Chemical Raw Materials Manufacturing Business Guide
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All 30 Documented Cases
Multas por Desvios em Registro de Lotes - Lei 15.022/2024
Fines: R$ 76–R$ 60,720,000 per violation (5% to 40,000× minimum wage @ R$ 1,518). Substance seizure/destruction: 100% product loss. Activity suspension: 100% revenue loss during suspension period. Estimated compliance cost per substance registration: R$ 2,000–R$ 10,000 (consultant + data generation).Law 15.022/2024 (effective Nov 15, 2024) mandates comprehensive chemical registration with GHS-compliant safety data, annual production reporting by March 31, and risk assessment documentation. Deviations in batch records—missing CAS numbers, incorrect hazard classifications, incomplete SDS, outdated concentration limits—constitute violations. Non-compliance penalties include: administrative fines (minimum 5% of 1 minimum wage; maximum 40,000 minimum wages), seizure and destruction of substances, suspension of manufacture/sales, and total/partial prohibition of company activities.
Custos de Conformidade e Taxas de Registro (Lei 15.022/2024)
Registration/Evaluation fees: TBD (est. R$ 500–R$ 5,000 per substance based on EU REACH precedent); Risk assessment studies: R$ 2,000–R$ 50,000+ per substance depending on complexity; Legal/consulting support: R$ 100,000–R$ 500,000+ for portfolio-wide compliance setupLaw 15.022/2024 introduces mandatory fees for (1) Registration of chemical substances, (2) Registration of new chemical substances, (3) Risk assessment of chemical substances, and (4) Protection of substance identity/CAS registration. While the statute is clear that fees will be charged, specific amounts and schedules remain to be defined in implementing regulations. This creates budget uncertainty for manufacturers with diverse chemical portfolios. Additionally, companies must invest in internal resources or hire consultants to prepare GHS-compliant Safety Data Sheets (SDSs) and conduct or source risk assessment studies.
Decisões Incorretas Baseadas em Dados de Lote Incompletos - Falta de Visibilidade
Remediation cost: R$ 10,000–R$ 50,000 per unregistered substance (emergency registration, back-compliance fees, potential fines). Lost sales opportunity: 2–4 weeks market delay during corrective batch record audit. Estimated per-decision error: R$ 25,000–R$ 100,000 (combination of delay + remediation).Manual batch record systems (spreadsheets, paper logs, siloed ERP instances) prevent consolidation of: (1) total annual production volume by substance (triggers >1 TPA registration requirement), (2) substance variants and concentration ranges (impacts risk assessment scope), (3) hazard classification consistency across batches, (4) SDS version control (out-of-date sheets in production). Decision-makers allocate resources to non-compliant formulations or approve ingredients without verifying registration status. Hidden violations accumulate until discovered by internal audit or regulatory inspection.
Multas por Não Conformidade com Lei 15.022/2024 (Brazil REACH)
R$ 705 - R$ 28,000,000 per fine (statutory range: 5% to 40,000 minimum wages); plus registration/evaluation fees (amounts TBD in future regulations); plus material seizure/destruction costsLaw 15.022/2024 (Brazil REACH) establishes mandatory registration and risk assessment for chemical substances. Non-compliance triggers fines (minimum 5% of one minimum wage, maximum 40,000 minimum wages), seizure of materials, destruction/rendering useless of chemical substance, suspension of sales/manufacturing, partial or total prohibition of company activities, and cancellation of registration. The regulation took effect November 15, 2024, with a 3-year transition period for digital infrastructure.