PChem for Regulation of Decision Support tools based on EU REACH and K-REACH, supports recommendations on the physicochemical properties required for regulation and provides user access to regulatory information in the target country as shown in Figure 2x2.
PChem for Regulation provides the following specific recommendations: in the case of EU REACH, substances are classified into solid (powder), liquid (suspension), and mixed forms. It is strongly recommended to test the particle size and shape for solid nanomaterials of size 1-100 nm in one or more dimensions in accordance with REACH Appendix 7.6.1. It is also recommended to test particle size distribution, aspect ratio, and crystal phase. For liquids that meet the definition, it is highly recommended to test the particle size, shape, surface properties (surface chemistry) and advised to test particle size distribution, aspect ratio, crystalline phase additionally. In the case of mixtures, the same recommendations are made depending on whether the test substance is solid or liquid after extraction.
K-REACH identifies three things: solid (powder), liquid (suspension), and mixture, expert and consumer use, and carbon form. The first consideration of these is the identification of 14 detailed uses that may be excluded from K-REACH in the use of raw materials and containing products. Otherwise, detailed use be identified in 55 uses.
In Korea, there is no clear standard yet, so the industry will be asked for one of two requirements. The first option is to submit size, size distribution, shape, and aspect ratio (and crystalline phase (size), specific surface area, surface chemistry, and chemical composition) information for particles based on the definition of REACH Appendix 7.6.1. Other option is to submit information about the size, shape, and aspect ratio (and crystalline phase (size), specific surface area, surface chemistry, and chemical composition) of solid particles, including fullerenes, SWCNTs, and graphene flakes of less than 1nm size in one dimension.