Pöördumine

Saatja: Phon van den Biesen <[email protected]> Saadetud: 01.12.2022 17:54 Adressaat: SM Info <[email protected]> Teema: Attn of Peep Peterson, Esq. Tobacco Control: EU Member States now can choose a measurement method not designed by Tobacco Industry: the EU Court has spoken [D20180022_I37516400] Tähtsus: Tavaline Manused: 2022-12-01 Estonia - Peep Peterson.pdf Excellency, as the attorney for Rookpreventie Jeugd, the City of Amsterdam and 13 Health Organisations I took the measurement method to the Rotterdam District Court and next to the Court of Justice of the European Union. The EU Court set aside the current ISO-standards prescribed by the Tobaccor Products Directive (TPD). In my attached letter I explain the tremendous importance of this Judgment of the Court and call upon you as well as your 12 colleagues who urged the Commissioner already in March 2020 to make the switch to WHO TobLabNet SOP01 to take the necessary steps to enforce the TPD in a proper manner. My clients would appreciate your taking action on this and make an end to the manipulative measurement method designed by the Tobacco Industry which made it possible that smokers inhale at a minimum two to three times more tar, nicotine and coal monoxide than the TPD allows for. We are available for any queries that you may have with respect to the legal issues involved. Thank you very much for your attention. Sincerely, Phon van den Biesen ADVOCATENKANTOOR VAN DEN BIESEN Leidsegracht 24 sous 1016 CL Amsterdam The Netherlands cell +31.652061266 e-mail: [email protected] website: www.vandenbiesen.eu Advocatenkantoor Van den Biesen is ingeschreven bij de Kamer van Koophandel te Amsterdam onder nummer 56695861 Dit e-mailbericht is uitsluitend bestemd voor de geadresseerde(n). Indien deze e-mail bij vergissing bij u terecht is gekomen, verzoeken wij u het e- mailbericht te vernietigen, de inhoud ervan niet te gebruiken en niet onder derden te verspreiden. Wij verzoeken u tevens ons per e-mail te berichten over de ontvangst van het e-mailbericht en/of telefonisch contact met ons op te nemen via het nummer . Het e-mailbericht kan vertrouwelijke informatie bevatten. Voor misbruik daarvan bent u aansprakelijk. Verzender is niet aansprakelijk voor enige schade die veroorzaakt wordt door het gebruik en/of acceptatie van de inhoud van dit bericht. This e-mail message is intended exclusively for the addressee. If the e-mail was sent to you by mistake, we request you to destroy the e-mail and neither to use the contents or disclose them in any manner to third parties. We also request you to inform us by (r)e-mail concerning the receipt of the e-mail message or contact us by telephone . The e-mail message may contain confidential information. You are liable for abuse of this information. Sender accepts no liability for any damage resulting from the use and/or acceptation of the content of this e-mail. Minister of Health and Labour Peep Peterson, Esq. Estonia [email protected] Leidsegracht 24 sous 1016 CL Amsterdam The Netherlands [email protected] www.vandenbiesen.eu Amsterdam, 1 December 2022 Re: Directive 2014/40/EU - consequences of legal findings (Court of Justice of the European Union and Rotterdam District Court) with respect to TNCO-measurement methods for cigarettes; the choice for a proper measurement method is now up to each EU Member State Excellency, In my capacity of attorney of my clients, Stichting Rookpreventie Jeugd (Youth Smoking Prevention Foundation), City of Amsterdam plus 12 health care Associations, I have the honor to share the following with respect to the “rigged cigarette” in connection to the Judgment of the EU Court of Justice (C-160/20), dated 22 February 20221, and the decision of the Rotterdam District Court of 4 November 2022.2 I am writing to you since, on behalf of your country, you have been one of the 13 signatories of the letter to Commissioner Kyriakides dated 2 March 2020 sent by the, then, State Secretary for Health, Welfare and Sport, Paul Blokhuis of the Netherlands on the topic of TNCO- measurement of cigarettes.3 The EU Court of Justice has decided that the authorities of each EU Member States need to choose a different measuring method than the ISO Standards prescribe in the Tobacco Products Directive. The Court in Rotterdam has ordered the Dutch enforcement authority to follow the EU Court’s Judgment. This will be explained in this letter. 1 In all EU languages (change the language on the top of the first page) : https://curia.europa.eu/juris/document/document.jsf?docid=254381&mode=req&pageIndex=1&dir=& occ=first&part=1&text=&doclang=NL&cid=727730 2 ECLI:NL:RBROT:2022:9297 3 Letter of Paul Blokuis and 12 other EU Ministers or State Secretaries to Ms Stella Kyriakides, Commissioner for Health and Food Safety; reference of the letter 1651638-202230-12 1 Contents of this letter Background ........................................................................................................................................................... 2 Position Tobacco Industry with respect to the EU Court’s Judgment ......................................... 3 The Judgment of the EU Court of Justice .................................................................................................. 3 The elements for an alternative measurement method provided by the EU Court .............. 4 Choosing an alternative measurement method is no longer the exclusive responsibility of the Commission.............................................................................................................................................. 5 The core of the EU Court’s Judment: point 5 of the declaratory ruling....................................... 5 Which measurement method is to be chosen? ...................................................................................... 6 The Decision of the Rotterdam District Court of 4 November 2022 ............................................ 7 Final remarks ....................................................................................................................................................... 7 Background My clients had requested the Dutch authorities to enforce the maximum emission levels prescribed by article 3(1) of the Tobacco Products Directive while making use of a measurement method that would be much better simulate the actual level of TNCO-values as inhaled by smokers inhaled by smoker. The request was denied since the authority did not see any room for it to deviate from the ISO methods prescribed by article 4(1) of the Directive). We took this case to the Rotterdam District Court which – based on our suggestions – referred the case to the EU Court of Justice. The latter referred the case to its Grand Chamber and delivered its Judgment on 22 February 2022.4 Given the Judgment of the EU Court, the Rotterdam Court, in short, ordered the Dutch enforcement authority to take a new decision on the enforcement request in its final Judgment of 4 November 2022. In our opinion, both the rulings referred to in the previous paragraph call for speedy action. In the first place action from the side of the Dutch authorities. However, this call for speedy action is not limited to the Dutch authorities only since the EU Court’s Judgment applies to all of the European Union and actually is, since 22 February 2022 “the law of the land”, i.e. the law of the European Union. This means that each EU Member State is now entitled, better: each EU Member State is now under a legal obligation, to go ahead and enforce the little protection that article 3(1) Directive 2014/40/EU5 provides for 4 In all EU languages (change the language on the top of the first page) : https://curia.europa.eu/juris/document/document.jsf?docid=254381&mode=req&pageIndex=1&dir=& occ=first&part=1&text=&doclang=NL&cid=727730 5 Article 3(1): The emission levels from cigarettes placed on the market or manufactured in the Member States (‘maximum emission levels’) shall not be greater than: 2  individual smokers as well as for second-hand-smokers. This protection will at least be especially more serious if a different measuring method for tar, nicotine and carbon monoxide than the ones currently provided for in Article 4(1) of the same Directive. Position Tobacco Industry with respect to the EU Court’s Judgment 1. We have noticed that from the side of the tobacco industry, the idea is widely spread that the issue of the measurement methods – even after the Judgment of the EU Court – is and remains within the exclusive domain of the European Commission and that, presumably, the EU Court would not be in the position to play any role here, let alone the Rotterdam District Court. Whatever the reasons for the tobacco industry to keep misrepresenting the truth about these matters may be, the very truth of the matter is that the Grand Chamber of the European Court of Justice has, with its Judgment of 22 February 2022, delivered to all of the European Union a game-changing ruling with respect to the actual meaning of the Tobacco Products Directive. The Judgment of the EU Court of Justice 2. In short, in our case the EU Court of Justice ruled that the (ISO-)measurement method prescribed in article 4(1) of the Directive is not binding on the public generally and that the national judge is to check measurement measures chosen by the national enforcement authorities against a particular set of elements listed in the Court’s Judgment. 3. This is what the Court considers about ISO-standards not being binding on the public generally: “48 Nevertheless, in view of the doubts of the referring court – summarised in paragraph 22 above – at the root of Question 1, it should also be stated that, in accordance with the principle of legal certainty as explained in paragraphs 41, 42 and 45 above, technical standards determined by a standards body, such as ISO, and made mandatory by a legislative act of the European Union are binding on the public generally only if they themselves have been published in the Official Journal of the European Union.” (emphasis added) and (a) 10 mg of tar per cigarette; (b) 1 mg of nicotine per cigarette; (c) 10 mg of carbon monoxide per cigarette. 3  “73 However, it should be recalled that Article 4(1) of Directive 2014/40 is not binding on the public generally in so far as it refers to ISO standards not published in the Official Journal of the European Union.” (emphasis added) 4. Earlier, f.e. in paragraph 32 of its Judgment, the Court found that article 4(1) in any event does maintain its validity for harmonization purposes. Also according to the Court6, this provision remains binding upon the tobacco-industry since it has full access to the ISO- standards involved given the organizational structure of ISO. So, at the one hand the ISO-standards remain binding on the tobacco-industry, but at the other hand and at the very same time, the ISO-standards are not binding on the public in general, which includes individuals and also organizations like Rookpreventie Jeugd. Further down in the Judgment (paragraph 74) the Court stresses that at this point paragraph article 4(1) is to be ignored.7 5. During the course of the written proceedings the Commission observed that the specifications of the measurement method only regard the tobacco industry and the national authorities and that accessibility of the substance of ISO Standards would not be in the interest of the general public. It is clear from the Judgment of 22 February 2022 that the Court decided otherwise. The elements for an alternative measurement method provided by the EU Court 6. The Court is certainly not suggesting that just any other method of measuring the contents of cigarettes may be applied; on the contrary, it makes it perfectly clear that – in case a different method of measuring than the one prescribed in article 4(1) of the Directive is applied – a variety of elements must be satisfied.8 The Court concludes: 6 paragraph 52 of the Judgment 7 Full text of paragraph 74: “Therefore, it is for the referring court, for the purpose of deciding the dispute before it, to determine whether the methods actually used to measure the emission levels of those substances comply with Directive 2014/40, without taking account of Article 4(1) thereof.” 8 The elements are presented in paragraphs 75-78 of the Judgment: “75 In that regard, it should be paragraphed out, first, that it is clear from Article 2(21) of Directive 2014/40 that the term ‘emissions’ refers to ‘substances that are released when a tobacco or related product is consumed as intended, such as substances found in smoke, or substances released during the process of using smokeless tobacco products’. 76 Second, pursuant to Article 4(2) of Directive 2014/40, measurements of the levels of tar, nicotine and carbon monoxide emissions are to be verified by laboratories which are approved and 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. 77 Third, in accordance with Article 4(3) of Directive 2014/40, adaptation by the Commission of the methods of measuring those emission levels must take account of scientific and technical developments or internationally agreed standards. 4  “79 Accordingly, the answer to Question 4(a) is that, should Article 4(1) of Directive 2014/40 not be binding on individuals, the method used for the purpose of applying Article 3(1) of that directive must be appropriate, in the light of scientific and technical developments or internationally agreed standards, for measuring the levels of emissions released when a cigarette is consumed as intended, and must take as a base a high level of protection of human health, especially for young people, while the accuracy of the measurements obtained by means of that method must be verified by laboratories approved and monitored by the competent authorities of the Member States as referred to in Article 4(2) of that directive.” Choosing an alternative measurement method is no longer the exclusive responsibility of the Commission 7. In paragraph 77 the Court referred to article 4(3) of the Directive in which provision the European Commission’s responsibility is established to decide for a different measuring method. In article 4(3) of the Directive the Commission is instructed to “take account of scientific and technical developments or internationally agreed standards”. Here, in paragraph 79, where the Court includes all of the elements discussed above in one full sentence, there is no longer an exclusive role for the Commission, rather the Court considers that the alternative “method … must be appropriate, in the light of scientific and technical developments or internationally agreed standards”, which are the same conditions that the Commission would need to be taken into account when it would be acting under article 4(3). It follows that it is up to the authorities of each EU Member State to enforce the maximum emission values laid down in article 3(1) of the Directive by making use of a measuring method that satisfies the elements of para. 79. It also follows that, if need be, it is up to the national Courts of the EU Member States “… to determine whether the methods actually used to measure the emission levels of those substances comply with Directive 2014/40, without taking account of Article 4(1) thereof”.9 The core of the EU Court’s Judment: point 5 of the declaratory ruling 8. Against the background of all of the above it becomes clear that the EU Court has stressed the principled difference between Article 3(1) and Article 4(1) of the Directive: Article 4(1) being about harmonization of the internal market and Article 3(1) being about protecting “human health, especially for young people” (however little that protection may be, since “healthy” maximum emission levels for tar, nicotine and carbon monoxide simply do not exist; at the same time, making use of a proper measurement method will 78 Fourth, any method of measuring the maximum emission levels prescribed in Article 3(1) of Directive 2014/40 must effectively meet its objective, reflected in Article 1 thereof, of ensuring a high level of protection of human health, especially for young people.” 9 para. 74 of the Court’s Judgment of 22 February 2022 5  lead to a very substantial lowering of the amount of poisonous substances – see below). The Court provides this important clarification and interpretation of this Directive: “On those grounds, the Court (Grand Chamber) hereby rules: 1. Article 4(1) 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 is to be interpreted as providing that the maximum emission levels for tar, nicotine and carbon monoxide from cigarettes intended to be placed on the market or manufactured in the Member States, prescribed in Article 3(1) of that directive, must be measured in accordance with the measurement methods arising from ISO standards 4387, 10315, 8454 and 8243, to which Article 4(1) refers. […] 5. Should Article 4(1) of Directive 2014/40 not be binding on individuals, the method used for the purpose of applying Article 3(1) of that directive must be appropriate, in the light of scientific and technical developments or internationally agreed standards, for measuring the levels of emissions released when a cigarette is consumed as intended, and must take as a base a high level of protection of human health, especially for young people, while the accuracy of the measurements obtained by means of that method must be verified by laboratories approved and monitored by the competent authorities of the Member States as referred to in Article 4(2) of that directive.” Which measurement method is to be chosen? 9. The number one question thus becomes which measurement method is to be used for a proper enforcement of the maximum emission levels of Article 3(1) of the Directive. As you know, the extensive research conducted in 2018 by the Netherlands National Institute for Public Health and the Environment (RIVM) demonstrates that not any single one brand of cigarettes sold in the Netherlands meets the maximum standards for emission levels set by Article 3(1) of the Directive, while all of the cigarettes tested showed values for tar, nicotine and carbon monoxide of at least 2 to 3 times the maximums defined in Article 3(1), with a great number of brands showing even much higher values, up to 26 times the prescribed maximum levels. These violations of the legal maximum emission levels, by definition, occur in each and every one of the EU Member States. So, the need for adopting a better measurement method is clear as ever and in itself undisputed. 10. My clients expect that in the Netherlands the choice for a better method will not need any extensive debate since: as you know at least since 2018 the Dutch authorities, including the Secretary of State for Health, Welfare and Sport, RIVM and the Netherlands Food and Consumer Product Safety Authority (NVWA) have taken the position that WHO 6  TobLabNet SOP01, would clearly be the method that much better approaches a simulation of the level of “emissions released when a cigarette is consumed as intended”. The SOP01- standard provides for the technical codification of the so-called “intense”-method.10 11. The Court was aware of the existence of this SOP01-standard, since we made a copy of this standard available to the Court by submitting it as an Annex to our written pleadings. In your joined letter of 2 March 2020 to Commissioner Kyriakides you and your 12 colleagues also called for replacing the ISO method by the intense method as developed by WHO TobLabNet. There can be no doubt whatsoever that SOP01 indeed is entirely satisfying the elements listed by the Court under point 5 of its Declaratory Judgement. 12. In the meantime the ISO-organization has also codified the “intense”-method leading to ISO-22078. The most decisive features of this standard are entirely the same as those in SOP01. I am only mentioning the existence of this particular ISO-standard because it confirms the approach of SOP01 and because ISO is – under EU law – considered as international standard organization, producing “internationally agreed standards”. The very concept of the latter is part of one of the elements under point 5 of the Court’s Judgment of 22 February quoted above. Of course, my clients are far from promoting this ISO-Standard in the context of this letter given the well-known influence of the tobacco industry on tobacco related ISO-standardization. At the same time the very existence of this ISO- 22078 provides for full support for the choice you made earlier for TobLabNet SOP01. The Decision of the Rotterdam District Court of 4 November 2022 13. The decision of the Rotterdam Court, for the Dutch authorities, adds to the urgency of this matter. However, there is no need for you to wait for a similar decision from any Court in your country, since the EU Court of Justice has in its Judgment of 22 February 2022 clearly stated the Law as it is, which Law needs to be applied in each and every one of the 27 EU Member States. So, this is the law that needs to be followed and implemented in your country as well. Final remarks 14. We thought it useful to send you this letter in order to inform you how the Tobacco Product Directive is to be understood since the EU Court’s Judgment of 22 February 2022. The issue at hand is the protection of EU citizens against the only legally available consumer product that kills at least half of its users when used as intended. Currently, all cigarettes sold within the EU contain multiple the maximum amounts of tar, nicotine and coal monoxide prescribed in the Directive. This situation calls for urgent redress. The EU 10 https://www.who.int/publications/i/item/standard-operating-procedure-for-intense-smoking-of- cigarettes 7 Court has clearly opened the way to true and effective enforcement of the limits set by the law. If you would need any clarification of all of the above, do not hesitate to get in touch, I will be more than happy to try and provide further clarifications. Please, Excellency, do accept the assurances of my highest esteem. Sincerely, Phon van den Biesen 8