The TPD and You - What is the Tobacco Products Directive?

THE TPD AND YOU

The Tobacco Products Directive is a package of regulations developed by the European Commission to cover the rules surrounding the sale and use of tobacco and tobacco-related products within the EU.

One article of the directive (Article 20) in particular addresses the sale and use of e-cigarettes.

19th of January 2016

WHAT IS THE TPD?

DEFINITION

Definition of e-cigarettes in the TPD:

Article 2 (16) - ‘electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank.

Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

(17)‘refill container’ means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette;

WHAT IS THE TPD?

OVERVIEW

• The provisions set out in the TPD will be transferred into law in all member states on the 20th May 2016. This is a set of standardised rules which apply to each member state, but individual countries have the power to add additional legislation on top at the national level.

• While the TPD comes into effect on May 20th, there is time allowed for products already on the market to continue to be sold while being brought into compliance. • After November 20th 2016, all new products entering the market must be TPD compliant.• After May 20th 2017, all pre-existing products must be TPD compliant or removed from

sale.

• It’s important to note, changes are still being made to various aspects of the directive and are subject to change.

WHAT IS THE TPD?

OVERVIEW

• Unlike earlier drafts of the TPD, the final directive does not state that e-cigarettes are to be treated as a medical product, which means that they are not subject to restrictive medical licensing rules.

• Nicotine-containing products (NCP) which claim/imply that they can be used to cut down or quit smoking are to be considered a medical product and must be licensed as such by the MHRA.

• Taking the proposed TPD into account, once implemented, e-cigs will be considered a tobacco-related product, subject to specific regulations.

WHAT THE TPD MEANS FOR UK VAPERS?

SALES AND TAXATION CHANGES

• E-cigs are not currently subject to product-specific legislation• E-cigarettes are, however, a consumer product and so must comply with relevant safety

legislation which covers all consumer goods (CE, RoHS etc.)

• Age restrictions:• Left to individual member states.• In England, sales of e-cigarettes to under 18s are already prohibited since October 1st

2015.• In Scotland, the same prohibition is planned as part of incoming legislation (Health

(Tobacco, Nicotine etc. and Care) (Scotland) Bill).• The other devolved administrations in Wales and Northern Ireland are likely to follow

suit.


SALES AND TAXATION CHANGES (cont.)

• Taxation:• Expected to remain covered by VAT in the UK, with no additional taxes imposed.

• Advertising• There will be EU-wide restrictions on the advertising or promotion of e-cigarettes, though

member states may choose to implement additional legislation at national level. There will be a complete ban on advertising in Scotland as a result*.

*Subject to change


PRODUCT RESTRICTIONS

• E-liquid will only be allowed to be sold in bottles no greater than 10ml in volume.

• Available in disposable (non-refillable) e-cigarette cartridge format OR• New 2ml max. capacity for tanks and carts, where tanks which hold 5ml or above are

relatively common at present.

• There will be a new limit of 20mg/ml (2%) maximum nicotine content, which will affect existing vapers currently using 20mg or above at present.


PRODUCT RESTRICTIONS (cont.)

• E-liquid will be prohibited from containing:• Additives (e.g. vitamins) which “create the

impression that a tobacco product has a health benefit or presents reduced health risks”.

• “Caffeine, taurine or other additives and stimulant compounds that are associated with energy and vitality”.

• “Additives that have colouring effects on emissions”.


VAPING RESTRICTIONS

• While not set out in the TPD itself, it is expected that in certain institutions throughout the UK, such as schools and hospitals, the use of e-cigarettes will be prohibited in line with the existing smoking ban.

• This is already happening in Scotland, with a ban on the use of e-cigs on NHS properties.• Although this is looking like it may be overturned and already has in some cases.


VAPING RESTRICTIONS (cont.) - WALES

• The devolved administration in Wales currently is considering further bans including:• The use of e-cigarettes prohibited in:• Schools• Public transport• “Eating places”• Places where there is a “potential risk to children”


VAPING RESTRICTIONS (cont.) - WALES

• The power to enforce further regulations under the following:• In specified circumstances.• At specified times.• If specified conditions are satisfied.• In specified areas, or any combination of these.

• Fine:• £200 ($310, €275) on vapers breaking the public usage rule.• £2500 ($3880, €3430) for failing to prevent vaping.


MARKET CHANGES

• Products available to UK vapers• The new rules state that products entering the market once the TPD has come into effect,

must be reported to the “competent authorities” 6 months in advance.• The “competent authorities” in the UK have not yet been established. These must be

reported to the European Commission within 3 months of the TPD coming into force.• A raft of toxicological and emissions data will be required for every product entering the

market.• The likely effect of this will be the slowdown of product development.• The high costs involved in producing the necessary data is likely to prove too expensive

for many smaller vendors to afford.


MARKET CHANGES

• Product design• To conform with the new directive, devices must “deliver the nicotine doses at consistent

levels under normal conditions of use”.• E-cigs and refill containers must be child- and tamper-proof, protected against breakage

and leakage and have a mechanism that ensures refilling without leakage.• TPD compliant warning labels will be required on all unit packs of e-cigarettes and refill

containers.


England Scotland Wales Northern Ireland

Age Restriction (18+) Yes Yes Yes Yes

Public place usage Minimum restrictions Minimum restrictions Smoking-levelrestrictions

Minimum restrictions

Advertising, promotion andsponsorship

TPD–levelrestrictions

Complete ban TPD–levelrestrictions


Product & packagingrestriction





Cross-border sales Allowed, TPD–levelrestrictions

Allowed, TPD–levelrestrictions



Information requirement TPD–levelrestrictions

TPD + retailersregister

TPD + retailersregister


Little or no regulation TPD level of regulation Heavier regulation than TPDKEY:

The TPD and You - What is the Tobacco Products Directive?

Government & Nonprofit

Transcript of The TPD and You - What is the Tobacco Products Directive?