Reporting obligation and annual fee

1. Submitting product data (ingredients, emission values according Art. 8) to the EU-CEG by 15th March every year (http://ec.europa.eu/health/euceg/). AGES created the following documents to facilitate your submission: AGES-Guideline, Annex I, Annex II
2. Submitting information on sales volumes in the previous year to the EU-CEG by 31st May every year (https://ec.europa.eu/health/euceg/)
3. Calculating the fee payable by 15th June every year CALCULATION FORM ANNUAL FEE
4. Transferring the appropriate fees by 30th June every year (see form)

Manufacturers and importers which place tobacco or related products on the market are required to pay an annual flat fee in line with TNRSG 2016/TabGebVO.

BMGF: Tobacco Law Implementing Regulation

The EU Common Entry Gate (EU CEG) is the EU-wide platform for recording mandatory information on businesses and products regulated in the Tobacco Directive. This system is designed to ensure the EU-wide availability of the relevant information and studies for participating institutions and EU citizens. The EU Commission states that registration and data submission must be conducted using the EU-CEG exclusively. The representatives of relevant businesses can find detailed information on the registration process on the EU-CEG website (http://ec.europa.eu/health/euceg). The data submitted to the EU-CEG is protected to the highest level possible.

Retailers or points of sale selling related products can use the following form so that their manufacturer/importer can confirm that the products obtained were registered with the EU CEG and that the appropriate annual fee was paid:

Confirmation of Registration with EU CEG and Payment of Annual Fee

Notification of novel tobacco products

In Austria novel tobacco products may only be placed on the market after being notified and authorised. The application for authorisation must be submitted electronically (tabakno@Spam@agesno.Spam.at) to the Austrian Agency for Health and Food Safety and the applicants must pay the notification fee of 7,953 EUR within four weeks of the application.

Guideline for approval of novel tobacco products

Application for approval

Monitoring

The Federal Minister for Health and Women has the task to monitor compliance with the regulations in line with § 9 Abs. 1 TNRSG. She is free to enlist the help of AGES for this task and appoint officials for inspections and supervisory tasks from the agency’s staff and commission AGES with the assessment and examination of samples taken from tobacco products and related products.
Inspections include large tobacco storage facilities, depositories and point of sales for tobacco products and related goods. Samples may be taken from tobacco products and related goods to the extent required for testing.

Analytics

AGES examines both tobacco products and non-tobacco products, such as E-cigarettes and liquids, in line with the Austrian Federal Act on the manufacturing and market placement of tobacco products and related products, as well as the advertising of tobacco products and related products and non-smoker protection (TNRSG).

Analysis of Tobacco Products

Tobacco products, such as filter cigarettes, hand-rolling tobacco, pipe tobacco, cigars and shisha tobacco, are tested for carbon monoxide, tar and nicotine content using standardised methods. These tests are designed to determine whether the amount of the substance contained complies with the regulations. Furthermore, the products mentioned above are also tested for additives, such as preservatives and humectants.

Non-Tobacco Products

Nicotine levels are an important parameter in the analysis of non-tobacco products. In addition, these tests focus on additives, such as flavourings and substances that are produced by vaporizing, such as formaldehyde, for instance.

The Tobacco and Non-Smoker Protection Act includes a number of regulations on the protection of the general public:

• Ban on placing chewing tobacco and snus on the market
• Warnings such as “Smoking kills – stop now!” or “Tobacco smoke contains over 70 substances known to cause cancer” or - for non-smoking tobacco products - “This tobacco product will damage your health and cause addiction”
• Regulations for electronic cigarettes, licensing regulations for novel tobacco products
• Non-smoker protection in enclosed spaces, such as schools, public buildings and restaurants.

Information Website by the Federal Ministry for Health and Women on the Topic of Tobacco and Non-Smoking

Health Risks

Consuming tobacco products and related products, such as E-cigarettes, poses a health risk.

Tobacco

Tobacco itself already contains a large number of problematic - for instance, carcinogenic - substances. Burning tobacco when smoking cigarettes, cigarillos, cigars, shisha tobacco etc. produces more substances that could have adverse health effects, including some which are carcinogenic. Four out of five lung cancer cases that end fatally can be attributed to smoking. However, smoking can also cause cancer in many other types of body tissue, such as the lips, tongue, throat, larynx, oesophagus (gullet), stomach, pancreas, bladder and the large intestine, to name but a few.

Additionally, the nicotine contained in tobacco bears further, more specific health risks. On the one hand, it increases blood pressure levels and heart rates, leads to the increased production of gastric acid and adrenaline release -- both discussed in connection with some chronic diseases -- and is also suspected to have a tumour-enhancing effect. On the other hand, nicotine has high addiction potential in connection with other substances in tobacco smoke that can lead to increases in tobacco consumption.

E-Cigarettes

While the vapor of e-cigarettes does not contain the carcinogenic substances typical for tobacco smoke, their consumption is not harmless from a health perspective, as users will still inhale nicotine. The consumption of e-cigarettes may also lead to addiction and ease the transition to tobacco products at a later point of time in the opinion of the German Federal Institute for Risk Assessment (BfR). In addition, other ingredients in e-liquids - such as carbonyl compounds, some of which are suspected of causing cancer (e.g. formaldehyde), or flavour additives that could cause inflammation in the respiratory tract (e.g. diacetyl) - may also pose a threat to human health. Furthermore, studies have shown the cell-damaging effects of e-liquids. These liquids and the fine particles, ultrafine particles and vapor producing substances (glycerine, propylene glycol) contained in them, also pose an additional health risk to children and young people whose lungs are not fully developed. As a result, the consumption of nicotine-free, e-cigarettes and e-shishas cannot be considered harmless from a health perspective.

Excessive consumption of e-cigarettes or the improper use of liquids (e.g. swallowing) may also cause acute nicotine poisoning.

A comprehensive risk assessment cannot be carried out at present, given that e-cigarettes are new products and the number of studies available on this subject is still insufficient, in particular in terms of information on the long-term effects of e-cigarette consumption.

http://www.bfr.bund.de/cm/343/nikotinfreie-e-shishas-bergen-gesundheitliche-risiken.pdf

http://www.bfr.bund.de/cm/343/gesundheitliche-bewertung-von-zusatzstoffen-fuer-tabakerzeugnisse-und-elektronische-zigaretten.pdf

http://www.bfr.bund.de/cm/343/liquids-von-e-zigaretten-koennen-die-gesundheit-beeintraechtigen.pdf

http://www.aerzteinitiative.at/Karzinogene05.pdf