🇧🇷Brazil

Custos de Conformidade REACH Brasil – Data Collection & Dossiê Assembly

2 verified sources

Definition

Lei 15.022/2024 established Brazil's National Inventory of Chemical Substances with REACH-like requirements. Manufacturers must register chemicals (1+ t/year threshold) with comprehensive dossiês including: CAS number, hazard classification, physical-chemical data, toxicity/ecotoxicity tests, and use-risk analysis. Deadline: Nov 15, 2026. Optical media coatings, adhesives, solvents in manufacturing trigger this. Manual process = fragmented systems, redundant testing, missed deadlines.

Key Findings

  • Financial Impact: Estimated: R$50,000–R$150,000 per substance (lab testing) + R$20,000–R$100,000 in consulting/internal labor per facility = R$100,000–R$400,000 aggregate for typical mid-sized manufacturer (5–10 regulated substances).
  • Frequency: One-time bulk compliance by Nov 15, 2026; ongoing for new chemicals added.
  • Root Cause: Decentralized data ownership (suppliers, labs, internal R&D); lack of integrated chemical inventory; no single source of truth.

Why This Matters

The Pitch: Magnetic/optical media makers waste R$100,000–R$400,000 annually on fragmented data gathering, external lab testing, and consultant hours for REACH dossiê prep. A unified compliance platform automates substance inventory, risk classification, and dossiê generation, cutting compliance costs by 40–50%.

Affected Stakeholders

Chemical/Substance Compliance Manager, R&D/Product Engineering, Procurement (raw material sourcing), Quality Assurance, External consultants/laboratories

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Financial Impact

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Current Workarounds

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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 FDS e FDSR (Resolução CFQ 335/2025)

Estimated: R$10,000–R$50,000 per audit failure; typical multiplier = 2–4 non-conformities per facility annually = R$20,000–R$200,000/year in potential fines + rework.

Multas por Não-Conformidade no Transporte de Produtos Químicos Perigosos (ANTT)

Estimated: R$5,000–R$20,000 per autuação (ANTT fiscal stop); typical facility = 2–4 annual violations = R$10,000–R$80,000/year; environmental penalties (IBAMA, state) = additional R$20,000–R$100,000 per spill/accident.

Atrasos Operacionais & Parada de Produção – Procedimentos Manuais de Inventário Químico

Estimated: 40–80 labor hours/month (administrative staff) = R$20,000–R$40,000/month; production delay per chemical approval = 5–10 hours of line downtime = R$10,000–R$50,000 in lost throughput. Annual impact: R$120,000–R$480,000.

Erros de Decisão – Falta de Visibilidade em Conformidade Química & Decisões Impulsivas de Sourcing

Estimated: 2–5% of chemical procurement budget lost to excess sourcing/rework = R$40,000–R$150,000/year; supplier penalties (non-compliance refunds) = R$10,000–R$50,000/year; expedited waste disposal (wrong classification) = R$5,000–R$20,000/incident = R$20,000–R$80,000/year. Aggregate: R$70,000–R$280,000/year.

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