or homes for elderly people.

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Also in the catering or beverage establishments, among others, they may be

reserved spaces for smokers, provided that they comply with certain requirements and not

possess any service, specifically bar and catering.

Despite these exceptions, workers in these places, as well as users do not

smokers, should be protected from exposure to tobacco environmental smoke, so if

institute more stringent ventilation measures, in the sense of preventing smoking if

spread to the areas for non-smokers.

Following the approval of the Framework Convention as respect Parties, including the Union

European and the Member States, adopted by consensus, during various conferences, a

set of guidelines for the implementation of its provisions. Being that, many of these

provisions, were inserted in Directive No 2014 /40/UE, of the European Parliament and of the

Council of April 3, 2014 on the approximation of the provisions of laws,

regulation and administrative of the Member States with respect to the manufacture,

presentation and sale of tobacco products and related products, which proceeded to the revocation of the

Directive No. 2001 /37/CE, which is now object of transposition.

The alluded Directive No 2014 /40/UE, of the European Parliament and of the Council, of April 3

of 2014, it mainly aims to introduce measures that deter young people from smoking, such as the

use of combined health warnings, with text and imagery, which show and explain

the consequences of smoking in health, and the prohibition of packaging and aromas that

can increase the attractives of these products among consumers.

Given that the combined health warnings are more effective than caveats

that only contain text, they become compulsory in all tobacco products with

combustion.

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The visibility of health warnings on tobacco products is ensured, and the

health warnings pass to cover a significant and visible part of the surface of the

individual packaging and be placed on the two main surfaces of the packaging of the

tobacco products. With respect to tobacco for water pipes (narguilé), which is

often seen as less harmful than traditional tobacco products to

smoking, it becomes covered by this labelling scheme, to prevent the

consumers are misled. To ensure the visibility and effectiveness of these

caveats, are set dimensions and or minimum areas for all warnings of

health, depending on the type of product and format of the packaging.

Individual packaging of tobacco products and their outer packaging shall not

include printed coupons, discounts offers, free distribution, two for the price of one, or

other similar offers that may suggest economic advantages for consumers,

inciting them to the purchase of such products.

The guidelines of the Framework Convention relating to the regulation of the composition of the

tobacco products and the regulation of the information to be provided on the products of the

tobacco, they invite in particular to the suppression of the ingredients that increase the

palatability, create the impression that tobacco products have benefits for health

and are associated with energy and vitality or have dye properties.

Tobacco products with distinctive aromas go on to be prohibited, an

transitional period until May 20, 2020, from the date of the entry into force of the law which

result of the present proposed law for additives used in tobacco products whose

volume of sales in the European Union is more than 3%, as is the case with menthol. The

ban on these distinctive scents, does not completely preclude the use of additives

specific, but obliges manufacturers to reduce the additive or combination of additives, of

mode to which additives stop conferencing a distinctive aroma.

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Certain additives used to create the impression that tobacco products have

health benefits or pose risks to reduced health or increase the

mental surveillance and physical performance, as well as additives that, in their form without

combustion, present cancerous, mutagenic or toxic properties for the

reproduction, or increase the potential to create dependence and toxicity, pass as well

to be banned.

Tobacco products or their packaging may not induce consumers in error,

in particular young people, by suggesting that these products are less harmful. It is, for example,

the case of certain terms or elements, such as the terms "low tar content",

" Light "," ultra-light " , "soft", "natural", "biological", "without additives", "without aromas", " slim ", or

certain names, images or figurative symbols. Other deceptive elements can

include, but the such is not limited, incarts or other additional material, such as labels

adhesives, stickers, brindles, scrapers and covers, or relate to the shape of the

own tobacco product. Certain packaging and tobacco products can also

induce consumers in error when they suggest benefits in terms of weight loss,

attractive appearance, social status, social life or qualities such as femininity,

masculinity or elegance. Thus, the prohibition of reference to this type of reference is hereby established.

elements or allegations.

The indication of the emission levels of tar, nicotine and carbon monoxide in the

individual packaging of cigarettes has proved misleading, which can lead to consumers

to believe that certain types of cigarettes are less harmful than others, so it leaves from

record of the labelling of these products.

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More exhaustive information on ingredients and emissions of products is required

of tobacco to assess their attractiveness, toxicity, or addictive potential of creation,

as well as the health risks associated with their consumption. For this purpose, they are

enhanced the reporting obligations of ingredients and emissions by

manufacturers and importers. Some ingredients pass the record on a priority list to

define by the European Commission, for which strengthened obligations are to be predicted

of communication.

The Framework Convention imposes that the European Union and the Member States fight against

illicit tobacco products, including those that are illegally imported into the Union

European, in the framework of a comprehensive tobacco control policy. In that sense, the

individual packaging of tobacco products go on to have a unique identifier and

security elements, which facilitate the verification of their authenticity and compliance

with the law that results from this proposed law and makes it possible to locate and

follow up on the national territory and the whole of the European Union.

All tobacco products have the potential to cause mortality, disease and

disability. It is, for that reason, necessary to monitor the developments in the field

of new tobacco products. Manufacturers and importers go on to become obliged

to notify new tobacco products, prior to their marketing, in order to be verified

your compliance with the requirements imposed by the law that result from the present proposal

of law, as it deals with products to smoke or from products without combustion.

Electrolytic cigarettes and refills, up to here without specific regulation, go on

regulated by the aforementioned Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014, with the exception of those who, due to their presentation or

function, are covered by the scope of Directive No 2001 /83/CE, of Parliament

European and Council of November 6, 2001, which establishes a Community Code

relating to medicinal products for human use, or Directive No 93 /42/CEE, of the Council,

of June 14, 1993, concerning medical devices.

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Electrolytic cigarettes and refills can pose a health risk when

handled by children. It is therefore necessary to ensure that such products are

safe and inviolable. Attending to that nicotine is a toxic substance and considering

the potential health and safety risks, even for the people to whom not if

is intended for the product, liquids containing nicotine should only be marketed in

electrolytic cigarettes or on refills that meet certain requirements of concentration of

nicotine, safety and quality. It matters to ensure that electro cigarettes are

unbreakable and the proof of stroke during use and padding.

In this sense, these products go on to include an informative brochure with rules of

safety and identification of the manufacturer or importer and to have to comply with certain

labeling rules, specifically the list of ingredients and a health warning,

may not make use of certain claims or contain misleading elements, nor

suggest economic advantages, contain offers of discounts or promotional or be

freely distributed.

Manufacturers and importers of electrolytic cigarettes and refills go on to be obliged

to notify these products and to inform you about your ingredients and possible

contraindications and adverse effects before commercializing them, however, a

transitional period for the products already marketed.

The individual packaging and outer packaging of electrolytic cigarettes and refills not

must include elements or characteristics that swirled that these products are less

harmful than others or aim to reduce the effect of certain harmful components of smoke,

or have revitalizing, energetic, curative, rejuvenating, natural properties,

biological or other health benefits or lifestyle, or have better

biodegradability or environmental advantages, and should bear appropriate information and

sufficient about their safe use, in order to protect human health and safety, and

display a health warning.

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Given that advertising for electrolytic cigarettes and plant-based tobacco for smoking

can induce the consumption of tobacco products, in particular among young people, establish themselves

the total ban on direct and indirect advertising to these products, including the televendas, the

placement of the product in radio or television programmes, advertising in the Internet , well

how of the use of the brands of these products in consumer objects, toys or games of

video.

The use of plant-based tobacco for smoking and electrolytic cigarettes, with or without

nicotine, in certain places may compromise or impede the effectiveness of the ban on

smoking tobacco products at these sites, contributing, on the other hand, to strengthen the

social acceptability of the act of smoking, in particular with children and young people, by the

to establish a ban on its use in all places where smoking is prohibited.

Considering that the plant-based products for smoking release monoxide from

carbon and other harmful substances and that nicotine is toxic and creates dependence, establishes itself

a ban on the sale of herbal products for smoking and electrolytic cigarettes to

less than 18 years and imposes an obligation to check age by resource the element

identiactive in the act of purchasing these products.

Cross-border distance sales and by Internet of tobacco products, from products to

plant base for smoking and electrolytic cigarettes and refills can facilitate access to

tobacco products, plant-based products for smoking and electrolytic cigarettes that

do not comply with the law that is the result of this proposed law. In addition, there is

also a greater risk of access for young people to these products. There is therefore a

risk of debilitating tobacco control legislation, by which the prohibition of the

sales by the Internet and the cross-border distance of tobacco products, from products to

base of plants for smoking and electrolytic cigarettes and refills.

It is established compulsory for the existence of responses in the National Health Service of

support for smoker people who need support to quit smoking.

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In accordance with the guidelines for the application of Article 5 (3) of the Convention-

Table, is established the obligation to affidavit of an absence of conflict of interest with the

avoidance and control objectives of smoking by the entities or personalities

that integrate the technical advisory group of the tobacco law.

The hearing of the National Consumption Council was promoted.

Thus:

Under the terms of the paragraph d ) of Article 197 (1) of the Constitution, the Government presents to the

Assembly of the Republic the following proposal for a law:

Article 1.

Object

1-A This Law proceeds from the first amendment to Law No. 37/2007 of August 14, which

approves standards for the protection of citizens from involuntary exposure to smoke from the

tobacco and demand reduction measures related to addiction and cessation

of your consumption.

2-A This Law further transposes to the internal legal order to Directive No 2014 /40/UE,

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

of the laws, regulations and administrative provisions of the Member States in the

respect to the manufacture, presentation and sale of tobacco products and related products and

repealing Directive No 2001 /37/CE, as well as the Delegated Directive

n ° 2014 /109/UE of the Commission of October 10, 2014 amending Annex II to the

Directive No 2014 /40/UE of the European Parliament and of the Council establishing a

library of illustrated warnings to be used in tobacco products.

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Article 2.

Amendment to Law No. 37/2007 of August 14

Articles 1, 2, 3, 5, 8, 10, 11, 12, 13, 14, 16, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18

19, 21, 22, 26, 27, 27 and 28 of the Law No. 37/2007 of August 14, passes

next essay:

" Article 1.

[...]

1-A This Law sets out standards for the prevention of smoking, in

particular with regard to the protection of exposure to environmental smoke from the

tobacco, the ingredients and emissions of tobacco products, to the information

to provide on these products, to the labelling and packaging of products of the

tobacco, to the ban on the marketing of tobacco for oral use, to sales to

cross-boundary distance of tobacco products, to the obligation of notification

of new tobacco products, the marketing and labelling of certain

products related to tobacco products, awareness and education

for health, the prohibition of advertising in favour of tobacco, promotion and

sponsorship, to the demand reduction measures related to the

dependence and cessation of consumption, on sale to minors and through

automatic means, so as to contribute to the decrease in risks or

negative effects that the use of tobacco brings to the health of individuals.

2-A This Law gives still implementation to the provisions of the Framework Convention of the

World Health Organization for Tobacco Control, approved by the

Decree No 25-A/2005 of November 8 and transposes to the legal order

internal to Directive No 2014 /40/UE, of the European Parliament and of the Council,

of April 3, 2014, the Commission Delegated Directive No 2014 /109/UE of the Commission of

October 10, 2014, and the Directive No 2003 /33/CE, of Parliament

European and the Council of May 26, 2003.

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Article 2.

[...]

For the purposes of this Act, it shall be understood by:

a) "Additive", a substance, with the exception of tobacco, which is added to

a tobacco product, to an individual packaging or to any

outer packaging;

b) "Combined Health Warning", a predicted health warning

in this Law and which consists of a combination of a warning

in text and of the corresponding photograph or illustration;

c) "Health Warning", a warning about the adverse effects of

a product in human health or other unintended consequences of the

its consumption, including the warnings in text, the warnings of

combined health, the general caveats and the messages

informations;

d) "Tar", the condensate of anhydrous and nicotine-free gross smoke;

e) "distinctive aroma", an odor or taste clearly perceivable that not

be of tobacco, resulting from an additive or a combination of

additives including, but not limited to, fruit, spices, herbs

aromatic, alcohol, rebued, menthol or vanilla, and which is found

before or during the consumption of the tobacco product;

f) "Aromatizing", an additive that transmits an odor and or a flavor;

g) "Exchange", a wrapping tobacco packaging, wants in the form of

rectangular bag with aba that covers the opening, whether in the form of

flat bottom bag;

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h) "Charuto", a roll of tobacco that can be consumed through a

combustion process and defined in more detail in the Code of

Excise Tax, approved by the Decree-Law

n. 73/2010 of June 21;

i) "Cicrilha", a cigar with a maximum weight of 3 g per unit;

j) "Cigarette", a roll of tobacco that can be consumed through a

combustion process and defined in more detail in the Code of

Excise Tax, approved by the Decree-Law

n. 73/2010 of June 21;

k) "Electronic Cigarette", a product that can be used for

consume steam that contains nicotine, by bokedown, or

any component of that product, including a cartridge, a

reservoir and the device without cartridge or reservoir, and may

electrolytic cigarettes being disposable or rechargeable through a

recharge and a reservoir, or recharged by cartridge do not

reusable;

l) "Marketing", the provision of products,

regardless of their place of manufacture, to consumers

located in the national territory, with or without payment, inclusive

through distance selling, being that in the case of distance selling

cross-border, it is considered that the product is marketed in the country

where the consumer is found;

m) "Consumer" means a natural person who attests for purposes other than if

include in the scope of their business activity, industrial, handcrafted or

professional;

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n) "Outer Packaging", any packaging in which the products of the

tobacco or related products are placed on the market and that includes

an individual packaging or set of packaging

individual, not being the transparent cashless invoses considered

as outer packaging;

o) "Individual packaging", the smallest individual packaging of a

product of tobacco or an end product that is placed on the market;

p) "Emissions", substances that are released when a product of the

tobacco or afim product is consumed according to the purposes

anticipated, such as substances contained in smoke or substances

released during the process of the use of tobacco products without

combustion;

q) "Establishment retailer", any establishment where they are

marketed tobacco products, including by a person

singular;

r) "Manufacturer" means the natural or collective person who fabrique a product

or make you conceive or manufacture, and market it in your name or under

your trade mark;

s) "Smoking", the consumption of tobacco products, with the exception of

non-combustion tobacco products, the consumption of products at the base

of plants for smoking or the use of electrolytic cigarettes;

t) 'Environmental Smoke', smoke released into the atmosphere coming from the

combustion of tobacco products;

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u) "Importer of tobacco products or related products", the owner

or the person who enjoys the right to dispose of the tobacco products and

of the related products that were introduced into the national territory,

coming from another Member State, or from a country or territory

third, as such defined in the Code of Special Tax of

Consumption, approved by Decree-Law No. 73/2010, of June 21;

v) "Ingredient", tobacco, an additive, as well as any substance or

element present in a product of finished tobacco or in a product

afim, including paper, filter, paints, capsules and adhesives;

w) [ Previous Article g )];

x) [ Previous paragraph h )];

y) [ Previous point I )];

z) "Maximum level" or "maximum emission level", the content or the issue

maximum, including a value equal to zero, of a substance in a

tobacco product, measured in milligrams;

aa) "New tobacco product", a tobacco product that:

i) Does not belong to any of the following categories: cigarettes,

enrolling tobacco, tobacco for pipe, tobacco to pipe

of water, cigars, cigarillos, chewing tobacco, rapé or tobacco

for oral use; and

ii) It is commercialized after May 19, 2014.

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bb) "Potential to create dependence", the pharmacological potential of a

substance of creating dependency, a state that affects the ability to

an individual controlling his / her behaviour, usually by

offer a reward effect or a relief from the symptoms of

deprivation, or both;

cc) "plant-based product for smoking", a product on the basis of

plants, aromatic herbs or fruits that does not contain tobacco and may be

consumed through a combustion process;

dd) "Product of tobacco without combustion", a tobacco product that does not

involves a combustion process, including chewing tobacco, rapé

and tobacco for oral use;

ee) "Tobacco products", products that can be consumed and which are

constituted, even if partially, by tobacco, genetically

modified or not;

ff) "Tobacco products for smoking", a tobacco product, except the

products of tobacco without combustion;

gg) 'Advertising to tobacco', any form of communication made by

entities of a public or private nature, in the framework of an activity

commercial, industrial, handcrafted or liberal, with the direct goal or

indirect of promoting, a product of tobacco or its consumption;

hh) "Rapé", a product of tobacco without combustion that can be

consumed by nasal route;

ii) "Refill", a container with liquid that contains nicotine, which can

be used to recharge an electrolyte cigarette;

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jj) "Recinto closed", all space fully delimited by walls,

walls or other surfaces and endowed with a cover;

kk) "Service of the information society", any service provided to the

distance, by electronic way, upon individual request of a

recipient of services and against payment of a price, on the terms

of Decree-Law No. 7/2004 of January 7, as amended by the Decree-Law

n ° 69/2009 of March 10 and Law No 46/2012 of August 29;

ll) [ Previous point p )];

mm) "Tobacco", the leaves and other natural parts, processed or not

transformed, from the tobacco plant, including expanded tobacco and

reconstituted;

nn) 'Rolling tobacco', tobacco that can be used to make cigarettes

by consumers or by retail outlets;

oo) "Chewing Tobacco", a product of tobacco without combustion

intended exclusively to be mastered;

pp) "Tobacco to pipe", tobacco that can be consumed through

a combustion process and intended exclusively to be

used in a pipe;

qq) "Tobacco to pipe water", a tobacco product that can be

consumed through water pipe (narguilé), considering,

for the purpose of the provisions of this Law, which tobacco to pipe

of water is a tobacco product to smoke, save if the product is

usable both in water pipes and curing tobacco, case

where it is considered that it is tobacco to curl;

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rr) "Tobacco for oral use", all tobacco products for oral use,

with the exception of those intended to be inhaled or masched, constituted

fully or partially by tobacco, in the form of powder or particulate matter

finishes or any combination of these forms, namely those that

they present themselves in individual doses or porous packages;

ss) "Televenda", the diffusion of direct offers to the public, carried out by

tv channels, with a view to the supply of cigarettes or other

products derived from tobacco, from plant-based products to

smoking or electrolytic cigarettes, upon payment;

tt) "Toxicity", the degree to which a substance can cause effects

harmful to the human organism, including effects that occur to

long term, usually by repeated consumption or exposure or

continuous;

uu) "Cross-border distance selling", the distance sales to

consumers in which, at the time they order the product

a retail establishment, the consumer finds himself in a country

other than the one in which the retail establishment is established,

considering that the retail establishment is established

in a country:

i) In the case of a natural person, if the latter has his or her place of

commercial activity in that country;

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ii) In the remaining cases, if the retail establishment has its

social headquarters, its central administration or its place of

commercial activity, including a branch, agency or

any other establishment, in that country.

Article 3.

[...]

The provisions of this Chapter aims to establish limitations on the consumption of

enclosed indoor tobacco intended for collective use of form a

guarantee the protection of exposure to tobacco environmental smoke.

Article 4.

[...]

1-[...]:

a) [...];

b) [...];

c) [...];

d) [...];

e) [...];

f) [...];

g) [...];

h) [...];

i) [...];

j) [...];

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l) In the fun enclosures, in the casinos, bingos, game rooms and other

type of precincts intended for spectacles of a non-artistic nature;

m) [...];

n) [...];

o) [...];

p) [...];

q) [...];

r) [...];

s) [...];

t) [...];

u) [...];

v) [...];

x) [...];

z) [...];

aa) [...];

bb) In any other place where, by determination of the management, of the

administration or other applicable legislation, specifically in

Occupational hazard prevention matter, if it prohibits smoking.

2-[...].

3-The provisions of the preceding paragraphs shall apply to the use of cigarettes

electrolytic with nicotine, i.e. products that can be used for

consume steam by bokeisland, and containing nicotine or

any component of that product.

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Article 5.

[...]

1-Without prejudice to the provisions of the paragraph d ) of paragraph 1 of the previous article, may be

created rooms exclusively aimed at smoker patients in hospitals

and psychiatric services, treatment and rehabilitation centres, units of

internment of addicts and alcoholics, nursing homes and

assisted residences, provided that:

a) Be properly flagged, with dystic affixing in

visible places, in accordance with the provisions of the following article;

b) Have, at the entrance, visible indication of the maximum lotion

permitted, to regulate by porterie to be approved by the members

of the Government responsible for the areas of the economy, the environment and

of health;

c) Be physically separated from the remaining premises or, in the case

of they are located in the interior of buildings, be fully

compartmenttered according to standards to be regulated by

would pore to approve by the members of the Government responsible for the

areas of the economy, the environment and health;

d) They have a ventilation system for the outside with

air extraction that allows for the maintenance of a negative pressure

of at least 5 Pa (Pascal), measured with differential pressostate,

defined in function of the lotation, dimension and location of the room and

autonomous of the general system of climatization of the building, the

regulating by portaria to be approved by the members of the Government

responsible for the areas of the economy, the environment and health.

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2-Without prejudice to the provisions of the previous article, they may be created in the

prison facilities units of accommodation, in cells or shrimps,

for smoker inmates, as long as they meet the requirements set out in the

points c ) and d ) of the previous number, being still admitted to smoking in the areas to

open air.

3-In the places mentioned in the points a ), b ), c ), d ), and ), h ), i ), j ), l ), n ), the ), p ), q ), r )

and t ) of paragraph 1 of the preceding Article, as well as in the places mentioned in the paragraph

g ) of paragraph 1 of the same article integrating the system of higher education, is

admitt to smoking in the outdoor areas.

4-[...].

5-In the places mentioned in the points j), l), n), (o), (q), and t) of the Article 1 (1)

previous can be reserved spaces for smokers, provided that

comply with the requirements mentioned in the ( a ) a d ) of paragraph 1 and not

possess any service, specifically bar and catering.

6-Access to the places mentioned in the previous number is reserved to larger

of 18 years.

7-In the places mentioned in the paragraph q) of paragraph 1 of the previous article, the spaces

provided for in paragraph 5 may only be constituted in the areas intended for

customers, if these have greater dimension to a limit to be regulated by

would pore to approve by the members of the Government responsible for the areas of

economics, the environment and health

8-In the places mentioned in the paragraph l) of paragraph 1 of the previous article, where there is

practice of games of fortune or chance, the spaces provided for in paragraph 5, only

may be constituted in an area not exceeding 40% of the game rooms.

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9-In the places mentioned in the paragraph p) of paragraph 1 of the previous article may be

reserved floors, lodging units or rooms for smokers,

up to a maximum of 40% of the total respect, occupying contiguous areas or the

totality of one or more floors, provided that they comply with the requirements

mentioned in the points a) a c) of paragraph 1 and have ventilation system or

of extraction from air to the outside that prevents the fume from spreading to the areas

contiguous.

10-[ Previous Article No 9 ].

11-[...].

Article 6.

[...]

1-[...].

2-[...].

3-[...].

4-[...].

5-The dystics must be affixed or glued to be hardly

removable and should be visible from the outside of the establishments.

Article 8.

Maximum emission levels of tar, nicotine, carbon monoxide and other

substances

1-The emission levels of cigarettes marketed or manufactured in

national territory may not be higher than:

a) 10 mg of tar per cigarette;

24

b) 1 mg of nicotine per cigarette;

c) 10 mg of carbon monoxide per cigarette.

2-The Government may fix, through porterie of the member of the Government

responsible for the area of health, maximum emission levels for others

emissions other than those provided for in the previous number, as well as for emissions

of tobacco products other than cigarettes, of which it must be notified

the European Commission.

Article 9.

[...]

1-The emissions of tar, nicotine and carbon monoxide from cigarettes are

measures, respectively, by the standards ISO 4387, ISO 10315 and ISO 8454.

2-A accuracy of the measurements concerning the tar, nicotine and monoxide of

carbon is determined according to ISO 8243.

3-The provisions of the previous figures shall be verified by laboratories of

test accredited by the Portuguese Institute of Accreditation, I.P., on the terms

of Article 3 of the Decree-Law No 81/2012 of March 27 or by the

competent authorities of the other Member States, and may not such

laboratories being held or controlled, directly or indirectly, by the

tobacco industry.

4-A list of the laboratories accredited by the Portuguese Institute of Accreditation,

I.P., is disclosed on the electronic site of that Institute and by this communicated to the

Directorate General of Health, up to January 31 of each year and whenever

occur changes, from it by constying the criteria used for accreditation

of each and the means of monitoring put in place.

25

5-A Directorate General of Health communicates to the European Commission the list of the

laboratories referred to in the previous number, specifying the criteria

used for approval and the means of monitoring put in place,

as well as the changes that occur.

6-The cigarettes are subjected to the measurements, in the laboratories provided for in the

n. 3, by the manufacturer or by the importer of tobacco products, which is

responsible for the respects charges.

7-The provisions of this Article shall apply, with the necessary adaptations,

at the emission levels referred to in paragraph 2 of the preceding Article.

8-[ Revoked ].

9-[ Revoked ].

10-[ Revoked ].

Article 10.

Priority list of additives and enhanced communication obligations

1-In addition to the communication obligations provided for in the previous article, they are

subject to enhanced communication obligations the additives contained in

cigarettes and enrolling tobacco that are listed on a priority list

established in accordance with the procedures set out in accordance with paragraph 1

of Article 6 and Article 25 of the Directive No 2014 /40/UE of the Parliament

European and the Council of April 3, 2014.

2-The manufacturers and importers of cigarettes and tobacco to enroll that

contain an additive that is conspicuous from the priority list provided for in the number

previous must do circumstantial studies to examine whether each

of the additives:

26

a) Contributes to the toxicity or addictive potential of products

in cause, and whether it has the effect of increasing toxicity or potential of

dependence on any of the products in question, to a degree

significant or measurable;

b) Results in a characteristic aroma;

c) Facilitates the inhalation or absorption of nicotine; or

d) Results in the formation of substances with carcinogenic properties,

mutagenic or toxic for reproduction, the quantities of these

substances, and whether that fact has the effect of increasing the properties

carcinogenic, mutagenic or toxic for the reproduction of any

of the products in question, to a significant extent or measurable degree.

3-The studies referred to in the preceding paragraph take into account the end to which if

are intended for the products concerned and examine, in particular, emissions

resulting from the combustion process in which the additive is involved in

cause, as well as the interaction of this additive with other ingredients

contained in the products in question, joint studies may be carried out

by manufacturers or importers using the same additive in their

tobacco products, provided that such an additive is used in a composition

comparable to the product.

4-The manufacturers or importers draw up a report on the results

of the studies provided for in the previous figures, which should include a summary

and a circumstantial compilation of the scientific literature available on

this additive and a summary of the internal data on the effects of the additive, and

presentam-no, within 18 months after the additive in question has been

included in the priority list referred to in paragraph 1, the Directorate General of Health and the

European Commission, and may by these be required information

supplementary, to be integrated into the report.

27

5-A The European Commission and the Directorate General of Health may apply for the

report to which refers to the previous number is object of revision by a

independent scientific body, in particular with regard to its

completeness, methodology and conclusions.

6-By the review of the report referred to in paragraph 4 are due fees, on the part of the

manufacturers and importers of tobacco products, to be fixed by porterie of the

members of the Government responsible for the areas of finance and health.

7-Small and medium-sized enterprises, in the acetation of Decree-Law No. 372/2007, of

November 6, as amended by Decree-Law No. 143/2009 of June 16,

shall be exempt from the obligations set out in this Article, if the report

on the additive in question is drawn up by another manufacturer or

importer.

Article 11.

General provisions

1-Each individual packaging of tobacco products and each packaging

exterior must present the health warnings provided for in the present

chapter, in Portuguese language, which must cover the entire surface of the

individual packaging or outer packaging that is reserved to you, no

may be commented on, paraphrased or referred to.

2-The health warnings in an individual packaging and in any

exterior packaging must be immovable in an immovable, indelible and

perfectly visible.

28

3-The health warnings in an individual packaging and in any

exterior packaging cannot be partially or fully concealed or

separated by special stacks, price marks, elements of

safety, casing, bags, wallets, boxes or other elements when

tobacco products are marketed, nor can they dissimulate or

separate, in no way, special stacks, price marks, brands of

location and follow up or safety elements in packaging

individual.

4-In the individual packaging of tobacco products other than cigarettes and

enrolling tobacco in fellowships, health warnings can be affixed

by means of stickers, as long as these are unremovable.

5-Health warnings must remain intact when the packaging

individual is opened, with the exception of the packs with articulated soft aba,

case in which the health warning can be divided when the packaging

is open, but only in a way that ensures graphic integrity and

visibility of the text, photographs and help information to be let out of smoking.

6-The dimensions of the health warnings provided for in Articles 11-A, 11.

and 11.-C are calculated in relation to the surface in question when the

packing is closed.

7-The health warnings are surrounded by a black frame with 1 mm of

width inside the surface reserved to these caveats.

8-To images of individual packaging and from any outer packaging

for advertising purposes are applicable to the rules of this Chapter.

9-[ Revoked ].

10-[ Revoked ].

11-[ Revoked ].

29

Article 12.

Appearance and content of individual packaging

1-Individual packagings of cigarettes must have parallelepipedic form.

2-The individual packaging of curling tobacco must have shape

parallelepiped, cylindrical or bag-like.

3-Individual packaging of cigarettes must contain at least 20

cigarettes.

4-The individual wrappers of curling tobacco must contain at least

30 g of tobacco.

5-Individual packagings of cigarettes may be cardboard or material

soft, without the opening could ever be closed or sealed after

open for the first time, with the exception of the articulated soft and the box

with articulated lid, being that, for the latter, the aba and the lid are

articulated only on the back of the individual packaging.

Article 13.

Presentation of the product

1-A labelling of individual packaging and any packaging

exterior, as well as the tobacco product itself, cannot include any

element or characteristic, constant of texts, symbols, assignments,

trademarks, figurative signs or others, which:

a) Promote a tobacco product or encourage your consumption

creating an erroneous impression as to their characteristics,

effects on health, risks or emissions, not the labels

include no information on the nicotine content, tar or

carbon monoxide from the tobacco product;

30

b) Suggest that a particular tobacco product is less harmful

that others or aims to reduce the effect of certain harmful components

of smoke or that it has revitalizing, energetic properties,

curative, rejuvenating, natural, biological, or other benefits

for health or lifestyle;

c) If it refers to the taste, odor, any flavor or other additives

or to their absence;

d) If you resemble a food product or a cosmetic; or

e) Suggest that certain tobacco product has better

biodegradability or present other environmental advantages.

2-Individual packaging and any outer packaging cannot,

through texts, symbols, assignments, trade marks, signs

figurative or other, suggest economic advantages by means of coupons

printed, offers of discounts, free distribution, two for the price of one,

or other similar offers.

Article 14.

Tobacco for oral use

The marketing of tobaccoes for oral use is prohibited.

Article 15.

Ban on sale of tobacco products, from plant-based products to smoking and from

electro cigarettes

1-The sale of tobacco products, from plant-based products is prohibited

for smoking and electrolytic cigarettes:

31

a) In the places referred to in points a ), d ), and ), f ), g ), h ), i ), r ), v ), aa )

and bb ) of Article 4 (1) and in the facilities referred to in paragraph 1 m )

of the same article;

b) [...];

c) To minors under the age of 18, to be substantiate through the

display of identifiable document with photography;

d) Through all distance selling techniques, specifically

of means of televenda and Internet .

2-A prohibition referred to in para. c ) of the preceding paragraph shall appear on notice

printed in easily readable characters, on contrasting background, and

posted in a visible manner at the places of sale of tobacco products, from

herbal products for smoking and electrolytic cigarettes.

3-[...].

4-[ Revoked ].

Article 16.

[...]

1-[...].

2-[...].

3-[...].

4-[...].

5-Free distribution or promotional sale of products of the

tobacco or any consumer goods, which they target, or have by effect

direct or indirect, the promotion of these tobacco products or their

consumption.

32

6-[...].

7-[...].

8-[...].

9-[...].

10-The audiovisual commercial communication, provided for in the Act, is prohibited

no 27/2007 of July 30, as amended by the Laws No 8/2011 of April 11, and

40/2014, of July 9, to tobacco products.

11-The provisions of this Article shall apply to plant-based products

to smoke.

Article 17.

[...]

1-[...].

2-[...].

3-[...].

4-The provisions of this Article shall apply to plant-based products

to smoke.

Article 18.

[...]

1-[...].

2-[...].

3-[...].

4-The provisions of this Article shall apply to plant-based products

to smoke.

33

Article 19.

[...]

Campaigns or other initiatives promoted or sponsored are prohibited

by the producing companies, distributors, subsidiaries or related products, of products

of tobacco and plant-based products for smoking, which they target, direct or

indirectly, the information and prevention of smoking.

Article 21.

[...]

1-intensive support consultations should be set up for smoking cessation in

all groupings of health centres and hospitals of the National Service

of Health, specifically in the services of cardiology, pneumology,

psychiatry and obstetrics, in the institutes and services of oncology, in hospitals

psychiatric and at the centers of care for alcoholics and

addictions.

2-Whenever the dimension of services and the population served does not justify

the creation of an intensive support consultation to the smoking cessation, must be

established protocols with other intensive cessation-intensive consultations

tabagic available in other groupings of health centres or hospitals

of the National Health Service, so as to ensure the appropriate access of the

smokers who will need this type of support to quit smoking.

Article 22.

[...]

1-[...].

34

2-The advisory technical group, designated by dispatching the director-general of the

Health, it is constituted, parity, by representatives of the Administration

Public and civil society, and, as to this, in particular of orders

professionals in the area of health, trade union and employer associations, de

scientific societies, as well as by personalities of recognized merit

in the field of prevention and control of smoking.

3-The persons referred to in the preceding paragraph shall declare the absence of

any conflict of interest with the objectives of the technical group

advisory, in the field of prevention and control of smoking.

Article 25.

[...]

1-[...]:

a) From 50 a to € 750, for the smoker who fumes at the places to which alludes

the points a ) a bb ) of Article 4 (1) and (2) or outside the areas

outdoor or from the areas for smokers provided for in the n. 1 a to 5 and 7

is 10 of Article 5;

b) [...];

c) From € 2500 a to € 10000, for entities referred to in the preceding paragraph

violating the provisions of paragraphs 1, 2, 4, 5, 6, 7, 9, 9 and 10 of the article

5. and in Article 6;

d) From € 10000 a to € 30000, for infractions to paragraphs 1 a to 7 and 10 of the

article 9, to Article 10 (2) and (4), to paragraphs 1 a to 3 of the article

14.-B, to paragraphs 3, 4, 6 and 8 of Article 14-C, to Article 14-F and to the

n. paragraphs 1, 2 and 4 of Article 14-H, being the reduced value for € 1500

and € 3000, respectively, if the offender is a natural person;

35

e) From € 30000 a to € 250000, for infractions to Article 8 (1),

to paragraphs 1, 2, 3 and 6 of Article 9, to paragraphs 1, 4 and 5 of Article 10, thereof,

to paragraphs 1 a to 8 of Article 11, to Articles 11, 11-B, 11-C, 12.

and 13, to paragraphs 1 a to 6, 8, 10 and 14 of Article 13, to n. 1 and 4 of the

Article 13-B, Articles 14 and 14-A, paragraphs 1 and 2 of Article 14-

C, to Article 14-D, to Article 14--E, to Article 14-G, to paragraphs 1 a

3 of Article 15, and Articles 16, 17, 18, and 19, being the value

reduced to € 2000 and € 3750, respectively, if the offender is

singular person.

2-[...].

3-[...].

4-[...].

5-To the counterordinations provided for in this Law, and in everything as to it if not

find especially regulated, the general regime of the

counterordinations, approved by the Decree-Law No. 433/82, 27 of

October.

Article 26.

[...]

1-In the case of the counterordinations provided for in points c ), d ) and and ) of paragraph 1 of the

previous article, ancillary sanctions may still be applied for in the

n Article 21 (1) of the general regime of the counterordinations, approved by the

Decree-Law No. 433/82 of October 27.

2-[...].

36

Article 27.

[...]

1-For the payment of the fines in which the agents of the

infractions to the provisions of Article 8 (1), in Article 9 (6), para. 1

a 7 and 10 of Article 9, in Article 10 (2) and (4), in paragraphs 1, 4 and 5 of the

Article 10, paragraph 1 a to 8 of Article 11, in Articles 11-A, 11-B, 11-C,

12 and 13, in paragraphs 1 a to 6, 8, 10 and 14 of Article 13-A, in paragraphs 1 and 4 of the

article 13-B, in Article 14, in paragraphs 1 a to 3 of Article 14-B, in paragraphs 1 a to 4, 6

and 8 of Article 14-C, in Articles 14-D, 14--E, 14.-F and 14.-G and in paragraphs 1,

2 and 4 of Article 14-H, are jointly and severally liable to the manufacturer and the

importer of tobacco products.

2-For the payment of the fines in which the agents of the

infractions to the provisions of the paragraph b ) of Article 15 (1) and in paragraph 2 of the

article 16, they are jointly and severally responsible the owner of the machine of

automatic sale of tobacco and the one that has the effective direction of space

in which the equipment is installed.

3-For the payment of the fines in which the agents of the

infractions to the provisions of Article 17, are jointly and severally liable to

manufacturer or importer and the owner of the places or the holders of the

exploration where these products are made available, in an onerous manner

or free.

4-For the payment of the fines in which the agents of the

infractions to the provisions of the paragraph d ) of Article 15 (1), in paragraphs 1, 5, 6, 8,

9, 10 and 11 of Article 16 and in Article 19, are jointly and severally liable to

advertiser, the professional, the advertising agency or any other

entity that exerts the advertising activity, the holder of the advertising support

or the concessionary respect, as well as any other intervener in the

issuance of the advertising message.

37

5-For the payment of the fines in which the agents of the

infractions to the provisions of Article 18, are jointly and severally liable to

sponsor entity and the sponsoring entity.

6-Entity holders of the advertising support used or the respect

concessionary eximem from the liability referred to in paragraph 4, case

demonstrem have not had prior knowledge of the advertising message

broadcast.

Article 28.

[...]

1-Without prejudice to the competences assigned by Article 7 to the authorities

administrative and police officers, the supervision of the provisions of this Law shall compete

to the Food and Economic Security Authority, except for the

monitoring of the matters relating to the publicity provided for in paragraph d ) of the n.

1 of Article 15, in Article 14-and, in Article 16 (1), paragraph 1 of the article

18. and in Article 19, which competes with the Consumer General Directorate.

2-[...].

3-It is up to the inspector-general of the Food and Economic Safety Authority

and to the director-general of the Consumer General Directorate, as per the case

applicable, the application of the fines and ancillary sanctions, which of them

give knowledge to the Directorate General of Health.

4-[...]:

a) [...];

b) 40% for the entity that instructed the process and applied the fine;

c) [ Repealed ]. "

38

Article 3.

Amendment to Annex II to Law No 37/2007 of August 14

Annex II to Law No. 37/2007 of August 14 is to have the wording set out in Annex I to the

present law and of which it is an integral part.

Article 4.

Addition to Law No. 37/2007 of August 14

They are deferred to Law No. 37/2007 of August 14, Articles 9-A, 10.-A, 11.-B, 11

11.-C, 13.-A, 13.-B, 14.-A, 14.-B, 14.-C, 14.-D, 14.-F, 14.-G, 14.-F, and 14.

29.--A, with the following essay:

" Article 9.

Communication of ingredients and emissions

1-The manufacturers and importers of tobacco products present to the

Directorate of Health, prior to its marketing, the following

information, by brand and by type:

a) A list of all ingredients, and respect quantities,

used in the manufacture of tobacco products, by order

descending the weight of each ingredient included in the products of the

tobacco;

b) The emission levels referred to in Article 8;

c) Information on other emissions and their levels, should these

there are, in this case, the methods of

measurement of the emissions used.

39

2-The manufacturers and importers of tobacco products shall also

communicating to the Directorate General of Health any change to the composition of

a product that affects the information provided under this article.

3-A list of ingredients referred to in para. a ) of paragraph 1:

a) Indicates the status of ingredients, including whether these have been registered

under Regulation (EC) No 1907/2006 of Parliament

European and Council, of December 18, 2006, as well as the

respects classification under Regulation (EC) No 1272/2008,

of the European Parliament and of the Council of December 16, 2008;

b) It is accompanied by the relevant toxicological data on the

ingredients, with or without combustion, as appropriate,

mentioning, in particular, their effects on the health of the

consumers, particularly the risk of creation of dependency;

c) It is accompanied by a statement that exposes the reasons for inclusion

of these ingredients in the tobacco products concerned;

d) It must still be accompanied by a technical document with a

general description of the additives used and their properties, in the case

of the cigarettes and the rolling tobacco.

4-Whenever the Directorate General of Health determines it, the manufacturers or

importers of tobacco products should carry out studies, in order to

assess the effects of ingredients on health, taking into account,

notably, the potential to create dependence and toxicity, owing

these bear the respects burdens.

40

5-The manufacturers and importers of tobacco products must submit to the

Directorate-General for Health internal and external studies that they have

about the market and the preferences of various consumer groups,

including young people and current smokers, in respect of ingredients and

emissions, as well as summaries of any market studies leading to

cable when launching new products.

6-The manufacturers and importers of tobacco products must still

communicating to the Directorate General of Health, annually, by September 30 of

each year, the sales volumes, discriminated by brand and by type,

expressed in number of cigarettes, cigarillos or cigars or in

kilograms, and by country of the European Union.

7-All data and information to be submitted under this article and

of the following article are communicated in an electro-format, to be defined by

would pore from the member of the Government responsible for the area of Health, owing

such information being electronically conserved and kept accessible to the

European Commission and the Member States, with respect to secrecy

commercial and other confidential information.

8-The format for presentation and making available to the public of the information

referred to in this article and in the following article is defined and, if necessary,

updated, in accordance with the procedures set out in the terms of paragraph 5

of Article 5 and Article 25 of the Directive No 2014 /40/UE of the Parliament

European and the Council of April 3, 2014.

9-A The Directorate General of Health ensures the dissemination, on its website,

of the data presented in accordance with paragraph 1 and the following article, having in

account, where appropriate, the information that constitutes secrecy

commercial and that for this have been specified by the manufacturer or

importer of tobacco products.

41

10-For tobacco products that are already being marketed at the date of

entry into force of this Law, the communication referred to in paragraph 1 shall

be done until November 20, 2016.

11-For the payee, conservation, treatment, analysis and publication of the information

provided for in this article are due fees, by manufacturers and

importers of tobacco products, to be fixed by porterie of the members of the

Government responsible for the areas of finance and health.

Article 10-The

Regulation of ingredients

1-The marketing of tobacco products with an aroma is prohibited

distinctive, not understanding itself as such the use of essential additives

for the manufacture of tobacco products, provided that these additives do not result

in a product with distinctive aroma and do not increase for the products of the

tobacco, in a significant or measurable degree, the toxicity, the potential of

creation of dependence or the carcinogenic, mutagenic properties or

toxic to reproduction.

2-A The Directorate General of Health may request the European Commission to

determine whether a tobacco product is covered by the scope

of paragraph 1 or consult the independent advisory panel established at the level

of the European Union prior to taking action in application of paragraph 1.

3-The rules regarding procedures for determining whether a product of the

tobacco is covered by the scope of paragraph 1 are defined from

agreement with the procedures set out in accordance with Article 7 (3) and

of Article 25 of the Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014.

42

4-The marketing of tobacco products containing the

following additives:

a) Vitamins or other additives that create the impression that a

tobacco product has health benefits or poses risks

reduced to health;

b) Caffeine or taurine or other additives and stimulant compounds

associated with energy and vitality;

c) Additives that confer colour on emissions;

d) For tobacco products to smoke, additives that facilitate the

inhalation or the absorption of nicotine; or

e) Additives which, in their form without combustion, have properties

carcinogenic, mutagenic or toxic for reproduction.

5-The marketing of tobacco products containing

flavourings in their components, such as filters, papers, packaging,

capsules or any technical characteristics that allow to modify the

odor or the taste of the tobacco products in question or the intensity of their

smoke, being that the filters, papers and capsules should not contain tobacco

or nicotine.

6-Tobacco products shall apply to the provisions and conditions

established under the Regulation (EC) No 1907/2006, of the

European Parliament and of the Council of December 18, 2006, as per

suitable.

43

7-On the basis of scientific data, the marketing of

tobacco products containing additives in quantities that increase

to a significant degree or measurable effect the toxic effect or dependence of

a product of tobacco or the carcinogenic, mutagenic properties or

toxic to the reproduction in the consumption phase, in terms to be defined by

would pore from the member of the Government responsible for the area of health.

8-A Directorate General of Health notifies the European Commission of the measures that

take in application of the previous number.

9-A The Directorate General of Health may request the European Commission to

determine whether a tobacco product is covered by the scope

of paragraph 7.

10-To tobacco products other than cigarettes and curl tobacco not if

applies the prohibitions provided for in paragraphs 1 and 7.

11-The manufacturers and importers of tobacco products bear the

charges required for assessment if a tobacco product has a

distinctive aroma, whether additives or forbidden aromas are used and if a

tobacco product contains additives in quantities that increase in grade

significant and measurable the toxic effect or dependence of the product of the

tobacco in cause or its carcinogenic, mutagenic properties or

toxic to reproduction.

Article 11-The

General warnings and informative messages in tobacco products for smoking

1-Each individual packaging and each outer packaging of products from the

tobacco to smoke should present the following general warning:

"Smoking kills-leave already".

44

2-Each individual packaging and each outer packaging of products from the

tobacco for smoking must present the following informative message:

" Tobacco smoke contains more than 70 causative substances from

cancer. "

3-A general warning and the informative message referred to in the numbers

previous must be:

a) Printed on black body Helvethics on white background, in

lowercase, with the exception of the first letter and the requirements

grammaticals, and with the size of letter that ensures that the text occupies

as much space as possible from the reserved surface for general warning

and the informative message;

b) Placed in the centre of the surface that is reserved to them and, in the

parallelepipedic packaging and in any outer packaging,

parallel to the lateral edge of the individual packaging or packaging

exterior.

4-In the packs of cigarettes as well as in the wrappers of rolling tobacco,

with parallelepipedic shape, the general warning should appear in the part

lower than one of the side surfaces of the individual packaging and the

informative message at the bottom of the other side surface, owing

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

5-In the packs with a box shape with an articulated lid, where the

side surfaces split into two parts when the packet is opened, the

general warning and the informative message should appear in its entirety

on the largest of these dividing surfaces, owing to the general warning

figure also on the inside of the upper aba which is visible when the

pack is open and not the side surfaces of this type of maço have

a height of less than 16 mm.

45

6-In the case of enrolling tobacco, the general warning and informative message

they must cover 50% of the surfaces in which they are printed, and shall appear:

a) On surfaces that ensure the full visibility of these

health warnings, in terms of establishing according to the

procedures as set out in Article 9 (6) and Article 25 of the

Directive No 2014 /40/UE, of the European Parliament and of the Council, of

April 3, 2014, if curing tobacco is commercialized in

bags;

b) On the outer surface of the cover of the packaging, for the warning

general, and on the inner surface of the cover of the packaging, for the

informative message, if the enrolling tobacco is marketed in

cylindrical packaging.

Article 11-B

Combined health warnings for tobacco products to smoke, including cigarettes,

enrolling tobacco and tobacco to water pipe

1-Each individual packaging and each outer packaging of products from the

tobacco to smoke, including cigarettes, curling tobacco and tobacco to

water pipe, must present combined health warnings, which

include one of the text caveats and a corresponding photograph a

colours, set out in Annex II to this Law, of which it is an integral part.

2-The combined health warnings are grouped into three series, being

each series used in a given year and in annual rotation, owing each

combined health warning available for use in a

determined year to be ostensed at equal number in each brand of

tobacco products.

46

3-The combined health warnings must present the same

warning in text and the corresponding color photograph in both

sides of the individual packaging and of any outer packaging, figuring

along the top board of an individual packaging and any

outer packaging and being positioned in the same direction as any

other information that figure on that surface of the packaging.

4-The combined health warnings must cover 65% of both faces

front and back external packaging and from any

outer packaging, and the cylindrical packaging shall present two

combined health warnings, equidistant with each other and covering each

health warning 65% of the respect half of the curved surface.

5-In the case of cigarette packs, the combined health warnings do not

may have a height of less than 44 mm and a width of less than 52 mm.

6-The technical specifications for the configuration, conception and format of the

combined health warnings, taking into account the different forms of the

packaging is established in accordance with the defined procedures

in the terms of Article 10 (4) and Article 25 of the Directive

n. 2014 /40/UE, of the European Parliament and of the Council, of April 3 of

2014.

Article 11-C

Labelling of tobacco products without combustion

1-Stay exempt from the obligation to bear the informative message provided for in the

n Article 11 (2) and the combined health warnings provided for in the

article 11-B, tobacco products for smoking, with the exception of cigarettes,

of rolling tobacco and tobacco to pipe water.

47

2-In cases provided for in the preceding paragraph, and in addition to the general warning

provided for in Article 11 (1), each individual packaging and each

exterior packaging of these products should bear one of the caveats

in text listed in Annex II to this Law.

3-A general warning provided for in Article 11 (1)-A, shall include a

reference to support services to quit smoking, such as numbers of

telephone, e-mail addresses and or sites in the Internet intended

informing consumers about the support programs available to

people who want to quit smoking and should figure on the surface

more visible from individual packaging and from any outer packaging.

4-Each warning in text must appear, where possible, in equal

number in each brand of products.

5-In-text caveats feature on the most visible surface following of the

individual packaging and any outer packaging.

6-In the individual packaging with articulated cover, the other surface more

visible next is the one that is visible when the packaging is opened.

7-A The general warning referred to in this article shall cover 30% of the

surfaces of individual packaging and any outer packaging and

figure on the two largest surfaces of the individual packaging and

any outer packaging.

8-A The warning in text referred to in this article shall cover 40% of the

relevant surface of the individual packaging and of any packaging

exterior.

48

9-In the case of the health warnings referred to in this article appear

on a surface greater than 150 cm2, the caveats must cover a

area of 45 cm2.

10-The health warnings referred to in this article comply with the

requirements set out in Article 11 (3).

11-The text of health warnings should be parallel to the main text of the

surface reserved for these caveats.

12-Health warnings are to be surrounded by a black frame of

width not less than 3 mm and not more than 4 mm, that is

frame must appear off the surface reserved for health warnings.

Article 13-The

Traceability

1-All individual packaging of tobacco-marketed tobacco products in

national territory must be marked with a unique identifier, which

must be printed or affixed in an unremovable, indelible manner, not being from

form some concealed or separate, including by special stacks

or price marks, or by the opening of the individual packaging, which allows

determine:

a) The date and place of manufacture;

b) The manufacturing facility;

c) The machine used to manufacture the tobacco products;

d) The production shift or the time of manufacture;

e) The description of the product;

49

f) The targeted retail market;

g) The planned dispatch route;

h) The importer, where applicable;

i) The route of dispatch really travelled, from manufacture to the

first retail establishment, including all warehouses

used, as well as the date of dispatch, the destination of the expedition, the

point of departure and the recipient;

j) The identity of all purchasers, from manufacture to the

first retail establishment; and

k) The invoice, the order number and the payment records of

all buyers, from manufacture to the first

retail establishment.

2-The information referred to in points a ) a g ) from the previous number and, when

applicable, the referred to in para. h ) of the same number, shall be part of the

single identifier, and the information referred to in points (s) i ), j ) and k )

of the previous number being electronically accessible via a link to the

unique identifier.

3-All economic operators involved in the trade in products of the

tobacco, from the manufacturer to the last economic operator before the

first retail establishment, must register the entry of all the

individual packaging in their possession, as well as all movements

brokers and the definitive departure of the individual packaging of their possession,

and such registration may be made by marking and registration of the packaging

aggregated, as long as it continues to be possible to find and follow all the

individual packaging.

50

4-All natural and collective persons involved in the chain of

provision of tobacco products must keep complete records and

exacts of all transactions referred to in this article.

5-Tobacco product manufacturers must provide to all the

economic operators involved in the trade in tobacco products,

from the manufacturer to the last economic operator before the first

retail establishment, including importers, stockpilers and companies

of transport, the equipment necessary for the registration of the products of the

tobacco purchased, sold, stored, transported or handled

in any other way, owing such equipment to be able to read and

transmit the data recorded electronically to a facility of

conservation of data.

6-For the purposes of the provisions of the final part of the preceding paragraph, the manufacturers and

the importers of tobacco products must conclude contracts of

conservation of data with an independent third party, with a view to albergating the

data conservation facility, owing to the conservation facility of

data to be physically located in the territory of the European Union and be

fully available for access by the European Commission, the authorities

competent of the Member States and the external auditor.

7-A suitability of the independent third party referred to in the preceding paragraph,

notably its independence and technical capabilities, well

as the data conservation contract, are approved by the Commission

European.

51

8-The activities of the independent third party must be monitored by a

external auditor, proposed and paid by the tobacco manufacturer and approved by the

European Commission, which is to submit an annual report to the Authority

Tax and Customs and the European Commission, evaluating in particular all

the irregularities in access matters.

9-In duly justified cases, access may be granted by

manufacturers or importers to the retained data, or by the Authority

Tax and Customs as by the European Commission, as long as the

commercially sensitive information remain properly

protected, in accordance with applicable law.

10-Registered data may not be modified or erased by any

economic operator involved in the trade in tobacco products, being

respected legislation regarding the protection of personal data.

11-The technical standards for the creation and operation of the system of

location and follow-up provided for in this article, including marking

with a unique identifier, the registration, the transmission, the processing and the

data conservation and access to the conserved data are approved of

agreement with the procedures set out in accordance with Article 15 (11).

and Article 25 of the Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014.

12-A numbering of the special stampile defined by the Tax Authority and

Customs and provided by the National Press-House of Currency, S. A, may

be used as a unique identifier, including the changes that if

disclose necessary to ensure compliance with the standards and functions

techniques required under Article 15 of the Directive No 2014 /40/UE, of the

European Parliament and of the Council of April 3, 2014.

52

13-The main elements of the data conservation contracts referred to

in paragraph 6, such as its duration, renewal, technical knowledge

necessary or confidentiality, including monitoring and evaluation

regular of these contracts, are defined in accordance with the procedures

defined in the terms of Article 15 (12) and Article 27 of the Directive

n. 2014 /40/UE, of the European Parliament and of the Council, of April 3 of

2014.

14-The provisions of paragraphs 1 a to 10 shall apply to cigarettes and tobacco from enrolling the

departure from May 20, 2019 and to tobacco products other than

cigarettes and curling tobacco as of May 20, 2024.

Article 13-B

Element of security

1-In addition to the unique identifier referred to in the previous article, all

individual packaging of marketed tobacco products must

present an element of inviolable safety, composed of elements

visible and invisible, which shall be imprinted or affixed in an unremovable manner and

indelible and which cannot be dissembled or separated, including by

special stacks and price marks.

2-The technical standards for the safety element and its eventual rotation

are approved in accordance with the procedures set out in the terms of the

n Article 16 (2) and Article 25 of the Directive No 2014 /40/UE, of the

European Parliament and of the Council of April 3, 2014.

53

3-A special stampile defined by the Tax and Customs Authority and

provided by the National Press-House of Currency, S. A, is used as

safety element, owing, to this achievement, to be adapted in a way

comply with the technical standards and functions required by Article 16 of the Directive

n. 2014 /40/UE, of the European Parliament and of the Council, of April 3 of

2014.

4-The provisions of paragraph 1 shall apply to cigarettes and rolling tobacco from enrolling

May 20, 2019 and to tobacco products other than cigarettes and

enrolling tobacco as of May 20, 2024.

Article 14-The

Trade in cross-border distance

1-Border purchases of cross-border distance, by a part of a

consumer established in national territory, from tobacco products, from

herbal products for smoking and electrolytic cigarettes and refills,

taken to a retailer established in another Member State or in a country

or third territory, as such defined in the Code of Special Taxates

of Consumption, approved by the Decree-Law No. 73/2010 of June 21.

Article 14-B

Notification of new tobacco products

1-The manufacturers and importers of new tobacco products must

to notify the Directorate General of Health, in an electro-format and with a

minimum six month notice, of any new tobacco product

that they wish to commercialize on national territory.

54

2-A notification referred to in the preceding paragraph shall be accompanied by a

detailed description of the new tobacco product in question, well

as by the instructions for use and the information regarding ingredients and

emissions, pursuant to Article 9-A, and should still be made available:

a) Scientific studies of which they have about toxicity, potential of

creation of dependence and attractiveness of the new tobacco product,

particularly with regard to ingredients and emissions;

b) Studies and respect summaries and market analyses of which

have them on the preferences of various consumer groups,

including young and current smokers;

c) Other available and pertinent information, including an analysis

of the risks and benefits of the product, its expected effects on

terms of the cessation of tobacco use and the initiation of consumption

of tobacco and predictions about the perceive of consumers.

3-The manufacturers and importers of new tobacco products must

communicating to the Directorate General of Health any new information or

updated on the studies, analyses and other information referred to

previous.

4-A The Directorate General of Health may request additional testing or

the presentation of supplementary information.

5-A The introduction of new tobacco products is subject to the authorisation of the

Directorate-General of Economic Activities, after Opinion of the Directorate General

of Health, in terms to be defined by the porterie of the members of the Government

responsible for the areas of the economy and health.

55

6-By the authorisation process referred to in the preceding paragraph are

charges fees, to be defined by porterie of the members of the Government

responsible for the areas of finance, the economy and health.

7-The new marketed tobacco products must comply with the requirements

provided for in this Law, depending on its framework in the products

of tobacco without combustion or in tobacco products for smoking.

Article 14-C

Electrolytic cigarettes and refills

1-Only electrolytic cigarettes and refills can be marketed that

comply with the requirements set out in this Law, with the exception of cigarettes

electrolytes and refills, which are subject to the provisions of the Decrees-Laws

n. paragraphs 176/2006, of August 30, 36/2007, of February 16, and 145/2009, of

June 17, as amended by the Laws No 21/2014 of April 16, and 51/2014, of

August 25.

2-Electrophic cigarettes and refills must be safe for children, well

as inviolable, unbreakable and the proof of stroke, owing to possess a

mechanism that ensures a padding without stroke.

3-The manufacturers and importers of electrolytic cigarettes and refills must

to notify the Directorate General of Health, in an electro-format and with a

minimum six month notice, of any such products that

intend to commercialize.

4-A notification referred to in the preceding paragraph shall include, depending on the

product be an electrolytic cigarette or a recharge, the following

information:

56

a) The name and contact elements of the manufacturer, of the person

collective or singular responsible and, where appropriate, of the importer

in the European Union;

b) A list of all ingredients contained in the product and the

emissions resulting from their use, by brand and by type,

including respect quantities;

c) The toxicological data on ingredients and emissions from the

product, including when heated, referring, in particular, the

its effects on the health of consumers when inhaled, and having

into account in particular the effect of creation of dependence;

d) Information about the doses and the absorption of nicotine, when

consumed under normal or reasonably foreseeable conditions;

e) A description of the components of the product, including, when

applicable, the mechanism of opening and filling the cigarette

electro and refills;

f) A description of the production process, specifically if this

implies serial production, and a statement that the process

of production ensures that it complies with this Article;

g) A statement that the manufacturer and the importer assume

full responsibility for the quality and safety of the product,

when marketed and used under normal conditions or

reasonably foreseeable.

5-A The Directorate General of Health may require that the information referred to in

previous number are completed, if you consider that the same are not

complete.

57

6-The manufacturers and importers of electrolytic cigarettes and refills must

to make the new notification for each substantial change in the products.

7-A The Directorate General of Health ensures the dissemination, on its website,

of the data presented in the terms of this Article, taking into account,

where appropriate, the information that constitutes commercial secrecy

and that for such an effect have been specified by the manufacturer or

importer of electrolytic cigarette products and refills.

8-For electro-electric cigarettes and refills that are already being marketed

on May 20, 2016, the communication referred to in this Article

must be done within six months , from that date.

9-The format for the notification provided for in this article, as well as the

technical standards for the filler mechanism referred to in paragraph 2,

are set in accordance with the procedures set out in the terms of the

n Article 20 (13) and Article 25 of the Directive No 2014 /40/UE, of the

European Parliament and of the Council of April 3, 2014.

10-By the recetion, conservation, treatment and analysis of the information provided for

in this article are due fees, by manufacturers and importers of

electrolytic cigarettes and refills, to be fixed by porterie of the members of the

Government responsible for the areas of finance and health.

Article 14-D

Ingredients and labelling of electrolytic cigarettes and refills

1-For electrolytic and recharged cigarettes, the liquid containing nicotine must

be manufactured exclusively with ingredients of great purity and:

58

a) Can only be marketed on own refills that do not exceed

a volume of 10 ml, in disposable electrolytic cigarettes or in

non-reusable cartridges, not the cartridges or the

reservoirs exceed a volume of 2 ml;

b) It can contain no more than 20 mg/ml nicotine;

c) It may not contain the additives provided for in Article 10 (4);

d) It may only include other substances, other than the ingredients

constants of the list referred to in point (s) b ) of the Article 4 (4)

previous, in the form of vestiges and if these are technically

unavoidable during manufacture;

e) It can only include, in addition to nicotine, ingredients that do not

constitute a risk to human health in the heated form or

not heated.

2-Electrophic cigarettes should free the doses of nicotine at levels

consistent, under normal conditions of use.

3-The individual packaging of electrolytic cigarettes and refills must include

a booklet with information about:

a) Instructions for use and conservation of the product, including the reference of

that the product is not recommended for young and non-smokers;

b) Contraindications;

c) Warnings for specific risk groups;

d) Possible adverse effects;

e) Potential for creation of addictions and toxicity, and

59

f) Contact elements of the manufacturer or importer and the person

collective or singular to contact.

4-The individual packaging and the outer packaging of cigarettes

electrolytes and refills shall present, in the terms provided for in paragraphs 2 and 3

of Article 11-C, the following health warning:

" This product contains nicotine, a substance that creates strong dependence.

It is not recommended for its use by non-smokers. "

5-The individual packaging and the outer packaging of cigarettes

electrolytic and refills must still contain the list of all ingredients of the

product, by descending order of weight, the indication of the nicotine content of the

product and release by dose, the lot number and a recommendation

in the sense of keeping the product out of the reach of children.

6-The individual packaging and the outer packaging of cigarettes

electrolytic and recharging cannot include the elements or characteristics

provided for in Article 13, with the exception of those provided for in points a ) and c ) from the

n. 1 of the same article, with regard to information on the content of

nicotine and on the flavourings.

Article 14-And

Advertising and sponsorship of electro-electric cigarettes and refills

1-Commercial communication in services of the society of the

information, in the press and other printed publications, that vise or have

by direct or indirect effect the promotion of electrolytic cigarettes and refills,

with the exception of publications intended exclusively for professionals

of the trade in electronic cigarettes and refills, and of the publications that are

printed and published in third countries, if those publications are not

target mainly to the European Union market.

60

2-Commercial communication on radio that is vise or has by effect

direct or indirect the promotion of electrolytic cigarettes and refills.

3-Any form of public or private input is prohibited for

radio programs that target or have either direct or indirect effect to

promotion of electrolytic cigarettes and refills.

4-Any form of public or private input is prohibited for any

event, activity or individual that vise or have by direct effect or

indirect the promotion of electrolytic cigarettes and refills, and which implies or

occur in several Member States or have any other effect

cross-border.

5-Is applicable to electrolytic cigarettes and recharges the provisions of paragraph 10 of the

article 16 and in Articles 17 and 19.

Article 14-F

Communications relating to electrolytic cigarettes and refills

1-The manufacturers and importers of electrolytic cigarettes and refills must

present annually to the Directorate General of Health:

a) Circumstantial data from sales volumes, by brand and by type

of the product;

b) Information about the preferences of the various groups of

consumers, including young people, non-smokers and the main

types of users at the moment;

c) Mode of sale of products; and

d) Syntheses of all market analyses carried out in the fields

constants of the previous points, including their translation in English.

61

2-A Directorate General of Health accompanies market developments

relatively to electrolytic cigarettes and refills, including any

elements that demonstrate that their use is an access route for the

dependence on nicotine and, ultimately, for tobacco use

traditional by young and non-smokers.

3-The manufacturers, importers and distributors of electrolytic cigarettes

or refills must establish and maintain a collection system of

information on all presumed adverse health effects

human of these products.

4-Whenever manufacturers, importers and distributors of cigarettes

electrolytic or recharge consider or have reason to believe that the

electrolytic cigarettes or refills that are in your possession and are

marketed, or as they are intended, are not safe, they are not good

quality or are not complying with this law, they must take

immediately all the corrective measures needed to adapt the

product in question to the provisions of this Law, or to withdraw it or collect it

of the market, as the case may be.

5-In cases provided for in the preceding paragraph, manufacturers, importers and

distributors of electrolytic cigarettes or refills inform of immediate

Food and Economic Security Authority and the Directorate-General of the

Health, indicating, in particular, the risk to human health and safety and

any corrective measures taken, as well as the results of these

measures.

62

6-A Food and Economic Safety Authority, as well as the

Directorate General of Health, may apply to manufacturers, importers and

distributors of electrolytic cigarettes or recharges additional information,

notably on the aspets of safety and quality or the effects

adverts of electrolytic cigarettes or refills.

7-In the case of electrolytic cigarettes and refills complying with the provisions of

this law, and without prejudice to the competences assigned to the entities that

exercise the power of health authorities, if the Safety Authority

Food and Economic to check or have reasonable grounds to believe that

a specific electrolytic or recharged cigarette, or a type of cigarettes

electrolytic or recharged, can constitute a serious health risk

human, may take the appropriate interim measures, and may be

requested to appear to the Directorate General of Health.

8-The measures adopted under the preceding paragraph shall be

immediately communicated to the European Commission and to the authorities

competent of the other Member States, and shall still be communicated

any data in which it is founded.

Article 14-G

Plant-based products for smoking

1-Each individual packaging and each outer packaging of products at the base

of plants for smoking must present the following health warning:

"Smoking this product harms your health"

2-A health warning provided for in the preceding paragraph shall be printed in the

front and rear external surface of the individual packaging and any

outdoor packaging and must comply with the requirements set out in paragraph 3 of the

article 11.

63

3-A health warning should cover 30% of the area of the surface

corresponding of the individual packaging and any outer packaging.

4-The individual packaging and any outer packaging of products à

plant base for smoking cannot include the elements or

characteristics to which the points are referred a ), b ) and d ) of Article 13 (1),

it may not also indicate that the product is free from additives or

flavourings.

Article 14-H

Communication of the ingredients of plant-based products for smoking

1-The manufacturers and importers of plant-based products for smoking

shall present to the Directorate General of Health the list of all ingredients,

and respect quantities, used in the manufacture of such products, by brand and

by type.

2-The manufacturers and importers of plant-based products for smoking

they must also communicate to the Directorate General of Health, and before their

marketing, any change to the composition of a product that affects

the information provided under this article.

3-A The Directorate General of Health ensures the dissemination, on its website,

of the data presented in the terms of this Article, taking into account,

where appropriate, the information that constitutes commercial secrecy

and that for such an effect have been specified by the manufacturer or

importer of plant-based products for smoking.

4-A submission of the list provided for in paragraph 1 shall be made before the

marketing of new plant-based products for smoking.

64

Article 29-The

Provision of information

For the purposes of the provisions of Chapters III, IV-A and IV-B, the obligation to provide

the required information is incumbent on the first instance to the manufacturer, if this

is established in the European Union, to the importer, if the manufacturer is

established outside the European Union and the importer is established in the

European Union, and jointly to the manufacturer and importer, if both

are established outside the European Union. "

Article 5.

Systematic changes

1-Are deferred to Law No. 37/2007 of August 14, Chapter V, with the epiggrafe " Tobacco

for oral use, cross-border distance sales and new tobacco products ", which

integrates Articles 14 to 14-B, as well as Chapter VI, with the epiggrafe " Cigarettes

electrolytic and plant-based products for smoking ", which integrates articles 14-C to

14.-H, being the current chapters V and following renumbered accordingly.

2-The current chapters III, IV and V of Law No. 37/2007, of August 14, go on

next essay, respectively: "Ingredients and emissions", "Labelling and packaging"

and " Sale of tobacco products, from plant-based products to smoking and cigarettes

electronically ".

65

Article 6.

Transient standard

1-Without prejudice to the provisions of the following number, the hotel establishments and others

tourist ventures where accommodation services are provided, as well as the

catering or beverage establishments, including those who own rooms or

spaces intended for dance and the casinos, bingos and game rooms which, at the date of entry

in force of this Law, have spaces intended for smokers or are intended

exclusively to smokers, may retain the permission of full or partial smoking,

provided that the requirements set out in Article 5 (5) of Law No 37/2007 have been fulfilled,

of August 14, in its original essay.

2-A The maintenance of the smoking permission to which the previous number is concerned is valid until 31

of December 2020.

3-Can be marketed until May 20, 2017 the tobacco products labelled in the

the terms of Law No. 37/2007 of August 14 in its original essay, the production of or

import into national territory, as well as its entry into the same territory when

coming from another Member State, occur before May 20, 2016, without

injury to the rules of validity of the special stampile provided for in the Portaria

n. 1295/2007, of October 1.

4-Can be marketed until May 20, 2017 the electrolytic cigarettes or refills,

whose manufacture or import into national territory, as well as its entry into the same

territory when coming from another Member State, occur before 20 of

november 2016, without prejudice to the rules of validity of the special stampile provided for

at the Portaria No. 1295/2007 of October 1.

66

5-Can be marketed until May 20, 2017 the plant-based products for

smoking, whose production or import into national territory, as well as its entry into the

even territory when coming from another Member State, occur before 20 of

may 2016.

6-Until May 20, 2019, the positioning obligation provided for in paragraph 3 of the

article 11-B passes to be:

a) In the case of an individual packaging made of card, the health warning

combined that should feature on the back face is positioned directly below the

special stampile;

b) In the case of individual packaging being made of soft material, it is reserved for the

special stampile a rectangular surface with height not exceeding 13 mm

between the top board of the packaging and the top board of the health warning

combined, it does not owe the marks and the logos to be positioned above the

health warnings.

7-A The list referred to in Article 9 (4) is communicated by the Portuguese Institute of the

Accreditation, I.P., to the Directorate General of Health, within 30 days, from the date of

entry into force of this Law.

Article 7.

Abrogation standard

They are revoked:

a) Paragraphs 8 a to 10 of Article 9, paragraphs 9 a to 11 of Article 11, Article 15 (4) and the

point ( c ) of Article 28 (4) of Law No 37/2007 of August 14;

b) The paragraph 1 of the Resolution of the Council of Ministers No 35/84 of June 11,

amended by Law No. 37/2007 of August 14.

67

Article 8.

Republication

It is republished, in Annex II to this Law, of which it is an integral part, the Act No. 37/2007, of

August 14, with the current essay.

Article 9.

Application in time

The provisions of Article 10-A shall apply from May 20, 2020 in the case of

tobacco products with a distinctive aroma whose sales volumes across the Union

European account for 3% or more of a given product category.

Seen and approved in Council of Ministers of April 23, 2015

The Prime Minister

The Minister of the Presidency and Parliamentary Affairs

68

ANNEX I

(referred to in Article 3)

" ANNEX II

(referred to in Article 11 (1)-B and Article 11 (2) thereof)

1-List of the caveats in text:

a) "Smoking causes 9 in every 10 cancers of the lung"

b) 'Smoking causes cancer of the mouth and throat'

c) "Smoking damages your lungs"

d) 'Smoking causes heart attacks'

e) 'Smoking causes cerebral vascular accidents and incapacities'

f) "Smoking causes the obstruction of the arteries"

g) "Smoking aggravates the risk of blindness"

h) 'Smoking causes lesions in your teeth and gums'

i) "Smoking can kill your child before he is born"

j) 'Your smoke harms your children, family and friends'

k) 'The children of smokers have higher propensity to smoke'

l) "Let it smoke already-think of who likes you"

m) "Smoking reduces fertility"

n) "Smoking aggravates the risk of impotency"

69

2-Photographs in colour-library of images (from health warnings

combined) referred to in Article 11.-B.

Series 1

70

71

Series 2

72

Series 3

73

74

"

75

ANNEX II

(referred to in Article 8)

Republication of Law No. 37/2007 of August 14

CHAPTER I

General provisions

Article 1.

Object

1-A This Law sets out standards for the prevention of smoking, in particular in the

referring to the protection of exposure to environmental smoke from tobacco, ingredients and

emissions from tobacco products, the information to be provided on these products, to the

labelling and packaging of tobacco products, the prohibition of marketing of

tobacco for oral use, to cross-border distance sales of tobacco products, to

obligation to notify of new tobacco products, to marketing and labelling

of certain products related to tobacco products, awareness and education

for health, the prohibition of advertising in favour of tobacco, promotion and sponsorship, to

measures to reduce demand related to dependence and cessation of the

consumption, for sale to minors and through automatic means, so as to contribute to

the decrease in the risks or negative effects that the use of tobacco brings to health

of the individuals.

2-A This Law gives still implementation to the provisions of the Framework Convention of the Organization

World of Health for Tobacco Control, approved by Decree No 25-A/2005,

of November 8, and transposes to the internal legal order to Directive No 2014 /40/UE,

of the European Parliament and of the Council of April 3, 2014, the Delegated Directive

n. 2014 /109/UE of the Commission of October 10, 2014, and the Directive

n. 2003 /33/CE, of the European Parliament and of the Council of May 26, 2003.

76

Article 2.

Definitions

For the purposes of this Act, it shall be understood by:

a) "Additive", a substance, with the exception of tobacco, which is added to a

tobacco product, an individual packaging or any packaging

exterior;

b) "Combined Health Warning", a health warning predicted in the

this law and which consists of a combination of a warning in text and of the

photography or corresponding illustration;

c) "Health Warning", a warning about the adverse effects of a

product in human health or other unintended consequences of its consumption,

including the warnings in text, the combined health warnings, the

general warnings and informative messages;

d) "Tar", the condensate of anhydrous and nicotine-free gross smoke;

e) "distinctive aroma", a clearly perceivable odor or flavor that is not from

tobacco, resulting from an additive or a combination of additives including,

but not limited to, the fruit, spices, aromatic herbs, alcohol, sweets,

menthol or vanilla, and which is ascertainable before or during the consumption of the product

of tobacco;

f) "Aromatizing", an additive that transmits an odor and or a flavor;

g) "Exchange", a wrapping tobacco packaging, whether in a bag form

rectangular with aba that covers the opening, either in the form of a background

plan;

77

h) "Charuto", a roll of tobacco that can be consumed through a process

of combustion and defined in more detail in the Code of Special Taxs

of Consumption, approved by the Decree-Law No. 73/2010 of June 21;

i) "Cicrilha", a cigar with a maximum weight of 3 g per unit;

j) "Cigarette", a roll of tobacco that can be consumed through a process

of combustion and defined in more detail in the Code of Special Taxs

of Consumption, approved by the Decree-Law No. 73/2010 of June 21;

k) "Electronic electronic cigarette", a product that can be used to consume steam

containing nicotine, by means of bokedown, or any component of that

product, including a cartridge, a reservoir and the cartridge without cartridge

or reservoir, and electro-cigarettes may be disposable or

rechargeable through a refill and a reservoir, or recharged by

non-reusable cartridge;

l) "Marketing", the provision of products, regardless of their

place of manufacture, to consumers located in the national territory, with or

without payment, including through distance selling, being that in the case of

Cross-border distance sales, the product is considered to be marketed

in the country where the consumer is found;

m) "Consumer" means a natural person who attests with purposes that do not include in the

scope of its commercial, industrial, artisanal or professional activity;

n) "Outer packaging", any packaging in which the tobacco products or

related products are placed on the market and that includes a packaging

individual or a set of individual packaging, not being the casing

transparent considered as outer packaging;

o) "Individual packaging", the smallest individual packaging of a product

of tobacco or an end product that is placed on the market;

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p) "Emissions", substances that are released when a tobacco product or

afim product is consumed in accordance with the intended purposes, such as substances

contained in smoke or substances released during the process of use

of tobacco products without combustion;

q) "Establishment retailer", any establishment where they are

marketed tobacco products, including by a natural person;

r) "Manufacturer" means the natural or collective person who fopens a product or makes it

conceive or manufacture, and market it in your name or under your brand

commercial;

s) "Smoking", the consumption of tobacco products, with the exception of the products of the

non-combustion tobacco, the consumption of plant-based products for smoking or

the use of electrolytic cigarettes;

t) 'Environmental Smoke', smoke released into the atmosphere from combustion

of tobacco products;

u) "Importer of tobacco products or related products", the owner or the

person who enjoys the right to have the products of tobacco and products

related to the purposes that were introduced in the national territory, coming from another

Member State, or of a third country or territory, as such defined in the

Code of Excise Taxes, approved by the Decree-Law

n. 73/2010 of June 21;

v) "Ingredient", tobacco, an additive, as well as any substance or element

present in a product of finished tobacco or an afim product, including

paper, filter, paints, capsules and adhesives;

w) "Place of work" all the place where the worker meets and in which he / she is,

directly or indirectly, subject to the control of the employer;

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x) "Place of sale of tobacco" any place where they are put up for sale

tobacco products;

y) "Nicotine" the nicotinic alkaloids;

z) Maximum level "or" maximum emission level ", the maximum content or emission,

including a value equal to zero, of a substance in a tobacco product,

measured in milligrams;

aa) "New tobacco product", a tobacco product that:

iii) It does not belong to any of the following categories: cigarettes, tobacco from

roll up, tobacco to pipe, tobacco to water pipe, cigars,

cigarillos, chewing tobacco, rapé or tobacco for oral use; and

iv) It is commercialized after May 19, 2014.

bb) "Potential to create dependence", the pharmacological potential of a substance

of creating dependency, a state that affects an individual's ability

control their behaviour, usually by offering an effect of

reward or a relief from the symptoms of deprivation, or both;

cc) "plant-based product for smoking", a herbal product, herbs

aromatics or fruit that does not contain tobacco and can be consumed through

a combustion process;

dd) "Product of tobacco without combustion", a tobacco product that does not involve

a combustion process, including chewing tobacco, snuff and tobacco for use

oral;

ee) "Tobacco products", products that can be consumed and which are

constituted, even if partially, by tobacco, genetically modified

or not;

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ff) "Tobacco products for smoking", a tobacco product, except the products of the

tobacco without combustion;

gg) "Tobacco advertising", any form of communication made by entities of

public or private nature, within the framework of a commercial, industrial activity,

artisanal or liberal, with the direct or indirect goal of promoting, a product

of tobacco or its consumption;

hh) "Rapé", a product of tobacco without combustion that can be consumed by way

nasal;

ii) "Refill", a container with liquid that contains nicotine, which can be

used to recharge an electrolyte cigarette;

jj) "Recinto closed", all space fully delimited by walls, walls or

other surfaces and endowed with a cover;

kk) "Service of the information society", any service provided at a distance, by

electronical, upon individual request by a recipient of services and

against payment of a price, pursuant to the Decree-Law No. 7/2004, of 7 of

January, amended by Decree-Law No. 69/2009, of March 10, and Law

n. 46/2012 of August 29;

ll) "Publicity support" the vehicle used for the transmission of the message

advertisement;

mm) "Tobacco", the leaves and other natural parts, processed or not

transformed, from the tobacco plant, including expanded and reconstituted tobacco;

nn) 'Rolling tobacco', tobacco that can be used to make cigarettes by the

consumers or by the retail outlets;

oo) "Chewing Tobacco", a product of tobacco without combustion intended

exclusively to be mastered;

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pp) "Tobacco to pipe", tobacco that can be consumed through a

combustion process and intended exclusively to be used in a

pipe;

qq) "Tobacco to pipe water", a tobacco product that can be

consumed through water pipe (narguilé), considering, for effects

of the provisions of this Law, that tobacco to pipe water is a product

of tobacco to smoke, unless the product is usable in both the cachimbos of

water as curing tobacco, in which case it is considered to be rolling tobacco;

rr) "Tobacco for oral use", all tobacco products for oral use, with the exception

of those intended to be inhaled or masted, constituted wholly or partially

by tobacco, in the form of powder or fine particulate matter or any combination

of these forms, particularly those in individual doses or

porous packages;

ss) "Televenda", the diffusion of direct offers to the public, carried out by channels

televisions, with a view to the supply of cigarettes or other derivative products

of tobacco, from plant-based products to smoke or from electrolytic cigarettes,

upon payment;

tt) "Toxicity", the degree to which a substance can cause harmful effects to the

human organism, including effects that occur in the long term,

habitually by repeated or continuous consumption or exposure;

uu) "Cross-border distance selling", distance sales to consumers in the

on which, at the time you order the product to an establishment

retailer, the consumer finds himself in a country other than the one in which he is

established the retail establishment, considering that the establishment

retailer is established in a country:

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i) In the case of a natural person, if this has your place of activity

commercial in that country;

ii) In the remaining cases, if the retail establishment has its registered office, the

your central administration or your place of commercial activity, including

a branch, agency or any other establishment, in that country.

CHAPTER II

Limitations on tobacco use

Article 3.

General principle

The provisions of this Chapter aims to establish limitations on the consumption of tobacco in

closed enclosures intended for collective use in such a way as to ensure the protection of the

exposure to tobacco environmental smoke.

Article 4.

Prohibition of smoking in certain places

1-It is forbidden to smoke:

a) In places where organs of sovereignty, services and bodies are installed

of the Public Administration and public collective persons;

b) In the places of work;

c) At the places of direct care to the public;

d) In establishments where health care is provided, particularly

hospitals, clinics, centres and health care homes, doctors ' offices, posts

aid and other similar, laboratories, pharmacies and places where to dispense

medicinal products not subject to medical prescription;

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e) In homes and other institutions that are welcoming elderly or disabled people

or disability;

f) In the places intended for under 18 years, namely nurseries, crèches

and other child care facilities, nursing homes and youth,

leisure centres of leisure, colonies and holiday camps and too much

similar establishments;

g) In educational establishments, regardless of the age of pupils and the

degree of schooling, including, inter alia, classrooms, from study, from

teachers and meetings, libraries, gymnasiums, attrios and corridors, bars,

restaurants, canteens, cafeterias and recreation spaces;

h) In vocational training centres;

i) In museums, visitable collections and places where cultural assets are guarding

classified, in the cultural centres, archives and libraries, in the rooms of

conference, reading and exhibition;

j) In the rooms and precincts of spectacles and other places intended for the diffusion of the

arts and spectacle, including the antech dates, accesses and contiguous areas;

l) In the fun enclosures, in the casinos, bingos, game rooms and other kind of

precincts intended for spectacles of a non-artistic nature;

m) In the closed areas of sports facilities;

n) On the precincts of the fairs and exhibitions;

o) On the sets and large commercial surfaces and in establishments

commercial of sale to the public;

p) At the hotel establishments and other tourist ventures where

are provided with accommodation services;

84

q) In catering or beverage establishments, including those who own

rooms or spaces intended for dance;

r) In the canteens, in the lunchrooms and in the bars of public and private entities

intended exclusively for personal respect;

s) In the areas of service and fuel supply stations;

t) At airports, at railway stations, at the road stations of

passengers and in the sea and river floats;

u) On the premises of the metropolitan affectations to the public, specifically in the

terminals or intermediate stations, in all their accesses and establishments

or contiguous facilities;

v) In the covered car parks;

x) In the lifts, lifts and similar;

z) In the closed telephone cabins;

aa) On the closed enclosures of the automatic money lifting networks;

bb) In any other place where, by determination of management, of the administration

or other applicable legislation, specifically in the matter of prevention of

occupational hazards, if it prohibits smoking

2-It is still forbidden to smoke in the vehicles affections for urban public transport,

suburban and interurban passenger, as well as in road transport,

rail, air, sea and river services, in the express, tourist and rental services,

in taxis, ambulances, transport vehicles of patients and telephones.

3-The provisions of the preceding paragraphs shall apply to the use of electro-cigarettes with

nicotine, that is, products that can be used to consume steam by means of

bokedown, and that contain nicotine or any component of that product.

85

Article 5.

Exceptions

1-Without prejudice to the provisions of the paragraph d ) of paragraph 1 of the preceding article, rooms can be created

exclusively aimed at smoker patients in hospitals and psychiatric services,

treatment and rehabilitation centres, internment units of addictions and

of alcoholics, nursing homes and assisted residences, provided that:

a) Be properly flagged, with attachment of dystics in visible places, in the

terms of the provisions of the following article;

b) Have, at the entrance, visible indication of the maximum allowable lotion, the

regulating by portaria to be approved by the responsible government members

by the areas of the economy, the environment and health;

c) Be physically separated from the remaining premises or, in the event that they are located

in the interior of buildings, are fully compartmented according to

standards to be regulated by portaria to be approved by the members of the Government

responsible for the areas of the economy, the environment and health;

d) They have a ventilation system for the outside with air extraction that

allow for the maintenance of negative pressure of at least 5 Pa (Pascal),

measured with differential prescaltate, defined in function of the lotation, dimension and

location of the room and autonomous of the general climatization system of the building, the

regulating by portaria to be approved by the responsible government members

by the areas of the economy, the environment and health.

2-Without prejudice to the provisions of the previous article, they may be set up in the establishments

prison units, in cells or shrimps, for reclusive smokers,

provided that they meet the requirements set out in the sub- c ) and d ) of the previous number,

being still admitted to smoking in the outdoor areas.

86

3-In the places mentioned in the points a ), b ), c ), d ), and ), h ), i ), j ), l ), n ), the ), p ), q ), r ) and t ) of the n.

1 of the previous article, as well as in the places mentioned in the g ) of paragraph 1 of the same

article integrating the higher education system, it is admitted to smoke in the areas by air

free.

4-In the places mentioned in the paragraph s) of paragraph 1 of the preceding Article shall be admitted to smoke in the

outdoor areas, with the exception of areas where the supply of vehicles is carried out.

5-In the places mentioned in the points j), l), n), (o), (q), and t) of paragraph 1 of the previous article

spaces for smokers can be reserved as long as they comply with the requirements

mentioned in the points a ) a d ) of paragraph 1 and do not possess any service,

specifically bar and catering.

6-Access to the places mentioned in the previous number is reserved to greater than 18

years.

7-In the places mentioned in the paragraph q) of paragraph 1 of the preceding Article, the spaces provided for

in paragraph 5 may only be constituted in the areas intended for customers, if they have

size higher than a limit to be regulated by portaria to be approved by members

of the Government responsible for the areas of the economy, the environment and health

8-In the places mentioned in the paragraph l) of paragraph 1 of the previous article, where there is practice of

games of fortune or chance, the spaces provided for in paragraph 5, may only be constituted

in an area not more than 40% of the game rooms.

9-In the places mentioned in the paragraph p) of paragraph 1 of the preceding Article may be reserved

floors, lodging units or rooms for smokers, up to a maximum of 40%

of the total respect, occupying contiguous areas or the totality of one or more floors,

provided that they comply with the requirements mentioned in the ( a) a c) of paragraph 1 and have

ventilation or air extraction system for the outside that prevents the fume from if

spread to the contiguous areas.

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10-Without prejudice to the provisions of paragraph 2 of the preceding Article and of the limitations set out in

regulations issued by the carrier companies or by the port capitals, is

allowed to smoke in the areas discovered in the boats affections to sea careers or

fluvial.

11-A The definition of the areas for smokers falls to the entities responsible for the

establishments in question, and the respected services of

safety, hygiene and health at work and the safety, hygiene and health committees in the

work, or, failing that, the representatives of workers for safety, hygiene

and health at work.

Article 6.

Signage

1-A interdiction or the conditioning of smoking within the places referred to in the articles

4 ° and 5 ° shall be noted by the relevant competent entities by means of

dystic fixation with red background, conforms to the model A constant of Annex I

of this Act and that it forms an integral part, the trait being, including the caption and the

cross, the white and with the minimum dimensions of 160 mm x 55 mm.

2-The areas where smoking is allowed are identified upon dystic affixing with

blue background and with the remaining characteristics indicated in the preceding paragraph,

to the model B constant of Annex I.

3-To the dystics referenced in the previous numbers should be in, at the lower end of the

model, a caption identifying the present law.

4-The dystic referred to in paragraph 1 shall still contain the amount of the maximum fine applicable to the

smokers who violate the ban on smoking.

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5-The dystics must be affixed or glued in such a way as to be hardly removable and

are to be visible from the outside of the establishments.

Article 7.

Responsibility

1-Compliance with the provisions of articles 4 to 6 shall be ensured by the entities

public or private persons who have their office the places referred to in this Law.

2-Where infractions are made to the provisions of Articles 4 to 6, the entities

referred to in the preceding paragraph shall determine to the smokers to abstain from

smoking and, should these fail to comply, call the administrative authorities or police, the

which ones should wash the self-respecting self of news.

3-All users of the places referred to in paragraph 1 shall have the right to demand compliance with the

provisions of Articles 4 to 6, and may submit written complaint, circumstantial,

using for the purpose, namely, the book of complaints available in the

establishment concerned.

CHAPTER III

Ingredients and emissions

Article 8.

Maximum emission levels of tartar, nicotine, carbon monoxide

and other substances

1-The emission levels of cigarettes marketed or manufactured on national territory

may not be higher than:

a) 10 mg of tar per cigarette;

b) 1 mg of nicotine per cigarette;

c) 10 mg of carbon monoxide per cigarette.

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2-The Government may set, through the porterie of the member of the Government responsible for

health area, maximum emission levels for other emissions other than those provided for in the

previous number, as well as for emissions of tobacco products that are not

cigarettes, of which the European Commission should be notified.

Article 9.

Methods of measurement

1-The emissions of tar, nicotine and carbon monoxide from cigarettes are measured,

respect, by the standards ISO 4387, ISO 10315 and ISO 8454.

2-A accuracy of the measurements on tar, nicotine and carbon monoxide is

determined according to ISO 8243.

3-The provisions of the preceding paragraphs shall be verified by testing laboratories

accredited by the Portuguese Institute of Accreditation, I.P., pursuant to Art. 3 para.

Decree-Law No 81/2012 of March 27 or by the competent authorities of the

other Member States, and may not such laboratories be held or controlled,

directly or indirectly, by the tobacco industry.

4-A The list of the laboratories accredited by the Portuguese Institute of Accreditation, I.P., is

disclosed on the electronic site of that Institute and by this communicated to the Directorate General of

Health, until January 31 of each year and whenever changes occur, of it constanting

the criteria used for the accreditation of each and the means of monitoring

put in place.

5-A Directorate General of Health communicates to the European Commission the list of laboratories

referred to in the preceding paragraph, specifying the criteria used for approval and the

means of monitoring put in place, as well as the changes taking place.

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6-The cigarettes are subjected to the measurements, in the laboratories set out in paragraph 3, by the

manufacturer or by the importer of tobacco products, which is responsible for the

respects charges.

7-The provisions of this Article shall apply, with the necessary adaptations, to the levels of

issue referred to in paragraph 2 of the preceding Article.

8-[ Revoked ].

9-[ Revoked ].

10-[ Revoked ].

Article 9-The

Communication of ingredients and emissions

1-The manufacturers and importers of tobacco products present to the Directorate General of the

Health, prior to its marketing, the following information, by brand and by type:

a) A list of all ingredients, and respect quantities, used in the manufacture

of tobacco products, by descending order of the weight of each ingredient

included in tobacco products;

b) The emission levels referred to in Article 8;

c) Information on other emissions and their levels, should these exist, owing,

in this case, the methods of measurement of the emissions used are stated.

2-The manufacturers and importers of tobacco products shall also communicate to the

Directorate of Health any change to the composition of a product that affects the

information provided under this article.

3-A list of ingredients referred to in para. a ) of paragraph 1:

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a) Indicates the status of ingredients, including whether these have been registered under the

Regulation (EC) No 1907/2006, of the European Parliament and of the Council, of 18

of December 2006, as well as the respective classification under the

Regulation (EC) No 1272/2008, of the European Parliament and of the Council, of 16

of December 2008;

b) It is accompanied by the relevant toxicological data on the ingredients, with

or without combustion, as appropriate, mentioning, in particular, its

effects on the health of consumers, particularly the risk of creating

dependency;

c) It is accompanied by a statement that exposes the reasons for the inclusion of these

ingredients in the tobacco products concerned;

d) It must still be accompanied by a technical document with a general description

of the additives used and of their properties, in the case of cigarettes and tobacco of

curl up.

4-Where the Directorate General of Health determines it, the manufacturers or importers of

tobacco products should carry out studies in order to evaluate the effects of ingredients

in health, taking into account, in particular, the potential to create dependence and the

toxicity, and these should bear the respects burdens.

5-The manufacturers and importers of tobacco products must submit to the Direction-

General Health studies internal and external studies of which they have on the market and the

preferences of various groups of consumers, including young people and current

smokers, in respect of ingredients and emissions, as well as summaries of any

market studies leading to the launching of new products.

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6-The manufacturers and importers of tobacco products must still communicate to the

Directorate General of Health, annually, until September 30 of each year, the volumes of

sales, discriminated against by brand and by type, expressed in number of cigarettes, cigarillos

or cigars or in kilograms, and by country of the European Union.

7-All data and information to be submitted under this article and of the article

next are communicated in an electro-format, to be defined by member of the member of the

Government responsible for the area of Health, owing such information to be retained

electronically and kept accessible to the European Commission and to the Member States,

with respect to commercial secrecy and other confidential information.

8-The format for presentation and making available to the public of the information referred to

in this Article and in the following article is defined and, if necessary, updated, of

agreement with the procedures set out in accordance with Article 5 (5) and the article

25. of Directive No 2014 /40/UE, of the European Parliament and of the Council, of 3 of

april 2014.

9-A The Directorate General of Health ensures the dissemination, on its website, of the data

presented in accordance with paragraph 1 and the following article, taking into account, where

is a case of this, the information that constitutes commercial secrecy and that for this they have

been specified by the manufacturer or importer of tobacco products.

10-For tobacco products that are already being marketed at the date of entry into

vigour of this Act, the communication referred to in paragraph 1 shall be made up to 20 of

november 2016.

11-By the recetion, conservation, treatment, analysis and publication of the information provided for

in this article are due fees, by the manufacturers and importers of products of the

tobacco, to be fixed by porterie of the members of the Government responsible for the areas of

finance and health.

93

Article 10.

Priority list of additives and enhanced communication obligations

1-In addition to the communication obligations provided for in the previous article, they are subject to

enhanced communication obligations the additives contained in cigarettes and tobacco from

enroll that are listed as a priority list established in accordance with the

procedures set out in accordance with Article 6 (1) and Article 25 of the Directive

n. 2014 /40/UE, of the European Parliament and of the Council of April 3, 2014.

2-The manufacturers and importers of the cigarettes and tobacco to enroll they contain

an additive that consents from the priority list provided for in the preceding paragraph shall be

circumstantial studies to examine whether each of the additives:

a) Contributes to the toxicity or dependence potential of the products in question, and

whether it has the effect of increasing the toxicity or dependence potential of any

of the products in question, to a significant extent or measurable;

b) Results in a characteristic aroma;

c) Facilitates the inhalation or absorption of nicotine; or

d) Results in the formation of substances with carcinogenic, mutagenic properties

or toxic for reproduction, the quantities of these substances, and if that fact

has the effect of increasing the cancerous, mutagenic or toxic properties

for the reproduction of any of the products in question, to a significant degree or

measurable.

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3-The studies referred to in the preceding paragraph take into account the end to which they are intended

products in question and examine, in particular, the emissions resulting from the process of

combustion in which the additive in question is involved, as well as the interaction of that

additive with other ingredients contained in the products in question, and may be

effectuate joint studies by manufacturers or importers using the same

additive in its tobacco products, provided that such an additive is used in a

comparable composition of the product.

4-The manufacturers or importers draw up a report on the results of the studies

predicted in the previous figures, which should include a summary and a compilation

circumstantial of the available scientific literature on that additive and a summary of the

internal data on the effects of the additive, and they present it, within 18 months after

the additive in question has been included in the priority list referred to in paragraph 1, to the General Directorate

of Health and the European Commission, and may by these be required information

supplementary, to be integrated into the report.

5-A The European Commission and the Directorate General of Health may require that the report to which

refers to the previous number be object of review by a scientific body

independent, in particular with respect to its completeness, methodology and

conclusions.

6-By the review of the report referred to in paragraph 4 are due fees, on the part of manufacturers and

Importers of tobacco products, to be fixed by porterie of the members of the Government

responsible for the areas of finance and health.

7-Small and medium-sized enterprises, in the acetation of Decree-Law No. 372/2007, of 6 of

november, amended by Decree-Law No. 143/2009 of June 16, shall be exempted from the

obligations set out in this Article, if the report on the additive in question is

drawn up by another manufacturer or importer.

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Article 10-The

Regulation of ingredients

1-The marketing of tobacco products with a distinctive aroma is prohibited, not if

understanding as such the use of essential additives for the manufacture of products of the

tobacco, as long as those additives do not result in a product with a distinctive aroma and not

increase for tobacco products, to a significant degree or measurable degree, the

toxicity, the potential for breeding dependence or the cancerous properties,

mutagenic or toxic for reproduction.

2-A The Directorate General of Health may request the European Commission to determine whether a

tobacco product is covered by the scope of paragraph 1 or consult the panel

independent advisory established at the level of the European Union before taking action

in application of paragraph 1.

3-The rules regarding procedures for determining whether a tobacco product is

covered by the scope of paragraph 1 are set out in accordance with the

procedures set out in accordance with Article 7 (3) and Article 25 of the Directive

n. 2014 /40/UE, of the European Parliament and of the Council of April 3, 2014.

4-The marketing of tobacco products containing the following is prohibited

additives:

a) Vitamins or other additives that create the impression that a tobacco product

has health benefits or poses reduced risks to health;

b) Caffeine or taurine or other additives and stimulant compounds associated with

energy and vitality;

c) Additives that confer colour on emissions;

d) For tobacco products for smoking, additives that facilitate inhalation or the

absorption of nicotine; or

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e) Additives that, in their form without combustion, have cancerous properties,

mutagenic or toxic for reproduction.

5-The marketing of tobacco products containing flavourings is prohibited

its components, such as filters, papers, packaging, capsules or any

technical characteristics that allow to modify the odor or taste of the products of the

tobacco in cause or the intensity of their smoke, with the filters, papers and the

capsules should not contain tobacco or nicotine.

6-Tobacco products shall apply to the provisions and conditions set out in

shelter from Regulation (EC) No 1907/2006, of the European Parliament and of the Council, of

December 18, 2006, as appropriate.

7-On the basis of scientific data, the marketing of products of the

tobacco containing additives in quantities that increase to a significant degree or

measurable the toxic or addictive effect of a tobacco product or the

cancerous, mutagenic or toxic properties for reproduction in the phase of

consumption, in terms to be defined by porterie of the member of the Government responsible for the

area of health.

8-A Directorate General of Health notifies the European Commission of the measures to be taken in

application of the previous number.

9-A The Directorate General of Health may request the European Commission to determine whether a

tobacco product is covered by the scope of paragraph 7.

10-To tobacco products other than cigarettes and curling tobacco do not apply as

prohibitions provided for in paragraphs 1 and 7.

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11-The manufacturers and importers of tobacco products bear the burden

necessary for evaluation if a tobacco product has a distinctive aroma, if they are

used additives or prohibited aromas and if a tobacco product contains additives in

quantities that increase to a significant degree and measurable the toxic effect or

dependence on the product of the tobacco in question or its cancerous properties,

mutagenic or toxic for reproduction.

CHAPTER IV

Labelling and packaging

Article 11.

General provisions

1-Each individual packaging of tobacco products and each outer packaging shall

to present the health warnings provided for in this chapter, in language

Portuguese, which must cover the entire surface of the individual packaging or packaging

exterior that is reserved to you, and may not be commented on, paraphrased or referred to.

2-The health warnings in an individual packaging and in any packaging

exterior must be immovable in an immovable, indelible and perfectly visible way.

3-The health warnings in an individual packaging and in any packaging

outside may not be partially or fully concealed or separated by

special stacks, price marks, safety elements, casings, bags,

wallets, boxes or other elements when tobacco products are

marketed, nor can they dissimulate or separate, in any way, stacks

specials, price marks, location marks and follow up or elements of

safety in individual packaging.

98

4-In the individual packaging of tobacco products other than cigarettes and tobacco from

curl up in handbags, health warnings can be affixed by means of

stickers, as long as these are unremovable.

5-Health warnings must remain intact when individual packaging

is open, with the exception of the packs with articulated soft aba, in which case the warning

of health can be divided when the packaging is opened, but only in a way

that ensure the graphic integrity and visibility of the text, photographs and information of

helps you quit smoking.

6-The dimensions of health warnings provided for in Articles 11-A, 11-B and 11-C are

calculated in relation to the surface in question when the packaging is closed.

7-The health warnings are surrounded by a black frame with 1 mm wide

within the surface reserved to these caveats.

8-To images of individual packaging and from any outer packaging for purposes

advertisements are applicable to the rules of this chapter.

9-[ Revoked ].

10-[ Revoked ].

11-[ Revoked ].

Article 11-The

General warnings and informative messages in tobacco products

to smoke

1-Each individual packaging and each outer packaging of tobacco products to

smoking must present the following general warning:

"Smoking kills-leave already".

2-Each individual packaging and each outer packaging of tobacco products to

smoking must present the following informative message:

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"Tobacco smoke contains more than 70 cancer-causing substances."

3-A general warning and the informative message referred to in the preceding paragraphs should

be:

a) Printed on black body Helvethics on white background, in lowercase, with

exception of the first letter and grammatical requirements, and with the size of letter

which ensures that the text occupies the largest possible space of the reserved surface

for general warning and the informative message;

b) Placed in the centre of the surface that is reserved to them and, in the packaging

parallelepipedic and in any outer packaging, parallel to the lateral side of the

individual packaging or the outer packaging.

4-In the packs of cigarettes as well as in the wrappers of rolling tobacco, with shape

parallelepipedic, the general warning should appear at the bottom of one of the surfaces

sides of the individual packaging and the informative message at the bottom of the other

lateral surface, owing to these health warnings having a width of not less than 20

mm.

5-In the packs with a box shape with an articulated cover, in which the surfaces

sides split into two parts when the packet is opened, the general warning and the

informative message should appear in its entirety on the largest of these surfaces

split, and the general warning should appear also on the inside of the aba

top that is visible when the packet is opened and not the side surfaces

of this type of maço having a height of less than 16 mm.

6-In the case of rolling tobacco, the general warning and the informative message should

cover 50% of the surfaces in which they are printed, and shall appear:

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a) On surfaces that ensure the full visibility of these health warnings,

in terms to be established in accordance with the procedures set out in paragraph 6 of the

Article 9 and in Article 25 of Directive No 2014 /40/UE of the European Parliament and

of the Council of April 3, 2014 if curing tobacco is commercialized in

bags;

b) On the outer surface of the cover of the packaging, for the general warning, and in the

interior surface of the cover of the packaging, for the informative message, if the

enroll tobacco for commercialized in cylindrical packaging.

Article 11-B

Combined health warnings for tobacco products to smoke,

including cigarettes, rolling tobacco and tobacco to water pipe

1-Each individual packaging and each outer packaging of tobacco products to

smoking, including cigarettes, curling tobacco and tobacco pipe tobacco, should

present combined health warnings, which include one of the caveats of

text and a corresponding colour photograph, set out in Annex II to this Law, of the

which is an integral part.

2-The combined health warnings are grouped into three series, with each series being

used in a given year and in annual rotation, owing to each health warning

combined available for use in a given year to be ostensiped in number

equal in each brand of tobacco products.

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3-The combined health warnings should present the same warning in text and

the corresponding colour photograph on both sides of the individual packaging and of

any outer packaging, figuring together from the top board of a packaging

individual and of any outer packaging and being positioned in the same direction

that any other information that appears on that surface of the packaging.

4-The combined health warnings must cover 65% of both external faces

front and back of the individual packaging and any outer packaging, owing

cylindrical packaging presents two combined health warnings,

equidistant with each other and covering every health warning 65% of the respect half of the

curved surface.

5-In the case of cigarette packs, combined health warnings can't have

a height of less than 44 mm and a width of less than 52 mm.

6-The technical specifications for the configuration, conception and format of the warnings of

combined health, taking into account the different forms of packaging are

established in accordance with the procedures set out in accordance with paragraph 4 of the article

10 and Article 25 of the Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014.

Article 11-C

Labelling of tobacco products without combustion

1-Ficam exempt from the obligation to bear the informative message provided for in paragraph 2 of the

article 11-A and the combined health warnings provided for in Article 11-B, the

tobacco products for smoking, with the exception of cigarettes, curd tobacco and the

tobacco to water pipe.

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2-In the cases provided for in the preceding paragraph, and in addition to the general warning provided in the

n Article 11 (1), each individual packaging and each outer packaging of those

products shall bear one of the caveats in text listed in Annex II to

present law.

3-A The general warning provided for in Article 11 (1), shall include a reference to the

support services to quit smoking, such as phone numbers, addresses of

e-mail and or sites in the Internet intended to inform consumers about

the support programmes available for people who want to quit smoking and

must appear on the most visible surface of individual packaging and any

outer packaging.

4-Each warning in text must appear, where possible, in equal numbers in

each brand of products.

5-In-text caveats feature on the most visible surface following packaging

individual and of any outer packaging.

6-In the individual packaging with jointed cover, the other most visible surface

next is the one that is visible when the packaging is opened.

7-A The general warning referred to in this article shall cover 30% of the surfaces of the

individual packaging and any outer packaging and figure in the two largest

surfaces of individual packaging and any outer packaging.

8-A The warning in text referred to in this article shall cover 40% of the surface

relevant of the individual packaging and any outer packaging.

9-In the case of the health warnings referred to in this article appear in a

surface area exceeding 150 cm2, the caveats must cover an area of 45 cm2.

10-The health warnings referred to in this article comply with the requirements set out

in Article 11 (3).

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11-The text of health warnings should be parallel to the main text of the surface

reserved for these caveats.

12-Health warnings must be surrounded by a black frame of width not

less than 3 mm and not more than 4 mm, with that frame being expected to appear outside the

surface reserved to health warnings.

Article 12.

Appearance and content of individual packaging

1-Individual packagings of cigarettes must have parallelepipedic form.

2-The individual wrappers of curling tobacco must have parallelepiped form,

cylindrical or purse.

3-Individual packaging of cigarettes must contain at least 20 cigarettes.

4-The individual wrappers of rolling tobacco must contain at least 30 g of

tobacco.

5-Individual packagings of cigarettes may be cardboard or soft material, without the

aperture can be back closed or sealed after open for the first time, with

the exception of the articulated soft and the box with articulated cover, being that, for these

last, the aba and the cover are articulated only on the back of the packaging

individual.

Article 13.

Presentation of the product

1-A labelling of an individual packaging and any outer packaging, well

as the tobacco product itself, it cannot include any element or

characteristic, constant of texts, symbols, assignments, trade marks, signs

figurative or other, which:

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a) Promote a tobacco product or encourage your consumption by creating a

erroneous printing as to its characteristics, effects on health, risks or

emissions, and the labels may not include any information on the content of

nicotine, tar or carbon monoxide from the tobacco product;

b) Suggest that a particular tobacco product is less harmful than others or visa

reduce the effect of certain harmful components of smoke or that it has

revitalizing, energetic, curative, rejuvenating, natural properties,

biological or other benefits for health or lifestyle;

c) Refer to the taste, odor, any flavor or other additives or to your

absence;

d) If you resemble a food product or a cosmetic; or

e) Suggest that certain tobacco product has better biodegradability or

present other environmental advantages.

2-Individual packaging and any outer packaging cannot, by means of texts,

symbols, assignments, trademarks, figurative signs or others, suggest advantages

economic by means of printed coupons, discounts offers, free distribution, two

by the price of one, or other similar offerings.

Article 13-The

Traceability

1-All individual packaging of tobacco products marketed in territory

national must be marked with a unique identifier, which must be printed or

fixed in unremovable, indelible mode, not being in any way concealed or

separate, including by special stacks or price marks, or by the opening of the

individual packaging, which allows to determine:

a) The date and place of manufacture;

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b) The manufacturing facility;

c) The machine used to manufacture the tobacco products;

d) The production shift or the time of manufacture;

e) The description of the product;

f) The targeted retail market;

g) The planned dispatch route;

h) The importer, where applicable;

i) The route of dispatch really travelled, from manufacture to the first

establishment retailing, including all the warehouses used, as well as the

date of dispatch, the destination of the expedition, the starting point and the consignee;

j) The identity of all buyers, from manufacture to the first

retail establishment; and

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

buyers, from manufacture to the first retail establishment.

2-The information referred to in points a ) a g ) of the preceding paragraph and, where applicable, the

referred to in paragraph h ) of the same number, shall be part of the unique identifier,

and the information referred to in points i ), j ) and k ) of the previous number being

electronically accessible through a link to the unique identifier.

3-All economic operators involved in the trade in tobacco products,

from the manufacturer to the last economic operator before the first establishment

retailer, must record the entry of all individual packaging into their possession,

as well as all intermediate movements and the definitive exit of packaging

individual of their possession, and such registration may be made upon marking and registration of the

aggregate packaging, as long as it continues to be possible to find and follow all the

individual packaging.

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4-All natural and collective persons involved in the supply chain of

tobacco products must keep complete and exact records of all transactions

referred to in this article.

5-Tobacco product manufacturers must provide to all operators

economic involved in the trade in tobacco products, from the manufacturer to the

last economic operator before the first retail establishment, including

importers, stockpilers and transport companies, the equipment necessary for the

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

handled in any other way, owing such equipment to be able to read and

transmit the data recorded electronically to a conservation facility of

data.

6-For the purposes of the provisions of the final part of the preceding paragraph, the manufacturers and the

importers of tobacco products must enter into data conservation contracts

with an independent third party with a view to albergating the conservation facility of

data, owing to the data conservation facility to be physically located in the

territory of the European Union and be fully available for access by the Commission

European, of the competent authorities of the Member States and of the external auditor.

7-A suitability of the independent third party referred to in the preceding paragraph,

notably its independence and technical capabilities, as well as the

contract for data conservation, are approved by the European Commission.

8-The activities of the independent third party must be monitored by an auditor

external, proposed and paid by the tobacco manufacturer and approved by the European Commission,

which is to submit an annual report to the Tax and Customs Authority and to the

European Commission, assessing in particular all irregularities in respect of

access.

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9-In duly justified cases, access by manufacturers may be granted or

importers to the retained data, either by the Tax and Customs Authority

as per the European Commission, provided that the commercially sensitive information

remain adequately protected, in accordance with applicable legislation.

10-Registered data may not be modified or erased by any operator

economic involved in the trade in tobacco products, being respected to

legislation on the protection of personal data.

11-The technical standards for the creation and operation of the location system and

follow-up provided for in this article, including marking with an identifier

single, the registration, transmission, processing and preservation of data and access to the

conserved data is approved in accordance with the procedures set out in the

terms of Article 15 (11) and Article 25 of the Directive No 2014 /40/UE, of the

European Parliament and of the Council of April 3, 2014.

12-A numbering of the special stampile defined by the Tax and Customs Authority and

provided by the National Press-House of Currency, S. A, can be used as

unique identifier, including the changes that prove necessary to ensure the

compliance with the standards and technical functions required under Rule 15 of the

Directive No 2014 /40/UE, of the European Parliament and of the Council of April 3 of

2014.

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13-The main elements of the data conservation contracts referred to in paragraph 6, such

such as its duration, renewal, necessary technical knowledge or

confidentiality, including the regular monitoring and evaluation of such contracts,

are defined in accordance with the procedures set out in the terms of paragraph 12 of the

Article 15 and Article 27 of Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014.

14-The provisions of paragraphs 1 a to 10 shall apply to cigarettes and tobacco from enrolling from 20 of

may 2019 and tobacco products other than cigarettes and tobacco from enrolling the

departure from May 20, 2024.

Article 13-B

Element of security

1-In addition to the unique identifier referred to in the previous article, all packaging

individual of marketed tobacco products must present an element of

inviolable safety, composed of visible and invisible elements, which must be

printed or affixed in an immovable and indelible manner and that it cannot be concealed or

separate, including by special stacks and price marks.

2-The technical standards for the safety element and its eventual rotation are

approved in accordance with the procedures set out in accordance with paragraph 2 of the article

16 and Article 25 of the Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014.

3-A special stampile defined by the Tax and Customs Authority and provided by the

National Press-Home of the Currency, S. A, is used as an element of security,

owing, for this achievement, to be adapted in order to comply with technical standards and functions

required by Article 16 of Directive No 2014 /40/UE, of the European Parliament and of the

Council, of April 3, 2014.

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4-The provisions of paragraph 1 shall apply to cigarettes and tobacco from enrolling as of May 20.

2019 and tobacco products other than cigarettes and rolling tobacco from 20

from May 2024.

CHAPTER V

Tobacco for oral use, cross-border and new distance selling

tobacco products

Article 14.

Tobacco for oral use

The marketing of tobaccoes for oral use is prohibited.

Article 14-The

Trade in cross-border distance

Cross-border distance shopping, by a consumer, is prohibited

established in national territory, from tobacco products, from plant-based products

for smoking and electrolytic cigarettes and refills, effectuated to an established retailer

in another Member State or in a third country or territory, as such defined in the Code

of the Excise Taxes, approved by the Decree-Law No. 73/2010, of 21 of

June.

Article 14-B

Notification of new tobacco products

1-The manufacturers and importers of new tobacco products must notify the

Directorate of Health, in an electro-format and with a minimum advance of six

months, of any new tobacco product that they wish to trade in territory

national.

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2-A notification to which the preceding paragraph is concerned is accompanied by a description

detailed of the new tobacco product in question, as well as by the instructions of

use and the information relating to ingredients and emissions, pursuant to Art. 9,

and should still be made available:

a) Scientific studies of which they have about toxicity, potential for creation of

dependence and attractiveness of the new tobacco product, particularly in what if

refers to ingredients and emissions;

b) Studies and respect summaries and market analyses of which they have on the

preferences of various groups of consumers, including young and current

smokers;

c) Other available and relevant information, including an analysis of the risks and

benefits of the product, its expected effects in terms of the cessation of

tobacco use and the initiation of tobacco use and predictions about the

perceive consumers.

3-The manufacturers and importers of new tobacco products must report to the

Directorate General of Health any new or updated information on the studies,

analyses and other information referred to above.

4-A Directorate General of Health may request additional testing or the

presentation of supplementary information.

5-A The introduction of new tobacco products is subject to the authorization of the Directorate General

of the Economic Activities, after appearing from the Directorate General of Health, in terms of

define by poration of the members of the Government responsible for the areas of the economy and

of health.

6-By the authorisation process referred to in the preceding paragraph shall be charged fees, the

define by poration of the members of the Government responsible for the areas of finance, da

economics and health.

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7-New tobacco products marketed must comply with the expected requirements

in this Law, depending on its framework in tobacco products without

combustion or tobacco products for smoking.

CHAPTER VI

Electrolytic cigarettes and plant-based products for smoking

Article 14-C

Electrolytic cigarettes and refills

1-Only electrolytic cigarettes and refills that comply with the

requirements set out in this Law, with the exception of electrolytic cigarettes and refills, which

are subject to the provisions of the Decrees-Laws No 176/2006 of August 30, 36/2007,

of February 16, and 145/2009, of June 17, as amended by the Laws n. ºs 21/2014, 16

of April, and 51/2014, of August 25.

2-Electrophic cigarettes and refills must be safe for children, as well as

inviolable, unbreakable and the proof of stroke, and must possess a mechanism that

ensure a padding without stroke.

3-The manufacturers and importers of electrolytic cigarettes and refills must notify the

Directorate of Health, in an electro-format and with a minimum advance of six

months, of any such products that they wish to commercialize.

4-A notification referred to in the preceding paragraph shall include, depending on the product

an electrolytic cigarette or a recharge, the following information:

a) The name and contact elements of the manufacturer, of the collective person or singular

responsible and, where appropriate, of the importer in the European Union;

b) A list of all the ingredients contained in the product and the resulting emissions

of its use, by brand and by type, including the respect quantities;

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c) The toxicological data relating to ingredients and emissions of the product, inclusive

when heated, referring, in particular, its effects on the health of the

consumers when inhaled, and taking into account in particular the effect of

creation of dependency;

d) Information about the doses and the absorption of nicotine, when consumed in

normal or reasonably foreseeable conditions;

e) A description of the components of the product, including, where applicable, the

mechanism of opening and filling of the electrolytic cigarette and refills;

f) A description of the production process, specifically if this implies the

serial production, and a statement that the production process ensures the

compliance with this article;

g) A statement that the manufacturer and the importer assume full

responsibility for the quality and safety of the product, when marketed and

used under normal or reasonably foreseeable conditions.

5-A The Directorate General of Health may require that the information referred to in the number

previous to be completed, if you consider that the same are not complete.

6-The manufacturers and importers of electrolytic cigarettes and refills shall proceed to

new notification for each substantial change of the products.

7-A The Directorate General of Health ensures the dissemination, on its website, of the data

presented in the terms of this article, taking into account, where appropriate

of this, the information that constitutes commercial secrecy and that for such an effect has been

specified by the manufacturer or importer of electrolytic cigarette products and

refills.

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8-For electrolytic and recharged cigarettes that are already being marketed in 20 of

may 2016, the communication referred to in this article shall be made on the deadline

of six months, from that date.

9-The format for the notification provided for in this article, as well as the standards

techniques for the filling mechanism referred to in paragraph 2, are fixed from

agreement with the procedures set out in accordance with Article 20 (13) and of the

Article 25 of Directive No 2014 /40/UE, of the European Parliament and of the Council, of 3

of April 2014.

10-By the recetion, conservation, treatment and analysis of the information provided for in the present

article are due fees, by manufacturers and importers of electrolytic cigarettes and

refills, to be fixed by porterie of the members of the Government responsible for the areas of

finance and health.

Article 14-D

Ingredients and labelling of electrolytic cigarettes and refills

1-For electrolytic and recharged cigarettes, the liquid containing nicotine must be manufactured

exclusively with ingredients of great purity and:

a) It can only be marketed on own refills that do not exceed a volume of

10 ml, in disposable electrolytic cigarettes or in non-reusable cartridges, no

may the cartridges or shells exceed a volume of 2 ml;

b) It can contain no more than 20 mg/ml nicotine;

c) It may not contain the additives provided for in Article 10 (4);

d) It may only include other substances, other than the constant ingredients of the

list as referred to in point b ) of paragraph 4 of the preceding article in the form of traces

and if these are technically unavoidable during manufacturing;

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e) It may only include, in addition to nicotine, ingredients that do not constitute a

risk to human health in the heated or non-heated form.

2-Electrophic cigarettes should free the doses of nicotine at consistent levels, in

normal conditions of use.

3-The individual packaging of electrolytic cigarettes and refills must include a leaflet

with information about:

a) Instructions for use and conservation of the product, including the reference that the

product is not recommended for young people and non-smokers;

b) Contraindications;

c) Warnings for specific risk groups;

d) Possible adverse effects;

e) Potential for creation of addictions and toxicity, and

f) Contact elements of the manufacturer or importer and of the collective person or

singular to contact.

4-The individual packaging and the outer packaging of electrolytic cigarettes and refills

shall submit, in the terms provided for in Article 11 (2) and (3) to the following

health warning:

5-" This product contains nicotine, a substance that creates strong dependence. It's not

recommended your use by non-smokers. "

6-The individual packaging and the outer packaging of electrolytic cigarettes and refills

must still contain the list of all ingredients of the product, by descending order

of weight, the indication of the nicotine content of the product and the release by dose, the number

of the lot and a recommendation to keep the product out of reach of the

children.

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7-The individual packaging and the outer packaging of electrolytic cigarettes and refills

may not include the elements or characteristics provided for in Article 13, with the exception

of those provided for in points a ) and c ) of paragraph 1 of the same article, as far as the information is concerned

on the content of nicotine and on flavourings.

Article 14-And

Advertising and sponsorship of electro-electric cigarettes and refills

1-Commercial communication in services of the information society is prohibited, in the

press and other printed publications, which aim to or have either direct or indirect effect

the promotion of electrolytic cigarettes and refills, with the exception of the targeted publications

exclusively to professionals in the trade in electronic cigarettes and refills, and das

publications that are printed and published in third countries, if those publications

are not primarily intended for the European Union market.

2-Commercial communication on radio that is aimed at or has by direct effect or

indirect the promotion of electrolytic cigarettes and refills.

3-Any form of public or private input for radio programmes is prohibited

which aim to or have by direct or indirect effect the promotion of electrolytic cigarettes and

refills.

4-Any form of public or private input is prohibited for any event,

activity or individual that vise or have by direct or indirect effect the promotion of

electrolytic cigarettes and refills, and that it implies or occurs in several Member States

or have any other cross-border effect.

5-It shall apply to electronic cigarettes and recharge the provisions of Article 16 (10) and in the

articles 17 and 19.

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Article 14-F

Communications relating to electrolytic cigarettes and refills

1-The manufacturers and importers of electrolytic cigarettes and refills must present

annually to the Directorate General of Health:

a) Circumstantial data from sales volumes, by brand and by type of the product;

b) Information on the preferences of the various groups of consumers, including

young people, non-smokers and the main types of users at the moment;

c) Mode of sale of products; and

d) Syntheses of all market analyses carried out in the constant domains of

previous points, including their translation in English.

2-A Directorate General of Health accompanies market developments regarding the

electrolytic cigarettes and refills, including any elements that demonstrate that the

its use is an access route for nicotine dependence and, ultimately,

for the consumption of traditional tobacco by young people and non-smokers.

3-The manufacturers, importers and distributors of electrolytic cigarettes or refills

shall establish and maintain a system for the collection of information on all the

presumed adverse effects to the human health of these products.

4-Whenever manufacturers, importers and distributors of electrolytic cigarettes or

refills consider or have reason to believe that electrolytic cigarettes or refills

that are in their possession and are marketed, or the such are intended, are not safe, not

are of good quality or are not in accordance with this law, they must take

immediately all the corrective measures necessary to adapt the product concerned

to the provisions of this Law, or to withdraw or collect it from the market, as the case may be.

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5-In cases provided for in the preceding paragraph, manufacturers, importers and distributors

of electrolytic cigarettes or refills immediately inform the Safety Authority

Food and Economic and the Directorate General of Health, indicating in particular the risk to

human health and safety and any corrective measures taken, as well as the

results of these measures.

6-A Food and Economic Safety Authority, as well as the Directorate General of

Health, may require manufacturers, importers and distributors of cigarettes

electrolyte or recharge additional information, notably on the aspets of the

safety and quality or the adverse effects of electrolytic cigarettes or refills.

7-In the case of electrolytic cigarettes and refills that comply with the provisions of this Law, and

without prejudice to the competences assigned to the entities that exercise the power of

health authorities, if the Food and Economic Safety Authority checks or

have reasonable grounds to believe that a specific electrolytic or recharged cigarette, or

a type of electrolytic cigarettes or refills, may constitute a serious risk to the

human health, may take appropriate interim measures, and may be requested

opinion to the Directorate General of Health.

8-The measures adopted under the previous paragraph shall be immediately

communicated to the European Commission and to the competent authorities of the other States-

Members, and any data in which it is founded, shall still be communicated.

Article 14-G

Plant-based products for smoking

1-Each individual packaging and each outer packaging of plant-based products

for smoking must present the following health warning:

"Smoking this product harms your health"

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2-A health warning provided for in the preceding paragraph shall be printed on the surface

front and back external packaging and from any outer packaging and

shall comply with the requirements set out in Article 11 (3).

3-A health warning should cover 30% of the area of the corresponding surface of the

individual packaging and any outer packaging.

4-The individual packaging and any outer packaging of plant-based products

for smoking may not include the elements or characteristics to which the points are referred

a ), b ) and d ) of Article 13 (1), and may not also indicate that the product is

free from additives or flavourings.

Article 14-H

Communication of the ingredients of plant-based products for smoking

1-The manufacturers and importers of plant-based products for smoking must

present to the Directorate General of Health the list of all ingredients, and respects

quantities, used in the manufacture of such products, by brand and by type.

2-The manufacturers and importers of plant-based products for smoking must

also communicate to the Directorate General of Health, and prior to its marketing,

any change to the composition of a product that affects the information provided to the

shelter of this article.

3-A The Directorate General of Health ensures the dissemination, on its website, of the data

presented in the terms of this article, taking into account, where appropriate

of this, the information that constitutes commercial secrecy and that for such an effect has been

specified by the manufacturer or importer of plant-based products for smoking.

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4-A submission of the list provided for in paragraph 1 shall be made prior to the marketing of

new plant-based products for smoking.

CHAPTER VII

Sale of tobacco products, from plant-based products to smoking and from

electro cigarettes

Article 15.

Ban on sale of tobacco products, from products to the base of

plants for smoking and electrolytic cigarettes

1-The sale of tobacco products, from plant-based products to smoking and

of electrolytic cigarettes:

a) In the places referred to in points a ), d ), and ), f ), g ), h ), i ), r ), v ), aa ) and bb ) of paragraph 1

of Article 4 and in the facilities referred to in paragraph m ) of the same article;

b) Through vending machines, whenever these do not gather

cumulatively the following requirements:

i) Be fitted with an electrolytic device or other blocker system

that prevents your access to minors of 18 years;

ii) Be located within the commercial establishment, in such a way

be viewed by the responsible of the establishment, and may not be

placed in the respects areas of access, ladders or similar areas and in the

corridors of shopping centres and large commercial surfaces;

c) To minors under the age of 18 years, to be compensates through the exhibition of

identitive document with photography;

d) Through all distance selling techniques, specifically by means of

televenda and Internet .

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2-A prohibition referred to in para. c ) of the preceding paragraph shall appear in printed notice in

easily readable characters, on contrasting background, and affixed in a visible way in the

places of sale of tobacco products, from plant-based products to smoking and from

electro cigarettes.

3-The marketing of promotional packaging or the reduced price is prohibited.

4-[ Revoked ].

CHAPTER VIII

Advertising, promotion and sponsorship of tobacco and tobacco products

Article 16.

Advertising and promotion

1-Are prohibited all forms of advertising and promotion to tobacco and products of the

tobacco, including hidden, dissimulated and subliminal advertising, through supports

advertisement national or with a registered office in Portugal, including the services of the society of

information, save the provisions of paragraphs 3, 4 and 7.

2-It is prohibited to advertise tobacco, or its use, in vending machines.

3-The provisions of paragraph 1 shall not apply to the commercial information circumscribed to the particulars

of price, mark and origin displayed exclusively within the establishments that

sell tobacco products, as long as this is not visible from the outside of the

establishments, specifically in the montras ' respective respects.

4-A advertising in the press and in other printed media is only permitted

in publications aimed exclusively at professionals in the tobacco trade or

in publications printed and edited in third countries, as long as they are not intended

mainly to the community market.

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5-Free distribution or promotional sale of tobacco products is prohibited or

of any consumer goods, which they target, or have for direct or indirect effect, the

promotion of these tobacco products or their consumption.

6-The distribution of brindles, award of prizes or the achievement of

competitions, albeit exclusively for smokers, by companies

directly or indirectly related to the manufacture, distribution or sale of

tobacco products.

7-It is only admitted to the promotion of tobacco products when this one is destine

exclusively to the professionals of the tobacco trade and be held outside the

scope of the sales activity to the public.

8-The introduction of coupons or other extraneous elements in packaging and

on packaging of tobacco products, or between these and those, in addition to the

own tobacco product and respect labeling.

9-The promotion of sales and the introduction in packaging consumption is prohibited

miniature of brands already marketed or marketing.

10-The audiovisual commercial communication, provided for in Law No. 27/2007, is prohibited from 30 of

July, amended by the Laws No 8/2011 of April 11, and 40/2014, of July 9, the

tobacco products.

11-The provisions of this Article shall apply to the plant-based products for smoking.

Article 17.

Advertising on consumer objects

1-In advertising actions, it is forbidden to place names, marks or emblems of a product

of tobacco in consumer objects other than the tobacco products themselves.

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2-Exceed from the ban provided for in the previous number the goods and services that make use

of identical names or marks to those of tobacco products, provided that they have filled the

following requirements:

a) Your sale or sponsorship are not related to the sale of products

of tobacco;

b) Such goods or services have been introduced in the Portuguese market

prior to the date of publication of this Law;

c) The method of use of such names and marks is clearly distinct from that of the names

and brands of tobacco products.

3-It is prohibited the manufacture and marketing of games, toys, video games, food

or treats with the form of tobacco products, or with logo-branded logos of

tobacco.

4-The provisions of this Article shall apply to the plant-based products for smoking.

Article 18.

Sponsorship

1-Any form of public or private input is prohibited, in particular by part

of companies whose activity is the manufacture, distribution or sale of products of the

tobacco, intended for an event, an activity, an individual, an audio-visual oeuvre, an

radiophonic or television program, which vise, or has for direct or indirect effect, the

promotion of a product of tobacco or its consumption.

2-Is prohibited the sponsorship of events or activities by companies of the tobacco sector that

engage in or perform in a number of member states or have any others

cross-border effects.

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3-Free distribution or promotional prices of tobacco products is prohibited, in the

context of the sponsorship referred to in the preceding paragraph, which vise or have by direct effect

or indirect the promotion of these products.

4-The provisions of this Article shall apply to the plant-based products for smoking.

CHAPTER IX

Measures for prevention and control of smoking

Article 19.

Information campaigns, prevention or sales promotion

Campaigns or other initiatives promoted or sponsored by the companies are prohibited

producers, distributors, subsidiaries or related products, of tobacco and product products to

base of plants for smoking, which target, directly or indirectly, information and prevention

of the smoking.

Article 20.

Information and education for health

1-The State, specifically the sectors of health, education, youth, sport,

of the defence of the consumer, the environment, labour, economy and culture, well

how the autonomous regions and local authorities, should promote the information of the

citizens, using, whenever possible, the sign language and the Braille language, and

contribute to the creation of conditions favourable to the prevention and control of the

tabagism.

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2-Health services, regardless of their legal nature, specifically

health centres, hospitals, clinics, doctors ' offices and pharmacies, should promote

and support the information and education for the health of citizens regarding the

malefices arising from tobacco use and the importance of smoking cessation,

through campaigns, programmes and initiatives aimed at the general population or the

specific groups, specifically children and young people, pregnant women, parents, women in age

fertile, sick people, teachers and other workers.

3-A thematic of the prevention and control of smoking should be addressed within the framework of the

education for citizenship, at the level of basic and secondary education and curricula of the

vocational training, as well as training pre- and postgraduate education of teachers

of these levels of education.

4-A The thematic of the prevention and treatment of tobacco use and dependence should do

part of the curricula of the pre- and post-graduate training of health professionals, in

particular of doctors, dentists ' doctors, pharmacists and nurses,

while privileged agents of education and health promotion.

Article 21.

Tabagic cessation consultations

1-intensive support consultations should be created on smoking cessation in all

Clusters of health centres and hospitals of the National Health Service,

specifically in the services of cardiology, pneumology, psychiatry and obstetrics, in the

institutes and services of oncology, in the psychiatric hospitals and in the centres of

care for alcoholics and addictions.

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2-Whenever the dimension of services and the population served does not justify the creation of

intensive support consultation to the smoking cessation, protocols should be established

with other intensive tobacco cessation support consultations available in others

groupings of health centres or hospitals of the National Health Service, so

to ensure adequate access for smokers who require this type of support for

leave to smoke.

Article 22.

Advisory technical group

1-It is created, in the direct reliance of the Director General of Health, an advisory technical group,

aiming to provide technical advice, as well as to provide collaboration in the definition and

implementation of programmes and other initiatives in the field of prevention and control

of the smoking.

2-The advisory technical group, designated by dispatch of the director-general of Health, is

constituted, parity, by representatives of the Public Administration and the society

civil, and, as to this, particularly of occupational orders from the area of health, of

trade union and employers ' associations, of scientific societies as well as by

personalities of recognised merit in the field of prevention and control of the

tabagism.

3-The persons referred to in the preceding paragraph shall declare the absence of any conflict

of interests with the objectives of the advisory technical group, in the field of prevention and

control of smoking.

Article 23.

Duty of collaboration

The Directorate General of Health promotes compliance with the provisions of this Law, with the

collaboration of public services and bodies with responsibilities in this area.

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Article 24.

Statistical study

1-A Directorate General of Health, in articulation with the National Observatory of Health and

with the advisory technical group, ensures statistical monitoring and

epidemiological consumption of tobacco in Portugal, as well as the resulting impact of

application of this Law, specifically as to its compliance, to the evolution of the

conditions in the places of work and service to the public, in order to allow to propose

appropriate changes to the prevention and control of tobacco use.

2-With the aim of assessing the impact of this law on the public health and health of the

workers, the Ministry of Health should enable the Assembly of the Republic with a

report containing the elements referred to in the preceding paragraph, every five years.

3-The first report is to be delivered in the Assembly of the Republic decorated three years

on the entry into force of the law.

CHAPTER X

Sanctionatory regime

Article 25.

Counterorders

1-Constituting counterordinations the infractions to the provisions of Articles 4 to 6, in paragraph 2 of the

article 7 and in Articles 8 to 19, which are punished with the following fines:

a) From 50 a to € 750, for the smoker who fumes at the places provided for in the points a ) a

bb ) of Article 4 (1) and (2) or outside of the outdoor areas or areas for

smokers provided for in Article 5 (1 a) (9);

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b) From 50 a to € 1000, for the owners of the private establishments, people

collectives, societies yet unlawlessly constituted, or associations without

legal personality, as well as for the governing bodies or leaders

maximum bodies, establishments or services of the Administration

Public violating the provisions of Article 7 (2);

c) From € 2500 a to € 10000, for entities referred to in the preceding paragraph which violate the

provisions of paragraph 1, 2, 4, 5, 6, 8, 9, 9 and 10 of Article 5 and Article 6;

d) From € 10000 a to € 30000, for infractions to paragraphs 1 a to 7 and 10 of Article 9, to the

n. paragraphs 2 and 4 of Article 10, to paragraphs 1 a to 3 of Article 14-B, to paragraphs 3, 4, 6 and 8 of the

article 14-C, to Article 14-F and to paragraphs 1, 2 and 4 of Article 14-H, being the value

reduced to € 1500 and € 3000, respectively, if the offender is person

singular;

e) From 30000 a to € 250000, for infractions to Article 8 (1), to n. ºs 1, 2, 3 and

6 of Article 9, to paragraphs 1, 4 and 5 of Article 10, to Article 11 (1 a) (8)

articles 11-A, 11.-B, 11-C, 12 and 13, to paragraphs 1 a to 6, 8, 10 and 14 of Article 13-

A, to paragraphs 1 and 4 of Article 13-B, to Articles 14 and 14-A, to n. paragraphs 1 and 2 of the

article 14-C, to Article 14-D, to Article 14-And, to Article 14-G, to paragraphs 1 a to 3

of Article 15, and Articles 16, 17, 18 and 19, being the reduced value for € 2

000 and € 3750, respectively, if the offender is a natural person.

2-A negligence is punishable, being the minimum and maximum limits of the applicable fines

reduced to half.

3-In cases provided for in paragraph and ) of paragraph 1, the attempt is punishable by being the minimum limits

and maximum of the applicable fines reduced to half.

4-When the infraction involves form of hidden or concealed advertising, it shall apply to

punishment provided for in the general standards on advertising activity.

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5-To the counterordinations provided for in this Law, and in everything as it if it does not find

specially regulated, the general regime of the counterordinations, approved by the

Decree-Law No. 433/82 of October 27.

Article 26.

Ancillary sanctions

1-In the case of the counterordinations provided for in points c ), d ) and and ) of paragraph 1 of the previous article,

the ancillary sanctions provided for in Article 21 (1) may still be applied.

general regime of the counterordinations, approved by the Decree-Law No. 433/82, of 27 of

October.

2-Failure to comply with the provisions of Article 15 (1 a) to (15) determines the application of the

ancillary sanction of interdiction of sale of any tobacco product.

Article 27.

Solidarity liability

1-For the payment of the fines in which the agents of the infractions are condemned to

provisions of Article 8 (1), Article 9 (6), paragraphs 1 a to 7 and 10 of Article 9, thereof,

in paragraphs 2 and 4 of Article 10, paragraphs 1, 4 and 5 of Article 10, in Article 1 a (1 a) of the article

11, in Articles 11-A, 11-B, 11-C, 12 and 13, in paragraphs 1 a to 6, 8, 10 and 14 of the article

13.-A, in Article 13 (1) and (4)-B, in Article 14, paragraph 1 a to 3 of Article 14-B, in the

n. paragraphs 1 a to 4, 6 and 8 of Article 14-C, in Articles 14-D, 14--E, 14.-F and 14.-G and in paragraphs 1,

2 and 4 of Article 14-H, are jointly and severally liable to the manufacturer and the importer of

tobacco products.

2-For the payment of the fines in which the agents of the infractions are condemned to

provisions of the paragraph b ) of Article 15 (1) and in Article 16 (2), are jointly and severally

responsible the owner of the automatic tobacco vending machine and the one who

have the effective direction of the space in which the equipment is installed.

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3-For the payment of the fines in which the agents of the infractions are condemned to

provisions of Article 17, they are jointly and severally liable to the manufacturer or importer and the

owner of the places or the holders of the farm where these products are

made available, either onerously or gratuitously.

4-For the payment of the fines in which the agents of the infractions are condemned to

provisions of the paragraph d ) of Article 15 (1), in paragraphs 1, 5, 6, 8, 10, 10 and 11 of Article 16 and

in Article 19, they are jointly and severally liable to the advertiser, the professional, the agency of

advertising or any other entity that exercises the advertising activity, the holder of the

advertising support or the concessionary respect, as well as any other

intervener in the issuance of the advertising message.

5-For the payment of the fines in which the agents of the infractions are condemned to

provisions of Article 18, they are jointly and severally liable to the sponsoring entity and the

sponsored entity.

6-Entity holders of the advertising support used or the concessionary respect

be eximited from the liability referred to in paragraph 4, if they demonstrate not to have had prior

knowledge of the disseminated advertising message.

Article 28.

Surveillance and procedural plotting

1-Without prejudice to the competences assigned by Article 7 to the administrative authorities and

police officers, the supervision of the provisions of this Law shall compete with the Security Authority

Food and Economic, except for the supervision of the precept in paragraph (d) of paragraph 1

of Article 15, Article 16 (1), Article 18 (1) and Article 19, which

compete with the Consumer General Directorate.

2-A The instruction of the counterordinance processes competes with the Safety Authority

Food and Economic or the Consumer General Directorate, in the context of the respect

assignments, and to whom the autos are to be sent by other entities should be sent.

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3-It is up to the inspector general of the Food and Economic Safety Authority and the Director-

general of the Consumer General Directorate, as per the applicable case, the application of the

respects fines and ancillary sanctions, which of them give notice to the Directorate General of the

Health.

4-The product of the fines is distributed as follows:

a) 60% for the State;

b) 40% for the entity that instructed the process and applied the fine;

c) [ Repealed ].

CHAPTER XI

Transitional and final provisions

Article 29.

Autonomous Regions

1-Autonomous Regions exercise the powers provided for in this Law through the

organisms defined by the governing bodies of their own.

2-The product of the fines applied in the Autonomous Regions constitutes own revenue from these.

Article 29-The

Provision of information

For the purposes of the provisions of Chapters III, IV-A and IV-B, the obligation to provide the

required information is incumbent on the first instance to the manufacturer, if this is

established in the European Union, to the importer, if the manufacturer is established outside the

European Union and the importer is established in the European Union, and jointly

to the manufacturer and to the importer, if both are established outside the European Union.

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Article 30.

Abrogation standard

They are revoked:

a) The Act No. 22/82 of August 17;

b) The Decree-Law No 226/83 of May 27;

c) The Decree-Law No 393/88 of November 8;

d) The Decree-Law No 287/89 of August 30;

e) The Decree-Law No 253/90 of August 4;

f) Article 18 and Article 24 (2) of the Code of Publicity, approved by the

Decree-Law No 330/90 of October 23;

g) The Decree-Law No 200/91 of May 29;

h) The Decree-Law No 276/92 of December 12;

i) The Decree-Law No 283/98 of September 17;

j) Article 95 of the Code of Excise Taxes, approved by the

Decree-Law No 566/99 of December 22;

l) The Decree-Law No 25/2003 of February 4;

m) The Decree-Law No 138/2003 of June 28;

n) The Decree-Law No 76/2005 of April 4;

o) The Decree-Law No 14/2006 of January 20;

p) The n. paragraphs 2 a to 5 of the Resolution of the Council of Ministers No 35/84 of June 11;

q) The Portaria No. 165/84 of March 26;

r) The Portaria No. 432/91 of May 24;

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s) The Portaria No. 735/93 of August 13;

t) The order No 19 /MS/88 of January 25, 1989;

u) The order n 8/ME/88 of February 8, 1989.

Article 31.

Entry into force

This Law shall come into force on the January 1, 2008.

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ANNEX I

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ANNEX II

(referred to in Article 11 (1)-B and Article 11 (2) thereof)

1-List of the caveats in text:

a) "Smoking causes 9 in every 10 cancers of the lung"

b) 'Smoking causes cancer of the mouth and throat'

c) "Smoking damages your lungs"

d) 'Smoking causes heart attacks'

e) 'Smoking causes cerebral vascular accidents and incapacities'

f) "Smoking causes the obstruction of the arteries"

g) "Smoking aggravates the risk of blindness"

h) 'Smoking causes lesions in your teeth and gums'

i) "Smoking can kill your child before he is born"

j) 'Your smoke harms your children, family and friends'

k) 'The children of smokers have higher propensity to smoke'

l) "Let it smoke already-think of who likes you"

m) "Smoking reduces fertility"

n) "Smoking aggravates the risk of impotency"

2-Photographs in colour-library of images (of combined health warnings)

referred to in Article 11.-B.

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Series 1

136

137

Series 2

138

Series 3

139

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