Particle Effects

Why Particle Effects Should Not Lead to a Classification under CLP

In Regulation (EC) No. 1272/2008 (CLP), the harmonised classification and labelling (CLH) of particulate, dusty substances increasingly leads to problematic evaluations: In recent years, substance classifications have sometimes been made based on well-known, non-specific dust effects. A concrete example is titanium dioxide, whose CLH classification is being reviewed in court. The result of these classifications are severe legal consequences for important application areas and occupational safety. It is feared that this will initiate a cascade of classification dossiers for particulate substances, which would have massive consequences in the EU. A new VCI position has been created to highlight the problems in the CLP regulation for important application areas and occupational safety. Particulate substances are used in many everyday products, including cosmetics, pharmaceuticals, tires, polymers, food additives, and construction chemical products. The position paper was developed and coordinated within the ‘VCI Taskforce Partikeleffekte’ and is available for download in German and English.

Recommendations and Demands of the VCI

• Only evaluate the relevant particle fraction in the CLH process: If a harmonised classification of a substance is considered regulatory necessary, only the relevant particle fraction of a marketed substance, which also triggers effects, should consequently be considered in the evaluation and specifically classified – usually the alveolar fraction. The classification of the marketed overall substance or its follow-up products is thus determined product-specifically (e.g., through a technical quantification of the particle content).
• Revision of the classification reference values for STOT RE for particles in the annex I of CLP.
• Substances must be tested according to the CLP legal text in OECD Test Guidelines in the form in which they are placed on the market and marketed in products.
• Clear concepts for dealing with particle effects from the legislator.
• Cooperation and technical discussions to find solutions with affected industries.
• European harmonisation in the form of a general dust limit value in occupational safety can be an appropriate approach.

Further details can be found in the full position paper in the download section: