Transcription

1

2

3 JAMP i

4 3(JEITA) WSSD ii

5 (1) (2) (3) 1

6

7 WSSD

8 SAICM 3 2 WSSD2020 CMR

9 UF (a) (b) 3 2 QSAR

10 WSSD2020 WSSD

11 WSSD2020 WSSD QSARGLP GLPGLP GLP GLPGLP GLPGLP GLPGLP QSARQSAR 7

12 WSSD

13

14 QSAR QSAR QSAR QSAR QSAR QSARin vitro CBI 10

15

16 2 a 24 b 12

17 c SMILES 13

18 WSSD2020 WSSD2020 GLP QSAR

19 SMILES 4 15

20 EU TSCA SNUR TSCA SNUR WSSD QSAR GLP

21 2020 GLP QSAR 3.2 QSAR 1% QSAR 3.3 WSSD

22 18

23 PFOS PFOS PFOS PFOS

24 (1) 1 (2) 40 PCB PCB PCB PCB PCB

25 POPs 1 1 PFOS

26 (3) HHHeBCNOFNePSClArAsSeBrKrTe IXeAt Rn 22

27 PCB PFOS PFOS

28 (4)

29 (1) (2) (a) 4 () CHRIPhttp:// J-CHECKhttp:// 14 ver

30 PNEC PNEC ACR 1t HP 26

31 PRTR PRTR (b) 3 16 (c)

32 (d) CAS MITI 4.1-6,

33 GHS PNEC GHS

34 TK TK GHS

35 (e) (f)

36 (1) ()() () () () () () () 21 (2) 3 30,000 / / PLC 7-8, PLC

37 (a) (b) (c) 3 (d) 20 (e)

38 (f) IUPAC % IUPAC 34

39 Pow 1- Ames OECD OECDGLP 1%

40 1 % 23 1 % QSAR QSAR QSAR 24,25 QSAR 16 NITE 26 (g)

41 t 10t

42 t

43 ののの (h) 2 5 (i) (3) (a) の の にづくのの での の にづくののでの のの

44 (b) (c) 3 (d) BOD 60% 3 60 HPLCGC Pow Pow 3.5 HPLC

45 1 NOEL PNEC PNEC 31 (i)(ii) (i) 99 (ii) 98% 2%99%98% % 50%

46 NO NO NO Yes % Yes NO NO NO Yes 1 Na,Mg,K,Ca 350% 50% 1000 ph ph4,7,9402 DOCIRGPC 5 n-n- THFDMF(or DMSO or NMP Yes Yes Yes 1000 Yes

47 (e) [1][4] [] 3 [] [1][4] 4 [1][4] [1][4] 5 [] [] (f) 5 43

48

49 Pollutant Release and Transfer Register; PRTR SDS (a) (i) PRTR SDS p/policy/chemical_m anagement/law/msds /pdf/sin1shu.pdf p/policy/chemical_m anagement/law/msds /pdf/sin2shu.pdf

50 (ii) 1% 0.1% % 0.1% PRTR PRTR 33 () PRTR

51 PRTR SDS Safety Data SheetSDS SDS SDS 24 3 JIS Z 7253 SDS JIS Z 7253 JIS Z SDS SDS SDS FAX 47

52 SDS 1 2 GHS GHS 3 CAS ph SDS

53 JIS Z

54 JIS Z 7253 SDS JIS Z

55 SDS ph GHS GHS 3 JIS Z 7253 A JIS Z

56 SDS 640 SDS E5%AE%B3%E3%82%92%E9%98%B2%E6%AD%A2%E3%81%99%E3%82%8B%E3%81%9F%E3%82%81%E3%83 %AA%E3%82%B9%E3%82%AF%E3%82%A2%E3%82%BB%E3%82%B9%E3%83%A1%E3%83%B3%E3%83%88 52

57 SDS GHS SDS 38 ILO

58 beppyo1.pdf dai1-doku.pdf beppyo2.pdf dai2-geki.pdf beppyo3.pdf dai3-toku.pdf in vitro LD50 50 mg/kg mg/kg LD mg/kg 200 1,000 mg/kg LC ppm (4h) 500 2,500 ppm (4h) LC mg/l (4h) mg/l (4h) LC mg/l(4h) mg/l (4h) 4h 3 1 Draize ,

59 (a) 5 6 (b) 30 (c) (d) (e) GHS kg 55

60 GHS (f) SDS 1 200mg JIS Z 7253 SDS SDS (g) 2 3 (h) (i)(iii) (i)(iii) 5 (i) 56

61 (ii) (iii) (i) 18 (j) (i)(ii) (iii)(iv) (k) (l) ( 97 ) ( 72 ) ()

62 (a) (1)(2)(3)(4)(5)(6) (7)(8)(9)(10)(11)(12) (13)(14)(15)(16)(17)(18) (19)(20)(21)(22)(23)(24) (25)(26)(27)(28)

63

64 , , [a]22(23) 1)2)3) ) (He) (Nm /h)10 He ) % 3) g/Nm g/Nm 1.0mg/Nm 46 60

65 30mg/Nm 80700mg/Nm 1.020mg/Nm 1030mg/Nm 1030mg/Nm VOC 40060,000ppm 234 () mg/Nm mg/Nm mg/Nm mg/Nm mg/Nm mg/Nm ( 138 ) ( 72 ) ( )

66 ( ) ( ) ( ()) ()() 50m m m 3 62

67 COD mg/l mg/l 0.06mg/l 0.02mg/l 0.06mg/l 0.03mg/l 0.2mg/l 0.1mg/l 0.1mg/l 10mg/l 230mg/l 1.4- EPN " 8mg/l 15mg/l 1L mg 0.5mg/l 0.03mg/l 1mg/l 1mg/l 0.1mg/l 0.5mg/l 0.1mg/l 0.005mgl 0.003mg/l 63

68 mg/l 0.1mg/l 0.2mg/l 0.02mg/l 0.04mg/l 1mg/l () BOD() 160mg/l ( 120mg/l) COD() 160mg/l ( 120mg/l) SS() 200mg/l ( 150mg/l) () 5mg/l () 30mg/l 5mg/l 3mg/l 2mg/l 10mg/l 10mg/l 2mg/l (1cm 3 ) 3000 /cm 3 120mg/l ( 60mg/l) 16mg/l ( 8mg/l)

69 ( 53 ) ( 51 ) 1 VOC mg/kg mg/l mg/l mg/l () mg/l , , , , ,1,1-1,1,

70 な mg/kg () 15mg/kg PCB (a)( 3 ) (b)( 4 ) (c)( 5 ) (c) 66

71 (a) (b) ()()() (c) () 67

72 JIPS/GPS GPSGlobal Product Strategy) ICCA JIPSJapan Initiative of Product StewardshipGPS GPS/JIPS GSS ICCA JCIA BIGDr 51 ICCA GSS QSAR QSAR LRI 53 QSAR (a) 10 (b) (c) QSAR ICCA LRI(Long-range Research Initiative) 68

73 (d) 982 (e) 110 (f) (g) Weight of Evidence Weight of Evidence 2JAMP JAMPJoint Article Management Promotion-consortium (a) JAMP HP (b)ais MSDSplus CAS DU AISJAMP DSU URL (c) (d)ais

74 JAMP-IT ID 104, , JAMP-IT 244 6% 41% 41% 12% 56 JAMP 3(JEITA) JEITA: Japan Electronics and Information Technology Industries Association 57 IT-IT- IT IoTAICPS IT chemsherpa chemsherpa chemsherpa 59 chemsherpa

75 TSCA6EU ELV 2011/37/EURoHS 2011/65/EU ANNEX IIPOPs(EC) No 850/2004 ANNEX IREACH(EC) No 1907/2006 Candidate List of SVHC for AuthorisationANNEX XIVANNEX XVII Global Automotive Declarable Substance List (GADSL)IEC DB Declarable substance groups and declarable substances IECIPC 284 JAMPchemSHERPA chemsherpa

76 EU EUPrimary Legislation Secondary LegislationCase-law EUEU ECEC EU (Regulation)(Directive)(Decision)(Recommendation)/ (Opinion) EUOfficial Journal of European UnionOJ 61 EU EU European Council EU Council European CommissionEuropean Commission 4 EU EU EU EU EU 6263 EU EU EU EUR-LexJETRO 62 EU JETRO 63 EU 72

77 4.2-1 EU EU EU (Regulation) (Directive) EU EU 3 EU EU (Decision) EU (Recommendation) EU (Opinion EU 73

78 4.2-2 EU European Council European Commission (Regulation) (Directive) (Decision) EU Council (Recommendation (Opinion) European Commission EU EU PRTR EU JETRO 65 EU JETRO

79 4.2-3 EU EU (REACH)REACH REACHRegistration,Evaluation,Authorisation and Restriction of Chemicals 1907/2006/EC 79/117/EEC REGULATION (EC) No 850/2004 OF THE EUROPEAN PARLIAMENT AND OF THE 850/ L / / /2007 COUNCIL of 29 April 2004 on persistent organic pollutants and amending Directive 304/ / / / /2014 [(POPs) 79/117/EEC ] 98/24/EC 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 (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Council Directives on the protection of workers from the risks related to exposure to 2004/37/EC carcinogens and mutagens at work (2004/37/EC) ( ECHAEUROPEAN CHEMICALS AGENCY ECHAEUROPEAN CHEMICALS AGENCY EU-OSHA European Agency for Safety and Health at Work) SDSREACH POPsXVII (REACH /2008CLP 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/ ECHA(EUROPEAN ECHAClassification CHEMICALS AGENCY) &Labelling InventoryCLP 40 (1102/2008/EC) EU /71/EURATOM REGULATION (EC) No 1102/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 October 2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation COUNCIL DIRECTIVE 2009/71/EURATOM of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations / HgCAS Hg2Cl2CAS HgOCAS % basic standards EU COUNCIL REGULATION (EC) No 111/2005 of 22 December 2004 laying down rules for the 111/ L221259/2013 monitoring of trade between the Community and third countries in drug precursors EU COMMISSION REGULATION (EC) No 1277/2005 of 27 July 2005 laying down 273/2004EU implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of 111/ the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down 1277/ L202297/ /2011 rules for the monitoring of trade between the Community and third countries in drug precursors EU COUNCIL REGULATION (EC) No 111/2005 of 22 December 2004 laying down rules for the 111/ L221259/2013 monitoring of trade between the Community and third countries in drug precursors EU COMMISSION REGULATION (EC) No 1277/2005 of 27 July 2005 laying down 273/2004EU implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of 111/ the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down 1277/ L202297/ /2011 rules for the monitoring of trade between the Community and third countries in drug precursors REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE 79/117/EEC 91/414/EEC COUNCIL of 21 October 2009 concerning the placing of plant protection products on the ECNo 107/200991/414/EEC market and repealing Council Directives 79/117/EEC and 91/414/EEC EFSAEuropean Food Safety Authority) / /128/EC DIRECTIVE 2009/128/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides 086:en:PDF IPM EU (91/676/EEC) Nitrates Directive Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture Feed Hygiene Regulation(EC)No183/ Food Standards Agency 022:EN:PDF White Paper on Food Safety,COM final, European Commission (EC)No178/2002 REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January EFSAEuropean Food Safety Authority) 024:EN:PDF EC)No853/2004 EC)No852/2004 EC No.1935/2004 ECNo396/2005 ECNo 1333/2008 EUNo 1169/ /83/EC No528/ /8/EC) (EC)No648/ /83/EC REGULATION (EC) No 853/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 REGULATION (EC) NO 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 February 2005 REGULATION (EC) No 1333/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on food additives REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption 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 Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents(detergents Regulation) Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription, COM(2012) 48 EFSAEuropean Food Safety Authority) 205:EN:PDF EFSAEuropean Food Safety Authority) 054:en:PDF EFSAEuropean Food Safety Authority) 017:EN:PDF EFSAEuropean Food Safety Authority) 016:EN:PDF EFSAEuropean Food Safety Authority) 033:en:PDF EFSAEuropean Food Safety Authority) 063:EN:PDF EFSAEuropean Food Safety Authority) ECHA(EUROPEAN CHEMICALS AGENCY) Directorate-General for Enterprise and Industry EMEA(European Medical Agency) 31&from=EN WHO EMEA EU76/768/EEC / / L / / / / / / / / /674/EU REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products ECHA(EUROPEAN CHEMICALS AGENCY) CPNPCosmetic Products Notification Portal COMMISSION IMPLEMENTING DECISION of 25 November 2013 on Guidelines on 1223/2009 I Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council 2013/674/EU L315 on cosmetic products / L190 COMMISSION REGULATION (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products ECHA(EUROPEAN CHEMICALS AGENCY) ECHA(EUROPEAN CHEMICALS AGENCY) 2013/674/EU

80 ELV /53/EC Directive 2000/53/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 September 2000 on end-of life vehicles 8f9f-eb201bd /DOC_1&format=PDF 8f9f-eb201bd /DOC_2&format=PDF 46 EU vol WEEE2012/19/EU RoHS2011/65/EU A Thematic Strategy on the prevention and recycling of waste DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on waste electrical and electronic equipment (WEEE) (recast) DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011on the restriction of the use of certain hazardous substances in electrical and electronic equipment J-MossJIS C velopment/l28168_en.htm RoHS draft /50/EC DIRECTIVE 2008/50/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 May 2008 on ambient air quality and cleaner air for Europe EEAEuropean Environment Agency SO2NOxPM VOCNH3 PM /30/EC 2000/69/EC2002/3/EC EEAEuropean 2001/81/EC National Emissions Ceiling DirectiveNECD Environment Agency 2010/75/EU Directive on industrial emissions 2010/75/EU (IED) EEAEuropean Environment Agency 1999/13/EC) 2004/42/EC) Directive 1999/13/EC on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations Directive 2004/42/EC on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products EEAEuropean m Environment Agency EEAEuropean Environment Agency VOC SO2NOXNH VOC VOC VOC 1999 VOC 2000 Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the Community action in the field of water policy Water Framework Directive 2000/60/EC EEAEuropean Environment Agency /464/EEC 75/440/EEC 2008/105/EC Directive on Priority Substances (Directive 2008/105/EC) EEAEuropean Environment Agency PHSPHS (2006/118/EC) Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration w_directive_en.htm EEAEuropean Environment Agency 1991/271/EC Council Directive 91/271/EEC concerning urban waste-water treatment EEAEuropean Environment Agency (91/676/EEC) Nitrates Directive EEAEuropean Environment Agency PRTR 85/337/EEC,97/11/EC1985 Council Directive of 27 June 1985 on the Assessment of the Effects of Certain Public 1997 and Private Pro EEAEuropean Environment Agency SEA 2001/42/EC Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment ) EEAEuropean Environment Agency / /2014 (PIC REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 concerning the export and import of hazardous chemicals ECHA(EUROPEAN CHEMICALS AGENCY) PICPrior Informed Consent) /98/EC Waste Framework Directive EEAEuropean Environment Agency EU DIRECTIVE 2001/80/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants EEAEuropean Environment Agency 001:EN:PDF /369/EEC COUNCIL DIRECTIVE of 8 June 1989 on the prevention of air pollution from new municipal waste incineration plants EN:HTML EEAEuropean Environment Agency Council Directive 89/429/EEC of 21 June 1989 on the reduction of air pollution from existing municipal waste-incineration plants mber&lg=en&type_do c=directive&an_doc=1989&nu_doc=429 EEAEuropean Environment Agency THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 December 2000 on the incineration of waste ment_centre/op_resources/incine ration_directive_2000_76.pdf EEAEuropean Environment Agency Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste EEAEuropean Environment Agency 76

81 REACH REACH (1) REACH REACH 1 68 (2) 1967 EU 67/548/EEC (the European Inventory of Existing Commercial SubstancesEINECS) EU 67/548/EEC EU (UNCED) (WSSD2002 )SAICM(ICCMI2006 ) REACH Registration,Evaluation,Authorisation and Restriction of Chemicals (European Chemicals AgencyECHA) REACH 69 (3) REACH EU EU 1 1 (4) Chemical Safety ReportCSR CMR PBT vpvb Substances of very high concernsvhc 68 REACH

82 70 REACH / REACH REACH Registration,Evaluation,Authorisation and Restriction of Chemicals European Chemicals AgencyECHA) REACH 1 EU 1 1 2%< (SVHC) 1,, IV,V REACH EU ELINCS 1t 1 10 Substance Information Exchange ForumSIEF 70 REACHCLP 78

83 (5) REACH REACHCLP REACHCLPSDS REACH REACH (European Chemicals AgencyECHA) (EU)EU EU /548/EEC 1999/45/EC /2008CLP REACH 67/548/EEC 1999/45/EC CLP 31 SDS 3(b)0.1% 2 1A1B ECHA EU XIV XIV EU 72 No ECHA proposes 15 substances for authorisationecha 79

84 4.2-5 EU European Commission OLAF EU-OSHA EMA) ECHA EFSA) EEA ENEA) 2 EU (1) (a) REACH 1 non-phase-in substance (phase-in substance) REACH EINECS REACH 15 EU REACH (No longer polymer)reach 80

85 4.2-6 REACH flavouring) 3 IV (N2) 40 V IV V ECNo987/ (EC)%20No% pdf (b) 1 (Manufacturer) (Importer)EU EU EU EU EU SDS Downstream Users :DUs 74 No

86 M/ICSA (CSA) (c) 3 ECHA (No data, no market) t/y t/y t/y 1000t/y 100t/y 1t/y CMR (d) EU ECHA 75 No (REACH/CLP) 77 REACH (CSA)() 78 No REACH 82

87 (e) Technical Dossier 10t CSR80 81 Technical Dossier 11 IUCLID5(International Uniform Chemical Information Databasehttp://iuclid.eu/index.php?fuseaction=home.iuclidHome) i Ii Iii Iv V Vi Vii Viii ix X xi CAS XI () XI 110t VIIVIIIIXX (Chemical Safety Report) 10t (Chemical Safety ReportCSR, TEMPLATE A B B Chemical Safety AssessmentCSA 80 (REACH/CLP) 81 REACH (CSA)() 83

88 A (CSR) EC CSA 2 3 B PBTvPvB 9 PBTvPvB 10 (f) (Substance Information Exchange ForumSIEF) QSAR read-across REACH 83 No

89 EUREACH) ( ,101.3kPa 1t/y 1-10t/y /y t/y 1000t/y N- *OECD

90 vivo vitro

91 / OECD421/ 422 OECD (OECD209) 87

92 9.2 (FELS) / ph OECD TG301C 88

93 / / / 89

94

95 110 VII 14 1,2 CMRPBTvPvB in vitro VII VIII in vivo VIIVIII IX VIIVIII IXX in vivo 1-10 ph 100-1, % PBT/vPvB PBT/vPvB PBT/vPvB / PBT/vPvB 1 /PBT/vPvB 10 % 84 80%1% 80%110%80% 1%10% UVCB Substances of Unknown or Variable composition, Complex reaction products or Biological materials1%pbt/vpvb0.1% REACH (CSA)() 85 Guidance for identification and naming of substances under REACH and CLPECHA 91

96 QSARread-across REACH in vitro QSARSARread-across in vitro in vivo QSARs read-acrossreach VIIVIIIIXX 86 QSAR REACH XI - QSAR -QSAR -/ - (read-across)(reach XI) - 1) 2) 3) 13 (3) 13 (3) (g) REACH (CSR) 2wt% 1 REACH 6 (3) (h) 3 ECHA (Reference Number) REACH () 87 REACH 92

97 (i) EU REACH (j) EU SVHC 0.1 % 1 90 (k) (SVHC) EU (SDS) 0.1 %(SVHC) EU (REACH/CLP) 89 REACH 90 (REACH/CLP) 91 (REACH/CLP) 93

98 (1) (a) REACH REACH EU EU ECHA 3 ECHA (ECHA ECHA CMR PBT/vPvB XIV // EU XVII 94

99 (b) (CSR) (CSR) ECHA EU ECHA 93 (c) CSAECHA (d) 1 10 (CSR) (i)(iv) i CMR CarcinogenicMutagenicReproductive toxicity DNELDerived Non-Effect LevelNOAELNo Observed Adverse Effect LevelLOAELLowest Observed Adverse Effect Level ii iii(pnec ) (PNEC Predicted No Effect Concentration) ivpbt/vpvb/ PBT/vPvB 10 REACH PBT/vPvB PBT/vPvB PBT/vPvB emission characterisation PBT/vPvB REACH (REACH/CLP) ban.pdf 93 No

100 PBT vpvb REACH XIII PBT vpvb (T1/2)60 (T1/2) 40 (T1/2) 180 (T1/2)120 (T1/2)120 (T1/2)60 (T1/2)180 (T1/2)180 BCF2000L/kg BCF>5000L/kg NOEC0.01mg/L ( 1 2)( 1 2) /548/EEC T,R48 Xn,R48 (i)(iv) 67/548/EEC 94 PBT vpvb (v)(vi) (DNEL)PNEC) (v) REACH ECETOC TRA European Centre for Ecotoxicology and Toxicology of ChemicalsECETOC COSHH-BAuAhttp:// EMKGhttp:// ConsExpohttp:// EUSES CHESARhttps://chesar.echa.europa.eu/ (vi) -REACH CSA 1)DNELPNEC 2) 3) 94 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 96

101 PBTvPvB Carcinogenic, Mutagenic and Reproductivetoxicity:CMR PBT/vPvB Substances of Very High Concern:SVHCsSVHCs SVHCs ECHA Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern 95 ECHAECHA2 PBTvPvB(CMR) 67/548/EEC 100 (REACH40 ) ECHA 1REACH4042 5% (REACH4142) (Community Rolling Action PlanCoRAP)CoRAPECHA REACH CoRAP (e) CMR PBT vpvb SVHC Substances of very high concern EU EU EU EU 95 REACH (CSA)() 96 No

102 EU CSR CSR XIV 18 REACHXIV143/ HBCDD BBPDBP6 125/ / / Candidate List of substances of very high concern for Authorisation 15/06/2015 ECHA SVHC (SVHCs) SVHCsSubstances of Very High Concern CMR PBT vpvb REACHXVII XVII ()2830(CLPVI CMR)1,000CMR (PPORD)76/768/EEC REACH List of Restrictions ECHA ECHA EU JETRO 98 (REACH/CLP) 99 No No

103 (f) REACH 77 (2)(e) 119 ECHA the Dissemination Portal ,441 51, REACH REACH 103 REACH 1 1 SVHC 0.1%% MITI 1 () 4 10 () EC CSR ECHA MITI 101 REACH Registered substancesecha

104 QSAR CoRAP QSAR READ-ACROSS 100 1% QSAR READ-ACROSS 1% 1% (federal law) (state law) TSCA Code of Federal Regulations : CFRTSCA CFR TSCA FFDCA CCACWAOSHAct FHSACPSIA

105 Clean Water Act(CWA) Toxic Substances Control Act TSCA) EPA Federal Insecticide, Fungicide, and Rodenticide Act FIFRA) EPA Federal Food, Drug, and Cosmetic Act FFDCA) FDA CAA) EPA The Safe Drinking Water Act (SDWA) Resource Conservation and Recovery Act (RCRA) The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) ( EPA abc9e3c10&mc=true&node=se _14&rgn=div8 Department of Labor, The Occupational Safety and Health Administration ( EPA ANSIAmerican National Standards Institute EPA EPA EPA EPA OSHA ANSI 101

106 2 CFR Title Part 21.Food and Drugs 170~190 FDA Labor 40.Protection of Environment OSHA 5093 EPA TRI) TSCA) TURA Toxic Use Reduction Act

107 4.3.3 Toxic Substance Control ActTSCA TSCA (Asbestos Hazard Emergency Response) 1988 ((Indoor Radon Abatement) 1992 (Lead Exposure Reduction) 2007 (Healthy High-Performance School) 2010 ( Formaldehyde Standards for Composite Wood Products) Toxic Substances Control TSCA Reform (3) TSCA 90 PMN TSCA PMN PMN PMN TSCA TSCA 2 EPA 103

108 5 (h)4 10 LVE 30 PMN 30 EPA TSCA PMN (4) 90 PMN EPA PMN (5) (a) (EPAEnvironmental Protection Agency) (OPPT : Office of Pollution Prevention and Toxics ) 104

109 (b) TSCA EPA EPA EPA (sensitive subpopulationes) EPA EPA TSCA Work Plan Chemicals Toxic Substances Control Act (TSCA)EPAEnvironmental Protection Agency Office of Pollution Prevention and Toxics (OPPT) (1) TSCA CAS (2) (a) EPA 105 URLhttp:// 105

110 1 EPA / PBT) 106

111 2 1 PBT PBT IRIS: 1986 Class A, B1; 1996 ; 1999 or 2005 IARC, 1, 2A NTP PBT TRI PBT Great Lakes Binational PBT P, B, T ( 3 ) LRTAP POPS POPs IRIS: / (/ RfD RfC) NTP CERHR: Cal Prop 65 IRIS 2006 IUR Children s List NHANES Drinking Water Contaminants Fish Tissue Studies Atomic Energy Act TSCA 108 TSCA TSCA 106 The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 107 The Federal Food, Drug, and Cosmetic Act (FFDCA) FR 46066, November 21,

112 TSCA PCB TSCA (b) (EPAEnvironmental Protection Agency) (OPPT : Office of Pollution Prevention and Toxics ) (c) (3) (1) TSCA TSCA TSCA EPA

113 (2) Yes PMN TSCA No No TSCA No 40 CFR No 10,000kg 40 CFR No 40 CFR No 40 CFR No 40 CFR No 90 PMN Yes Yes Yes Yes PMN 40 CFR (a)-(h) SNUR No PMN CFR EPA (202) (202) (202) No PMN Yes PMN EPA New Chemicals Program Bulletin (EPA-743-F , May 1995) 109

114 (a) 112 PMN (PMN; Premanufacture Notification) PMN PMN PMN TSCA PMN1 1 TME; Test Marketing Exemption LVE; Low Volume Exemption2 10,000kg LoREXLoREX; Low Environmental Releases and Human Exposure LoREX a,b,c PMN a.oecd 114 b. (i) (ii) 2 (iii) (iv)2 % TSCA 2% (v) 10, OECD

115 (vi)cf3 c. (i) 1,000 10, % 1,000 25% (ii) 10, % 1,000 5% (iii)98 1 PMN 2 LVE EPA (b) (c) 90 PMN PMN TME LVE LoREX NOC (d) EPA; Environmental Protection AgencyOPPT; Office of Pollution Prevention and Toxics (e) PMN TME, LVE, LoREXEPA No NOC EPA No (f) PMN

116 PMN 1 2 CAS CAS % 3 CAS % % 8 SDS PMN QSAR PMNCAS % 115 EPA 112

117 QSAR TSCA TSCA New Chemical Program (NCP) Chemical Categories (EPA, 2010)PMN (g) apmn TME, LVE, LoREX, ,12, EPA TME LVE LoREX 1 2 CAS CAS 3 CAS % TSCA 5 (h)(4)lve LoREX ,000kg EPA 10,000kg 10,000kg PMN

118 (h) PMN EPA (NOC) EPA NOC TSCA PMN EPA 90 EPA PMN EPA 90 EPA TSCA 5 e TME 45 EPA LVE/LoREX 30 EPA 5 (e) PMN SNUR NOC; Notice of Commencement 1 PMN 2 PMN 3 4 NOC i PMN NOC TSCA ,500US 1 25,000US 1 114

119 (3) (a) [1 ] PMN [8-12 ] [9-13 ] TSCA Non-5(e)SNUR 5(e) 5 EPA [15-19 ] [23-27 ] [57-61 ] [79-82 ] [90 ()] Non-5(e)SNUR SNUR) 5(e) SNUR EPA EPA New Chemicals Program Bulletin (EPA-743-F May 1995) PMN %9F%E5%8A%B4%E5%83%8D%E7%9C%81' 115

120 (b) (EPAEnvironmental Protection Agency) (OPPT : Office of Pollution Prevention and Toxics ) (c) EPA 90 () EPA EPA (d) EPA :: LADD6 q1* LADD q1* 1.Reference dose 2.Reference concentration 4.No observerd adverse-effect level 5.Lowest observed abverse-effect level 7.Enviromental toxicity profile MOE 13 Enviromental toxicity profile7 CC 8,9 Enviromental toxicity profile acute values Enviromental toxicity profile CC Enviromental toxicity profile acute values RfD RfC 1 2 NOAEL 4 / LOAEL 5 / 3.Margin of exposure 6.Lifetime average daily dose RfD RfC MOE100 MOE1000 LADDq1*1.0-5 LADDq1*1.0-5 SWC20CClow risk(swc>cc 20) SWC>CC20moderate risk SWC>acute valye high risk 11 CClow risk >CCmoderate risk >ChVhigh risk acyte value high risk 12 8.Concern concentrationenviromental toxicity profile ChV(chonic value)1/10chvchronic no-effect concentration 98Enviromental toxicity profileccpmncc ChV)PMN 10.Steam water concentration 11.SWC/acute value4moderate risknabholts(2002)"if a SWC is within 4 times of the acute value,then the potential for as acute risk is expected be moderate."

121 (2) (f) (e) SNUREPA EPA PMN PMN ( )SNUR (5(e)SNUR) PMN SNUR (Non-5(e)SNUR) (f) PMNNOC Federal Register EPA PMN EPA 117

122 (1) 118 (2) CEPA (Canadian Environmental Protection Act) CEPA CEPA New Substance Notifications RegulationsNSNR (3) CEPA1999 (a) (b) (c) (d) (e) (f) 1 (g)

123 (4) 120, DSL 1994 (DSL) NDSL SNAc significant new activity (5) CEPAHC CMP

124 (1) 123,124 2 DSLDomestic Substance List kg ,000 CAS DSL DSL NDSLNon- Domestic Substance List DSL TSCA TSCA 1985 DSL DSL NDSL TSCA USEPAUnited States Environmental Protection Agency s TSCA NDSL DSL 58,000 (2) (a) 125,126 3 DSL A Guide to Understanding the Canadian Environmental Protection Act,

125 DSL Schedule (b) (c) DSL 23, CMP2020 CEPA (d) CEPA (a) (b) (c) 121

126 CEPA (e) DSL 23, Toxic Substance List (Schedule1) HP 128 Toxic Substance List-Schedule Schedule 1 DSL CEPA1999 Schedule 1 Schedule 1 CEPA First Priority Substance List(PSL1) Second Priority Substance List(PSL2) (f) Canada Gazette, Part 60 Canada Gazette, Part Chemicals Management Plan Progress Report, Issue5, Fall A-F4BF E

127 (1) (DSLDomestic Substance List) (2) (a) DSL NSN DSL web DSL 1 2% (b) (c) NDSL Schedule 132 DSL 123

128 4.4-2 NDSL 1 Schedule kg Schedule Schedule Schedule Schedule Schedule NDSL 10 Schedule ,134 RRR 1 Schedule Schedule Schedule Schedule Schedule NDSL 1 DSL NDSL 4NDSL DSL DNSL kg// 134 (a) (b) 1 (c) 124

129 (d) (e) NSN New Substances Notification (NSN) Reporting Form 135 (f) NDSL NDSL NDSL NDSL 10t 1-10t 100kg-1t 10t 1-10t NDSL IUPAC CAS CAS SDS in vitro in vitro in vivo %20C%26P%20-%20EN.pdf 125

130 kg/ 16 1 IR, UV, MS, NMR 200g/L 2GLP 126

131 NDSL >1 1 DSLNDSL 10 NDSL 10 NDSL IUPAC CAS CAS SDS >2% in vitro in vitro in vivo 2 127

132 kg/ 22 1: (a) (b) NDSL (c) DSL NDSL (d) 1 DSL NDSL 2GLP pH7 >2% 6pH7 2% 128

133 NOEQNotice of Excess QuantityNOEQ NOMINotice of Manufacture or Import NOEQ NOMI DSL NDSL DSL (a)1 1 3kg (b) NDSL NDSL DSL/NDSL (a)1 1 3kg 50 (b) 10 NOEQ (Q)SAR 137 QSAR (Q)SAR QSAR (g) NDSL kgNDSL 100kg 137 Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers 129

134 4.4-7 NDSL 1 1 2%DSL 100 kg (a) 1 (b) 50%1 3 (c) 50% (d) 124 (a)(b)(c) (a) NAMW10,000 MW 500 2% 1,000 5% (b) 1,000NAMW10, % 1,000 25% (c)

135 (h) 2 2 (i) CEPA 100 CA CA 50 CA 3 (3) (a) NSN 2 DSL DSL

136 (b) (c) NDSL 4.4-2,3 (d) CEPA (2)(d) 4.4-4,5 (e) toxic SNAc Significant New Activity (g) 120 DSL 132

137 toxic 2 90 SNAc 30 NOEQNotice of Excess Quantity NOMI Notice of Manufacture or Import 120 DSL (1)

138 (2) LRCCLow Regulatory Concern ChemicalsLRCC LRCC LRCC Amendment GHS 140 (3) Hazardous chemicals 5 4AA NOHSC Approved Criteria for Classifying Hazardous Substances, 3 rd editionnohsc1008(2004) ASCC HSIS:Hazardous Substances Information System ASCC Safe Work Australia (4) Australian Inventory of Chemical Substances AICS Priority Existing ChemicalsPEC AICS NICNAS(National Industrial Chemicals Notification and Assessment Scheme) 1 PEC Priority Existing ChemicalsPECPEC (5) Inventory Multi-Tiered Assessment and PrioritizationIMAP The National Industrial Chemicals Notification and Assessment Scheme(NICNAS) Department of Health 140 A Vol.34No.9 134

139 4.5.2 (1) Australian Inventory of Chemical SubstancesAICSAICS New Chemicals Program AICS Stage One Chemical Tier Stage One Chemical 142 NICNAS NICNAS 2006 NICNAS NICNAS Petroleum Sector Stream Approach CMR Cosmetic Regulation EC No 1223/2009 Annex EPA EU REACH EU REACH Regulation 2006 Annex OECD Environmental Working Group Greenpeace World Wildlife Fund UK (2) (a) Industrial Chemicals (Notification and Assessment) Act 1989CwlthThe National Industrial Chemicals Notification and Assessment Scheme(NICNAS)(1990 ) NICNAS IMAP OECDWHO QSAR data/assets/excel_doc/0010/6121/stage-one-list-published-13-feb-2015.xlsx

140 Tier 3 Tier TierTier Tier 3 Tier IMAP 1 3 (PCLs) AICS Tier Tier TierTier Tier Tier Tier Tier TierTier data/assets/word_doc/0004/5575/identification-of-polymers-of-low-concern-to-human -health.docx data/assets/word_doc/0003/5574/identification-of-chemicals-of-low-concern-to-huma n-health.docx 136

141 4.5-2 (b) IMAP (c) 2012 PEC 1 (d) Tier Tier

142 0 ( ) () i i i i i i i i i ii i i i ii ii i i ii ii ii i ii ii ii ii i Tier I ii Tier II Tier Tier

143 NICNAS Tier = band = band = band = band 4 100t 139

144 4.5-6 = band 4 = band 3 = band 2 = band 1. = band 0 ii) / i ii 3 / LD mg/kg bw; LD mg/kg bw; LC50 10 mg/l iii / l LOAEL 10 mg/kg bw/d; LOAEL 20 mg/kg bw/d; LOAEC 50 ppm/6-h/d, 0.2 mg/l/6-hr/d 0.02 mg/l/6-hr/d // iii () 2 / LOAEL >10 mg/kg bw 100 mg/kg bw/d; LOAEL >20 mg/kg bw/d 200 mg/kg bw/d; LOAEC > mg/l/6-hr/d, > mg/l/6-hr/d >0.02 and 0.2 mg/l/6-hr/d // iii 1 LD50 > mg/kg bw; LD50 > mg/kg bw; LC50 >10 20 mg/l ) iii () i. the European Commission s Endocrine Disrupters website. ii. US Agency for Toxic Substances and Disease Registry (ATSDR). iii. GHS 140

145 Tier Tire Environmental risk assessment guidance manual for industrial chemicals (EPHC, 2009) 145 Department of the Environment (DoE) PBT () t1/2 = 2 days t1/2 = 2 months (that is: 60 days) t1/2 = 6 months t1/2 = 6 months BAF 2000 or BCF 2000 or log Kow 4.2 log Koa >6 and log Kow 2 BMF >1-96 h LC50 1 mg/l / 48 h EC50 1 mg/l / h ErC50 1 mg/l - NOEC ECx 0.1 mg/l / NOEC ECx 0.1 mg/l / NOEC ECx 0.1 mg/l PEC LC50/EC50 PNECPEC/PNEC PEC PEC/PNEC 1 1 Tier IMAP IMAP Hazard Flag Identification Tool (HazFIT) Hazardous Substances Information System (HSIS); Regulation on Classification, Labelling and Packaging (EU CLP) International Agency for Research on Cancer (IARC); National Toxicology Program Report on dustrial-chemicals pdf 141

146 Carcinogens (NTP ROC); US EPA Cancer Guidelines; American Conference of Industrial Hygienists (ACGIH) categories; EU list of endocrine disrupters List of neurotoxic chemicals from ATSDR. DSL EU REACH EU C&L European Commission Cosmetic Ingredient Database Scientific Opinions on Cosmetic Substances by European Commission committees;, US EPA Action Plans Agency for Toxic Substances and Disease Registry Publications OECD OECD QSAR Application Toolbox OECD echemportal International Program on Chemical Safety (IPCS) OASIS TIMES models QSAR TOPKAT QSAR OECD QSAR Toolbox UVCB QSAR DSL UVCBs AICS IMAP IMAP 142

147 NICNAS NICNAS 2006 NICNAS NICNAS EU Cosmetics Ingredients List (CosIng) IUR/CDR OECD/ SIDS NIHHP (National Institute of Health Household Product Database) HSDB (Hazardous Substances Data Bank) CCRIS (Chemical Carcinogenesis Research Information System) Toxnet Multi-Database Galleria Nordic SPIN database Water Utilities Data National Pollutant Inventory (NPI) State Environment Agencies Public Health Association Australia State health authorities Australian Life Cycle Assessment Society (ALCAS) Australian Institute of Occupational Hygienists (AIOH) ACCORD Website Poison Information Centre Product ingredients list- Johnson& Johnson Pollutant Release and Transfer Register (PRTR) REACH (e) IMAP PEC (f) PEC PEC PEC 143

148 (1) Australian Inventory of Chemical SubstancesAICS 146 (2) (a) Australian Inventory of Chemical Substances AICS (b) National Industrial Chemicals Notification and Assessment SchemeNICNAS (c) (d) National Industrial Chemicals Notification and Assessment SchemeNICNAS (e) NICNAS New Chemicals Forms 148 Chemical Gazette No.C (f) QSAR STDLTDPLCLVCCECCUPEIPR&D NCECE PLC 5 (1)(2) 4J 28 15%off

149 QSAR QSAR STDStandard 1 Notification 1,000 LTDLimited Notification PLCPolymer of Low Concern Notification 2 A,B,C 90 A,B,C,D 90 1,000 1 A,B,C,D A,B A,B,D A,B,D 90 1,000 1, A,B,D A,B A,B,D A,B,D 90 FormPLC-1 90 UV A,B,C,E A,B,C,D,E LVC 100kg 1,000kg

150 CEC 4,000kg/2 - CUP) - EIP R&D NCE PLC) 30 1% kg kg NCE-Form - - CE 10kg Form kg Form15-146

151 Part A B C (23 23 (4)(9) 5 // / / MSDS

152 D E % % 5001,000% 36 UV (g) 139 AICS 2 % 2 % AICS 100kg 1,000kg

153 6 (i) 1,000 () 1,000 (h) (i) penalty unitau AU

154 (3) (a) STD) (LTD) (PLC) (LVC) (CEC) (CUP) (R&D) (NCE) (CE) (b) National Industrial Chemicals Notification and Assessment SchemeNICNAS (c)

155 (d) NICNAS NICNAS Environment Australia 151 NICNAS GHS B %off EU NICNAS 43 (STD)(LTD)(PLC) (e) NICNAS

156 NICNAS Chemical Gazette 152 (f) CAIUPAC 5 28 Chemical Gazette AICS 100kg 1,000kg MITI 1 () 4 10 ()

157 CAS MITI STDLTDPLC PLC QSAR QSAR READ-ACROSS wt% 1wt% QSAR READ-ACROSS 1% 1% 4.6 K-REACH (1) (2)

158 (3)

159 (4) 1 R&D (1) R&D

160 (2)(g) 4.6.2(2)(d) ,158 1 SDS

161 ( 0.1%) (5) KCMA

162 (1) 162 KECL , ,142 PECs K-REACH

163 (2) (a) (b) (c) 1 (d)

164 CAS KE

165

166 (e)

167 LD50300mgkg LD501000mgkg 1)LC504h2500ppm 10mg/L 2)LC504h1.0mg/L 3 1 1)LC5096h1.0mgL 2)EC5048h1.0mgL 3)IC5072h 96h1.0mgL NOEC ECx 0.01mgL 1) 2) 1) 2) 3) 4) 1) 2) 1) 2) 1) 1% 2) 0.1% 164 A

168 ) 2) 1) 2) 3) 4) 1) 2) 1)3) 1) ) ) 1)2) 1) ) 5000 (f) 164

169

170 (1) (2) (a) (b) (c) (d) (NIER) (e) (f)

171 QSAR EPA Suite OECD in vitro OECD OECD OECD 100 QSAR QSAR 167

172 10 QSAR (g) (i)(ii) (i) % 500 2% (ii) % % 2%

173 500 10% 2% NIER KCMA 169

174 165 2% % 50%

175 (h) (i) (3) (a) Yes No

176 (b) (c) (d) 172