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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > Sweden Announces Product Registration Requirement for Nanomaterials

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
On December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products.

December 7th, 2017

Sweden Announces Product Registration Requirement for Nanomaterials

On December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products. See https://www.kemi.se/nyheter-fran-kemikalieinspektionen/2017/kemikalieinspektionen-infor-anmalningskrav-for-nanomaterial/ The announcement, available in Swedish, states that the requirement will enter into force on January 1, 2018, and the first reports will be due in February 2019. According to KEMI, the purpose of the new notification requirements is to obtain information on the identity and quantity of the nanomaterials used in Sweden. As reported in our June 13, 2017, blog item, on June 7, 2017, Sweden notified the draft regulation to the European Commission (EC). See https://nanotech.lawbc.com/2017/06/sweden-to-require-information-on-nanomaterials-in-product-register-notifications/ 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.

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