Selgitustaotlus

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