E-Cigarettes and E-Liquids

Product requirements

These apply to e-cigarettes (including rebuildable devices, those sold without nicotine content and components and replacement parts) and to e-liquids (refill containers for e-cigarettes):

• Maximum tank size of an e-cigarette, 2ml (when assembled if necessary) (Max 600 puffs for disposable e-cigarettes)

• Maximum strength of nicotine-containing liquid if present, 20mg/ml nicotine

• Maximum volume of a nicotine-containing refill container, 10ml

• Tamper-evident and child-resistant packaging

Labelling requirements

On pack as sold (must be on bottle or device if no outer packaging):

• List of ingredients in nicotine-containing liquid, if present

• Indication of nicotine content and delivery per dose

• Batch number

• Recommendation to keep the product out of the reach of children

• Prominent health warning in black text on a white background on front and back - “This product contains nicotine which is a highly addictive substance”

• Prohibited on packs – offers and discounts, product safety / health claims

An accompanying leaflet must be provided with each unit pack and include:

• Instructions for use and storage, including instructions for refilling where appropriate

• Contra-indications, warnings for specific risk groups and possible adverse effects, addictiveness and toxicity

• Contact details of the producer; also a contact within the UK if the producer is based outside the UK (this may be an EU contact for products supplied in Northern Ireland) Exceptions where these are not required

• Identical replacement parts where you and the consumer can clearly identify from the labelling the notified e-cigarette product for which the part is a replacement

• Parts such as battery units that do not come into contact with nicotine-containing liquid when in use

• A disposable e-cigarette or e-liquid product containing 0mg nicotine when sold

Notification requirements

Always check with your supplier that the products you are offered have been notified to MHRA. You can verify this by checking the MHRA published lists of notified products, updated weekly, available online at https://cms.mhra.gov.uk/ecig. If a product has not been notified the manufacturer or importer may not supply it to you.

Please note the existence of an EC-ID or GB-ID is not an indication of compliance and products must not be supplied until the notifications have been published as a notified product by the competent authority in each national market.

We are asking you to review your products on sale to ensure compliance with the regulations. We would particularly request that you review any disposable e-cigarette products and remove non-compliant items from sale. You should consult with your suppliers on this matter and ensure that you do not purchase additional non-compliant stock.

Additional information is available at https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products

Other Regulations continue to apply to e-cigarettes and e-liquids including:

Classification, Labelling & Packaging Regulations;
The Electrical Equipment (Safety) Regulations 1994;
The Electromagnetic Compatibility Regulations 2006;
Plugs and Sockets etc. (Safety) Regulations 1994;
The General Product Safety Regulations 2005.

The Classification, Labelling and Packaging (CLP) Regulations (EC No. 1272/2008)

The Classification, Labelling and Packaging of Substances Regulations requires the following information:

the name, full address and telephone number of a person in an EEA State who is responsible for supplying the substance,

identification of the constituents of the preparation which result in it being classified as a dangerous preparation (e.g. Nicotine),
the signal word: DANGER
Hazard statements:

•Toxic if swallowed,

•Toxic in contact with skin,

•Toxic to aquatic life with long-lasting effects,

nominal mass or nominal volume
Pictogram

Tactile warning label- (raised triangle):

Note Information under CLP may vary due to strength of nicotine

In addition Annex VIII of the EU CLP Regulation applies in EU member states and in NI. Importers and downstream users placing hazardous mixtures on the NI market are required to provide specific information on their products to the National Poisons Information Service (NPIS) in accordance with Annex VIII. This will provide them with a Unique Formula Identifier (UFI) code for traceability. Further information on submitting chemical information to the NPIS is available at;

https://www.gov.uk/guidance/submitting-chemicals-information-to-the-national-poisons-information-service

Further guidance on compliance with Annex VIII of CLP and the need for a UFI code is available at;

https://echa.europa.eu/documents/10162/17235/guidance_on_annex_viii_to_clp

https://poisoncentres.echa.europa.eu/documents/1789887/1803644/ufi_what_it_means

Health (Miscellaneous Provisions) Act (Northern Ireland) 2016

As you will be aware from the 1^st February it became an offence to sell nicotine inhaling products, including e-cigarettes, to persons under the age of 18 in Northern Ireland. A further offence in relation to the proxy purchasing was also introduced making it an offence for a person over the age of 18 to buy, or attempt to buy, a nicotine inhaling product on behalf of someone underage.

As a proprietor you have a legal responsibility to ensure that you or your staff do not sell e-cigarettes to anyone under the age of 18. In order to comply with your legal responsibility you must ensure that you have a policy and procedures in place to prevent a breach of the above legislation.

In order to ascertain the level of compliance with these laws we may carry out test purchase exercises. This involves sending a person under 18 years old into your premises to ask for e-cigarettes. Should a sale take place this may result in a fixed penalty notice of £250 or, on conviction, a court fine of up to a maximum of level 5 on the standard scale.

In addition, the new laws will integrate the sale of nicotine inhaling products into the existing enforcement regime relating to the persistent commission of tobacco offences. A person or a business found to be repeatedly selling nicotine inhaling products to children could receive a Restricted Sales Order or a Restricted Premises Order from the court. Such an order can prohibit the sale of nicotine inhaling products and tobacco products by a named individual or a business premises for up to 3 years.

I would advise that you ensure your staff members fully understand what the changes in the law mean and how these changes will be enforced.