Resolution - RDC 104, of May 31, 2001 (*)

Republished in the Federal Official Gazette - DOU of 8/8/2001
The Collegiate Board of Directors of the Brazilian Sanitary Surveillance Agency, in pursuance of the attribution conferred upon it by Article11, Numeral IV, of the Bylaws of ANVISA, as approved by Decree 3.029, of April 16, 1999, c/c paragraph 1 of Article 111, Numeral I, item "b", of the Internal Regulation approved by Administrative Rule 593 of August 25, 2000, republished in the Federal Official Gazette - DOU of December 22, 2000, at the meeting convened on May 30, 2001,

whereas the various provisions a set forth in Law 9.294, of July 15, 1996;
whereas provision set forth in Law 9.782, of January 26,1999, which determines the regulation, monitoring and inspection of products and services that involve a risk to public health;

whereas the provisions contained in Federal Law 10.167, of December 27, 2000;

whereas the provisions contained in Resolution 46 of March 28, 2001;

whereas the provisions contained in Provisional Remedy 2. 134-33, of July 21, 2001.

has hereby adopted the following Resolution of the Collegiate Board of Directors, applicable to smoking products derived from tobacco and marketed in Brazilian national territory, whether the products are produced domestically or imported, and I, Director- Chairman hereby determine that it should be republished:

Article 1 - All smoking products derived from tobacco shall display on the packaging and in all the associated publicity a warning to consumers about the harmful effects that can result from consumption of these products.

Paragraph 1 - Packaging shall be understood to mean packs, whether soft or cardboard, packets, tins, boxes or any other packaging method used to present the products on the market to the end consumer.

Paragraph 2 - Publicity shall be understood to mean posters, advertising panels and placards on the inside areas of the places where such products are sold.

Article 2 - For the smoking products derived from tobacco, the warnings appearing below shall be displayed simultaneously or sequentially, and in the latter case must be varied at least every five months (maximum). The warnings must be legible and must be prominently displayed and shall also display images, all of which preceded by the words "The Ministry of Health Warns" :

1. SMOKING CAUSES BAD BREATH, TEETH LOSS AND MOUTH CANCER.
2. SMOKING CAUSES LUNG CANCER
3. SMOKING CAUSES HEART ATTACKS
4. SMOKERS ARE SHORT OF BREATH
5. SMOKING DURING PREGNANCY HARMS YOUR BABY
6. IN PREGNANT WOMEN CIGARETTE SMOKING CAUSES PREMATURE BIRTHS, UNDERWEIGHT BABIES AND BABIES LIABLE TO CONTRACT ASTHMA
7. CHILDREN BEGIN TO SMOKE WHEN THEY SEE ADULTS SMOKING
8. NICOTINE IS A DRUG AND CAUSES DEPENDENCY
9. SMOKING CAUSES SEXUAL IMPOTENCE

On Packaging

Article 3 - As regards the packaging of cigarettes, in what are normally called packs (either paper or cardboard), the above warning, the image, the brand name and the number of the Stop Smoking Dial Service must be printed prominently on the part of the packaging most easily visible to the consumer, in accordance with the standard format provided by the Brazilian Sanitary Surveillance Agency. This can be accessed on the ANVISA electronic page www.anvisa.gov.br or can be obtained by applying direct to the headquarters of the Brazilian Sanitary Surveillance Agency.

Paragraph 1 - For any type of packaging for smoking products derived from tobacco, and of the same size as that referred to in the header clause of this Article, the warning, the image, the logotype and the number of Stop Smoking Dial Service, must conform in their entirety to all the printing instructions and must be prominently displayed on the part of the packaging most easily visible to the consumer, in accordance with the standard format or model as provided by the Brazilian Sanitary Surveillance Agency.

Paragraph 2 - For any type of packaging for smoking products derived from tobacco, smaller than that referred to in the header clause of this Article, it is the responsibility of the manufacturer or importer of the product to retain the standard image made available by the Brazilian Sanitary Surveillance Agency, in proportion to the rest of the packaging but without modifying its graphic characteristics, so that this can be displayed on a prominent part of the packaging and be clearly and easily visible to the consumer.

Paragraph 3 - For any type of any packaging for smoking products derived from tobacco larger than that referred to in the header clause of this Article, the warning, the image, the logotype and the number of Stop Smoking Dial Service, must conform in their entirety to all the aforementioned graphic instructions and must be displayed on the lower right-hand corner of the largest side of the packaging visible to the consumer, in accordance with the standard format as provided by the Brazilian Sanitary Surveillance Agency.

Article 4 - In order to comply with Article 3 of Resolution 46 of March 28, 2001, of the Brazilian Sanitary Surveillance Agency, cigarette packs must display along 2/3 (two thirds) of their length, and occupying the width of the whole of one of the sides of the pack, using letters printed in white on a black rectangular background, the levels of tar, nicotine and carbon monoxide contained in the product, together with the following message: "No safe levels exist for the consumption of these substances".

Paragraph 1 - The parameters for informing consumers of the various levels and any further information shall be made available by the Brazilian Sanitary Surveillance Agency on its electronic homepage: www.anvisa.gov.br, and cannot be altered under any circumstances.
Publicity

Article 5 - On all the sales publicity pertaining to the products referred to in Article1, appearing on posters, panels and placards and displayed in the interior of sales points of the products, the warning and the logotype, plus the number of the Stop Smoking Dial Service shall be printed in white letters on a black rectangular background with a white internal band as a frame, in accordance with the Univers font 65 Bold, so that visibility is guaranteed. The minimum size is shown as follows:

0 to 250 cm2 Body 20
251 to 500 cm2 Body 24
501 to 1000 cm2 Body 26
1001 to 1500 cm2 Body 30
1501 to 2000 cm2 Body 36
2001 to 3000 cm2 Body 40
3001 to 4000 cm2 Body 48
4001 to 5000 cm2 Body 52

Paragraph 1 - In all other advertising materials, where there is no specified size, all the messages must be in proportion, using an area of 1000 cm2 as a basis.

General Provisions

Article 6 - The printing of the warnings, together with their respective images and the logotype and the telephone number of the Stop Smoking Dial Service on the cartons, may be replaced by a sticker in the case of the packaging being made from material that renders such printing unfeasible or difficult.

Paragraph 1- The sticker shall be in accordance with the format or model made available by the Brazilian Sanitary Surveillance Agency, and all the other printing characteristics shall be retained. The sticker shall not be inserted onto the external part of the material in which the packages are wrapped.

Paragraph 2- The provisions of this Article apply to imported cigarettes and to other smoking products derived from tobacco.

Paragraph 3 - The provisions of this Article do not apply to cigarettes or packaged in this country.

Article 7 - The use of any type of wrapping or device that impedes or makes the warnings, images, logotype and the number of the Stop Smoking Dial Service difficult to read is hereby expressly forbidden.

Sole paragraph - The control seal of the Brazilian Federal Revenue Agency shall not be placed over the warnings, which must remain clearly visible and easy to read by consumers.

Deadlines for Compliance

Article 8 - All the provisions covered by the present Resolution shall be complied with by January 31, 2002, and special colors will be used instead of the traditional polychrome technique for printing the warning, the image, the logotype and the number of the Stop Smoking Dial Service.

Sole paragraph - Those products manufactured and distributed to the sales outlets before the end of deadline established in this Article may be sold up to the expiry date appearing on the control seal placed on the product by the Federal Revenue Agency.

Article 9 - Manufacturing companies must comply by January 31, 2002 with the provisions set forth in Numeral I, paragraph 1 of Article1, in the sole paragraph of Article 2 and in paragraph 3 of Article 3 of Resolution 46 of the Brazilian Sanitary Surveillance Agency, of March 28, 2001.

Article 10 - Each and every incident of non-compliance with the provisions set forth in this Resolution constitutes a sanitary violation, and the offender shall be liable to the penalties set forth in Law 6.437, of August 20, 1977 and in Federal Law 9.294 of July 15, 1996.

Article 11 - The Brazilian Sanitary Surveillance Agency, through its Office of Smoking Products may establish normative instructions relative to situations not provided for in this Resolution.

Article 12 - This Resolution of the Collegiate Board of Directors enters into force on the date of its publication.

Gonzalo Vecina Neto

(*) Republished on account of errors in the original version, published in the Federal Official Gazette - DOU, Issue no. 106-E, of 1 June 2001, Section I, page