Considerations on the EU definition of a nanomaterial : science to support policy making

In recent years, an increasing number of applications and products containing or using nanomaterials have become available. This has raised concerns that some of these materials may introduce new risks for humans or the environment. A clear definition to discriminate nanomaterials from other materials is prerequisite to include provisions for nanomaterials in legislation. In October 2011 the European Commission published the 'Recommendation on the definition of a nanomaterial', primarily intended to provide unambiguous criteria to identify materials for which special regulatory provisions might apply, but also to promote consistency on the interpretation of the term 'nanomaterial'. In this paper, the current status of various regulatory frameworks of the European Union with regard to nanomaterials is described, and major issues relevant for regulation of nanomaterials are discussed. This will contribute to better understanding the implications of the choices policy makers have to make in further regulation of nanomaterials. Potential issues that need to be addressed and areas of research in which science can contribute are indicated. These issues include awareness on situations in which nano-related risks may occur for materials that fall outside the definition, guidance and further development of measurement techniques, and dealing with changes during the life cycle

Considerations on the EU definition of a nanomaterial : science to support policy making

In recent years, an increasing number of applications and products containing or using nanomaterials have become available. This has raised concerns that some of these materials may introduce new risks for humans or the environment. A clear definition to discriminate nanomaterials from other materials is prerequisite to include provisions for nanomaterials in legislation. In October 2011 the European Commission published the 'Recommendation on the definition of a nanomaterial', primarily intended to provide unambiguous criteria to identify materials for which special regulatory provisions might apply, but also to promote consistency on the interpretation of the term 'nanomaterial'. In this paper, the current status of various regulatory frameworks of the European Union with regard to nanomaterials is described, and major issues relevant for regulation of nanomaterials are discussed. This will contribute to better understanding the implications of the choices policy makers have to make in further regulation of nanomaterials. Potential issues that need to be addressed and areas of research in which science can contribute are indicated. These issues include awareness on situations in which nano-related risks may occur for materials that fall outside the definition, guidance and further development of measurement techniques, and dealing with changes during the life cycle

Considerations on the EU definition of a nanomaterial : science to support policy making

In recent years, an increasing number of applications and products containing or using nanomaterials have become available. This has raised concerns that some of these materials may introduce new risks for humans or the environment. A clear definition to discriminate nanomaterials from other materials is prerequisite to include provisions for nanomaterials in legislation. In October 2011 the European Commission published the 'Recommendation on the definition of a nanomaterial', primarily intended to provide unambiguous criteria to identify materials for which special regulatory provisions might apply, but also to promote consistency on the interpretation of the term 'nanomaterial'. In this paper, the current status of various regulatory frameworks of the European Union with regard to nanomaterials is described, and major issues relevant for regulation of nanomaterials are discussed. This will contribute to better understanding the implications of the choices policy makers have to make in further regulation of nanomaterials. Potential issues that need to be addressed and areas of research in which science can contribute are indicated. These issues include awareness on situations in which nano-related risks may occur for materials that fall outside the definition, guidance and further development of measurement techniques, and dealing with changes during the life cycle

Making sense of ecotoxicological test results: towards process-based models.

Abstract The environmental risk of chemicals is rou-tinely assessed by comparing predicted exposure levels to predicted no-effect levels for ecosystems. Although pro-cess-based models are commonly used in exposure assessment, the assessment of effects usually comprises purely descriptive models and rules-of-thumb. The prob-lems with this approach start with the analysis of labora-tory ecotoxicity tests, because only a limited amount of information is extracted. Standard summary statistics (NOEC, ECx, LC50) are of limited use in part because they change with exposure duration in a manner that varies with the tested species and the toxicant. As an alternative, process-based models are available. These models allow for toxicity measures that are independent of exposure time, make efficient use of the available data from routine toxicity tests, and are better suited for edu-cated extrapolations (e.g., from individual to population, and from continuous to pulse exposure). These capabilities can be used to improve regulatory decisions and allow for a more efficient assessment of effects, which ultimately will reduce the need for animal testing. Process-based modeling also can help to achieve the goals laid out in REACH, the new strategy of the European Commission in dealing with chemicals. This discussion is illustrated with effects data for Daphnia magna, analyzed by the DEBtox model