Vastuskiri

Dear Keelie Turnbull,

Thank you for your enquiry.

The legal restrictions and rules on tobacco and tobacco-related products are designed to ensure the protection of human health. The device described by you is equipped with refill tanks, and using the device could lead to the accidental consumption of a high dose of nicotine. Nicotine is acutely toxic and can endanger the user’s safety, particularly if the product comes into contact with the skin or is ingested.

According to § 17, Quantity of Tobacco Products and Products Related to Tobacco Products in Sales Packaging of the Tobacco Act: (3) Nicotine-containing disposable electronic cigarettes and single-use cartridges or tanks shall not exceed a volume of 2 ml.

The product types that include a prefilled 2ml device and a 10mL refill container used as a docking system are prohibited from the Estonian market.

Kind regards,

Chemical Safety Department

Republic of Estonia Health Board

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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 Dear Sir/Madam,

We are a compliance company that helps manufacturers ensure their e-cigarette products are compliant in the EU, UK and many other jurisdictions around the world.

We are seeing a wave of new product types that include a prefilled 2mL device and a 10mL refill container used as a docking system. This is completely within the regulations of the TPD, (see the implementing decision 1(b) below)  however, we are contacting you to clarify your stance on these product types.

COMMISSION IMPLEMENTING DECISION (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016D0586&from=PL

1. Member States shall ensure that refillable electronic cigarettes and refill containers are only placed on the market if the mechanism by which the electronic cigarettes are refilled meets one of the following conditions:

(a) it entails the use of a refill container possessing a securely attached nozzle at least 9 mm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected to atmospheric pressure alone at 20 °C ± 5 °C;

(b) it operates by means of a docking system which only releases refill liquids into the tank of the electronic cigarette when the electronic cigarette and refill container are connected.

I look forward to hearing from you.

Many thanks in advance.