Tobacco Product Directive: Registration fee, annual fee, testing fee

As mentioned in earlier blog postings here, the various fees for being compliant with the Tobacco Product Directive is not set yet.

However:

Before the hearings, the Norwegian government informed that the fee could be around NOK 50.000 for registration, and an additonal NOK 20.000 a year for “maintenance”. In addition, there could be a fee for testing the product. This fee could be from NOK 50.000 to NOK 500.000 per product. If you change the contents of a product, you have to start all over.

TPD in Norway from July 1, 2017

Ordinary tobacco

The legal grounds for so-called “standardised tobacco packs” are made effective on July 1, 2017:

Both tobacco and snuff boxes will become green and unattractive to the consumer.

E-cigarettes

E-cigarettes and vapors are incorporated and made effective from the same date under the Smoke Act (“Røykeloven”). Various restaurants in Norway have made their premises “vaper friendly” and even invited vapers to vape in their restaurant. The owner of the premises cannot decide anymore if the premises could be used for vaping or not.

This means that vaping is prohibited in the following premises and areas:

  • Premises and means of transport where the public has access (§25)
  • Meeting rooms, workrooms and catering facilities (§25). There are some strict exceptions for nursing homes, drilling platforms, etc.
  • Outdoor entrances to health institutions and public enterprises (§25)
  • Kindergartens and surrounding areas (§26)
  • Schools are surrounding areas. Pupils has to be tobacco-free during school hours (§27)

The introduction of these new regulations mentioned above will not affect importing or sales of the products.

TPD

After a long battle against the introduction of the EU Tobacco Product Directive (TPD), the vaping products have been subject to the EU tobacco legislation. The vaping products does not contain tobacco. Hence, they shouldn’t be a part of the TPD.

In Norway, the authorities received 643 responses from various organisations as a response on the development of this new legislation. Most of the responses was filed from the vaping organisations, especially Norsk Dampselskap (NDS). NDS also participated in the hearings organised by the National Health Committee.

The new legislation is now (April 2017) published but not implemented.

There has been an ongoing process between EFTA and the EU regarding the tobacco directive. This is also the reason why there are delays in the process of incorporating the directive. It was proposed that amendments to the Tobacco Injury Act should be implemented from July 1, 2017, but this is now postponed to January 2018. The Parliament must consent to the inclusion of the Directive in the EEA Agreement and they have their Summer holiday every year from June to October.

Restrictions and fees

Requirements and the size of the fees are not published as of April 2017.

Probable requirements are:

  • The volume of tanks should not exceed 2 ml.
  • E-liquid cannot be sold in containers above 10 ml.
  • Nicotine strength cannot exceed 20 mg/ml unless a product is registered specifically as a medical product and sold as a medical product.
  • Child protection is required.
  • Certain additives become illegal, for instance dye and caffeine.
  • Health warnings are mandatory and will be standardised and must be in Norwegian.
  • Content attachment is mandatory.
  • Products must be registered via Helsedirektoratet (Directorate of Health) to be allowed to be sold in Norway.

How can consumers buy vape equipment and e-liquid after the legislation is implemented?

Vape equipment will be a part of the tobacco legislation, because vape equipment is defined as “tobacco surrogate”. You can buy this legally in Norway.

Right now (April 2017), it’s not allowed to sell or buy e-liquid with nicotine in Norway.

E-liquid with nicotine can be bought from countries within the EU/ EEA which is allowed to sell e-liquid with nicotine: If e-liquid with nicotine is allowed in the country you are importing from, and the country is a member of EU or EEA, you are allowed to import it into Norway.

You cannot import from Denmark, Finland and Hungary.

One obvious solution for Norwegian vapers is to travel to Sweden and buy whatever they want there. Half of the Norwegian population live in Eastern Norway (greater Oslo area), which is within driving range from Sweden.

Alternatively Norwegians can import e-liquids with nicotine by ordering online.

Regardless of the Sweden-solution or the online-solution, Norwegians can import up to 10800 mg (equivalent to three months supply) e-liquid with nicotine, but for personal consumption only.

E-liquid with nicotine is today (April 2017) regulated by the Medicines Act in Norway.

After July 1, 2017, consumers may be required to produce a medial certificate to confirm that the e-liquid is used for smoking cessation. This certificate can for example state

“LEGAL DECLARATION

This patient uses nicotine-containing inhalation fluid in the case of smoke depletion and has the right to import such products for his own consuption only. Smoking cessation is recommend by the doctor.”