Leaflet and Label Requirements Check List for E-liquids

Here’s a free check list to help you comply with leaflet and label requirements for e-liquid (refill and pods). This guidance is based on UK official guidance and can be used as a basis for EU member states, however, you should check local requirements for country-specific requirements.

Overview

Key elements

Leaflet

Refills: Indicate width of nozzle or width of tank opening to allow user to identify compatibility

Pods/Devices: Types of docking system used with which such e-cigarettes are compatible

Label

• Name, address and contact telephone number of supplier

Ingredient list

• List of ingredients in descending order of weight.
• ‘Nicotine’ (EC number 200-193-3 optional)

Include statement ‘Keep out of reach of children’

Include: ‘Leaflet inside: Read leaflet carefully before use.’

Nicotine dose per inhalation (optional) or delivery per dose (can be mg/ml).

Health Warning

The TPD allows for each EU member state to decide on one of two health warnings. Each member state considered both and settled on one. Same with UK. Below are the options:

‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non- smokers’

‘This product contains nicotine which is a highly addictive substance.’

The UK chose option 2 which means this must be displayed on the front and back surface of the outer carton. But it should be noted that there is a slight difference. According to UK legislation, the statement is without the ‘.’ as shown below:

‘This product contains nicotine which is a highly addictive substance’

Note: For UK it is important to leave out the ‘.’ at the end for full compliance with UK law.

Coverage at least 30%

Health warning should cover 30% for one language (more for two). See law for full specification (font type, size etc.).

CLP

Contains nicotine EC number 200-193-3

Different strengths

CLP pictograms and text depends on the ingredients and nicotine concentration.

Over 17mg/ml nicotine is classified as ‘Toxic’

‘Danger’ with skull and cross bones pictogram

Toxic if swallowed.

Harmful if inhaled.

Fatal in contact with skin.

May produce an allergic reaction.

IF SWALLOWED: Immediately call a POISON CENTRE or doctor if you feel unwell. Rinse mouth.

IF ON SKIN: Wash with plenty of water.

If medical advice is needed, have product container or label at hand.

Wash hands thoroughly after handling.

Harmful to aquatic life with long lasting effects. Avoid release to the environment.

Dispose of contents / container to approved disposal site, in accordance with local regulations.

Between 4.9mg/ml and 17mg/ml is classified as ‘Harmful’

Under 4.9mg/ml of nicotine is not classified

Text Size

Child-Resistant

Tamper-evident

Triangle (tactile warning labels) for ‘Toxic’

Packaging Rules

E-liquid Refill Bottle

• Securely attached nozzle
• at least 9 mm long
• fits in compatible e-cigarettes
• Possess a flow control mechanism at emits no more than 20 drops of e-liquid per minute when placed vertically and subjected to atmospheric pressure alone at 20 degrees C + or – 5 degrees.

Resources

Business Companion