The Tobacco Products Directive (TPD) regulates the manufacture, sale and marketing of most safer nicotine products (as well as combustible tobacco products) across the EU.
The TPD is the most comprehensive regulatory framework for safer nicotine products worldwide and is also the only regional framework. This gives the TPD global as well as regional significance because (1) regulators worldwide look to it as a legislative model; and (2) the EU is a powerful player in WHO FCTC and COP (Conference of the Parties),which has global affect. The tobacco control field does not operate in silos and so there is considerable overlap and inter connectivity between tobacco control activity and actors, at global, regional and national levels.
Which tobacco harm reduction products does the TPD regulate? Not snus: the TPD prohibits the sale of snus throughout the EU, except for in Sweden, which gained an exemption when joining the EU. The World Health Organisation published European data in 2018 which indicated that Sweden had the lowest rate of tobacco-related mortality and the lowest incidence of male lung cancer. So, the safest harm reduction product is actually banned by the TPD. White nicotine pouches are not covered by the TPD, because they do not contain tobacco and are not e-cigarettes. Heated tobacco products are regulated under the TPD, they fall into the "novel tobacco products" category and, like e-cigarettes, have to undergo a notification procedure before being placed on the market.
The current TPD is the second TPD and so is often referred to as TPD2. TPD2 entered into force in May 2014 and became applicable in EU Member States in May 2016. TPD2 states that:
"No later than five years from 20 May 2016, and whenever necessary thereafter, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the application of this Directive". From Article 28 of the current Tobacco Products Directive.
The application report process is now well underway and the report should be ready in May 2021. This report is important as it is likely to lead to decisions on whether and how TPD2 should be revised.
Frustratingly, it is difficult to find information on how the TPD application report is being produced and so here we present what we know. We will update this article as information becomes available.
If you spot any errors or have any additional information do please write to us via our Contact form or tweet to @europethra
TPD Milestones 2020 - 21
TPD Application Report – the legal basis (Article 28)
TPD2’s article 28 mandates the scope and timing for the TPD application report (also often referred to as “TPD review” or “TPD evaluation”).
- DG SANTE is preparing the report on behalf of the European Commission, to be ready in May 2021
- If the Commission deems it necessary to adapt the TPD then the European Commission should indicate which elements should be reviewed. If the conclusions of the report do not indicate that the described developments require amending then the EU Commission has no obligation to propose amendments.
- Article 28 states: “When drafting the report, the Commission shall be assisted by scientific and technical experts in order to have all the necessary information at its disposal.”
The areas to be focussed on include, among other things:
“market developments concerning electronic cigarettes and refill containers considering, amongst others, information collected in accordance with Article 20, including on the initiation of consumption such products by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavours;”
as well as:
“market developments concerning novel tobacco products”
- Member states are to have a key role:
“The Member States shall assist the Commission and provide all available information for carrying out the assessment and preparing the report.”
(See Tobacco Products Directive )
Our comment: Consumers reading this will appreciate that the report is examining some highly controversial topics in vaping: youth initiation, influence on smoking cessation and flavours. Two member states, Denmark and the Netherlands, are currently legislating to restrict e-liquid flavourings and flavour bans are already in place in several other member states.
Who are the scientific and technical experts who are assisting the Commission, with this evaluation - which is likely to affect consumer lives worldwide? What are the data sources for the report? What questions are being asked? What is the role of member states? Where are consumers in all this? What follows is the little we know.
INPUT TO THE TPD2 APPLICATION REPORT
Report on the Application of the Directive 2014/40/EU
Indicative Description of Data Sources for Article 28 of Directive 2014/40/EU - Tobacco Products Directive
INFORMATION WEBINAR ON TOBACCO POLICY (given to member states)
1. Product perception study aimed at assessing consumer perceptions of tobacco and novel tobacco products
The “Consumer preference and perception of specific categories of tobacco and related products” study is being conducted by Open Evidence, with London School of Economics, BDI Research and the Catalan Institute of Oncology. See Open Evidence’s press release, here and ”Article 28 report update”, from here.
- The study will also examine initiation and cessation potential as well as “attractiveness”. (see here)
- The agency responsible is the Consumers, Health, Agriculture and Food Executive Agency (Chafea)
- The report was due in Quarter 1, 2020
2. Scientific Opinion commissioned by SCHEER (Scientific Committees on Health, Environmental and Emerging Risks)
DG SANTE asked SCHEER to provide scientific input for the report mentioned in Article 28 (link to request).
A core working group was formed – referred to here. We cannot find any information on who the Working Group members are.
The reasons for the report:
“The SCHEER identified a need for an additional expertise in the following areas: addiction to tobacco and e-cigarettes; relation between (abandoning) smoking and use of e-cigarettes; exposure scenarios for e-cigarettes; modelling of exposure scenarios for e-cigarettes and parametrization of these models; analytical expertise specific for (e-)cigarettes; risk assessment and risk management advice in relation to e-cigarettes.” (from these SCHEER minutes)
Opportunity for engagement?
Various references have been made to the Scientific Opinion being opened for consultation but what form this will take is unclear, as the published references to it are inconsistent:
"Deadline for the final Opinion is September/October 2020. A preliminary opinion is planned to be ready for a public consultation in May 2020." (from these SCHEER Working Group on e-cigarettes minutes, April 2019)
“Deadline for the Opinion (SCHEER Committee’s scientific opinion on e-cigarettes and its effects on cessation and initiation) that will be opened for comments is planned in autumn. However, delays may occur in view of the COVID-19 crisis limitations.” (from these SCHEER Working group on e-cigarettes minutes, May 2020)
“The preliminary Opinion is planned to be adopted in September before publication and minimum consultation due to legislative constraints. However, delays may occur in view of the COVID-19 crisis limitations.” (from these SCHEER Working Group on e-cigarettes minutes, July 2020)
UPDATE 9 SEPTEMBER
"The preliminary Opinion is planned to be adopted by written procedure in September before publication and four weeks consultation planned to run during October." (from these SCHEER Working Group on e-cigarette minutes, 1st September 2020)
Our comment: there is much that is unclear about this hugely important Scientific Opinion on e-cigarettes, especially with regards to who is involved in writing this report and what the opportunities for engagement will be. It is ominous that the consultation, initially referred to as “a public consultation” was most recently described as “minimum consultation”.
UPDATE 24 SEPTEMBER
The SCHEER preliminary Opinion on electronic cigarettes was published yesterday. The Opinion is very biased against THR and it will be crucial for a large volume of high quality contributions to be submitted to the 4 week public consultation. We think it is likely that the contributions will be published in a report.
From the consultation page:
"Interested parties are invited to submit comments on the scientific evidence online before 26 October 2020".
The consultation page also states:
"An electronic template provided with the documents should be used exclusively for the submission of comments, with reference made to the line and page numbers. Please note that comments submitted by email or post cannot be taken into account."
"a submission will not be considered if:
-it is submitted after the deadline set out in the call,
-it is presented in any other form than the template provided,
-it exceeds the maximum length indicated for each section, or contains comments which do not correspond to the indicated title of that particular section,
-it contains information on individual cases or any other material not included in published report,
-it contains complaints against institutions, personal accusations or irrelevant or offensive statements or material. Complaints should be made according to the existing procedures,
-it is related to policy or risk management aspects."
UPDATE 30 SEPTEMBER
See our Respond to the SCHEER consultation article for our first impressions on the report and how to submit to the consultation.
The public consultation page
The preliminary Opinion
Guidelines for submission of contributions
UPDATE 23 FEBRUARY 2021
ETHRA's submisions to the SCHEER Preliminary Opinion on e-cigarettes public consultation is available here
UPDATE 4 MARCH 2021
"The Rapporteur of the working group presented the comments received during the public consultation and the main changes in the final Opinion. There was a discussion among the SCHEER members on clarifications as regards the weight of evidence on using a range of risk e.g. ‘weak to moderate’. The SCHEER concluded that the working group should address the comments and submit the final Opinion for adoption via written procedure. The next meeting will take place on 12 March" (from the SCHEER 17th Plenary meeting minutes, 3 - 4 March)
UPDATE 12 MARCH 2021
"The WG discussed draft replies to comments received in public consultation and proposed changes to the Opinion. The finalisation of the Opinion and the table of comments will continue in the next meeting. Timeline for the finalisation of the Opinion: adoption by written procedure in mid-April 2021" (from the SCHEER Working Group on e-cigarette minutes, 12 March)
3. Application study. A support study to the report on the application of the Directive
DG SANTE (Directorate General for Health and Food Safety) contracted external consultants, ICF, to carry out the support study
“The purpose of the study is to examine the practical application of Directive 2014/40/EU (hereinafter TPD) and its specific provisions, which strengthened existing rules on how tobacco products are manufactured, produced and presented in the EU, and introduced new rules for certain tobacco-related products. The study will assess the level of implementation of the TPD by exploring both achievements and hindering factors.” From Denmark’s Member State’s Questionnaire, posted here.
Stakeholder consultation meetings were undertaken in December 2019 (see here). We can’t find any information on which stakeholders were involved in these meetings but as far as we are aware, no consumer groups were invited to participate.
Work for the Support Study also includes three questionnaires /surveys, sent to Member States, to industry and to Civil Society & Health Experts.
- The Questionnaire to Member States was sent out in March 2020. Member States have a legal obligation to contribute to the report (referred to here) .
- ETHRA wrote to the European Commission and to the consultants, ICF, to protest at consumers not having been consulted and at the Member State questionnaire’s failure to examine the potential consequences of bad regulation for safer nicotine products, our letter is here.
- Questionnaires / surveys were sent out in April to industry, NGO’s and to some consumer groups, including ETHRA.
ETHRA participated in the Civil Society & Health Experts survey (online) and in a follow up phone interview and later published a summary of our views, see our article here.
- An example of the Member States Questionnaire can be seen here (Denmark)
- An example of the CSO and Health Experts Survey can be seen here
Our comment: It is not clear why some consumer groups and not others were invited to participate in the stakeholder surveys. This selectiveness and lack of transparency will prevent the Study from being representative of consumer views in the EU region.
4. JATC: joint Action on Tobacco Control [ website ]
This project supports the implementation of the TPD throughout the Member States.
JATC is a collaborative action between the European Commission and the EU Member States
Runs for 36 months
The objective is to “provide support for the implementation of the Tobacco Products Directive throughout the 28 EU MS” (see here)
30 EU Partners (“scientific and governmental institutions” ) & 13 international Collaborating Partners (including WHO FCTC) (see here)
Organised in 9 work packages under the lead of national organisations (see here)
Work package 7, “E-cigarette Product Evaluation”, deals exclusively with e-cigarettes, see here for the materials
Target date for completion is October 2020
5. Expert Group on Tobacco Policy – Link to group documents
“The purpose of this group will be to assist the Commission in the preparation of policy initiatives for incentive measures in the area of tobacco control, to facilitate cooperation with Member States in this area and to act as a forum through which Member States' experts can be consulted on the preparation of reports, legislative proposals and delegated acts in the framework of Union legislation on tobacco, in particularly those delegated acts provided for under the revised Tobacco Products Directive (Directive 2014/40/EU)” (from the Expert Group’s Transparency Register entry, here)
- Each Member State has a representative in the Group
- There is also an Expert Subgroup for Electronic Cigarettes, which sits below the Expert Group on Tobacco Policy
- The published documents for both groups are a good source of information on the TPD Application Report and the TPD more generally, here are links to some:
MEETING OF THE GROUP OF EXPERTS ON TOBACCO POLICY 21 MARCH 2019, summary record
6. Euromonitor commercial database to provide market data on sales of tobacco and related products - website
Target date for completion March 2021
7. Eurobarometer. Survey on the use and opinion on tobacco and related products across the EU
UPDATE 3 FEBRUARY 2021
The Eurobarometer Report, “Attitudes of Europeans towards tobacco and electronic cigarettes,” was published on 3 February.
See our Eurobarometer: Attitudes of Europeans towards tobacco and electronic cigarettes article for a detailed breakdown of the report.
Our comment: The report makes a strong case for the importance of wide variety safer nicotine products in reducing smoking prevalence. Consumers of safer nicotine products that completely stopped smoking increased by an incredible 121% (from 14% to 31%). Non-tobacco flavours remain the most popular, and evidence of a gateway to smoking is non-existent.
Postscript – COP9 and Europe’s Beating Cancer Plan
What does the TPD application report have to do with COP9?
There exists a close relationship between the EU and the WHO Framework Convention on Tobacco Control (FCTC). Wikipedia describes the FCTC as a “watershed moment” for the European Union, adding:
"Worldwide tobacco control set a precedent for EU Commission participation and negotiation in multilateral treaties, and further defined the powers and capabilities of the EU as a supranational entity."
WHO Framework Convention on Tobacco Control, Wikipedia, accessed 28 August 2020
The European Union is the only regional economic organisation to become a full signatory member and party to the FCTC. This Commission sponsored research paper from 2010 has some interesting discussion on how the EU mandate for COP is negotiated and the role of the EU within the FCTC. Many of the same actors are involved in FCTC COP and EU and national tobacco control efforts.
COP9 was originally scheduled for November 2020, and so would have taken place before the publication of the TPD application report. It seems therefore a fair guess that DG SANTE might have planned to use decisions made at COP9 to define the revision strategy for TPD2. However, COP9 has been postponed and will now take place after the TPD application report has been issued. Will the TPD application report now be used to influence COP?
Europe’s Beating Cancer plan
Europe’s Beating Cancer plan is a key initiative for the current EU agenda and will include cancer prevention in its terms of reference. The initiative includes a Special Committee on Cancer, which was established in June 2020. In the text for the European Parliament’s decision to establish the Committee, tobacco control – including implementation of current legislation and identification of future measures - is identified as a key focus for the Committee:
‘identifying specific actions, including the strict implementation of current legislation and the identification of future measures in the fields of tobacco control” see 1 (d) here
This implies that the Committee will be looking at the TPD and possible areas for review.