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Terviseamet · 16. aprill 2026
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- 10.2-7/26/3116-1
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- 16. aprill 2026
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- 10.2-7/2026
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- Mikaela Pakosta (TA, Peadirektori asetäitja (1) vastutusvaldkond, Kemikaaliohutuse osakond)
- Lahendamise tähtaeg
- 1. mai 2026
Failid
Sisu (failidest)
Saatja: "Vjaceslavs Levinoks" <[email protected]>
Saaja: [email protected]
Teema: Request for clarification regarding TPD notification requirements for device modifications
Kuupäev: 2026-04-15 19:11
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada.
Dear Sir or Madam,
Our company places electronic cigarette devices on the Estonian market under
its own brand and has submitted the relevant notifications via the EU-CEG
system in accordance with the Tobacco Products Directive 2014/40/EU.
In light of the upcoming requirements under the Regulation (EU) 2023/1542,
we are currently assessing certain technical modifications to ensure future
compliance. These may include:
* minor dimensional changes (approximately 1 mm),
* introduction of a removable or service-replaceable battery,
* a limited increase in battery capacity (approximately 150 mAh),
while maintaining the same e-liquid composition, nicotine strength, intended
use and overall product category.
From a technical perspective, these changes are not expected to
significantly affect emissions, nicotine delivery or user exposure.
We would appreciate your guidance on the following:
1. Would such modifications be considered a “substantial modification”
requiring a new notification via EU-CEG in Estonia?
2. Does a change in battery capacity and/or battery accessibility
(non-removable vs removable or service-replaceable) automatically trigger a
re-notification requirement?
3. Is it acceptable to consider such changes as non-substantial if it can be
demonstrated that emissions and nicotine delivery remain unchanged?
Thank you in advance for your guidance.
Vjaceslavs Levinoks
SIA Latliq
Tomu iela 4, Riga, LV-1003