Bußgelder für CMR-Stoffe in Kosmetika
Definition
From 1 September 2025, 21 CMR substances are banned in Annex II of CLP Regulation; non-compliant cosmetics must be immediately withdrawn or recalled by competent authorities if Responsible Person fails to act, causing direct financial losses from stock disposal, reformulation, and enforcement actions.
Key Findings
- Financial Impact: €50,000+ per product batch recall (reformulation, withdrawal, lost inventory); typical for mid-sized manufacturer with 10% inventory turnover affected
- Frequency: Ongoing from 1 Sep 2025; immediate for non-compliant stock
- Root Cause: Manual ingredient sourcing without automated CMR/allergen tracking fails to meet updated Annex II prohibitions
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Personal Care Product Manufacturing.
Affected Stakeholders
Responsible Person, Supply Chain Manager, Quality Assurance
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.
Related Business Risks
Reformulierungs- und Lieferantenkosten durch Allergen-Tracking
Kosten für CPSR-Überarbeitung und Rückrufe
Kosten der schlechten Qualität durch GMP-Verstöße
Überlaufkosten durch Abfall in Batch-Produktion
Strafen bei GMP-Auditversagen
Kapazitätsverluste durch manuelle Qualitätsprüfungen
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