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ANSES Calls for the EC to Adopt a “More Protective” Definition of Nanomaterials

By Lynn L. Bergeson & Carla N. Hutton on May 31, 2023
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The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a May 17, 2023, news item stating that it believes that the European Commission’s (EC) revised Recommendation on the definition of nanomaterial, published in June 2022, “is too restrictive and could lead to a regression in the protection of public health and the environment.” ANSES “is therefore urging the French authorities to take a more inclusive definition into account and work towards its integration in the revision of sectoral regulations at [the] European level,” including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) regulations.

According to ANSES, the EC’s revised definition “tend[s] to restrict the number and type of objects that will ultimately be considered as such. Applied as it stands, this definition will, for example, lead to some nanoscale objects being overlooked, such as micellar nanovectors (vesicles, liposomes, lipid particles, etc.) designed to carry substances of interest in medicine, nutrition or agriculture, which are currently stimulating a great deal of interest and development.” Instead, ANSES recommends providing the “broadest possible definition” of the term “nanomaterial” based solely on dimensional criteria. ANSES also recommends establishing a uniform definition, regardless of the sector in which nanomaterials are used. ANSES calls for a broader definition of ”nanomaterial” than that recommended by the EC, to consider nanomaterials more comprehensively and not overlook any that could be a health concern. ANSES states that it developed a guide detailing the various parameters of such a definition, “pointing out those that may require choices to be made by the public authorities because they go beyond the strictly scientific field.” ANSES notes that in practice, it “invites the public authorities to take advantage of the revision of the European regulations on chemicals (REACH and CLP) and cosmetics to propose a broader definition. They will be able to do so once the review of other sectoral regulations has begun.”

Photo of Lynn L. Bergeson Lynn L. Bergeson

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…

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 process allows her to develop client-focused strategies whether advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.

Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

She served as chair of the American Bar Association Section of Environment, Energy, and Resources, and has served in many Section leadership positions. She has served on the Board of Directors of the Environmental Law Institute, the NanoBusiness Commercialization Association, and the Product Stewardship Society, among other business and law organizations, and lectures and writes frequently on legal, regulatory, and science policy issues. Ms. Bergeson is also President of The Acta Group (Acta®), B&C’s scientific and regulatory consulting arm, which assists chemical and product manufacturers in marketing and sustaining their products globally, and President of B&C Consortia Management, L.L.C., which helps the chemical industry leverage resources and maximize impact by forming consortia to achieve shared research, testing, regulatory, and access goals.

According to the Chambers USA Guide: “The universally highly regarded Lynn Bergeson of Bergeson & Campbell, P.C. has developed an enviable reputation in chemical and pesticide regulatory work, with particular expertise in nanotechnology. ‘She is probably the premier pesticide lawyer in DC,’ notes one impressed commentator. Peers predict that she is set to become ‘one of the most important lawyers in America.'”

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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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  • Posted in:
    Environmental and Climate
  • Blog:
    Nano and Other Emerging Chemical Technologies Blog
  • Organization:
    Bergeson & Campbell, PC

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