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ECHA Interviews KEMI Regarding Nano Reporting Requirement

The May 2018 ECHA Newsletter includes an interview with Robert Johansson, Head of the Swedish Chemicals Agency’s (KEMI) Chemical Statistics and Registries Unit.  As reported in our December 7, 2017, blog item, KEMI has established a mandatory reporting scheme to obtain information on the quantities and types of nanomaterials used in Sweden, with the first reports due in February 2019.  According to Johansson, “[t]his information can then provide a basis for making changes to legislation or taking other measures regarding nanomaterials, in areas such as healthcare, the environment or workplace safety.”  The article provides the following list of actors required to notify if their products contain nanomaterials:

  • Professional manufacturers or importers of chemical products and biotechnical organisms;
  • Those who, in their own name, package, repackage, or change the names of chemical products or biotechnical organisms for further distribution;
  • Those who make mixtures of chemical products and biotechnical organisms for further distribution;
  • Manufacturers or importers of notifiable chemical pesticides; and
  • Third parties that report the products on behalf of the manufacturers or importers.

According to the article, Kemi expects to receive between 900 and 2,600 notifications.  The current reporting requirements include exemptions for nanomaterials that occur naturally or are accidentally produced, as well as nanomaterials used as pigments.  Johansson notes that these figures are somewhat uncertain and are based in part on a study made at the European Union (EU) level.  The article offers tips for other countries planning to establish a national registry.  Johansson suggested that when setting up a national registry, it should “be planned together with different stakeholders, taking into account their views and needs during the entire process.”

©2018 Bergeson & Campbell, P.C.

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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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