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ECHA Publishes Q&A Document Following the April 5, 2023, PFAS Restriction Proposal Online Information Session

By Lynn L. Bergeson, Carla N. Hutton & Edith G. Nagy on May 4, 2023
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The European Chemicals Agency (ECHA) published on May 3, 2023, the Question and Answer (Q&A) document following the April 5, 2023, online information session on the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. As reported in our April 7, 2023, memorandum, national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted the proposal after finding risks in the manufacture, placement on the market, and use of PFAS that are not, in their view, adequately controlled and need to be addressed throughout the European Union (EU) and the European Economic Area (EEA). The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. A six-month consultation on the proposal started on March 22, 2023. The April 5, 2023, online information session explained the restriction proposal, how the REACH restriction process works, and how to participate in the consultation.

ECHA will publish the Q&A document in two parts. The first part, published on May 3, 2023, focuses on questions regarding the consultation, the evaluation, and the opinion-making process by ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC), and the REACH restriction process. The responses to these questions come from ECHA experts. The second part of the Q&A document, which ECHA expects to publish later in May or in June 2023, will focus on questions regarding the content of the proposed restriction and will include replies from the five national authorities that have prepared the proposal.

In this first Q&A document, readers can find responses to practical questions regarding the consultation and submitting information, such as where to find certain information or documents, how to submit comments, or how to claim information as confidential. Other questions relate to the opinion-making process by ECHA’s scientific committees, for example, how the committees will manage the expected flood of derogation requests received during the consultation. Lastly, the Q&A document provides responses to miscellaneous questions relating to the provisions of the restriction proposal, such as what types of PFAS would be covered, how the restrictions would apply in practice, or how the proposed restrictions would relate to existing restrictions on PFAS.

A similar blog post will be published here and on The Acta Group’s (Acta®) PFAS Resource Center upon publication by ECHA of the second part of the Q&A document.

The scientists, regulatory specialists, business consultants, and attorneys of Acta and our affiliated law firm Bergeson & Campbell, P.C. (B&C®) relentlessly participate in and track developments regarding the global regulatory approach to PFAS. We offer a PFAS Resource Center, a constantly updated library of PFAS resources, to help those in the chemical and chemical products industry understand what they need to know and what it means to their business.

Photo of Lynn L. Bergeson Lynn L. Bergeson

President of The Acta Group (Acta®), Ms. Bergeson counsels clients on issues pertaining to chemical hazard, exposure and risk assessment, and risk communication. She has earned an international reputation in the legal and regulatory aspects of conventional and nanoscale chemical regulatory…

President of The Acta Group (Acta®), Ms. Bergeson counsels clients on issues pertaining to chemical hazard, exposure and risk assessment, and risk communication. She has earned an international reputation in the legal and regulatory aspects of conventional and nanoscale chemical regulatory programs under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and on issues pertinent to nanotechnology and other emerging transformative technologies. Specialties include chemical product approval and regulation under TSCA, FIFRA, and REACH, as well as nanoscale substances and nanomaterials law, policy, and regulation.

Today, Ms. Bergeson works with corporations and a wide range of trade associations on evolving regulatory and policy matters pertinent to products of conventional, biotechnology, biobased chemicals, nanotechnologies, and other emerging technologies particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

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Photo of Carla N. Hutton Carla N. Hutton

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…

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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Photo of Edith G. Nagy Edith G. Nagy

Edith G. Nagy is a Regulatory Consultant with The Acta Group (Acta®). Ms. Nagy assists multinational companies with matters pertaining to product registration, chemical hazards, data compensation, enforcement actions/dispute resolution, risk communication, and evolving regulatory and policy matters regarding conventional and…

Edith G. Nagy is a Regulatory Consultant with The Acta Group (Acta®). Ms. Nagy assists multinational companies with matters pertaining to product registration, chemical hazards, data compensation, enforcement actions/dispute resolution, risk communication, and evolving regulatory and policy matters regarding conventional and nanoscale chemicals.

Ms. Nagy assists clients with Toxic Substances Control Act (TSCA) compliance, including assisting companies in responding to Information Request Letters (IRL), Significant New Use Rules (SNUR), Premanufacture Notices (PMN), and Chemical Data Reporting (CDR). She also offers support for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossiers in the European Union (EU) and in markets that recently passed new or amended chemicals regulation frameworks (United Kingdom (UK), Turkey, South Korea, Canada, and Latin America).

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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    REACHblog™
  • Organization:
    The Acta Group

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