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Table 1 USA, European, and Canadian regulatory frameworks relevant to and specific for nanomaterials

From: Expert consensus on an in vitro approach to assess pulmonary fibrogenic potential of aerosolized nanomaterials

Location Regulatory body Regulation NM-specific inclusions
USA Food and Drug Administration Federal Food, Drug, and Cosmetic Act (FD&C Act) None
Environmental Protection Agency Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Significant New Use Rules (SNURs) for any new uses not provided in the original submission
Toxic Substances Control Act (TSCA) Premanufacture notice (PMN) required for new NMs
Europe European Chemicals Agency Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) None
Classification, Labelling and Packaging (CLP) None
Biocidal Products Regulation (BPR) Products containing NMs are excluded from the simplified authorization procedure. Information regarding the nanoform needs to be submitted separately, and the nanoform is thoroughly assessed for potential risk
Canada Health Canada and Environment Canada Canadian Environmental Protection Act, 1999 (CEPA 1999) via New Substances Notification Regulations (NSNR) (Chemicals and Polymers) (SOR/2005-247 2005) Significant New Activity (SNAc) notices issued for short-tangled MWCNTs