Mionsonraí an Fhógra | TRIS - European Commission

Dréachtghníomh lena leasaítear an Gníomh um Shrian ar Úsáid Tobac agus Táirgí Gaolmhara

Uimhir an Fhógra:

2023/0636/SI (Slovenia)

An dáta ar a bhfuarthas é/í:

10/11/2023

Deireadh leis an Tréimhse Neamhghníomhaíochta:

13/02/2024 (closed)

Eisiúint barúlacha ó:

European Commission

Czechia

Dréacht-téacs:

SL BG HR CS DA NL EN ET FI FR GA DE EL HU IT LV LT MT PL PT RO SK ES SV

Téacs Deiridh:

SL BG CS DA DE EL EN ES ET FI FR GA HR HU IT LT LV MT NL PL PT RO SK SV

Cliceáil anseo chun teacht ar leagan inphriontáilte den leathanach seo

Message

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Teachtaireacht ón gCoimisiún — TRIS/(2023) 3148

Treoir (AE) 2015/1535

Fógra a thabhairt 2023/0636/SI

Dréacht-téacs a fhógairt ó Bhallstát

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20233148.GA

1. MSG 001 IND 2023 0636 SI GA 10-11-2023 SI NOTIF

2. Slovenia

3A. Slovenski inštitut za standardizacijo, Kontaktna točka, Ulica gledališča BTC 2, SI - 1000 Ljubljana, e-mail:contact@sist.si, tel. 386, 1 478 3065

3B. Ministrstvo za zdravje, Direktorat za javno zdravje, Štefanova ulica 5, SI - 1000 Ljubljana, tel. 386 1 478 6854

4. 2023/0636/SI - X60M - Tobac

5. Dréachtghníomh lena leasaítear an Gníomh um Shrian ar Úsáid Tobac agus Táirgí Gaolmhara

6. Tobac agus táirgí gaolmhara

7.

8. Forlíontar leis an Dréachtghníomh in Airteagal 3 den Ghníomh maidir le Srian ar Úsáid Tobac agus Táirgí Gaolmhara (dá ngairtear ‘ZOUTPI’ anseo feasta) na sainmhínithe ar thoitíní leictreonacha agus ar choimeádáin athlíonta, ionas go dtagraíonn siad freisin do tháirgí nach bhfuil nicitín iontu. Tá feidhm ag ceanglais uile na Treorach agus ZOUTPI (Airteagal 26) freisin maidir le toitíní leictreonacha atá saor ó nicitín agus maidir le coimeádáin athlíonta atá saor ó nicitín.

Le hAirteagal 3 den ZOUTPI forlíontar freisin an sainmhíniú ar tháirge luibhe lena chaitheamh, ionas go n-áirítear an próiseas téimh leis freisin, sa bhreis ar an bpróiseas dócháin.

Foráiltear le hAirteagal 26(3) den ZOUTPI nach bhféadfaidh aon bhlastáin seachas blas nó boladh tobac nó menthol a bheith sa leacht ná in aon líontán eile, bíodh nicitín ann nó ná bíodh, a úsáidtear i dtoitíní leictreonacha nó i gcoimeádáin in-athlíonta. Cinnfidh an t-aire atá freagrach as an tsláinte blastáin nó substaintí a cheadófar i dtoitíní leictreonacha agus i gcoimeádáin athlíonta trí bhíthin rialacha a bheidh le glacadh laistigh de thrí mhí ó theacht i bhfeidhm an ghnímh.

9. Le Treoir 2014/40/AE ó Pharlaimint na hEorpa agus ón gComhairle 3 Aibreán 2014 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát a bhaineann le monarú, cur i láthair agus díol tobac agus táirgí gaolmhara agus lena n-aisghairtear Treoir 2001/37/CE (dá ngairtear ‘Treoir’ anseo feasta), tá an fhreagracht ar na Ballstáit rialacha a ghlacadh maidir le blastáin i dtoitíní leictreonacha. Dá bhrí sin, tugtar isteach leis an dréachtghníomh srian ar bhlastáin i dtoitíní leictreonacha agus ina leachtanna, nó i gcoimeádáin in-athlíonta. De réir shampla na Danmhairge agus na hEastóine, beidh toirmeasc ar gach blastán, seachas blas nó boladh tobac nó menthol. Trí bhlastáin i dtoitíní leictreonacha a theorannú, is mian linn a n-achomharc a laghdú agus gach duine, go háirithe leanaí agus déagóirí, a chosaint ar rochtain a fháil ar thoitíní leictreonacha, agus ar an gcaoi sin a sláinte a chosaint freisin, rud a d’fhéadfadh a bheith i mbaol trí shubstaintí díobhálacha a ionanálú in aerasól de thoitíní leictreonacha. Tá blastáin ar cheann de na príomhthosca i roghnú táirgí agus tosaíonn an chuid is mó de dhéagóirí ag úsáid táirge ina bhfuil blastáin. Laghdaíonn siad seo freisin an dearcadh ar dhochrachas agus méadaíonn siad an toilteanas chun iarracht a dhéanamh ar an táirge, ag déanamh an aerasóil níos taitneamhaí a ionanálú nó an táirge a úsáid níos taitneamhaí, rud a fhágann go bhfuil sé níos éasca tosú agus leanúint ar aghaidh ag baint úsáide as. Léiríonn níos mó agus níos mó taighde go méadaíonn úsáid toitín leictreonach go mór an dóchúlacht (suas le ceithre huaire) go dtosóidh siad ar thoitíní rialta a chaitheamh i measc déagóirí nach ndéanann tobac ar shlí eile. Fágann blastáin nach meastar go bhfuil toitíní leictreonacha chomh díobhálach céanna le toitíní traidisiúnta nó fiú go bhfuil siad neamhdhíobhálach, rud a bhaineann freisin le braistint daoine fásta. Is féidir le blastáin éifeachtaí díobhálacha tromchúiseacha ar shláinte a bheith acu, go háirithe ar shláinte riospráide.

Léiríonn na sonraí go bhfuil céatadán na n-úsáideoirí toitíní leictreonacha sa tSlóivéin i measc déagóirí suntasach agus i bhfad níos airde ná i measc daoine fásta. Leis an bhfaireachán tréimhsiúil ar shonraí le haghaidh na Slóivéine ón suirbhé Idirnáisiúnta ar Iompar Sláinte i Leanaí atá ag Aois Scoile (HBSC), atá bunaithe ar shampla ionadaíoch náisiúnta de dhaltaí idir 11, 13 agus 15, fuarthas amach gur tháinig méadú ar úsáid toitíní leictreonacha i measc na ndaoine sin atá 15 bliana d’aois a d’fhreagair go n-úsáideann siad toitíní leictreonacha ó 1 % in 2014 go 17 % in 2022. I measc daoine fásta (18-74 bliana d’aois), léirigh suirbhé PANDA 2022 gur bhain 7 % de dhaoine fásta úsáid as toitíní leictreonacha tráth an tsuirbhé, rud atá i bhfad níos lú ná i measc daoine 15 bliana d’aois. Léiríonn réamhshonraí HBSC le haghaidh 2022 gur bhain 3.6 % de dhaoine 11 bhliain d’aois úsáid as toitíní leictreonacha ag am éigin ina saol, agus gur bhain 2.2 % de dhaoine 11 bhliain d’aois úsáid as toitíní leictreonacha tráth an tsuirbhé.

Tá baint ag úsáid toitíní leictreonacha le riosca méadaithe galar cardashoithíoch, galar riospráide agus ailse freisin. Chomh maith le greannú béil agus scornach, casacht, sos, tinneas cinn agus andúil nicitín, áirítear ar éifeachtaí gearrthéarmacha sláinte taomanna titimis agus damáiste scamhóg. In 2019, d’fhulaing na mílte duine i Stáit Aontaithe Mheiriceá, daoine óga den chuid is mó, gortuithe géara scamhóg a bhain le húsáid toitíní leictreonacha, agus bhí go leor básanna agus iarmhairtí tromchúiseacha don tsláinte riospráide ann.

Chomh maith le srian a chur ar bhlastáin, táimid ag leathnú an tsainmhínithe ar thoitíní leictreonacha agus ar choimeádáin leachtacha in-athlíonta chun táirgí nach bhfuil nicitín iontu a chur san áireamh anois. Tá an sainmhíniú leasaithe riachtanach chun caitheamh go cothrom leis na toitíní agus na leachtanna leictreonacha nó leis na coimeádáin athlíonta le nicitín nó gan nicitín (mar shampla, maidir leis an bhfógra oifigiúil nach mór a chur isteach sé mhí sula mbeartaítear iad a chur ar an margadh, a dtoirt, an toirmeasc ar vitimíní a chur leis, a áirithiú nach féidir le leanaí na táirgí sin a úsáid agus forálacha eile a fhorordaítear leis an Treoir do thoitíní leictreonacha agus do choimeádáin athlíonta nicitín). Tá an t-athrú thuasluaite riachtanach mar gheall ar úsáid mhéadaithe toitíní leictreonacha i measc leanaí agus déagóirí agus mar gheall ar úsáid mhéadaitheach leachtanna nó líontóirí nach bhfuil nicitín iontu, ach a bhfuil blastáin éagsúla iontu, a mheasctar níos déanaí leis an líontán nicitín nó leis an leacht.

Chomh maith leis an bpróiseas dócháin, cuirtear próiseas téimh leis an sainmhíniú ar tháirgí luibhe lena gcaitheamh, ós rud é go bhfuil níos mó agus níos mó táirgí luibhe nua le feiceáil ar an margadh nach n-áirítear próiseas dócháin leo, ach atá téite amháin agus, dá bhrí sin, nach dtagann faoin sainmhíniú a tugadh isteach leis an Treoir maidir le táirgí luibhe lena gcaitheamh agus, dá bhrí sin, níl siad faoi réir na srianta ón Treoir ná ón ZOUTPI (UL RS, Uimh. 9/17 agus Uimh. 29/17). Mura n-áirímid an próiseas téimh sa sainmhíniú, beidh níos mó agus níos mó táirgí luibhe ar an margadh a théitear agus nach bhfuil tobac iontu murach sin, ach atá tuilte le nicitín nó ina bhfuil cannabas iontu agus ní bheidh siad faoi réir e.g. toirmeasc ar dhíolacháin le mionaoisigh agus gach toirmeasc eile a bhfuil feidhm acu cheana féin maidir le táirgí tobac agus táirgí luibhe lena mbaineann próiseas dócháin. Leis an mbeart seo, ba mhaith linn leanaí agus déagóirí go háirithe a chosaint ó tháirgí nua a úsáid agus ó bheith gafa leis an nicitín a chuirtear leis na táirgí seo.

Leis na bearta thuasluaite, glacfaimid céim thábhachtach i dtreo fís fhadtéarmach na Straitéise maidir leis an tSlóivéin atá Saor ó Thobac a bhaint amach, eadhon go mbeidh an tSlóivéin ina sochaí saor ó thobac in 2040. Ciallaíonn sé seo nach mbeidh an céatadán den daonra atá 15 bliana d’aois nó níos sine a úsáidfidh tobac, táirgí gaolmhara agus táirgí nicitín eile nach bhfuil cláraithe mar theiripe athsholáthair nicitín níos mó ná 5 %. Is mian linn cur le sláinte daoine níos fearr agus le hinbhuanaitheacht an chórais cúraim sláinte amach anseo.

10. Tagairtí do bhuntéacsanna

11. Ní hea

12.

13. Ní hea

14. Ní hea

15. Ní hea

16.
Gnéithe BTT:
Tá tionchar suntasach ag an dréacht ar thrádáil idirnáisiúnta

Gnéithe SPS: Ní hea

**********
An Coimisiún Eorpach
Pointe teagmhála Treoir (AE) 2015/1535
ríomhphost: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	Bliain Ó Shin	Uimhir	Tír	Type	Title	An dáta ar a bhfuarthas é/í	Is answer to
105969	2023	3149	COMAn Coimisiún Eorpach	003	Receipt of the draft text	10-11-2023
105970	2023	3150	COMAn Coimisiún Eorpach	037	Competitiveness analysis	10-11-2023
107036	2024	0350	COMAn Coimisiún Eorpach	303	Comments	08-02-2024
107061	2024	0358	CZCzechia	103	Comments	12-02-2024
107846	2024	1012	SISlovenia	201	Answer of the notifying Member State	15-04-2024	2024-350
107847	2024	1013	SISlovenia	201	Answer of the notifying Member State	15-04-2024	2024-358
108817	2024	1879	COMAn Coimisiún Eorpach	049	Acknowledgement of receipt of the adopted text	12-07-2024

Teangacha

Aighneachtaí Geallsealbhóirí

Ar shuíomh gréasáin TRIS is furasta duitse nó do d’eagraíocht do thuairimí a chur in iúl faoi fhógra ar leith.

Mar gheall ar stádas an fhógra nó deireadh a chur leis an tréimhse neamhghníomhaíochta, nílimid ag glacadh le haon aighneachtaí eile maidir leis an bhfógra seo tríd an suíomh gréasáin.

This documents contains arguments which might be used when considering solutions envisaged in the Slovenian bill through the prism of the medical profession.

From a medical point of view, there are two issues that need to be addressed:

Equalize nicotine containg e-cigs with nicotine free ones
Assigning tobacco heating products (THPs) to the smoking tobacco category

The document will present certain hypotheses on both of these issues, supported by studies conducted by renowned international institutions.

2. Equalize nicotine containg e-cigs with nicotine free ones

It is reasonable to expect that the implementation of the proposed solution will not only cancel the positive effect of reducing the number of smokers, which is the paramount public health interest, but also potentially increase their number and the number of users of other smoking tobacco products (primarily cigarettes).

The following studies support the abovementioned:

A 2021 Eurobarometer study shows that 57% smokers or past smokers in Europe successfully took up e-cigarettes to stop or reduce smoking (30% of e-cigarette users stopped smoking tobacco completely, while another 27% reduced their tobacco consumption).

A report drawn up on behalf of the European Commission states that 54% of persons aged 26 and older said that they had begun to use e-cigarettes “to stop or reduce the consumption of another tobacco product”. In the 18-25 age group, the same reason was given by 33% of e-cigarette users. Furthermore, 24% of the former vapers in the 18-25 age group stopped using all tobacco products; the same is true of 23% users in the 26+ age group. This shows that vaping products are an important stage in switching from smoking to a complete nicotine abstinence. Overall, the report shows that 87% of the current exclusive e-cigarette users are all past cigarette smokers.

A systematic review by the internationally renowned Cochrane Tobacco Addiction Group shows that “quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT)”, which, in absolute terms, translates to “an additional three quitters per 100”.

A 2018 report commissioned by Public Health England (PHE) confirms that vaping products are 95% less harmful than smoking tobacco products. According to the PHE update from 2021, “the extensive use of vaping products in quit attempts compared with licensed medication suggests vaping products may reach more people who smoke and so have more impact than NRT and varenicline”. Moreover, both documents conclude that “misperceptions of the relative harms of smoking and vaping should be addressed”, while the 2018 report states that “knowledge about the role of nicotine in the development of cancers and other diseases caused by smoking needs improvement”.

A study by France’s National Institute for Health and Medical Research (INSERM) finds that “electronic cigarettes use may be associated with a decreased tobacco consumption and an increased likelihood of cessation attempts in those who have used them for less than one year”, adding that “additional benefits on these smoking outcomes can probably be expected in the case of longer electronic cigarette use”.

A 2021 review of the data from a study conducted by the French Public Health Agency (Santé Publique France) concludes that “among men who already tried to quit before, smoking cessation was associated with the use of an electronic cigarette (with or without NRT)”.

A Greek study of the profile of e-cigarette users reveals that 98% of the study participants were smokers before e-cigarette use initiation, while 58.9% of the participants were using non-tobacco flavors. The study states that “most participants experienced health benefits, mainly improvement in physical status, exercise capacity, olfactory and gustatory senses”, and concludes with the following: “Vapeshops customers in Greece are mainly current and former smokers with the majority of them having quit smoking. E-cigarette use by never smokers is rare and none of them subsequently initiate smoking.”

Sweden has demonstrated that by allowing snus – a bagged, smokeless reduced harm product – to be marketed alongside combustion products, one could achieve 7% smoking prevalence, as measured by the Public Health Agency of Sweden. Sweden also has the lowest lung cancer incidence (17.7 cases per 100,000 inhabitants) in the EU, as shown in the data by the World Health Organization, with the lowest lung cancer death rate (14.4 cases per 100,000 inhabitants). The same data source shows that Sweden has the lowest death rate for any type of cancer among men (96.0 cases per 100,000 inhabitants).

Other countries with targeted prevalence of 5% – e.g. the United Kingdom, New Zealand, and France – actively urge smokers to switch to e-cigarettes via government sponsored campaigns (see here, here and here) and by employing proportional e-cigarette restrictions that encourage the switch. For instance, all three countries allow flavored e-liquids, online sales, and retail, and have not imposed excise duties on the product category.

According to the data published by the European Commission, the four EU and UK countries with the highest vaping product use (average of 5% in 2020) – Austria, France, Ireland and the UK – have also noticed an average drop in smoking prevalence by 12 percentage points between 2009 and 2020, as compared to the average of all EU+UK countries of 6 percentage points. None of the four countries has imposed any restrictions or bans on e-cigarette flavors.

According to the data published by the European Commission, in the period between 2017 and 2020, Hungary reported an increase in smoking of 1 percentage point. This coincides with the implementation of some of the strictest measures concerning e-cigarettes and THPs, including excise duties, ban on national and cross-border online sales, ban on flavored e-cigarettes, and restricted availability of all tobacco products and e-cigarettes in retail.

2. Assigning tobacco heating products (THPs) to the smoking tobacco category

The potential of the THPs must be exploited to achieve the paramount public health goal of reducing the number of active smokers. This potential lies in the absence of combustion during the consumption of such products, which means that automatically identifying THPs with other smoking tobacco products does not help with exploiting the potential in question.

The following studies support this claim:

According to this study, in Japan, overall cigarette sales fell by 38% between 2011 and 2019; however, before the introduction of the THPs, the annual percent change (APC) for cigarette sales was -3.1%. After the introduction of the THPs, the APC went up to -16.38%.

This study shows that THP aerosol does not cause any DNA mutations. Moreover, it induces 90% less cytotoxicity than tobacco smoke. The other tests proved negative regarding potential tumor-promoting activity.

A review by Cochrane, a UK-based charitable organization, reveals that “there was moderate‐certainty evidence that exposure to some measured toxicants and carcinogens was lower in smokers randomized to switch to heated tobacco than continue smoking cigarettes, but very low‐ to moderate‐certainty evidence of higher exposures than in those attempting abstinence from all tobacco”.

In the US, the Food and Drug Administration (FDA) has recognized the reduced risk profiles of tobacco heating devices and snus, issuing a marketing approval for modified risk tobacco products for PMI and Swedish Match products.

The following can provide further help when addressing misperceptions:

“The right to health” is recognized under international law. The human rights framework is based on the principle that governments have a duty to protect the basic rights of their citizens. This includes the right to the enjoyment of the highest attainable standard of physical and mental health, as stated in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The tobacco control community agrees that “the collective failure to offer and promote cessation support to tobacco users who need it is not only a public health failure, it is also a human rights failure”. Therefore, the failure to facilitate wider access to safer alternative products or discourage such products’ use by limiting their availability or acceptability for consumers – considering the solid evidence of their effectiveness – is in direct opposition to the European Union’s international obligations.

People continue to smoke despite being aware of the harmful health risks associated with smoking. Those smokers would benefit from a wider access to alternative products, which can effectively provide them with nicotine and a pleasant and, more importantly, reduced risk alternative to smoking. Having an effective tobacco harm reduction policy is critical for this particular group of people. In their review, Renée O’Leary and Dr. Riccardo Polosa confirm that “in consideration of the available evidence, advice to tobacco smokers should include trying substitute products. The obvious fact so often overlooked is that smoking is rewarding and people like to do it. Giving smokers an alternative with efficient nicotine delivery means that they might prefer one of these products over cigarettes.”

The barriers to effective tobacco harm reduction originate in misperceptions: This leads to a disproportionately strict product regulation and rejection by smokers. Thus, there is a need to separate the consequences of nicotine addiction from the concern about the harmfulness of adult smoking in the minds of healthcare workers, regulatory bodies, and the public. This article states that alternative nicotine delivery systems should always be “compared with smoked tobacco products (relative harms), and the mistaken public beliefs that nicotine is the cause of disease risk and cancer, rather than the smoke from combustion, must be dispelled”. This is because “a misinformed public lacks the information required to take health-protective action”.

Most health clinicians come from the general specialization, and do not have much time to keep abreast of scientific developments and product innovation. They receive (incorrect) information from the media and there is very little time allotted to tobacco use in medical training. As a result, there is a widespread false perception that nicotine is a problem in itself, and a surprising number of clinicians are not aware of nicotine’s safety profile. A study carried out among Spanish, Italian, and Portuguese public health departments has shown that the majority will tie nicotine to all smoking-related diseases, while 62% think that nicotine causes cancer. It has also indicated that the awareness of tobacco harm reduction is very low among all study.

Misperceptions can also come from inaccurate information and sensationalist headlines. An example of misrepresentation in the media is the reporting on the outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) in the United States in 2019. Accordingly, this study states that “the potential consequences of this misreporting include public misunderstanding, mistrust and potentially cases that could have been avoided if the correct information was widely communicated”. This stresses the importance of allowing communication with the smokers on the advantages of using safer alternative products.

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