🇧🇷Brazil

Multas por Desvios em Registro de Lotes - Lei 15.022/2024

4 verified sources

Definition

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 Deviations in batch records—missing CAS numbers, incorrect hazard classifications, incomplete SDS, outdated concentration limits—constitute violations.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.

Key Findings

  • Financial Impact: 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).
  • Frequency: Annual registration (March 31 deadline); continuous risk of deviation discovery during inspections or audits.
  • Root Cause: Manual batch record management prone to transcription errors, incomplete hazard data, inconsistent GHS classification across batches, delayed SDS updates, missing concentration limit documentation.

Why This Matters

Pitch: Chemical manufacturers in Brasil waste significant resources on manual batch record verification and suffer unquantified penalty exposure from deviation handling failures. Automated batch-to-registry validation eliminates registration deviations and eliminates fine risk.

Affected Stakeholders

Compliance Officer, Batch Record Manager, Quality Assurance Lead, Regulatory Affairs, Chemical Inventory Controller

Deep Analysis (Premium)

Financial Impact

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Current Workarounds

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Get Solutions for This Problem

Full report with actionable solutions

$99$39
  • Solutions for this specific pain
  • Solutions for all 15 industry pains
  • Where to find first clients
  • Pricing & launch costs
Get Solutions Report

Methodology & Sources

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

Evidence Sources:

Related Business Risks

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

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%

Request Deep Analysis

🇧🇷 Be first to access this market's intelligence