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Health, Environment, and Justice Organizations Seek Clarification from ECHA on Nano and Biocidal-Treated Products

On January 20, 2021, Health Care Without Harm (HCWH) Europe and 12 other health, environment, and justice organizations sent a letter to Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA) “seeking clarifications on both the applicable legal framework and risk management measures in place, for nano/biocidal-treated articles in the context of the current COVID-19 pandemic.”  The letter states that “[a]s a result of laboratory tests supposedly showing antiviral activity against a range of viruses, the use of biocides/nanoparticles to combat SARS-CoV-2 transmission (particularly silver) is rapidly growing.”  According to the letter, the European Union (EU) market currently includes products such as face masks treated with silver, zinc oxide, or copper nanoparticles; “anticovid” paper containing nanostructured zinc-silver; and nanosilver-containing surface disinfectants.  The letter states that according to market research, “the demand is growing for antimicrobial and antiviral nanocoatings as (new) products come to the market.”  The organizations seek clarification on several issues, including the following ones regarding nanomaterials:

  • While articles treated with a biocide placed on the EU market do not need authorization, individual active biocidal substances must be approved (or reviewed) under the Biocidal Products Regulation (BPR) before being used in the EU.

    • What measures are/will be taken regarding nano-treated masks sold on the EU market for example?

  • Under the BPR, when a treated article placed on the market refers to the biocidal properties of the active substances contained therein, the label should include a statement that the treated article incorporates biocidal products, the names of the active substances, and if present, the names of each biocidal (nano-)substance followed by the word “nano” in brackets. The recently published report on the first harmonized enforcement project (BEF-1) held under the umbrella of the BPR Subgroup of the Enforcement Forum reveals that in 2019 the quality of information provided on these labels was inadequate in 36% of cases, and that basic information, such as the name of the biocidal active substance used for treatment of the product, was often missing.

    • As this report only covered treated articles in 2019, and considering the significant rise of biocide/nanomaterial treated articles in 2020, is ECHA considering an extra compliance check in the near future?

    • Is a list of all “antimicrobials” used in newly marketed products treated with biocides available (which chemicals and in which (nano?-)forms)?

  • The anti-pathogen properties of certain nanoparticles may also make them toxic to human cells and organ systems. Potential exposure largely depends on whether nanoparticles can migrate into the human body and/or the environment.  Risks may be higher if products are older or worn down by abrasion, weathering, or disposal.  The most relevant and concerning exposure routes are inhalation, dermal, and ocular.  Can you clarify what are the obligations of manufacturers to study and report on biocides/nanoparticles migration (or confirm a lack thereof) throughout the product lifespan?

The 12 other health, environment, and justice organizations that signed the letter are Association de Veille et d’Information Civique sur les Enjeux des Nanosciences et des Nanotechnologies (AVICENN); Agir pour l’Environnement (France); BUND/Friends of the Earth Germany; Center for International Environmental Law (CIEL); ClientEarth; Ecologistas en Acción; European Environmental Bureau (EEB); Health and Environment Alliance (HEAL); Health and Environment Justice Support (HEJSupport); Pesticide Action Network Germany (PAN Germany); Women Engage for a Common Future (WECF); and ZERO — Association for the Sustainability of the Earth System.

©2023 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 27

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 client...