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ECHA Urges Companies to Provide More Data on Nanoforms

The European Chemicals Agency (ECHA) issued a press release on February 24, 2020, stating that it has received a low number of registration dossiers for nanomaterials.  ECHA states that it has received only 95 unique submissions for 36 substances covering nanoforms according to the updated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements.  ECHA expected to receive updated registrations for approximately 300 substances, based on data from the Belgian and French national inventories and the European Commission’s (EC) catalog of nanomaterials used in cosmetic products.  With the submission rate so low and half of the incoming dossiers failing the technical completeness check, ECHA notes that a webinar is available with practical advice for companies on how to prepare their registration dossiers for nanoforms.  According to the press release, ECHA is working closely with key industry associations and Member States to understand better the additional actions needed to raise awareness on the legal obligations.  ECHA states that it is also engaged in several short-term actions to help improve compliance, for example, by revising the Nanomaterials Expert Group’s mandate to allow more support for decision making and updating manuals, instructions, and guidance for human health and environmental endpoints.  Where validated test methods for meeting REACH Annexes VII and VIII information requirements are not yet available, ECHA has published a template to support registrants in documenting practical constraints and to help ensure they can show they have made all possible efforts to meet the information requirements.  ECHA reminds companies that without a valid registration, nanomaterials that fall within the scope of REACH are currently illegally on the market.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 55

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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...

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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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