🇦🇺Australia

AICIS Chemical Authorisation Failures

1 verified sources

Definition

Private label specs often overlook chemical categorisation (Listed/Exempted/Reported), exposing firms to AICIS penalties and import bans.

Key Findings

  • Financial Impact: AUD 222,000 - 500,000+ fines per serious breach; annual declaration failures add AUD 50,000+
  • Frequency: Per unauthorised chemical introduction
  • Root Cause: Manual spec management misses risk-based categorisation for cosmetic ingredients

Why This Matters

The Pitch: Personal care product manufacturers in Australia 🇦🇺 face AUD 500,000+ fines for unauthorised chemical introductions. Automation of spec-to-AICIS categorisation prevents violations.

Affected Stakeholders

Formulation Specialists, Supply Chain Managers, Regulatory Affairs

Deep Analysis (Premium)

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

Non-Compliance Fines for Cosmetic Labelling

AUD 10,000+ civil penalties per breach; recall costs 1-5% of batch value

Supplier Agreement Disputes

AUD 20,000-50,000 per supplier dispute; rework costs 5-10% batch value

Cost of Poor Quality in Batch Production

AUD 20,000-100,000 per year in rework, disposal, and stability testing for SMEs (2-5% of production costs based on industry standards)

Capacity Loss from Quality Rework

AUD 10-40 hours per rework incident (AUD 500-2,000 at AUD 50/hr labor + overhead)

GMP Non-Compliance Audit Failures

AUD 5,000-20,000 per failed GMP audit (re-audit fees, consultant costs, production halts)

AICIS Non-Compliance Fines

Fines up to $10 million AUD for corporations; product recalls and market withdrawal.

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