Draft Presidential Decree for the Implementing Regulations of Brazil's Chemical Management Law No. 15022

The draft applies to manufacturers, importers and exclusive representatives of foreign manufacturers that produce, import or use chemical substances as ingredients in mixtures in Brazil. Substances with an average annual production or import volume of at least one tonne over the preceding three years must be registered; substances below the threshold may be registered voluntarily. Registrants must provide information on the entity, the substance's IUPAC name, CAS number, NCM code, GHS hazard classification, production/import volume range, uses, use sectors and product categories, and update changed information by 31 March of the following year. New substances may be marketed only after registration is completed and they are included in the National Inventory of Chemical Substances. The system also provides for substance prioritization, health and environmental risk assessment, risk-management measures, responsibilities of technical and deliberative committees, and fees for registration, assessment and confidentiality review.