🇧🇷Brazil

Custos de Conformidade - Taxa de Registro e Avaliação de Risco

2 verified sources

Definition

Law 15.022/2024 establishes a new 'Registration, Evaluation and Inspection Fee' structure, but specific amounts and payment schedules are deferred to future regulation (expected 2025). Applicability: (1) Initial substance registration, (2) New substance registration, (3) Risk assessment requests, (4) CAS identity protection requests. Companies with large batch record portfolios, multiple formulations, or complex substance variants face multiplicative fee exposure. Manual deviation tracking creates uncertainty about total fee liability.

Key Findings

  • Financial Impact: 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.
  • Frequency: Annual recurring; triggered by each substance registration, reformulation, or risk assessment request.
  • Root Cause: Regulation (Law 15.022/2024 Article 5) established fee framework but delegated amount/timing to future regulation. Manual batch record management cannot reliably consolidate substances or reuse existing risk assessments, increasing number of registrations.

Why This Matters

Pitch: Brazilian chemical manufacturers face uncertain but significant compliance costs under Law 15.022/2024 registration fees (amounts TBD in 2025 regulation). Batch record optimization and risk assessment consolidation reduce duplicate registrations and minimize total fee exposure.

Affected Stakeholders

Finance/Budget Controller, Regulatory Affairs, Product Development, Supply Chain Planning

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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 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).

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

Multas Ambientais por Falha em Conformidade IBAMA/ANVISA em Processos Químicos

R$ 500,000 - R$ 5,000,000 per year per facility in IBAMA fines; additional ANVISA registration delays (2-6 months per product) = R$ 1-3M revenue delay

Retrabalho e Rejeição de Lotes por Controle de Reação Inadequado

R$ 1,000,000 - R$ 4,000,000 per year per facility (2-5% of production value lost to rework/refunds); 20-40 additional labor hours per failed batch; material loss of 10-20%

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