,"On May 13, 2025, Brazil released a draft implementing regulation for Law No. 15,022—known as Brazil REACH—marking a key step in establishing a national chemical substance registration system. Open for public consultation until June 13, 2025, the draft provides detailed procedures for substance registration, confidentiality protection, and regulatory fees under the National Registry of Chemical Substances System. Key Provisions: Mandatory Registration: Producers and importers handling ≥1 ton/year of chemical substances must register. Required information includes company identification (CNPJ/CPF), substance data (IUPAC, CAS, GHS classification), and usage/application categories. Polymers: Specific regulations for polymers will be issued separately. Timeline: Existing substances must be registered within three years of system launch. Updates to registrations are due by March 31 annually. Confidential Business Information (CBI): CBI protection is available for 5 years (extendable to 10 years for unpublished Brazilian studies), with applications reviewed within 90 days. Fees: Registration and evaluation fees vary by company size and production volume, with reduced rates for individuals and small businesses. CBI protection fees are R$312 for small entities and R$780 for others. Animal Testing: Testing must follow the ""3Rs"" principle—prioritizing non-animal alternatives. Redundant animal tests are prohibited if valid data already exists. The regulation aligns with global chemical safety standards and aims to enhance transparency, sustainability, and regulatory clarity across Brazil’s chemical industry. Stakeholders are encouraged to submit comments by the June 13 deadline to influence final implementation."
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