Product Registration Requirement for Nanomaterials Required in Sweden

As of January 1, 2018, notifiers are now required to provide information on nanomaterials contained in chemical products in Sweden according to a decision made by The Swedish Chemicals Agency (KEMI) in December 2017. The first reports under the new rule are due in February 28, 2019. The rule applies to all chemicals in which nanomaterials have been intentionally added and serves to assess how many and for what purpose nanomaterials are being used in Sweden. The European Commission's definition of a nanomaterial will be used under this rule (Please see the EC website for their full nanomaterial definition). It has been proposed that nanopigments and entities with an annual turnover of less than SEK 5 million should be exempt from this rule.

The following stakeholders are subject to the reporting requirements:

  • Manufacturers or importers of chemical products and biotechnical organisms;
  • Companies which package, repackage or change the names of chemical products or biotechnical organisms for distribution;
  • Companies which make mixtures of chemical products and biotechnical organisms for distribution;
  • Manufacturers or importers of notifiable chemical pesticides; and
  • Third parties that report the products on behalf of manufacturers or importers.

Companies will be required to report the classification of the nanomaterial according to CLP Regulation, what purpose the nanomaterial has in the specific product, primary particle size, and average size of the agglomerate or aggregate for nanomaterials usually found in a product in an agglomerated or aggregated state. Companies also need to report properties including the nanomaterial shape, crystal structure, surface area, and surface treatment.