_資料 3－2 _ 欧州共同体委員会におけるナノマテリアルの規制状況
Contents
1. European Group on Ethics in Science and New Technologies2. 2
3. REACH REACH
4. 5 1 COM 2004 338 final of 12 5 2004 2 2005 243 final of 7 6 2005
5. 2000 2 2 24 1st Meeting of OECD s Working Party on Manufactured Nanomaterials
6. 5
7. 2 1 e a REACH 2 REACH RBACH REACH REACH 1 10 3 C 2008 424 final of 7 2 2008 Regulation
8. OECD OECD Working Party on Manufactured Nanomaterials International Organization for Standardization ISO Nanotechnologies An action plan for Europe 2005 2009 First Implementation Report 2005 2007 Nanosciences and 28 COM 2007 505 final http ec europa eu nanotechnology pdf comm_2007_0505_en pdf 32
9. 4 A
10. 89 391 EEC 11 12Articles of 11 and 12 of the Framework Directive 89 391
11. 2 2 Framework Directive 89 391 EBC 89 391 EEC 5 mutagenic toxic to reproduction persistent bioaccumulating toxic PBT or very persistent very bioaccumulating vPvB or substances giving rise to an equivalent level of concern CMR PBT vPvB 1 6 OJ L 183 29 6 1989
12. REACH 1 NA NN SN
13. 34 REACH Regulation No 1907 2006 Article 14 4 Anex 35 35 Directive 84 450 of 10 9 1984 relating to the approximation of laws regulations administrative provisions of the Member States concerning misleading advertising Directive 84 450 of 10 9 1984 13 34 4 2
14. BEU 2 2 2 4
15. 3 EU The EU Scientific Committee on Emerging on Emerging Newly Identified Health Risks SCENIHR the Scientific Committee for Consumer Products SCCP 2 2
16. 2006 12 EC FLEP EU
17. NH 2 3 3
18. 1488 94 http ecb jrc it tgd EN ISO 14971 2000 Medical devices Application of risk management to medical devices ISO14971 2000 EN ISO 14971 2000 1 2003 EN ISO 14971 2000 SO14971 2000 EN ISO 14971 2000 1 2003 31 Notes of guidance of the Scientific Committee for Consumer Products for the testing of cosmetics ingredients and their safety evaluation 6th revision 6 http ec europa eu health ph_risk committees 04_sccp docs sccp_o_03j pdf http ec europa eu european_group_ethics activities docs opinion_21_nano_en pdf 3 EMEA Reflection paper on nanotechnology based medicinal products for Human Use http www emea europa eu pdfs human genetherapy 7976906en pdf 12 TUN LTOS De RITR E RETA k ICER CHE
19. IPPC Seveso ID IPPC EU 32 000 BAT BAT XE BREFs TIPPC IPPC COM 2008 49 final 2008 0025 COD 5 2 2008 Council 2 2008 1 concerning integrated pollution prevention control OJ L 24 29 01 2008 2008 1 EC OJ L 24 29 01 2008 8 Seveso
20. gt Directive 96 82 on the control of 2 accident hazards involving dangerous substances OJ L10 of 14 1 1997 96782 OJ L10 of 14 1 1997 6 Directive 2000 60 OJ L 327 22 12 2000 7 Decision No 2455 2001 OJ L 331 15 12 2001 Directive 2006 118 OJ L 372 27 12 2006 9 Directive 2006 12 OJ L 114 27 4 2006 20 Directive 91 689 OJ L 377 31 12 1991 1 electrical and electronic equipment end of life vehicles packaging and packaging materials batteries titanium dioxide 2 Directive 2001 80 OJ L 309 27 11 2001 23 Directive 1999 31 OJ L 182 16 07 1999
21. European Medicines Agency European Food Safety Authority European Agency for Safety and Health at Work OSHA European Scientific Committees 9 Technical Guidance Document in support of Commission Directive 93 67 on risk assessment for new notified substances Commission regulation 1488 94 on risk assessment for existing substances 93 67 EBEC
22. 3 1 Joint Research Center BEU es s
23. FP6 FP7 OECD ISO 2 2 2 2 3 14
24. OECD 1 WPMN http www oecd org7department70 3355 en_2649_37015404_1_1_1 1 1 00 html subsequent updates 25 modified Opinion after public consultation on appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies 10 March i 10 2 http ec europa eu health ph_risK committees 04_scenihr docs scenihr_o_003b pdf 26 http ec europa eu health ph_risk committees 04_sccp docs sccp_o_099 pdf 2 Com 2000 1 final 10 76
25. 2 3 General Product Safety Directive REACH ka D
26. 7 Directive 2004 37 of 29 4 2004 OJ L 158 30 4 2004 8 Directive 98 24 of 7 4 1998 OJ L 131 5 5 1998 9 Directive 89 655 EEC of 30 11 1989 OJ L 393 30 12 1989 10 Directive 89 656 EEC of 30 11 1989 OJ L 393 30 12 1989 1l Directive 1999 92 of 16 12 1999 OJ L 23 28 1 2000 12 Directive 2001 95 OJ L 11 15 1 2002 2
27. Seveso 6 2000 60 33 2001
28. 3 2 Commission of European Communities Communication from the Commission to the European Parliament The Council and the European Economic and Social Committee Regulatory Aspect of Nanomaterials June 17 2008 lt http eur lex europa eu LexUriServ LexUriServ do uri COM 2008 0366 FIN EN PDF gt COMMISSION OF THE EUROPEAN COMMUNITIES Brussels 17 6 2008 COM 2008 366 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE REGULATORY ASPECTS NANOMATERIALS SEC 2008 2036 EE OYK 4 4 5 6 7 8 10 11 E anaa a a a n a a N AR 12 A EE 13 3 4 kkk 14 AE TIEREN E
29. No 1907 2006 L 396 of 30 12 2006 European Chemicals Agency REACH A
30. ES EE ER ER E EE OAE 14 EEA 1 BEU 2005 2009 EU
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