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, snuff or tobacco for oral use - and are to be placed on the market for the first time after 19 May 2014.

In accordance with Section 10a of the Tobacco and Non-Smokers Protection Act (TNRSG), authorisation from the Federal Ministry of Health is required to place novel tobacco products on the market. Detailed requirements for authorisation are set out in the Ordinance on the Authorisation of Novel Tobacco Products (NTZulV).

According to Section 10a (4) TNRSG, authorisation 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 individual products to be authorised separately. A separate application for authorisation, including all necessary documentation, 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 Section 10a para. 2 subpara. 2 TNRSG in conjunction with Section 8 para. 1 TNRSG).

The application for approval of a novel tobacco product must be submitted to the Federal Ministry of Labour, Social Affairs, Health, Care and Consumer Protection (BMASGPK), but can also be submitted electronically by e-mail or in the form of a storage medium (by post or in person) to the assessment office of the Office for Tobacco Coordination.

Addresses:

AGES
tabak@ages.at

Austrian Agency for Health and Food Safety GmbH

Office for Tobacco Coordination
Spargelfeldstrasse 191
A-1220 Vienna, Austria

BMASGPK
werner.pilz@gesundheitsministerium.gv.at

Federal Ministry of Labour, Social Affairs, Health, Care and Consumer Protection

For the attention of Werner Pilz
Dept. VI/A/5 - Competence Centre for Tobacco Coordination
Radetzkystrasse 2
A-1030 Vienna, Austria

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 possibly in exceptional cases (e.g. original scientific/technical reports) in English.

The authorisation fee of EUR 7,953 for novel tobacco products prescribed by § 3 of the Tobacco Fees Ordinance (TabGebV) must be paid no later than four weeks after submission of the application.

In the interests of safeguarding public health and consumer protection, authorisation shall only be granted if the technical assessment does not reveal any evidence that the product subject to authorisation 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. Measured emission 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 decisive for a health assessment due to specific product designs or certain ingredients (e.g. aluminium emissions from an aluminium 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 authorisation of novel tobacco products can also be found on the website of the Ministry of Health.