The Danish Order on a register of mixtures and articles that contain nanomaterials as well as the requirement for producers and importers to report to the register entered into force on June 18, 2014. The Order establishes a Nano Product Register of mixtures and articles that contain nanomaterials and are intended for sale to the general public. The Danish Environmental Protection Agency will maintain the Nano Product Register.
Mixtures and articles that contain nanomaterials and are intended for sale to the general public are required to be listed on the Register where: (1) the nanomaterial is released under normal use of the mixture or article, or (2) the nanomaterial releases substances in soluble form that are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) or environmentally dangerous.
Food-contact materials are exempt from the requirement to be listed on the Register pursuant to Article three of the Order. Other exemptions apply for medicinal products, medical devices, cosmetics, pesticides, articles and labels to which the nanomaterial is applied directly as ink, and mixtures and articles containing nanomaterials that are not intentionally produced in nanoscale form.
The definition of a nanomaterial in the Danish Order, which follows the European Commission Recommendation 2011/696/EU definition, is "a natural, incidental, or manufactured material that contains particles in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm (nanometres)."
The first reports are due by August 30, 2015, for the period of June 20, 2014 to June 20, 2015.