UK: Detailed TPD implementation plan

The UK’s implementation plan has been released today and is also available in pdf version. A few extracts related to e-cigarettes are available below. For the full text, please refer to official documents.

An “electronic cigarette” is defined as a product that

Notification about electronic cigarettes and refill containers

A transition period for products not compliant with the TPD will allow them to remain on sale until 20th May 2017. It principally defines:

“a new transitional product”: a product which is not a modified product during the period beginning with 20th May 2016 and ending with 19th November 2016

“an existing product”: a product first supplied before 20th May 2016 that is being supplied on or after 20th November 2016

Annual reporting requirement and submission of information

The Secretary of State is at the center of the process and will receive notifications. Notifications should be submitted through the EU gateway and become valid after paying the notification fee.

In turn, the Secretary of State must ensure that submitted information is made publicly available on a website, taking the need to protect trade secrets duly into account. The Secretary of State must also provide the European Commission and the competent authorities of other member States with access to information submitted in accordance with any provision of this Part on request, ensuring that trade secrets are treated in a confidential manner.

Product requirements

• Nicotine-containing liquid which is presented for retail sale must be in
  • a dedicated refill container in a volume not exceeding 10 millilitres; or
  • a disposable electronic cigarette, a single use cartridge, or a tank, in a volume not exceeding 2 millilitres.
• The capacity of the tank of a refillable electronic cigarette must not exceed 2 millilitres.
• Nicotine-containing liquid which is presented for retail sale in an electronic cigarette or refill container must not contain nicotine in excess of 20 milligrams per millilitre.
• Nicotine-containing liquid in an electronic cigarette or refill container
  • must not contain any additive referred to in regulation 16 (no vitamins, colourings or prohibited additives in tobacco products);
  • must be manufactured using only ingredients of high purity;
  • must not contain substances other than the ingredients notified under regulation 31, unless present in trace levels, where such trace levels are technically unavoidable during manufacture; and
  • must not include ingredients (except for nicotine) which pose a risk to human health in heated or unheated form.
• An electronic cigarette must be able to deliver a dose of nicotine at consistent levels under normal conditions of use.
• An electronic cigarette or refill container must be
  • child-resistant and tamper-evident; and
  • protected against breakage and leakage.
• An electronic cigarette or refill container must have a mechanism for ensuring re-filling without leakage (unless it is a disposable electronic cigarette).

Product information and labelling requirements

• Each unit packet of the electronic cigarette or refill container must include a leaflet with information on:
  • instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;
  • contra-indications;
  • warnings for specific risk groups;
  • possible adverse effects;
  • addictiveness and toxicity;
  • contact details of the producer; and
  • if the producer is not based in a member State, a contact person within a member State.
• Each unit packet and any container pack must include
  • a list of all ingredients contained in the product set out in descending order by weight;
  • an indication of the nicotine content of the product and the delivery per dose;
  • the batch number; and
  • a recommendation to keep the product out of reach of children.
• Each unit packet and any container pack must carry a health warning consisting of the text: “This product contains nicotine which is a highly addictive substance”.
• The health warning must
  • appear on both the front and back surfaces of the unit packet and any container pack;
  • cover 30% of the area of each of those surfaces, calculated in relation to the area of the surface concerned when the pack is closed;
  • be in black Helvetica bold type on a white background;
  • be in a font size which ensures that the text occupies the greatest possible proportion of the surface area reserved for it; and
  • appear at the centre of that area.
• The health warning must be parallel to the main text on the surface concerned.

Product presentation requirement

• The unit packet and any container pack of the electronic cigarette or refill container may not include any element or feature that:
  • promotes an electronic cigarette or refill container, or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions;
  • suggests that a particular electronic cigarette or refill container
    • is less harmful than other electronic cigarettes or refill containers,
    • has vitalising, energising, healing, rejuvenating, natural or organic properties, or
    • has other health or lifestyle benefits;
  • refers to taste, smell or other additives (except flavourings) or the absence of any such thing;
  • resembles a food or a cosmetic product; or
  • suggests that a particular electronic cigarette or refill container has improved biodegradability or other environmental advantages.
• The unit pack or container pack in which an electronic cigarette or refill container is, or is intended to be, presented for retail sale may not contain any element or feature which suggests economic advantage by including printed vouchers or offering discounts, free distribution, two-for-one or other similar offers.

Vigilance requirements

A producer of electronic cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.

In addition to that, a producer can also warn the Secretary of his State or of any other State if he considers that the product he has is not:

• safe;
• of good quality; or
• in conformity with this Part of the Regulations.

The Secretary of State or the competent authority of any other member State may request additional information from a producer of electronic cigarettes or refill containers, including information on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.

Action to protect human health

If the Secretary of State has reasonable grounds to believe that an electronic cigarette or refill container, or a type of electronic cigarette or refill container, could present a serious risk to human health.

The Secretary may take appropriate provisional measures to address the risk to human health. The measures include, but are not limited to

• prohibiting the supply of the electronic cigarette or refill container, or the type of electronic cigarette or refill container;
• requiring each supplier of the electronic cigarette or refill container, or the type of electronic cigarette or refill container, to recall the product.

The Secretary of State may take appropriate follow-up measures to implement any conclusions of the European Commission in relation to the matter. Any producer or supplier of a product that is the subject of a provisional measure or a follow-up measure must comply with the measure insofar as it applies to that producer or supplier.

Electronic cigarette advertising

It means an advertisement with:

• the aim of promoting an electronic cigarette or refill container; or
• the direct or indirect effect of promoting one.

No advertising of electronic cigarettes in the press (newspaper, periodical or magazine) except:

• a newspaper, periodical or magazine which is intended exclusively for professionals in the trade of electronic cigarettes or refill containers; or
• a newspaper, periodical or magazine which is printed and published in a third country and is not principally intended for the Union market.

No advertising of electronic cigarettes in information society services. The derogation condition:

• necessary for the purposes of public policy, the protection of public health or the protection of consumers (“the objective”);
• relates to an information society service that prejudices the objective or presents a serious and grave risk of prejudice to the objective; and
• proportionate to the objective.

This does not apply:

• to an information society service which is intended exclusively for professionals in the trade of electronic cigarettes or refill containers; or
• to an electronic cigarette advertisement which is not principally intended for the Union market.

No sponsorship of events. In this regulation “electronic cigarette sponsorship” means any form of public or private contribution to any event, activity or individual, with the aim or direct or indirect effect of promoting an electronic cigarette or refill container:

• an event or activity which takes place in or has an effect in two or more member States (“a cross-border event or activity”); or
• an individual taking part in a cross-border event or activity.

Distance sales to consumers

Cross-border distance sales of tobacco products and electronic cigarettes by foreign companies to UK consumers will continue to be permitted. It requires the person to register with the Secretary of State if he/she is:

• a retailer established in the United Kingdom who engages or intends to engage in a crossborder distance sale of a relevant product with a consumer located in any other member State; and
• a retailer who is established elsewhere than in the United Kingdom who engages or intends to engage in a cross-border distance sale of a relevant product with a consumer located in the United Kingdom.

A person seeking registration must submit to the Secretary of State the retailer information, the additional information and such other information as the Secretary of State may reasonably require.

The retailer information is:

• the retailer’s name;
• the retailer’s trading name, if different;
• the address of each place of business used by the retailer for the supply of a relevant product;
• the date on which the retailer first supplied or, if the retailer has not yet so supplied, intends to supply a relevant product via a cross border distance sale;
• the address of any website on which the retailer offers or intends to offer to supply a product, together with any other information required to identify the website; and
• a description of the details and functioning of the retailer’s age verification system.

The additional information is:

• a confirmation of any registration provided by the competent authority of any member State in which the retailer is registered to supply products via a cross-border distance sale to a consumer located in that member State; and
• the name of any other member State to which the retailer has applied, or is intending to apply, for registration.

The Secretary of State must:

• provide confirmation of registration to a retailer who complies with paragraph (2);
• publish a list of retailers registered with the Secretary of State.

A cross-border distance sale can only be concluded if:

• the retailer has received confirmation of registration from the Secretary of State and from the competent authority of any member State in which the consumer is located or in which the retailer is established;
• the retailer operates an age verification system; and
• prior to, or at the time of sale, the retailer’s age verification system confirms that the consumer’s age is not lower than the minimum age applicable for the purchase of the product in the member State in which the consumer is located.

A retailer must not supply a relevant product via a cross-border distance sale to a consumer located in a member State in which cross-border distances sales are prohibited in accordance with Article 18(1) of the Tobacco Products Directive.

Penalties and enforcement

Guilty of an offence:

• breaches any provision of Part 6 (electronic cigarettes) except regulations 32(5) (annual reporting requirement) and 34 (Secretary of State duty to publish notifications);
• breaches any provision of regulations 42, 43 or 44 (advertising and sponsorship); or
• supplies a product in breach of regulation 47 (cross border distance sales of tobacco products and electronic cigarettes etc.).

Is guilty of an offence a producer or retailer who provides information to a person pursuant to any obligation in these Regulations if

• the information is false or misleading in a material particular; and
• the producer or retailer who provides the information either knows it to be false or misleading in a material particular, or is reckless as to whether it is false or misleading in a material particular.

Penalties. A person guilty of an offence under these Regulations is liable

• on summary conviction:
  • in England and Wales to imprisonment for a term not exceeding three months, or a fine or both, or
  • in Scotland, to imprisonment for a term not exceeding twelve months, or a fine not exceeding level 5 on the standard scale, or both;
  • in Northern Ireland, to imprisonment for a term not exceeding three months, or a fine not exceeding level 5 on the standard scale, or both; or
• on conviction on indictment to imprisonment for a term not exceeding 2 years, or a fine, or both.

Enforcement. It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these Regulations within their area.

In determining how to comply with paragraph (1) in relation to regulations 42 and 43 (electronic cigarette advertising), every enforcement authority must have regard to the desirability of encouraging control of advertising by such established means as it considers appropriate, having regard to all the circumstances of the particular case.

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