🇧🇷Brazil

Custos de Conformidade e Taxas de Registro (Lei 15.022/2024)

3 verified sources

Definition

Law 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.

Key Findings

  • Financial Impact: 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 setup
  • Frequency: Annual (March 31 updates); per new substance registration; per risk assessment cycle; per substance identity protection request
  • Root Cause: Regulatory requirement to fund national chemical inventory database and CONASQ operations; lack of standardized fee framework; need for external technical expertise to conduct hazard and risk assessments

Why This Matters

The Pitch: Chemical manufacturers in Brasil 🇧🇷 face undefined but mandatory compliance fees for registration and risk assessment. Companies with 50+ registered substances face exponential cost accumulation. Automated compliance and document management systems reduce submission errors (which trigger re-evaluation fees) and consolidate multi-batch registrations.

Affected Stakeholders

Production Scheduler, Finance/Budget Manager, Supply Chain Procurement, Quality & Regulatory Affairs, R&D (for risk assessment data generation)

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Financial Impact

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

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 costs

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).

Custos de Conformidade - Taxa de Registro e Avaliação de Risco

Fee amounts TBD; estimated range R$ 500–R$ 5,000 per substance registration (analogous to EU REACH fee structure ~€500–€5,000). Company with 500 registered chemicals: R$ 250,000–R$ 2,500,000 in annual compliance fees. Risk assessment requests add 20–50% overhead.

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).

Consumo Excessivo de Químicos por Monitoramento Inadequado

R$ 2,000,000 - R$ 8,000,000 per year per facility (estimated waste + penalties); equivalent to 3-7% of chemical raw materials cost

Perda de Capacidade por Atrasos em Otimização Manual de Processos

R$ 4,000,000 - R$ 6,000,000 per year per facility (foregone margin from inability to optimize for price signals); 15-25% capacity utilization loss

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