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SOI ›Tobacco and related products›Nicotine pouches

Nicotine pouches

Reporting obligation - nicotine pouches without tobacco

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In the meaning § 15a Act no. 89/2016 Coll. on the production, labeling, and sale of tobacco products and related products and amending certain acts, „the manufacturer, importer or distributor of nicotine pouches without tobacco content is obliged to send a notice to the Slovak Trade Inspection (hereinafter „STI“) about each product they want to make available on the market. This notification shall be submitted in electronic form no later than three months before the intended market launch“.

The notification shall contain the following information:

a) the name and contact details of the manufacturer, importer, or distributor,
b) a list of all ingredients contained in the product,
c) available toxicological data regarding the product's ingredients according to
point (b), referring in particular to their effects on the health of consumers during consumption and any addictive effect,
d) information on the nicotine doses and uptake when consumed under normal or
reasonably foreseeable conditions,
e) a declaration that the manufacturer and importer bear full responsibility for the quality
and safety of the product, when placed on the market and used under normal or
reasonably foreseeable condition,
f) planned date launching on the market.

The notice send by email to: info@soi.sk.

Under Act no. 89/2016 Coll., there will be a transitional period for products, which were placed on the market before the new regulation. They could remain on the market until the end of 2023, however, the economic operators responsible for the above-mentioned products (manufacturer, importer, or distributor of nicotine pouches without tobacco content) are obliged to send a notification according to § 15a to the STI in electronic form no later than one month after new regulation (01.01.2023).