Minimum physicochemical characterisation requirements for nanomaterial regulation

• Published in: Environment international 2013-02, Vol.52, p.41-50
• Main Authors: Pettitt, Michala E., Lead, Jamie R.
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Characterisation; Chemical and industrial products toxicology. Toxic occupational diseases; Ecotoxicology; Environment; Environmental Policy; Environmental Pollutants - chemistry; Environmental Pollutants - standards; Humans; Inorganic dusts (pneumoconiosises) and organic dusts (byssinosis etc.); Medical sciences; Nanomaterial; Nanoparticle; Nanostructures - chemistry; Nanostructures - standards; REACH; Regulation; Toxicity Tests - standards; Toxicology
• ISSN: 0160-4120; 1873-6750
• DOI: 10.1016/j.envint.2012.11.009

Appropriate characterisation of manufactured nanomaterials (NMs) is vital for many aspects of their synthesis, product formulation, toxicological testing and regulation. As the range and quantity of NMs in production has expanded, the interest in their potential environmental and toxicological consequences has grown. With this growth, there is increased need for clarity and rigour in characterising appropriate physicochemical parameters. Which physicochemical parameters should be characterised and under what conditions remains a topic of debate, along with the most appropriate techniques and methodologies to best describe any one characteristic. This review assesses the characterisation requirements of current and future regulatory frameworks for NMs, with specific focus on the incoming REACH framework of the EU. For regulatory compliance, characterisation requirements will be necessarily prescriptive. The minimum physicochemical parameters required to adequately describe NMs for regulatory purposes are proposed, along with a discussion of the most appropriate mechanisms to obtain those data in terms of the overarching delivery mechanism. Guiding principles for particle characterisation during the hazard testing required to comply with regulations are examined. ► Robust regulation relies on accurate description and hence characterisation of NMs. ► Approaches to differentiating between bulk substances and nanoforms are described. ► Criteria for differentiating related nanoforms of the same substance are presented. ► Strategies for improving access to characterisation facilities are proposed. ► Definition, variability and material dynamics of NMs are explored as common themes.