CLP application to nanomaterials: a specific aspect.
Maria Alessandrelli1, Maria Letizia Polci
1Centro Nazionale Sostanze Chimiche, Istituto Superiore di Sanità, Rome, Italy. maria.alessandrelli@iss.it
Annali Dell'Istituto Superiore Di Sanita
|June 29, 2011
Summary
The Classification, Labelling and Packaging (CLP) regulation covers nanomaterials, but requires separate hazard classification and labelling if nanoscale forms differ from bulk. Manufacturers must ensure data reflects market forms, with further guidance needed for specific nanomaterial provisions.
Area of Science:
- Chemical safety
- Nanomaterial regulation
Background:
- Concerns exist regarding potential adverse effects of nanomaterials on human health and the environment.
- The European Union's Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 governs substance classification but lacks specific provisions for nanomaterials.
Purpose of the Study:
- To describe key aspects of classifying, labelling, and packaging nanomaterials under current regulations.
- To highlight the implications of the CLP regulation for nanomaterials, considering their unique properties.
Main Methods:
- Analysis of the CLP Regulation (EC) No 1272/2008 in relation to nanomaterials.
- Review of requirements for data collection and hazard assessment for substances placed on the market.
Main Results:
- Nanomaterials are covered by the general definition of 'substance' in the CLP Regulation.
- Different particle sizes or forms of the same substance may necessitate distinct classifications and labelling if hazard properties differ.
- Manufacturers must ensure classification data corresponds to the forms marketed and reasonably expected to be used.
Conclusions:
- Separate classification and labelling may be required for nanoscale versus bulk forms of a substance if data indicates differing hazard classes.
- The CLP Regulation mandates testing for physical hazards when information is inadequate for classification.
- Enhanced guidance documents and implementation tools are necessary for more specific coverage of nanomaterials within the CLP framework.
