Environmental exposure assessment of engineered nanoparticles: why REACH needs adjustment.

Engineered nanomaterials (ENMs) possess novel properties making them attractive for application in a wide spectrum of fields. These novel properties are not accounted for in the environmental risk assessment methods that the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) proposes in their guidance on environmental exposure estimation, although ENMs are already applied in a variety of consumer and industrial products. It is thus necessary to evaluate the guidance document REACH provides on environmental exposure estimation on its applicability to ENMs. This is most urgently the case for engineered nanoparticles (ENPs), as the novel properties are most often only applicable to them. The environmental fate of ENPs was reviewed and compared to the environmental fate of chemicals according to the REACH guidance. Major deviations between the fate of ENPs and predicted fate by REACH were found. They were related to at least 1 of 3 major assumptions made in REACH guidance: 1) in REACH, environmental alteration processes are all thought of as removal processes, whereas alterations of ENPs in the environment may greatly affect their properties, environmental effects, and behavior, 2) in REACH, chemicals are supposed to dissolve instantaneously and completely on release into the environment, whereas ENPs should be treated as nondissolved nanosized solids, and 3) in REACH, partitioning of dissolved chemicals to solid particles in air, water, and soil is estimated with thermodynamic equilibrium coefficients, but in the case of ENPs thermodynamic equilibrium between "dispersed" and "attached" states is generally not expected. The environmental exposure assessment of REACH therefore needs adjustment to cover the specific environmental fate of ENPs. Incorporation of the specific environmental fate processes of ENPs into the environmental risk assessment framework of REACH requires a pragmatic approach.