1. European Union Tobacco Products Directive (EUTPD) The Story of the Devil and the Detail
Dr Alan Hardacre 21st May 2014 Williamsburg

2. 4. Expected impact of the EUTPD
Agenda
1. Brief History…
2. What is in the EUTPD
3. What next?
4. Expected impact of the EUTPD

3. 1. Brief History 2012 2013 2014 From 2007 onwards… Consultations
Proposal 1
DG SANCO
PP/90% PHW
Slims ban
Ingredients ban
Ban on e-cigs
Ban on smokeless
Proposal 2
COM
75% PHW
Characterising flavours ban
E-cigs = medicines
Flavour ban for smokeless
Final Text
65% PHW
Slims allowed
Menthol derogation until 2020
E-cigs: 2 routes
Smokeless/ flavours allowed
From 2007 onwards…
Consultations
Impact Assessment
Fact Sheets
Studies

4. Extension of EUTPD [what’s new]
2. What is in the EUTPD
Introduction of “Delegated Acts”
Nicotine-Containing Products
Novel Tobacco Products
Cross-border distance sales
Herbal products
Extension of EUTPD [what’s new]
Larger PHWs + additional warnings
Semi-pack standardisation
Extensive Track & Trace + additional security features
TNCO status-quo, but no communication
Pack & Product
Characterising flavour
Additional reporting on ingredients, including sales vol.
Additional measures on emission ceilings and reporting
Ingredients

5. 2. Packaging & Labelling
Unit packets should include irremovably printed:
65% PHW (top)
General warning (side)
Unique identifier & security feature
Smoking cessation information (side)
FCT: min. 30 gr.
FMC: min. 20 cigarettes
Cigarettes: cuboid shape, flip top, soft packs allowed
RYO: cuboid, cylindrical or pouch

6. 2. Products & Ingredients
Cigarettes & FCT
Definition “ingredient”, “additive”
Prohibition of products with increased toxicity and addictiveness
Increased ingredients & emissions reporting (incl. justification)
Enhanced reporting and comprehensive studies on 15 additives from Commission’s priority list (forthcoming)
Ban on TNCO references on pack
Ban of “characterising flavours” (incl. menthol)
(!) Derogation for menthol: until 2020

7. 2. Nicotine containing products
Electronic cigarettes
Dual approach
Nicotine threshold 20mg/1ml
Refillable containers are allowed
Notification system 6 months before placing on the market
Packaging include ingredients list contained in the product
Flavours allowed, but no reference on pack permitted
No features that create an erroneous impression about its characteristics, health impression, risks or emissions
Advertisement is prohibited
Annual reporting on sales volumes, market survey, consumer preferences
Below threshold
Above threshold
“tobacco product”
“Curative/preventive”
(e.g. Nicorette)
no limitations on sales channels
1 general health warning on nicotine addictiveness*
Authorised as medical products
* (on the two largest surfaces % depending on the MSs official language)

8. 2. Nicotine containing products Open Questions
Member States have 24 months to tackle the transposition of the Directive into national law – making them rush this important decision
Choice of regime depending on concentration
Notification and ingredient disclosure regimes
Ban on Cross-Border internet sales possible
Adult flavours only
Points of sale linked to choice of regime
Advertising & Communication restrictions
Commission to report by 2016….on potential risks to public health
* (on the two largest surfaces % depending on the MSs official language)

9. 2. Cigars
EUTPD primarily aimed at preventing youth smoking/ smoking initiation
Therefore, cigars are excluded from Characterizing Flavour ban and restrictive labeling requirements
Risk
“Substantial change of circumstances”
Article 2 (28)
“Increase in sales volumes by product category by at least 10 % in at least five MSs based on sales transmitted in accordance with Art. 5 (8) or an increase of the level of prevalence of use in the under 25 years of age consumer group by at least 5 % points in at least five MSs for the respective product category <…>”.
Cigars are exempted if “the sales volume at retail level does not exceed 2,5 % of total sales of tobacco products at the EU level”.
Current estimated sales volume is 1,2 % (?)

10. 2. Track & Trace Unique identifier Pack level
Industry technology allowed
FMC/FCT: as of April 2019
Scanning: to the last economic operator before the first retail outlet
Challenges
Requires huge databases and technological capacity
? Open or closed standards for the operating systems
Tackling smuggling (Illicit trade)
Scan in
Scan out
Scan in (retour)
Scan in
Scan out

11. 3. And now for the detail A legislative act is established
European Union Tobacco Products Directive
To IMPLEMENT
the legislative act
To SUPPLEMENT
or AMEND
IN ITS NON ESSENTIAL ELEMENTS
Subsequent decisions are needed
Delegated acts: to supplement, amend or delete certain non-essential elements of the legislative act (Art. 290 TFEU)
Implementing acts: to provide detailed implementing rules (Art. 291 TFEU)

12. 3. EUTPD Implementing Acts
Article
Content
Timeline
5.5
laying down and, if necessary, updating the format for the submission and the making available of information referred to in paragraphs 1 and 6 of this Article and Article 6
No fixed timeline
6.1
laying down and subsequently updating a priority list of additives. This list shall contain additives: a) for which initial indications, research, or regulation in other jurisdictions exist suggesting that they have one of the properties set out in points (a) to (d) of paragraph 2 of this Article; and
b) which are amongst the most commonly used additives by weight or number according to the reporting of ingredients pursuant to paragraphs 1 and 3 of Article 5.
Deadline for list: May 2016 (entry into force + 24 months)
7.2
determine whether a tobacco product has a characterising flavour and shall be prohibited by MS
No fixed timeline. At the request of a MS or on its own initiative
7.3
uniform rules for the procedures for determining whether a tobacco product falls within the scope of paragraph 1
No fixed timeline. Likely to be triggered before bans of products at MS level or if MS ban products in a disharmonised manner
7.4
To lay down procedures for establishment and operation of an independent advisory panel
No fixed timeline, but likely to be established prior to the national transposition, May 2016 at the latest
7.10
determine whether a tobacco product falls within the scope of paragraph 9
9.6
determine the precise position of the general warning and the information message on roll-your-own tobacco marketed in pouches, taking into account the different shapes of pouches
To be determined prior to national transposition, May 2016 at the latest
10.4
define the technical specifications for the layout, design and shape of the combined health warnings, taking into account the different packet shapes
15.11a
determine the technical standards for the establishment and the operation of the tracking and tracing system as provided for in this article, including the marking with a unique identifier, the recording, transmitting, processing and storing of data and access to stored data
Needs to be defined prior to implementation of T&T Feature are applied, namely May 2019 (May 2016 at the latest + 3 years).No deadlines are fixed for the adoption of the necessary, mandated implementing acts and their implementation at the national level
16.2
define the technical standards for the security feature and their possible rotation and adapt them to scientific, market and technical developments
Needs to be defined prior to implementation of T&T Feature are applied, namely May 2019 (May 2016 at the latest + 3 years)
20.13
a common format for the notification provided for in paragraph 2 and technical standards for the refill mechanism provided for in paragraph 3(g)

13. 3. EUTPD: Delegated Acts Article Content Timeline 3.2 3.4 4.3 4.5 7.5
to decrease the maximum emission levels laid down in paragraph 1, where this is necessary based on internationally agreed standards
No fixed timeline
3.4
to integrate standards agreed by the parties to the FCTC or by the WHO relating to maximum emission levels for emissions from cigarettes other than the emissions referred to in paragraph 1 and for emissions from tobacco products other than cigarettes into Union law
4.3
to adapt the methods of measurement of the tar, nicotine and carbon monoxide emissions, where this is necessary, based on scientific and technical developments or internationally agreed standards
4.5
to integrate standards agreed by the parties to the FCTC or by the WHO for measurement methods into Union law
7.5
to set maximum content levels for those additives or combination of additives that result in the characterising flavour
Triggered if 3 MS have prohibited the additive or a combination of additives
7.11
to set maximum content levels for those additives
7.12
to withdraw that exemption for a particular product category, if there is a substantial change of circumstances as established in a Commission report
Triggered if change of circumstances (in a COM report)
9.5
to adapt the wording of the information message laid down in paragraph 2 to scientific and market developments
No fixed timeline.
10.3a,b
to: a) adapt the text warnings listed in Annex I to this Directive taking into account scientific and market developments;
b) establish and adapt the picture library referred to in point (a) of paragraph 1 of this Article taking into account scientific and market developments
Commission Directive 2012/09 has new transposition deadline 28 March 2016 at the latest and MS sell-through of non-compliant product until 28 March 2018
11.6
to withdraw the possibility of granting exemptions for any of the particular product categories referred to in paragraph 1 if there is a substantial change of circumstances as established in a Commission report for the product category concerned
12.3
to adapt the wording of the health warning laid down in paragraph 1 to scientific developments
15.12
to define the key elements of the data storage contracts referred to in paragraph 8 of this Article, such as duration, renewability, expertise required or confidentiality, including the regular monitoring and evaluation of those contracts
Needs to be defined prior to implementation of T&T Feature are applied, namely May 2019 (May 2016 at the latest + 3 years)
20.11
to extend such a prohibition to all Member States, if such an extension is justified and proportionate
No specific date. Triggered if 3 MS have prohibited a specific e-cigarette, or refill containers
20.12
to adapt the wording of the health warning in paragraph 4(b). When adapting that health warning, the Commission shall ensure that it is factual

14. 3. What next? Transposition: From 1…to 28…
2014
2015
2016

15. + 4. Expected Impact of EUTPD
Illicit trade %
Demand for FCT +2%
Strict rules on packages and attractive flavours should help to deter young people from experimenting with, and becoming addicted to, tobacco. The revision is expected to lead to a 2% drop in consumption of tobacco over a period of 5 years. This is roughly equivalent to 2.4 million fewer smokers in the EU. +
annual healthcare saving to the amount of €506 million.
EUR 5bn lost in tax revenue
Up to 175k jobs lost
Maturing of E-cig market hindered by increased regulation?

16. Extra: Questions for Panel
How to reconcile the approaches being taken in the US and the EU on E-cigarettes – when apparently we both think the other is better?
How do you think this EUTPD text will impact the global regulatory environment – which aspects do you think will travel the most?
How can we have a more balanced, evidence-based debate about tobacco in the EU – like you do here in the US? Why is harm reduction not getting traction in the EU?

17. Thank you for your attention !
Questions and answers
Thank you for your attention !