force of this Protocol1
”. More importantly, this Protocol cannot give mandate to the
Commission for the adoption of secondary legislation, as these can only be based on Article
27 of the 2014 Tobacco Products Directive, a Directive which explicitly excludes export
• How can the Commission state that this inclusion of export products respects the
principle of proportionality when it fails to explain arriving at such a conclusion?
The draft Implementing Regulation simply attributes: “practices that entails the false
declaration of exports
” to illicit trade, without providing any further details. ESTA believes
that the inclusion of export products disproportionally impacts smaller companies and
distorts the internal market. There is currently no benefit of this inclusion since the EU
system may not be internationally shared. Smaller companies and family-owned
businesses are rooted in their locality of origin and export their traditional Western
European products (e.g. fine-cut tobacco, pipe tobacco, traditional nasal snuff, cigars and
cigarillos) to the rest of the world. They cannot (economically viable) relocate, whilst large
multi-national companies can shut down manufacturing plants in Europe and shift
production outside of the EU avoiding export restrictions and self-imposed barrier to trade.
• We would like to understand how is the Commission applying the Better Regulation
principle when re-introducing in the Implementing Regulation, elements that the
Legislators intentionally kept out from the Directive?
In the 2014 Tobacco Products Directive the Legislator never prescribed that the Unique
Identifier must be supplied by an independent third party. Amendments 156, 67, 185,
189 and 108 (point 3a) to the 2014/40 Directive2, adopted by the European Parliament
on 8 October 2013, included references to “independent
” third-party. These amendments
were nonetheless abandoned following the negotiations with the Member States and the
Commission, thereby excluding explicitly the involvement of “independent
” ID issuers.
The requirement for providing a commercial third-party ID Issuer with information in
advance of manufacturing or shipping must in any case be removed from the draft
Implementing Regulation. Some of this information cannot be available prior to packaging
or shipping (when UI are applied onto the unit pack) without creating bottlenecks in the
manufacturing and trading process, transforming a tobacco market economy into a “state-
• Finally, we would like to understand how is the Commission considering the
specificities of smaller tobacco companies, especially those involved in the
manufacturing of niche tobacco products?
As an example, the European Commission was supposed to set a European standard for
the Security Feature to be applied on the packaging of all tobacco products. Instead, the
Commission simply set a list of 19 compliant technologies and requires Member States to
determine the combination or combinations that are to be used in the security features
(leading to thousands of possible combinations).
1 WHO Framework Convention on Tobacco Control; Protocol to Eliminate Illicit Trade in Tobacco Products (AIT); Article 8 (3); page 15 –
available online: http://www.who.int/fctc/protocol/illicit_trade/protocol-publication/en/
2 Amendments adopted by the European Parliament on 8 October 2013 on the proposal for a Directive of the European Parliament and
of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the
manufacture, presentation and sale of tobacco and related products – P7_TA(2013)0398 – Available online:
This fully fails to ensure a uniform application of the security feature in the EU, defeating
the harmonisation objective of the 2014 Directive and hindering the functioning of the
Internal Market. Besides, refusal to apply a mutual recognition principle, allowing one
security feature accepted by one Member State to be used in all other Member States, is
counterproductive. This lack of harmonisation will disproportionally impact smaller
companies greatly increasing compliance cost per unit produced, and ignoring the
specificities of the packaging of pipe tobacco and traditional European nasal snuff and
Despite our numerous attempts to flag these irregularities, DG SANTE still claims to have
consulted relevant stakeholders and applying the Better Regulation guidelines. DG SANTE
did not consider one single suggestion made by smaller companies. ESTA is concerned that
the Commission is pursuing a political agenda that will inevitably result in driving smaller
manufacturers out of business and further concentrate the sector.
ESTA and VdR therefore request your assistance in clarifying the interpretation of Articles
15 and 16 of the Tobacco Products Directive and the principles of “Better Regulation
your colleagues in DG SANTE.
Peter van der Mark,
Michael von Foerster,
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.
The Verband der deutschen Rauchtabakindustrie is the German trade association representing typical
German Mittelstand manufacturing tobacco products. The VdR is a founding member of ESTA and has 18