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Volume XIII, Number 266

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

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.”

©2023 Bergeson & Campbell, P.C.National Law Review, Volume XIII, Number 152
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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

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...

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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...

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