Anvisa -


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Resolution - RDC 105 of May 31, 2001 (*)
Federal Official Gazette - DOU of 13/12/2001

The Collegiate Board of Directors of the National Sanitary Surveillance Agency, in pursuance of the prerogatives conferred upon the Board by Article11, Numeral IV, of the Regulation of ANVISA as approved by Decree 3.029, of April 16, 1999, c/c paragraph 1 of Article111, Clause I, item "b", of the Bylaws approved by Administrative Rule 593 of August 25, 2000, republished in the Federal Official Gazette - DOU - DOU of December 22, 2000, at their meeting convened on May 30, 2001,

WHEREAS

the provisions set forth in Law 9.782, of January 26, 1999, which determine the regulation, monitoring and inspection of products and services that involve a risk to public health,

has adopted the following Resolution, applicable to tobacco leaves and tobacco products which are processed, manufactured, transported, marketed and/or stored throughout the territory of Brazil , and whether imported or for purposes of export.

Article 1 - All Brazilian national manufacturing companies and companies which import or export products derived from tobacco, whether smokable or not, must be compulsorily registered, all the products derived therefrom and tobacco processing companies must be registered annually.

Sole Paragraph - For the purposes of this Resolution, the following definitions apply:

I - Processing company: any company headquartered in Brazilian territory which purchases, processes and stores tobacco leaves for the purpose of commercialization to national or foreign companies that manufacture tobacco products;

II - National manufacturing company: any company headquartered in Brazilian territory which processes or manufactures any product derived from tobacco, whether smokable or not, for the purpose of commercialization in the Brazilian domestic and/or foreign market;

III - Importing company: any company which imports processed tobacco or any manufactured product derived from tobacco, whether smokable or not, with the purpose of distribution or commercialization in the Brazilian domestic market.

IV - Exporting company: any company which exports processed tobacco or any manufactured product derived from tobacco, whether smokable or not, with the purpose of distribution or commercialization in the foreign market.

Registration of the Company

Article 2 - All tobacco processing companies, national manufacturing companies, importers or exporters of products derived from tobacco, whether smokable or not, must present an application for registration to the Docket Sector of ANVISA. The application must be supported by the following documents:

I - Form 1 – Company Registration Information; and

II - A Statement, registered at a Public Notary Office, indicating the qualifying status of the company making the application, in accordance with its size, and in line with the model shown in the annex of Resolution RDC no 6 of 2 January 2001, which can be obtained on the homepage of ANVISA, http://www.anvisa.gov.br.

Paragraph 1 - In the case of tobacco processing companies, the registration application must also be accompanied by the data on the processed tobacco throughout the fiscal year, included in Form 2 - General List of Types of Tobacco and Additives Used, displayed in the Annex.

Paragraph 2 - After the company has been duly registered, any alteration of this information must be directed to ANVISA within a maximum period of 30 (thirty) days from the date the information is modified.

Paragraph 3 - The form required for registration of the company, displayed in the Annex, is available on-line, from the System for the Registration of Tobacco Products (SISTAB), which can be found on the electronic page of ANVISA, and can also be obtained directly from ANVISA headquarters.

Paragraph 4 - The information completed on the SISTAB system must be handed over in diskette or CD-ROM to the Docket Sector of ANVISA upon application for registration.

Deadlines for Company Registration

Article 3 - The application for company registration is to be forwarded only once.

Sole paragraph - The application for registration of processing company is to be forwarded annually by January 31 of the year following the fiscal year.

Registration of the Product

Article 4 - All national manufacturing companies, as well as those companies which import or export tobacco products, whether smokable or not, must present to the Docket Sector of ANVISA a separate application for registration for each product marketed under a brand name, applicable to each product according to the features distinguishing it from others such as tar levels, composition, flavor, aroma and others.

Paragraph 1 - The application for registration must be supported by the following documentation:

I – An original receipt proving payment of the Inspection Fee effected through the Sanitary Surveillance Fee Collection Voucher (GRVS), drawn up under RDC 28 of December 20, 1999, and available on the electronic page of ANVISA, or by completing the Federal Tax Collection Voucher (DARF). Instructions on how to fill out the latter can also be obtained from the ANVISA electronic page.

II – A photocopy in color of the complete packaging intended for presentation to the end consumer, in accordance with the instructions set forth in Resolution RDC 104, of May 31, 2001;

III – The registration details referring to the production, sale and composition of the product according to the type of product.

Cigarettes

Article 5 - Regarding cigarettes, the registration data included in the following forms and tables, published in Annex, shall be required:

I - Form 2 – General List of Types of Tobacco and Additives Used;

II - Form 3 - Product Registration Information

III - Table 1 - Composition of the Product - type and amount of tobacco used in the product;

IV - Table 2 - Composition of the Product - additives contained in the product;

V - Table 3 - Composition of the Product - specifications of the filter and wrappers;

VI - Table 4 - Composition of the Product - studies undertaken;

VII - Table 5 - Compounds present in the mainstream smoke of the product;

VIII - Table 6 - Compounds present in the sidestream smoke of the product;

IX - Table 7 - Compounds present overall in the tobacco;

X - Table 8 - Data regarding Sale and Production - monthly amount of the product sold per (Brazilian) state ;

XI - Table 9 - Data regarding Sale and Production - monthly amount exported, according to country of destination;

XII - Table 10 - Data regarding Sale and Production - monthly amount imported , according to country of origin;

XIII - Table 11 - Data regarding Sale and Production - monthly amount produced; and

XIV - Table 12 - Data regarding Sale and Production - monthly sale price charged to consumers according per (Brazilian) state).

Smokable tobacco products, except cigarettes

Article 6 - For smokable tobacco products, except cigarettes, the registration data included in the following forms and tables, published in Annex, shall be required:

I - Form 2 – General List of Types of Tobacco and Additives Used;

II - Form 3 - Product Registration Information

III - Table 1 - Composition of the Product - type and amount of tobacco used in the product;

IV - Table 2 - Composition of the Product - additives contained in the product;

V - Table 4 - Composition of the Product - studies undertaken;

VI - Table 7 - Compounds present overall in the tobacco - companies may present a summary report containing only pH determination and nicotine, ammonia and euginol levels present in overall tobacco;

VII - Table 8 - Data regarding Sale and Production - monthly amount of the product sold per (Brazilian) state ;

VIII - Table 9 - Data regarding Sale and Production - monthly amount exported, according to country of destination;

IX - Table 10 - Data regarding Sale and Production - monthly amount imported , according to country of origin;

X - Table 11 - Data regarding Sale and Production - monthly amount produced; and

XI - Table 12 - Data regarding Sale and Production - monthly sale price charged to consumers according per (Brazilian) state).

Non-smokable tobacco products

Article 7 - For non-smokable tobacco products the registration data contained in the following forms and tables, published in Annex, shall be required: