Liquids for electronic cigarettes and for refill containers for electronic cigarettes (e-liquids) containing not more than 20 mg/ml nicotine.

Draft regulations amending the Swedish Chemicals Agency’s regulations (KIFS 2017:7) on chemical products and biotechnological organisms

In order to handle particularly hazardous chemical products in a non-professional capacity, a permit is required in accordance with Chapter 7, § 1 of the Ordinance (2008:245) on chemical products and biotechnological organisms. What constitutes a particularly hazardous chemical product is laid down in Chapter 4, § 2 of the Swedish Chemicals Agency’s regulations (KIFS 2017:7) on chemical products and biotechnological organisms.

It can be inferred from the provision that, under certain conditions, e-liquids containing nicotine shall be considered to be particularly hazardous chemical products. The requirement to have a permit in order to handle particularly hazardous products in a non-professional capacity therefore includes, under certain conditions, e-liquids containing nicotine. The Swedish Chemicals Agency considers the requirement to have a permit in this
respect incompatible with provisions on the placing of electronic cigarettes and refill containers on the market in Directive 2014/40/EU of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products (Tobacco Products Directive).

Against the background outlined above, the Swedish Chemicals Agency proposes that an exemption is to be made from the requirement to have a permit in accordance with § 7, point (1) of the Ordinance on chemical products and biotechnological organisms. Since the transfer to someone who is going to handle particularly hazardous chemical products in a non-professional capacity in accordance with § 9, point (2) of said Ordinance
may take place only if they have a permit for such handling in accordance with § 7 of the same Ordinance, an exception from § 9, point (2) must be made to ensure that such transfer may take place to those who are now not going to need a permit for their handling in a non-professional capacity.

By virtue of the authorisation laid down in § 26 of the Ordinance on chemical products and biotechnical organisms, exceptions are to be regulated by the introduction of a new paragraph, Chapter 4, § 3a, in KIFS 2017:7.

The current draft regulation intends an exemption from the requirement laid down in § 7, point (1) of the Ordinance (2008:245) on chemical products and biotechnological organisms to have a permit for handling, in a non-professional capacity, liquids for electronic cigarettes and refill containers for electronic cigarettes (e-liquids) containing nicotine which, under the conditions specified in Chapter 4, § 2 of the Swedish Chemicals Agency’s regulations (KIFS 2017:7) on chemical products and biotechnological organisms are counted as particularly
hazardous products requiring a permit. The exception has been limited to e-liquids containing not more than 20 mg/ml nicotine. Since the transfer to someone who is going to handle particularly hazardous chemical products in a non-professional capacity in accordance with § 9, point (2) of said Ordinance may take place only if they have a permit for such handling in accordance with § 7 of the same Ordinance, an exception from § 9, point (2) is being proposed to ensure that such transfer may take place to those who are now not going to need a permit for their handling in a non-professional capacity. All e-liquids containing nicotine up to the specified strength that today require a permit may therefore be handled in a non-professional capacity without a permit in the event of the draft regulation being implemented. The exception applies regardless of where the product has been manufactured and regardless of the manufacturing rules that applied to the product’s manufacture. The
very purpose of the draft is to ensure compatibility with the provisions on the placing of electronic cigarettes and refill containers for electronic cigarettes on the market in Directive 2014/40/EU of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products (Tobacco Products Directive). Against the background outlined above, the Swedish Chemicals Agency considers there to be no
reason for a mutual recognition clause.