Authorisation of Novel Tobacco Products
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.
According to § 10a of the Tobacco and Non-Smokers Protection Act (TNRSG), a marketing 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).
The application for approval of a novel tobacco product has to be submitted to the Ministry of Health, but also electronically to the Evaluation Unit of the Office for Tobacco Coordination at email@example.com. For this purpose, each tobacco product subject to the application has to be listed in the application form. For this purpose, an application has to be submitted for each product that is subject to an application separately.
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.
The following documents must be submitted for each individual product subject to application:
- a completed and signed application form
- the required information/data in full
- the completed assignment list for application documents
- product samples
In the interest of ensuring public health and consumer protection, an authorisation is only to be granted if there are no indications that the product that is subject to authorisation could have more harmful effects than a comparable conventional product.
For the assessment of tobacco heating products, the following information/data in particular shall be submitted for each individual product that is subject to application:
A. Emission measurement values (to be submitted in Excel format)
- 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. aluminium emissions in the case of 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 in comparison with cigarettes based on emission measurement values and toxicological studies”.
Further information on the authorisation of novel tobacco products can be found on the website of the Ministry of Health.
Last updated: 20.09.2022