Purpose of reporting
The purpose of reporting on tobacco, tobacco products, electronic cigarettes and refillable containers is to ensure high levels of protection in the fields of health, environmental and consumer protection.
In line with the provisions of the Restriction on the Use of Tobacco Products and Related Products Act (Official Gazette of RS, No. 9/17 and 29/17, hereinafter: ZOUTPI), all manufacturers and importers of tobacco products and related products must submit specific information, including the ingredients, emissions and sales data of such products.
The National Laboratory of Health, Environment and Food (hereinafter: NLZOH) is the competent body of the Ministry of Health in the Republic of Slovenia for receiving, storing, discussing, analysing and publishing data and emission measurements concerning tobacco products.
All information on tobacco and related products must be submitted by the manufacturers or importers of such products via the common electronic portal managed by the European Commission, the so-called European Common Entry Gate (hereinafter: EU-CEG system). The instructions for the registration and acquisition of the applicant identification number (ID) are available at the European Commission. An account must be created and an ID number must be requested to register. The application and instructions may be downloaded from the EU-CEG website, which is accessible via the following link:
https://ec.europa.eu/health/eu-common-entry-gate-eu-ceg/providing-information-tobacco-products-e-cigarettes-and-refill-containers-eu-common-entry-gate-eu_sl.
On 17 February 2018, the Rules on reporting on tobacco and related products (Official Gazette of RS, No. 9/18), published at :
http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV13018, entered into force in Slovenia in line with Article 8, paragraph five, Article 9, paragraph eleven, Article 10, paragraph seven, Article 12, paragraph four, Article 25, paragraph three, Article 26, paragraph fourteen, and Article 28, paragraph three of the ZOUTPI.
General terms and definitions|
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Official notifications
Official notifications (hereinafter: notification) is a process that begins after the adoption of the official notification on every brand and type of tobacco, tobacco product or related product that is intended to be launched on the Slovenian market. All applications or changes regarding tobacco, tobacco products or related products are adopted and discussed following the payment of the corresponding fees.
Manufacturer
Manufacturer of tobacco, tobacco products or related products is, as per the ZOUTPI, is a natural or legal entity that produces the product or orders its design or production and markets it under their own name or brand. It has the reporting and notification obligations to the NLZOH on tobacco, tobacco products or related products that it intends to launch on the market in Slovenia in line with the Slovenian legislation.
Importer
Importer of tobacco or related products is, in line with the ZOUTPI, the owner of these products imported into the EU, or a person who has the right to dispose of them. Their obligation to the NLZOH is that of reporting and notifying about tobacco, tobacco products or related products that it intends to launch on the Slovenian market in line with the Slovenian legislation.
Distributor
Distributor of tobacco, tobacco products or related products has no reporting and notifying obligations to the NLZOH, providing they are the distributor of products for which the notification-related obligations on the Slovenian market have already been fulfilled by the manufacturer or importer of these products.
Prior to distribution, the distributor of tobacco, tobacco products or related products in Slovenia should verify whether the manufacturers or importers of such products have met their notification-related obligations, which is evident on the website of the NLZOH, section “Reporting results” on the list “Reporting results - tobacco” and “Reporting results - e-cigarettes”, accessible at:
www.tobak.si.
Seller
Seller of tobacco, tobacco products or related products has no reporting and notifying obligations to the NLZOH concerning tobacco and related products. Prior to the sale, the seller of tobacco, tobacco products or related products in Slovenia should verify whether the manufacturers or importers of such products have met their notification-related obligations, which is evident on the website of the NLZOH, section “Reporting results” on the list “Reporting results - tobacco” and “Reporting results - e-cigarettes”, accessible at:
www.tobak.si.
If the product to be distributed or sold is missing from the aforementioned lists, then information should be obtained from the manufacturer or importer whether the respective product is in the notification process at NLZOH.
If the product is not on the list or in the notification process, then that product must not be placed on the market in the Republic of Slovenia.
Requirements regarding the form and method of reporting
Requirements regarding the form and method of reporting are defined in the Rules on reporting on tobacco and related products (Official Gazette of RS, No. 9/18) regarding tobacco products, electronic cigarettes, new tobacco products, and herbal products for smoking.
The manufacturer or importer must enter the information of the product they intend to launch on the market into the EU-CEG system. Following the entry of information for the Republic of Slovenia, the NLZOH is notified of the intent to launch the declared products on the market in the Republic of Slovenia.
On the basis of the above, the NLZOH initiates the notification process as follows:
- received message at the NLZOH on the intent to launch the product(s) of the specific proposer on the market in the Republic of Slovenia,
- communication with the proposers and fee payment for the verification and discussion of information on the declared product(s),
- implementation of the verification and discussion process of the entered information,
- conclusion of the process and notification,
- publicly accessible publication of the notified product(s) on the NLZOH website.
Discussion
Discussion is a review and analysis process of the data entered into the EU-CEG system for every brand and product type, for which a notification is received on launching the product on the Slovenian market.
Notified tobacco or related product
Notified tobacco or related product is every product for which correctness has been established regarding the notification and reporting obligation as per Articles 9, 10, 25, 26, and 28 of the ZOUTPI and for which, following its publication on the NLZOH website, the process of receiving, storing, discussing, analysing, and publishing data on this product has been concluded, which is evident in the section “Reporting results” on the list “Reporting results - tobacco” and “Reporting results - e-cigarettes”, accessible at:
www.tobak.si.
Definitions of various products
Definitions of various products in line with Article 3 of the ZOUTPI in alphabetical order:
- Smokeless tobacco product is a tobacco product that does not include the combustion process and includes chewing tobacco, snuff tobacco and tobacco for oral use,
- Cigar is a tobacco roll that, when used, includes a combustion process and is defined in more detail in Article 83 of the Excise Duty Act (Official Gazette of RS, No. 47/16 92/21 and 192/21, hereinafter: Excise Duty Act),
- Cigarette is a tobacco roll that, when used, includes a combustion process and is defined in more detail in Article 82 of the Excise Duty Act,
- Cigarillo is a small cigar weighing max. 3g,
- Electronic cigarette is a product that can be used to feed nicotine through a mouthpiece or any other integral part of this product, including a filler, reservoir and device without the filler or reservoir. Electronic cigarettes are made in such a way that they are discarded after use, refilled with the refilling container and reservoir or with single-use fillers,
- New tobacco product is a tobacco product that does not fall into any of the following categories: cigarettes, fine-cut tobacco, pipe tobacco, water pipe tobacco, cigars, cigarillos, chewing tobacco, snuff tobacco, or tobacco for oral use and that was launched on the market after 19 May 2014,
- Refilling container is packaging that includes a nicotine liquid and that may be used to refill electronic cigarettes,
- Tobacco product for smoking is a tobacco product, excluding smokeless tobacco products,
- Tobacco products are products that may be used and are produced, albeit partially, from tobacco, whether genetically modified or otherwise,
- Nasal tobacco is a smokeless tobacco product that is consumed through the nose,
- Pipe tobacco is a tobacco that, when used, includes a combustion process and that is meant to be used exclusively in the pipe,
- Water pipe tobacco is a tobacco product that may be used together with a water pipe. For the purposes of the ZOUTPI, it is considered that water pipe tobacco is a tobacco product for smoking. If the product can be used in the process of smoking with a water pipe and as a fine-cut tobacco, then such a product is considered to be fine-cut tobacco,
- Roll-your-own tobacco (RYO) is a cut tobacco, which is defined in more detail in Article 84, paragraph three of the Excise Duty Act,
- Chewing tobacco is a smokeless tobacco product that is consumed by chewing,
- Herbal product for smoking is a product on the basis of plants, herbs or fruit that does not include tobacco and that, when used, includes a combustion process.
Obligation and process of product notification
Manufacturers and importers of tobacco, tobacco products or related products are obligated to inform the NLZOH on the intent to launch the following products in the following time periods on the market:
-
cigarettes, cigars, cigarillos, fine-cut tobacco, pipe tobacco, water pipe tobacco, chewing tobacco, snuff tobacco - 30 days prior to the intended market launch;
- new tobacco products - 6 months prior to the intended market launch;
- electronic cigarettes and refilling containers - 6 months prior to the intended market launch;
- herbal products for smoking - 6 months prior to the intended market launch.
The entry of the required information into the EU-CEG system alone does not meet the reporting requirements for Slovenia. If the manufacturer and/or importer do not submit an
official notification on the intent to launch the product on the
Slovenian market and fail to submit all the information as required by law, then the supervisory authority is
alerted thereof, which is the
Health Inspectorate (hereinafter: ZIRS),
on the failure to comply with the provisions of the ZOUTPI.
Article 41 of the ZOUTPI includes the supervision rules concerning the implementation of the provisions of this law. In line with this Article, the NLZOH is obligated to report the following identified irregularities to the supervisory authority (ZIRS):
- 41(4) On the basis of the findings provided by the NLZOH, namely that the manufacturers and importers of a certain brand and type of tobacco, tobacco product or related product are not meeting the reporting or notification obligations on products as per Articles 9, 10, 25, 26 and 28 of this law, the ZIRS prohibits the sale of such products with a ruling and orders their removal from the market.
Manufacturers and importers (proposers) are hereby notified that the form for the payment of the fee as per Article 10 of the Rules (item 1) for tobacco is accessible
here, while the form for e-cigarettes is accessible
here. Enter the ID numbers of the products that you have or will register in the EU-CEG system into the form.
Please send us the completed form to the following e-mail addresses:
tobak@nlzoh.si or
ecigarete@nlzoh.si. You may also address all questions regarding the reporting obligations related to tobacco, tobacco products and related products to the above e-mail addresses.