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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.
WHAT THE TPD MEANS FOR UK VAPERS?
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
WHAT THE TPD MEANS FOR UK VAPERS?
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.
WHAT THE TPD MEANS FOR UK VAPERS?
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”.
WHAT THE TPD MEANS FOR UK VAPERS?
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.
WHAT THE TPD MEANS FOR UK VAPERS?
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”
WHAT THE TPD MEANS FOR UK VAPERS?
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.
WHAT THE TPD MEANS FOR UK VAPERS?
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.
WHAT THE TPD MEANS FOR UK VAPERS?
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.
WHAT THE TPD MEANS FOR UK VAPERS?
England Scotland Wales Northern Ireland
Age Restriction (18+) Yes Yes Yes Yes
Public place usage Minimum restrictions Minimum restrictions Smoking-level
restrictions
Minimum restrictions
Advertising, promotion
and
sponsorship
TPD–level
restrictions
Complete ban TPD–level
restrictions
TPD–level
restrictions
Product & packaging
restriction
TPD–level
restrictions
TPD–level
restrictions
TPD–level
restrictions
TPD–level
restrictions
Cross-border sales Allowed, TPD–level
restrictions
Allowed, TPD–level
restrictions
Allowed, TPD–level
restrictions
Allowed, TPD–level
restrictions
Information requirement TPD–level
restrictions
TPD + retailers
register
TPD + retailers
register
TPD–level
restrictions
Little or no regulation TPD level of regulation Heavier regulation than TPD
KEY:

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

  • 1. 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
  • 2. 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;
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. WHAT THE TPD MEANS FOR UK VAPERS? 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
  • 7. WHAT THE TPD MEANS FOR UK VAPERS? 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.
  • 8. WHAT THE TPD MEANS FOR UK VAPERS? 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”.
  • 9. WHAT THE TPD MEANS FOR UK VAPERS? 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.
  • 10. WHAT THE TPD MEANS FOR UK VAPERS? 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”
  • 11. WHAT THE TPD MEANS FOR UK VAPERS? 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.
  • 12. WHAT THE TPD MEANS FOR UK VAPERS? 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.
  • 13. WHAT THE TPD MEANS FOR UK VAPERS? 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.
  • 14. WHAT THE TPD MEANS FOR UK VAPERS? England Scotland Wales Northern Ireland Age Restriction (18+) Yes Yes Yes Yes Public place usage Minimum restrictions Minimum restrictions Smoking-level restrictions Minimum restrictions Advertising, promotion and sponsorship TPD–level restrictions Complete ban TPD–level restrictions TPD–level restrictions Product & packaging restriction TPD–level restrictions TPD–level restrictions TPD–level restrictions TPD–level restrictions Cross-border sales Allowed, TPD–level restrictions Allowed, TPD–level restrictions Allowed, TPD–level restrictions Allowed, TPD–level restrictions Information requirement TPD–level restrictions TPD + retailers register TPD + retailers register TPD–level restrictions Little or no regulation TPD level of regulation Heavier regulation than TPD KEY: