September 19, 2018

September 19, 2018

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September 18, 2018

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September 17, 2018

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ECHA Article Addresses New REACH Information Requirements for Nanomaterials

The September 2018 issue of the ECHA Newsletter includes an article entitled “Are the new REACH information requirements for nanos relevant for you?” written by Jenny Holmqvist, Coordinator for Nanomaterials for the European Chemicals Agency (ECHA).  As reported in our April 26, 2018, blog item, the European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials.  Holmqvist’s article provides answers to what the revised Annexes change, who the changes impact, when the new Annexes come into force, what ECHA is doing to help companies prepare, whether there are test methods already available to comply with the amended requirements, and if the new information requirements imply that nanomaterials on the European Union’s (EU) market are unsafe.  Holmqvist recommends that manufacturers and importers familiarize themselves “at the earliest opportunity, with the introduced changes to assess whether they are relevant for your substances.”  Industry must comply with the new requirements by January 2020.  ECHA is examining which parts of the existing guidance need to be updated or whether new guidance is necessary.  Holmqvist states:  “We also plan to increase our efforts in reaching out to industry organisations both in bilateral meetings and also through our guidance process.  This way, we hope to ensure that there is sufficient support available for companies that are preparing possible updates to their registration dossiers.”  Regarding whether the new information requirements imply that nanomaterials currently on the market are unsafe, Holmqvist notes that “without changing the legal information requirements, it would be very difficult for authorities to verify whether companies registering their chemicals have demonstrated the safe use of nanomaterials throughout the supply chain or whether further regulatory actions for managing their risks would be needed,” emphasizing the word verify.  Holmqvist states:  “I think we all agree that the realisation of the great opportunities that nanotechnology and nanomaterials may offer society should go hand-in-hand with the transparent demonstration by industry of their safety and sustainability.”  The article lists the following guidance that is already available to help companies prepare for the revised information requirements:

©2018 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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