JRC REFERENCE REPORTS Considerations on a Definition of Nanomaterial for Regulatory Purposes Göran Lövestam, Hubert Rauscher, Gert Roebben, Birgit Sokull Klüttgen, Neil Gibson, Jean-Philippe Putaud and Hermann Stamm 2 0 1 0 EUR 24403 EN The mission of the JRC is to provide customer-driven scientific and technical support for the conception, de- velopment, implementation and monitoring of EU policies. As a service of the European Commission, the JRC functions as a reference centre of science and technology for the Union. Close to the policy-making process, it serves the common interest of the Member States, while being independent of special interests, whether private or national. 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Nanomaterials available today 7 1.3. Applications of nanomaterials 8 2. The need for a definition of the term ‘nanomaterial’ 10 3. Overview of proposed nanomaterial definitions 12 3.1. Definitions regarding nanomaterials by the International Organisation for Standardisation (ISO) and the European Standardisation Committee (CEN) 12 3.2. Definitions regarding nanomaterials by other international organisations and committees 14 3.2.1. Organisation for Economic Co-operation and Development (OECD) 14 3.2.2. EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) 14 3.2.3. EU Scientific Committee on Consumer Products (SCCP) 15 3.2.4. European Union: Cosmetic Products Regulation 15 3.2.5. European Union: Recast of the Novel Foods Regulation 15 3.2.6. American Chemistry Council 16 3.3. National definitions of nanomaterials 16 3.3.1. Australia 16 3.3.2. Canada 16 3.3.3. Denmark 17 3.3.4. The United Kingdom 17 3.3.5. The United States of America 17 3.4. Related definitions in the broader area of Nanotechnology 18 3.4.1. Definition of nanotechnology 18 3.4.2. Definitions of aerosols 20 3.4.3. Definitions of colloids 20 JRC Reference Report 4. Considerations on a definition for regulatory purposes – elements of a definition 21 4.1. The term ‘material’ 22 4.2. The ‘nanoscale’ 22 4.2.1. Size measurement 23 4.2.2. Upper size limit 24 4.2.3. Lower size limit 24 4.2.4. Size distribution 25 4.2.5. Size-related properties 26 4.2.6. Bulk nanomaterials, nanostructured materials, and mixtures 26 4.3. Physico-chemical properties 27 4.3.1. Scalable versus non-scalable properties 27 4.3.2. The role of non-scalable properties and confinement effects 27 4.3.3. Matrix effects 28 4.3.4. Problems related to nanoscale properties included in a definition 29 5. Conclusions 30 Acknowledgements 32 Appendix 33 List of abbreviations 36 JRC Reference Report Executive summary The term ‘nanomaterial’ is now frequently used for The report suggests that a definition for regulatory a variety of materials. It usually refers to materials purposes should: with external dimensions, or an internal structure, measured in nanometres that exhibit additional or • only concern particulate nanomaterials, different properties and behaviour as compared to coarser materials with similar chemical composition. • be broadly applicable in EU legislation, and in Nanomaterials are now used in many innovative line with other approaches worldwide, technological applications and products, including a wide range of consumer products, and there is • use size as the only defining property. growing concern about their safe use and possible impact on human health and the environment. This calls both for a clarification of the meaning of the word ‘material’ and a clear definition of the In a European Parliament resolution from 2009 it nanoscale limits. Enforceability of the definition is questioned whether, in the absence of any nano- requires the adoption of instructions on how such material specific provisions, Community legislation limits can be applied for nanoscale materials with covers all relevant risks related to nanomaterials. size distributions. Size-derived properties, nano- The European Parliament also called for, inter alia, scale materials incorporated in a matrix and the a comprehensive science-based definition of the origin of the material are also points that should term ‘nanomaterial’. The aim of this report is to re- be considered. view and discuss issues and challenges related to a definition of ‘nanomaterial’, and to provide practical It is clear that any definition will have implications guidance for a definition for regulatory purposes. within the context in which it is used and may need adaptation for specific regulations or directives. It should therefore be emphasised that adoption of a definition will also involve policy choices, and ac- cordingly will entail political decisions. 5 JRC Reference Report 1. Introduction The introduction of new technologies often creates from June 20082, addressed to the European Parlia- new challenges for the legislator, particularly if the ment (EP), the EC considers that the management associated consumer products, in addition to the of the possible risks from nanomaterials in relation expected benefits, raise concerns about health and to health, environment and safety is in principle environmental risks. In this case, new regulations covered by existing legislation even if nanomateri- or the adaptation of the existing ones may be re- als are not explicitly mentioned. However, the EC quired, and the regulatory authority has to define will also consider changes to legislation whenever what needs to be regulated. the need for specific risk management measures becomes apparent. Nanotechnology holds considerable promise in many different technological areas and industrial The EC review was extensively debated within sectors. Many nanotechnology applications are the EP. In its report on regulatory aspects of based on novel as well as conventional materials nanomaterials, of 24 April 20093, the EP concluded deliberately engineered to be nanostructured, for that ‘the current discussion about nanomaterials which the term ‘nanomaterial’ is now frequently is characterised by a significant lack of knowledge used. The term broadly refers to materials with and information, leading to disagreement internal structures and/or external dimensions and political struggles starting at the level of within the size range measured in nanometers definitions’. Consequently, the EP called (nm) where 100 nm is frequently used as a delimit- ing size between the nanoscale and the micro and ‘for the introduction of a comprehensive macroscopic scales. In the nanoscale regime, some science-based definition of nanomaterials in materials exhibit additional or different features or Community legislation as part of nano-spe- properties as compared to coarser materials with cific amendments to relevant horizontal and similar chemical composition. These materials are sectoral legislation’, and now used in a wide range of innovative technologi- cal applications and products, including many con- ‘on the Commission to promote the adop- sumer end-products. tion of a harmonised definition of nanoma- terials at the international level and to adapt While there are today many nanotechnology the relevant European legislative framework products being introduced onto the market, there accordingly’. is also a considerable lack of knowledge concerning the biological effects and environmental impact of With ‘science-based’ it is here understood that the nanomaterials. This has triggered an increasing definition should be based on established scientific worldwide effort to understand the possible principles. The EC presented a positive feedback to impact of nanomaterials on human health and the the EP resolution. environment. There is to date limited evidence of actual harm resulting from the use of nanomaterials, The introduction of a definition of ‘nanomaterial’ is, nevertheless