Vastuskiri

Dear Amina Tlepova,

Thank you for your inquiry.

The sale of nicotine pouches is legal in Estonia. Pursuant to the Tobacco Act, tobacco products and tobacco-related products are subject to the following restrictions: sale to persons under 18 years of age is prohibited; distance sales, including online and mail order sales to consumers, are prohibited; products may not be visibly displayed at points of sale and must remain concealed from customers; and advertising, promotion, and sponsorship of such products are prohibited.

In accordance with the Tobacco Act, nicotine pouches are considered products related to tobacco products. However, the Tobacco Act does not provide for a notification obligation.

Pursuant to § 18 (1) of the Tobacco Act, a notice of economic activities must be submitted when engaging in the sale of tobacco products in the following areas of activity: retail trade, wholesale trade, and catering.Under § 18 (5) of the Tobacco Act, the obligation to submit a notice of economic activities also applies to products related to tobacco products.

Excise duty must be paid to the Tax and Customs Board in accordance with the Alcohol, Tobacco, Fuel and Electricity Excise Duty Act.

The labelling and packaging of the product must meet the requirements of the CLP Regulation (https://eur-lex.europa.eu/legal-content/ET/TXT/?qid=1524226676976&uri=CELEX:02008R1272-20180301). The requirements are provided in Title III of the regulation. The information on the label must be the same as the information in section 2.2 of the safety data sheet.

As of 1 January 2025, in accordance with Annex I, Article 45, and Annex VIII of the CLP Regulation, the labeling (on the packaging) of mixtures classified as hazardous must include a UFI code. A notification of such mixtures must be submitted via the European Chemicals Agency’s Poison Centres Notification (PCN) Portal. The notification process is associated with the UFI code. More information is available on the website of the Health Board (https://www.terviseamet.ee/kemikaali-tooteohutus/clp-maarus) and on the ECHA Poison Centres portal (https://poisoncentres.echa.europa.eu/et/home).

Additional information can be found on the following websites:

The Chemicals Agency's guide in English: https://echa.europa.eu/guidance-documents/guidance-on-clp

The European Chemicals Agency’s guide: https://echa.europa.eu/en/regulations/clp/labelling

The European Chemicals Agency’s guide: https://echa.europa.eu/view-article/-/journal_content/title/guidance-on-the-compilation-of-safety-data-sheets

Please note that the information on the packaging and labelling and the safety data sheet must be in Estonian.

CLP user support ([email protected]) answers additional questions regarding the aspects regulated by the CLP Regulation.

Best regards,

Mikaela Pakosta

Chief Specialist

Department of Chemical Safety

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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