Regulatory Focus™ > News Articles > New ISO Standard Released for Characterizing Nanoparticles

New ISO Standard Released for Characterizing Nanoparticles

Posted 03 July 2012 | By Alexander Gaffney, RAC 

The International Standards Organization (ISO), an international body whose standards are often used by regulatory authorities, has unveiled new guidance on conducting toxicology tests on nanomaterials.

ISO's 3 July 2012 technical report, "Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment" (ISO/TR 13014:2012) is intended to be used to help researchers understand a nanomaterial's physicochemical properties before subjecting them to toxicological testing.

"By understanding the chemical and physical characteristics of nano-objects, we are working to decrease toxicity of materials and promote the development of safer alternatives," Dr. Richard Pleus, ISO's team lead for the standard, said. "The work done in this document has a fundamental importance in toxicology, as it tells scientists the material being tested needs to be understood: What does it look like? What is it made of? How does it interact with the surrounding environment?"

ISO's effort is the latest in a long line of efforts by regulatory agencies to better understand the potential risks associated with nanotechnology-derived products. In April, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her agency was likely to become "more nuanced" in approach to nanomaterial regulation over time.

The agency released a draft guidance in April for nanomaterials in cosmetic products as part of an "FDA-wide nanotechnology regulatory science program to further enhance FDA's scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products."

Read more:

ISO report on toxicological tests for nano-objects

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