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Sweden to Require Information on Nanomaterials in Product Register Notifications

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.

©2017 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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