Opinion of the Advocate General — ECLI:EU:C:2021:618
Date: 2021-07-15
Language of the case: Dutch
Subject matter: Right of establishment;Approximation of laws;Freedom to provide services
Procedure: Reference for a preliminary ruling
Origin: Netherlands

Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
24 March 2020 
Referring court: 
Rechtbank Rotterdam (Netherlands) 
Date of the decision to refer: 
20 March 2020 
Applicants: 
Stichting Rookpreventie Jeugd 
Stichting Inspire2Live 
Rode Kruis Ziekenhuis BV 
Stichting ClaudicatioNet 
Nederlandse Vereniging voor Kindergeneeskunde 
Nederlandse Vereniging voor Verzekeringsgeneeskunde 
Accare, Stichting Universitaire en Algemene Kinder- en 
Jeugdpsychiatrie Noord-Nederland 
Vereniging Praktijkhoudende Huisartsen 
Nederlandse Vereniging van Artsen voor Longziekten en 
Tuberculose 
Nederlandse Federatie van Kankerpatiëntenorganisaties 
Nederlandse Vereniging Arbeids- en Bedrijfsgeneeskunde 
Nederlandse Vereniging voor Cardiologie 
Koepel van Artsen Maatschappij en Gezondheid 
Nederlandse Vereniging voor Kindergeneeskunde 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-160/20 
 
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Koninklijke Nederlandse Maatschappij tot bevordering der 
Tandheelkunde 
College van burgemeester en wethouders van Amsterdam 
Defendant: 
Staatssecretaris van Volksgezondheid, Welzijn en Sport 
  
Subject of the action in the main proceedings 
The main proceedings arise from a request to the Netherlands Voedsel- en 
Warenautoriteit (Food and Consumer Product Safety Authority; ‘the NVWA’) to 
take enforcement action, more particularly by withdrawing from the market filter 
cigarettes which do not comply with the maximum emission levels for tar, 
nicotine and carbon monoxide. 
Subject and legal basis of the request for a preliminary ruling  
The request for a preliminary ruling concerns the interpretation and the validity of 
Article 4 of Directive 2014/40/EU of the European Parliament and of the Council 
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 2014 
L 127, p. 1). Also at issue is the interpretation of Article 24(3) of Directive 
2014/40/EU. 
The request for a preliminary ruling was made pursuant to Article 19(3)(b) TEU 
and Article 267 TFEU. 
Questions referred 
Question 1: Is the form of the measurement method provided for in Article 4(1) of 
Directive 2014/14/EU, based on ISO standards which are not freely accessible, in 
accordance with Article 297(1) TFEU (and Regulation (EU) No 216/2013) and 
with the underlying principle of transparency?  
Question 2: Must the ISO standards 4387, 10315, 8454 and 8243 referred to by 
Article 4(1) of Directive 2014/14/EU be interpreted and applied in such a way 
that, in the interpretation and application of Article 4(1) of that directive, 
emissions of tar, nicotine and carbon monoxide should not be measured (and 
verified) only by the prescribed method, but that those emissions may or must also 
be measured (and verified) in a different manner and with a different intensity?  
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Question 3(a): Is Article 4(1) of Directive 2014/14/EU contrary to the underlying 
principles of that directive and to Article 4(2) thereof as well as to Article 5(3) of 
the WHO Framework Convention on Tobacco Control, given that the tobacco 
industry played a role in determining the ISO standards referred to in Article 4(1) 
of that directive?  
Question 3(b): Is Article 4(1) of Directive 2014/14/EU contrary to the underlying 
principles of that directive, to Article 114(3) TFEU, to the spirit of the WHO 
Framework Convention on Tobacco Control and to Articles 24 and 35 of the 
Charter, in so far as the measurement method prescribed therein does not measure 
the emissions from filter cigarettes during their intended use since, with that 
method, no account is taken of the effect of the ventilation holes in the filter which 
are largely closed off during their intended use by the smoker’s lips and fingers? 
Question 4(a): Which alternative measurement method (and verification method) 
may or must be used should the Court of Justice: 
- answer question 1 in the negative? 
- answer question 2 in the affirmative? 
- answer question 3(a) and/or question 3(b) in the affirmative? 
Question 4(b) (If the Court is unable to give an answer to question 4(a)): Does the 
temporary unavailability of a measurement method give rise to a situation such as 
that referred to in Article 24(3) of Directive 2014/14/EU?  
Provisions of EU law cited 
Treaty on European Union: Article 19(3)(b). 
Treaty on the Functioning of the European Union: Article 114(3); Article 267, and 
Article 297(1). 
Charter of Fundamental Rights of the European Union: Articles 24 and 35.  
Council Regulation (EU) No 216/2013 of 7 March 2013 on the electronic 
publication of the Official Journal of the European Union (OJ 2013 L 69, p. 1). 
Directive 2014/40/EU of the European Parliament and of the Council 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 2014 L 127, 
p. 1): recitals 8 and 59; Articles 1, 3, 4 and 24(3). 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-160/20 
 
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Provisions of national law cited 
Netherlands Grondwet (Constitution): Article 22(1). 
Wet van 10 maart 1988, houdende maatregelen ter beperking van het 
tabaksgebruik, in het bijzonder ter bescherming van de niet-roker (Law of 
10 March 1988 laying down measures to limit tobacco use, in particular, to protect 
the non-smoker) (Staatsblad 1988, 342; Tabaks- en rookwarenwet): Article 2(1); 
Article 3(1); Article 14, and Article 17a(1), (2) and (4). 
Besluit van 14 oktober 2015, houdende samenvoeging van de algemene 
maatregelen van bestuur op basis van de Tabakswet tot één besluit (Decree of 
14 October 2015, combining the general administrative measures based on the 
Tobacco Act into a single decree) (Staatsblad 2015, 398; Tabaks- en 
rookwarenbesluit): Article 2.1. 
Regeling van de Staatssecretaris van Volksgezondheid, Welzijn en Sport van 10 
mei 2016, kenmerk 966398-150196-WJZ, houdende regels inzake de productie, 
de presentatie en de verkoop van tabaksproducten en aanverwante producten 
(Regulation of the State Secretary for Health, Welfare and Sport of 10 May 2016, 
No 966398-150196-WJZ, laying down rules on the production, presentation and 
sale of tobacco products and related products) (Staatscourant 2016, 25446; 
Tabaks- en rookwarenregeling): Article 2.1. 
Brief summary of the facts and the procedure in the main proceedings 
1 By letters of 31 July and 2 August 2018, the applicants in the main proceedings 
requested the NVWA to ensure that filter cigarettes offered for sale to consumers 
in the Netherlands comply during their intended use with the maximum emission 
levels for tar, nicotine and carbon monoxide pursuant to Article 3 of Directive 
2014/40/EU. In addition, the NVWA was requested to take enforcement action by 
withdrawing from the market filter cigarettes which do not comply with the 
maximum emission levels for tar, nicotine and carbon monoxide.  
2 The enforcement request was based on a study by the Rijksinstituut voor 
Volksgezondheid en Milieu (National Institute for Public Health and the 
Environment) of 13 June 2018, from which it follows that, using the ‘Canadian 
Intense’ measurement method, all filter cigarettes sold in the Netherlands 
significantly exceed the maximum emission levels for tar, nicotine and carbon 
monoxide laid down in Article 3(1) of Directive 2014/40/EU.  
3 By a decision of 20 September 2018, the NVWA rejected the enforcement request 
of the Stichting Rookpreventie Jeugd (Youth Smoking Prevention Foundation). 
4 By a decision of 31 January 2019 (‘the contested decision’), the Staatssecretaris 
van Volksgezondheid, Welzijn en Sport (‘the defendant’) declared the objection 
STICHTING ROOKPREVENTIE JEUGD AND OTHERS 
 
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lodged by the Stichting Rookpreventie Jeugd unfounded and the objection lodged 
by the other applicants inadmissible. 
5 The applicants lodged an appeal against the contested decision before the 
Rechtbank Rotterdam (District Court, Rotterdam). 
Main submissions of the parties to the main proceedings  
6 The applicants contend that the ‘Canadian Intense’ measurement method must be 
used when the emissions of tar, nicotine and carbon monoxide from filter 
cigarettes because that method, unlike the measurement method provided for in 
Article 4 of Directive 2014/40/EU, measures emissions from filter cigarettes 
during their intended use.  
7 The applicants note in that regard that tobacco producers make small holes in 
cigarette filters and that clean air is drawn through the filter via those holes (so-
called filter ventilation). As a result, tar, nicotine and carbon monoxide levels are 
diluted. During intended use, however, those holes are largely closed by the 
smoker’s fingers and lips meaning that he or she inhales significantly higher levels 
of tar, nicotine and carbon monoxide than the maximum emission levels laid 
down in Article 3 of Directive 2014/40/EU. According to the applicants, the 
measuring method provided for in Article 4 of that directive does not take that into 
account and therefore does not measure the levels released during the intended 
use. The filter cigarettes sold in the Netherlands are therefore even more harmful 
to health and even more addictive than smokers might assume on the basis of the 
aforementioned directive.  
8 The defendant rejected the request by a decision of 20 September 2018. In its 
view, Article 4 of Directive 2014/40/EU leaves no scope for the use of a 
measurement method other than the method prescribed therein, and, when that 
measurement method is used, the filter cigarettes sold in the Netherlands comply 
with the maximum emission levels of Article 3 of that directive.  
Brief summary of the reasons for the referral 
9 Questions have arisen for the referring court as to the interpretation and validity of 
Article 4 of Directive 2014/40/EU.  
10 Article 4(1) of that directive provides that the tar, nicotine and carbon monoxide 
emissions from cigarettes are to be measured on the basis of ISO standard 4387 
for tar, ISO standard 10315 for nicotine, and ISO standard 8454 for carbon 
monoxide, and that the accuracy of the tar, nicotine and carbon monoxide 
measurements is to be determined in accordance with ISO standard 8243. 
11 According to Article 4(2) of that directive, the measurements referred to in 
paragraph 1 thereof are to be verified by laboratories which are approved and 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-160/20 
 
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monitored by the competent authorities of the Member States. Those laboratories 
are not to be owned or controlled directly or indirectly by the tobacco industry.  
First question 
12 The referring court notes that the measurement method provided for in Article 4 
of Directive 2014/40/EU is based on ISO standards. Those ISO standards are not 
publicly accessible, and can be consulted only for a fee. The question which then 
arises is whether such a method of regulation is in accordance with the publication 
regime applicable to EU legislation, i.e. publication in the Official Journal of the 
European Union in accordance with Article 297(1) TFEU (and Regulation 
No 216/2013), and with the principle of transparency.  
Second question 
13 Furthermore, the referring court states that it is not clear whether the measurement 
method laid down in Article 4 of Directive 2014/40/EU is the only measurement 
method permitted.  
14 In that regard, it notes that ISO standard 3308, referred to by each of the ISO 
standards cited in Article 4 of the directive, itself recommends that emissions also 
be measured using machines which measure a different smoke intensity than that 
set out in those standards.  
15 If it were to follow from the ISO standards declared applicable in Article 4 of the 
directive themselves that the emission levels of tar, nicotine and carbon monoxide 
should not be measured (and verified) on the basis of the prescribed method alone, 
but that those emissions may or must also be measured (and verified) in a different 
manner and at a different intensity, then, in the view of the referring court, the 
consequence of that could be that Article 4(1) of Directive 2014/40/EU must be 
applied in such a way that, in order to determine whether the cigarettes placed on 
the market are in conformity with the permitted maximum emission levels, it is 
not sufficient to measure (and verify) by means of the smoking machine as 
referred to in the ISO standards, or that the result of that measurement is in any 
event inconclusive.  
Third question 
16 The referring court also notes that, should the second question be answered in the 
negative, a third question must be referred to the Court of Justice for a preliminary 
ruling. By that question, it seeks to ascertain whether the measurement method 
provided for in Article 4 of the directive is consistent with the purpose and intent 
of Directive 2014/40/EU as well as with higher legal standards. 
17 The referring court states that the measurement methods provided for in 
Article 4(1) of Directive 2014/40/EU were developed with input from the tobacco 
industry.  
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18 The question which arises in that regard is whether the measurement and 
validation methods thus set out are contrary to the underlying principles of that 
directive, with the intent of Article 4(2) of that directive — which provides that 
the measurements are to be verified by laboratories not owned or controlled 
directly or indirectly by the tobacco industry — and to Article 5.3 of the World 
Health Organization Framework Convention on Tobacco Control, which provides 
that, in setting and implementing their public health policies, those policies are to 
be protected from commercial and other vested interests of the tobacco industry. 
19 The referring court also questions whether, given the fact that ventilation holes are 
made in the filters of filter cigarettes, the measurement and validation methods 
referred to in Article 4(1) of Directive 2014/40/EU are in accordance with the 
objective of that directive as is set out in the recitals and in Article 3 thereof.  
20 Failing to meet the target of maximum emissions from the intended use of filter 
cigarettes would, in its view, seriously undermine the objective of a high level of 
health protection, whereby account should be taken, in particular, of any new 
developments based on scientific facts, as is set out in recital 8 of Directive 
2014/40/EU. In that case, the referring court cannot rule out the possibility that 
Article 4(1) of that directive is contrary to Article 114(3) TFEU, to the spirit of the 
World Health Organisation Framework Convention on Tobacco Control, and to 
Articles 24 and 35 of the Charter.  
Fourth question 
21 Should the Court of Justice answer the second question in the affirmative, the 
question arises, according to the referring court, as to which alternative method 
may or must be used. It notes that that question also arises if the Court of Justice 
answers the first question in the negative and/or answers the third question in the 
affirmative. In that regard, it also notes, however, that it is uncertain whether the 
Court of Justice can prescribe an alternative method. 
22 In the event that the Court of Justice cannot answer the question regarding the 
alternative method which may or must be used, the referring court wishes to 
ascertain whether the temporary unavailability of a measurement method 
constitutes a situation such as that referred to in Article 24(3) of Directive 
2014/40/EU. Under that provision, a Member State may prohibit a certain 
category of tobacco or related products on grounds relating to the specific 
situation in that Member State and provided it is justified by the need to protect 
public health.