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Volume XIII, Number 156


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June 03, 2023

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ECHA Enforcement Forum Project Finds Most Downstream Users Adhere to “Fundamental” Authorization Duties

The European Chemicals Agency (ECHA) announced on March 8, 2023, the results of the Enforcement Forum’s European Union (EU)-wide project on inspections of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) authorization duties. During the project, the enforcement authorities of 28 countries carried out 690 inspections at 516 companies. According to ECHA, the most commonly controlled substances of very high concern (SVHC) were chromium trioxide and strontium chromate. The inspections primarily focused on downstream users, specifically small- and medium-sized enterprises (SME), who are the final users of the SVHCs.

ECHA states that in one of four inspections (26 percent) of downstream users, inspectors found that the substance was not used in compliance with conditions set out in the European Commission’s (EC) authorization decision granted to their supplier. Consequently, in these companies, workers or the environment were not being adequately protected from possible adverse effects of the SVHCs. According to ECHA, inspectors also discovered that for 20 percent of the checked authorized substances, downstream users did not notify ECHA of their use. In addition, for 35 percent of the checked substances, suppliers failed to communicate information about operational conditions, risk management, or monitoring arrangements specified in the authorization decision to the rest of the supply chain.

ECHA states that while there is “clear room for improvement in the levels of compliance” with specific authorization requirements, the results show that most downstream users adhere to the fundamental authorization duties. In three percent of the inspections, instances were uncovered where companies used or marketed substances without obtaining or applying for an authorization or being covered by an applicable exemption.

Enforcement Measures

According to ECHA, when finding non-compliance, inspectors took 254 enforcement measures to bring all companies into compliance. The measures included mainly written advice and administrative orders, as well as fines and, in some cases, criminal complaints.


The project report outlines recommendations for industry, the Enforcement Forum, national authorities, ECHA, and the EC. For example, suppliers of authorized substances should improve the quality of safety data sheets (SDS) while downstream users should ensure that the authorized substance is used in accordance with the conditions in the authorization decision.

To improve the implementation by duty holders and the enforceability of REACH authorizations, a number of recommendations are provided for the EC on the content and clarity of future authorization decisions.

©2023 Bergeson & Campbell, P.C.National Law Review, Volume XIII, Number 87

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...

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...