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June 13, 2017

Sweden to Require Information on Nanomaterials in Product Register Notifications

Lynn L. Bergeson Carla N. Hutton

On June 7, 2017, Sweden notified the European Commission (EC) that it intends to amend the information requirements concerning the Swedish Chemicals Agency’s (KEMI) product register to require notifiers to provide information on nanomaterials contained in the product.  Under the draft regulation, the requirement will apply to nanomaterials that have been intentionally added to the product, regardless of the concentration of the nanomaterials.  The definition of nanomaterial will reflect the EC’s recommended definition, except that nanomaterials that are natural or incidental shall not be notified to the product register.  Exemption from the notification obligation is proposed for nanopigments and for entities with an annual turnover of less than SEK 5 million.  Those covered by the exemption will provide information only as to whether a component is a nanomaterial.  Other information may be provided on a voluntary basis.  These exceptions will be valid for an evaluation period of three years.  Product groups that are already exempt from the required registration in the product register will remain exempt, including waste, foodstuffs and animal feed, medicinal products, cosmetics, and tattoo inks.  KEMI intends the rules on notification of nanomaterials to the product register to enter into force on January 1, 2018.  Information on the presence of nanomaterials will be reported to KEMI’s product register beginning in February 2019.