Tobacco use represents the main risk factor for disease and mortality in developed countries; therefore, the regulation and control of their consumption is a priority of public health.

In the framework of the measures developed by the European Union, various Community Directives have been adopted in this field: Directive 89 /622/EEC of 13 November 1989 on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to legal, regulatory and administrative provisions of the Member States relating to the labelling of tobacco products; Directive 90 /239/EEC of 17 May 1990 on the approximation of provisions laid down by law, regulation or Member States ' administrative authorities in respect of the maximum tar content of cigarettes, and Directive 92/41/EEC of 15 May 1992 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the labelling of tobacco products. These rules are laid down in the Royal Decrees 192/1988 of 4 March 1988 on restrictions on the sale and use of tobacco for the protection of the health of the population; 510/1992 of 14 May 1992 on the labelling of products of tobacco and certain restrictions on commercial aircraft, and 1185/1994 of 3 June 1994 on the labelling of tobacco products other than cigarettes and prohibiting certain oral tobacco products and updating the Sanctions regime for tobacco.

The latest legislation in this field has been Directive 2001 /37/EC, which substantially modifies and expands the existing regulation on tobacco products.

The purpose of this Royal Decree is the incorporation into our legal order of Directive 2001 /37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of laws, regulatory and administrative provisions of the Member States relating to the manufacture, presentation and sale of tobacco products, and in their preparation the entities concerned have been heard.

This Royal Decree, which has the character of a basic rule, is dictated by the provisions of article 149.1.16. of the Spanish Constitution and in the development of Articles 24, 25.2, 32 to 37, 40.5 and 40.6 of Law 14/1986, of 25 April, General of Health.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of 18 October 2002,

DISPONGO:

Article 1. Definitions.

For the purposes of this Royal Decree, the following definitions shall

:

(a) Tobacco products: products intended to be smoked, sucked, sucked or chewed, from the moment they are made up, even partially, by tobacco, genetically modified or not.

b) Renting: the anhydrous and nicotine-free raw smoke condensate.

c) Nicotine: nicotinic alkaloids.

(d) Tobacco for oral use: all products intended for oral use, with the exception of smoking or chewing products, consisting wholly or partly of tobacco in the form of powder, fine particles or any combination of those forms, in particular those presented in dose sachets or in porous envelopes, or with an appearance to suggest an edible product.

(e) Ingredients: any substance or component other than the leaves and other natural or non-processed parts of the tobacco plant used in the manufacture or preparation of a tobacco product which remains present in the product produced, even if in a modified form, including paper, filter, inks and adhesive rubber.

Article 2. Tobacco for oral use.

The placing on the market of oral tobacco, as defined in paragraph (d) of Article 1, is prohibited.

Article 3. Maximum levels of tar, nicotine and carbon monoxide of cigarettes.

1. From 1 January 2004, cigarettes released for free circulation, placed on the market or manufactured in Spain, may not have higher levels than:

a) 10 milligrams of tar per cigarette,

b) 1 milligram of nicotine per cigarette,

c) 10 milligrams of carbon monoxide per cigarette.

2. For cigarettes produced in Spain, but exported outside the European Community, the limits on the contents provided for in this Article shall apply from 1 January 2007.

Article 4. Measurement methods.

1. The tar, nicotine and carbon monoxide content of the cigarettes will be measured according to the standards of the International Organization for Standardization (ISO) 4387, 10315 and 8454, respectively. The accuracy of the tar and nicotine particulars entered in the packages shall be determined in accordance with ISO 8243.

These tests will be verified by the laboratories determined by the Ministry of Health and Consumer Affairs.

The Ministry of Health and Consumer Affairs shall communicate to the European Commission the list of approved laboratories and their modification each time, specifying the criteria used for approval and the means of supervision. which are applied.

2. The Ministry of Health and Consumer Affairs may require manufacturers and importers of tobacco to carry out further tests in order to evaluate the content, specified by individual brands and types, of other substances produced by their products. tobacco, as well as its health effects, taking into account, among other things, the danger of addiction. It may also be required that these tests be verified by the laboratories established by the Ministry of Health and Consumer Affairs.

3. The results of the tests carried out in accordance with paragraph 2 shall be submitted annually to the Ministry of Health and Consumer Affairs, and at a higher frequency, to be determined by the Ministry of Health and Consumer Affairs, where there is no there have been variations in product specifications. The Ministry of Health and Consumer Affairs will have to be informed when changes to these product specifications occur.

The Ministry of Health and Consumer Affairs shall, by whatever means it deems appropriate, disseminate the information submitted in accordance with the requirements of this Article, in order to inform consumers, taking into account, where applicable, any information constituting a trade secret.

4. The Ministry of Health and Consumer Affairs shall communicate annually to the European Commission all data and all the information referred to in this Article.

Article 5. Tagged.

1. The tar, nicotine and carbon monoxide content of cigarettes placed on the market in Spain, measured in accordance with Article 4, shall be printed on one side of the cigarette packs, at least in Spanish, official language of the State, occupying at least 10 per 100 of the corresponding area.

2. All packaging units for tobacco products, except for non-combustion tobacco, shall bear the following warnings:

a) A general warning:

1. º "Smoking kills" or "Smoking can kill".

2. º "Smoking severely damages your health and the health of those around you."

The previous general warnings will be alternated so as to ensure the regular occurrence of each warning in an equal quantity of packaging units, with an annual tolerance of plus or minus 5 per 100. These warnings shall be printed on the most visible face of the packaging unit, as well as on any outer packaging used in the sale of the retail product, with the exception of the transparent wrappers used in the sale of the product to the per child; and

(b) An additional warning of those listed in the Annex.

The additional warnings referred to above shall be alternated, in such a way as to ensure the regular occurrence of each warning in an equal quantity of packaging units, with an annual tolerance of more or less the 5 per 100.

This warning will be printed on the other most visible face of the packaging unit, as well as on all the outer packaging used in the retail sale of the product, except for the transparent wrappers used in the packaging. retail product sales.

3. The packaging units of the non-combustion tobacco products shall bear the following specific warning:

"This tobacco product can be harmful to your health and creates addiction."

This warning shall be printed on the most visible face of the packaging unit, as well as on any outer packaging used in the sale of the retail product, with the exception of the transparent wrappers used in the sale of the retail product.

4. The general warnings referred to in paragraph 2 (a) and the specific warning for the products of the non-combustion tobacco referred to in paragraph 3 shall cover at least 30 per 100 of the outer surface of the face. corresponding to the tobacco packaging unit in which they are to be printed. The additional warning referred to in paragraph 2 (b) shall cover at least 40 per 100 of the outer surface of the corresponding side of the tobacco packaging unit in which it must be printed. However, in the packaging units for products other than cigarettes, the most visible of which is more than 75 square centimetres, the surface of the warnings referred to in paragraphs 2, a) and 2, b) shall be at least 22,5 square centimeters.

5. The text of the warnings and the particulars relating to the tar, nicotine and carbon monoxide content required by this Article shall be printed:

a) In bold, in black "Helvetic" characters on white background, with a font size of the characters in such a way as to occupy as much space as possible on the surface reserved for the effect.

b) In lowercase.

c) Focused on the surface reserved for effect, parallel to the top edge of the package.

(d) In tobacco products other than those referred to in paragraph 3, surrounded by a black border of a minimum width of three millimetres and a maximum of four millimetres, which does not interfere in any way with the text of the warning or information provided.

e) In Spanish, official language of the State.

6. All the warnings referred to in paragraphs 2 and 3 shall be preceded by the words 'Health authorities warn'. This indication shall be outside the box provided for in paragraph 5 (d); it shall occupy an additional area of at least four millimetres in the cigarette packaging units and shall be equal to the same proportion when In the case of packaging units for other tobacco products, it shall be immediately above the health warnings; it shall be the same length as the space provided for the health warnings, and the text shall be characteristics referred to in paragraphs (a), (b), (c) and (e) of paragraph 5.

7. The content of tar, nicotine and carbon monoxide, as well as the warnings required under this Article, must be printed by the manufacturers at source or by a third party with the approval of the manufacturers. The texts required under this Article shall not be printed on the tax premises of the packaging units. They shall be printed in an immovable, indelible form and must not in any case be concealed, veiled or separated by other indications or images, and must not appear anywhere that can be damaged when the product is opened. In the case of other tobacco products other than cigarettes, the texts may be affixed by adhesives, provided that they cannot be taken off.

8. To ensure the identification and traceability of the product, the tobacco products shall be marked, by the batch number or equivalent in the packaging unit, so that the place and time of manufacture can be determined.

9. The sale or delivery of cigarettes that are not packaged and do not have outer packaging is prohibited.

Article 6. Other information on tobacco products.

1. The Ministry of Health and Consumer Affairs shall require all manufacturers, importers and marquists of tobacco products to list all tobacco ingredients and the quantities of such ingredients used in the manufacture of tobacco products. tobacco products, specified by individual brands and types.

This list shall be accompanied by a declaration stating the reasons for the inclusion of these ingredients in tobacco products, indicating their role and category. The list shall also be accompanied by the toxicological data available to the manufacturer or the importer concerning those ingredients, whether or not burning, as appropriate, with particular reference to their health effects and indicating, other things, their potential addictive effects. The list will present all the ingredients that make up the product, in order of decreasing weight.

The information provided for in this paragraph shall be submitted annually and for the first time before 31 December 2002.

2. The Ministry of Health and Consumer Affairs shall, by means of appropriate means, disseminate the information provided in accordance with the requirements of this Article in order to inform consumers. However, due account shall be taken of the protection of all information on the formula of specific products constituting a trade secret.

3. The Ministry of Health and Consumer Affairs will publish the list of ingredients by product, which will mention the contents of tar, nicotine and carbon monoxide.

4. The Ministry of Health and Consumer Affairs shall communicate annually to the European Commission all data and all the information referred to in this Article.

Article 7. Product descriptions.

As from 30 September 2003, and without prejudice to the provisions of Article 5 (1), the use in the packaging units of tobacco products placed on the market in Spain of texts, names, trade marks and products is prohibited. images or other signs that give the impression that a particular tobacco product is less harmful than others.

Article 8. Infringements and penalties.

Failure to comply with the provisions of this Royal Decree will be of an administrative infringement of the health legislation, as provided for in Chapter VI of Title I of Law 14/1986 of 25 April, General (a) health, and other provisions resulting from application, and shall be subject to the corresponding administrative penalties, subject to the instruction of the appropriate file in accordance with the provisions of Title IX of Law No 30/1992 of 26 November 1992, Legal status of public administrations and the common administrative procedure. This shall be without prejudice to any civil, criminal or other order that may be held.

In particular, they are considered very serious, serious and minor infringements, respectively, as provided for in Article 35 of Law 14/1986 of 25 April, General of Health, the following:

a) Mild infractions:

1. The incorrect compliance with the rule of alternation of the warnings referred to in Article 5 (2), considered as supposed to be provided for in Article 35.A. 1. of the General Law of Health.

2. In general, the non-compliance with the provisions of this Royal Decree, provided that the infringement is not considered to be a serious or very serious fault, as required by Article 35.A. 3. of the General Law of Health.

b) Serious infractions:

1. Failure to comply with the specific requirements of the health authorities, provided that they are produced for the first time, considered to be the case provided for in Article 35.B. 4. of the General Law of Health.

2. The resistance to providing data, providing information or collaboration with health authorities or their agents, as required by Article 35.B. 5. of the General Health Law.

3. The recidivism in the commission of minor infractions, in the last three months, as provided for in article 35.B. 7. of the General Law of Health.

c) Very severe infractions:

1. The placing on the market of tobacco products for oral use, with the understanding of oral tobacco as defined in paragraph (d) of Article 1, considered to be the case provided for in Article 35.C. 1 of the Law General of Health.

2. The non-registration or incorrect registration of general, additional, specific warnings, tar, nicotine and carbon monoxide warnings, and the mention of the health authorities in the packaging units of tobacco products, as referred to in Article 5, considered as being of course provided for in Article 35.C. 1. of the General Law on Health.

3. The placing on the market, manufacture and release of cigarettes for free circulation which have higher tar, nicotine and carbon monoxide content than those provided for in Article 3, considered as being of the provided for in Article 35.C. 1. of the General Health Law.

4. The absence of the batch number or equivalent in the unit of packaging of tobacco products, as referred to in Article 5 (8), considered as being of course provided for in Article 35.C. 1. of the General Law Health.

5. The refusal or resistance of tobacco products manufacturers, importers and marquists to provide the Ministry of Health and Consumer with the list of all tobacco ingredients, as set out in Article 6, considered as supposed to be provided for in Article 35.C. 1. of the General Law of Health.

6. The use in the packaging units of tobacco products, texts, names, marks and images or other signs giving the impression that a certain tobacco product is less harmful than another, considered to be This is the case provided for in Article 35.C. 1 of the General Health Law.

7. The recidivism in the commission of serious misconduct in the last five years, as required by article 35.C. 8. of the General Law of Health.

The violations cited will be sanctioned according to their respective levels of gravity, in accordance with the provisions of Article 36 of Law 14/1986 of 25 April, General of Health.

Single transient arrangement. Marketing extension.

Notwithstanding the provisions of the single derogation provision, cigarettes may continue to be placed on the market until 30 September 2003 until 30 September 2004 for all other tobacco products which do not comply with the provisions of this Regulation. the provisions of this Royal Decree. As appropriate, the provisions of the Royal Decrees 510/1992 of 14 May 1992 on the labelling of tobacco products and establishing certain restrictions on commercial aircraft will apply, in the meantime, to the provisions of the Royal Decree No 510/1992 of 14 May 1992. 1185/1994 of 3 June 1994 on the labelling of tobacco products other than cigarettes and on the prohibition of certain oral tobacco products and the updating of the system of penalties in the field of tobacco.

Single repeal provision. Regulatory repeal.

They are repealed, without prejudice to the provisions of the single transitional provision, the Royal Decrees 510/1992 of 14 May 1992, which regulates the labelling of tobacco products and lays down certain restrictions on commercial aircraft, and 1185/1994 of 3 June 1994 on the labelling of tobacco products other than cigarettes and on the prohibition of certain oral tobacco products and the updating of the system of penalties in the field of tobacco; and how many provisions of equal or lower rank are opposed to the provisions of this Royal Decree.

Final disposition first. Competence title.

This Royal Decree has the character of a basic rule, dictated by the provisions of article 149.1.16. of the Constitution and in the development of Articles 24, 25.2, 32 to 37, 40.5 and 40.6 of Law 14/1986, of 25 of 25 April, General Health.

Final disposition second. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to make the necessary provisions for the development of the provisions of this Royal Decree.

Final disposition third. Entry into force.

This Royal Decree will enter into force on the day of its publication in the "Official Gazette of the State".

Given in Madrid to October 18, 2002.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

ANA MARIA PASTOR JULIAN

ANNEX

Listing additional health warnings

1. Smoking shortens life.

2. Smoking obstructs the arteries and causes heart disease and strokes.

3. Smoking causes fatal lung cancer.

4. Smoking during pregnancy harms your child's health.

5. Protect children: do not breathe in tobacco smoke.

6. Your doctor and pharmacist can help you stop smoking.

7. Tobacco is very addictive: don't start smoking.

8. Quitting smoking reduces the risk of fatal heart and lung disease.

9. Smoking can be a cause of slow and painful death.

10. Help to stop smoking: talk to your doctor or pharmacist.

11. Smoking can reduce blood flow and cause impotence.

12. Smoking causes skin aging.

13. Smoking can damage sperm and reduce fertility.

14. The smoke contains benzene, nitrosamines, formaldehyde and hydrogen cyanide.