OFFICIAL JOURNAL I OF THE REPUBLIC OF CHILE SECTION

Ministry of the Interior and Public Security

LAWS, REGULATIONS, DECREES AND RESOLUTIONS OF GENERAL ORDER No. 44.079 | Wednesday, February 19, 2025 | Page 1 of 21

General Standards CVE 2609695 MINISTRY OF HEALTH

Undersecretary of Public Health E

STABLISHES HEALTH WARNING FOR PACKAGING OF PRODUCTS OF TOBACCO, HEATED TOBACCO AND ITS ACCESSORIES, SEAN, SEAN, NICOTINE AND NON-NICOTINE VAPING LIQUIDS AND THEIR ACCESSORIES

No. 41.- Santiago, September 10, 2024.

Seen: The provisions of Article 32 No. 6 of the Political Constitution of the Republic, the text of which was consolidated, coordinated, and systematized by Supreme Decree No. 100 of 2005 of the Ministry of the General Secretariat of the Presidency; in Law No. 19,419, which regulates activities related to tobacco; the international obligations assumed by the State of Chile when ratifying the Framework Convention on Tobacco Control of the World Health Organization, promulgated by Decree No. 143 of 2005 of the Ministry of Foreign Affairs; the provisions of Articles 1 and 4 of Decree No. 1 of 2005 of the Ministry of Health, which establishes the consolidated, coordinated, and systematized text of Decree Law No. 2,763 of 1979 and Laws No. 18,933 and No. 18,469; in Articles 5, 6 and 9 of Supreme Decree No. 136 of 2004, of the Ministry of Health, Organic Regulations of the Ministry of Health; the provisions of the first transitory article of Law No. 21,642, which modifies Law No. 19,419, to prohibit the sale of electronic cigarettes to minors; assimilating electronic nicotine delivery systems, similar nicotine-free mechanisms, and heated tobacco products to tobacco products; and, regulate alternative devices with or without nicotine; the provisions of Supreme Decree No. 5, of 2021, of the Ministry of Health, which establishes a health warning for packaging of tobacco products; Supreme Decree No. 57 of November 26, 2019, which approves the Regulations for the Classification, Labeling and Notification of Hazardous Substances and Mixtures; and in resolution No. 7 of the Office of the Comptroller General of the Republic.

Inasmuch:

1° That, the first article of the transitory provisions of Law No. 21,642 states that it will begin to take effect at the time the modification of the supreme decree referred to in Article 6 of Law No. 19,419 is published. To this end, said decree must be adapted, incorporating the requirements established in Law No. 21,642.

2° That, for its part, the aforementioned Article 6 of Law No. 19,419 establishes that all packaging of tobacco products, heated tobacco and their accessories, whether domestic or imported, intended for distribution within the national territory, must contain a clear and precise warning of the damages, diseases or effects that, on the health of persons, implies its consumption or exposure

3° That, the same article establishes that the containers of ENDS, SESN, their accessories and vaping liquids with and without nicotine, whether national or imported destined for national distribution, must contain a clear and precise warning on the main face.

4° That, in accordance with the aforementioned article, the health warnings for tobacco products and their accessories, including heated tobacco products, must be designed by the Ministry of Health and will be valid for a minimum of one year and a maximum of two years. It is also established that these conditions must be approved by supreme decree of the Ministry of Health.

5° That, likewise, Article 6 of the law determines that the supreme decree must establish between two and six warnings for tobacco products and heated tobacco, which may be designed with drawings or photographs and legends. It also indicates that ENDS, SESN, their accessories and vaping liquids with and without nicotine must incorporate warnings in white letters with a black background on the main face with the following characteristics: ENDS and its accessories: Size 20% containing the following texts: "Electronic nicotine delivery systems are potentially addictive" and "Sale exclusively for people over 18 years of age". Vaping liquids with nicotine: Size 20% containing the following texts: "This vaping liquid is potentially addictive because it contains nicotine" and "sale exclusively for people over 18 years of age". SESN, nicotine-free vaping liquids and their accessories: Size 10% containing the following text: "Exclusive sale for people over 18 years of age".

6° That, the final paragraph of Article 9 of Law No. 19,419 establishes that the containers of cigarettes, ENDS and SESN, and their vaping liquids, must clearly and visibly express on one of their sides the main components of this product in the terms established by the Ministry of Health.

7° That, by means of Supreme Decree No. 57, of 2019, of the Ministry of Health, which approves the regulations for the classification, labeling and notification of chemical substances and dangerous mixtures, a series of obligations were established to incorporate obligations to protect the rights of consumers through the provision of relevant information related to the composition of dangerous substances and mixtures, associated with people's health and environmental protection.

8° That, the Ministry of Health approved, through exempt resolution No. 15 of January 11, 2023, the official classification list of substances that will contain their classes and categories of danger.

9° That, in said list of substances, nicotine is included because it is considered a category 2 toxic substance, therefore, it is appropriate to incorporate the label corresponding to acute toxicity on the containers that contain it.

10° That, during the review process for the establishment of the warnings in question, the Ministry of Health developed tender No. 757-93LE-23, "Design and implementation of a study of a health risk communication campaign associated with the consumption of tobacco and electronic cigarettes of the Ministry of Health 2023 aimed at the adolescent public", which was carried out by the Integration Consultancy, with the aim of evaluating the population's appreciation of warning images. The results obtained guided the selection of the images and texts of this decree, maintaining the style of explicit communication of the damages attributable to tobacco consumption.

11° That the scientific evidence provided by the World Health Organization and the Secretariat for the Framework Convention on Tobacco Control shows that the periodic renewal of images on tobacco products makes the warning and its message more effective.

12° That the legal mandate established in Article 6 of Law No. 19,419 is currently regulated through Supreme Decree No. 5, of 2021, of the Ministry of Health, which will be repealed in the terms and opportunity indicated in this decree.

13° That, in order to establish in a timely manner such warnings on the consumption or exposure to the use of these products, due to the foregoing, I issue the following:

Decree: Article One.- The following rules are hereby approved for the purpose of regulating the health warning for tobacco product packaging; heated tobacco and its accessories; ENDS, SESN, nicotine and non-nicotine vaping liquids and their accessories:

1.- All packaging of tobacco products; heated tobacco and its accessories; SEAN, SESN, their vaping liquids with and without nicotine and their accessories, whether national or imported, destined for distribution within the national territory, must contain the health warnings that correspond in accordance with this decree, and must conform to the technical specifications specified in the following numerals.

2.- The "Graphic Regulations for the use of warnings on the packaging of tobacco products, heated tobacco products and their accessories, ENDS, SESN, their accessories and vaping liquids with and without nicotine" is approved by this decree in the terms transcribed below:

General indications

The photographs and elements to be used must be downloaded from the website of the Ministry of Health in www.minsal.cl and their use must be adapted to the graphic regulations for the use of health warnings. Only the photographs that appear in these regulations may be used.

The framing of the photos must be strictly respected, following the rules indicated. Any adulteration violates the regulations. Photographs must be printed in high resolution, i.e. above 300 DPI, for the entire application of the warnings on product packaging

In all warnings, the body of the letter (size) is the minimum recommended for correct reading, so it should be increased proportionally to the size of the product packaging.

Health warnings for packaging of tobacco products, heated tobacco and their accessories

Health Warning Application Scheme

The photographs together with their health warning messages must occupy the bottom 50% of the 2 main sides of all packs of cigarettes, tobacco products, heated tobacco and their accessories.

Example, pack of 20 "BOX" or "Soft pack" type cigarettes:

Example, pack of 10 "BOX" or "Soft pack" type cigarettes:

Example, packet or envelope of chopped tobacco extended:

Example, accessory box:

Example, circular tobacco packaging: Side Deployment View: Health warnings for tobacco products, heated tobacco and their accessories.

Pack of 20 cigarettes: Terminal cancer

Layout of artwork The Ministry of Health makes available to those interested the graphic regulations in PDF format and the original photographs for the preparation of the different pieces linked to the new health warnings on the www.minsal.cl website.

3.- In the case of cigarette packets and all containers of tobacco products, heated tobacco products and their accessories, they must contain one of the warnings provided in the "Graphic Regulations for the use of warnings on the packaging of tobacco products, heated tobacco products and their accessories, SEAN, SESN, their accessories and vaping liquids with and without nicotine", approved in numeral 2 of this article.

4.- This graphic regulation will be in force for twenty-four months from the entry into force of this decree, and must be applied to all national and imported production of cigarettes, tobacco products, heated tobacco and its accessories, ENDS, SESN, their accessories and vaping liquids with and without nicotine intended for both distribution and marketing within the national territory.

5.- The corresponding health warnings must be printed on all the containers of the corresponding products, in any of their presentations and may not be removable. In the case of imported products, it must be adhered to the containers so that it cannot be easily peeled off.

6.- In no case may the warning be covered by drawings, colors and patterns printed on the transparent paper or plastic that wraps the containers, nor be adhered to or printed on this paper. Nor may it be covered by inserts or other types of elements located between said wrapping and the containers.

7.- Components A and B of the warning for tobacco products must appear on the two main sides of each of the containers referred to in paragraph 2, letter A.1 of this article. Likewise, they must occupy the lower 50% of each face, placing component A on the front side and component B on the back side of the container as indicated in the "Graphic Regulations for the use of warnings on packaging of tobacco products, heated tobacco products and their accessories, ENDS, SESN, their accessories and vaping liquids with and without nicotine". approved in paragraph 2 of this article. In the event that an insert is incorporated into the packaging of any tobacco product, heated tobacco and its accessories, the warning must be on both sides and in the same proportion. The cartons of these products must include both components of the warning on 50% of each of their main sides, unless the warning printed on the packaging is visible because they are wrapped in transparent paper or plastic. In the latter case, the packets must be ordered in such a way that both components of the warning are visible.

8.- The warnings must appear, as established in letters A, B and C of numeral 2 of this article, on all the containers of tobacco products, heated tobacco and their accessories, ENDS, SESN, their accessories and vaping liquids with and without nicotine, whether national or imported for distribution within the national territory. In any case, children and adolescents may not be induced to consume tobacco products, ENDS and SESN or their accessories or use means that take advantage of their credulity. The sale of these products may not be carried out through commercial hooks such as gifts, contests, games or other elements of children's attraction. Each of the warnings referred to in paragraph 5 must be incorporated into 25% of the total production of the containers referred to in said article. Consequently, each box or batch of tobacco products, heated tobacco and their accessories intended for distribution to points of sale, shall contain in equal proportions containers with the different warnings. To this end, and only at the beginning of the validity of the warnings, the producers, marketers or distributors shall inform the Ministry of Health in writing by means of a letter from the ministerial office of the respective quantities of tobacco products and the distribution of the warnings therein. Any modification to the information indicated must be communicated to the Ministry of Health immediately.

9.- The warnings of tobacco products and heated tobacco must always be in sight at all points of sale.

10.- All containers of ENDS, SESN, their accessories and vaping liquids with and without nicotine, intended for distribution within the national territory, must contain a clear and precise warning in white letters with a black background, located at the top of the main face of all containers, which must conform to the technical specifications specified in the "Graphic Regulations for the use of warnings on product packaging of tobacco, heated tobacco products and their accessories, ENDS, SESN, their accessories and vaping liquids with and without nicotine", approved in the second numeral of this article, in accordance with the following:

WARNING FOR SEAN AND ITS ACCESSORIES: Size 20% of the main face of the container, containing the texts "Electronic nicotine delivery systems are potentially addictive" and "Sale exclusively for people over 18 years of age".

WARNING FOR NICOTINE VAPING LIQUIDS: Size 20% of the main face of the container, containing the texts "This vaping liquid is potentially addictive because it contains nicotine" and "Sale exclusively for people over 18 years of age".

WARNING FOR SESN, NICOTINE-FREE VAPING LIQUIDS AND THEIR ACCESSORIES: Size 10% of the main face of the container, containing the text "Exclusive sale for people over 18 years of age".

In the event that an insert is incorporated into the packaging of the products mentioned in this paragraph, the warnings must be on both sides of it and in the same proportion in relation to the size of the insert. However, the aforementioned inserts may not contain additional information to the provisions of Article 18 of Law 19,419 Title II "Electronic Systems for the Administration of Nicotine and without Nicotine, and their Vaping Liquids", as amended by Law No. 21,642.

11.- In the warnings indicated in the preceding paragraphs, the body of the letter, the line spacing, the typography, the expanded font, contrast, colors and other characteristics of the image and text, dimensions, relationships and technical specifications of the images and the warnings, must conform to the technical specifications indicated in the graphic regulations approved in the second paragraph of this article. On the packaging of tobacco products, heated tobacco and its accessories, ENDS, SESN, vaping liquids with and without nicotine and their accessories not included in the previous paragraphs, it must be placed according to the natural placement of the object according to its shape at the point that is most visible.

12.- The producers or importers of the products indicated in this decree may request the Ministry of Health to approve the original printing press for printing. To this end, this Ministry will instruct the Office for the Prevention of Tobacco Consumption of the Division of Healthy Public Policies and Promotion to report through the corresponding official letter on the evidence presented. On the sole merit of the favorable report, it will be understood that the Ministry of Health does not present objections.

13.- The Ministry of Health will make available to interested parties the images and technical specifications corresponding to each warning, as well as the content of the "Graphic Regulations for the use of warnings on the packaging of tobacco products, heated tobacco products and their accessories, ENDS, SESN, their accessories and vaping liquids with and without nicotine". approved in the second paragraph of this article, through electronic files, which will be available for download on the website of the Ministry of Health www.minsal.cl.

14.- If, upon the entry into force of this decree, there are balances left in the warehouse of the manufacturer or importer that do not comply with the established regulations, for their distribution, the latter must request authorization from the Regional Ministerial Secretariat of Health that corresponds to its parent company. This exception may only reach an amount equivalent to the production distributed during the month prior to the entry into force of this decree. This request must be submitted no later than the tenth business day prior to the entry into force of this decree, accompanied by the background information in which the volume of said distribution is accredited. Production distributed during the previous month shall mean the volume of production dispatched from warehouses or factories.

15.- It is prohibited to incorporate in the packaging of products indicated in this decree any element designed to cover the warning or that through its manipulation allows it to be eliminated, such as a pre-chopped container.

16.- It is forbidden to include terms such as light, mild, light, low tar, low nicotine, low carbon monoxide or other similar terms in the name or properties associated with the brand of cigars or cigarettes Likewise, it is prohibited for the packaging of ENDS, SESN, vaping liquids with and without nicotine and their accessories, including their manuals or other inserts, to indicate or suggest that the product is less harmful than another, or that it has vitalizing, energetic, curative, rejuvenating, natural, ecological or other positive effects on health or lifestyle such as anti-stress, activating, relaxing, harmless, healthy.

17.- The containers of cigarettes, ENDS and SESN, and their vaping liquids must clearly and visibly express on one of their side faces the main components of this product in the terms indicated in the "Graphic Regulations for the use of warnings on the packaging of tobacco products, heated tobacco products and their accessories, SEAN, SESN, their accessories and vaping liquids with and without nicotine", approved in numeral 2 of this article.

18.- The advertising of tobacco and heated tobacco products and also of the elements of the brands related to such products is prohibited. The aforementioned prohibition extends in the same terms and with the same effects to indirect advertising carried out by means of a summons, where the consumption of products or brands of products made of tobacco is shown in the mass media. Similarly, the appearance of people smoking or indicating characteristics favourable to tobacco consumption is prohibited in programmes broadcast live, on television or radio, at the time permitted for minors. Likewise, advertising is prohibited in the international signals of the Chilean media or Internet pages whose domains correspond to the ending "dot cl"

19.- The industry, defined in the terms of paragraph b) of Article 2 of Law No. 19,419, shall report annually through a letter to the Ministry of Health the details of donations made, as well as the expenses incurred by virtue of agreements with public institutions, sports organizations, community organizations, academic and cultural entities and non-governmental organizations.

20.- Violations of this decree shall be sanctioned in accordance with the provisions of Articles 15 to 17 of Law No. 19,419, and their inspection shall correspond to the Health Authority and, if appropriate, shall carry out the corresponding sanitary summary, all in accordance with the rules established in Book X of the Sanitary Code.

Article Two.- Supreme Decree No. 5, of 2021, of the Ministry of Health, which establishes a health warning for tobacco product packaging as of the effective date established in the following article, is hereby repealed.

Article Three. - This supreme decree will enter into force three months after its publication, the date from which supreme decree No. 5, of 2021, of the Ministry of Health will be understood to be repealed.

Be it noted, reasoned and published.- GABRIEL BORIC FONT, President of the Republic.- Andrea Albagli Iruretagoyena, Minister of Health (S). I transcribe for your knowledge supreme decree No. 41 of September 10, 2024 of the Undersecretary of Public Health.- Establishes a health warning for containers of tobacco products, heated tobacco and their accessories, whether vaping liquids with or without nicotine and their accessories.- By order of the Undersecretary of Public Health.- Yours sincerely, Yasmina Viera Bernal, Head of the Legal Division, Ministry of Health.