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Ingredients, emissions and fire safety notifications
Prior to selling or otherwise supplying a tobacco product to consumers, manufacturers or importers shall submit to Valvira:
a. a list of the tar, nicotine and carbon monoxide emissions of the cigarettes that are for sale as well as information about the laboratory that has carried out the measurements and verification;
b. lists with information on cigarette emission levels other than the emissions referred to in paragraph a and the methods used for measuring them (only if maximum levels for the said emissions have been established under section 12(3) of the Tobacco Act);
c. information on emission levels other than those referred to in paragraphs a and b, where available;
d. test reports and statements by an approved verification laboratory or research institute showing brand-specific compliance with fire safety requirements as well as information about the verification laboratory or research institute
e. a technical document setting out a general description of the additives used in the product and their properties
for roll-your-own tobacco
a. a technical document setting out a general description of the additives used in the product and their properties
for tobacco products
a. a list, by brand name and type, of all ingredients and quantities thereof used in the manufacture of each tobacco product (see Information to be included in notification regarding ingredients)
for tobacco products other than cigarettes
a. the emission levels (only if maximum levels for the said emissions have been established under section 12(3) of the Tobacco Act)
The brand name and type-specific list of ingredients must include notifications concerning:
the reasons for the inclusion of the ingredients in the product;
the status of the ingredients, including information on whether the ingredients have been registered in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC;
the classification of the ingredients in accordance with the Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006;
the relevant toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, and concerning particularly their effects on the health of consumers, taking into account addictive effects, among other things.
The ingredients and their quantities in a product shall be notified in descending order of the weight of each ingredient.
Market research and sales volumes
With respect to the ingredients and emissions of a tobacco product, manufacturers or importers shall provide Valvira with available market research and studies on the preferences of various consumer groups. Furthermore, manufacturers or importers shall provide Valvira with the executive summaries of any market surveys the manufacturer or importer carries out when launching a new tobacco product.
Manufacturers or importers shall also annually submit to Valvira the sales volumes of tobacco products by brand name and product type. The sales volumes of cigarettes, cigars and cigarillos shall be reported in sticks and the sales volumes of other tobacco products in kilograms. The sales volumes must be reported for the previous calendar year.
The aforementioned information shall be submitted to Valvira annually by May 20th at latest.
Manufacturers or importers of a tobacco product shall inform Valvira if the composition of the product is modified in a way that affects the information provided with the notifications regarding emissions, ingredients or fire safety (the information provided under section 14 of the Tobacco Act). Manufacturers or importers shall submit the modified information to Valvira prior to selling or otherwise supplying the product to consumers.
Manufacturers or importers of cigarettes or roll-your-own tobacco shall carry out studies examining certain additives that are included in a priority list (primary additives) in accordance with the Article 6(1) of Directive 2014/40/EU. Manufacturers or importers of cigarettes or roll-your-own tobacco shall also establish a report on the results of these studies. That report shall include an executive summary and a comprehensive overview compiling the available scientific literature on each additive examined and summarizing internal data on the effects of the additive.
Manufacturers or importers shall submit the reports concerning primary additives to the Commission and a copy thereof to Valvira and the competent authorities of those EU Member States where a tobacco product containing the additive examined is placed on the market at the latest 18 months after the additive concerned has been included in the priority list. These obligations are not applied to small and medium-sized enterprises if a report on that additive is prepared by another manufacturer or importer.
The Commission and Valvira may also request supplementary information from manufacturers or importers regarding the additive examined. This supplementary information shall form a part of the report. The Commission and Valvira may also require these reports to be peer-reviewed by an independent scientific body.
Novel tobacco product
A novel tobacco product means a tobacco product which does not fall into the definition of any existing product category that are listed in the Tobacco Act’s section 2 paragraphs 4-12 and which has been made available to consumers located in the EU after 19 May 2014.
Manufacturers or importers of tobacco products shall submit a notification to Valvira of any novel tobacco product they intend to sell or otherwise supply to consumers. The notification shall be submitted at the latest six months before the product is placed on the market.
The notification shall be accompanied by:
a detailed description of the product concerned,
instructions for its use, as well as
notifications on the ingredients and emissions of the product concerned (see: notifications regarding emissions, ingredients and fire safety),
available scientific studies on the toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions,
available studies, executive summaries thereof and market research concerning the product on the preferences of various consumer groups, and
a risk/benefit analysis of the product, its expected effects on the cessation and initiation of tobacco consumption and the predicted consumer perception of the product as well as other available and relevant information about the product.
Valvira may require manufacturers or importers to carry out additional tests or submit additional information on the product.
List of primary additives
ANNEX of the Commission Implementing Decision (EU) 2016/787 laying down a priority list of additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations:
CAS number(s) applicable to the substance (not exhaustive)