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

Regulatory Toxicology and Pharmacology

Volumn 65, Issue 1, 2013, Pages 119-125

  Bleeker, Eric A J ^a   de Jong, Wim H ^a   Geertsma, Robert E ^a   Groenewold, Monique ^a   Heugens, Evelyn H W ^a   Koers Jacquemijns, Marjorie ^a   van de Meent, Dik ^a   Popma, Jan R ^a   Rietveld, Anton G ^a   Wijnhoven, Susan W P ^a   Cassee, Flemming R ^a   Oomen, Agnes G ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Definition; Guidance; Measurement techniques; Nanomaterials; Regulatory frameworks; Risk assessment

Indexed keywords

NANOMATERIAL;

ARTICLE; CHANGE MANAGEMENT; CLASSIFICATION; EUROPEAN UNION; FRACTIONATION; GOVERNMENT REGULATION; LAW; MEDICAL TERMINOLOGY; NANOTECHNOLOGY; PARTICLE SIZE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; SURFACE PROPERTY;

EUROPEAN UNION; HEALTH POLICY; HUMANS; NANOSTRUCTURES; NANOTECHNOLOGY; POLICY MAKING; RISK ASSESSMENT;

EID: 84871445326     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.11.007     Document Type: Article

References (57)

1. Antunović B., et al. Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA Journal 2011, 9:2140.
2. Auffan M., et al. Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective. Nature Nanotechnology 2009, 4:634-641.
3. Bleeker, E.A.J., et al., 2012, Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. National Institute for Human Health and the Environment (RIVM), Bilthoven, The Netherlands, pp. 43.
4. Bootz A., et al. Comparison of scanning electron microscopy, dynamic light scattering and analytical ultracentrifugation for the sizing of poly(butyl cyanoacrylate) nanoparticles. European Journal of Pharmaceutics and Biopharmaceutics 2004, 57:369-375.
5. Brunauer S., et al. Adsorption of gases in multimolecular layers. Journal of the American Chemical Society 1938, 60:309-319.
6. Choi J.Y., et al. The impact of toxicity testing costs on nanomaterial regulation. Environmental Science and Technology 2009, 43:3030-3034.
7. Costanza J., et al. Comment on " 120 Years of Nanosilver History: Implications for Policy Makers" Environmental Science and Technology 2011, 45:7591-7592.
8. Dekkers, S., et al., 2012. Knowledge gaps in risk assessment of nanosilica in food: evaluation of the dissolution and toxicity of different forms of silica. Nanotoxicology. (Early online).
9. Dekkers S., et al. Presence and risks of nanosilica in food products. Nanotoxicology 2011, 5:393-405.
10. Domingos R.F., et al. Characterizing manufactured nanoparticles in the environment: multimethod determination of particle sizes. Environmental Science and Technology 2009, 43:7277-7284.
11. ECHA, Guidance on information requirements and chemical safety assessment - Appendix R7-1 recommendations for nanomaterials applicable to Chapter R7a endpoint specific guidance. Guidance for the implementation of REACH. European Chemicals Agency (ECHA), Helsinki, Finland, 2012.
12. EU Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Official Journal L 1989, 183:1-8.
13. EU Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Official Journal L 1990, 189:17-36.
14. EU Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal L 1993, 169:1-43.
15. EU Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work. Official Journal L 1998, 131:11-23. (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).
16. EU Directive 98/79/EC of the European parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices. Official Journal L 1998, 331:1-37.
17. EU Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. Official Journal L 2001, 311:67-128.
18. EU Directive 2001/95/EC of the European parliament and of the council of 3 December 2001 on general product safety. Official Journal L 2001, 11:4-17.
19. EU Directive 2002/95/EC of the European parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Official Journal L 2003, 37:19-23.
20. EU Directive 2002/96/EC of the European parliament and of the council of 27 January 2003 on waste electrical and electronic equipment (WEEE). Official Journal L 2003, 37:24-38.
21. EU Directive 2004/37/EC of the European parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. Official Journal L 2004, 158:50-76. (sixth individual directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version).
22. EU Regulation (EC) No 1907/2006 of the European parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal L 2006, 396:1-849.
23. EU Regulation (EC) No 1272/2008 of the European parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending regulation (EC) No 1907/2006. Official Journal L 2008, 353:1-1355.
24. EU Regulation (EC) No 1331/2008 of the European parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. Official Journal L 2008, 354:1-6.
25. EU, 2009a. EU NanoSafety Cluster. Available from: (Cited June 2012). http://www.nanosafetycluster.eu/eu-nanosafety-cluster-projects/seventh-framework-programme-projects/ennsatox.html.
26. EU Regulation (EC) No 1107/2009 of the European parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing council directives 79/117/EEC and 91/414/EEC. Official Journal L 2009, 309:1-50.
27. EU Regulation (EC) No 1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products (recast). Official Journal L 2009, 342:59-209.
28. EU Commission regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European parliament and of the council on food additives. Official Journal L 2010, 80:19-27.
29. EU Commission recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU). Official Journal L 2011, 275:38-40.
30. EU Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. Official Journal L 2011, 12:1-89.
31. EU Commission regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting commission regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. Official Journal L 2011, 328:22-29.
32. EU Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. Official Journal L 2011, 304:18-63.
33. EU, 2012a. European Parliament/Plenary. (Cited June 2012). http://www.europarl.europa.eu/plenary/en/texts-adopted.html.
34. EU Regulation (EU) No 528/2012 of the European parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Official Journal of the European Union L 2012, 167:1-123.
35. Fruijtier-Pölloth C. The toxicological mode of action and the safety of synthetic amorphous silica - A nanostructured material. Toxicology 2012, 294:61-79.
36. Health Canada, 2011. Policy Statement on Health Canada's Working Definition for Nanomaterial. Available from: (Cited 2012).
37. ISO, Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate. International Organisation for Standardisation (ISO), Genève, Switserland, 2008.
38. ISO, 2012. Online Browsing Platform. (Cited May 2012). http://www.iso.org/obp/ui/#home.
39. Kreyling W.G., et al. A complementary definition of nanomaterial. Nano Today 2010, 5:165-168.
40. Linsinger T., et al. Requirements on measurements for the implementation of the European Commission definition of the term 'nanomaterial' 2012, Joint Research Centre (JRC), Ispra, Italy.
41. Lövestam G., et al. Considerations on a Definition of Nanomaterial for Regulatory Purposes 2010, Joint Research Centre of the European Commission, Ispra, Italy, pp. 40.
42. N&ET, 2007. New and emerging technologies on medical devices working group (N&ET). Available from: (Cited May 2012). http://ec.europa.eu/health/medical-devices/scientific-technical-assessment/working-group/.
43. NICNAS, 2010. Adjustments to NICNAS new chemicals processes for industrial nanomaterials. National Industrial Chemicals Notification and Assessment Scheme, Chemical Gazette. C 10, 14.
44. Nowack B., et al. 120years of nanosilver history: Implications for policy makers. Environmental Science and Technology 2011, 45:1177-1183.
45. OECD, 2007. OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials. (Cited May 2012). http://www.oecd.org/document/47/0,3746,en_2649_37015404_41197295_1_1_1_1,00.html.
46. OECD, Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials. Organisation for Economic Co-operation and Development (OECD), Paris, France, 2010.
47. Oomen, A.G., et al., Nanomaterials in consumer products - Detection, characterization and interpretation. National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands, 2011.
48. PEN, 2005. The Project on Emerging Nanotechnologies. (Cited May 2012). http://www.nanotechproject.org/.
49. Rauscher H., et al. The European Commission's Recommendation on the Definition of Nanomaterial makes an impact 2012, Nanotoxicology, Early online.
50. SCCS, Guidance on the safety assessment of nanomaterials in cosmetics. Scientific Committee on Consumer Safety (SCCS), Brussels, Belgium, 2012, pp. 62.
51. SCENIHR, Opinion on the scientific basis for the definition of the term " nanomaterial" Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), European Commission Brussels, Belgium, 2010.
52. Schäfer B., et al. Nanosilver in Consumer Products and Human Health: More Information Required!. Environmental Science and Technology 2011, 45:7589-7590.
53. Schroeder A., et al. Remotely activated protein-producing nanoparticles. Nano Letters 2012, 12:2685-2689.
54. Shin W., et al. Calibration and numerical simulation of Nanoparticle Surface Area Monitor (TSI Model 3550 NSAM). Journal of Nanoparticle Research 2007, 9:61-69.
55. Tiede K., et al. Detection and characterization of engineered nanoparticles in food and the environment. Food Additives and Contaminants: Part A 2008, 25:795-821.
56. US-FDA, 2011. Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology - Guidance for Industry. (Cited May 2012). http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm.
57. Weir A., et al. Titanium dioxide nanoparticles in food and personal care products. Environmental Science and Technology 2012, 46:2242-2250.