20169. The Commission is empowered to adopt implementing10 and delegated acts11, notably
as regards the elements mentioned in article 15, paragraph 12. The provisions regarding track
and trace “shall apply to cigarettes and roll-your-own tobacco from 20 May 2019 and to tobacco
products other than cigarettes and roll-your-own tobacco from 20 May 2024”12.
Articles 15 of the directive and 8 of the protocol both regulate track and trace of tobacco
products placed on the market.
While article 8, paragraph 12, of the protocol reads that obligations as regards track and trace
“shall not be performed by or delegated to the tobacco industry”, article 15 of the directive
does not contain, expressis verbis
, any similar prohibition and only provides in its paragraph 8
that the relevant data as regards track and trace must be stored by an independent third party
with whom the manufacturers and importers of tobacco products conclude data storage
contracts for that purpose.
This difference between the two texts raises the question of how, as a matter of the European
Union law, Member states can, or must, transpose the directive.
The present legal opinion considers that the directive does not compel member states to
entrust the tobacco industry with the track and trace of tobacco products (I) and that, even if it
seems to allow member states to do so (II), its correct interpretation leads to consider that it is
prohibited to adopt transposition measures allowing them to do so (III).
No obligation to entrust the tobacco industry with tobacco track and trace
First of all, it is a certainty that the directive does not compel member states to entrust track
and trace operations – particularly affixing the unique identifier to each tobacco products’
unitary packet – to the manufacturers and importers of these products. Indeed, there is no such
provision in the directive. If its text did impose such an obligation, it would obviously be contrary
to the protocol. Of course, formally, the protocol did not limit the European regulator’s freedom
at the time of the adoption of the directive insofar as it did not bind the Union (yet). However,
it must be reminded that the Union signed the protocol before it adopted the directive, so that
it is bound by a minimum good faith obligation to “refrain from acts which would defeat the
object and purpose of a treaty”: codified under article 18 of the Vienna convention on the law
9 Directive, article 29.
10 Directive, article 25.
11 Directive, article 27.
12 Directive, art. 15 § 13.
of treaties, this obligation being considered as international customary law and as corollary, in
international public law, to the principle of protection of legitimate expectation in the
community legal order13.
Therefore, it appears that national transposition measures excluding the tobacco industry from
track and trace operations, particularly in entrusting the affixing of the unique identifier to a
public authority or to an independent third party controlled by a public authority, cannot be
considered as contrary to the directive since it does not compel member states to entrust these
operations to the tobacco industry.
Permission to entrust the track and trace operations to the tobacco industry?
Insofar as it does not compel member states to entrust track and trace operations to the
tobacco industry, does the directive allow it? Many arguments can be put forward to affirm that
member states have this freedom on the grounds of the directive and that they should exercise
it this way:
a) The directive does not prohibit member states to entrust track and trace operations to
the industry, while it only requires them to “ensure that all unit packets of tobacco
products are marked with a unique identifier”14, without mentioning who should affix
b) The directive imposes member states to ensure “that the manufacturers of tobacco
products provide all economic operators involved in the trade of tobacco products,
from the manufacturer to the last economic operator before the first retail outlet,
including importers, warehouses and transporting companies, with the equipment that
is necessary for the recording of the tobacco products purchased, sold, stored,
transported or otherwise handled. That equipment shall be able to read and transmit
the recorded data electronically to a data storage facility pursuant to paragraph 8.”15
13 T-115/94, Opel Austria
, 22 January 1997, §94: therefore, « economic operators can rely on the
principle of legitimate expectation to oppose the adoption, by the institutions, during the period before
the entry into force of this international agreement, of any act contrary to the provisions of the said
agreement which, after its entry into force, have direct effect on their legal situation.”
By virtue of the same principle of legitimate expectation deriving from the good faith principle of article
18 of the Vienna Convention on the law of treaties, a member state cannot claim that an international
agreement, concluded with other member states and the Commission, and aiming to share the
construction costs of a diplomatic building in Abuja, was not ratified in order to oppose the debt and to
a financial compensation measure imposed by the Commission as soon as this state did not clearly
express its intention not to participate to this common project anymore (T-231/04, Greece v
, 17 January 2007, §§85-104).,
14 Directive, article 15 §1.
15 Directive, article 15 §8.
According to the directive, the tobacco industry must provide the necessary equipment
to ensure the track and trace of tobacco products to all intermediaries of the supply
chain at its own cost. Therefore, it could be argued that the tobacco industry is tasked
to affix the unique identifier since it is tasked to provide the equipment necessary to
exploit the information: having to purchase and provide the equipment to read the
unique identifier, the industry would be entitled to choose this equipment, as well as
the identifier, and to affix it.
c) The directive imposes member states to ensure that the tobacco industry concludes a
service contract with an independent third party in order to store the data generated
by the use of the equipment enabling the reading of the information contained in the
unique identifier.16 Therefore, it can be affirmed that the track and trace system would
be perfectly robust and secure, so that the manufacturers could be entrusted with the
affixing of the unique identifier. This would be even reinforced by the fact that data
storage is the only operation that is prevented from being entrusted to the tobacco
industry on the grounds of the directive: a contrario
, and considering the absence of
such specific mention in the directive regarding any other track and trace operation,
member states would be free to entrust the tobacco industry with any other operation
and, considering the silence of the directive on that matter, it would be logical that it
be this way.
d) The preparatory documents show that the more restrictive positions of the European
Parliament, referring to the Seoul protocol, have finally not been retained by the Union
regulator following the trilogues.17
The prohibition to entrust the track and trace operations to the tobacco
None of the above arguments are convincing.
a) If the directive does not expressly prohibit to entrust the affixing of the unique identifier
to the tobacco industry, article 15 paragraph 1 nevertheless imposes upon member
states an obligation to achieve a result: it consists in ensuring that “all unit packets of
tobacco products are marked with a unique identifier”. In other words, national
transposition measures creating the risk that certain unit packets would not bear such
an identifier, must be considered as contrary to the member states’ obligation resulting
from the directive. If affixing of the unique identifier is an operation entrusted to the
tobacco industry, nothing guarantees that all
unit packets will bear one. In that sense,
16 Directive, article 15, §8.
17 See the procedural file 2012/0366(COD),
article 15 paragraph 1 can reasonably be interpreted as excluding a unique identifier’s
affixing method with the industry’s intervention.
b) The deduction proceeding from the second argument is not necessary. Indeed, it is
perfectly possible to impose to the tobacco industry to provide the equipment
necessary for the exploitation of the unique identifier, without making it responsible
for its affixing. Since it falls on the Commission to determine through implementing acts
the tracking and tracing systems’ technical standards18, the tobacco industry will not
have an unlimited choice as to the equipment to be provided to the intermediaries for
the exploitation of the unique identifier and the generation of the data transmitted and
collected by the independent third party. Without having the freedom to choose the
track and trace technology, the industry cannot argue that it has to provide the track
and trace equipment to the intermediaries of the supply chain in order to affirm that it
should logically be entrusted with the initial operation enabling track and trace.
c) It cannot be deducted from the specific obligation imposed on member states to ensure
that manufacturers and importers of tobacco products must conclude data storage
contracts with independent third parties that all operations of track and trace could be
entrusted to the tobacco industry. Even if the a contrario
argument appears logical, it
does not impose itself on the grounds of article 15 read as a whole. Indeed, data storage
is the ultimate link in the track and trace chain, so that its effectiveness relies on the
transmitted data: it is useless to entrust an independent third party with track and trace
data storage if the generation of this data for each unit is not perfectly ensured.
Considering the reality of tobacco products’ trade, storing incomplete data does not
allow to comply with the objectives of article 15. What point is there in tasking an
independent third party with the storage of data which carry the risk of being partial,
since the industry is entrusted to affix the unique identifiers? The obligation to task an
independent third party with the data storage is made compulsory in order to ensure
that the industry does not tamper or erase the data. This would be useless if the data
could fail to exactly reflect the reality of tobacco products’ trade since, on the upper
stream, each unit packet would not generate data. Far from meaning, a contrario
all track and trace operations can be entrusted to the tobacco industry, the obligation
to ensure that data storage is undertaken by an independent third party must be
understood as meaning that member states are compelled to ensure the integrity of
such data on the upper stream, and their comprehensiveness with regard to the reality
of the tobacco products’ trade.
d) The argument deducted from the preparatory documents cannot succeed: “indeed,
according to settled case-law, in the absence of preparatory documents expressing
clearly the intention of the authors of a provision, it should only be relied upon the
scope of the text, as the time of drafting, and confer the meaning that flows from its
literal and logical interpretation (see, in that sense, case of 1 June 1961, Simon v
18 Directive, article 15, § 11.
European Court of Justice, 15/60, Rec
. p. 223, 244; case from Tribunal of 14 December
2006, André v Commission, F-10/06, RecFP
p. I-A-1-183 and II-A-1-755, point 44)”19. It
should also be noted, according to Advocate general Kokott, that the directive was
adopted “following tough negotiations and an extremely animated legislative
procedure”. 20 It is therefore necessary to stick to the text of the directive, its
preparatory documents being irrelevant to interpret it.
Moreover, as the European Court of Justice reminded it in a judgment of 4 May 2016 which
confirmed the validity of the directive, “The Court has consistently held that, if the wording of
secondary law is open to more than one interpretation, preference should be given to the
interpretation which renders the provision consistent with the Treaty rather than to the
interpretation which leads to its being incompatible with the Treaty (see, inter alia, judgment
in Ordre des barreaux francophones et germanophone and Others
, C-305/05, EU:C:2007:383,
paragraph 28).”21 Yet, article 168 of the Treaty on the Functioning of the European Union (TFEU)
imposes that a “high level of human health protection […] be ensured in the definition and
implementation of all Union policies and activities.”
Considering that tobacco products’ track and trace is indispensable to tackle such products’
illicit trade, that illicit trade undermines the efforts put into the struggle against tobacco
prevalence, policy which is part of the protection of human health, the interpretation of the
directive in a way that would leave member states free to entrust the tobacco industry with all
the track and trace operations excluding data storage would not be consistent with the
objectives of the Treaty aiming to ensure a high level of protection of human health. Indeed,
such involvement of the tobacco industry bears the risk that track and trace would not be
thorough, and would reduce the level of protection of human health which could otherwise be
attained. Thus, article 168 TFEU imposes to retain another interpretation of the directive that
prohibits member states to entrust the tobacco industry with any operations as regards track
Finally, still “according to settled case-law, European Union legislation must, so far as possible,
be interpreted in a manner that is consistent with international law, in particular where its
provisions are intended specifically to give effect to an international agreement concluded by
the European Union (see, inter alia, Case C-341/95 Bettati
 ECR I-4355, paragraph 20, and
Case C-306/05 SGAE
 ECR I-11519, paragraph 35).”22 The consistent interpretation of
19 Case F-11/08, judgement from the Civil Service Tribunal of 4 June 2009, Jörg Mölling v Europol
20 Opinion of advocate general Ms Juliane Kokott, delivered on 23 December 2015, Case C-547/14 Philip
Morris Brands SARL and others v Secretary of State for Health
, § 1.
21 Case C-547/14 Philip Morris Brands SARL and others v Secretary of State for Health
22 C-135/10, Società Consortile Fonografici (SCF)
, 15 March 2012, §51 ; see also C-61/94 Germany v
Council, 10 September 1996, §52; C-76/00 P, Petrolub
, 9 January 2003, §56; C-286/02, Bellio
, 1st April
2004, §33; C-511/13 P, Philips Lighting Poland S.A.
, 8 March 2016, §60.
secondary legislation with international law is not conditioned by the direct applicability of the
norm of international law,23 but it nevertheless supposes that the Union be bound by this norm
in the international legal order.
In this particular case, the Union might not yet be bound to implement the Seoul protocol;
however, the directive was adopted in order to implement the World Health Organization
framework convention.24 In fact, the latter also contains provisions regarding track and trace.
Particularly, article 15(2) of the framework convention reads that Parties shall adopt all
“measures to ensure that all
unit packets and packages of tobacco products and any outside
of such products are marked to assist Parties in determining the origin of tobacco
products.” Of course, the framework convention does not bind the parties to adopt a track and
trace system – which is the object of the protocol – but only to consider the adoption of such a
system.25 Nevertheless, as long as the framework convention is to apply to all packets and any
outside packaging of tobacco products, it is all the more logical to consider that when a party
adopts (on purpose) a track and trace system, it must ensure that such a system does not carry
the risk that certain units of conditioning circumvent the system. However, this would be the
case if the tobacco industry was entrusted with the responsibility to affix the unique identifier.
Henceforth, it is necessary to take account of the prohibition contained in the protocol. Surely,
it has not entered into force in the international legal order. Still, it was often ruled according
to standard case-law that an external agreement not yet entered into force, but whose
instrument of ratification had been deposited by the Community (the Union), could serve as a
ground for an action in annulment of an act of secondary legislation.26 The reason for relying
to that end on an external agreement not yet entered into force is the principle of good faith
which “is the corollary in international public law of the principle of the protection of legitimate
expectations, which forms part of the European Union legal order.”27 It can be considered that
if the external agreement not yet entered into force can be used as a ground in the contentious
proceedings about the legality of secondary legislation, member states must also take it into
account when they transpose such act in their domestic legal order. Indeed, the principle of
sincere cooperation requires member states to “take any appropriate measure, general or
particular, to ensure fulfilment of the obligations arising out of the Treaties or resulting from
the acts of the institutions of the Union.”28 The adoption, today, of transposition measures that
will be contrary tomorrow to an international obligation of the Union which is already known
and to which the Union clearly expressed its intention to adhere to does not appear consistent
23 C-53/96, Hermès
, 16 June 1998, §28; C-300/98 and C-392/98, Dior
, 14 December 2000, §47.
24 Directive, recital 7 and article 1.
25 Framework convention, article 15 (2) b).
26 Endnote 13.
27 T-468/08, Tisza Erőmű v Commission
, 30 avril 2014, §321.
28 Article 4(2) Treaty on the European Union. It must be reminded that international treaties concluded
by the Union are considered in its legal order as acts adopted by its institutions: Case 181/73, Haegeman
, 30 April 1974, §§4-5.