The Public Health Agency of Sweden
Updated 4 July 2019

Rules regarding herbal products for smoking

The information on this page is for importers, manufacturers or traders of herbal products for smoking intended for consumers on the Swedish market. Here you will find information about rules under the Act and the Decree of tobacco and similar products and regulations that apply to herbal products for smoking.

What defines herbal products for smoking?

Herbal products for smoking means products based on plants, herbs or fruits which contains no tobacco and that can be consumed via a combustion process.

The Act shall not apply to herbal products for smoking classified as drugs under the Narcotics Drugs Punishment Act (1968:64) or as substances harmful to health according to the Act (1999:42) on the prohibition of certain goods dangerous to health.

General information

Rules regarding herbal products for smoking are mainly regulated in the Act and Decree on tobacco and similar products, and the regulations in accordance to this Act and Decree. There are no official translations of the Act, the Decree or the regulations into English or any other language. Links to the regulation in Swedish:

 

Providing herbal products for smoking to consumers on the Swedish market

If you provide herbal products for smoking to consumers on the Swedish market you must be aware of the following rules:

  • Reporting of ingredients of herbal products for smoking shall be done before you provide the product to consumer

  • Packaging of herbal products for smoking shall have correct health warnings.

If the herbal products for smoking do not comply with these rules it shall not be placed on the market. You can find more information about these rules further down on this page.

Reporting of ingredients of herbal products for smoking

Manufacturers and importers of herbal products for smoking are required to submit to the Public Health Agency of Sweden a list of all ingredients, and quantities thereof that are used in the manufacture of such products by brand name and type. Manufacturers or importers shall also inform the Agency when the composition of a product is modified in a way that affects the previous submitted information.

The above required information shall be submitted via EU-CEG six weeks prior to the placing on the market of a new or modified herbal product for smoking. This is also the case when you decide to remove herbal products for smoking from the Swedish market. In that case the product should be withdrawn in the EU-CEG with a withdrawal date.

For information about EU-CEG, ECAS account and Submitter ID see the following links:

Confidential data

In their submission, manufacturers and importers shall mark all information which they consider to be a trade secret or otherwise confidential and shall, upon request by the Agency, duly justify their claims.

Publicly available reports of ingredients of herbal products for smoking

Here you will find information submitted to the Public Health Agency of Sweden about the ingredients of herbal products for smoking and that is not considered as trade secrets.

We have the intension to make this information publicly avaliable during 2019.

Health warnings on packets of herbal products for smoking

Each unit packet and any outside packaging of herbal products for smoking that is intended for consumers on the Swedish market shall have health warnings. It is the manufacturer and importer that is responsible for supplying the packets with correct health warnings.

Each unit packet and any outside packaging of herbal products for smoking shall carry the following health warning:

Att röka denna produkt skadar din hälsa.

The health warning shall:

  • be printed on the front and back external surface of the unit packet and on any outside packaging

  • cover 30 % of the area of the corresponding surface of the unit packet and of any outside packaging

  • be printed in black Helvetica bold type on a white background

  • use the font size that ensures that the text occupies the greatest possible proportion of the surface reserved for the health warning

  • be at the centre of the surface reserved for them, and on cuboid packets and any outside packaging they shall be parallel to the lateral edge of the unit packet or of the outside packaging.

Forbidden elements or features on unit packets and any outside packaging of herbal products for smoking

Unit packets and any outside packaging of herbal products for smoking shall not include any elements or features that:

  • promotes a product or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions

  • labels shall not include any information about the nicotine, tar or carbon monoxide content of the product

  • suggests that a particular product is less harmful than others or aims to reduce the effect of some harmful components of smoke or has vitalising, energetic, healing, rejuvenating, natural, organic properties or has other health or lifestyle benefits

  • resembles a food or a cosmetic product

  • state that the product is free of additives or flavourings.

The elements and features that are prohibited may include but are not limited to texts, symbols, names, trademarks, figurative or other signs.