REGULATION ON PROCEDURES AND PRINCIPLES CONCERNING THE PRODUCTION TYPE, LABELING AND INSPECTION OF TOBACCO PRODUCTS FOR THE PURPOSE OF PROTECTION FROM HARMFUL EFFECTS OF TOBACCO PRODUCTS (Official Gazette dated 06/01/2005 and numbered 25692) CHAPTER ONE Purpose, Scope, Legal Basis and Definitions Purpose ARTICLE 1- The purpose of the Regulation herein is to establish the procedures and principlesfor the purpose of preventing any kind of harmful effects in public, social or medical nature resulting from consumption of tobacco products in various manners, and to determine the maximum tar, nicotine and carbon monoxide yields in tobacco products, and the health warnings and other information to be placed on unit packs of these products as well as the inputs and definitions of these products. Scope ARTICLE 2- The Regulation herein covers the procedures and principles concerning the production type and supply to the market oriented at protection from harmful effects of tobacco products, which are manufactured from tobacco leaf, whether genetically modified or not, as whole or partial raw material intended for smoking, snuffing, sucking or chewing. Legal Basis Article 3- (Amended article: Official Gazette dated 05/04/2009 and numbered 27191, Regulation/Article 1) The Regulation herein has been enacted; a) based on the paragraph five of the Article 4 of the Law dated 7/11/1996 and numbered 4207 on the Prevention and Control of Harmful Effects of Tobacco Products, and the Law dated 3/1/2002 and numbered 4733 on Organization and Duties of Tobacco and Alcohol Market Regulatory Authority, b) in parallel with the provisions of the Directive 2001/37/EC of the European Union on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States concerning the Manufacture, Presentation and Sale of Tobacco Products.1 Definitions ARTICLE 4- The following terms appearing in this Regulation shall have the corresponding meanings as they have been defined below; (Amended definition: Official Gazette dated 05/04/2009 and numbered 27191; Regulation / Article 2) Authority means the Tobacco and Alcohol Market Regulatory Authority,2 (Supplementary definition: Official Gazette dated 05/04/2009 and numbered 27191; Regulation / Article 2) Board means the Tobacco and Alcohol Market Regulatory Board, Unsecretariat means the Undersecretariat of Foreign Trade, - (Version prior to amendment) The Regulation herein has been enacted based on the “Law No. 4733 on Restructuring the General Directorate of the Tobacco, Tobacco Products, Salt and Alcohol Administration, and the Production, Domestic and Foreign Trade of Tobacco and Tobacco Products; based on the Law Amending the Law No. 4046 and the Decree Law No. 233” and based on the provisions of the “Directive 2001/37/EC of the European Union on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States concerning the Manufacture, Presentation and Sale of Tobacco Products.” 2 - (Version prior to amendment) The Authority means Tobacco, Tobacco Products and Alcoholic Beverages Market Regulatory Authority, 1 1 / 10 Commission means the European Union Commission, Producer means natural or legal person producing the tobacco product, or introducing himself/itself as the producer by affixing his/its commercial brand or distinctive mark; in the event that the producer is located outside Turkey, the representative and/or importer authorized by such producer; furthermore, the natural or legal person involved in the supply chain of the product and whose activities affecting the properties of the product relating to its safety, Conformity assessment body means the private or public body carrying out activities with respect to testing, inspection and/or certification of the conformity of the product to the relevant technical regulation, Conformity assessment means any and all of the activities with respect to testing, inspection and/or certification of the conformity of tobacco products to the provisions of the Regulation herein, Supply to the market means the initial activity carried out to place the product on the market for supply or use purposes of the product, Market monitoring and supervision means supervision by the Authority, or making others supervise, whether the tobacco products have been produced in compliance with the Regulation herein and other relevant technical arrangements during the supply to the market, or distribution of, or while the product is on the market, and whether the product is safe in this respect, Tobacco products means all the products manufactured by utilization of tobacco leaf whether genetically modified or not, as whole or partial raw material intended for smoking, snuffing, sucking or chewing, Tar means raw smoke condensate which does not contain water and nicotine, Nicotine means nicotinal alcoloids, Tobacco for oral use means tobacco products, other than for smoking or chewing purposes, made wholly or partially from tobacco, in state of powder or particles or in any combination of the powder and particle, supplied to the market in single-use pouch [bag] or porous pouch or in a way resembling foodstuff, Input means materials used in manufacture or preparation of a tobacco product and any and all kinds of material, substance and component including paper, filter, ink and adhesives despite being modified or changed in the finished product, with the exception of tobacco leaf and parts of tobacco plant in natural or processes status used in manufacture of tobacco products, Yield means compounds such as tar, niconite and carbonmonoxide directly taken into the system during the machine smoking of cigarette, Source list (Supplementary definition: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 1) means the list of “combined warnings” kept in electronic media by the Authority, Combined warning (Supplementary definition: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 1) means the warning comprising the texts in additional warnings given in the annex hereof, and the texts, photographs, drawings or pictures corresponding to such texts and included in the source list, Additional transparent packaging (Supplementary definition: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 1) means the transparent external packaging over unit pack and groupings of tobacco products put on retail sales and which does not preclude the visibility and readability of all labeling information, Grouping (Supplementary definition: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 1) means the packaging, made of any material, outside additional transparent packaging, put on retail sales by putting tobacco products in the same brand and one than one tobacco product in terms of tobacco product kind, Pack (Supplementary definition: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 1) means the unit package, made of any material, used for retail sale of tobacco products and outside the additional transparent packaging. CHAPTER TWO Maximum Tar, Nicotine and Carbon Monoxide Yields and Methods of Measurement 2 / 10 Maximum tar, nicotine and carbon monoxide yields ARTICLE 5- (Amended article: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 2) The maximum tar yield must be 10 mg, maximum nicotine yield 1 mg, and carbon monoxide must be 10 mg from 1/1/2009 on per one cigarette stick produced, placed on free movement and supplied to the market.3 Methods of measurement ARTICLE 6 - The tar, nicotine and carbon monoxide yields of cigarettes are measured according to TS ISO 4387 for tar, TS ISO 10315 for nicotine and ISO 8454 for carbon monoxide. The accuracy of phrases regarding tar and nicotine indicated on packs are approved in conformity with the ISO 8243 standard. The measurements mentioned in the paragraph one are conducted or approved by the conformity assessment bodies delegated by the Authority. The Authority communicates the list of the subject conformity assessment bodies and the criteria and inspection methods applied for delegation to the Commission via the Undersecretary. Any change to be made on issues regarding such notification is communicated to the Commission in the same way. The Authority may require the tobacco products manufacturers to conduct the other tests to be specified on the basis of each brand and type for the purpose of assessing the impacts of inputs of tobacco products on health and their properties of causing addiction, or to have these tests conducted or approved by conformity assessment bodies. The results of tests conducted are submitted to the Authority on annual basis. Where the properties of a tobacco product is not changed and modified, the Authority may require the submission of the test results on a less frequent basis. The changes in the properties of a tobacco product are notified to the Undersecretary by the Authority to be then communicated to the Commission. The Authority discloses the data and information submitted as per this article to the public in order to ensure that the consumers are informed of the same by paying attention to the commercially confidential nature of such data and information, and notifies every year the same to the Undersecretary to be communicated to the Commission. CHAPTER THREE Labelling Label information ARTICLE 7 - Tar, nicotine and carbon monoxide yields of cigarettes measured according to the method laid down in the Article 6 herein are written in Turkish on the long side surface of cigarette packs in a way covering at least ten percent (10%) of the relevant surface. (Amended paragraph: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 3) One of two general warnings and one of the combined warnings as “Smoking kills” and “Smoking seriously harms you and others around you” are written on each unit pack of all tobacco products save for the smokeless tobacco products permitted to be on free sale.4 3 - (version prior to amendment) The maximum tar yield must be 12 mg, maximum nicotine yield 1 mg, and carbon monoxide must be 10 mg from 1/1/2007 on per one cigarette stick produced, placed on free movement and supplied to the market. 4 - (version prior to amendment) The main warning as “Legal warning: Harmful for health” is included on each unit pack of all tobacco products in an easily seen and readable way in a uninterrupted form save for the tobacco intended for oral use and other smokeless tobacco products. From 1/1/2006 on, the same packs must bear one of the two general warnings as “Smoking kills” or “Smoking may kill” and “Smoking seriously harms you and others around you” along with one of the additional warnings defined in Appendix-1. 3 / 10 (Amended paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The general warnings are applied on the wide outer back of unit pack of tobacco products on the principal display surface. The combined warnings, on the other hand, are applied on the wide outer back of unit pack of tobacco products on the principal display surface to start from the upper level of surface or from cover opening or revenue stamp ending point. Order and duration of use in turns of the general warnings and combined warnings are determined for each brand by the manufacturer or importer company and are notified to the Authority. The Authority may modify the order and duration of use the warnings when it deems necessary. These warnings are written on the surface of each unit pack put on retail sale excluding the additional transparent packaging. The Authority may determine the surfaces for these warnings to be applied and their location on these surfaces.5 (Amended paragraph: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 3) The unit pack of smokeless tobacco products permitted to be supplied to the market bears the warning “This tobacco product can damage your health and is addictive.” This warning is written on the principal display surface of each unit pack used for sale excluding the additional transparent packages. The Authority may determine the location of these warnings on the package surface.6 (Amended paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The general warning to be applied in accordance with the paragraph two of this article and the warning for the smokeless tobacco products laid down in the paragraph four must occupy thirty percent (30%) of the wider outer surface of unit tobacco product pack it is printed on. The combined warning to be printed as per the paragraph two must occupy sixty five (65%) of the other wider outer surface of the same tobacco product along with the black border lines. For the unit packs, which have more than two wider outer surfaces or which can be made to have more than two wider display surfaces, or which shall be placed on the market by manufacturing in a way to expand the wider display surface area by means of different developments, it is compulsory that the same application is made on each wider display surface of these packs, and where it is possible to expand the surface, the application must be made by calculating the area to be created by expansion of the pack.7 The phrases showing tar, nicotine and carbon monoxide yields and warning message texts obligatory to be printed on packages of tobacco products pursuant to this article must be; 5 - (Version prior to amendment) The above specified general warnings are applied on the wider surface of unit pack of tobacco product on principal display surface and the additional warnings are applied on the other principal display surface of the unit pack of the same tobacco product. Order and duration of use in turns of the general warnings and additional warnings are determined for each brand by the manufacturer company and notified to the Authority. The Authority may modify the order and duration of use the warnings when it deems necessary. These warnings are written on the surface of each unit pack put on retail sale excluding the additional transparent packaging. The Authority may determine the location of these warnings on the package surface. 6 - (Version prior to amendment) In addition to the main warning on unit pack of tobacco and smokeless tobacco products intended for oral use, permitted to be supplied to the market, the warning “This tobacco product may damage your health and is addictive” is included on the pack. This warning is written on the principal display surface of each unit pack used for sale excluding the additional transparent packages. The Authority may determine the location of these warnings on the package surface. 7 - (Version prior to amendment) The compulsory general warning as per the paragraph two of this article and the warning for the smokeless tobacco products specified in the paragraph four must occupy at least thirty percent (30%) of the wide outer surface of unit pack of tobacco products they are printed on, and the combined warning to be printed as per the paragraph two must occupy at least forty percent (40%) of the other wider outer surface of the same tobacco product. For the unit packs, which have more than two wider outer surfaces or which can be made to have more than two wider display surfaces, or which shall be placed on the market by manufacturing in a way to expand the wider display surface area by means of different developments, it is compulsory that the same application is made on each wider display surface of these packs, and where it is possible to expand the surface, the application must be made by calculating the area to be created by expansion of the pack. 4 / 10 a) Printed on white background with dark black Helvetica font. The font size is established by the Authority in a way to cover the maximum possible section on the area allocated for the text. b) The text is written in lower case except for the first letter. c) It must be aligned on the area to be written and be parallel to the upper edge of the pack. d) Save for the tobacco products specified in the paragraph four of this article, it must be encircled with a dark border line of no less than 3 mm and no more than 4 mm in thickness, which does not make the warning tex illegible or not interfere with other phrases or statements in any way. e) The text must be in Turkish. The texts and phrases described in this article must not be written on revenue stamp, stamp and other similar additions. The writings must be printed in a fixed and non-erasable way; must not be hidden and precluded by other images or texts or by opening the pack. These texts may be affixed on tobacco products other than cigarettes provided that they are non-removable. (Inserted paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The combined warnings to be put on unit packs of tobacco products as per this article; a) are published and announced on the web site of the Authority and provided in electronic media by the Authority. b) are bordered by a black border line of no less than 3 mm and no more than 4 mm in width in a way not interfering with the textual and/or visual components it contains. c) are positioned in parallel to the upper edge of the surface it is on, and in the same direction with the other information on the surface it is placed. ç) must be printed a in fixed and non-erasable way. However, the requirement for the warnings to be non-removability in tobacco products other than cigarette may be addressed by means of sticking on the pack. d) are affixed on the surface in a way not damaged while opening the pack. Visibility of textual and/or visual components cannot be obstructed by revenue stamp, stamp, price labels and other elements. e) The format, ratio, colors and graphical integrities of textual and/or visual element they contain are applied without making any change. However, where required by the pack sizes, the additional warning text, which is one of the components of combined warning, can be relocated to the right side or under the text, photograph, drawings or images corresponding to the additional warning text by the decision of the Authority during the evaluation of the applications. (Supplementary paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The texts to be included in the combined warnings; a) must be in Turkish. b) must be printed in Helvetica font type. c) must be written in lower case except for the first letter. The line spacing must be the same with the font size to be used. ç) must be left aligned in the section allocated to the texts. d) the words of the texts must be written without separation. (Supplementary paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The minimum requirement for printing the combined warnings is “four colors / Blue-Red-Yellow-Black (CMYK) / 133 line print for every 2.54 cm (133 LPI).” (Supplementary paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) Wider outer front principal display surface means the surface in hard packs opened from front side, and any of the principal display surfaces in other hard packs and soft packs. (Supplementary paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The companies must plan and implement their manufacturing and import programs in a way each combined warning is separately visible in the ratios of 5 % and 9 % during the period and on each type of the products. 5 / 10 (Supplementary paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2) The procedures and principles established herewith for the unit packs of tobacco products are also applicable and valid for the grouping. The Authority may require that the Authority must be cited as reference outside the border line in additions to the warning specified in this article. Lot number or similar markings to indicate the place and date of production might be put on the unit pack of tobacco products for the purposes of ensuring description and tracking of tobacco products. (Repealed paragraph: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 2)8 (Amended paragraph: Official Gazette dated 10/07/2010/ and numbered 27637; Regulation / Article 1)9 In addition to the labeling information stipulated hereby, it is compulsory to include the manufacturer, brand, barcode of the product; phrases and amounts enabling differentiation among the types of products manufactured under the same brand, and the warning that “Not for sale to those under 18 years” on any outer surface of unit packs of tobacco products, and the brand name on cigarettes and inner packages of tobacco products for water pipe and if any on inner packages of cigar and cigarillos. (Supplementary paragraph: Official Gazette dated 10/07/2010/ and numbered 27637; Regulation / Article 1) Where the distinctive phrase comprises more than one component, these components are put on any outer principal display surface of unit pack. (Supplementary paragraph: Official Gazette dated 10/07/2010/ and numbered 27637; Regulation / Article 1) Label can be affixed on transparent groupings provided that the combined and general warnings and yield amounts are not visually covered and obstructed. This label bears the brand, place and date of manufacture, distinctive phrase, information on amount and barcode as a minimum. The place of manufacture and date of manufacture in month and year are clearly written next to the coding or similar markings on box groupings. CHAPTER FOUR Other Product Information and Product Descriptions Other product information ARTICLE 8 - The manufacturers of tobacco products are required to submit a list showing all the inputs and their amounts used in production of tobacco products on brand and type basis to the Authority every year. The first communication of such list must be done by 31/12/2005 at latest. The list must be accompanied by a statement explaining the function and category of these substances and the reasons for including in the manufacturing process. The list must also contain the data on impacts on health of such substances in burned or unburned forms, and toxicological data available to the manufacturer which shows the addictive properties of the same. The list must be created in descending order of weights pertaining to each input in the tobacco product. The Authority discloses the information it obtains pursuant to this article to the public in order to inform the consumers by observing the protection of information on product formula in commercially confidential nature. The Authority ensures that the list of product inputs including the yields of tar, nicotine and carbon monoxide of each type of tobacco product is publicly available. The Authority sends all the information and data, submitted each year in accordance with this article, to the Undersecretary to be communicated to the Commission. 8 - (Version prior to repeal) The procedures and principles concerning the application of combined warnings are established by the Authority by obtaining the approval of the Ministry of Health. 9 - (Version prior to amendment) In addition to the labeling information stipulated hereby, it is compulsory to include the manufacturer, brand, barcode of the product; phrases and amounts and the warning that “Not for sale to those under 18 years” on outer display surfaces of unit packs of tobacco products, and the brand name on cigarettes. 6 / 10 Restrictions on definitions in tobacco products ARTICLE 9- (Amended article: Official Gazette dated 05/04/2009 and numbered 27191, Regulation / Article 4)10 Any text, name, brand, type name, figurative speech, metaphor, figure, sign and other elements and definition, brand, type name, color, figure or marks that imply a tobacco product is less harmful and/or superior than the others or promoting or encouraging the consumption or deceiving the consumers cannot be placed on outer package, opening strip, inner package and aluminum foil of unit packs and on cigarettes. CHAPTER FIVE Supply to Market, Market Surveillance and Supervision Supply to the market ARTICLE 10 - The tobacco products to be supplied and placed on the market must be in compliance with the arrangements laid down by the Regulation herein. (Repealed paragraph: Official Gazette dated 05/04/2009 and numbered -27191; Regulation / Article 7)11 In the event of supply to the market of tobacco products not manufactured in compliance with the provisions hereof as if they are, the provisions set forth in the Article 12 hereof shall apply and such circumstances shall be notified to the Undersecretary to be communicated to the Commission. (Supplementary paragraph: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 4) Supply of tobacco for oral use is prohibited. Market surveillance and supervision ARTICLE 11—The market surveillance and inspection of tobacco products are carried out by the Authority, or the Authority may assign third parties to do the same, within the framework of the provisions set forth in the “Regulation concerning the Market Surveillance and Supervision of Products” passed by the Decree dated 13/11/2001 and numbered 2001/3529 of Council of Ministers and promulgated in the Official Gazette dated 17/01/2002 and numbered 24643. Provisions to be applied for contradictory acts ARTICLE 12- (Amended article: Official Gazette dated 05/04/2009 and numbered 27191; Regulation / Article 5)12 The provisions of the paragraph twelve of the Article 5 of the Law No. 4207 shall be applied by the Authority for those importing or putting on sale the tobacco products not bearing the health warning messages on unit packs in contradiction with the provisions hereof; and for the manufacturer companies giving incorrect or incomplete information on properties, effects on health, hazards or emissions of tobacco products on the packages and acting in violation of these obligations by means of using misleading description, brand, color, figure or marks. Except for the provisions of paragraph one of this article, the provisions of the legislation issued by the Undersecretary of Foreign Trade within the framework of the Law No. 4703 on Preparation and Imposition of Technical Legislation on Products and this Law shall apply for 10 - (Version prior to amendment) Any text, name, brand name, figurative speech or other marks implying that a certain tobacco product is less harmful than others cannot be put on packages of tobacco products from 1/1/2006 on. 11 - (Version prior to repeal) However, the tobacco products manufactured and supplied to the market before the dates established in the Articles 5, 7 and 9 of the Regulation herein and not complying the necessary qualifications in the said articles can be kept in the market for a period of maximum one year. 12 - (Version prior to amendment) The provisions of the legislation issued by the Undersecretary of Foreign Trade within the framework of the Law No. 4703 on Preparation and Imposition of Technical Legislation on Products, and as well as this Law shall apply for those acting in contradictory with the Regulation herein and other relevant technical arrangements. 7 / 10 those acting in contradictory with the Regulation herein and other relevant technical arrangements. CHAPTER SIX Final Provisions PROVISIONAL ARTICLE 1 - The entry into implementation and effect of the Regulation herein is notified to the Undersecretary to the communicated to the Commission. PROVISIONAL ARTICLE 2 - (Amended article: Official Gazette dated 27/02/2010/ and numbered 27506; Regulation / Article 3) The implementation of additional warnings defined in the Appendix-1 instead of the combined warnings specified in the paragraph two of the Article 7 hereof shall continue until 1/5/2010 provided that the same are applied in a way occupying no less than forty percent (40%) of the wide principal display back side of unit pack of tobacco product, and the implementation of general warnings occupying no less than thirty percent (30%) of the wide front principal display surface of unit pack of the same tobacco product. If requested, the Authority may grant permission to proceed with the use of combined warnings on unit pack of tobacco products before the date 1/5/2010. The tobacco products manufactured before 1/5/2010 and not bearing combined warnings on unit packs and grouping packages may be supplied to the market up to 30/06/2010 at latest and be kept on the market up to 31/12/2010.13 PROVISIONAL ARTICLE 3 - (Amended article: Official Gazette dated 25/11/2008/ and numbered 27065; Regulation / Article 6) The source list shall be determined by 31/05/2009 at latest with the approval of the Ministry of Health, and be published and announced on the website of the Authority. PROVISIONAL ARTICLE 4 - (Amended article: Official Gazette dated 25/11/2008 and numbered 27065; Regulation / Article 7) The cigarettes for which Sale Certificate on Product Basis issued by the Authority before 1/1/2009 and having the maximum tar yields exceeding the limit specified in the Article 5 may be supplied to the market until 31/10/2009 and be kept on the market until 31/12/2009 at latest. PROVISIONAL ARTICLE 5 - (Amended article: Official Gazette dated 08/04/2010 and numbered 27546 Regulation / Article 1)14 The manufacturer companies are required to submit the designs of of their unit packs to be made in compliance with the Regulation herein to the Authority within six months at latest from 14/04.2009. The manufacture of tobacco products for which Sale Certificate on Product Basis issued by the Authority before 15/04/2009 may continue until the commencement date of manufacture of unit packs and groupings with combined warnings. These products may be supplied to the market until the latest date when the unit packs and groupings not bearing combined warnings can be supplied to the market, and be kept in the market by the deadline when the circulation of unit packs and groupings not having combined warnings shall end. 13 - (Version prior to amendment) The implementation of additional warnings defined in the Appendix-1 instead of the combined warnings given in the paragraph two of the Article 7 hereof shall continue until 1/3/2010. The Authority may allow to proceed with the use of combined warnings before the date 1/3/2010. The tobacco products manufactured before 1/3/2010 and not bearing combined warnings on unit packs and grouping packages may be supplied to the market up to 30/06/2010 at latest and be kept on the market up to 31/12/2010. 14 - (Version prior to amendment) The manufacturer companies must submit their designs of unit packs they shall make in compliance with the Regulation herein to the Authority within six month at latest from 15/04/2009 on. The manufacture of tobacco products for which Sale Certificate on Product Basis issued by the Authority before 15/04/2009 may continue with the manufacture for one year from this date on. These products may be kept in the market for a period of 6 months from the end date of manufacture. 8 / 10 PROVISIONAL ARTICLE 6 - (Amended article: Official Gazette dated 10/07/2010/ and numbered 27637; Regulation / Article 2) The manufacturing of tobacco products not conforming to; a) the requirements in the paragraph seventeen of the Article 7 concerning putting the phrase for differentiating among product types manufactured under the brand, and putting the brand name on inner packages of tobacco products for water pipe and inner packages, if any, of cigar and cigarillos, b) the requirements set forth in the paragraph eighteen and nineteen of the Article 7 for which sale certificate on product basis issued by the Authority before 10/7/2010 may continue manufacturing of these products for a period of 6 months from 10/7/2010 on. The said products may be kept in the market for a period of one year from 10/7/2010. Entry into Force ARTICLE 13 - The Regulation herein shall enter into force on the date of proclamation to be valid and effective from 1/1/2005. Enforcement ARTICLE 14 - The President of the Authority enforces the provisions hereof. APPENDIX-1: List of Additional Health Warnings 1. Smokers die younger. 2. Smoking clogs arteries and causes heart attacks and strokes. 3. Smoking causes lethal lung cancer. 4. Smoking while pregnant harms your child. 5. Protect children: Do not let them inhale cigarette smoke. 6. Health institutions may help you stop smoking. 7. Smoking is highly addictive, do not even start. 8. Quitting smoking reduces the risk of deadly heart and lung diseases. 9. Smoking can cause a slow and painful death. 10. Get help from your doctor and from .... to stop smoking. (The phone, mail/internet address of health institutions to seek help shall be determined by the Ministry of Health and the Authority.) 11. Smoking can slow down blood circulation and cause impotence. 12. Smoking causes early aging of the skin. 13. Smoking can damage sperms and reduce fertility. 14. Smoke contains carcinogens such as benzene, nitrosamines, formaldehyde and hydrogen cyanides Note: For other tobacco products, the word “cigarette” is replaced with “tobacco.” ****** The additional warning given in the 10th order must be written as “Get help to stop smoking from your doctor and closest local health clinic,” in accordance with the “Resolution 9 / 10 of the Board on Implementation of Technical Details set forth in the Regulation No. 1763 on Procedures and Principles concerning the Production Type, Labeling and Inspection of Tobacco Products oriented at Protection from Harmful Effect of Tobacco Products” published and proclaimed in the Official Gazette dated 04/06/2005 and numbered 25835. The additional warning in 14th order must be written as “Smoke of cigarettes contains carcinogens such as benzene, nitrosamines, formaldehyde and hydrogen cyanides.” ****** 10 / 10