Law Amending And Supplementing The Law On Tobacco And Tobacco Products

Original Language Title: Закон за изменение и допълнение на Закона за тютюна и тютюневите изделия

Read the untranslated law here: http://parliament.bg/bg/laws/ID/15671/

Name of law Law amending and supplementing the law on tobacco and tobacco products Named on the Bill a bill amending and supplementing the law on tobacco and tobacco products date of acceptance 24/03/2016 number/year Official Gazette 28/2016 Decree No 89

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on tobacco and tobacco products, adopted by the National Assembly of the HLIÌI 24 March 2016.

Issued in Sofia on 6 April 2016.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Catherine Dana

LAW

amending and supplementing the law on tobacco and tobacco products (promulgated, SG. 101 of 1993; amended 19/1994, no. 110 of 1996 No. 153 of 1998 No. 113 of 1999, no. 33 and 102 of 2000, 110/2001, no. 20 of 2003 and 57/70 by 2004. , PC. 91, 95, 99 and 105 by 2005, issue. 18, 30, 34, 70, 80, 108, 2006, issue. 53 and 109 from 2007, PCs. 36, 67 and 110 in 2008, PCs. 12, 82 and 95 of 2009, PCs. 19 of 2011, issue. 50 by 2012. 12 and 14 by 2015 and St. 19 of 2016)

§ 1. In the name of the law, the words "and tobacco" are replaced by "tobacco and related".

§ 2. In art. 1 the words "and the marketing of tobacco" are replaced by "presentation and sale of tobacco and related".

§ 3. In art. 2 make the following amendments and additions:

1. In paragraph 8. 1 the words "and tobacco" are replaced by "tobacco and related".

2. in the Al. 3, after the word "tobacco" is added "and related".

§ 4. In art. 23 the Union ' and ' shall be replaced by a comma and add "water-pipe tobacco and tobacco product."

§ 5. Chapter nine is created "a" with art. 26 a-26 c:

"Chapter 9" a "

NEW TOBACCO PRODUCTS

Art. 26. (1) producers, importers and persons who enter the territory of another Member State of the European Union, new tobacco products shall inform the Ministry of economy for any new tobacco product, they want to place on the market.

(2) the notification under paragraph 1. 1 in electronic form shall be submitted six months prior to the placing on the market of the product.

(3) the notification under paragraph 1. 1 contains:

1. a single identification code (UIC) of the merchant and for the persons registered in another Member State of the European Union or in another State party to the agreement on the European economic area – another identification code or number;

2. the address and phone number of the manufacturer, the natural or legal person within the European Union and of the importer in the case of imports.

(4) notification under paragraph 1. 1 shall apply:

1. a detailed description of the new tobacco product;

2. user guide;

3. information on constituents and emissions in accordance with art. 35 (b), para. 1-3;

4. available scientific studies on toxicity, the dangers of addiction and the attractiveness of the new tobacco product, particularly in respect of constituents and emissions;

5. available studies, summarized the new tobacco product evaluations and market research on the preferences of the various user groups, including young people and smokers;

6. any other available and relevant information, including analysis of the risks and benefits of the new tobacco product, expected consequences at the start and at the cessation of tobacco use, as well as assumptions relating to the perception by consumers.

(5) the notification under paragraph 1. 1 and the annexes thereto shall be considered by the Minister for Economic Affairs authorised by officials within 14 days from the date of submission of the notification and the annexes thereto.

(6) in the event that the information provided in the notification under paragraph 1. 1 and the annexes thereto is incomplete or inaccurate, the Ministry of economy requires that within 14 days, the manufacturer, the importer or the person who enters the territory of another Member State of the European Union, new tobacco products, to supplement the information or to correct any inaccuracies.

(7) the Ministry of the economy, the requirements of the Ministry of health and the Institute of tobacco and tobacco products to submit a reasoned opinion concerning the compliance of the new tobacco product with the requirements of the law. The opinions shall be made available to the Ministry of economy within two months from the date of receipt of the request in the administration.

(8) where necessary, or on the basis of the opinions referred to in paragraph 1. 7 the Ministry of economy may require from manufacturers, importers or persons who enter the territory of the country by another Member State of the European Union, new tobacco products, to carry out additional tests or to submit additional information.

(9) the manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, new tobacco products, provide the Ministry of the economy, any new or updated information for research, studies and other information under para. 4, became known after their submission of the notification referred to in para. 1.

(10) the Ministry of the economy, the European Commission provided all the information under para. 1-9.

Art. 26 (b) (1) in the Ministry of economy shall establish and maintain a public register of new tobacco products.


(2) in the public register under subsection. 1 shall be entered in a separate section, persons who have submitted a notification for a new tobacco product, and describes the number and type of attached documents. The entry shall be made in the order of submission of the notification, noting the movement of file for entry in the register.

Art. 26. new tobacco products placed on the market shall comply with the requirements of the law. Depending on the category in which the fall new tobacco products, smokeless requirements apply to tobacco or tobacco products for smoking. "

§ 6. In the name of Chapter ten ' and tobacco "are replaced by" tobacco and related ".

§ 7. In art. 30 the following modifications are made:

1. Paragraph 2 shall be replaced by the following:

(2) prohibited the supply and sale of:

1. tobacco and related products in the territory of the crèches and kindergartens, schools, hostels for students, medical and health facilities and their adjacent areas;

2. tobacco and related articles on sporting events and public events organised for children and students;

3. tobacco and related articles on and by persons under 18 years of age;

4. tobacco and related products with damaged packet, except in the case when selling hand shaped cigars;

5. tobacco and related items without a purchase invoice (invoice) of selling tobacco or related products;

6. tobacco and related products with damage and defects impairing their user properties;

7. tobacco and related products without the required elements listed on the packaging to inform consumers of the Bulgarian language and encoding of the product to the manufacturer;

8. tobacco and related articles without announcing their prices on a customer-accessible place and in an appropriate way to digest;

9. tobacco products in bulk or individual pieces and pieces of open packaging, except in the case when selling hand shaped cigars;

10. tobacco and related products from vending machines for the sale of tobacco or related products and self-service stands, with the exception of duty-free entities;

11. cigarettes, not satisfying the requirements of art. 35 a, para. 1;

12. liquids containing nicotine, not satisfying the requirements of art. 43 e;

13. tobacco and related products with customized packaging, not satisfying the requirements for labelling and packaging;

14. tobacco products on the packaging of who has texts, names, trade marks and figurative or other marks that mislead that a product is less harmful;

15. consumer packages of cigarettes containing fewer than 20 cigarettes;

16. consumer packages of tobacco for hand-rolling of cigarettes containing less than 30 g of tobacco;

17. tobacco products containing:

a) vitamins or other supplements that mislead that tobacco is good for health or that is less harmful to health;

b) caffeine or taurine, or other supplements and performance-enhancing compounds that are associated with energy and vitality;

in the add-ins with paint) properties for emissions;

d) supplements to facilitate inhalation or absorption of nicotine;

e) additives, which have a carcinogenic, mutagenic or toxic to reproduction properties (KMTR) in neizgorena form;

18. cigarettes and tobacco for hand-rolling of cigarettes:

a) with typical food-aromatic qualities;

b) flavourings containing, in one of their constituent parts, such as filters, paper, packaging, capsules or other technical elements, making it possible to change the smell or the taste of the tobacco or the intensity of their smoke; Paper filters and capsules may not contain tobacco or nicotine;

19. tobacco and related products containing plants and substances prohibited by the law on the control of narcotic substances and precursors. "

2. Paragraph 3 shall be repealed.

§ 8. Create a new article. 31 and article. 31A:

"Art. 31. the placing on the market of tobacco for oral use.

Art. 31. cross-border sales are prohibited from a distance, as well as the supply and sale of tobacco and related products through the services of the information society. "

§ 9. Article 32 shall be amended as follows:

"Art. 32. (1) the importation of tobacco and related products are consistent in terms of the requirements of the law by the competent authorities designated by the regulation for implementation of the law.

(2) Tobacco and related products that are offered and sold in duty-free outlets under the Act for duty free trade must satisfy the requirements of this law. "

§ 10. In art. 35 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and in the text) before item 1, the words "and tobacco" are replaced by "tobacco and related";

b) in point 1, the words "or tobacco" are replaced by "tobacco or related" and the words "and tobacco" are replaced by "tobacco and related";

c) in item 2 Add "via other external signs of advertising image with specific or special character that is recognizable mainly or only by persons under the age of 18".

2. in the Al. 2 the words "tobacco" are replaced by "tobacco and related".

3. in the Al. 3:

and in the text) before item 1, the words "and tobacco" are replaced by "tobacco and related";

b) in point 1 the words "everywhere and tobacco" shall be replaced by the words "tobacco products, electronic cigarettes and containers for multiple filling".

4. in the Al. 4 and 5, the words "and tobacco" are replaced by "tobacco and related".

5. a para. 7:


"(7) are audiovisual commercial communications for electronic cigarettes and containers for repeated filling. The law applies to messages for radio and television. "

§ 11. The name of the chapter ten ' a ' shall be replaced by the following: "ingredients and emissions.

§ 12. Article 35 (a) shall be replaced by the following:

"Art. 35. (1) the maximum level of emissions of cigarettes produced and/or placed on the market should not exceed:

1.10 mg tar for a cigarette;

2. one mg of nicotine for a cigarette;

3.10 mg carbon monoxide for a cigarette.

(2) the content of tar, nicotine and carbon monoxide yields of cigarettes shall be measured emissions on the basis of ISO standards 4387 for tar,-standard ISO 10315 – for nicotine, and 8454 – ISO standard for carbon monoxide. The accuracy of the measurements of tar, nicotine and carbon monoxide shall be determined in accordance with ISO standard 8243.

(3) the measurements under para. 2 verified by laboratories accredited by the Executive Agency "Bulgarian accreditation service" to the Minister of the economy or by laboratories accredited by the competent authority of another Member State of the European Union.

(4) the laboratories under para. 3 may not be owned or controlled directly or indirectly by manufacturers of tobacco products.

(5) the Executive Agency "Bulgarian accreditation service" provided to the European Commission a list of laboratories accredited by it under para. 3, stating the applicable criteria for approving and monitoring methods. The list is updated each time you change. "

§ 13. Article 35 (b) shall be replaced by the following:

"Art. 35 (b). (1) producers, importers and persons who enter the territory of another Member State of the European Union, tobacco products, presented to the Institute for tobacco and tobacco products:

1. a list of all used in the manufacture of tobacco products ingredients and their quantity in descending order according to the weight of each ingredient included in the product by brands and types of tobacco products; the list shall be accompanied by:

a) Declaration, which sets out the grounds for the inclusion of such ingredients in tobacco products concerned;

(b)) the status of the ingredients, including whether the ingredients are registered pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Council Regulation (EC) No 1488/94 the Commission as well as Council Directive 76/769/EEC and directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC;

in the classification of ingredients) under Regulation (EC) no 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (OJ, L 353/1 of 31 December 2008);

d) toxicological data on ingredients in burnt or neizgorena form, including their impact on the health of users, taking account of all addictive properties;

2. the level of emissions under art. 35 a, para. 1;

3. information about other feeds and their content in cases where they have such information;

4. information about all methods used to measure the emissions of tobacco products.

(2) manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, cigarettes and tobacco for hand-rolling of cigarettes, in addition to the information referred to in paragraph 1. 1 presented to the Institute for tobacco and tobacco products and:

1. technical document, containing a general description of the additives used and their properties;

2. information on the additives included in the priority list of additives; the priority list of additives shall be determined by the regulation for implementation of the law.

(3) manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, tobacco products, inform the Institute of tobacco and tobacco products, if the composition of a device is altered in a way that affects data and information under para. 1 and 2.

(4) prior to the placing on the market of new and/or amended tobacco manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, tobacco products, provide data and information under para. 1 and 2 for the products concerned.

(5) data and information under para. 1 and 2 shall be made available by electronic means under the conditions and in accordance with procedures laid down by the regulation for implementation of the law.

(6) upon presentation of the data and information under para. 1 and 2 manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, tobacco products, indicating which part of them considered a trade secret.

(7) the Institute for tobacco and tobacco products:

1. store the data and information under para. 1 and 2 in electronic form and provides access to the European Commission and the other Member States of the European Union, the information for the purposes of the implementation of the law and Directive 2014/40/EC of the European Parliament and of the Council of 3 April 2014, on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127/1, of 29 April 2014);


2. publish on its website the data and information under para. 1 and 2, with the exception of data and information, representing a trade secret;

3. take appropriate technical and organizational measures to protect with regard to the processing of data and information that represent commercial or other secret protected by law;

4. notify the European Commission of any maximum level of emissions, the emission of cigarettes other than emissions under art. 35 a, para. 1, as well as the emissions of tobacco products other than cigarettes;

5. notify the European Commission of all methods of measurement to be used for the emissions of cigarettes other than emissions under art. 35 a, para. 1, as well as the emissions of tobacco products other than cigarettes;

6. propose to the Ministry of economy on the basis of scientific evidence to introduce a ban on the placing on the market of tobacco products which contain additives in amounts which, at the time of consumption increases substantially or measurable extent toxic effect, addictive properties, or properties of KMTR tobacco;

7. may require manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, tobacco products, to conduct additional studies to assess the impact of the ingredients on the health of users, taking into account the danger of addiction to them and their toxicity.

(8) Employees, processing and storing data and information under para. 7, item 1, shall be obliged not to divulge information and facts that become known to them on the occasion of the performance of their duties, except in cases where this is provided for in law or at the written request of a public authority.

(9) in the event of the introduction of prohibition under para. 7, t. 6 Ministry of economy shall notify the European Commission. "

§ 14. In article 35 shall be replaced by the following:

"Art. 35. (1) the manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, cigarettes and tobacco for hand-rolling of cigarettes must carry out in-depth studies of the products containing an additive included in the priority list under art. 35 (b), para. 2, item 2, and which studies are designed to determine whether this add-on:

1. contribute to the toxicity of the products concerned, addictive or lead to significant or measurable increase in toxicity, or the risk of addiction to any of the products concerned;

2. gives characteristic taste aromatic qualities;

3. facilitate inhalation or absorption of nicotine, or

4. leads to the formation of substances that have properties, KMTR their quantity or leads to significant or measurable increase of KMTR properties of any of the relevant articles.

(2) the studies on al. 1 you need to take into account the planned use of the products concerned and shall be assessed in particular emissions resulting from the combustion process, which includes the supplement referred to in para. 1. In the studies is evaluated and the interaction of the supplement referred to in para. 1 with other ingredients of the products concerned. Manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, cigarettes and tobacco for hand-rolling of cigarettes, which use the same plug-in, you can carry out a joint study, when use the same add-in comparable tobacco.

(3) manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, cigarettes and tobacco for hand-rolling of cigarettes shall draw up a report on the results of the studies referred to in paragraph 1. 1. the report includes a summary and a comprehensive overview of the studies indicate the available scientific literature on the supplement referred to in para. 1 and summarizes data about its impact.

(4) manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, cigarettes and tobacco for hand-rolling of cigarettes, the report sent under subsection. 3 of the European Commission, providing a copy of the Institute for tobacco and tobacco products at the latest 18 months after the inclusion of the supplement referred to in para. 1 in the priority list under art. 35 (b), para. 2, item 2.

(5) in cases where the European Commission and/or the Institute for tobacco and tobacco products have requested additional information about the supplement referred to in para. 1, this information shall be included in the report referred to in para. 3.

(6) the Institute for tobacco and tobacco products shall check on the reports referred to in para. 3 as to their completeness, methodology and conclusions. "

§ 15. Article 35 shall be replaced by the following:

"Art. 35. Article 35 (b), para. 2, item 2 and art. 35 c shall not apply to small and medium-sized enterprises within the meaning of the law on small and medium-sized enterprises, where another manufacturer, importer, or a person who enters the territory of another Member State of the European Union, tobacco products, has submitted a report under art. 35 in, al. 3. "

§ 16. In Chapter ten "and" creating art. 35 (e):

"Art. 35 (1), manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, tobacco products, presented to the Institute for tobacco and tobacco products in electronic format:

1. own and other studies that have associated with market research and the preferences of the various user groups, including young people and smokers for constituents and emissions;


2. Summary evaluations of market studies, which carried out related to the release of new tobacco products;

3. information about the volume of sales of tobacco products by brand name and type, in pieces or in kilograms, and the Member State of the European Union, on an annual basis, with effect from 1 January 2015.

(2) upon presentation of the data and information under para. 1 manufacturers, importers and persons who enter the territory of another Member State of the European Union, tobacco products, indicating which part of the data and information considered to be a trade secret.

(3) the National Revenue Agency and/or the Customs Agency provide the Institute for tobacco and tobacco products to the volume of sales data at their disposal.

(4) the Institute for tobacco and tobacco products stored data and information under para. 1 and 3 in electronic form and provides access to the European Commission and the other Member States of the European Union, subject to the requirements for the protection of information. "

§ 17. Chapter ten shall be "b" with art. 35-35 at:

"Chapter 10" b "

LABELLING AND PACKAGING

Art. 35. (1) Every consumer packaging and any outside packaging of tobacco products must bear health warnings.

(2) health warnings under para. 1 must:

1. take up the entire surface of the packet, or the outer packaging, which is designed for them; the surface of the packet is accepted and the surface of the bevelled or rounded edges, if any;

2. are retold, recast, or refer to them in any form;

3. are printed in a way that does not allow to be removed;

4. be indelible and entirely visible, including not to hide or interrupt all or part of the bands, labels with price, security features, casings, covers, boxes or other items;

5. can be placed through stickers on the consumer packaging of tobacco products other than cigarettes and rolling tobacco in the case, provided that such stickers can be removed;

6. remain complete when opening a packet, with the exception of packages with closing latch is where health warnings may be divided at the opening of the packaging, in such a way as to only the graphical integrity and visibility of text, photos, and information on cessation of tobacco use.

(3) health warnings under para. 1 should not hide or interrupt the bands, price markings for surveillance and tracking, as well as the security features on consumer packaging.

(4) the size of the health warnings under art. 35 h, para. 1, art. 35 k, al. 1, art. 35 l, al. 1 and art. 35 m, al. 1 shall be calculated in relation to the surface when the container is closed.

(5) health warnings under art. 35 h, para. 1, art. 35 k, al. 1 and art. 35 l, al. 1 must be enclosed by a black line of width 1 mm under the surface, designed for them.

(6) health warnings under art. 35 h, para. 1, art. 35 k, al. 2, item 1, art. 35 l, al. 1 and art. 35 m, al. 1 on tobacco intended for duty-free outlets, can be printed in English and must meet the requirements of the law. Information on cessation of tobacco use, which is placed on packages of tobacco products destined for the duty-free outlets, shall be determined by the regulation for implementation of the law and can be printed in English.

Art. 35. (1) on the packet and on the outer packaging of tobacco products, as well as on the tobacco product cannot be pasted elements or distinguishing marks:

1. advertise or promote tobacco use by mislead about its characteristics, health effects, hazards or emissions, representing him;

2. contain information about the content of tar, nicotine or carbon monoxide yields of tobacco;

3. mislead, that a tobacco product is less harmful or that leads to reducing the effects of some harmful components, or that the smoke improves vitality and energy that has healing, rejuvenating, natural or organic properties or carry other health benefits or ways of life;

4. refer to the taste, smell or other additives or their absence;

5. mimic nutritional or cosmetic product;

6. mislead, that a tobacco product has improved biodegradability or other environmental benefits.

(2) Consumer packaging and outer packaging of tobacco should not influence economic benefit, including printed vouchers offering discounts, free distribution, offering "two-for-one" or other additives, as defined by law.

(3) Prohibited items and distinctive markings in the Al. 1 and 2 may include texts, symbols, names, trademarks, figurative or other signs, but are not limited to them.

Art. 35. (1) on any consumer packaging and any outside packaging of cigarettes, tobacco for hand-rolling of cigarettes and water-pipe tobacco is placed:

1. General warning "smoking kills – give it up now";

2. an information message "tobacco smoke contains over 70 substances known to cause cancer".

(2) For packages of cigarettes and rolling tobacco in the form of parallelepiped packs with:


1. a general warning on al. 1, item 1 is placed at the bottom of one of the side surfaces of the packaging and information message in the Al. 1, item 2 shall be placed at the bottom of the other side surface of the consumer packaging;

2. the breadth of the general notice for al. 1, item 1 and message information under para. 1, item 2 is not less than 20 mm;

3. the breadth of the general notice for al. 1, item 1 and message information under para. 1, item 2 must be parallel to the longest side of the package and the reading order of the warning.

(3) For packages of cigarettes and tobacco for hand-rolling tobacco in the form of a rigid box with a drop-down latch where the lateral surfaces are divided into two parts when you open the package, the general warning under para. 1, item 1 and the information message on al. 1, item 2 shall be located entirely on the larger of the two parts of the surface. General notice for al. 1, item 1 is placed on the inner side of the upper surface, which is visible when you open the package. The height of the surface of this type of packaging is not less than 16 mm.

(4) For rolling tobacco in:

1. packaging-shaped carrying case – the general warning under para. 1, item 1 and the information message on al. 1, item 2 shall be placed on surfaces, which provide full visibility of these health warnings;

2. cylindrical packaging – general warning under para. 1, item 1 on the outer surface of the lid and the information message on al. 1, item 2 of the inner surface of the lid.

(5) For packets of cigarettes, rolling tobacco and tobacco for water pipe general warning under para. 1, item 1, as well as information communication under paragraph 1. 1, item 2 shall cover 50 percent of the surface.

Art. 35. a general warning and information communication under art. 35 h, para. 1 must be:

1. printed on Bulgarian language with black solid font "Helvetica" on a white background;

2. situated in the Centre of the surface, designed for them, such as packaging in the form of parallelepiped with all external packaging – parallel to the lateral edge of the custom packaging or of the outer packaging.

Art. 35 HP. (1) every consumer packaging and any outside packaging of cigarettes, tobacco for hand-rolling of cigarettes and water-pipe tobacco put combined health warnings.

(2) the combined health warnings under para. 1 must:

1. contain a text alert from the list in annex 3 and corresponding color photo from the Gallery of images by Annex 3 b;

2. to consist of the same text alert from the list in annex 3 and corresponding color photo from the Gallery of images by Annex 3 (b) on both sides of the packet and on any outside packaging;

3. include the following information for the cessation of tobacco use: "aid for smoking: 0700 10 323";

4. to cover 65 percent of the outside front and back surface of the packet and on any outside packaging; the cylindrical containers are placed two combined health warnings, which are the same distance from one another, like any health warning covers 65 percent of the half-rounded surface;

5. to be placed at the top of the packet and on any outside packaging in the same way as any other information placed on the same side of the package;

6. are in the format, layout, design and proportions laid down in the Decision to implement (EU) 2015/1842 of 9 October 2015 concerning the technical specifications for the layout, design, and shape of a compound health warnings for tobacco products for smoking (OJ, L 267/5 of 14 October 2015);

7. in consumer packs of cigarettes are:

(a) with height)-not less than 44 mm;

(b)) with width-not less than 52 mm.

(3) Over the combined health warnings under para. 1 not putting trademarks or logos.

(4) the combined health warnings under para. 1 are divided into three groups, set out in annex 3 (b). The groups are used consistently for a period of one year, starting with Group 1.

(5) any combined health warning under para. 1 used in the relevant year group in annex 3 (b) is printed, as far as possible on an equal number of custom and external packaging in the same year, for each brand of tobacco product.

(6) the Ministry of the economy shall provide the manufacturers and/or importers of tobacco products technical specifications for the layout, design, and shape of a compound health warnings for tobacco products for smoking.

(7) in the provision of technical specifications referred to in paragraph 1. 6 manufacturers and importers of tobacco products shall sign the Declaration in annex 3 in.

Art. 35 l. (1) on any consumer packaging and any outside packaging of smokeless tobacco is placed following health warning: "This tobacco product damages your health and is addictive."

(2) the health warning under para. 1 must:

1. meet the requirements of art. 35 and;

2. printed parallel to the surface, designed for him;

3. on the two largest surfaces of the packet and on any outside packaging;

4. cover 30 percent of the surface of the packet and on any outside packaging.


Art. 35 m. (1) on any consumer packaging and any outside packaging of tobacco products for smoking, other than cigarettes, rolling tobacco and tobacco water pipe, place:

1. General warning referred to in art. 35 h, para. 1, item 1;

2. one of the text alerts from the list in annex 3A.

(2) the general warning under para. 1 includes the following information for the cessation of tobacco use: "aid for smoking: 0700 10 323".

(3) the general warning referred to in art. 35 h, para. 1.1 must:

1. on the most visible surface of the packet and any outside packaging;

2. cover 30 percent of the corresponding surface of the packet and on any outside packaging.

(4) The notice under subsection. 1, item 2 shall:

1. cover 40 per cent of the corresponding surface of the packet and on any outside packaging;

2. appears, as far as possible, with the same frequency for each brand of these articles;

3. on the next surface visibility of consumer packaging and any outside packaging; in consumer packaging with drop-down latch next vision surface is one that becomes visible when you open the package.

(5) in the event that health warnings under para. 1 must be located on a surface of more than 150 kV. cm, the warning must cover an area of 45 sqm. cm.

(6) health warnings under para. 1 must:

1. meet the requirements of art. 35 and; the text of health warnings is parallel to the main text of the surface, designed for those warnings;

2. are surrounded by a black line, not less than 3 mm and not more than 4 mm; This line is placed outside the surface, designed for health warning.

(7) article 35 (h), para. 1, item 2 and art. 35 k, al. 3 do not apply to smoking tobacco products other than cigarettes, rolling tobacco and tobacco water pipe.

Art. 35. Packets of cigarettes must:

1. are the shape of a parallelepiped, including those with rounded or beveled edges;

2. be of cardboard or soft material;

3. do not have aperture that can be locked or sealed again after the initial opening, but is closing the latch and pull-down latch on the rigid box; packaging with sealing and drop-down latch cover is pushed to the back of the packet.

Art. 35. The custom packaging of tobacco for hand-rolling of cigarettes are shaped like a cuboid or cylinder or are in the form of case.

Art. 35 p. (1) the Consumer packaging of tobacco products intended to be placed on the market shall be marked with a unique identifier.

(2) the unique identifier under para. 1 must:

1. be printed or affixed in such a way that it cannot be removed or compromised his integrity;

2. be indelible and hides or interrupts, including through the band and label with the price or when opening the packet;

3. allows for the determination of:

a) date and place of production;

b) production site;

in) machine used for the production of tobacco products;

d) production shift or hours of production;

(e)), the description of the product;

is market) retail for which tobacco products are intended;

(g)) the intended journey for transportation;

h) importer in the case of imports;

and the actual transport route) from the production site to the first commercial site for retail sale, including all the warehouses, the date of dispatch, destination, point of departure and the recipient;

k) the identity of all buyers of the manufacturing entity to the first commercial site for retail sale;

(l)), order number invoice and payment documents for all buyers of the manufacturing entity to the first commercial site for retail.

(3) the information referred to in para. 2, item 3, (a) – (g), as well as the letter "h" in the case of imports, is part of a unique identifier in the Al. 1.

(4) the information referred to in para. 2, item 3, "and", "k" and "l" is available electronically via a link with a unique identifier in the Al. 1.

Art. 35 p. (1) all economic operators involved in the marketing of tobacco products from the manufacturer to the last economic operator before the first commercial site for retail (economic operators in the supply chain), recorded in their receipt of all consumer packages, as well as any intermediate movement and final delivery.

(2) the obligation under paragraph 1. 1 can be accomplished by tagging and recording of large packs, such as stacks, or pallet boxes, provided that the monitoring and tracking of consumer packaging remains possible.

Art. 35. All economic operators in the supply chain for tobacco products before the first commercial site for retail maintain complete and accurate records of all relevant transactions.

Art. 35 (1) manufacturers of tobacco products provide the necessary equipment, allowing for storing data on purchased, sold, stored, transported or subject to any other type of tobacco transactions of all economic operators in the supply chain for tobacco products before the first commercial site for retail sale, including importers, warehouses and transport companies.

(2) the equipment referred to in paragraph 1. 1 should provide an opportunity for reading and transmission of recorded data by electronic means to the facility for storage of data in accordance with para. 3.


(3) manufacturers and importers of tobacco products shall conclude a contract for the storage of the data referred to in para. 1 with an independent third party, to be situated storage facility of all data.

(4) Facility at al. 3 must be situated in the territory of the European Union.

(5) the independence and technical capability of the independent third party as well as the Treaty under paragraph 1. 3 shall be approved by the European Commission.

(6) the activities of the independent third party shall be monitored by an external auditor proposed and remunerated by the manufacturer of tobacco products and is approved by the European Commission.

(7) the European Commission, the national Customs Agency and the external auditor have full access to the storage facility at al. 1.

(8) in duly justified cases, the European Commission or the national Customs Agency in compliance with art. 17, al. 1, item 6 of the Customs Act may provide manufacturers or importers access to stored data under para. 1, provided that the information is protected under the law of the European Union and of the Bulgarian legislation.

(9) the data referred to in para. 1 should not be altered or deleted by economic operators in the supply chain for tobacco products before the first commercial site for retail.

(10) Personal data are processed in compliance with the requirements of the data protection act.

(11) the basic elements, such as duration, possibility of renewal required experience or privacy policy, including regular monitoring and evaluation of the operation of treaties under para. 3 shall be determined by the regulation for implementation of the law.

Art. 35. (1) on the consumer packaging of tobacco products that are placed on the market, must be placed a protective element.

(2) the security element in the Al. 1 must be:

1. secure against counterfeiting;

2. composed of visible and invisible parts;

3. printed or affixed so that it can not be removed;

4. the indelible and not to hide or interrupted, including the bands and labels with price or other items. "

§ 18. Chapter Twelve is created with art. 43 a-43 (h):

"Chapter twelve

ELECTRONIC CIGARETTES

Art. 43. (1) producers, importers and persons who enter the territory of another Member State of the European Union, electronic cigarettes and/or containers for repeated filling, shall notify the Ministry of economy for each device you want to place on the market.

(2) the notification under paragraph 1. 1 in electronic form shall be submitted six months prior to the placing on the market of the product.

(3) depending on whether the device is an electronic cigarette, or container for repeated filling, the notification under paragraph 1. 1 contains:

1. a single identification code (UIC) of the merchant and for the persons registered in another Member State of the European Union or in another State party to the agreement on the European economic area – another identification code or number;

2. the address and phone number of the manufacturer, the natural or legal person within the European Union and, in the case of the importer;

3. list of ingredients contained in the product, and, as a result of its use, for each brand and each type, including their quantities;

4. the toxicological data available to constituents and emissions of the product, including warming, indicating, in particular, their impact on the health of consumers through inhalation and eventualniâtim effect of addiction;

5. information on the doses of nicotine and its absorption when consumed under normal or reasonably foreseeable conditions;

6. a description of the components of the device; where applicable a description of the mechanism to open and for loading the electronic cigarette or containers for repeated filling;

7. Description of the production process, including whether it includes series production, and a statement that the manufacturing process ensures compliance with the requirements of this article;

8. a statement that the manufacturer, the importer and the persons who enter the territory of the country by another Member State of the European Union, electronic cigarettes and/or containers for repeated filling, bear full responsibility for the quality and safety of the product when it is placed on the market and is being used under normal or reasonably foreseeable conditions.

(4) in the event that the information provided in the notification under paragraph 1. 1 information is incomplete, the Ministry of economy may require completion of relevant information.

(5) the Ministry of economy made an entry in the register under para. 8 after removal of limitations under para. 4.

(6) For any substantial modification of the electronic cigarette and/or the container for multiple engine manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, electronic cigarettes and/or containers for repeated filling, submit a notification under the conditions and by the order of al. 1-4.

(7) the Ministry of the economy may require additional information from the persons referred to in para. 1 associated with safety and quality, for the presence of adverse effects, and other information about the device.

(8) the Ministry of the economy maintains a public register of the persons referred to in para. 1 and their products.

(9) the Ministry of economy published on its website the information under para. 3 and part of the register under para. 8, with the exception of information that is a trade secret.


Art. 43 (b) (1), manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, electronic cigarettes and containers for repeated filling, an annual grant of the Ministry of economy:

1. details of the sales volume for each brand and each type of product;

2. information about the preferences of the various user groups, including young people, non-smokers and the main types of smokers;

3. information on the means of sale of the products;

4. Summary evaluations of market studies carried out in connection with items 1-3, with an English translation.

(2) the Ministry of the economy shall publish on its website the information under para. 1 and part of the register under art. 43 (a), para. 8, with the exception of information that is a trade secret.

(3) at the request of the Commission or a Member State of the European Union, the Ministry of economy shall provide the information referred to in para. 1 in compliance with the requirements for protection of the information.

Art. 43. Manufacturers, importers, persons who enter the territory of another Member State of the European Union, and traders of electronic cigarettes and containers for filling repeatedly establish and maintain a system to collect information about all of the adverse effects of these products for human health.

Art. 43. Economic operators in cases where they think or has reason to believe that the electronic cigarettes or containers for repeated filling are not safe or are not of good quality, or otherwise not in accordance with the requirements of the law:

1. take immediate action to bring the product with the requirements of the law or for its withdrawal from the market;

2. immediately notify the Ministry of economy of the action taken by them under item 1.

Art. 43 (1) Liquids containing nicotine:

1. shall not be placed on the market only in special containers for repeated refilling with a volume of no more than 10 ml, disposable electronic cigarettes in cartridges or disposable, as the volume of bullets or tanks shall not exceed 2 ml;

2. must not contain more than 20 mg/ml nicotine;

3. must not contain:

a) vitamins or other supplements that mislead that this is useful to health or represent a reduced risk to health;

b) caffeine or taurine, or other supplements and performance-enhancing compounds that are associated with energy and vitality;

in the add-ins with paint) properties for emissions;

d) supplements to facilitate inhalation or absorption of nicotine;

e) supplements that have properties on KMTR neizgorena form.

(2) in the production of liquids containing nicotine, using only ingredients with a high degree of purity. The presence of substances other than those referred to in the list under art. 43 (a), para. 3, item 3, shall be permissible only in the form of residues which it is technically impossible to avoid.

(3) with the exception of nicotine, in liquids containing nicotine, using only ingredients which do not present a danger to human health in heated or nenagrât type.

Art. 43. Electronic cigarettes, which are placed on the market, you need to submit the same nicotine in doses under normal conditions of use.

Art. 43 g. electronic cigarettes and containers for repeated filling, which is placed on the market, must be resistant to damage by children, cannot be faked, are protected from breakage and leakage and to have a mechanism that secures the filler without leaks.

Art. 43. (1) in the custom packaging of electronic cigarettes and/or multiple containers filling includes leaflet with:

1. instruction for use and storage of the product, indicating that the product is not recommended for use by young people and smoking;

2. contraindications;

3. alerts for specific risk groups;

4. possible side effects;

5. warnings about the dangers of addiction and toxicity;

6. the data of the manufacturer and/or importer, as well as a legal or natural person on the territory of the European Union.

(2) Consumer packaging and any outside packaging of electronic cigarettes and containers for repeated filling must contain:

1. a list of all ingredients in the product in descending order according to their weight;

2. indication of the nicotine content of the product and quantity of poemanoto nicotine dose;

3. batch number;

4. a recommendation to keep the device away from children;

5. information on the content of nicotine and flavorings.

(3) the packet and any outside packaging of electronic cigarettes and containers for repeated filling must not include elements or distinguishing marks:

1. promote the product or promote its use by mislead on the characteristics, health effects, hazards or emissions, representing him;

2. mislead, that a product is less harmful than others, or that leads to reducing the effects of some harmful components, or that the smoke improves vitality and energy that has healing, rejuvenating, natural or organic properties or carry other health benefits or ways of life;

3. refer to the taste, smell or other additives or their absence;

4. approximate nutritional or cosmetic product;

5. mislead, that is definitely a product has improved biodegradability or other environmental benefits.


(4) on the packet and on any outside packaging of electronic cigarettes and containers for repeated filling place health warning: this product contains nicotine, which is highly addictive. Not recommended for use by smoking. "

(5) the health warning applies to art. 35 l, al. 2. "

§ 19. Article 46 shall be amended as follows:

"Art. 46. (1) that stores, offers for sale or trade items in stores or tobacco and/or related articles or new tobacco products in violation of art. 26A, 26 c, 29, art. 30, para. 2, items 1-8 and 10-18, art. 31, 31A, art. 35 a, para. 1 – 4, art. 35-35, with art. 35 t, al. 1 – 4 and al. 9 and art. at 35, is punishable by a fine of 1000 to 3000 EUR, respectively, have proprietary sanction from 2000 to 5000 EUR

(2) in the event of a repeated offence under subsection. 1 the fine is from 2000 to 5000 EUR, and the proprietary sanction – from 4000 to 8000 LV. "

§ 20. Art is created. 46A:

"Art. 46. In cases where it is established, offering storage or sale in commercial stores or outlets of tobacco products in violation of art. 30, para. 2, item 9, the Commission shall inform the consumer and shall send a certified copy of the record with the established facts and circumstances of the Customs Agency, which establishes and enforces administrative penalty in accordance with the law on excise duties and tax warehouses. "

§ 21. Article 49 shall be amended as follows:

"Art. 49. Who violates the provisions of art. 32, is punishable by a fine of 1000 to 3000 EUR, respectively, have proprietary sanction from 2000 to 5000 LEVs. "

§ 22. In art. 50 following amendments and supplements shall be made:

1. The current text becomes paragraph 1.

2. a para. 2:

"(2) in the event of a repeated offence under subsection. 1 or failure to comply with the requirements under art. 52A, al. 6 the fine is from 50 000 to 100 000 BGN, and the proprietary sanction – from 100 000 to 150 000 LEVs. "

§ 23. In art. 51 and following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "art. 35 in, al. 2 and art. 35 "is replaced by" article. 35 (b), para. 1 – 5 and art. 35 in, al. 1-4.

2. a para. 3:

"(3) in the case of an infringement as defined in para. 1 the Institute for tobacco and tobacco products shall inform the Ministry of agriculture and food, and shall send a certified copy of the record with the established facts and circumstances. "

§ 24. Create art. 51 (b), (c) and (d) 51 51:

"Art. 51 (b) (1) that stores, offers or sells electronic cigarettes and/or containers for repeated filling in violation of art. 43 (a), para. 1, 2 and 6, art. 43 (b), para. 1 and art. 43-43 (h) is punishable by a fine of 1000 to 3000 EUR, respectively, have proprietary sanction from 2000 to 5000 EUR

(2) in the event of a repeated offence under subsection. 1 the fine is from 2000 to 5000 EUR, and the proprietary sanction – from 4000 to 8000 EUR

Art. 51. the person who contravenes art. 35 (b), para. 8, if not subject to more severe punishment, is punishable by a fine of 100 to 1000 EUR

Art. 51. In the case of violation or suspected violation of the law in the exercise of its activities, the Customs authorities shall immediately inform the relevant authority under art. 52, para. 1. "

§ 25. Article 52 shall be amended as follows:

"Art. 52. (1) the offences under the Act are established by acts, consisting of:

1. authorized by the Director of the Customs Agency officials – for violations under art. 46 on the art. 32, 35 p-35 c, art. 35 t, al. 1 – 4 and al. 9 and art. at 35, and under art. 49;

2. authorized by the Minister of agriculture and food officials – for violations under art. 51A;

3. the directors of the regional directorates for agriculture or authorised by them – officials for violation of art. 44A and 44B;

4. authorized by the Minister of economy officials – for violations under art. 46 on the art. 26 a, para. 1 and 2, art. 26 c and art. 51 (b) art. 43 (a), para. 1, 2 and 6, art. 43 (b), para. 1 and art. 43 (h);

5. authorized by the President of the Commission for consumer protection officials – for violations under art. 46 on the art. 29, art. 30, para. 2, items 1-8 and 10-18, art. 31, 31A, 35, art. 35 a, para. 1 – 4, art. 35-35, under art. 50 and art. 51 (b) art. 43-43 (h).

(2) the penal provisions shall be issued by:

1. the Director of the customs agency or an official authorised by him – in the Al. 1, item 1;

2. the Minister of agriculture and food or by an official authorized by him – in the Al. 1, 2 and 3;

3. the Minister of economy, or by the officer authorized by him – under par. 1, item 4;

4. the President of the Commission for the protection of consumers or by an official authorized by him – in the Al. 1, item 5. "

§ 26. Article 52 (a) shall be replaced by the following:

"Art. 52. (1) the control of compliance with the requirements under art. 26 a, para. 1 and 2, art. 26, 29, art. 30, para. 2, items 1-8 and 10-18, art. 31, 31A, 35, art. 35 a, para. 1-3, art. 35-35 o, art. 43 (a), para. 1 and art. 43-43 (h) shall be carried out by the Commission for the protection of consumers.

(2) where, as a result of the checks referred to in paragraph 1. 1 establish non-compliance with the requirements under art. 30, para. 2, item 17 and 18, art. 35 a, para. 1, art. 43 e, 43 and 43 (g), the cost of the inspection shall be borne by the investigation. When non-compliance is found, not the cost of the inspection shall be borne by the Commission for the protection of consumers.

(3) in cases where the market is offering new tobacco products tobacco products, electronic cigarettes and containers for repeated filling, which do not meet the requirements of art. 26 a, para. 1 and 2, art. at 26, art. 35 a, para. 1-3, art. 35-35, at art. 43 e-43 (h), the control authorities shall issue an order with the compulsory requirements to manufacturers, importers and retailers to withdraw devices from the market.

(4) in cases where the producers, importers and traders do not comply with the order, the inspection authority shall seize and destroy these devices.

(5) in the case of violation of art. 26 a, para. 1 and 2, art. at 26, art. 43 (a), para. 1 and 2, art. 43, 43 (d) the Commission shall notify the Ministry of the economy and shall send a certified copy of the record with the established facts and circumstances.


(6) where, as a result of the checks referred to in paragraph 1. 1 establish non-compliance with the requirements of art. 35, the President of the Commission for the protection of consumers or authorised by him officer issued an order to the compulsory requirements for it to be corrected within a specified period of time.

(7) in cases where electronic cigarettes and repeatedly filling containers shall meet the requirements of the law, but the consumer protection Commission has reasonable grounds to believe that this product may pose a serious risk to human health, it may apply the measures referred to in paragraph 1. 3.

(8) the Commission shall notify the European Commission, the competent authorities of the Member States of the European Union, the Ministry of the economy and of the measures taken under paragraph 1. 6 and the grounds for taking them. "

§ 27. In the additional provision, the following amendments and supplements shall be made:

1. The designation "Additional provision" shall be replaced by the following: "additional provisions".

2. In paragraph 1:

(a) in item 1) creates a third sentence: "Tobacco" means tobacco leaves and other natural and processed or unprocessed tobacco plant parts, including padded and reconstituted tobacco. ';

(b)) created new item 5, 6, 7, 8 and 8A:

"5." tobacco products for smoking "are tobacco products, other than smokeless tobacco products.

6. "water-pipe tobacco" means tobacco smoking, which can be consumed through a water pipe. If the device can be used both for human consumption through a water pipe and hand-rolling of cigarettes, it is considered to be the tobacco for the rolling of cigarettes by hand.

7. "New tobacco" means tobacco product which:

a) does not fall within the scope of paragraph 4 (a)-4 (e), (g) and 4-4 and 6;

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

8. "Articles related to tobacco products" are electronic cigarettes, repeatedly filling containers and liquids containing nicotine.

8A. "tobacco products other than cigarettes and tobacco for hand-rolling of cigarettes" are articles which fall within the scope of paragraph 4 (b) – 4 d, 4-4 and, (6) and (7) item. ";

in the past) became item 5 and item 9 shall be amended as follows:

"9." ingredient "means tobacco additive, as well as all substances or elements, contained in the tobacco or related materials, including paper, filter, inks and adhesives, the capsules.";

(d)) the current item 6 becomes item 10 and in her words "tobacco smoke" are replaced by "smoke";

(e)) the current item 7 becomes item 11;

create new) 12, 13, 14 and 15 and 16, 17 and 18:

"12." emissions "are substances that are released for use as intended the tobacco product and/or related materials, such as the substances in smoke or substances emitted in the use of smokeless tobacco products.

13. "Supplement" is a substance, other than tobacco, added to tobacco, to its consumer packaging or to any outer packaging.

14. "flavor enhancer" is an add-in that adds smell and/or taste.

15. "the typical food-aromatic qualities" are clearly capture the smell or taste different from that of tobacco, and derived from the combination of the additive or additives, including but not limited to, fruit, spice, herb, alcohol, sugar, menthol or vanilla that is felt before or during the use of tobacco.

16. "the maximum level of emissions is the maximum content or emission of a substance in tobacco, including zero measured in milligrams.

17. "danger of addiction" is the potential of a substance pharmacovigilance to lead to addiction – a condition that affects a person's ability to control his behavior, generally creates a sense of satisfaction or to relieve the symptoms of withdrawal symptoms, or both.

18. "Toxicity" is the degree to which a substance can have adverse effects on the human body, including effects occurring after time, usually with repeated or prolonged use or exposure to the substance concerned. ";

(g)) the current item 8 becomes item 19 shall be replaced by the following:

"19." Custom package "is the smallest standalone package of a tobacco product and/or a related device, which is placed on the market. ';

(h) the current item 8) and becomes n. 20 and is replaced by the following:

"20." consumer packaging for manually bent cigars "is the smallest private packaging manufacturer, importer or wholesaler delivers to retailers, who have the permission to trade in tobacco products. In cases where the custom package of hand-bent cigars from limited edition gives added value as a result of its special construction or value of investments in her material, then consumer packaging is considered the outer packaging of the product. ';

and so on are created) 21-31:

"21." limited edition "under item 20 is a product that is produced in limited quantity at a specified or for a specific period of time and is intended exclusively for collectors.

22. "outer packaging" means any package in which tobacco and related products are placed on the market and which includes a custom package or set of consumer packages. Transparent packaging shall not be considered as external packages.

23. "Case" is consumer packaging of rolling tobacco in the form of a rectangular pocket with flap, which covers the hole, or Pack in an upright position.


24. "health warning" warning about the adverse effects to human health or other undesirable effects of tobacco use, which includes text warnings, combined health warnings, public warnings and information messages, according to art. 35 h, para. 1, art. 35 k, al. 1, art. 35 l, al. 1, art. 35 m, al. 1 and art. 43 h, para. 4 and annex 3.

25. "the combined health warning" is a health warning, which consists of a combination of a text warning in annex 3 and relevant picture of the Gallery of images by Annex 3 b.

26. "user" is a natural person who is acting for purposes which are outside his trade, business or profession.

27. "producer of tobacco and/or related articles" is a natural or legal person who manufactures a product or cause its creation or production and offers this product on the market under his name or his trademark.

28. "the import of tobacco or related products" is the introduction in the European Union of tobacco and/or related articles unless these articles are placed under a customs procedure or regime of postponed payment on their introduction in the territory of the European Union, as well as exemption from customs procedure or procedure.

29. "importer of tobacco or related products" is the owner or the person who has the right to dispose of the tobacco or related products, which have been brought into the territory of the European Union.

30. "placing on the market ' is a representation, providing or offering of tobacco and related products, regardless of where they are produced, consumers in the Republic of Bulgaria against payment or free of charge, including by means of distance selling, cross-border distance selling, as well as sales through the use of information society services.

31. "commercial site for retail" is a commercial entity within the meaning of art. 90 (b), para. 1 of the law on excise duties and tax warehouses, which marketed tobacco products. ';

(k) the current item 9) becomes p. 32;

l) current item 10 item becomes 33 finally added "and/or related materials;

m) the current item 11 shall become item 34 and then added "and/or related materials;

n) current t. 12, 13 and 14 shall become item 35, 36 and 37;

o) established that 38-45:

"38." economic operator "is a manufacturer, importer and distributor of tobacco and/or related articles or his authorized representative and any trader within the meaning of the commercial code, engaged in wholesale of tobacco and/or related articles.

39. "e-cigarette" is a device which can be used for the consumption of products containing nicotine vapor through a mouthpiece or a component of this product, including a cartridge and a tank, and the device without a cartridge or tank. Electronic cigarettes can be disposable or reusable by multiple container filling and tank, or to be refilled by disposable cartridges.

40. "container for multiple filling" is a container with a liquid that contains nicotine, which can be used to recharge the e-cigarette.

41. "Systematic violation" is carrying out three or more violations of the same kind over a two-year period for which the person subject to administrative penalties with penal provisions entered into force.

42. "the Amended tobacco product" means a product whose composition is altered in a way that affects information provided under art. 35 (b), para. 1, item 1 – 3.

43. "normal conditions of use" means the use of the device in accordance with the information provided in the instructions for use and storage of the product.

44. "normal or reasonably foreseeable conditions" means use of the product in a way that is referred to in the instructions for use and storage of the device and that can be the result of predictable human behaviour.

45. "cross-border distance selling" is distance selling of members who, at the time of ordering or tobacco related materials are located in the Republic of Bulgaria and ordered by the commercial site for retail, which is established in another Member State of the European Union or a third country; the commercial site for retail sale shall be deemed to be established in a Member State of the European Union:

a) in the case of a natural person – if the place of business is in the same Member State;

b) in other cases – if there is a seat and registered office, Central Administration or place of business, including a branch, agency or other business unit, in the same Member State. '

3. § 1a shall be inserted:

"§ 1 (a). This law introduces the requirements of:

1. Directive 14/40/EC of the European Parliament and of the Council of 3 April 2014, on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC;

2. Delegated directive 14/109/EC of 10 October 2014, amending Annex II to Directive 14/40/EC of the European Parliament and of the Council through the establishment of a gallery of warnings in the form of images, to be used for tobacco products (OJ L 360/22, of 17 December 2014). "

§ 28. Annex 3 shall be set up and to art. 35 k, al. 2, item 1 "annex 3 a to the article. 35 k, al. 2, paragraph 1 a list of text alerts


1. Smoking causes nine out of 10 cases of lung cancer 2. Smoking causes cancer of the oral cavity and throat

3. smoking damages your lungs 4. Smoking causes heart attacks 5. Smoking causes brain strokes and disabilities 6. Smoking clogs the arteries You 7. Smoking increases the risk of blinding 8. Smoking damages the teeth and gums You 9. Smoking can kill your unborn child 10. With tobacco smoke harm children, family and friends 11. Children of smokers are more likely to become smokers also 12. Quitting – stay alive for his family 13. Smoking reduces the reproductive performance 14. Smoking increases the risk of impotence. "

§ 29. Annex 3 shall be b to art. 35 k, al. 2, item 1:

"Annex 3 b of art. 35 k, al. 2, item 1

 

See annex

 

 

 

§ 30. Annex 3 shall be established in the article. 35 k, al. 7:

"Annex 3 c to art. 35 k, al. 7

DECLARATION

The undersigned (s) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (first, middle, and last name)

with the UCC _ _ _ _ _ _ _ _ _, ID card no _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ issued to the _____ of MI g. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _, with permanent address: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ as _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ with the seat and address of management in _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ entered in the commercial register with the UIC ____ _____,

тел.: ___ , факс: ____________ и адрес за кореспонденция:

________________________________________________  

________________________________________________  

________________________________________________

Д Е К Л А Р И Р А М, Ч Е:

1. To engage I use my from the Ministry of economy with the Declaration annexed to this Protocol, technical specifications for the layout, design, and shape of a compound health warnings for tobacco products for smoking, adopted by decision to implement (EU) 2015/1842 of 9 October 2015 concerning the technical specifications for the layout, design, and shape of a compound health warnings for tobacco products for smoking (OJ , L 267/5 of 14 October 2015), hereinafter referred to as ' the Decision of implementation (EU) 2015/1842 ", solely for the purpose of drawing up the user and external packaging of tobacco products for smoking.

2. Be engaged not to use and not to distribute in any way my technical specifications for the layout, design, and shape of a compound health warnings, except for the purposes referred to in paragraph 1.

3. To engage in preparation for the printing of the user and the external packaging of tobacco products for smoking in the part of the technical specification for information about cessation of tobacco use, to add the following text: "aid for smoking: 0700 10 323", in compliance with the requirements of the Decision to implement the (EU) 2015/1842.

I know the responsibility under art. 172 and 172, (b) and 313 of the Penal Code.

____________ г.         ПОДПИС: ________________________ “

Transitional and final provisions

§ 31. (1) When the band is attached to the upper corner of the outer, combined consumer packaging health warning under art. 35 k, al. 1, which must be positioned on the rear surface of the package, you may to 20 may 2019, to be placed just below the band.

(2) where the custom package is made of a soft material for the band may to 20 may 2019, to maintain a rectangular area with a height of not more than 13 mm between the upper edge of the container and the beginning of the combined health warnings.

§ 32. For electronic cigarettes and containers for repeated filling, which are produced or placed on the market until May 20, 2016, manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, electronic cigarettes and containers for repeated filling, submit a notification to the 20 November 2016 under the conditions and by the procedure of art. 43 (a), para. 1-4.

§ 33. Tobacco products which do not comply with the requirements of this law, are labelled in accordance with the Ordinance on requirements for labelling, marking and layout of tobacco products and for setting standards for carrying out conformity assessment of the content of tar, nicotine and carbon monoxide in tobacco products (promulgated, SG. 69/04; amend., no. 2 of 2005, no. 92 from 2013 and 22 by 2015) and were produced or released for free circulation to May 20, 2016, may continue to be placed on the market until stocks last, but by no later than May 20, 2017.

§ 34. Electronic cigarettes or containers for repeated filling, which do not meet the requirements of this Act and are manufactured or released for free circulation until 20 November 2016, may continue to be placed on the market until stocks last, but by no later than May 20, 2017.

§ 35. Article 30, para. 2, item 18 applies to tobacco products with the typical food-aromatic qualities, with effect from 20 may 2020, if it is established that throughout the European Union the volume of sales of tobacco products with the typical food-aromatic qualities equals three or more than three percent for a given product category.

§ 36. (1) manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, tobacco products, provide up to November 20, 2016. the information referred to in art. 35 (b), para. 1 for tobacco products placed on the market until May 20, 2016.


(2) manufacturers, importers and persons who enter the territory of the country by another Member State of the European Union, new tobacco products, electronic cigarettes or containers for repeated filling, notify until 20 November 2016, the Ministry of economy for new tobacco products, electronic cigarettes or containers for repeated filling, which are placed on the market until November 20, 2016. the notification shall be carried out under the conditions and by the procedure of art. 26A and article. 43 (a), para. 1-4.

§ 37. Within 6 months from the entry into force of this law the Council of Ministers brought into conformity with it regulations for its implementation.

§ 38. In the law on seeds and propagating material (official SG. 20 of 2003; amend., SG. 27 of 2005 30/97 and 2006/36 and 43 of 2008., no. 25 and 41 of 2010 and no. 8 and 39 from 2011) in art. 1, al. 2 the words "tobacco" are replaced by "tobacco and related".

§ 39. The Food Act (promulgated, SG. 90 of 1999, amend., 102/2003, no. 70 by 2004, no. 87, 99 and 105 by 2005, issue 30, 31, 34, 51, 55, 80 and 96 06, issue 31, 51 and 53 of 2007 No. 36 and 69 since 2008, 23/41, 74 , 82 and 93 from 2009, PCs. 23, 25, 59, 80 and 98 of 2010, PC. 8 by 2011, issue. 54 and 77 by 2012 PCs. from 2013, 68, St. 26 by 2014, PC. 14 and 56 by 2015.) in art. 2, al. 3, t. 6, the words "tobacco and tobacco" are replaced by "tobacco, tobacco and related".

§ 40. The law shall enter into force on the day of its publication in the Official Gazette, with the exception of:

1. paragraph 5, § 7 on art. 30, para. 2, 12 and 15-18, § 8 on art. 31 a, § 9 on art. 32, para. 2, § 10-16 and 17 on the art. 35-35, § 18, § 19, § 21-26 and 28-36, which shall enter into force on May 20, 2016;

2. paragraph 17 concerning art. 35 p-35 at coming into force by:

a) may 20, 2019, for the manufacture and sale of cigarettes and tobacco for hand-rolling of cigarettes;

(b)) may 20, 2024-for the manufacture and sale of tobacco products other than cigarettes and tobacco for hand-rolling of cigarettes.

The law was adopted by 43-Rd National sat Rainier on 24 March 2016 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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