Electronic cigarettes are a relatively new product on the Swedish market. If you import, manufacture or sell liquids for e-cigarettes you are responsible for ensuring that the products conform to the requirements of several legislations. This information concerns mainly the legislations for which the Swedish Chemical Agency and the Public Health Agency of Sweden are responsible.
Liquids for e-cigarettes, also known as e-liquids, are regarded as chemical products and therefore covered by several different legislations. In addition to general rules for chemical products, e-liquids that contain nicotine are also covered by specific legislation on electronic cigarettes, which implements parts of the EU Tobacco Products Directive. The authorities responsible for the legislations are the Swedish Chemical Agency and the Public Health Agency of Sweden. The specific legislation on electronic cigarettes is hereafter mentioned as the legislation on e-cigarettes.
As well as the common EU rules in the Tobacco Products Directive and in the CLP Regulation on classification, labelling and packaging, e-liquids are also covered by rules that apply in Sweden only, for example notification to the Swedish Products Register.
E-liquids without nicotine are not covered by the legislation on e-cigarettes, but the CLP Regulation and other rules for chemical products apply.
Duplicate rules for e-liquids containing nicotine
Some rules for e-liquids overlap each other, such as requirements for product notification, information requirements and rules for the design of packaging. Both the CLP Regulation and the legislation on e-cigarettes set requirements that you must inform about content and hazardous properties, as well as how containers for e-liquids must be designed. You may also need to notify your e-liquids and report sales volumes to both the Public Health Agency of Sweden and the Swedish Chemicals Agency.
Swedish permit rules
According to the Swedish permit rules, a permit is required for the professional sale and private handling of chemical products that are very hazardous. Very hazardous chemical products are for example those which are classified as acutely toxic and labelled with the skull and crossbones symbol, in accordance with the CLP-regulation.
Previously the Swedish Chemical Agency’s assessment was that the Swedish rules on permits for very hazardous chemical products should apply to e-liquids containing nicotine. The Swedish rules on permits for very hazardous chemical products would then restrict some e-liquids labelled with the skull and crossbones symbol although the content of nicotine in the liquids is allowed according to the EU Tobacco Products Directive.
However, we have reconsidered our previous assessment and have reached the conclusion that there is no legal basis to apply the Swedish permit rules on liquids containing nicotine. Therefore, a restriction due to national permit rules is not without reason allowed according to the Tobacco Products Directive.
Thus, our new assessment means that the Swedish rules on permits for very hazardous chemical products may not apply to e-liquids covered by the Tobacco Products Directive.
However, the rules on permits for very hazardous chemical products shall apply to e-liquids that are not covered by the Tobacco Products Directive, provided that the products are considered to be very hazardous due to their classification and labelling.
Labelling and packaging of e-liquids
Requirements according to the CLP Regulation
The CLP Regulation contains common EU rules for classifying, labelling and packaging of chemical products. Those who sell e-liquids need to be aware of and follow these rules. The labelling must be in Swedish and it must inform about the product’s hazardous properties and how it can be handled safely. The information in the labelling depends on which hazardous substances are included and how the product is classified.
Many e-liquids containing nicotine or other hazardous substances needs to be classified and labelled according to the CLP Regulation. However, there are also nicotine free e-liquids or liquids with low concentrations of nicotine or other hazardous substances, that do not need to be labelled according to the CLP-regulation.
According to the CLP Regulation, information about the product’s hazards must also be included in advertising, such as when you market it on a website. In this way, customers may receive information about the product’s hazards before they buy it.
Depending on how the e-liquid is classified, the packaging may need to have a child-resistant fastening or a tactile warning of danger. The packaging of hazardous chemical products shall not have a shape or design that might attract children or mislead consumers. Neither shall it have a design that might be confused with food, medicines or cosmetics, for example.
Requirements according to the legislation on e-cigarettes
The legislation on e-cigarettes also have requirements for the labelling and design of the containers of e-liquids with nicotine.
Notification of e-liquids
The Products Register
If you manufacture e-liquids or import them into Sweden, you must give notification of your activities to the Swedish Chemicals Agency’s Products Register. If the annual volume per product is at least 100 kg, you must also register the e-liquids and report the quantities.
The Swedish Poison Information Centre
According to the CLP Regulation, if you manufacture or import e-liquids you may need to provide information about the e-liquids to the Swedish Poison Information Centre. You can follow the link below to read more about what information must be provided, how it is to be submitted and who needs to submit the information. The Swedish Poison Information Centre may need to use this information in the event of an accident.
The Classification and Labelling Inventory
Those who import liquids for e-cigarettes may also need to provide information about the classification and labelling of the substances in the liquids to the Classification and Labelling Inventory of the European Chemicals Agency (ECHA).
The Public Health Agency of Sweden and local authorities
Manufacturers and importers of e-cigarettes and refill containers must make a product notification and report sales volumes annually to the Public Health Agency of Sweden. Only liquids containing nicotine needs to be notified. In the case of cross-border distance sales, the sales volumes must be reported to the Public Health Agency of Sweden. Shops that sell e-liquids containing nicotine must instead report their sales to their local authority.
As a manufacturer, importer or distributor of e-liquids in Sweden, you are responsible for ensuring that the liquids comply with the requirements of the various legislation. In addition to the rules that have already been mentioned, e-liquids may be covered by requirements in other chemicals legislation. For example, you may need to provide safety data sheets in Swedish, according to the rules of the REACH Regulation.
If you also sell electronic cigarettes, you are responsible for ensuring that these comply with the requirements of various legislation for articles, such as the EU rules for electrical and electronic equipment in the RoHS Directive.
Certain nicotine products have been subject to a specific nicotine tax since 1 July 2018. Liquids for electronic cigarettes that contain nicotine are also covered by this tax.