The European Chemicals Agency (ECHA) has introduced additional requirements for inquiries related to Carbon Black (CAS 1333-86-4 | EC 215-609-9), highlighting key compliance gaps:

Key Issues

1. Missing Nanoform Data
   Under REACH Annex VI, manufacturers and importers must provide detailed substance identification. Given that Carbon Black is produced in nanoform, registrants are required to report:

• Particle size distribution, including the proportion of particles within the 1–100 nm range
  
• Surface treatment or functionalization details
  
• Morphological characteristics (shape, aspect ratio)
  
• Specific surface area
  
  

However, many registration dossiers lack nanoform-specific data in Sections 1.2 (Substance Composition) and 1.4 (Analytical Reports). Some registrants have attempted to classify Carbon Black as non-nanoform based solely on particle size metrics (e.g., D10: 0.3 μm, D50: 2.2 μm, D90: 6.3 μm) without specifying testing methodologies or providing crucial electron microscopy images and sample preparation protocols—key evidence for nanoform classification.

2. Insufficient Analytical Methods & Results
   Many registrants rely on routine tests such as elemental analysis, X-ray diffraction (XRD), and thermogravimetric analysis-differential scanning calorimetry (TGA-DSC). However, these methods are inadequate for precisely quantifying Carbon Black’s primary components or detecting impurities, particularly volatile organic compounds (VOCs) such as polycyclic aromatic hydrocarbons (PAHs).

To ensure regulatory compliance, manufacturers should implement more advanced analytical techniques, including:

• Gas Chromatography-Mass Spectrometry (GC-MS), Gas Chromatography-Flame Ionization Detector (GC-FID), or High-Performance Liquid Chromatography (HPLC) for PAH identification and quantification
  
• Comprehensive methodological documentation to improve data accuracy and reproducibility 
  

Recommended Actions

To maintain compliance and facilitate EU market access, nanoform substance manufacturers should:
Enhance nanoform reporting – Provide complete particle size distribution, surface treatment details, and validated electron microscopy images
Strengthen analytical protocols – Utilize advanced methods like GC-MS/HPLC for precise PAH quantification
Perform targeted testing – Identify and report hazardous components such as PAHs

Implementing these measures will improve dossier quality and support sustainable market access within the EU.

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