Last updated: December 3, 2021

Disclosure Requirements

Disclosure by manufacturers and importers of cigarettes to government authorities of information on the contents and/or ingredients used in the manufacture of their cigarettes

Required
Regulatory Authority

General Directorate of Public Health

Analysis

Manufacturers and importers of tobacco products are required to report to the General Directorate of Public Health on the ingredients and additives contained in tobacco products detailed per individual brand and product, in compliance with the European Union (EU) regulations. This report must include a statement with the reasons for the inclusion of each ingredient, including their toxicological level, and information on their effects on consumer health and addictiveness. In the case of cigarettes and fine-cut tobacco, a technical document containing a general description of the additives used and their properties is also mandatory. Disclosures must be made six months before the launch of any new tobacco product or modified versions.

Additional studies must be submitted along with these reports when tobacco products contain additives that may contribute to the toxicity or addictiveness of the products, generate a characterizing flavor, facilitate inhalation or nicotine uptake, or that lead to the formation of substances that have CMR properties, following EU regulations.

The law aligns with FCTC Art. 10 and the FCTC Arts. 9 & 10 Partial Guidelines in that it requires disclosure by manufacturers and importers to government authorities of information on the contents and/or ingredients used in the manufacture of their cigarettes.

Disclosure by manufacturers and importers of cigarettes to government authorities of information on the emissions of their cigarettes

Required
Regulatory Authority

General Directorate of Public Health

Analysis

Manufacturers and importers of tobacco products are required to report to the General Directorate of Public Health on the emissions of tobacco products detailed per individual brand and product, including their levels and measurement methods, in compliance with the European Union (EU) regulations. Disclosures must be submitted six months before the launch of any new tobacco product or modified versions.

When additional studies on additives are required according to the law and EU regulations, these must contain information on the emissions resulting from the combustion process involving the additive in question.

The law aligns with FCTC Art. 10 and the FCTC Arts. 9 & 10 Partial Guidelines in that it requires disclosure by manufacturers and importers to government authorities of information on the emissions of their cigarettes.

Disclosed information readily available to the public

Required
Regulatory Authority

Ministry of Health, Consumption and Social Welfare

Analysis

The law requires disclosed information to be available on the website of the Ministry of Health, taking into account the need to protect trade secrets.

The law aligns with FCTC Art. 10 and the FCTC Arts. 9 & 10 Partial Guidelines in that it requires that disclosed information be made readily available to the public.