Liquids for e-cigarettes
If you import, manufacture or sell liquids for electronic cigarettes, 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 legislation on e-cigarettes and in the CLP Regulation on classification, labelling and packaging, e-liquids are also covered by rules that apply in Sweden only, for example national permit rules for very hazardous chemical products.
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. This apply for instans for e-liquids with a high content of nicotine.
From the 1 of July 2022 there is a new exemption from the permit required. The new exemption applies for private handling of e-liquids containing nicotine in not more than 20 mg/ml. This means that private consumers can buy and handle e-liquids labelled with skull and crossbones without a permit. The exemption can be found in the Swedish Chemical Agency’s Regulations (KIFS 2021:8, , 29 kB. in Swedish).
Regarding the professional sale of very hazardous chemical products the permits will apply from the 1 July 2022. Previously, the Swedish Chemical Agency’s has assessed that the permit rules should not apply to e-liquids covered by the legislation on e-cigarettes pending investigation. However, according to our new assessment the requirement on permits shall apply for professional sale.
This means that if you are selling very hazardous e-liquids you will need a valid permit from the 1 July 2022. The requirement applies to all companies that sell e-liquids labelled with skull and crossbones in Sweden, regardless of whether you sell the product to another company or directly to private consumers. You apply for a permit from the county administrative board where you conduct your business.
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.
E-liquids without nicotine are not covered by the legislation on e-cigarettes, but the CLP Regulation and other rules for chemical products apply.
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 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 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 Poisons Information Centre
If you manufacture or import e-liquids classified as hazardous you may need to provide information that can be used for emergency medical advices. You submit the information via the European Chemical Agency's (ECHA) portal. In Sweden it is the Swedish Poisons Information Centre that shall have access to the data. In the link below you can read more about what information must be provided, how it is to be submitted and who needs to submit the information.
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.
The tobacco legislation also contains provisions on the marketing of e-cigarettes and refill containers. The Swedish Consumer Agency has developed general advice on these provisions (KOVFS 2019:2).
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.
Proposals for stricter legislation on new nicotine products
The Swedish Government has made a review on certain issues in the area of tobacco and similar products in Sweden and presented in March 2021 its final report SOU 2021:22 Hårdare regler för nya nikotinprodukter (only in Swedish). The report includes proposals about ban on flavouring of e-liquids.