E-cigarettes and chemicals act

The Danish Safety Technology Authority has received several inquiries from the electronic cigarette industry about the interfaces between law on electronic cigarettes, etc. and the Chemicals Act.

Regarding the impact of the CLP regulation on the law on electronic cigarettes

Nicotine is a chemical, which has an EU harmonised classification as acutely toxic in category 1 by contact with skin and category 3 if ingested. Consequently, nicotine must, pursuant to the Chemicals Act, be marked with the indication of danger very toxic or toxic.

The Chemicals Act includes provisions on inter alia sale of very toxic and toxic substances and mixtures, including that such substances can only be sold against requisition signed by the police. The Chemicals Act includes, however, a provision that the law only applies to substances, mixtures or products in so far as other legislation includes no such provisions hereof.

The Act on electronic cigarettes, etc. handles the considerations for protection of human health which would otherwise be ensured by the Chemicals Act, in relation to electronic cigarettes and refillable containers with nicotine. Therefore, the Act on electronic cigarettes, etc. and not the Chemicals Act applies to electronic cigarettes and refillable containers with nicotine. Thus, the Chemicals Act’s requirements for sale against requisition signed by the police does not apply for electronic cigarette or refillable containers with nicotine.

CLP regulation on classification and labelling does, however, remain applicable

CLP regulation’s requirement for labelling applies in addition to the requirements for labelling according to the law on electronic cigarettes, etc. To the extent that electronic cigarettes and refillable containers with nicotine-containing mixtures exceed this lower limit, they shall also be labelled according to the CLP regulation.

Nicotine is toxic and has an EU harmonized classification as acute toxic 1 by contact with skin and acutely toxic category 3 if ingested, respectively.

Also other ingredients in e-cigarettes and refilling containers can be classified as dangerous. Depending on the concentration of nicotine and other hazardous substances in e-cigarettes and refillable containers, there may be requirements on classification and hazard labelling of these according to the CLP Regulation.

(Please note: In October 2016 EU approved an update to harmonized classification of nicotine as acute toxic category 2 by both ingestion, skin contact and inhalation. The new classification is expected to enter into force during 2018.)

The control of the CLP regulation in relation to electronic cigarettes and refillable containers with nicotine is handled according to the Act on electronic cigarettes, etc. by the Danish Safety Technology Authority.

As a consequence, to the Act on electronic cigarettes, etc. applying to electronic cigarettes and refillable containers, the Danish Safety Technology Authority supervises that electronic cigarettes and refillable containers with nicotine meet the CLP regulation’s requirements for classification and labelling according to the provisions of this Act on electronic cigarettes, etc.