March 18, 2019

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Berlin Declaration on Nanomaterials Submitted to Environment Council of the Council of the EU

The Environment Council of the Council of the European Union (EU) met on October 9, 2018.  According to the outcome of the Council meeting, the items debated under any other business included the “Berlin Declaration” on nanomaterials, submitted by the German delegation and supported by the French and Luxembourg delegations.  The Berlin Declaration summarizes the conclusions and recommendations of the 12th International Nano-Authorities Dialogue of Germany, Liechtenstein, Luxembourg, Austria, and Switzerland, and was acknowledged by the environment ministers of those countries at their annual meeting in June 2018.  The Declaration “acknowledges the progress that has been made in the regulatory framework for nanomaterials in the last few years, and especially the European Commission’s Decision to adapt the annexes of the REACH Regulation to the requirements of nanomaterials.  It also sets out the needs identified for further activities in this field, most of which will have to be addressed at EU level.”  According to the Berlin Declaration, these needs include:

  • The adaptation of test methods within the context of the Organization for Economic Cooperation and Development (OECD);
  • A transversal definition of nanomaterials in all relevant regulatory contexts in the EU;
  • The approach to be taken to the emerging topic of “advanced materials”;
  • The continued support of research activities and the small- and medium-sized enterprises (SME) in the field of nanomaterials; and
  • Provisions to give the European Chemicals Agency (ECHA) a permanent mandate for the EU Observatory for Nanomaterials (EUON).

Germany asked the Environment Council to take note of the Declaration.

©2019 Bergeson & Campbell, P.C.


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...

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.