After the adoption of the 2014 Tobacco Products Directive, ESTA and its Members have
committed themselves to work closely with DG SANTE and the Commission in developing
the necessary implementing legislation. This was clear when developing the Act for
Ingredients Reporting where industry experts were in continuous – monthly and later
weekly – contact with Commission experts developing a working IT platform.
Where it concerns the current three acts an entirely different approach was followed. Over
a three-year period in a mere three workshops the emphasis was on presenting politically
inspired ideas rather than consulting trade and IT experts and developing technical
standards. We understand that DG SANTE, but also, the contractor has never visited a
smaller logistical trading company, such as a wholesaler or distributor of consumer goods
including tobacco products.
Representing many smaller and mid-sized companies as well as SMEs, ESTA remarks that
the Small Business Act and the “Think Small First approach
” have simply been cast aside.
The whole system is developed for large scale cigarette manufacturing and is clearly not
tailored for other (niche) tobacco products manufactured by smaller companies in Europe.
Including export products and aggregate packaging in its own right to carry Unique
Identifiers (UIs) are two examples where the implementing regulation is contradicting the
In several instances, the draft regulation violates EU competition law by requiring that UIs
are supplied by a single commercial third-party, appointed by each Member State, thereby
establishing an unnecessary monopoly transforming the tobacco market economy into an
unprecedented “state-like-directed” business. A further example of anti-competitive
measures is the EU-level repository system, for which the operator will be designated either
by the commercial companies operating the sub-systems if they can “agree amongst
” or by the Commission “based on an assessment of objective criteria
The Commission's draft decision fails to provide the necessary details and specifications
for the Security Feature to be placed on tobacco packaging. It establishes stringent and
costly requirements, which are incompatible with current packaging materials used for
traditional and niche tobacco products. While the 2014 European Tobacco Products
Directive aims to further harmonise tobacco regulation in the EU, the optional nature of the
draft implementing decision will result in too many different security features in use in the
EU Member States and further distorting the internal market.
Considering the above and the complexity of the system, the number of economic
operators involved, the amount and sophisticated structure of the data to be recorded and
transmitted (for approximatively 80 million products daily), the ambitious missions and
obligations falling on the repository systems providers, the lengthy selection procedures to
be implemented by the Members States and the stringent obligations of the security
feature, it seems nearly impossible that such a Track & Trace system can be implemented
and functional by the required deadline. The draft regulation even shortens the
implementation deadline as prescribed in the Directive by requiring all economic operators,
including wholesalers and distributors, to establish a “functional
” system by 20 March
2019 (only 15 months after the expected adoption of the Acts).
Given that half of the Member States were late in implementing the 2014 Directive, how
can the Commission again set unrealistic deadlines? Using a regulation and a decision
make this even more problematic.
The implementation of Track & Trace cannot be qualified as better regulation at all.
Implementing technical standards served as a pretext for DG SANTE to introduce its own
policy agenda that was intentionally kept out of the primary law by European Legislators.
The alternative health motive of impacting large multinationals will inevitably not be
achieved, but will drive many smaller tobacco manufacturers out of business, leading to
further concentration of the sector.
ESTA therefore requests your assistance in clarifying the interpretation of Articles 15 and
16 of the Tobacco Products Directive and the principles of “Better Regulation
” with your
colleagues in DG SANTE.
For your information, we have attached a full position on the subject and remain at your
Peter van der Mark,
The European Smoking Tobacco Association (ESTA) represents mainly mid-sized companies including SMEs
and several generation-old family-owned businesses. These companies manufacture and distribute fine-cut
tobacco, pipe tobacco, traditional European nasal snuff and chewing tobacco. Many ESTA members are still
rooted in their original locality and have moved from manufacturing and selling only locally, to truly European
companies selling across the EU and beyond. These traditional and artisan European tobacco products are
part of European cultural heritage.