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Key Facts

Netherlands

Map of Netherlands

Reception Date

19.07.22

Category

GOODS AND MISCELLANEOUS PRODUCTS

Precious metals

Ministries & Departments

Ministerie van Volksgezondheid, Welzijn en Sport, Directie Wetgeving en Juridische Zaken

Responsible Departments

Ministerie van Financiën

Products & Services concerned

Re: setting rules on additives that create flavours other than tobacco flavour in liquids containing nicotine, nicotine-free liquids and other e-cigarette components

Related EU Law

- The parts of the Tobacco and Smoking Products Act [Tabaks- en rookwarenwet] and the amendment to the Tobacco and Smoking Products Decree [Tabaks- en rookwarenbesluit], on which this Ministerial Order is based, will be sent along as an annex.

Explanation

Mounting scientific evidence indicates that e-cigarettes are harmful, addictive and attractive. E-cigarette use also appears to make young people more likely to start smoking tobacco compared to young people who do not use these products. To make e-cigarettes less attractive, this draft Ministerial Order now bans additives that create flavours other than tobacco flavours in liquids containing nicotine, nicotine-free liquids and other e-cigarette components. This will ban the production and sale of e-cigarettes in flavours other than tobacco. This helps reduce the temptation for young people and former smokers to purchase these e-cigarettes. To enable regulation of flavours other than tobacco in liquids for e-cigarettes, the text now only permits additives that are relatively more common in tobacco-flavoured liquids than in sweet, attractive flavours. The Dutch Government deems this highly likely to make it impossible to place the sweet, attractive flavours on the market. By allowing only certain flavouring additives as ingredients, monitoring for the indicated ingredients can verify compliance with the regulations. Moreover, in cases of doubts as to whether the product meets the regulations, chemical analysis can determine whether unauthorised additives are present in the liquids. Also banning the use of undesignated flavouring additives as ingredients in other components of electronic vapour products prevents the addition of unauthorised flavouring additives by means of cartridges, separate mouthpieces or other e-cigarette components. Due to the harmful effects of inhaling chemicals in liquids for e-cigarettes and the addictiveness of nicotine e-cigarettes, reducing the attractiveness of e-cigarettes offers health benefits. For this reason, regulating flavourings for e-cigarettes is justified by the need to protect public health. Here, the requirements will apply to all e-cigarettes placed onto the market in the Netherlands, meaning that application of this measure is non-discriminatory. The government further deems the measure to be proportionate given that the exhaustive list will only indicate permitted flavouring additives and will not be used to prescribe all ingredients in liquids and other e-cigarette components. Thus, the measure does not go beyond what is necessary. A less restrictive alternative that can achieve the same goal is not conceivable either, making this form of state intervention justified. It is proportionate because it does not ban the sale or use of e-cigarettes, but rather sets rules by ministerial order on the ingredients that can be added to the liquid as flavouring additives. It is therefore still possible to use e-cigarettes as an aid to quit smoking. The measures are also necessary in a democratic society because the legitimate objectives of a smoke-free generation by 2040, in which no young people start smoking, preventing smoking in general and helping current smokers quit are more likely to be achieved if e-cigarettes are less attractive.

Summary

The draft amendment to the Tobacco and Smoking Products Decree was notified to the European Commission on 29 September 2021, in accordance with Article 5(1) of Directive (EU) 2015/1535. This did not give rise to any comments from the European Commission or any EU Member State. This amendment to the Tobacco and Smoking Products Decree, which is yet to be published, is intended to make e-cigarettes less attractive by banning e-cigarette flavours other than tobacco. Article 2.4(2) (new) of the Tobacco and Smoking Products Decree states that it is not permitted to use flavouring additives other than those designated by ministerial order as ingredients in liquids containing nicotine, nicotine-free liquids or other e-cigarette components. This draft Ministerial Order exercises the above option by including an exhaustive list of 16 flavouring additives in Article 2.12 of the Tobacco and Smoke Products Order which may be added to liquids for and other components of e-cigarettes, which only allows flavouring additives that provide a tobacco flavour. In addition, Articles 3.9 and 3.10 prohibit packages or accompanying leaflets indicating flavouring additives that do not appear on the exhaustive list. This is to prevent giving the impression that an e-cigarette features a flavour other than tobacco. These provisions may be regarded as technical regulations.

Notification Timeline

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Law is drafted in Netherlands Netherlands notifies the draft law 19.07.22 Draft law returns to Netherlands Commenting Periode Ends 20.10.22 1 Member States & EC Responses 0 Detailed Opinions 1 Comments 23 External Stakeholders Responses

Notification Comparison

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Document Corner
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Originating Department: Ministerie van Volksgezondheid, Welzijn en Sport, Directie Wetgeving en Juridische Zaken
Responsible Department: Ministerie van Financiën
Received: 2022-07-19 00:00:00
Country: Netherlands
Category: GOODS AND MISCELLANEOUS PRODUCTS

Amendment of the Tobacco and Smoking Products Order for regulation of e-cigarette flavours

Notification No.: 2022-0508-NL

3363001-1028723-WJZ
GOVERNMENT GAZETTE

No 32367

28 November 2022

Official publication of the Kingdom of the Netherlands since 1814.

Order of the State Secretary for Public Health, Welfare and Sport of 22 November 2022, reference 3456548-1038502-WJZ, amending the Tobacco and Smoking Products Order for the regulation of e-cigarette flavours

The State Secretary for Public Health, Welfare and Sport,


Article 2.12

1. Only the following flavouring additives shall be permitted as ingredients in liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products:
1. Only the following flavouring additives shall be permitted as ingredients in liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products:

CAS number Substance name in English Substance name in Dutch 35044-68-9 beta-Damascone beta-Damascon 23726-91-2 (E)-beta-Damascone (E)-beta-Damascon 23726-92-3 (Z)-beta-Damascone (Z)-beta-Damascon 23696-85-7 Damascenone Damascenon 23726-93-4 (E)-beta-Damascenone (E)-beta- Damascenon 1125-21-9 Ketoisophorone Ketoisophoron 4883-60-7 2-Hydroxy-3,5,5-trimethyl-2- cyclohexenone 2-Hydroxy-3,5,5- trimethyl-2- cyclohexenon 536-78-7 3-Ethylpyridine 3-Ethylpyridine 350-03-8 3-Acetylpyridine 3-Acetylpyridine 91-10-1 2,6-Dimethoxyphenol 2,6-Dimethoxyfenol 67-47-0 5-(Hydroxymethyl)-2-furfural 5-(Hydroxymethyl)- 2-furfural 591-12-8 alpha-Angelica lactone alpha-Angelica lacton 503-74-2 Isovaleric acid Isovaleriaanzuur 1139-30-6 (-)Caryophyllene oxide (-)Caryophyllene oxide 3738-00-9 Ambroxide Ambroxide 564-20-5 (3aR)-(+)-Sclareolide (3aR)-(+)-Sclareolide
CAS number Substance name in English Substance name in Dutch 35044-68-9 beta-Damascone beta-Damascon 23726-91-2 (E)-beta-Damascone (E)-beta-Damascon 23726-92-3 (Z)-beta-Damascone (Z)-beta-Damascon 23696-85-7 Damascenone Damascenon 23726-93-4 (E)-beta-Damascenone (E)-beta- Damascenon 1125-21-9 Ketoisophorone Ketoisphorone 4883-60-7 2-Hydroxy-3,5,5-trimethyl-2- cyclohexenone 2-Hydroxy-3,5,5- trimethyl-2- cyclohexenon 536-78-7 3-Ethylpyridine 3-Ethylpyridine 350-03-8 3-Acetylpyridine 3-Acetylpyridine 91-10-1 2,6-Dimethoxyphenol 2,6-Dimethoxyfenol 67-47-0 5-(Hydroxymethyl)-2-furfural 5-(Hydroxymethyl)- 2-furfural 591-12-8 alpha-Angelica lactone alpha-Angelica lactone 503-74-2 Isovaleric acid Isovaleriaanzuur 1139-30-6 (-)Caryophyllene oxide (-) Caryophyllene oxide 3738-00-9 Ambroxide Ambroxide

B
564-20-5 (3aR)-(+)-Sclareolide (3aR)-(+)-Sclareolide B

A new paragraph is added to Article 3.9, reading:

3. An accompanying leaflet for liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products shall not indicate any flavouring additives other than those listed in Article 2.12 or their customary designations.
3. An accompanying leaflet for liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products shall not indicate any flavouring additives other than those listed in Article 2.12 and no indication referring to a flavour other than tobacco.

C

A new paragraph is added to Article 3.10, reading:

5. A packaging unit or outer packaging for liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products shall not indicate any flavouring additives other than those listed in Article 2.12 or their customary designations.
5. A packaging unit or outer packaging for liquids containing nicotine, nicotine-free liquids and other components of electronic vapour products

1

shall not indicate any flavouring additives other than those listed in Article 2.12 and nor any indication referring to a flavour other than tobacco.

D

A new paragraph is added to Article 7.3, reading:

6. Liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products that meet the requirements of Tobacco and Smoking Products Order as of 31 December 2022 and that were produced or released for free circulation before 1 January 2023 may be placed onto the market until 1 July 2023.
5. Liquids containing nicotine, nicotine-free liquids or other components of electronic vapour products that meet the requirements of Tobacco and Smoking Products Order as of 31 December 2022 may be placed onto the market until 1 October 2023, provided:

Article II
These products were produced or released for free circulation before 1 July 2023; and

for which no later than the day of issue of the State Gazette, in which the Order of the State Secretary for Health, Welfare and Sport of 22 November 2022, amending the Tobacco and Smoke Products Regulation for the regulation of flavours of e-cigarettes (State Gazette 2022, ....), a notification as referred to in Article 4.6 of the Decree has been made through the common entry gate.

ARTICLE II

This Order shall come into force on 1 January 2023.

This Order and the explanatory notes shall be published in the Government Gazette.

,
The State Secretary for Public Health, Welfare and Sport, M van Ooijen

Let op: vul A.U.B. de ondertekengegevens NIET handmatig in. De ondertekengegevens “OndertekeningFunctie” en “OndertekeningNaam” worden automatisch door Marjolein ingevuld. NB: please DO NOT enter the signature details by hand. Marjolein will automatically fill the ‘SignatureFunction’ [OndertekeningFunctie] and ‘SignatureName’ [OndertekeningNaam] fields. Daarbij mag dit gele plaatje NIET worden verwijderd! Bij digitaal onderteken wordt door Marjolein de juiste handtekening automatisch geplaatst en bij handmatig onderteken wordt dit plaatje vervangen door een aantal witregels. In addition, DO NOT remove this yellow box! For digital signing, Marjolein will automatically apply the correct signature and for manual signing, this box will be replaced with blank lines.
2 Government Gazette 2022 No 32367 28 November 2022

1 Government Gazette 2022 No 32367 28 November 2022

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