Brazil has officially adopted Bill No. 6120/2019, known as Brazil REACH, establishing a national chemical registry that will require registration of all chemicals produced or imported in volumes of one ton or more per year. For overseas chemical suppliers and importers, this means new compliance obligations starting from the bill's publication date, with implementation regulations expected within 180 days and a full registration system within three years.
Legislative background
On October 15, 2024, Brazil's Senate approved Bill No. 6120 of 2019, a comprehensive chemical management framework modeled after the EU REACH regulation. The bill aims to minimize adverse impacts on human health and the environment through systematic assessment and risk control of chemicals used, produced, or imported in Brazil. The government will establish a Chemical Substance Assessment Committee to oversee risk evaluation and management recommendations.
Registration requirements
All chemicals produced or imported in Brazil with an annual volume of one ton or more must be registered in the national registry before manufacturing or import activities begin. Required information includes: identification data of the producer or importer, annual production and import quantities, chemical identification including CAS number, a GHS-compliant Safety Data Sheet (SDS) with recommended uses and hazard classification, and risk assessment analysis studies. For already registered chemicals, any new uses or data changes require re-registration by March 31 of the following year.
Exemptions
The bill exempts several categories from registration: food, food additives, flavorings, pharmaceuticals, naturally occurring unmodified substances, radioactive substances, substances under development, research-only substances, non-isolated intermediates, defense-related substances, residues, substances under customs supervision without processing, temporary storage or transit goods, unintentionally produced substances, tobacco components, metal alloys, explosives and accessories, and cosmetics.
Risk assessment and management
Substances will be prioritized for risk assessment based on criteria including human or environmental exposure levels, production or export quantities, persistence, bioaccumulation and toxicity, carcinogenicity, mutagenicity, reproductive toxicity, endocrine disruption, and inclusion in international agreements to which Brazil is a party. Violations such as failure to register or providing false information will result in administrative penalties.
What buyers should watch
Overseas chemical exporters to Brazil should begin preparing registration dossiers for products meeting the one-ton threshold, particularly for industrial chemicals, solvents, polymers, and intermediates. The 180-day window for implementation regulations means detailed compliance requirements will emerge by mid-2025. Companies should monitor Brazil's development of the registration information system and plan for potential supply chain disruptions during the transition period. Re-registration deadlines for existing chemicals with new uses will be March 31 of each following year.
Source: Read the original report | Published: November 01, 2024