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Italy: Implementation of European Legislation on Tobacco Products

(Feb. 2, 2016) On January 12, 2016, Italy issued legislation implementing a European directive on the sale of tobacco and tobacco products; the new legislation will enter into effect on February 2, 2016. (Legislative Decree No. 6 of January 12, 2016, Implementing Directive 2014/40/EU (D.L. No. 6), GAZETTA UFFICIALE [OFFICIAL GAZETTE] No. 13 (Jan. 18, 2016), available at NORMATTIVA  (in Italian); Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014, on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products and Repealing Directive 2001/37/EC, 2014 O.J. (L127) 1, EUROPA.)

The purpose of the new legislation is to guarantee a high level of protection of human health, particularly for young people, through the implementation of European and domestic legislation aimed at preventing tobacco addiction. (D.L. No. 6, art. 1(1)(a).)  To that end, the new legislation regulates such matters as the ingredients, composition, and emission levels of cigarettes, as well as the labeling and manufacturing of tobacco products.  (Id. art. 1(2)(a) & (b).)

Standards for Emission of Harmful Substances 

The law establishes the maximum levels tolerated for the emission by cigarettes of tar, nicotine, carbon monoxide, and other substances. (Id. art. 3.)  The law covers the technical parameters and methodology for the determination of these maximum levels.  (Id. art. 4.)  The Italian Superior Health Institute (Istituto Superiore di Sanità (last visited Jan. 28, 3016)) supervises the laboratories that verify compliance with the established maximum emissions levels. (D.L. No. 6, art. 5(4).)  Manufacturers and importers of tobacco products must furnish the Health Ministry and the Customs and Monopolies Agency with the technical information required for the verification of the standards established in this new legislation.  (Id. art. 6(1).)

Labeling and Packaging

The new legislation also includes stringent labeling and packaging requirements for the marketing of cigarettes. (Id. art. 9.)  In particular, it prescribes the use of mandatory warning and informative messages on smoking product packages, including the following: “Smoking Kills–Stop Immediately” (id. art. 10(1)), and “Tobacco Smoke Contains More Than 70 Cancer-Causing Substances” (id. art. 10(2)).  These visible warnings must also be included on the packaging of other tobacco products, such as rolled tobacco (tabacco da arrotolare) and tobacco for water pipes.  (Id. art. 12(1).)  Smokeless tobacco products are also subject to the new warning regulations, and their packages must include this message: “This Tobacco Product Damages Your Health and Causes Dependence.”  (Id. art. 13(1).)  Smoking products based on herbs are also subject to severe restrictions on their manufacture and sale in Italy, and their packages must include this warning: “The Smoke of This Product Damages Your Health.”  (Id. art. 22(1).)

There are also restrictions on labeling tobacco products in ways that could mislead customers, such as advertising that would encourage them to consume tobacco products, that would underestimate the stated possible damage to human health, or that would seek to make tobacco products more attractive. (Id. art. 14.)


The new legislation includes traceability requirements for tobacco products, including the stipulation that specific information be provided about, among other aspects, the place and date of manufacturing of the product, the machinery utilized in production, the product description, and the transit history of the product. (Id. art. 16.)

New Tobacco Products

Manufacturers and importers of new tobacco products must immediately notify the Italian health authorities and furnish all the scientific, technical, and other relevant information about these products. (Id. art. 20.)  Among other obligations, manufacturers and importers of electronic cigarettes and containers of recharging liquid for e-cigarettes must notify the authorities of the intended introduction of these products into the Italian market and provide information about them in the same manner as required of importers of any other smoking product.  (Id. art. 21.) 

Prohibitions, Restrictions, and Penalties

The law prohibits the sale of tobacco products for oral use (id. art. 18), i.e., products “made wholly or partly of tobacco and … intended for any oral use except smoking or chewing and … either (a) in powder or particulate form, whether in a sachet or not, or (b) presented in a form resembling a food product.” (Shisha Tobacco Products: A Guide to the Legislation, Niche Tobacco Products Directory website (last updated July 16, 2013).) The sale of tobacco products from abroad to customers located in Italian territory is also forbidden.  (D.L. No. 6, art. 18(1).)

The law contains measures for limiting the offering of tobacco products to minors and pregnant women. (Id. art. 24(2).)

Finally, the law establishes severe penalties of imprisonment and fines for manufacturers and importers who violate its provisions. (Id. art. 25.)