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How can I make a notification of an e-cigarette or an e-cigarette liquid?
All e-cigarette products (incl. e-cigarette liquids with or without nicotine) that are intended to be placed on the market in Finland have to be notified to the Finnish authorities (Valvira).
The exact requirements, as well as how this information should be submitted to Member States, are set out in two Implementing Decisions. These Decisions clarify that the information should be submitted to Member States via an EU common entry gate (EU CEG) – an IT tool designed to ensure uniform application of the reporting and notification obligations, harmonize the submission of data, facilitate comparison and reduce administrative burden for regulators and industry stakeholders alike. The Commission has set up a website on EU CEG with information on how the notifications can be done (http://ec.europa.eu/health/euceg/).
Who is responsible for making the notifications (manufacturer or importer or both)?
Manufacturers or importers of electronic cigarettes or refill containers shall submit a notification to Valvira of any such products they intend to sell or otherwise supply to consumers. Therefore, a notification can be made either by the manufacturer or the importer. Valvira recommends that the notification is made by the manufacturer whenever possible.
If the manufacturer hasn’t made the notification, all importers of the product need to make a separate notification.
Please note that both manufacturer and importer are responsible that the product complies with the applicable provisions.
After I have made a notification of an e-cigarette or an e-cigarette liquid, when can I place it on the Finnish market?
A notification must be submitted at least six months before the product is placed on the market. Similarly, a notification shall be submitted for each substantial modification of the product prior to selling or otherwise supplying the product to consumers.
Are the any fees for notifying a product or a liquid?
According to the Tobacco Act, Valvira may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them. The amount of the fees is regulated in the statutory regulation on fees (section 90 subsections 3 and 4 of the Tobacco Act). According to the statutory regulation on fees, the fee is 150 euros per notification. The same fee applies for all notification types.
When will I have to pay a fee for the notification that I’ve made?
Valvira sends invoices to each company for the notification fees due in relation to all products for which information has been submitted via the EU-CEG. Valvira also sends yearly invoices for the notifications on sales volume. The due date and the details of Valvira’s bank account will be indicated in the invoice.
If we make a correction to a notification, will it change the date the product can be introduced on the market?
If you’re making a correction to an already existing notification, the EU-CEG system still shows when the original notification has been made. If the product for which the notification has been made still is the same, the correction does not affect the date the product can be introduced on the market.
Are there any country specific regulations that I should be aware of before making a notification of an e-cigarette liquid?
The Finnish Tobacco Act prohibits nicotine liquids with a characterizing flavor or aroma (section 24 and section 11). The only allowed flavor is tobacco flavor or completely without flavor or aroma. This prohibition also applies to nicotine-free liquids.
A characterising flavor or aroma means a smell or taste other than one of tobacco, resulting from an additive or a combination of additives, which is clearly noticeable in a tobacco product, nicotine-containing liquid or nicotine-free liquid intended for vaporization before or during its consumption (section 2).
A flavor or taste that is distinctive to a tobacco variety, like Virginian tobacco or Oriental tobacco, is not considered as characterising flavor.
There’s no transition period for menthol flavored liquids and, therefore, they are forbidden in Finland.
What kind of methodology is being used for analyzing e-liquids or checking e-cigarettes emissions?
According to the commission implementing decision (EU) 2015/2183 in order to ensure the quality and comparability of data submitted, Member States should, where applicable, encourage manufacturers and importers to use agreed standards or testing methods. In the absence of agreed Union or international standards or testing methods, manufacturers and importers should clearly describe in their notifications the measurement methods used and should ensure that they are reproducible. In the annex of this implementing decision (point 5 concerns emissions) it is stated that the notification should include a description of the measurement methods used to assess the emissions, including reference to the relevant approved standard, when available.
How can I report the annually required information (e.g. sales volumes) to Valvira?
All information must be submitted through EU CEG yearly by 20 May. The sales volumes shall be reported for the previous calendar year.
What are the requirements for the packages/labelling of electronic cigarettes?
The requirements for the packages/labelling of electronic cigarettes are regulated in the Finnish Tobacco Act chapter 5, section 36. According to said section, subsection 1, unit packets of electronic cigarettes and refill containers shall include:
a list of all ingredients contained in the product in descending order of weight (also applicable to nicotine-free liquids)
an indication of the nicotine content of the product and delivery per dose
the batch number
a recommendation to keep the product out of reach of children
carry health warnings in Finnish and in Swedish
include a leaflet with information on the product and its usage and on all necessary contact information.
Subsections 1(1), (2) and (5) do not apply to electronic cigarettes that are not pre-filled with nicotine-containing liquid.
Electronic cigarettes, refill containers or unit packets thereof shall not include any of the prohibited labelling elements referred to in section 33 of the Finnish Tobacco Act. This does not apply to information on nicotine content, delivery per dose and flavourings. (also applicable on nicotine-free liquids)
The information in subsection 1(5) and 1(6) has to be included in both Finnish and Swedish. Therefore, it isn’t sufficient to include said information only in English.
Taking into consideration the purpose behind the labelling regulation, it is recommended that all labelling is provided in both Finnish and Swedish.
More detailed regulations on the text, font and font size, colour, surface area, position and other properties of the health warning referred to in subsection 1(5) as well as on the information to be included in the leaflet referred to in subsection 1(6) have been issued by decree of the Ministry of Social Affairs and Health (591/2016). Unfortunately, the decree has not been translated to English yet.
What is the scope of unit packet and outside packaging? If the packaging contains a bottle in an individual box and several boxes in outside packaging, should all of the packaging elements comply with TPD packaging requirement?
According to the Finnish Tobacco Act chapter 1 section 2 point 31, unit packet means the smallest individual packaging of a tobacco product or any other product referred to in the Tobacco Act that is placed on the market. The provisions on the unit packets of tobacco products, herbal products for smoking, electronic cigarettes or refill containers also apply to any outside packaging. All units therefore have to comply with the packaging and labelling requirements. This means that the outside packaging and the box in which the single bottle is sold has to contain all information required by the law.
Cross Border Sales
The cross-border distance sales of tobacco products, electronic cigarettes, nicotine-containing liquids and herbal products for smoking (transition period until 1.11.2022) are prohibited. Furthermore, an economic operator established in Finland shall not sell or otherwise supply the mentioned products to consumers using a means of distance communication as referred to in Chapter 6, section 7(2) of the Consumer Protection Act (38/1978).