The Public Health Agency of Sweden
Updated 13 June 2018

Exceptions to the requirement for a permit

Information about the Public Health Agency's regulations FoHMFS 2014:3 on exceptions to the requirement for a permit in accordance with the Prohibition of Certain Goods Dangerous to Health Act (SFS 1999:42). The regulations only concern gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD).

Background

On 1 May 2006, the Public Health Agency took over the responsibility from the Medical Product Agency for licensing, surveillance, and regulation in accordance with the Prohibition of Certain Goods Dangerous to Health Act (SFS 1999:42). At the same time, regulations on exceptions to the requirement for a permit were issued (FHIFS 2006:1).

These regulations were revised in January 2014 with the purpose of facilitating the handling of mixtures containing GBL and 1,4-BD (FoHMFS 2014:3).

The Public Health Agency's regulations, FoHMFS 2014:3 (in Swedish)

The definition of mixtures complies with the Swedish Chemicals Agency's Classification and Labelling Regulations (KIFS 2005:7).

  • Mixtures: combinations or solutions composed of two or more substances.
  • Chemical products: chemical substances and mixtures of chemical substances.

The new regulations

Exceptions to the requirement for a permit applies to the person who handles mixtures containing GBL and/or 1,4-BD for industrial or scientific purposes and who meets the demands of the exception to the requirement for a permit in accordance with 2 § of the regulations.

The requirements in accordance with 2 § of the regulations state that the GBL and 1,4-BD cannot easily be extracted through methods that are easy to apply or are profitable.

The responsibility for assessing whether a mixture containing GBL and/or 1,4-BD meets the demands of the exception to the requirement for a permit lies with the person who handles the mixture.

For example, denaturations can be exempted from the requirement for a permit if they meet the demands stated above.

If the demands are not fulfilled, one can apply for a permit according to these instructions.