January 23, 2022

Volume XII, Number 23

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January 21, 2022

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January 20, 2022

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German Agencies Publish Joint Perspective on Risk Governance of Advanced Materials

In December 2021, the German Environment Agency (UBA) published a document entitled Risk Governance of Advanced Materials: Considerations from the joint perspective of the German Higher Federal Authorities BAuA, BfR and UBA. The document summarizes the current activities, considerations, and recommendations of UBA, the German Federal Institute for Risk Assessment (BfR), and the Federal Institute for Occupational Safety and Health (BAuA) aiming to establish good governance of advanced materials to ensure their responsible development, use, and recycling considering human and environmental safety. Within the document, advanced materials are understood as “materials that are rationally designed through the precise control of their composition and internal or external structure in order to fulfil new functional requirements.” The document notes that this working definition “is explicitly not intended as a basis for fundamental regulation of [advanced materials] or to be used in an existing regulation!” According to the document, chemicals legislation in the European Union (EU) in general covers advanced materials, although most of the statutes neither explicitly mention advanced materials nor provide specific requirements for most advanced materials. Some regulations include provisions and/or guidance specifically addressing nanomaterials, however. The document states that due to their complexity and broad possibilities for application, the distinction of an advanced material being a substance, mixture, or article “might be hampered which challenges legal clarity on regulatory requirements.” To identify materials that give rise to specific concerns, the agencies propose to implement the term “materials of concern,” along with the following criteria to decide whether a material falls under that term:

  1. A material meeting the criteria for classification as a “hazardous substance” or “hazardous mixture” within the meaning of the criteria set out in Annex I to the Regulation on classification, labeling, and packaging of substances and mixtures (EC 1272/2008);

  2. A material from which hazardous substances or mixtures according to (i) can arise or be released during its production or over its life cycle;

  3. A material that does not meet criteria (i) or (ii) but which, because of its morphological, physico-chemical, chemical, (eco)toxicological, or release properties, could pose a risk to humans or the environment during its production or over its life cycle; or

  4.  A material that could pose a concern regarding additional sustainability aspects.

The agencies’ recommendations include proposals to promote action on safe handling and to foster sustainable development of advanced materials, including:

  • Identifying materials of concern by setting criteria and an early warning system;

  • Enabling regulatory preparedness and shaping regulations to keep the regulatory framework up to date;

  • Promoting safe and sustainable design of advanced materials;

  • Supporting stakeholder exchange and co-creation; and

  • Ensuring adequate regulation by enhancing preparatory research and strengthening regulatory research.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 12
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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

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 process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
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...

202-557-3809
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