Opinion of the Advocate General — ECLI:EU:C:2025:44
Date: 2025-01-30
Language of the case: English
Procedure: Reference for a preliminary ruling
Origin: Ireland

summary of the key points: 
a. The reference request concerns the validity of Commission Delegated Directive 
(EU) 2022/2100 of 29 June 2022 in respect of heated tobacco products5 (the 
"Delegated Directive"), which amends Directive 2014/40/EU of 3 April 2014 
on the manufacture, presentation and sale of tobacco and related products6 
("Directive 2014/40/EU" or the "Tobacco Products Directive" / "TPD"). 
b. The Delegated Directive creates a new "particular product category" that was not 
foreseen in the TPD and was therefore not defined thereunder, that of a heated 
tobacco product, which it defines as "a novel tobacco product that is heated to 
produce an emission containing nicotine and other chemicals, which is then 
inhaled by user(s), and that, depending on its characteristics, is a smokeless 
tobacco product or a tobacco product for smoking." 
c. At the same time, the Delegated Directive removes for this new product category 
the exemption from the prohibition to place on the market tobacco products with 
a characterising flavour (Article 7(1) TPD) or tobacco products containing 
flavourings in any of their components (Article 7(7) TPD). In other words, the 
Delegated Directive requires Member States to prohibit these products. 
d. The Delegated Directive also removes the possibility for Member States to 
exempt heated tobacco products that are "for smoking" from the obligations to 
carry the information message and combined health warnings under the TPD 
(Articles 9(2) and 10 TPD). 
e. The Delegated Directive is based on Articles 7(12) TPD and 11(6) TPD which 
require the European Commission ("Commission") to adopt delegated acts to 
withdraw the exemptions for an existing "particular product category" if there is 
a "substantial change of circumstances", as defined in Article 2(28) TPD. This 
was purportedly established by the Commission in a report published on 15 June 
20227 ("Commission Report"), on the basis that (in accordance with the Article 
 
1 McNeill A, Brose LS, Calder R, Bauld L & Robson D., Evidence review of e-cigarettes and heated 
tobacco products 2018, A report commissioned by Public Health England, available here, at 220. 
2 UK Committee on Toxicology, Toxicological evaluation of novel heat-not-burn tobacco products – non-
technical summary, 2017, available here, at 4. 
3 Slob W, Soeteman-Hernandez LG, Bil W, Staal YCM, Stephens WE, Talhout R. A Method for Comparing the 
Impact on Carcinogenicity of Tobacco Products: A Case Study on Heated Tobacco Versus Cigarettes. Risk Anal. 
2020 Jul;40(7):1355-1366, available here, at 1362. 
4 Order of the High Court of Ireland of 6 November 2023 in PJ Carroll & Co Ltd & Anor v Minister for Health 
& Ors 2022/1085 JR, lodged with the Court of Justice on 7 December 2023. The detailed judgment of the 
referring Court in relation to the reference is appended to the Order as Appendix 1. 
5 Commission Delegated Directive (EU) 2022/2100 of 29 June 2022 amending Directive 2014/40/EU of the 
European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of heated 
tobacco products, OJ L 283/4, 3.11.2022. 
6 Directive 2014/40/EU of 3 April 2014 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 and repealing Directive 2001/37/EC, OJ L 127/1, 29.4.2014. 
7 Annex A.1, Report from the Commission on the establishment of a substantial change of circumstances for 
heated tobacco products in line with Directive 2014/40/EU, 15.6.2022, COM(2022) 279 final. 
4 
2(28) TPD definition): 
i. There had been an increase in the sales volume for heated tobacco products 
by at least 10% in at least five Member States; and 
ii. The sales volume for heated tobacco products at retail level exceeded 2.5% 
of total sales of all tobacco products at EU level, with the Commission 
calculating this to be 3.33%. The Commission Report also set out an 
alternative calculation, based on data for total EU tobacco products sales by 
value, divided by product categories, which it stated came to 3.51%.8 
5. On 13 December 2022, the Applicants commenced Irish judicial review 
proceedings inter alia challenging Ireland's transposition of the Delegated Directive 
on the basis that it was invalid. In its Judgment delivered on 15 September 2023 and 
subsequent Order, the referring Court considered that several of the Applicants' 
arguments were well- founded and, pursuant to Article 267 TFEU, referred the 
following two questions to the Court of Justice: 
a. Question 1: Is the Delegated Directive invalid on the basis that it goes beyond 
the powers granted by Articles 7(12) and 11(6) of Directive 2014/40/EU, in light 
of Article 290 TFEU, and taking into account Article 2(14), 19 and 28 of 
Directive 2014/40/EU? 
b. Question 2: Is the Delegated Directive invalid on the basis that the Commission 
was not entitled to conclude that there was a substantial change of circumstances 
within the meaning of Article 7(12) and/or 11(6) and/or 2(28) of Directive 
2014/40/EU? 
6. The Applicants consider that the Court of Justice should respond to these questions 
in the affirmative, as explained in further detail in Part II of these observations. 
Finally, in Part III of these observations, the Applicants respectfully suggest that the 
Court of Justice order measures of organisation of procedure or measures of inquiry, 
as appropriate, in connection with Question 2. 
7. Before addressing in detail the legal issues, the Applicants want to stress the extent 
and seriousness of the legal violations at issue - in summary: 
a. The Commission has amended a legislative measure, namely the TPD, using a 
delegated power it does not have. The relevant provisions of the TPD only allow 
amendment in relation to established categories of tobacco products. They do 
not allow amendments regarding novel tobacco products such as heated tobacco 
products (which are subject to a different, specific regime under Article 19 
TPD). 
b. The Commission has used this delegated power to make an amendment that it 
could not have made even in relation to an established product category (i.e. 
non-novel tobacco products). The delegated power in question only allows for 
the withdrawal of certain exemptions in Articles 7 and 11 TPD in relation to 
established product categories as defined under Article 2 TPD. The Commission 
has used that power to introduce a new product definition, a matter that is 
 
8 The Commission Report however considered that one of the other relevant criteria under Article 2(28) TPD – 
whether there had been an increase in the level of prevalence of use in the under 25 years of age consumer group 
by at least five percentage points in at least five Member States for the product category based on the Special 
Eurobarometer 385 report of May 2012 or equivalent prevalence studies – was not satisfied. In other words, that 
there was no evidence of significant youth uptake of heated tobacco products. 
5 
covered by Article 2 TPD and which cannot be amended using the delegated 
powers. That new category, impermissibly created by the Commission, also 
conflicts with the fundamental structure and system of the TPD. Firstly, the new 
product category is simultaneously a "novel tobacco product" and a "particular 
product category", while the TPD defines these as mutually exclusive groups. 
Secondly, the new product category comprises both products that are 
"smokeless" and products "for smoking", while the TPD makes a clear 
distinction between the two. 
c. Even if this delegated power to create a new product category for a novel 
tobacco product had been available in principle (and the illegalities described in 
points (a) and (b) above were not to arise), it would have been impossible for the 
Commission to lawfully exercise this power in respect of heated tobacco 
products because the factual conditions to activate the delegated power are not 
fulfilled (the so-called "substantial change of circumstances"). 
d. The Commission has consistently refused to disclose the information and 
calculations underlying its claim that the factual conditions for the activation of 
the delegated power are fulfilled (i.e. the "substantial change of circumstances"). 
It is not acceptable, however, that the Commission would be the sole arbiter of 
the existence of conditions determining its own rule-making competence and 
that it can shield itself from judicial review by refusing to disclose the 
information on which its competence is allegedly based. 
PART II: OBSERVATIONS ON THE QUESTIONS OF THE REFERRING 
COURT 
A. Question 1: Invalidity of the Delegated Directive on the basis of excess of 
delegated powers 
1) Applicable legal principles relating to the delegation of powers to the 
Commission 
8. Article 290(1) TFEU provides that: "[a] legislative act may delegate to the 
Commission the power to adopt non-legislative acts of general application to 
supplement or amend certain non-essential elements of the legislative act" and that " 
The essential elements of an area shall be reserved for the legislative act and 
accordingly shall not be the subject of a delegation of power." (emphasis added) 
9. Pursuant to established case-law, an element is to be considered as "essential" 
within the meaning of Article 290(1) TFEU if it requires political choices falling 
within the responsibilities of the EU legislature, in that it requires conflicting 
interests at issue to be weighed up on the basis of a number of assessments.9 In 
determining whether an element is to be considered as "essential" for these purposes, 
the characteristics and particular features of the field concerned must also be taken 
into account.10 
 
9 Judgment of 26 July 2017, Czech Republic v European Commission, C-696/15 P, EU:C:2017:595, paragraph 
78; judgment of 5 September 2012, Parliament v Council, C-355/10, EU:C:2012:516, paragraphs 65 and 76; 
judgment of 11 May 2017, Dyson v Commission, C-44/16 P, EU:C:2017:357, paragraph 61. 
10 Judgment of 26 July 2017, Czech Republic v European Commission, C-696/15 P, EU:C:2017:595, paragraph 
77; judgment of 5 September 2012, Parliament v Council, C-355/10, EU:C:2012:516, paragraph 68; judgment of 
11 May 2017, Dyson v Commission, C-44/16 P, EU:C:2017:357, paragraph 62. 
6 
10. By way of example, the Dyson v Commission judgment11 concerned the issue of 
the energy labelling of vacuum cleaners and an action for annulment against a 
Commission delegated regulation supplementing legislative Directive 2010/30/EU. 12 
The Commission delegated regulation provided for measuring of energy efficiency 
with an empty receptacle whereas legislative Directive 2010/30/EU referred to 
energy consumption "during use" (when the receptacle is not normally empty). The 
Court of Justice had to consider whether a requirement that the information supplied 
to consumers must reflect energy consumption while the machine is "in use", as had 
been provided for in Directive 2010/30/EU, is an essential element of that Directive. 
The Court concluded that was the case and that the change to the measuring of 
energy efficiency with an empty receptable amounted to "a political choice falling 
within the responsibilities of the EU legislature". 13 The delegated regulation was 
therefore annulled. 
11. Article 290(1) TFEU further requires that the EU legislator sets out the "objectives, 
content, scope and duration of the delegation of power." The Court of Justice has 
explained that this requirement, "is intended precisely to ensure that such a power 
emanates from an express decision of the legislature and that its use by the 
Commission respects the bounds the legislature has itself fixed in the basic act."14 In 
connection with this, the Commission has stated in its own guidelines on delegated 
acts that: "[t]he legislator must explicitly and precisely describe the powers it intends 
to delegate to the Commission " and " vague formulations [.] are not possible ."15 
12. It therefore follows that the Commission's delegated powers must be determined 
precisely and not interpreted expansively. 
2) The delegated powers do not extend to novel tobacco products 
13. Heated tobacco products are "novel tobacco products" within the meaning of 
Article 2(14) TPD, namely, "a tobacco product which: (a) does not fall into any of 
the following categories: cigarettes, roll-your-own tobacco, pipe tobacco, waterpipe 
tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or tobacco for oral use; 
and (b) is placed on the market after 19 May 2014", which is the date when the TPD 
entered into force. 
14. Consistent with the applicable legal principles addressed above, the EU legislator 
could not have lawfully delegated to the Commission the power to regulate a novel 
tobacco product, such products being new products that simply did not exist at the 
time the TPD was adopted. As such, they could not have been the subject of specific 
consideration from a policy and health perspective by the EU legislator to assess their 
risk profile, which in the case of heated tobacco products is very different compared 
to cigarettes. 
15. Importantly, even the EU legislator itself is banned from going as far as 
 
11 Judgment of 11 May 2017, Dyson v Commission, C-44/16 P, EU:C:2017:357. 
12 Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by 
labelling and standard product information of the consumption of energy and other resources by energy-related 
products, OJ L 153/1. 
13 Judgment of 11 May 2017, Dyson v Commission, C-44/16 P, EU:C:2017:357, paragraph 64. 
14 Judgment of 26 July 2017, Czech Republic v European Commission, C-696/15 P, EU:C:2017:595, paragraph 
51. 
15 Annex A.2, Delegated acts - Guidelines for the services of the Commission, 24 June 2011, SEC(2011) 
588, paragraph 52. 
7 
harmonising tobacco health policy pursuant to Article 168(5) TFEU. This inevitably 
implies that any regulatory action in this area is especially sensitive and that many 
aspects will be "essential" in nature. It would be most remarkable if the Commission, 
by a delegated act, could interfere with a Member State's ability to authorise the sale 
of certain novel tobacco products with reduced risk profiles (relative to cigarettes) as 
an instrument of public health. If this were possible then this would render 
meaningless the value of a Treaty safeguard of EU Member State competence such as 
that provided for in Article 168(5) TFEU. 
16. In that context, the regulation of heated tobacco products by the Commission 
through the Delegated Directive inevitably involves policy choices that cannot be 
addressed by a delegated act. By analogy with the Dyson case, if specifying that an 
empty receptacle must be used when measuring energy efficiency instead of a 
partially filled receptacle, constituted the regulation of an "essential element", it 
should be abundantly clear that the threshold is met in the current case. The 
Delegated Directive takes the much more substantive step of creating an entirely new 
product category and simultaneously prohibiting a significant proportion of this 
category in a policy area for which the Treaty bans harmonisation. 
17. The fundamentally different treatment of novel tobacco products and the tobacco 
products in the established categories is further confirmed by the structure and 
legislative history of the TPD and by the Court of Justice's case law. 
18. To begin with, the Explanatory Memorandum to the European Commission's 
proposal for the TPD states: 
"Novel tobacco products are products containing tobacco which do not fall within 
any of the established product categories (e.g. cigarette, roll-your-own tobacco, 
pipe tobacco, water-pipe tobacco, cigar, cigarillo, chewing tobacco, nasal tobacco 
or tobacco for oral use) and which are placed on the market after the entry into 
force of the Directive. [...]"16 (emphasis added) 
19. In other words, it was specifically acknowledged that novel tobacco products are to 
be distinguished from the established product categories and the TPD adopts a 
different approach to their regulation. For the established categories, the TPD sets the 
requirements that tobacco products need to comply with in order to be placed on the 
market throughout the EU (often in minute detail). By contrast, and as noted above, 
novel tobacco products are subject to a special regime set out in Article 19 TPD. This 
requires that manufacturers notify new products in advance along with the available 
scientific studies and evidence in relation to their impact and allows Member States 
to authorise them or not. Article 19 TPD also reflects the policy of the TPD that 
novel tobacco products are to be monitored with a view to identifying specific 
responses to new developments by the EU legislator.17 
20. This was recognised by the Court of Justice in the Swedish Match judgment, in 
which the Court stated that:18 "taking into consideration when they were placed on 
 
16 Annex A.3, 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, COM(2012)788 final, 19.12.2012, Explanatory 
Memorandum, point 3.6. 
17 Or in the words of the Explanatory Memorandum, with a view "to increasing the knowledge base as regards 
these products for the purpose of possible future amendments to the Directive". 
18 Judgment of 22 November 2018, Swedish Match, C-151/17, EU:C:2018:93 8. 
8 
the market, the effects of novel tobacco products on public health could not, by 
definition, be observed or studied at the time when Directive 2014/40 was adopted 
[…]" and that "While it is true that the EU legislature brought the former products 
within the scope of that directive, it did so in order that those products should be the 
subject of studies as to their effects on health and as to consumption practices, in 
accordance with Article 19 of that directive."19 
21. It is therefore clear that the delegated powers in Articles 7(12) and 11(6) are not 
concerned with novel tobacco products at all but with the differentiation that the TPD 
makes between the established product categories. This is further supported by 
Recitals 19 and 26: 
"(19) Considering this Directive's focus on young people, tobacco products other 
than cigarettes and roll-your-own tobacco, should be granted an exemption from 
certain requirements relating to ingredients as long as there is no substantial 
change of circumstances in terms of sales volumes or consumption patterns of 
young people." 
"(26) For tobacco products for smoking, other than cigarettes and roll-your-own 
tobacco products, which are mainly consumed by older consumers and small 
groups of the population, it should be possible to continue to grant an exemption 
from certain labelling requirements as long as there is no substantial change of 
circumstances in terms of sales volumes or consumption patterns of young people. 
[...] As regards waterpipe tobacco, which is often perceived as less harmful than 
traditional tobacco products for smoking, the full labelling regime should apply in 
order to avoid consumers being misled." 
22. As such, these delegated powers are related to a policy choice by the EU legislator 
to treat certain established categories differently to others. Cigarettes and roll-your-
own tobacco were considered as attractive to young people and waterpipe tobacco 
was seen as requiring specific treatment due to misperceptions about its harmfulness. 
The remaining categories were considered as "mainly consumed by older consumers 
and small groups of the population." Considering the list of "particular product 
categories" in Article 2(14)(a) and the fact that oral tobacco is banned in all Member 
States with the exception of Sweden, it is clear that the legislator had in mind the 
following: pipe tobacco, cigars, cigarillos, chewing tobacco and nasal tobacco (each 
of which is indeed "mainly consumed by older consumers and small groups of the 
population"). 
23. The legislator then built in a safety valve through Articles 7(12) and 11(6) to allow 
for the removal of these exemptions in case demand were to shift from cigarettes and 
roll- your-own to one of these less popular product categories (i.e. pipe tobacco, 
cigars, cigarillos, chewing tobacco or nasal tobacco). Such a delegated power is 
indeed of a purely "technical" nature, as it simply requires the Commission to 
establish whether a "substantial change of circumstances" has occurred in relation to 
one of these categories. If so, the Commission has to remove the exemption for that 
category. 
24. This safety valve is not relevant for novel tobacco products, which are subject to 
the special regime set out in Article 19 TPD, pursuant to which Member States can 
have their own authorisation regimes and take their own decisions about these novel 
 
19Ibid., at paragraph 32. 
9 
tobacco products (which is not the case for the established categories). It is 
completely wrong, therefore, to extend the delegated powers of Article 7(12) and 
11(6) to novel tobacco products. 
25. In this respect, it is useful to consider the hypothetical example of a novel tobacco 
product that contains 99% less tobacco than a traditional cigarette. It surely cannot 
be the case that once sales of such a product exceed the thresholds of "substantial 
change of circumstances", the TPD requires that the Commission forces Member 
States to ban characterising flavours in these products and impose the TPD's strictest 
labelling requirements that are also applicable to cigarettes. The only reasonable 
conclusion is that pursuant to Article 19 TPD, Member States can take their own 
view on such products (while also respecting applicable TPD requirements). 
26. The distinction between novel tobacco products and established product categories 
in this regard is further confirmed by the following key aspects / provisions of the 
TPD: 
a. The language of Articles 7(12) and 11(6) TPD themselves, which specifically 
refer to the ability of the Commission to withdraw the benefit of the relevant 
exemptions in respect of a "particular product category". As explained by the 
Court of Justice in the Planta Tabak judgment, 20 the term "particular product 
category" corresponds to the existing product categories listed in Article 
2(14)(a) TPD, to which "novel tobacco products" are defined in 
contradistinction. 
b. Article 28(2) TPD, which lists the elements of the TPD which the Commission 
must pay special attention to in its report on its application. This list sets out 
separately, and as such differentiates between, market developments concerning 
novel tobacco products (Article 28(2)(b)) and market developments which 
constitute a "substantial change of circumstances" (Article 28(2)(c)). This again 
clearly suggests that novel tobacco products are distinct from the product 
categories referred to in Articles 7(12) and 11(6) TPD and which are subject to 
the Commission's delegated power. 
c. The first criterion laid down in Article 2(28) TPD for establishing whether there 
is a "substantial change of circumstances" - that there has been an increase of the 
sales volume of the relevant product category by at least 10% in at least five 
Member States. In the case of novel tobacco products, such as heated tobacco 
products, the starting level, by definition, will be zero, making it mathematically 
impossible to establish a 10% increase. Even if one were to take as a starting 
point a date just after the novel tobacco product was first placed on the market, 
any calculation starting from a very low baseline will result in huge percentage 
increases, even if very limited in actual terms, depriving the condition 
effectively of any practical meaning. This is evident from the Commission 
Report on substantial change of circumstances itself, which purportedly shows 
percentage increases of over 999% for certain Member States, based on very low 
starting amounts in 2018.21 This is absurd and cannot have been the intention of 
the EU legislator. This part of the test for establishing a substantial change of 
circumstances is only meaningful if it is applied in relation to established 
 
20 Judgment of 30 January 2019, Planta Tabak-Manufaktur, C-220/17, EU:C:2019:76, paragraphs 61 to 67. 
21 Annex A.1, Table 1. 
10 
product categories. 
27. Finally, the Applicants would emphasise that their position as regards the 
Delegated Directive unlawfully derogating from an "essential element" is in line with 
the view expressed separately by four Member States during the scrutiny process for 
the Delegated Directive, which noted that the Delegated Directive: 
a. "has a deep impact on the discipline of heated tobacco products" introducing a 
"complex and comprehensive reform"; and 
b. "goes beyond the delegated power under Directive 2014/40/EU and involves 
essential elements reserved for the European legislators ".22 
28. The making of such a statement is highly unusual and reinforces the Applicants' 
position. 
The counter-arguments made in the proceedings before the referring Court cannot be 
accepted 
29. The main counter-arguments made in the proceedings before the referring Court in 
support of the validity of the Delegated Directive were as follows: 
a. "Novel tobacco products" fall within the TPD's definition of "tobacco products" 
in Article 2(4) as "products that can be consumed and consist even partly of 
tobacco". As the relevant provisions of Articles 7 and 11 refer to "tobacco 
products", the delegated powers afforded to the Commission would apply to all 
"tobacco products" including novel tobacco products such as heated tobacco 
products. The Commission should therefore be empowered to withdraw the 
exemptions from the prohibitions under Articles 7(12) and 11(6) in respect of 
any tobacco product where it falls within the definition of a "tobacco product" 
whether novel or not. 
b. Any other approach would leave the TPD and the Commission unable to 
respond to market developments and would allow for the unregulated 
introduction of flavoured novel tobacco products, contrary to the TPD's 
objective under Recital 8 of ensuring a "high level of health protection ". 
30. These counter-arguments do not withstand scrutiny and must be rejected. In 
particular: 
a. The counter-argument regarding the application of Articles 7(12) and 11(6) to 
all "tobacco products" is inconsistent with the wording, structure and logic of the 
TPD, its legislative history and the Court of Justice's judgments in Swedish 
Match and Planta Tabak, which indicate that "novel tobacco products" and the 
"particular product categories" are separate concepts covering different products. 
This position would furthermore require that the term "particular product 
category" used in Articles 7(12) and 11(6) has no specific meaning in this 
context and is general wording for any type of tobacco product which could then 
be defined more precisely by the Commission. If the intention of the EU 
legislator was that novel tobacco products should be covered, it would have used 
a different term in Articles 7(12) and 11(6) (as well as Article 2(28)), for 
 
22 Annex A.4, 'I/A' Item Note from General Secretariat of the Council: Joint Statement of Bulgaria, Cyprus, 
Greece and Italy, concerning the Commission Delegated Directive (EU) …/… amending Directive 2014/40/EU 
of the European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of 
heated tobacco products, 12560/22 ADD 1, 23 September 2022. 
11 
example "types of tobacco products", or it would have expressly included "novel 
tobacco products". In the absence of such wording, it is clear that the legislator's 
intention was that the delegated powers in Articles 7(12) and 11(6) are 
concerned with the differentiation that the TPD makes between categories of the 
established tobacco products (based on their relative popularity and use by 
specific groups of the population). They are not concerned with novel tobacco 
products. 
b. The Member States do not need the Commission to exercise a delegated power 
to save their public health policy from novel tobacco products. Member States 
decide this themselves based on Article 19 TPD. By adopting the Delegated 
Directive, the Commission trespasses upon an area reserved to the Member 
States and therefore exceeds the scope of its delegated powers in light of the 
established case-law.23 For the avoidance of doubt, the scope of the 
Commission's delegated powers also cannot be re-interpreted in light of later 
developments and expanded to encompass novel tobacco products. The case-law 
makes it clear that alleged factual developments since a delegated power was 
granted do not allow for a more flexible interpretation of that power and that if 
the Commission considers that there is a need to make changes, it should 
propose an amendment to the legislation granting the delegated power.24 
31. Another counter-argument made in the Respondents' written submissions in the 
proceedings before the referring Court is that there is a distinction between 
implementing and delegated powers, in that the latter involve more discretion, and as 
between delegated powers "to supplement" and delegated powers "to amend", in that 
the latter is more expansive. The powers conferred upon the Commission under 
Articles 7(12) and 11(6) are delegated powers "to amend", thereby, it is argued, 
conferring the greatest degree of discretion upon the Commission. This counter-
argument must also be rejected for the following reasons: 
a. What matters is not abstract considerations but the delegated or implementing 
power as described in the basic legislation granting that power. The powers that 
are delegated to the Commission under Articles 7(12) and 11(6) TPD are 
entirely prescriptive and limited. As the Commission itself stated in its 
Explanatory Memorandum to the Delegated Directive, these provisions do "not 
confer discretion on the Commission but leave it with the technical task of 
establishing whether there has been a substantial change of circumstances for a 
particular product category …".25 
b. The only relevant distinction for these purposes is rather between "non-essential 
elements" of the TPD, which are within the scope of the Commission's delegated 
powers, and "essential elements" of the TPD, which are not. The text of Article 
290 TFEU and the way in which the established case-law has consistently 
interpreted and applied the test of whether something is an "essential element" 
do not make a meaningful relevant distinction between delegated acts that amend 
 
23 Judgment of 16 March 2022, MEKH and FGSZ v ACER, Joined Cases T-684/19 and T-704/19, EU:T:2022:13 
8, paragraphs 100-141. 
24 Judgment of 16 December 2015, Sweden v Commission, T-521/14, EU:T:2015:976, paragraphs 60-62. 
25 Annex A.5, Commission Delegated Directive (EU) …/… OF 29.6.2022 amending Directive 2014/40/EU 
of the European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of 
heated tobacco products - Explanatory Memorandum, section 2. 
12 
and delegated acts that supplement. As the Court of Justice explained in a similar 
context in the Dyson judgment: "It follows that the question whether, as its 
wording appears to indicate, the regulation at issue seeks only to supplement 
and not to amend Directive 2010/30 is not relevant in the present case. As 
pointed out […] above, in any event neither of those two categories of delegated 
powers authorises the Commission to disregard an essential element of the 
enabling act."26 
3) By creating the new "particular product category" of a "heated tobacco 
product" the Delegated Directive unlawfully amends an "essential element" 
32. Even if it were in principle possible for the Commission to regulate a novel 
tobacco product using a delegated power (quod non), the Delegated Directive goes 
beyond the delegated powers as these do not empower the Commission to create and 
define a new "particular product category" of a "heated tobacco product". 
33. The delegated power under Article 7(12) and 11(6) TPD only permits the 
Commission to withdraw the exemptions provided for in Articles 7 and 11 in respect 
of the established product categories. It did not permit the Commission to create and 
define new products under Article 2 TPD. In an attempt to sidestep the absence of 
such power, the Delegated Directive impermissibly seeks to introduce a definition of 
"heated tobacco products" in Article 7(12) and refer back to that it in its amended 
version of Article 11(1). That amended version of Article 11(1) refers to "heated 
tobacco products as defined in Article 7(12), second subparagraph" (emphasis 
added). However, introducing a definition in Article 7(12) does not resolve the 
fundamental problem that there is no delegated power to create and define a new 
particular product category under Article 2 TPD. 
34. This interpretation is supported by the Commission's own report pursuant to 
Article 28 TPD from 20 May 2021.27 In this report, the Commission expresses the 
view that the definitions in the TPD should be amended and improved28 and that the 
TPD does not provide the "flexibility to define new product categories",29 with 
particular reference to heated tobacco products.30 This point was also made by four 
Member States during the scrutiny process for the Delegated Directive, which noted 
that: "In particular, the Commission, by introducing a definition of "heated tobacco 
products" in the [Delegated Directive] […], is according to us exceeding the limits of 
the delegation powers granted to it by the Directive 2014/40/EU"?31 
35. Furthermore, it would be illogical if the Commission were able to create new 
product categories to which it could then retrospectively apply historical data in order 
to establish a "substantial change of circumstances". This would also violate the 
principles of legal certainty and legitimate expectations which require that the 
application of rules "must be foreseeable by those subject to them".32 
 
26 Judgment of 11 May 2017, Dyson v Commission, C-44/16 P, EU:C:2017:357, paragraph 65. 
27 Annex A.6, Report from the Commission to the European Parliament, the Council, the European Economic 
and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning 
the manufacturer, presentation and sale of tobacco and related products, COM(2021) 249 final, 20.5.2021. 
28 Ibid., footnote 43. 
29 Ibid., page 12. See also, inter alia in relation to heated tobacco products the statement that the TPD "does not 
(…) provide flexibility to address rapid product developments" (page 12). 
30 Ibid. 
31 Annex A.4. 
32 Judgment of 10 September 2009, Plantanol, C-201/08, EU:C:2009:539, paragraph 46: "The principle of legal 
13 
36. This retroactive application would also allow the Commission to take into account 
the historical data when tailoring the definition of a new product category to ensure 
that the test of a "substantial change of circumstances" is satisfied. Put differently, by 
defining a new product category broader or narrower in light of historical data, the 
Commission could indirectly control whether the substantial change of circumstances 
occurred, which could not have been what the EU legislator intended. Indeed, the 
Commission seems to have done so in this instance by creating a new product 
category comprising of both products for smoking and smokeless products. This has 
enabled the Commission to create and regulate a new type of product, namely heated 
tobacco for smoking that, to the Applicants' knowledge, does not exist on the EU 
market and certainly not in volumes that would meet the threshold of "substantial 
change of circumstances". 
37. In addition, the new "particular product category" created by the Commission and 
its definition of "heated tobacco product" is inconsistent with the system of the TPD 
for the following two reasons. 
38. First, the new category of "heated tobacco product" is simultaneously both a novel 
tobacco product, as well as a "particular product category" for the purposes of the 
TPD. This is not possible, since, as explained above, the "particular product 
categories" and novel tobacco products are mutually exclusive groups, and the same 
product category cannot be part of both groups. The Commission could not have been 
empowered to collapse the distinction drawn by the legislature between the defined 
concept of a novel tobacco product and particular product categories identified in the 
TPD. 
39. Second, the new category of "heated tobacco product" is defined as comprising 
both tobacco products that are "smokeless" as well as tobacco products that are "for 
smoking". The TPD clearly distinguishes between smokeless tobacco products and 
tobacco products for smoking and sets very different and more onerous labelling and 
packaging rules for the latter, reflecting their fundamentally different nature. The 
TPD further provides for novel tobacco products to fall within one category or the 
other, explaining at Article 19(4) that: "Which of the provisions of this Directive apply 
to novel tobacco products depends on whether those products fall under the definition 
of a smokeless tobacco product or of a tobacco product for smoking" – the difference 
between them therefore being predicated on the existence or not of "combustion". 
40. It is therefore not legally possible under the TPD for a single product category for 
the purposes of the TPD to comprise both smokeless tobacco products and tobacco 
products for smoking, and by creating such a product category, the Commission 
exceeded its delegated powers. 
 
certainty, the corollary of which is the principle of the protection of legitimate expectations, requires, on the one 
hand, that rules of law must be clear and precise and, on the other, that their application must be foreseeable by 
those subject to them […]. That requirement must be observed all the more strictly in the case of rules liable to 
entail financial consequences, in order that those concerned may know precisely the extent of the obligations 
which those rules impose on them […]." 
14 
B. Question 2: Invalidity of the Delegated Directive on the basis of no "substantial 
change of circumstances" 
1) The flawed calculations in the Commission Report of June 2022 exclusively 
focus on an inappropriate "stick based" analysis and ignore tobacco weight 
41. Articles 7(12) TPD and 11(6) TPD permit the Commission to adopt delegated acts 
to withdraw the exemptions for an existing "particular product category" if there is a 
"substantial change of circumstances", as defined in Article 2(28) TPD. 
42. The Commission purportedly established the required "substantial change of 
circumstances" in relation to heated tobacco products in the Commission Report of 
June 2022. In particular, the Commission Report claims that the sales volume for 
heated tobacco products at retail level exceeded 2.5% of total sales of all tobacco 
products at EU level, a necessary condition under Article 2(28) TPD for there to be a 
"substantial change of circumstances".33 
43. The Commission Report assesses the criterion of 2.5% market share for heated 
tobacco products on a "stick basis". This is a fundamentally flawed approach as sticks 
are an unsuitable basis for comparison between the various tobacco products sold 
within the EU. In particular, and fundamentally for the purposes of the Commission's 
calculation, a cigarette stick contains approximately double the amount of tobacco in 
a heated tobacco stick. The Commission's approach in using stick data was therefore 
not justified as it amounts to comparing apples with oranges. 
44. This is further supported by a report prepared by Professor […] and Professor […], 
experts in statistical methods and regulatory analysis, enclosed with these 
observations (the "[…] and […] Report" 34 ), which explains that the Commission's 
approach, "engages in misleading and incorrect mathematical practices by attempting 
to simply add up dissimilar things in coming up with volume measures".35 
45. Instead, the Commission should have assessed the market share criterion on a 
"tobacco weight basis". This is the only metric that allows comparing the sales 
volumes of different types of products including cigarettes, cigars, cigarillos, roll-
your-own, heated tobacco products, etc. on a like for like basis and is therefore the 
only appropriate criterion. Using weight as the regulatory unit also corresponds with 
how EU law conceives of non-cigarette tobacco products for tax purposes under 
Council Directive 2011/64/EU, the Tobacco Excise Directive.36 Using weight as the 
market share criterion is also in line with the objective of TPD, the Delegated 
Directive and the Tobacco Excise Directive, namely to reduce consumption of 
tobacco. 
46. A "tobacco weight basis" would have also allowed for considerable simplification 
of the Commission's analysis. In particular, owing to its use of a "stick basis", the 
Commission was required to engage in a series of complex and ultimately 
questionable data adjustments and calculations in order to convert the data for roll-
 
33 According to Article 2(28) TPD, "in any case, a substantial change of circumstances is deemed not to have 
occurred if the sales volume of the product category at retail level does not exceed 2,5 % of total sales of 
tobacco products at Union level". 
34Annex A.7, Report of Professor […] and Professor […], Analysis of the establishment of a substantial change 
of circumstances for heated tobacco products in line with Article 2(28) of Directive 2014/40/EU, 12 June 2023 
35 Ibid., at page 6. 
36 Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to 
manufactured tobacco, OJ 176/24, 5.7.2011, Article 14(2). 
15 
your-own tobacco and pipe and chewing tobacco into "stick" equivalents for 
comparison with the other product categories: 
a. Roll-your-own tobacco was converted into "sticks" based on the assumption that 
0.7 grams of the product is equal to one cigarette stick, which was not supported 
by any evidence. 37 
b. Pipe and chewing tobacco were converted into "sticks" by taking the market 
share of this product category by retail value and applying this to the overall 
market size in sticks.38 This approach was not justified in any way and was 
seemingly based on the arbitrary assumption that the sales volume of pipe 
tobacco and chewing tobacco are proportionately equivalent to their sales value. 
47. The Commission Report further relies on non-official commercial data in making 
this stick-based calculation, namely, the Euromonitor dataset. As explained in the 
[…] and […] Report,39 this is flawed because, as may be expected from a 
commercial data provider, Euromonitor does not fully document its methodology,40 
meaning that the data cannot be properly reproduced and interrogated. The use of 
such commercial datasets is unsuitable in a quasi-legislative context as here for 
determining the competence of the Commission to change EU legislation. In 
addition, the Euromonitor dataset does not include data for Luxembourg, Malta and 
Cyprus41 and therefore does not even provide complete data for the EU. 
48. The Commission Report then combines this data with two other datasets, in a 
number of different and complex ways.42 In devising and relying on this flawed and 
complex methodology, the Commission exceeds the scope of the task conferred upon 
it under Articles 7(12) and 11(6) TPD, which as the Commission itself explains in its 
Explanatory Memorandum to the Delegated Directive, "do not confer discretion on 
the Commission but leave it with the technical task of establishing whether there has 
been a substantial change of circumstances for a particular product category".43 
What the Commission has actually done goes far beyond a technical calculation that 
did not involve discretion (as it should have been). Rather the Commission has 
devised a complex methodology involving incorrect choices that apparently lead to 
the desired result of exceeding the 2.5% threshold. 
49. A calculation based on tobacco weight would have avoided such complexities and 
the use of problematic datasets described above. Accurate tobacco weight-based data 
would have been readily available to the Commission for all product categories in the 
form of the data submitted pursuant to Article 5(6) TPD and Commission 
Implementing Decision (EU) 2015/2186544 (referred to in the Commission Report as 
 
37 Annex A.1, Commission Report, Table 3 asterisk and footnote 3. 
38 Ibid., Table 3 double asterisk and Table 5 asterisk. 
39 Annex A.7, […] and […] Report, pages 11-12. 
40 Given that Euromonitor's commercial incentive is to avoid replicability of its dataset. 
41 As noted in the Commission Report itself, at page 1. 
42 In particular, the Commission Report uses EU-CEG data and Euromonitor data for EU heated tobacco 
products sales (Commission Report, Table 2); Euromonitor data for total EU tobacco products sales, divided by 
product categories (Commission Report, Tables 3 and 5); except for cigarettes and roll-your own tobacco 
products, for which the Commission Report uses traceability production figures, time- adjusted production 
figures for cigarettes and non-time adjusted production figures for roll-your-own (Commission Report, Tables 4 
and 5). 
43 Annex A.5, Delegated Directive, Explanatory Memorandum, section 2. 
44 Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the 
submission and making available of information on tobacco products, OJ L 312/5, 27.11.2015. 
16 
the "EU-CEG" data). This dataset contains data on the number of sticks sold and the 
weight of tobacco in one such stick,45 which would have enabled the Commission to 
make a straightforward weight-based calculation. 
50. Had the Commission assessed the market share criterion on a "tobacco weight 
basis", the 2.5% threshold would not have been met. Cigarettes represent the great 
majority of the tobacco products market46 and a cigarette contains roughly double the 
amount of tobacco of a heated tobacco stick. Therefore, as a matter of simple and 
straightforward mathematics, the market share of heated tobacco products measured 
by weight will be close to half the market share measured by stick. This implies it 
will not be 3.33% as assessed in the Commission Report, but approximately 1.66%, 
which is well below 2.5%.47 
51. In any event, and by analogy to other areas of EU law, the Commission was bound 
to consider this weight data and take it into account in its assessment in order to be 
able to establish with sufficient certainty that the 2.5% market share threshold was 
met. In particular, in the competition law sphere, the EU Courts have repeatedly held, 
even in the case where complex assessment has been made by the Commission, that 
it must be ascertained, not only that "the evidence relied on is factually accurate, 
reliable and consistent" but also "whether that evidence contains all the information 
which must be taken into account".48 Indeed, Commission decisions have been 
annulled on account of the Commission's failure to properly assess and take account 
of all the economic evidence available to it. 49 
52. As an absolute minimum the Commission Report should have flagged that a 
weight-based analysis would have resulted in a different outcome, also taking into 
account (i) that a 50% lower tobacco content (and consumption) is important in its 
own right; and (ii) the reduced risk profile of heated tobacco products relative to 
cigarettes. These are important considerations that the Member States and the 
European Parliament should have been made aware of. The Commission Report, 
however, does not even mention the tobacco weight-based data, let alone justify why 
proceeding on the basis of stick-based data as opposed to tobacco weight data was 
nonetheless appropriate in the circumstances. For this reason, the Delegated 
Directive, which relies on the Commission Report, must also be considered as being 
inconsistent with the obligation to state reasons under Article 296 TFEU50 and the 
Commission also infringes the principle of good administration. 
 
45 Among the information that must be provided under the EU-CEG system, is the "total weight of the tobacco in 
one product unit in mg" (a product unit is a stick or 1g for loose tobacco) – see Commission Implementing 
Decision (EU) 2015/2186, Annex, Section 3. 
46 See Annex A.1, the Commission Report, Table 5. 
47 See further in this regard, Annex A.7, […] and […] Report, at page 11, which based on the information 
available, calculates the market share as being much less than the required 2.5% market share threshold. 
48 Judgment of 26 March 2019, Commission v Italy, C-621/16 P, EU:C:2019:251, paragraph 104; judgment of 6 
November 2012, Otis and Others, C-199/11, EU:C:2012:684, paragraph 59; judgment of 15 February 2005, 
Commission v Tetra Laval, C-12/03 P, EU:C:2005:87, paragraph 39. 
49 See e.g., judgment of 26 January 2022, Intel v Commission, T-286/09 RENV, ECLI:EU:T:2022:19. 
50 The obligation to provide a statement of reasons for a legal act under Article 296 TFEU is "an essential 
procedural requirement" and "must disclose in a clear and unequivocal fashion the reasoning followed by the 
institution which adopted that measure in such a way as to enable the persons concerned to ascertain the 
reasons for it and to enable the competent European Union judicature to exercise its power of review" – see 
Judgment of 2 September 2021, EPSU v Commission, C-928/19 P, EU:C:2021:656, paragraph 108; judgment of 
14 October 2010, Deutsche Telekom v Commission, C 280/08 P, EU:C:2010:603, paragraph 130. 
17 
The counter-arguments made in the proceedings before the referring Court must be 
rejected 
53. The main counter-arguments made in the proceedings before the referring Court in 
support of the validity of the Commission's approach in purportedly establishing the 
required "substantial change of circumstances" were that: (i) Article 2(28) TPD does 
not specify the method by which sales volumes are to be assessed; and (ii) Article 
5(6) TPD and Commission Implementing Decision (EU) 2015/21865 do envisage 
sales data to be submitted on a "stick basis". 
54. While it is true that Article 2(28) TPD does not specify any particular data or 
metric for the Commission to use in assessing the market share criterion, it must be 
the case that the Commission is required to choose the approach that best allows for a 
fair and proper comparison taking into account the particular circumstances of the 
case. 
55. In that regard, it is clear that the Commission had access to tobacco weight data, in 
addition to stick data, and that a tobacco-weight approach would have been 
manifestly more appropriate for the reasons explained above. 
2) Additional flaws in the Commission Report and its methodology 
56. The Commission's calculation is also clearly erroneous on its own terms as it does 
not even take into account all of the established tobacco product categories 
enumerated in Article 2(14) TPD. It ignores waterpipe tobacco, nasal tobacco and 
tobacco for oral use when calculating the total market for tobacco products in the 
EU.51 Waterpipe tobacco, in particular, is widely sold and consumed across the EU. 
This means that the Commission's market share for heated tobacco products is over-
inflated and may not be above the 2.5% threshold even when calculated on a stick 
basis as done in the Commission Report. 
57. Furthermore, in terms of the Commission Report's alternative calculation based on 
data on tobacco products sales by value (see paragraph 4(e)(ii) above), this must be 
disregarded, as such an approach is contrary to Article 2(28) TPD itself, which 
requires the calculation to be made with reference to sales volume, not sales value. 
Therefore, any attempt to justify the Delegated Directive with reference to this 
calculation would be contrary to the delegated powers conferred. 
PART III: MEASURES OF ORGANISATION OF PROCEDURE / INQUIRY 
58. In connection with Question 2 of the referring Court, the Applicants respectfully 
suggest that the Court of Justice order measures of organisation of procedure or 
measures of inquiry, as the Court sees fit, pursuant to Articles 61-62 and 64 of the 
Rules of Procedure and Article 24 of the Statute of the Court of Justice, to require the 
European Commission to produce information in relation to: (i) the market share of 
heated tobacco products by tobacco weight; and (ii) its existing "stick based" analysis 
relied upon in the Commission Report, as further specified at paragraph 70 below. 
59. The Applicants are requesting that the Court order production of the specified 
information as it is highly pertinent to whether the Commission was entitled to 
conclude that there was a "substantial change of circumstances", as raised by 
 
51 See Annex A.l, Commission Report, Table 5, which only takes into account cigarettes, roll-your-own, cigars, 
cigarillos, pipe and chewing tobacco, and heated tobacco products, but not the product categories mentioned 
above. 
18 
Question 2 of the referring Court. 
A. Request for information in relation to market share by tobacco weight 
60. As explained above, the Applicants consider that the Commission should have 
assessed the market share criterion on a "tobacco weight basis". The Applicants 
submit that had the Commission adopted this correct approach, the 2.5% threshold 
would not have been met, as the market share would have been close to half of the 
market share assessed on a "stick" basis and therefore close to half of the 3.33% 
averred in the Commission Report. 
61. The Applicants are now requesting that the Court of Justice require the 
Commission to produce information in relation to the market share for heated 
tobacco products on a "tobacco weight" basis, specifically, the calculation of the 
market share itself, as well as the underlying weight-based data used to make this 
calculation. This will enable the Court to confirm definitively that the 2.5% market 
share threshold would not have been satisfied, and consequently, that the Delegated 
Directive must be invalid. The adoption of measures of organisation of procedure or 
measures of inquiry to require the production of such information would therefore be 
appropriate in light of Article 24 of the Statute of the Court of Justice.52 
B. Request for information in relation to the Commission's existing "stick based" 
analysis 
62. The Applicants are also requesting that the Court of Justice direct the Commission 
to produce further information in relation to the Commission Report on substantial 
change of circumstances and their analysis on a "stick basis" relied upon in that 
report, specifically, documents pertaining to the preparation of this analysis, 
including intermediary documents such as data / calculation spreadsheets, draft 
analysis, reports, studies, emails, and meeting notes / minutes, as well as the 
underlying data. 
63. This information will enable the Court to assess properly the analysis relied upon 
in the Commission Report. Without access to the data used by the Commission and 
the relevant intermediary documents, the Commission's analysis cannot be 
reproduced and there is no way of assessing whether the Commission's calculations 
were accurately carried out. The Commission's calculations would, in effect, benefit 
from an irrebuttable presumption of validity and possible defects would go 
undetected, with the result that a potentially unlawful measure is allowed to continue 
to produce effects in the EU's legal order. 
64. The Applicants submit that the adoption of measures of organisation of procedure 
or measures of inquiry to require the production of such information would therefore 
also be appropriate in light of Article 24 of the Statute of the Court of Justice. 
C. Previous requests pursuant to Regulation (EC) No 1049/2001 
65. The Applicants and their legal representatives had previously requested such 
abovementioned information from the Commission in 2022 pursuant to Regulation 
(EC) No 1049/2001.53 However, these requests were unjustifiably refused by the 
 
52 Article 24 of the Statute states that: the Court may require the parties to produce all documents and to supply 
all information which the Court considers desirable; and the Court may also require the Member States and 
institutions, bodies, offices and agencies not being parties to the case to supply all information which the Court 
considers necessary for the proceedings. 
53 Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission 
19 
Commission54 thereby shielding its calculations from any possible scrutiny. 
66. In essence, the Commission claimed that no other documents pertaining to the 
preparation of the Commission's analysis existed, beyond the final analysis itself, 
which the Applicants submit is simply not possible, given the necessary 
methodological choices and intermediate steps that would have had to be taken in 
order to develop the analysis, which would necessarily have generated further 
documents. This is supported by a further statement by Professor […], enclosed with 
these observations, which concludes that it is not credible that the Commission is not 
in possession of any further documents.55 In terms of the sales data requested, the 
Commission claimed that such data was allegedly not subject to the Regulation 
despite being within the Commission's possession, and that the provision of such data 
would amount to the "creation of a new document", even though some of the same 
data would have been used by the Commission itself in making its calculations. 
67. These grounds are being challenged in separate proceedings by the Applicants and 
their legal representatives on appeal.56 But the Applicants' position is that the 
Commission's unjustified refusal to provide access to the information requested 
undermines the credibility of the Commission's analysis, reinforcing the 
appropriateness of the requested measures of organisation of procedure or measures 
of inquiry. 
68. The Applicants' position is that it cannot be the case that the Commission is the 
sole arbiter of the existence of conditions determining its own rule-making 
competence and that it can shield itself from judicial review by refusing to disclose 
the data and calculations on which that rule-making competence is based. Such a 
position would be incompatible with the rule of law and the principle of good 
administration and cannot be sustained. 
69. In any event, the Court's powers to require the production of evidence in these 
proceedings are wider than the right to access to documents under Regulation 
1049/2001. 57 
D. Information to be produced 
70. In light of the above, the Applicants respectfully suggest that the Court adopt 
measures of organisation of procedure or measures of inquiry, as the Court sees fit, to 
request the Commission to produce the following information: 
 
documents, OJ L 145/43. 
54 Annex A.8, Decision of the European Commission Pursuant to Article 4 of the Implementing Rules to 
Regulation (EC) No 1049/2001, Brussels, 3.7.2022 C(2022) 4816 final; Annex A.9, Decision of the European 
Commission pursuant to Article 4 of the Implementing Rules to Regulation (EC) No 1049/2011, Brussels, 
4.8.2023 C(2023) 5453 final. These decisions are currently subject to appeal in Case T-570/22 Herbert Smith 
Freehills v Commission and Case-T-311/23 British American Tobacco Polska Trading v Commission. 
55 Annex A.10, Statement of Professor […] of 7 September 2022. This document was prepared in connection 
with the action for annulment brought by the Applicant's legal representatives, Herbert Smith Freehills, against 
the Commission's above refusal decision of 3 July 2022, Case T-570/22 Herbert Smith Freehills v Commission. 
The Applicants have sought and obtained permission from Herbert Smith Freehills to reproduce this document in 
the present proceedings. 
56 Case T-570/22 Herbert Smith Freehills v Commission and Case-T-311/23 British American Tobacco Polska 
Trading v Commission. If the Court were to order the Commission to produce the requested information in the 
context of the present proceedings, the Applicants would consider arranging for these appeals to be discontinued, 
in the interest of procedural economy. 
57 See to this effect, judgment of of 12 July 2022, Nord Stream 2 v Parliament and Council, C-348/20 P, 
EU:C:2022:548, paragraphs 133-134. 
20 
a. The 2020 EU market share for heated tobacco products on a "tobacco weight" 
basis, using the tobacco weight and sales volumes data submitted pursuant to 
Article 5(6) TPD and Commission Implementing Decision (EU) 2015/2186; 
b. The underlying data used by the Commission in making this calculation; and 
c. All documents pertaining to the preparation of the analysis relied upon in the 
Commission Report on substantial change of circumstances, including (but not 
limited to) the intermediary documents such as data / calculation spreadsheets, 
draft analysis, reports, studies, emails, and meeting notes / minutes, as well as 
the underlying data. 
PART IV: FORM OF ORDER SOUGHT 
71. For the reasons set out above, the Applicants respectfully request that the Court of 
Justice: 
a. Responds to the first question that the Delegated Directive is invalid because 
the delegated powers of Article 7(12) and 11(6) cannot be used for novel 
tobacco products and cannot be used to define a new particular product 
category, nor in any event, one that is defined inconsistently with the system of 
the TPD. 
b. Responds to the second question that the Delegated Directive is invalid 
because the Commission incorrectly concluded that there was a substantial 
change of circumstances within the meaning of Article 7(12), 11(6) and 2(28) 
TPD. 
Lode Van Den Hende, Advocaat Morris Schonberg, Advocaat 
Katie O'Connor, Solicitor 
21 
SCHEDULE OF ANNEXES 
Annex 
no. 
Document, date, author, and address (where applicable) No of 
pages58 
Page no of 
first page 
Page no of 
last page 
Page and reference in 
the Observations 
A.1 
Report from the Commission on the establishment of a 
substantial change of circumstances for heated tobacco products 
in line with Directive 2014/40/EU, 15.6.2022, COM(2022) 279 
final. 
7 1 8 Page 4, paragraph 4(e), 
footnote 7. 
A.2 
Delegated acts – Guidelines for the services of the Commission, 
24 June 2011, SEC(2011) 588. 
39 9 48 
Page 8, paragraph 11, 
footnote 15. 
A.3 
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, COM(2012)788 final, 19.12.2012, Explanatory 
Memorandum 
13 49 62 Page 10, paragraph 18, 
footnote 16. 
 
58 Excluding Annex cover page. 
22 
 
Annex 
no. 
Document, date, author, and address (where applicable) No of 
pages58 
Page no of 
first page 
Page no of 
last page 
Page and reference in 
the Observations 
A.4 'I/A' Item Note from General Secretariat of the Council: Joint 
Statement of Bulgaria, Cyprus, Greece and Italy, concerning the 
Commission Delegated Directive (EU) …/… amending Directive 
2014/40/EU of the European Parliament and of the Council as 
regards the withdrawal of certain exemptions in respect of heated 
tobacco products, 12560/22 ADD 1, 23 September 2022. 
2 63 65 Page 13, paragraph 
27(b), footnote 22. 
A.5 
Commission Delegated Directive (EU) …/… OF 29.6.2022 
amending Directive 2014/40/EU of the European Parliament and 
of the Council as regards the withdrawal of certain exemptions in 
respect of heated tobacco products – Explanatory Memorandum. 
3 66 69 Page 16, paragraph 
31.a, footnote 25. 
A.6 
Report from the Commission to the European Parliament, the 
Council, the European Economic and Social Committee and the 
Committee of the Regions on the application of Directive 
2014/40/EU concerning the manufacturer, presentation and sale 
of tobacco and related products, COM(2021) 249 final, 
20.5.2021. 
18 70 88 Page 17, paragraph 34, 
footnote 27. 
23 
 
Annex 
no. 
Document, date, author, and address (where applicable) No of 
pages58 
Page no of 
first page 
Page no of 
last page 
Page and reference in 
the Observations 
A.7 
Report of Professor […] and Professor […], Analysis of the 
establishment of a substantial change of circumstances for heated 
tobacco products in line with Article 2(28) of Directive 
2014/40/EU, 12 June 2023 
31 89 120 Page 19, paragraph 44, 
footnote 34. 
A.8 
Decision of the European Commission Pursuant to Article 4 of 
the Implementing Rules to Regulation (EC) No 1049/2001, 
Brussels, 3.7.2022 C(2022) 4816 final 
13 121 134 Page 26, paragraph 65, 
footnote 54. 
A.9 
Decision of the European Commission pursuant to Article 4 of 
the Implementing Rules to Regulation (EC) No 1049/2011, 
Brussels, 4.8.2023 C(2023) 5453 final. 
8 135 143 Page 26, paragraph 65, 
footnote 54. 
A.10 Statement of Professor […] of 7 September 2022. 12 144 156 
Page 26, paragraph 66, 
footnote 55.