Notification Detail

Draft regulations relating to tobacco and nicotine products, electronic cigarettes and refill containers

Notification Number: 2019/9019/N (Norway)
Date received: 21/11/2019
End of Standstill: 24/02/2020

da de en fr
de en fr


Message 901

Communication from the Commission - TRIS/(2019) 03252
Procedure for the provision of information EC - EFTA

Notificación - Oznámení - Notifikation - Notifizierung - Teavitamine - Γνωστοποίηση - Notification - Notification - Notifica - Pieteikums - Pranešimas - Bejelentés - Notifika - Kennisgeving - Zawiadomienie - Notificação - Hlásenie-Obvestilo - Ilmoitus - Anmälan - Нотификация : 2019/9019/N - Notificare.

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201903252.EN)

1. Structured Information Line
MSG 901 IND 2019 9019 N EN 21-11-2019 N NOTIF


2. Member State
N


3. Department Responsible
Royal Ministry of Trade, Industry and Fisheries
Departement of Trade Policy
P.O. Box 8090, Dep
NO-0032 Oslo
Norway

Email: technicalregulations@bis.gsi.gov.uk


3. Originating Department
Royal Ministry of Health and Care Services
Department of Public Health
P.O.Box 8011 Dep
0030 Oslo
Norway


4. Notification Number
2019/9019/N - X00M


5. Title
Draft regulations relating to tobacco and nicotine products, electronic cigarettes and refill containers


6. Products Concerned
Tobacco products, nicotine products, electronic cigarettes and refill containers;
retail and marketing


7. Notification Under Another Act
- Directive 2006/123/EC on services in the internal market
- 98/48/EC information society services only


8. Main Content
As an EFTA State, Norway has not yet implemented the Tobacco Products Directive 2014/40/EU (the TPD), but this is expected to happen shortly. Norway has previously notified legislative changes that go beyond the TPD
- 2015/9023 Requirement for Norwegian user manual for e-cigarettes and refill containers (statutory authority)
- 2016/9013 TPD Article 7(6) applied to oral tobacco (statutory authority)
- 2016/9021 E-cigarettes without nicotine must also register and are subject to the non-nicotine specific product requirements of the TPD

Norway is currently working on finalizing the regulations connected to the implementation of the TPD, and hereby notifies the following regulations that go beyond the TPD:

1) Deadline for the notification of changed or new products under TPD Art. 5(1) last paragraph: 12 weeks before placing on the Norwegian market.

2) TPD Art. 7(6) letters a), b) and e) are applied to oral tobacco. The provision bans certain additives creating the impression of health benefits or reduced health risk, such as vitamins, caffeine, taurine and additives that have CMR properties in unburnt form.

3) The precise positioning and format of health warnings mandated by TPD Art. 12 for smokefree tobacco. Size and design of mandatory cessation information.

4) Criterias for authorisation for novel tobacco and nicotine products, cf. TPD Article 19.

5) Language requirement on information supplied with electronic cigarettes, cf. TPD Article 20(4) letters a) and b) point (i). This information comprises the details on the label and in the instructions for use.

6) Requirement for age verification on delivery of tobacco products or e-cigarettes sold through distance sale, cf. TPD Article 18.

7) Registration system for delivery agents.

8) Excemption for e-cigarettes and refill containers from the Norwegian point of sale display ban.

9) Excemption for e-cigarettes and refill containers from the Norwegian advertising ban related to distance sale.


9. Brief Statement of Grounds
1) Deadline for notification of changed or new products under TPD Art. 5(1) last paragraph
Norway considers that the competent authority needs a periode of 12 weeks before a new or changed product is placed on the market, in order to do a pre-screening of the product ingredients and emissions, and to have an updated overview of the market. From what we understand, several EU States have such national deadlines.

2) TPD Art. 7(6) is applied to oral tobacco
Oral tobacco (snus) is not covered by the TPD Article 7 regarding ingredients, as stated in Article 7(15). Nevertheless, the TPD preamble point 20 states that since the Directive prohibits the placing on the market of tobacco for oral use in the EU, the responsibility for regulating the ingredients of tobacco for oral use should remain with Sweden where the sale of tobacco for oral use is permitted.

The sale of snus is in the same way permitted in Norway, and Norway is thus free to choose if and how ingredients in oral tobacco are to be regulated. The additives in Article 7(6) letters a, b and e increases the attractivness of oral tobacco, and creates an impression of health benefits or reduced health risks. The use of oral tobacco in Norway has increased dramatically in the last decade, especially among young people.

3) The precise positioning and format of health warnings mandated by TPD Art. 12 for smokefree tobacco. Size and design of mandatory cessation information.
Norway considers that there is a need to specify the positioning and format of the health warnings on smokeless tobacco products, among other things to ensure harmonisation with the Norwegian standardised packaging regulations. Norway has since 2009 (when combined health warnings were introduced in Norway), required all tobacco products to carry cessation information in connection to the health warning.

4) Criterias for authorisation for novel tobacco and nicotine products, cf. TPD Article 19
Norway has since 1989 had a ban on import and sale of novel tobacco and nicotine products. This ban will be lifted and replaced by an authorisation scheme according to the TPD Art. 19. Norway proposes to list the relevant assessment criterias in the regulations to ensure a balanced assessment of the authorisation applications.

5) Language requirement for information supplied with e-cigarettes, cf. TPD Article 20(4)
Norway currently has a ban on the import and sale of e-cigarettes with nicotine. When the TPD is implemented, this ban will be lifted. There has in many countries been an increase in cases of poisoning related to the use of electronic cigarettes. When allowing electronic cigarettes on the Norwegian market, it is likely that more people will use them and that there will be an increase in cases of misuse and adverse effects. To avoid this, each electronic cigarette must be accompanied by an information leaflet in Norwegian instructing how to use the product safely and properly.

6) Requirement for age verification on delivery of tobacco products or e-cigarettes sold through distance sale, cf. TPD Article 18
To ensure that tobacco products and e-cigarettes are not handed over to any minors, Norway proposes that the undertaking delivering the products to the consumer, must ensure that the receiving person is above 18 years old. A system where tobacco products and e-cigarettes are sent directly through the post system is considered insufficient to enforce the minimum age limit.

7) Registration system for delivery agents
To ensure that tobacco products and e-cigarettes bought online are only handed out to consumers aged 18 or above, Norway proposes a duty for the undertaking delivering such products to be registered with the Norwegian Directorate of Health. The arrangement is considered to be necessary in order to ensure that the person doing the physical delivery has sufficient knowledge about the rules on age control. The requirement is not extensive, but sufficient to establish internal routines with the undertaker delivering the tobacco products and/or electronic cigarettes. The deliverer will receive information about the age limit when registering.

8) Excemption for e-cigarettes and refill containers from the Norwegian display ban
All tobacco products, tobacco imitations (except sweets) and tobacco surrogates (including e-cigarettes) are subject to a ban on the visible display at points of sale in Norway. Since e-cigarettes are a more varied product group, the consumer has a greater need to visually inspect the product before purchasing. It is therefore proposed to excempt e-cigarettes and refill containers from the point of sale display ban.

9) Excemption for e-cigarettes and refill containers from the Norwegian advertising ban related to distance sale
All types of advertising for tobacco products, tobacco imitations and tobacco surrogates (including e-cigarettes) are banned in Norway. This includes pictures/photos and product information online, as such information is considered to be indirectly promotional. The TPD Article 20(5) bans commercial communication online with the aim of direct or indirect effect of promoting e-cigarettes and refill containers. Since e-cigarettes are a more varied product group than tobacco products, there is a need for the consumers to visually see the products before purchasing. It is therefore proposed to excempt e-cigarettes and refill containers from the Norwegian advertising ban, insofar as that online stores may show pictures and neutrally describe the products. Norway has assessed whether such an excemption is in line with the TPD Article 20(5), without concluding, and would welcome views on this.


10. Reference Documents - Basic Texts
References of the Basic Texts: Basic text is attached (2 regulations).


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

Yes

SPS aspect

No - The draft is not a sanitary or phytosanitary measure



**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

Stakeholders Contributions

The TRIS website makes it easy for you or your organization to share your views on any given notification.

You may submit your position in any of the official languages of the EU. We encourage you to submit your opinion at least one month before the end of the standstill period to make sure that your views are duly considered taking into account the time needed for analysis and internal processing. In any event, your contributions will be accepted until 23:59:59 CET of the date of end of the standstill period. Your contribution will be made public in TRIS (translations into other languages will not be publicly available) unless you signal that you wish to keep them confidential.

Your views are important for the assessment of the notification by the Commission and the Member States. However, it is important to underline that any Commission decision is taken independently, in the light of the information in its possession and in line with its internal decision-making rules.

Please note you will not receive any further feedback concerning the merits of your contribution.

At the end of the standstill period, you will find at this webpage an indication of any formal reaction issued by the Commission and/or the Member States.


No contributions were found for this notification