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Adjustment Of The Hellenic Legislation To Directive 2014/40/eu Of The European Parliament And Of...

Original Language Title: Adjustment of the Hellenic legislation to Directive 2014/40/EU of the European Parliament and of...

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PART A ' GENERAL PROVISIONS

Article 1

The purpose of this law is: 1. The adaptation of Greek legislation to,

Directive 2014 /40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of products (ii) tobacco and related products and repealing Directive 2001 /37/EC (No L 127/1 of 29.4.2014), Delegated Directive 2014 /109/EU amending Annex II to Directive 2014 /40/EU of the European Parliament and of the Council with the adoption of the library of pictographic warnings to be used To be used for the product and other relevant provisions.

2. The provisions of this law are applied to tobacco products, to tobacco products, to new tobacco products, to e-cigarettes and refillable containers, and to tobacco products for smoking tobacco.

Article 2 Definitions

(Article 2 of Directive 2014/40)

For the purposes of this law the following definitions shall apply:

(1) "tobacco": leaves and other natural, processed or unprocessed tobacco plants, including inflated and mixed tobacco;

(2) "pipe smoke" means a smoke which can be consumed by a combustion process and intended solely for use in a pipe;

(3) 'tobacco for spinning cigarettes': tobacco which can be used to manufacture cigarettes from or from retail shops;

(4) 'tobacco products' or 'tobacco products' means products which can be consumed, whether or not in part, of tobacco, whether genetically modified or not;

(5) 'non-smoking tobacco product' means a tobacco product consumed without a combustion process, including tobacco smoke, tobacco obtained from the nose and tobacco taken from the mouth;

MEMBER OF THE GREEK EXCERPT

First, From the Proceedings of the RIP, 8 September 2016, No. Meetings of the Assembly of the House, in which

The following draft law was adopted:

Adaptation of the Greek legislation to Directive 2014 /40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of laws, regulations and administrative provisions

And administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products and related products and repealing Directive 2001 /37/EC

(number) L 127/1 of 29.4.2014), as Annex II of this Directive was amended by Commission Delegated Directive 2014 /109/EU of 10 October 2014 amending Annex II to Directive 2014 /40/EU Parliament,

And the Council with the establishment of the library of the pictographic warnings to be used for tobacco products and other relevant provisions

(b) 'asthma' means non-smoking tobacco intended solely for asthma;

7) 'tobacco taken from the nose': non-smoking tobacco product which can be consumed through the nose,

(8) "Tobacco products obtained from the mouth": all tobacco products obtained from the mouth, other than those intended for inhalation, and which are manufactured in whole or in smoke, in powder or in form Particles or in any combination of these forms, in particular the products packaged in a single-or porous sachets,

(9) 'tobacco products for smoking': tobacco products other than tobacco products;

(a) Smoke cylinders which can be smoked as they are and which are not cigars or cigarillos; (b) the cylinders of smoke which have a simple non-industrial handling slide into the Chi-cat tubes; c) the smoke cylinders; Simple non-industrial handling is wrapped in cigarettes,

(a) Smoke cylinders with outside natural smoke, (b) Smoke cylinders with a mixture of smoke and with an outer packaging in the normal colour of the cigar, from reconstituted tobacco, which fully covers the product and where The filter is needed, not the mouthpiece in the case of products with a mouthpiece, where the weight per unit, including the filter or the filter, is not less than 2.3 lines, not more than 10 lines and the For a period of at least one third of the duty is not less than 34 hi-liins,

12) "cigaraki": a cigar weight of 3 grams, 13) "tobacco for bong": tobacco product

To be consumed via bong. For the purposes of this law, tobacco for bong is considered to be a tobacco product intended for smoking. If a product can be used both by bong and in smoke for striped cigarettes, it is considered as smoke for cigarettes;

14) 'new tobacco product' means a tobacco product which: (a) does not belong to one of the following categories: chi-garo, tobacco for spinning cigarettes, pipe tobacco, cigar smoke, cigar, mashed potatoes, smoke inhalation, smoking, and tobacco obtained from the nose and tobacco Taken orally and (b) is on the market with-on 19 May 2014,

15) 'plant product for smoke' means a plant based on plants, herbs or fruit, which does not contain tobacco and which can be consumed through a combustion process;

16) 'electronic cigarette' means a product which can be used for consumption of a product containing an epithelial or an element of the product in question, including the container, container and apparatus without a container or container. The electronic cigarettes may be or re-lubricate through a reclamation and receptacle or replete with a disposable container,

17) 'refilling container' means a container containing a liquid containing nicotine, which can be reused to re-use an electronic cigarette;

(18) 'ingredient' means tobacco, additive, and any substance or evidence present in the final product of tobacco or related products, including paper, filter, melons, capsules and adhesives,

19) "nicotine": nicotine alkaloids, 20) "tar": the raw anhydrous nicotine

In this case, the Commission has decided to consult the Commission on the application of the principle of equal treatment.

A tobacco or a related product is used in accordance with its intended use, such as substances present in the released smoke or substances discharged in the process of using non-smoking tobacco products,

(22) "maximum level" or "maximum discharge level" means the maximum content or exposure, including zero, of a substance in a tobacco product, measured in milligrams;

23) 'additive' or 'additive': any substance, with the exception of tobacco, added to a tobacco product, its packaging unit, or any external preparation;

(24) 'aroma' means an additive which gives the flavour and/or taste;

25) "flavouring/taste": clearly perceived or taste, different from the point of view and the meal of tobacco, resulting from additive or co-production of additives, including, but not specified in, the fruit, the fruit, the fruit, the Aromatics plants, alcohol, caramels, ingots or vanilla, which is noticeable before or during the consumption of the tobacco product,

26) 'addictive': the pharmacological ability of a substance to cause an addiction, a condition that affects the ability of a person to control its behaviour, usually through a feeling of whether or not withdrawal from symptoms of withdrawal or Two;

27) 'toxicity' means the extent to which a substance may cause harmful effects in the human body, including effects that occur over time, usually through repeated or continuous consumption or exposure,

(28) 'substantial change in the circumstances' means an increase in sales volume by product category by at least 10 % in at least five Member States on the basis of the sales figures transmitted in accordance with Article 5 (5) or increased A level of prevalence of use in the group of illiterates under 25 years of age by at least five percentage points in at least five Member States for the corresponding product category with regard to the Special Report 385 of the Eurobarometer May 2012 or equivalent prevalence studies; in each case, it is considered not to have been reduced Substantial change in the circumstances when the volume of sales of the product category at retail level did not exceed 2,5 % of the total sales of tobacco products at Union level,

(29) 'outer packaging' means any packaging with which tobacco products or related products are placed on the market and which includes a unit of preparation or a packaging unit group; the adverts are not considered to be external Packaging;

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30) 'packaging unit' means the lower individual packaging of a tobacco product or a related product placed on the market;

31) 'pouch' means a tobacco packaging unit for spinning cigarettes either in the form of a rectangular casing with a cap covering the opening or in the form of a goulash with a flat bottom,

32) 'health warning' means a warning concerning the adverse effects on human health of a product or other undesirable effects of its use, including verbal warnings, combinations of Health warnings, general warnings and medicinal products, as provided for in the law,

33) 'combined health warning' means a health warning consisting of a combination of verbal warning and corresponding photo or picture, as provided for in this law;

(34) "distance selling cross-border sales" means a distance selling of products to consumers where the consumer, when ordering the product from a retailer, is located in a Member State other than the Member State; or The third country where the said retail store is located; the retail store is deemed to be located in a Member State: (a) in the case of a natural person: if such a natural person has his business headquarters In the Member State in question, (b) in the other cases: if the retailer has In the said Member State, its registered office, central administration or place of business, including a substitute, anti-personal or any other establishment,

(35) "consumer" means any natural person who is involved for purposes unrelated to the commercial, business or business activity;

(36) 'Age verification system' means a computer system confirming electronically in a questionable manner the consumer's age in accordance with national requirements;

(37) 'manufacturer' means any natural or legal person who manufactures a product or which instructs the product to be designed or manufactured and has this product on the market under the name or in its trade mark;

(38) 'import of tobacco products or related products' means the entry of the products in question into the territory of the Union, unless the products are placed in a customs procedure or a suspension procedure on entry into the Union, and their release from Customs procedure or suspension arrangement;

(39) 'importer of tobacco products or related products' means a person who has the ownership or right to dispose of tobacco products or related products imported into the territory of the Union;

(40) 'placing on the market' means the placing of products, irrespective of their place of manufacture, to consumers in the Union, with or without payment, including distance selling;

Case of cross-border sales, the product is deemed to be placed on the market in the Member State in which the consumer is located;

41) 'Retail sales pitch': any deposit on the market of tobacco products, including the release of the products from a natural person.

OTHER B) TOBACCO PRODUCTS

CHAPTER I-REFERENCES AND EMISSIONS

Article 3 Maximum levels for tar pitch,

Nicotine, carbon monoxide and other substances (Article 3 of Directive 2014/40)

The maximum levels of cigarette smoke which are placed on the Greek market or manufactured in the Member States ("peak levels of emissions") are not: a) 10 mg of tar per cigarette; b) 1 mg of nicotine per cigarette; c) 10 mg of monoxide. Carbon per cigarette.

Article 4 Measurement methods

(Article 4 of Directive 2014/40)

1. The tar, nicotine and carbon monoxide of cigarettes are measured according to ISO standard 4387 for tar, ISO 10315 for nicotine and standard ISO 8454 for carbon monoxide. The accuracy of tar, nicotine and carbon monoxide measurements shall be determined according to ISO standard 8243.

2. The measurements referred to in paragraph 1 shall be verified by the accredited laboratory of the General State of the State or other laboratories accredited by the Self-Employed Operating Unit of the National Assembly of Quality Assets (') Article 6 of the Law. 4109/2013 (PARAGRAPH 16). Those laboratories shall meet the following criteria: Must be located within the Greek language

Territory, b. They must not be owned or controlled immediately.

Or between the tobacco industry, c. Must have an Accreditation Certificate

In force in relation to the methods covered by the provisions of this law and which should be based on the relevant harmonised standard in the accreditation of laboratories, ISO/IEC 17025 in the fields of application of the above To be measured. These criteria may be amended in order to comply with the relevant national and national legislation.

3. The accredited laboratories shall notify the Department of Health and Safety of Health and Dependencies of the Health Department of the Health Department of the Ministry of Health in the Department of Health and Safety at the Department of Health and Safety at the Department of Health.

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The Committee of the Environment, Public Health and Consumer Protection and the Committee of the Environment, Public Health and Consumer Protection and the Committee of the Environment, Public Health and Consumer Protection and the Committee of the Environment, Public Health and Consumer Protection. Each accredited laboratory must inform the Health Department directly in the event of suspension or revocation of its accreditation by the Accreditation Unit (IFF). If a laboratory fails to inform the Health Department directly, then this laboratory shall be excluded from any future evaluation of its inclusion in the list of accredited laboratories. The Health Department shall communicate the decision to close the laboratory from the list of designated laboratories to manufacturers and importers of tobacco products. The Ministry of Health maintains a list of accredited laboratories. This conclusion, as well as the amendments to it, shall be communicated to the Commission. The European Commission shall also inform the European Commission of the methods used for cigarette smoking, other than tar, nicotine and carbon monoxide and for tobacco products other than cigarettes.

4. For the verification of the measurements of variant 1 carried out in the accredited laboratories of the General Secretariat of the State, manufacturers and importers of tobacco products advance from-compensation in accordance with 3002640 /152/6.2.2002 from - Deputy Minister for Economic Affairs (Bl 161).

Article 5 Notification of ingredients and products

(Article 5 of Directive 2014/40)

1. Manufacturers and importers of products and products shall submit to the Department of Health and Safety at the Department of Health and Dependencies of the Health Department of the Ministry of Health, in a special format, as defined in the Executive Board. (a) 2015/2186 (OJ L 312, 25.11.2015) and is Annex III to this law, the following information per article and formula: (a) list of all ingredients and quantities

(b) the levels of exposure referred to in the article in the manufacture of tobacco products, in descending order of weight, in the manufacture of tobacco products;

3, c) information on other cases and on -

(b) where available, where appropriate. For products already placed on the market,

This information is provided by 20 November 2016. Manufacturers or importers shall inform on -

To the Ministry of Health if the composition of a product is modified in such a way as to affect the information provided under this Article. For a new or modified tobacco product, the information

The provisions of this Article shall apply before the products in question are placed on the market.

2. The list of ingredients referred to in paragraph 1 of paragraph 1 shall be accompanied by a statement explaining the reasons why these ingredients are contained in the tobacco products concerned. This list also refers to the status of ingredients, including if it has been broken down by the Implementing Decision of the European Commission 2015/2186, the content of which is an integral part of this Annex. In accordance with Annex III, Annex III to the Regulation (EC) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, as well as their classification on the basis of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 18 December 2006. Opinion of the European Parliament and of the Council of 16 December 2008.

3. The list referred to in point (a) of paragraph 1 shall also be accompanied by the relevant toxicological data concerning the components before or after incineration, where appropriate, indicating in particular their impact on the health of consumers. And taking into account, inter alia, any addictive activities. In addition, for cigarettes and tobacco for spinning cigarettes, the manufacturer or importer shall submit a technical document containing a general description of the additives used and their properties. With the exception of tar, nicotine and carbon monoxide and the last paragraph of Article 4 (3), the manufacturers and importers shall indicate the methods of measurement used and carried out. Studies, if requested by the Ministry of Health, by decision of the Minister in order to assess the effects of ingredients on health, taking into account, inter alia, their toxicity and their addiction.

4. The information submitted in accordance with paragraph 1 and Article 6 shall be published on a dedicated website of the Ministry of Health, which shall take due account of the need to protect confidentiality when it publishes In accordance with paragraph 1 and Article 6, manufacturers and importers shall determine, in accordance with paragraph 1 and Article 6, information which they consider to be confidential.

5. Manufacturers and importers shall submit to the Department of Health and Safety at the Department of Health and Dependencies of the Health and Health Department of the Ministry of Health the internal and external studies available to them. However, in the context of the reform of the common agricultural policy, the Commission adopted a proposal for a Regulation on the common organisation of the market in milk and milk products and amending Regulation (EC) No 3265regulation on the common organization of the market in bananas. Marketing of new products. Manufacturers and importers refer to the Department of Health and Safety at the Department of Health and Dependencies of the Health and Safety Directorate of the Ministry of Health and the Ministry of Finance for the volume of sales Units and type, expressed in number of cigarettes or in kilogram, on an annual basis, on the Greek territory, from 1 January 2015.

6. All information and information provided

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To the Ministry of Health and the Ministry of Economy and the Ministry of Health under this Article and Article 6 shall be submitted in electronic form. These data shall be kept electronically and shall ensure that the European Commission and the accountable Member States have access to these information for the purposes of the application of this law. The Ministry of Health ensures the confidentiality of confidentiality and other confidential information. Manufacturers and importers shall specify, in the submission of the information, in accordance with paragraph 1 of this Regulation and in Article 6, the information provided for confidentiality.

Article 6 List of additives and adjuvants

Reporting obligations (Article 6 of Directive 2014/40)

1. In addition to the notification obligations laid down in Article 5, aid obligations to submit notifications to specific additives contained in cigarettes and tobacco for shrimped cigarettes shall be included in a list. Hierarchy of additives, based on an implementing act of the European Commission. This list includes: (a) for which there are initial indications, research or

Regulatory arrangements in other jurisdictions that indicate that one of the properties is defined in points (a) to (d) of para graph 2, (b) that are most commonly used.

Non-adjuvant additives by weight or number according to the notifications of constituents according to Articles 5 and 3 of Article 5.

2. Manufacturers and importers of cigarettes and tobacco for shrimped cigarettes containing an additive included in the list of hierarchies, as provided for in paragraph 1, should be carried out; Examine for each additional if: (a) contribute to the toxicity or addiction of

Of relevant products and if this results in an increase in toxicity or addiction of any of the relevant products in a significant or measurable manner, (b) result in an indication of flavour/taste; (c) Inhale or inhale Nicotine intake,

Or (d) leads to the formation of substances having properties

Carcinogenic, mutagenic, toxic to reproduction (CMR), their quantitiesand whether this result in an increase in the CMR properties in any of the relevant products to an important or semi-trainable extent.

3. These studies shall take into account the envisaged use of the products concerned and examine, in particular, the deductions arising from the combustion process in which the relevant additive is involved. The studies also examine the interaction of this additive with other ingredients contained in the relevant products. Manufacturers or importers

Using the same additive in their products may carry out a joint study using this additive in a comparable composition of the product.

4. Manufacturers or importers shall prepare each other for the results of these studies. This report includes a brief description and an overview of the available scientific literature for this additive and summarises the internal data for the effects of the additive. Manufacturers or importers shall submit these reports to the Ministry of Health, as well as to the European Commission, at the latest 18 months after the relevant additive has been included in the ranking list in accordance with paragraph 1. The Ministry of Health and the European Commission may also request additional information from manufacturers or importers for the relevant additive. This information is part of the report. The Ministry of Health, with a decision by the Health Minister, and the European Commission may request a comparative analysis of these reports through an independent scientific body, in particular with regard to the content, methodology and methodology. And their conclusions. The information received helps the Ministry of Health, as well as the European Commission in decision-making under Article 7 of this law.

5. In the case of a proposed report by another manufacturer or importer, it is exempted from the obligations under this Article, the very small, small and medium-sized undertakings. The category of micro, small and medium-sized enterprises (SMEs) consists of enterprises with fewer than 250 employees and whose annual turnover does not exceed 50 million euro or the total annual turnover The balance sheet does not exceed EUR 43 million. In the SME category, a small enterprise is defined as the enterprise which employs fewer than 50 employees and whose annual turnover or annual balance sheet total does not exceed EUR 10 million. In the SME category, a micro-enterprise is defined as the enterprise which employs fewer than ten employees and whose annual turnover or annual balance sheet total does not exceed EUR 2 million.

Article 7 Adjustment of the ingredients

(Article 7 of Directive 2014/40)

1. The placing on the market of tobacco products that have a characteristic flavour/taste is prohibited. It is not prohibited to use additives which are necessary for the manufacture of tobacco products, for example sugar replacing sugar, which is lost during the drying process, provided that such additives do not have As a-despote product with a characteristic flavour/taste and do not increase in significant or measurable extent the addiction, toxicity or CMR properties of the smoke product. The Ministry of Health has communicated to the

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In accordance with this paragraph, the measures taken each time shall be adopted by the European Commission.

2. The Ministry of Health, with the decision of the Minister of Health, may initiate an investigation into whether a tobacco product falls within the scope of paragraph 1, while informing the European Commission and its other Member States. European Union. European Union.

3. The Ministry of Health may consult the independent advisory committee recommended at Union level before adopting measures in accordance with paragraphs 1 and 2.

4. The placing on the market of tobacco products containing the following additives: (a) vitamins or other additives set up by the

Replication that a tobacco product benefits health or-has reduced health risks, b) caffeine or taurine or other additives and tonic

(c) additives which are considered to give effect and vital; (c) additional colour pigments for the marketing of tobacco products; d) for tobacco products;

Additives that facilitate inhalation or intake of nicotine, e) additives having CMR properties prior to

Burning them. 5. The placing on the market of products shall be prohibited;

Containing flavouring substances in any of their constituents, such as filters, cigarettes, packaging, packaging, capsules or any other characteristic permitting the modification of the smell or flavour of the products concerned Tobacco or the intensity of the tobacco released. The filters, the chi-garb and the capsules do not contain any tobacco or niko-tin.

6. The provisions and conditions laid down in Regulation (EC) No 1907/2006 (REACH) are applied to tobacco products, as appropriate.

7. On the basis of scientific data, the placing on the market of tobacco products containing additives in quantities that increase the toxic or addictive effect or the properties of KMT product at the stage of consumption is prohibited. -To-train extent. The Ministry of Health shall notify the European Commission of the measures taken in accordance with this paragraph.

8. Tobacco products other than cigarettes and non-smoking cigarettes shall be exempt from the requirements laid down in paragraphs 1 and 5.

9. The Ministry of Health may initiate a procedure to assess whether a product of tobacco has a characteristic taste, whether or not additives or flavourings are used, and whether a tobacco product contains additives. In quantities that increase to a significant and measurable extent the toxic or addictive effect or CMR properties of the tobacco product concerned. The Commission referred to in Article 17 (3) of this law shall be responsible for establishing the existence of the prohibited ingredients in this Article. The Commission is consulted on the request of the Minister for Health, or following a complaint by any person, and submits an explanation to the Minister for Health, who, after the Commission's opinion, is prohibited;

In the case of products, the composition of which is not harmonised with the provisions of this Article.

10. In the case of tobacco products with a characteristic taste/taste of which at least 3 % of product category sales account for at least 3 %, the provisions of this Article shall apply from 20 May 2020.

11. This article is not applicable to oral tobacco.

CHAPTER II LABELLING AND PACKAGING

Article 8 General provisions

(Article 8 of Directive 2014/40)

1. Each unit of packaging of a tobacco product and any outer packaging thereof available on the Greek market shall bear the health warnings provided for in this Chapter in the Greek language.

2. Health warnings shall cover the entire surface of the packaging unit or of the outer packaging intended for them and shall not be commented upon, paraphrase or bonded in any form.

3. The health warnings in the preparation unit and on each outer packaging shall be printed in such a way that they cannot be removed, indelibly and fully visible, as well as not hiding in part or entirely or in part. They are interrupted by tax stamps, labels of values, safety features, envelopes, boxes or other objects when the tobacco products are placed on the market. In the case of tobacco products, with the exception of cigarettes and tobacco for striped cigarettes in bags, health warnings may be pasted with stickers, provided that these stickers cannot be removed. The warnings for the marketing remain intact with the opening of the packaging unit, except for packages with an articulated lid, when health warnings can be used to open the package, but only in a way that ensures The graphic integrity and the visibility of the site, photographs and information on the detox from smoking.

4. Warnings for health do not hide, or interrupt, in any way the taxes, labels indicating what is, the surveillance and tracking signals, or the safety features of packaging units.

5. The dimensions of the health warnings provided for in Articles 9, 10, 11 and 12 shall be calculated in relation to the relevant surface when the package is closed.

6. Health warnings shall be surrounded by a 1 mm wide area within the surface of the surface intended for these warnings, with the exception of health warnings referred to in Article 11.

7. The pictures of the packing unit and each outside -

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End-of-life packaging which is addressed to consumers in the Union comply with the provisions of this Chapter.

Article 9 General warnings and information messages

For tobacco products for smoking (Article 9 of Directive 2014/40)

1. Each packaging unit and any external packaging of tobacco products for tobacco shall bear the following general warning:

"The smoking gun kills." 2. Each pack unit and any external events;

For the manufacture of tobacco products for smoking, the following information is provided:

"The tobacco smoke contains over 70 substances, which are known to cause cancer."

3. In cigarette packets and cigarette smoke in cigarette cases in a rectangular parallelepiped, the general warning appears in the section of one of the side surfaces of the packaging units and the updated message. It is seen at the bottom of the other side surface. These health warnings shall be at least 20 mm wide. For hard packets of type to which the side surfaces are divided into two when the package is opened, the general warning and the updated message appear to be whole at the top of the above surfaces from these surfaces. They burp. The general warning shall also appear on the inside of the top surface visible when the package is open. The side surfaces of this package type shall be at least 16 mm high. In the tobacco for screened cigarettes sold in a bag, the general warning and the updated message appear on the surfaces that ensure the full visibility of these health warnings. In the smoke for spinning cigarettes in cylindrical packages, the general warning appears on the outer surface of the cap and the updated message on the inside surface of the cap. Both the general warning and the updated message cover 50 % of the surfaces in which they are printed.

4. The general warning and the updated message referred to in paragraphs 1 and 2: a) are printed with a strong aura of Helvetica type elements on a white background with a selection of the line, provided that the size of the data ensures that The relevant text covers as far as possible the surface of the area intended for such health warnings and b) they are placed in the centre within the area provided for them, and in the rectangular shape of the area. Parallelism, as well as on any external packaging they are aligned with the Side of the pack-pack or outer packaging unit.

5. The exact position of the general warning and the information concerning tobacco for shrivelled cigarettes placed on the market in bags-and is determined by 2015/1735 Executive Decision (EU) of the European Commission of 24 September/September

It shall enter into force as from the entry into force of the existing law as set out in Annex IV of this law.

Article 10 Combined health warnings

For tobacco products for smoking (Article 10 of Directive 2014 /40/EU)

1. Each packaging unit and any external packaging of tobacco products for smoking brings together health warnings. The combined health warnings: (a) contain the verbal warnings that are available;

Are available in Annex I and a corresponding colour photograph specified in the image library of Part II, (b) www.moh.gov.gr the website www.moh.gov.gr

("Dependency Information: www.moh.gov.gr") for information on prevention of drug dependence aimed at informing consumers about the available support programmes that want to stop smoking, (c) cover 65 % of the external trade

The packaging and the rear end of the packing unit, and any outer packaging. The cylindrical packages carry two combinations of health warnings, at an equal distance one on the other, which covers 65 % of the corresponding area of the surface, (d) carry the same verbal warning and instead of -

A coloured photo on both sides of the packing units and any external packaging; e) appear at the upper end of the pack

And each other outer packaging and placed in the same direction as all other information provided on that surface of the preparation. This obligation is provided by a-ceiling exemption for the position of the combined health-care system as follows: (aa) where the tax rate (injection of a film)

Or the national identifier used for fiscal purposes is affixed to the upper end of a cardboard packaging unit, the plus-dued warning for the health that must appear on the back surface is placed (b) when a unit of packaging is made up of a packaging unit, it should be used as a means of disposal.

A rectangular space with a height not exceeding 13 mm between the upper edge of the package and the upper edge of the combined health care, intended for use in the phasing-out (injection) or the upper end of the package. National identification marking, which is used for curative purposes. The exceptions referred to in points (a) and (b)

(bb) shall apply for a period of three (3) years after the entry into force of this law. They shall not be placed above one of the health warnings or logbooks,

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(f) they shall be reproduced in accordance with the format, classification, design and ratios established by the European Commission, g) in the case of cigarette packaging units,

The following dimensions: aa) height: not less than 44 mm, b) width: not less than 52 mm. 2. Combined health warnings are recommended.

Are grouped in three sets, as set out in Annex II, and each set to be used as follows: 1 Total: from the entry into force of this law;

Until 31.12.2017 (b) Total: from 1.1.2018 to 31.12.2018 Total: from 1.1.2019 to 31.12.2019 and alternates annually by following it;

"Ra" Each combined health alert available for use in a particular year shall be treated as far as possible in a number of tobacco products.

3. Implementing Decision (EU) 2015/1842 of the European Commission of 9 October 2015 lays down the technical specifications for the provision, the relationship and the shape of the combined health warnings, as reflected in the Parr-Section V of this law.

Article 11 Labelling of tobacco products for tobacco other than cigarettes, tobacco for spinning cigarettes

And tobacco for bong (Article 11 of Directive 2014 /40/EU)

1. In addition to the general warning referred to in Article 9 (1), each packing unit and any outer packaging of tobacco products other than cigarettes, tobacco for shrimping cigarettes and tobacco for bong The series of warnings listed in Annex I. The general warning referred to in Article 9 (1) shall include a reference to support services for recovery from smoking referred to in point (b) of paragraph 1 of Article 10. The general warning shall appear on the most visible surface of the packaging unit and any non-foreign packaging. Each verbal warning shall be shown as far as possible at an equal number in each of these products. The verbal warnings shall appear in the next more visible surface of the packing unit and any external preparation. For casket type packaging units, the next most visible surface is the one shown when the package is opened.

2. The general warning referred to in paragraph 1 shall cover 30 % of the relevant surface area of the preparation unit and each outer packaging.

3. The word warning referred to in paragraph 1 shall cover 40 % of the relevant surface of the preparation unit and each outer packaging.

4. When the health warnings referred to in paragraph 1 are to be made up to a surface of more than 150 cm2, warnings are covered with walking 45 cm2.

5. The health warnings referred to in paragraph 1 shall meet the requirements laid down in

Article 9 (4) shall apply. The text of the health warnings is parallel to the main text on the surface limited to these warnings. The warnings for the area are surrounded by a thickness of at least 3 and not more than 4 mm. This outline shall be displayed outside the surface intended for health warnings.

Article 12 Labelling of non-smoking tobacco products

(Article 12 of Directive 2014 /40/EU)

1. Each packaging unit and any external packaging of smoking tobacco products shall bear the following health warning:

"This tobacco product harms your health and is addictive."

2. The health warning referred to in paragraph 1 shall meet the requirements laid down in Article 9 (4). The text of the promotions is parallel to the main text on the surface intended for these warnings. In addition: (a) it appears in the two largest packaging units and each outer packaging; (b) covers 30 % of the surfaces of the packing unit and any external procurement.

Article 13 Presentation of the product

(Article 13 of Directive 2014 /40/EU)

1. The labelling of packaging units and each outer packaging, as well as the tobacco product itself, do not include any element or designation which: a) promotes the tobacco product or encourages the manufacture of tobacco products.

In addition, the Committee of the Committee on the Environment, Public Health and Food Safety and the Committee on the Environment, Public Health and Food Safety and the Committee on the Environment, Public Health and Food Safety and the Committee on the Environment, Public Health and The tobacco product, b) indicates that a certain product of tobacco

Are less harmful than others, or is intended to reduce the effects of certain harmful tobacco constituents or have rejuvenating properties, properties providing energy or therapeutic, renewable, natural or biological properties; or Offers other health benefits or social behaviour, (c) refers to flavour, smell, flavourings, or

Other additives or suffix their absence, (d) looks like a food product or with a cosmetic, e) indicates that a certain product of tobacco,

It has improved biodegradability or other environmental benefits.

2. Packaging units and any external preparation do not indicate economic benefits by providing printed coupons, offering a discount or a distribution or including "two to one" type offers. Or similar offers.

3. Paragraphs 1 and 2 prohibited elements and characteristics may include

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There are no signs, symbols, signs, representations or other signals, without running out on them.

Article 14 The appearance and content of packaging units

(Article 14 of Directive 2014 /40/EU)

1. Cigarette packaging units have a high level interlayer. Smoke packaging units for spinning cigarettes shall have a rectangular parallelepiped or cylindrical or sachet. Cigarette packaging units contain at least 20 cigarettes. Smoke packaging units for cigarette smoke shall contain at least 30 grams of tobacco.

2. Cigarette packaging units can be made of cardboard or soft material and do not open that can be re-closed or re-sealed after the first opening, except for packages with an articulated lid and press packages. A casket. In the packages with the modular lid and the container type packages the cap is only joined with the back of the packing unit.

CAPITAL OF A KIND OBTAINED FROM THE MOUTH

AND NEW PRODUCTS

Article 15 Tobacco taken from mouth

(Article 17 of Directive 2014 /40/EU)

It shall be prohibited to release on the market of tobacco taken from the mouth.

Article 16 Cross-border distance selling of electronic cigarettes and containers

Replacements (Articles 18 and 20 par. 6 of Directive 2014 /40/EU)

1. Non-cross-border distance selling of electronic cigarettes and revolvers from abroad to Greece are prohibited. However, cross-border distance selling of electronic cigarettes and re-entrances from Greece to the outside will be permitted, provided that the Member States, on the market for which these products are to be marketed, do not Prohibit such cross-border sales.

2. Retailers wishing to sell to consumers in another Member State of the European Union electronic cigarettes and refillable containers, must: (a) use a verification system of the age of the consumer, in accordance with Which the consumer has, at the time of sale, the required age for the purchase and consumption of the product in force in the Member State of the European Union where the products are to be placed on the market; Are registered in a register kept in the General Insurance Section;

Product of the Directorate-General for Quality Policy of the Directorate-General for the Implementation of Regulations, Infrastructure and Control of the General Secretariat of the Ministry of Economic Affairs, Development and Tourism, (c) be registered in a corresponding register kept in the Official Journal of the European Communities. To the Member State of the European Union where the products are to be marketed.

3. The registration in the register kept in the Directorate-General for Product Safety Directorate-General for the Directorate-General for Implementation of the Directorate-General for Implementation of the Directorate-General for Economic Affairs, Infrastructure and Control of the General Secretariat of the Ministry of Economic Affairs; Respiratory and Tourism includes the following information: (a) name or corporate name and permanent address

The place of business of the undertaking, (b) date of commencement of the export activity;

The business via internet services, (c) address of the website or websites

They shall be used for the activity in question and any relevant information on the site of the site.

4. The Directorate-General for Product Safety of the Directorate-General for the Quality Policy of the Directorate-General for Regulations, Infrastructure and Control of the General Secretariat of the Ministry of Economic Affairs, Development and Tourism A certificate of writing of the abovementioned retail stores in the register referred to in paragraphs 2 and 3. The adoption of this certificate is necessary for the provision of such products abroad without prejudice to paragraph 1.

5. The Member States for the intended use of electronic vessels and refillable containers may require retailers to designate a natural person as responsible, in order to verify, before disposal of the products. On the market in the Member State of destination, that the products to be disposed of are compatible with the requirements of this law. In addition, retail sales of electronic cigarettes and reproducible containers shall submit to the competent authorities of the Member States for the purpose of the products to be disposed of a description of the details and the functioning of the system. Age verification available under paragraph 2 (a).

6. The processing of personal data from retailers from retail stores shall be made in accordance with the n. 2472/1997 (' 50). The retail sale of electronic cigarettes and replexing agents that make cross-border sales abroad do not reveal the personal data of consumers of their products abroad or to their customers. Manufacturers of electric cigarettes and reclamation containers, not to companies belonging to the same group as these manufacturers or to any third party. Personal data of consumers are not used or altered for purposes other than the particular cross-border market. The same applies in the case where the retailer belongs to a manufacturer of electronic cigarettes and replethrosis.

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Article 17 Notification-Authorisation of new tobacco products

(Article 19 of Directive 2014 /40/EU)

1. Manufacturers and importers of new tobacco products are required to submit a notification to the Ministry of Health of any such product which they are proposing to make available on the Greek market. The notification shall be submitted in electronic form six (6) months before the intended placing on the market and is accompanied by a detailed description of the new tobacco product concerned as well as the instructions for use and the information provided for in Is provided for in Article 6 with regard to the ingredients and to the reports. (a) the available scientific studies on the toxicity of a new tobacco product are also provided by manufacturers and importers for a new product.

(b) the available studies, summary descriptions, and the attractiveness of the new tobacco product and the attractiveness of the new tobacco product,

(c) other available and relevant information, including market research, and market research on the promotion of various consumer groups, including new and current smokers;

The risk/benefit analysis of the product, its expected effects on the cessation of tobacco consumption, its expected effects on the onset of tobacco consumption and foreseeable effects on consumers.

2. Manufacturers and importers of new tobacco products shall be required to transmit any new or updated information on the studies, research and other information referred to in points (a) to (c) of paragraph 1. The Health Department may require manufacturers or importers of new tobacco products to take additional tests or to submit supplementary information. The Ministry of Health shall make it available to the European Commission. The information received pursuant to this Article.

3. It is recommended that the Ministry of Health be responsible for evaluating new tobacco products, which is composed of one (1) representative of the Ministry of Health and the Deputy, one (1) representative of the Ministry of Economic Affairs and his deputy, One (1) representative of the Ministry of Economy, Development and Tourism and its Deputy, one (1) representative of the National Organization for Medicines and its Deputy and one (1) person of the Hellenic Pneumological Society and his deputy. In order to establish the Commission, the Ministry of Economic Affairs, the Ministry of Economy, Development and Tourism, the National Organization for Economic and Financial Affairs and the Hellenic Alcoholics Company define their representatives with their documents to the Minister of Health. The Health Minister, after having appointed the representatives of his own Ministry, shall establish a decision by the Commission. In the event that the F.D.A. and the Hellenic Panic Company do not appoint representatives, the Minister of Health shall appoint two additional persons, or-an officer of the EFF and one lung -

Director of the N.C.U., or a pneumologue, LLC, University Hospital. The term of office of members of the Commission shall be two years.

4. Manufacturers and importers of new tobacco products shall be obliged, at least four (4) months before the entry into service of a new tobacco product, to submit a technical file to the Commission of the European Communities or, if it does not The Commission referred to in paragraph 3 shall be set up by the Minister for Health. The dossier shall be submitted in writing and electronically and shall include the following: (a) the evidence referred to in paragraph 1 (b) of full compliance with all agreements;

(c) complete qualitative and quantitative recording of all the relevant safety standards and the maintenance of all relevant regulatory requirements;

(d) a description of the technical characteristics of the ingredients;

(e) draft instructions for use and labelling; (f) toxicology studies and physico-chemical tests

Concerning the ingredients of new tobacco products and their expulsions, in accordance with which the substances contained therein and the substances released during the operation of the products falling within the scope of this law are not applicable. They pose a health risk within the meaning of Regulation (EC) No 1907/2006 and Regulation (EC) No 1907/2006. The toxicological studies are conducted in accordance with the Principles of Good Laboratory Practice (GLP) and in accordance with Regulation (EC) No 440/2008 (OJ L 142/). Laboratories, where the toxicological studies are carried out, are in accordance with the Principles of Good Laboratory Practice and laboratories, where the physical tests are conducted, is accredited according to EN ISO 17025, (g) Description of the production process and the

Quality assurance measures, which should be taken, (h) a report on the safety of appliances, a -

Of which the product is made up and corresponding to the security, a) responsible declaration of compliance with the provisions;

Inscriptions of this law, whether it is a new tobacco product in the definition of non-smoking tobacco or in the definition of tobacco product for smoking, j) Epidemiological and/or clinical studies

To be prepared in accordance with the principles of good clinical practice, in so far as they concern the product under licence, (k) proof of payment of a fee of EUR 1 000 for

The examination of the technical file, as specified in Article 25. The scientific data to be communicated by

The technical documentation shall be covered by industrial and commercial confidentiality.

5. If, within thirty (30) days of the submission of the technical file, the Commission finds that the technical file is not complete or that the dossier submitted is not complete

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Evidence does not show that the laws of authorisation have been met, it shall invite the interested party to be able to meet or correct the details of the dossier in that regard.

6. Each member of the Commission shall examine the details of the dossier falling within the competence of the Ministry representing and drawing up together with the other members of the Commission common opinion (consistent opinion) to the Minister of Health on Licensing or The product, within a period of three (3) months from the deposit of the dossier, in accordance with paragraph 4 of this Regulation. For the purposes of acceptance or rejection of the permit application, the decision of the Minister of Health shall be adopted, taking into account the Commission's opinion.

7. If the Commission opinions in favour of the rejection of the application by reason of a lack of progress in the period referred to in paragraph 5, the authorisation holder shall be compulsorily rejected.

8. If no opinion is drawn up within the three-month period referred to in paragraph 6, the Commission is required to justify, in particular, and by means of a letter addressed to the Minister for Health at the request of the Minister of Health to exercise her opinion. No-divisibility. The Minister for Health, if he considers reasonable the Commission's reasoning, may extend the time-limit for one (1) month. In the event that the latter deadline lapsed, then the new tobacco product is put into circulation without permission. If, in hindsight, a negative opinion is drawn up, the Minister for Health is obliged by his decision to prohibit the marketing of the product.

9. The authorisation concerns exclusively the product, that this is described in the submitted technical package and covers only the manufacturer and the producer, to whom it was granted. Any intended modification to the authorised product shall be notified to the Commission referred to in paragraph 3. The latter shall decide whether the proposed modifications are so essential that the assessment and authorisation of the new product is required.

10. If, during the inspection, inspection or sampling carried out by the supervisory authorities, there are significant changes to the licensed product for which the Ministry of Health has not been informed, in accordance with paragraph 9, the marketing authorisation May be withdrawn.

11. The manufacturer and importer already of the new tobacco product are obliged to inform the Ministry of Health immediately in the event of an adverse event to a user of their products. In such a case, the Commission referred to in paragraph 3 shall be taken immediately and immediately the procedure set out in paragraphs 3 to 9 shall be activated in accordance with the procedure referred to in paragraph 3.

12. New tobacco products made available to the market must comply with the requirements of this law. The inclusion of these products at the present time depends on whether the products in question fall under the definition of tobacco or tobacco products for smoking.

OTHER G ' ELECTRONIC CIGARETTES AND VEGETABLE

PRODUCTS FOR SMOKING

Article 18 Electronic cigarettes

(Article 20 of Directive 2014 /40/EU)

1. Electronic cigarettes and reflexes are placed on the market only if they comply with the provisions of this Regulation and the other provisions of the text. This law shall not apply to electronic cigarettes and refillable containers subject to an authorisation requirement under the reference number 31637/2004 of a joint decision of the Economic and Financial Affairs and Economic, Health and Social Affairs Solidarity (B11176) or the requirements of DY8D/G/Q. 130 648/2009 Common decision of the Ministers for Economic and Financial Affairs, Development, Health and Social Solidarity (B2198).

2. Manufacturers and importers of electronic cigarettes and refillable containers shall submit a notification to the Department of Safety and Health at the Department for Health and Safety of the Health Department of the Ministry of Health; Any relevant products which they intend to place on the market. The notification shall be submitted electronically (6) months before the intended placing on the market in a common format, as set out in 2015/2183 of the Implementing Decision of 24 November 2015, as reflected in the Commission Decision of 24 November 2015. In Annex VI of this law. The notification shall be submitted within six (6) months after the date of entry into force of this law, in respect of electronic cigarettes and on-board containers which are already on the market at the time of entry into force of this law. A new notification shall be submitted for any substantial modification of the product. Depending on whether the product is an electronic cigarette or a refill, the notification shall contain the following information: (a) the manufacturer's and the contact details of the manufacturer, the legal or natural person responsible within it; (b) a list of all the ingredients present in the product and of all the components of the product and of the use of, per gram and type, including those quantities, (c) toxicologically relevant data. These ingredients and products, including when heated, indicating (d) information on the dosage and the intake of nicotine when the product is consumed under normal or specific health effects on the health of consumers when inhaled, and consistent with, inter alia, the effects of breast-feeding; Reasonably foreseeable conditions, e) the description of the components of the product, including, where appropriate, the opening and refilling of the electronic cigarette or refilling container, (f) description of the procedure Production, inter alia, if it includes the production line, and a declaration that the process Production meets the requirements of this Article, (g) de-termination that the manufacturer and importer bear full responsibility for quality and safety

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Of the product, when placed on the market and used in normal or reasonably foreseeable circumstances. Where it is considered that the information provided is incomplete, the relevant information may be requested by the competent authorities of the Member States for Health and Safety at the Directorate for Health and Safety at the Department of Mental Health. Department of Health.

3. Electronic cigarettes and refresher containers must also satisfy the following specifications: (a) the liquid containing nicotine is placed on the market in special replete containers, the volume of which does not exceed 10 ml Disposable electric cigarettes or single-use vials, and the volume of bottles or containers does not exceed 2 ml, b) the nicotine containing no nicotine containing 20 mg/ml, c) the nicotine containing liquid does not contain any nicotine. Additives listed in Article 7 (4) (d) for the manufacture of liquid containing nicotine Use only high-purity ingredients. Substances other than those referred to in point (b) of the fifth subparagraph of paragraph 2 are only available at the level of traces in the liquid containing nicotine, since these traces cannot be technically avoided when manufacturing, e) Nicotine, in the liquid containing nicotine only use ingredients that are not dangerous for human health at room temperature or in the form; (f) the electronic cigarettes dispense the doses of nicotine at stable levels under normal conditions; (g) electronic cigarettes and refillable containers are protected from one of the following: Children and inviolable, are protected by breakage and leakage and have a mechanism that ensures refilling without leakage.

4. Electronic cigarettes and reflexes must satisfy the following specifications: (a) Electronic cigarette packaging units

(e) the instructions for use and storage of the product as well as the indication that the use of the product is not recommended for young and non-smokers, including information about the use and storage of the product; (bb) the contraindications, (cc) warnings for specific hazards; (d) any harmful effects; (e) the risk of addiction and toxicity, and the contact details of the manufacturer or the importer and the legal or natural person; Contact person within the Union, (b) packing units and all external events;

(e) include a list of all the ingredients in the product in descending order of weight and indicate the content of nicotine in the product and the administration per dose; The number of the receiving lot and a recommendation in Greek to store the product from children, (bb) with the retention of the site (aa) of this item, do not include particulars or characteristics referred to in Article 13 except for the exception of Article 13 (1) (a) and (c) of Article 13 concerning information concerning the A nickety content and with regard to flavourings, and (cc) bear the following health warning:

"This product contains nicotine, which is exponential addictive", (c) health warnings shall comply with the requirements;

Referred to in Article 12 (2).

5. In relation to electronic cigarettes and periodic replexes, the following prohibitions apply: (a) commercial communication is prohibited;

Network, in the form and in other forms, with a view to or direct or indirect effect of the promotion of electricityand refilling containers, with the exception of the forms intended solely for the purchase of electronic cigarettes; or (b) non-commercial communications shall be prohibited for the purpose of reprocessing and the forms printed and circulated in third countries where such forms are not intended primarily for the Union market;

(c) any form of public or private placements may be used to promote electronic cigarettes and to direct or indirect effect on the promotion of electronic cigarettes and reclamation containers;

(d) any form of public or private participation in radio and television programmes with a view to or indirect or indirect effect of promoting electronic cigarettes and reclamation containers;

The contribution to any event, activity or person with a view to direct or indirect or indirect effect of the promotion of electronic cigarettes and containers, which is carried out in more than one Member State or in which they are involved. In the case of electronic cigarettes or other cross-border implications, e) shall be prohibited for electronic cigarettes and

Recreation containers the audiovisual communications to be applied in paragraph 109/2010 (A'190).

6. Manufacturers and importers of electronic cigarettes and refillable containers shall submit to the Department of Health and Safety at the Department of Health and Safety of Health at the Ministry of Health and the Ministry of Health and (b) information on the promotion of sales agents, including young people, including young people, non-smokers and the main types of consumers, as a whole: a) comprehensive data on sales agents, per gram and type of product, b) information on the promotion of various consumer groups, including young people, non-smokers and the main types of consumers (c) how to sell products, and (d) summary descriptions of any such products; Market research carried out on the above, including their translation into English. The Health Department monitors market developments relating to electronic cigarettes, as well as referrals, including any evidence that the use of non-smokers and non-smokers leads to addiction. To nicotine and ultimately to traditional tobacco consumption.

7. On a website of the Ministry of Health website, the information received in accordance with paragraph 2 of the provisions relating to commercial confidentiality is published. The Ministry of Health, on request, shall make all the information received in accordance with this Article, at the disposal of the European Commission and other States;

12

'; The Ministry of Health ensures the confidential handling of the confidentiality and other confidential information.

8. Manufacturers, importers and distributors of cigarette-based cigarettes and refillable containers shall create and maintain a system of collection of information on all possible harmful effects on human health. If either of these economic operators considers or reasonably considers that electronic cigarettes or refill containers held by it and intended to be placed on the market or marketed are not safe, or Of good quality or otherwise not complying with the provisions of this law, the economic operator concerned shall immediately take the necessary corrective measures to comply with the provisions of this Regulation, the conclusion or revocation of the decision. Product, as a matter of case. In such cases, the economic operator must immediately inform the market surveillance authorities as set out in Article 23, as appropriate. In addition, the economic operator is required to inform the supervisory authorities of the Member States, which is or is intended to make it available to the public, giving specific information on human health and safety in particular. Any corrective measure has been taken and the results of these measures. The Ministry of Health may request additional information from the economic operator, in particular on safety and quality aspects, or on any harmful effects of electronic cigarettes or on reproducible containers.

9. With regard to electronic cigarettes and replexing receivers complying with the requirements of this Article, where the Ministry of Health is responsible or has reasonable grounds to believe that specific electronic cigarettes or containers Replacements or a type of electronic cigarette or periodic monitoring may constitute a serious risk to human health, and may, with a decision by the Health Minister, temporarily prohibit its placing on the market. The Ministry of Health shall inform the European Commission and the competent authorities of the other Member States of the measures taken and communicate any supporting data to the provisional measure.

Article 19 Vegetable products for smoking

(Article 21 of Directive 2014 /40/EU)

1. Each packaging unit and any external packaging of herbal products for smoking includes the following health warning:

"The smoking of this product harms your health."

2. The health warning shall be printed on the front and back outer surface of the packaging unit and on each outer packaging.

3. Health warning coincided with

The requirements laid down in Article 9 (4). It covers 30 % of the surface of the packaging unit and each with the outer packaging.

4. Packaging units and all external preparations of plant products for smoking do not include any of the elements or characteristics specified in points (a), (b) and (d) of Article 13, and do not indicate that The product does not contain additives or flavourings.

Article 20 Notification of ingredients

Vegetable products for smoking (Article 22 of Directive 2014 /40/EU)

1. Manufacturers and importers of plant products for smoking shall submit a list of all ingredients in the Health and E-Health Department of the Health and Safety Directorate of the Health and Safety Directorate of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority of the Health and Safety Authority. The quantities of these products used in the manufacture of these products by arica and type. Manufacturers or importers shall also inform the Health Department when the composition of a product is modified in such a way as to affect the information submitted under this Article. The information required in accordance with this Article shall be submitted prior to the disposal of a new or rectified plant product for smoking in the field.

2. The website of the Ministry of Health www.moh.gov.gr shall publish the information provided in accordance with paragraph 1, of the provisions on confidentiality, in the case where such information is published. The economic operators shall specify precisely which information they consider to be confidential.

Article 21 Cooperation and compliance

(Article 23 of Directive 2014 /40/EU)

1. Manufacturers and importers of tobacco and manufactured products shall provide the Ministry of Health and the other competent authorities referred to in Article 23 of the Annex, as well as to the European Commission, within the limits set, full and accurate. Information requested in accordance with the provisions of this law. The obligation to supply the requested information shall be borne primarily by the manufacturer if the manufacturer is established in the Union. The obligation to provide the information requested primarily affects the importer if the manufacturer is established outside the Union and the importer is established in the Union. The obligation to apply the information requested shall be borne by the manufacturer and the importer if both are established outside the Union.

2. Tobacco products and related products which do not comply with the products are not placed on the market

13

Provisions of this Regulation. Tobacco products and related products are not placed on the market if the notification obligations laid down in the provisions of this law are not complied with.

3. National competent authorities shall cooperate with each other, with the competent authorities of the Member States of the European Union and with the European Commission in order to ensure that the provisions of this law are properly applied and enforced; and Exchange all necessary information with a view to their proper implementation.

Article 22 Freedom of movement

(Article 24 of Directive 2014 /40/EU)

1. The competent authorities shall not prohibit or restrict the placing on the market of tobacco products or products which comply with the provisions of this Regulation and without prejudice to paragraphs 2 and 3.

2. By decision of the Minister for Health, further requirements may be laid down, applicable to all products placed on the Greek market, on the standardization of the packaging of tobacco products, when justified on grounds of In the case of public health, account should be taken of the high level of protection of human health which is achieved through the provisions of this law. These measures should be in accordance with the principle of proportionality and cannot constitute a means of arbitrary discrimination or a disguised restriction in trade between Member States. These measures shall be notified to the European Commission, together with the maintenance or adoption of such measures.

3. By decision of the Minister for Health, it is possible to prohibit, by taking into account the high level of protection of human health, which is achieved through the provisions of this Regulation, a certain number of categories of tobacco or related products, provided that the Prohibition is justified by the need to protect public health. These decisions of the Health Minister are notified to the European Commission, accompanied by a clarification of their reasons for their interpretation. The Commission shall, within six (6) months following the receipt of the notification referred to in this paragraph, approve or reject the national provisions. If no decision is taken by the European Commission within the six-month period, it is noted that the national provisions have been adopted.

Article 23 Competent authorities

(Article 26 of Directive 2014 /40/EU)

1. The National Authority for the exercise of the responsibilities arising from the provisions of this law is the Ministry of Health (Section for Risk Factors, Social Presents for Health and Health at the Ministry of Mental Health of Hypor; In cooperation with the General Secretariat of the Industry of the Ministry of Economic Affairs, Development and Tourism, the Directorate for Energy Industrial and Chemicals and the regional Xi -

Service of the Directorate-General of the General Secretariat of the State, as well as the Directorate-General for Customs and Special Conditions of Consumer Affairs and Customs of the General Secretariat of the Department of Finance of the Ministry of Finance. The competent authorities shall ensure that the provisions of this law are applied, they shall establish and control the actions of the services concerned.

2. The relevant market surveillance authorities are defined as the Services of the Local Self-Administration of Local Administration, the R & D Services of the Territorial Units of the Country, the Customs offices and the General Services of the General Secretariat. State of the State. The market surveillance authorities shall carry out inspections, inspections, samples and carry out market control programmes, where appropriate, to assess the application of the provisions of this law. Inspections, inspections and inspections on the market and in the production, storage, storage and distribution areas shall be carried out on a case-by-case basis and on a case-by-case basis by the following competent market surveillance authorities or by-units. Or from close range.

3. The General State of the State shall be responsible for the laboratory physico-physical control and control of the classification, labelling and packaging of products falling within the provisions of this law. Inspections, examinations, examinations, appeals and any other relevant issues relating to samples shall be carried out in accordance with the provisions of 1100/1987 Decision of the Minister for Economic Affairs (B788, Encoding and Compilation of the Provisions The Code of Food and Beverages with a movable component system) and the provisions of n. 4177/2013 ('173) without prejudice to other specific provisions.

4. In order to control the device of the electronics, the relevant labelling, the battery of the mechanism for refilling the electronic joints which fall under the provisions of the Directive. Decision of the Ministers of Ministers of the Interior, Public Administration and Decentralisation, Economic and Finance, Development, Health and Social Security, Justice, Transport and Communications (B1885). General Secretariat of the Industry, Directorate of Political Quality of the Ministry of Economy, Development and Tourism. In particular, for electrical and electrical related to electronic cigarettes (electronic cigarette charger, whether sold as an integral part of the device or automatically), the department of the General Secretariat is consulted. Industry (Technical Biotechnology Directive) of the Ministry of Economy, Development and Tourism, in the field of which the provisions of the legislation on electrical equipment intended to be used within certain categories of machinery (i) the scope of the action plan; Opinion of the Committee on Economic and Monetary Affairs and Industrial Policy on the proposal for a Council Regulation (EC) amending Council Regulation (EC) No 51157/No 1129/ 17.5.2016.

5. The Competent Authorities and the Audit Institutions for the application of the provisions of Article 24 (1) and (2) shall be the bodies referred to in Article 5 of the Law. 3730/2008 (A262). The relevant procedure is regulated by the

14

Gist of the European Parliament 104720/2010 decision of the Ministers of the Interior, Decentralisation and Electronic Governance, Economic, Labour and Social Welfare, Health and Social Solidarity, Civil Protection, Culture and Tourism (BO-1315), from the number of Regulation (EEC) No 93828/2011 (B2026) a-decision of the Ministers for Economic, Health and Social Solidarity, from the point of view. Decision of the Minister for Health and Welfare (Β-1001).

6. The Health and Mental Health Control Board of the Health and Welfare Services Inspection Service (SEE) investigates the related offences, cooperates in accordance with its responsibilities with the other audit authorities, Certifies infringements and imposes fines for the proper application of the provisions of this Regulation.

7. For the purposes of applying the provisions of this law, the market surveillance authorities, as well as the instruments to check for the application of the provisions of Article 24 (1) and (2), in the performance of their duties and at their request They are assisted by local police and other authorities, who are under an obligation to respond.

8. The competent authorities shall carry out exceptional and unexpected-dimensional inspections and sampling in order to establish the degree of compliance with the requirements of the provisions of this Article and the instruments of checks referred to in this Article. Reporting on the results of the audits and the finding of infringements and reporting on the responsibility of the Head of the Service to which the audit bodies have identified the infringement in the Annex. Producers of Risk, Social Security for Health and Dependencies of the Directorate Mental Health of the Health Department, as well as the Department of Economic Affairs.

Article 24 Penalties

(Article 23 of Directive 2014 /40/EU)

1. For the sale and advertising of tobacco products, new tobacco products, electronic cigarettes and foodstuffs for smoking, the provisions of Article 2 of the Law shall apply. Regulation (EEC) No 3730/2008 (') and the provisions of Article 3 of C. P. Oke. Decision No 104720/2010 of the Ministers of the Interior, Decentralisation and Electronic Governance, Economic, Labour and Social Security, Health and Social Solidarity, Civil Protection, Polite, Culture and Tourism (B315). They also apply to tobacco products, new tobacco products, electronic cigarettes and vegetable products for smoking and other classes of tobacco products. L1/GIFRS 81348/2005 Decision of the Ministers of Interior, Public Administration and A-Posting, Economic and Economic, Health and Social Solidarity, State of the Union (B1075).

2. For the use of tobacco products, new tobacco products, electronic cigarettes and plant products, the provisions of Article 3 of the Law shall apply. 3730/2008 (EU-262) and the provisions of Article 3 thereof. 104720/2010 Judgment of Y -

Internal Affairs, Decentralisation and Electronic Governance, Economic, Labour and Social Security, Health and Social Solidarity, Public Health and Civil Protection, Culture and Tourism (BO-1315). They also apply to new tobacco products, new tobacco products, electronic cigarette products and tobacco products and the provisions of the Directive. A decision by the Secretary of State for Health and Welfare (B' 001) and the provisions of the H1/C. 93828/2011 decision of the Ministers for Economic Affairs, Health and Social Interaction (B2-2026).

3. In the event of non-compliance with the obligation to notify Articles 5,6 and 7 of this law, in the event of failure to notify in breach of Articles 5, 6 and 7 of this law and in the case of false notifications contrary to Articles 5, 6 And 7 of the present law, with a decision of the Minister of Health, a four-hundred (400) euro product. By a joint ministerial decision of the Ministers for Health and Economic Affairs, the amounts of the above fines may be adjusted. These precepts are collected in accordance with the Code of Conduct for Revenue (CIPs, N.d 354/1974, A90) and are revenue from the State Budget, which may cover expenditure on the implementation of public health programmes. (ii) and a more detailed programme for the management of the use of tobacco products and other related products, and in the case of dependencies. The above amounts after the date of entry into the revenue of the State Budget are written as appropriations in the budget of the Health Department (CDE 5117 E 15 -210). The Minister of Health, in the event of an infringement of the provisions of this Regulation, taking into account the nature and gravity of the infringement, and its consequences for public health, may be published by means of printed and electronic information, and Of the Internet or by any other appropriate means, any sanctions imposed.

4. In the event of breaches of the obligations laid down in Articles 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 (1), (2) and (11), 18 (1) to (6) and (21) of this law, the provisions of Article 3 shall be imposed by a decision of the Minister of Health. Paragraph 1 (1) of the First Amendment No 1. Decision No 104720/2010 of the Committee of Ministers of the Interior, Decentralisation and Electronic Governance, Economic, Labour and Social Security, Health and Social Solidarity, Civil Protection, Polite, Culture and Tourism (B1315).

5. In the event that the electrical or electrical engineering of the electronic cigarette does not comply with the requirements of the technical industrial legislation in accordance with Articles 22 to 31 of the Law. No 4072/2012 (' 86) and Annex IV v. The provisions of Article 32 of Law No 4072/2012 (A-86) shall apply. SEE ANNEX 'QUESTION TIME'. In the event that the electrical equipment of the electronic cigarette does not comply with the provisions of the Decision of the Ministers for Economic Affairs, Development and Tourism-Environment and Energy (B' 1425) on the availability on the market for matchmaking materials intended to be used

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Within certain voltage limits, the provisions of Article 23 of the Directive shall apply. Decision of the Ministers for Economic Affairs, Development and Tourism and the Environment and Energy (B' 1425).

Article 25 Proportional Fees

(Articles 5, 6, 7, 19, 20 of Directive 2014 /40/EU)

1. For the reception, storage, handling, analysis and publication of the information submitted in accordance with Article 5 and Article 18 (2), it shall be determined by a fee of 50 kg per product to manufacturers and importers. These fees are levied in accordance with the Code of Conduct for Revenue (K.E.D., p.354/1974, 90) and are revenue from the State budget, from which it is possible to cover expenditure on the implementation of public contracts. Health and in particular programmes for the management of the use of tobacco products and other related products and in general the dependencies. The above amounts after their occurrence in the revenue of the State Budget are entered as appropriations in the budget of the Ministry of Health (OEM 5117 E 15 -210).

2. To assess the reports of the manufacturers or importers by carrying out a comparative analysis of these reports by an independent scientific body in accordance with Article 6 (4), as well as to assess whether a product Tobacco has a characteristic taste, whether or not to use any additives or mineral substances, and whether a tobacco product contains additives in quantities that increase in significant and measurable extent the toxic or addictive effect, or The TTBER of the tobacco product concerned, pursuant to Article 7 (9), Manufacturers and importers of the product in question shall pay the amount and the procedure for its recovery and performance, as well as any adjustments to be made by the Minister for Health.

3. The cascade of paragraph 4 of Article 17 (4) of the present is collected in the ECE recovery code 3741 (Irrespective of any cause).

Article 26 Transitional provision

(Article 30 of Directive 2014 /40/EU)

The following products, which are not in conformity with the provisions of this Regulation, may be placed on the market until 28.2.2017:

Vibration and infestation are shown in accordance with the number of PSPs. (b) electronic cigarettes or reflexes for electronic cigarettes or containers shall be replaced by a common decision by the Health and Welfare and Agriculture Ministers (II) before the entry into force of this law;

(c) plant products for smoking which are produced or released for free circulation before 20.11.2016;

They shall be released for free circulation before the start of this law.

Article 27 Repeal

(Article 31 of Directive 2014 /40/EU)

Since the entry into force of this law, the number of Y1/GPs has been adopted. Regulation (EEC) No 2075/2003 on the common organisation of the market in milk and milk products (presented by the Commission) Council Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the territory of the Member States of the European Union and their families moving within the Community.

Article 28 Annexes

They shall be annexed and shall form an integral part of this below I, II, III, IV, V, and VI annexes.

Article 29

The first paragraph of paragraph 1. Article 41 of the EC Treaty 4058/2012 (A-63), as replaced by par. Article 182 of the EEC Treaty Shall be replaced by the following: 4261/2014 (1 107);

" The NHS hospitals, the Health Centers for island, mountainous and remote areas, the VRA-ELPIDA, the O.K.A. of the K.E.D. and the A.E.U. SA with a decision of their Board of Directors, may, in order to meet their staff needs, and For their proper functioning, as long as their staff are not sufficient, to cooperate with doctors of any speciality, psychologists, social workers, sociologists, nurses and specialist therapists who have completed E-a successful therapeutic programme for the authorised agents or bodies of n. 4139/2013 (A ' 74), with each-hand version of a service voucher for their services provided. '

Article 30

From the bar. Article 54 of the EC Treaty (EC) No 4272/2014 (1 145), as amended in the second indent of (a). Article 52 of the EC Treaty 4410/2016 (1 141), the sentence is deleted: "... if the position is not opened ...". Also, the phrase "... which expires on 30.9.2016 ..." A-denotes from the words' which ends until 30.9.2016. '

Article 31 Entry into force-Implementation

The validity of this law shall start from its publication in the Official Journal of the Government, unless otherwise specified in its provisions.

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Athens, 2016

THE PRESIDENT OF PARLIAMENT

NICOLAOS DIVE

THE SECRETARY-GENERAL OF THE COUNCIL OF THE DIRECTORATE-GENERAL FOR ADMINISTRATION

LEGISLATIVE WORK

ATHANASIOS, ANTI-ANAJUN. PERIPHANT