Novel tobacco products are tobacco products that do not fall into one of the categories cigarettes, roll-your-own tobacco, pipe tobacco, water pipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or tobacco for oral use - and was first placed on the market after 19 May 2014.

According to § 10a of the Tobacco and Non-Smokers Protection Act (TNRSG), an authorisation from the Federal Ministry of Health is required for placing novel tobacco products on the market. Detailed requirements for approval are regulated in the Ordinance on the Approval of Novel Tobacco Products (NTZulV).

According to § 10a para. 4 TNRSG, approval must be granted if the applicable regulations for the novel tobacco product in question are complied with. Consequently, all variants of a product are considered as individual products to be authorized separately. A separate application for authorization including all necessary documents must be submitted for each product. These documents must relate to the specific composition of the product as stated in the application documents (pursuant to § 10a para. 2 no. 2 TNRSG in conjunction with § 8 para. 1 TNRSG).

The application for authorisation of a novel tobacco product must be submitted to the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK), but also electronically by e-mail or in the form of a storage device (e.g. USB-Stick; by post or in person) to the Evaluation Unit of the Office for Tobacco Coordination (AGES).

Addresses:

AGES
tabak@ages.at

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

Büro für Tabakkoordination
Spargelfeldstrasse 191
A-1220 Wien, Österreich

BMSGPK
werner.pilz@gesundheitsministerium.gv.at

Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz

Persönlich z.Hd. Mag. Werner Pilz
Abt. VI/A/5 – Kompetenzstelle Tabakkoordination
Radetzkystrasse 2
A-1030 Wien, Österreich

The following documents must be submitted for each individual product covered by the application:

Documents can only be accepted in German (official language in Austria) or in exceptional cases (e.g.: original scientific/technical reports) possibly in English.

The authorisation fee of € 7,953.00 for novel tobacco products, as stipulated in § 3 of the Tobacco Fees Ordinance (TabGebVO), must be paid no later than four weeks after submission of the application.

In the interest of ensuring public health and consumer protection, an authorization shall only be granted if the technical assessment does not reveal any evidence that the product subject to authorization could have more harmful effects than a comparable conventional product.

For the assessment of heated tobacco products and other novel tobacco products consumed in the form of an aerosol, the following information/data in particular must be submitted for each individual product subject to the application:

A. Emission measurement values

The Excel Template provided must be used for this purpose and submitted as an Excel file. This file must contain information on emissions when used as intended, with each associated consumer appliance, in comparison with a reference product.

The following measured emission values must be submitted:

• of parameters/substances according to the WHO priority list
• Further information on emissions that are crucial for a health assessment due to specific product designs or certain ingredients (e.g. aluminum emissions from an aluminum coating)

B. in vitro toxicological studies

• Cytotoxicity test
• Bacterial reverse mutation test
• Gene mutation test or chromosome aberration test in mammalian cells

A detailed description of the data to be submitted can be found in the "Guideline for the evaluation of tobacco heating products with regard to their health effects compared to cigarettes on the basis of measured emission values and toxicological studies”.

Further information on the approval of novel tobacco products can also be found on the website of the Ministry of Health.