REACHணഛⓏ㘓ࡢࡓࡵࡢᐇ㊶ⓗࢫࢸࢵࣉ໬Ꮫ≀㉁ࡢணഛⓏ㘓ࢆ⾜࠸ᮇ㛫ෆ࡟Ⓩ㘓ࢆ⾜࠺ሙྜࡢࡳ࡟ࠊࡑࡢ≀㉁ࡢ〇㐀ࠊ㍺ධཪࡣ౑⏝ࢆ⥅⥆࡛ࡁࡿࠋḢᕞ໬Ꮫ≀㉁ᗇ

1 ࡇࡢ࢞࢖ࢻࡣࠊECHA ࡢチྍࢆᚓ࡚ࠊ⎔ቃ┬࡛௬ヂࢆ⾜࡞ࡗࡓࡶࡢ࡛ࡍࠋ ཎᩥ㸦ⱥㄒ㸧ࡣࠊ௨ୗࡢ ECHA ࢙࢘ࣈࢧ࢖ࢺ࠿ࡽࢲ࣮࢘ࣥࣟࢻ࡛ࡁࡲࡍ㸦08/06/01 ⌧ᅾ㸧ࠋ
http://echa.europa.eu/doc/pre-registration/080403%20ECHA-08-B-01-EN_PracticalSteps-web.pdf
2 ㄗヂ➼࡟࠾Ẽ࡙ࡁࡢሙྜ࡟ࡣࠊ㟁Ꮚ࣓࣮ࣝ࡟࡚⎔ቃ┬⎔ቃಖ೺㒊໬Ꮫ≀㉁ᑂᰝᐊ࡬ᚚ㐃⤡࠸ࡓࡔࡅࡿ࡜ᖾ࠸࡛ࡍࠋ
㸦㟁Ꮚ࣓࣮ࣝ
࢔ࢻࣞࢫ㸸chem@env.go.jp㸧
3 ᮏ㈨ᩱࡣ REACH ࡟㛵ࡍࡿ᝟ሗᥦ౪ࢆ┠ⓗ࡟సᡂࡉࢀࡓࡶࡢ࡛ࡍࠋ␲ၥⅬࡸヲ⣽࡞Ⅼ࡟ࡘ࠸࡚ࡣࠊᚲࡎཎ඾㸦REACH つ๎ࡢᮏᩥ➼㸧ࢆࡈ☜ㄆࡃࡔࡉ࠸ࠋ

ཧ↷␒ྕ 㸸ECHA-08-B-01-ENⓎ⾜᪥㸸2008ᖺ4᭶2᪥ゝㄒ㸸ⱥㄒᮏᩥ᭩ࡣࠊ௨ୗࡢ22ゝㄒ࡛Ⓨ⾜ࡉࢀ࡚࠸ࡿࠋࣈࣝ࢞ࣜ࢔ㄒࠊࢳ࢙ࢥㄒࠊࢹ࣐࣮ࣥࢡㄒࠊ࢜ࣛࣥࢲㄒࠊⱥㄒࠊ࢚ࢫࢺࢽ࢔ㄒࠊࣇ࢕ࣥࣛࣥࢻㄒࠊࣇࣛࣥࢫㄒࠊࢻ࢖ࢶㄒࠊࢠࣜࢩࣕㄒࠊࣁ࣮ࣥ࢞ࣜㄒࠊ࢖ࢱࣜ࢔ㄒࠊࣛࢺࣅ࢔ㄒࠊࣜࢺ࢔ࢽ࢔ㄒࠊ࣐ࣝࢱㄒࠊ࣏࣮ࣛࣥࢻㄒࠊ࣏ࣝࢺ࢞ࣝㄒࠊ࣮࣐ࣝࢽ࢔ㄒࠊࢫࣟࣂ࢟࢔ㄒࠊࢫࣟ࣋ࢽ࢔ㄒࠊࢫ࣌࢖ࣥㄒࠊࢫ࢙࣮࢘ࢹࣥㄒᮏᩥ᭩ࡣREACH࡬ࡢணഛⓏ㘓ฎ⌮ࡢᴫせࠊཬࡧ㛵㐃ࡍࡿREACH࢞࢖ࢲࣥࢫᩥ᭩ࡢධᡭඛࢆグ㍕ࡍࡿࠋᮏᩥ᭩࡟㛵ࡍࡿ㉁ၥࡸពぢࡣࠊᩥ᭩␒ྕࠊⓎ⾜᪥ࠊཬࡧ࡝ࡢゝㄒࡢ∧࠿ࢆ᫂グࡋࠊinfo@echa.europa.eu࡬㟁Ꮚ࣓࣮ࣝࢆ㏦௜ࡍࡿࡇ࡜ࠋᮏᩥ᭩ࡢᑐ㇟⪅ᮏᩥ᭩ࡢᑐ㇟ࡣEUᇦෆ࡛≀㉁1ࢆ〇㐀ࡍࡿ〇㐀⪅ࠊ㠀EUᅜ࠿ࡽEU࡬≀㉁ࢆ㍺ධࡍࡿ㍺ධ⪅࡛࠶ࡿࠋᮏᩥ᭩࡟ࡼࡾࠊREACHࡀㄢࡍ㈐ົࢆ☜ㄆࡋࠊ᪂ࡋ࠸EUࡢ໬Ꮫ≀㉁つไ࡟㛵ࡍࡿࣅࢪࢿࢫୖࡢࣜࢫࢡࢆ᭱ᑠ㝈࡟ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋREACHࡣࠊ໬Ꮫ≀㉁ࡢⓏ㘓ࠊホ౯ࠊㄆྍཬࡧつไࢆ⾜࠺ࡓࡵࡢ᪂ไᗘ࡛࠶ࡿࠋணഛⓏ㘓ࡣࠊEUᕷሙ2࡟⌧Ꮡࡍࡿ≀㉁ࢆ᪂ไᗘ࡬ẁ㝵ⓗ࡟ᑟධࡍࡿࡓࡵࡢࠊ௒ᚋ11ᖺ㛫࡟࠾ࡅࡿసᴗࡢ➨୍ẁ㝵࡛࠶ࡿࠋREACH࡟࠾ࡅࡿ≀㉁ࡢணഛⓏ㘓ᮇ㛫ࡣ2008ᖺ6᭶1᪥ࡢ㛤ጞ࠿ࡽ2008ᖺ
12᭶1᪥ࡢ⤊஢ࡲ࡛࡛࠶ࡿࠋ⣙30,000✀ࡢ≀㉁ࡀࠊREACHࡢⓏ㘓せ௳ࡢᑐ㇟࡜࡞ࡿ࡜ᛮࢃࢀࡿࠋ≀㉁ࡢⓏ㘓ࡣࠊ௨ୗࡢᡭ㡰࡟ࡼࡾ⾜ࢃࢀࡿࠋ1.

≀㉁ࡢ᭷ᐖ≉ᛶ࡜ࡑࡢᏳ඲౑⏝᮲௳ࡢ⦅㞟ཬࡧホ౯2.

ࡑࡢ᝟ሗࡢḢᕞ໬Ꮫ≀㉁ᗇ㸦ECHA: European Chemicals Agency㸧࡬ࡢᥦฟ

3.

ᙜヱⓏ㘓ᩱࡢᨭᡶ࠸஦ᴗ⪅ࡀ௨ୗࡢㅖάືࡢ࠸ࡎࢀ࠿ࢆ⾜࠺ሙྜࠊᮏᩥ᭩ࡢᑐ㇟࡜࡞ࡿࠋ·EUᇦෆ࡟࠾࠸࡚ࠊᖺ㛫1ࢺࣥ௨ୖࡢ≀㉁㸦ศ㞳ࡋࡓ୰㛫యࢆྵࡴ㸧ࢆ〇㐀ࡋ࡚࠸ࡿࠋ·㠀EUᅜ࠿ࡽᖺ㛫1ࢺࣥ௨ୖࡢ≀㉁㸦౛㸸ᰁᩱࠊ࣏࣐࣮ࣜ㸧ࢆࠊ≀㉁ࡑࡢࡲࡲࠊཪࡣ
ㄪ๣ࡢᙧ㸦౛㸸ሬᩱࠊ⁥๣㸧࡛㍺ධࡋ࡚࠸ࡿࠋ·ᖺ㛫1ࢺࣥ௨ୖࡢ≀㉁ࢆྵࡳࠊࡇࢀࢆពᅗⓗ࡟ᨺฟࡍࡿᡂᙧရࢆ㍺ධࡋ࡚࠸ࡿࠋ⏝ㄒ≀㉁ࠊㄪ๣ࠊᡂᙧရࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋ
2 2008 ᖺᚋᮇࡼࡾࠊḢᕞ⤒῭ᆅᇦ㸦EEA㸧ᅜ࡛࠶ࡿࣀ࢙࣮ࣝ࢘ࠊ࢔࢖ࢫࣛࣥࢻཬࡧࣜࣄࢸࣥࢩࣗࢱ࢖ࣥ࡟ࡶࠊ〇㐀⪅ཬࡧ㍺ධ⪅࡟ㄢࡍࡍ࡭࡚ࡢ᮲௳ࢆḞࡃࡇ࡜࡞ࡃ REACH ࢆ㐺⏝ࡍࡿࠋ1European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu≀㉁ࡢ〇㐀ࠊㄪ๣ࡢㄪᩚࠊᡂᙧရࡢ〇㐀ࢆEUᇦእ࡛⾜࠺௻ᴗࡣࠊ≀㉁ࡢ㸦஦๓㸧Ⓩ㘓ࡣ⾜࠼࡞࠸ࠋࡋ࠿ࡋࡇࢀࡽࡢ௻ᴗࡶࠊEUᇦෆ࡟㍺ධࡍࡿ≀㉁࡟ᚲせ࡞㸦஦๓㸧Ⓩ㘓ࡢࡓࡵ࡟ࠊ
EUᇦෆ࡟ᡤᅾࡍࡿ၏୍ࡢ௦⌮ே3ࢆᣦྡࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋ

ᮏᩥ᭩ࡣࠊணഛⓏ㘓ࡢᇶᮏ᝟ሗཬࡧணഛⓏ㘓᏶஢࡟ᚲせ࡜࡞ࡿࡶࡗ࡜ࡶ㔜せ࡞࢞࢖ࢲࣥࢫ
ᩥ᭩ࡸࢶ࣮ࣝࡢධᡭඛࢆグ㍕ࡍࡿࠋ

ணഛⓏ㘓ࡢࡓࡵ࡟ᥦฟࡍ࡭ࡁ᝟ሗணഛⓏ㘓࡛ࡣࠊྛ≀㉁ࡢ௨ୗࡢ᝟ሗࢆⓏ㘓ࡍࡿࠋ·IUPAC࿨ྡἲࠊEINECSࠊCASཪࡣࡑࡢ௚ࡢ㆑ูࢥ࣮ࢻ࡟ࡼࡾ㆑ูࡋࡓ≀㉁ྡ⛠ࠋὀ㸸࣭㍺ධㄪ๣࡟ࡘ࠸࡚ࡣㄪ๣඲య࡛ࡣ࡞ࡃࠊΰྜ≀ෆࡢ༢୍≀㉁ࢆணഛⓏ㘓ࡍࡿࡇ࡜ࠋ࣭ ᡂᙧရ4࠿ࡽពᅗⓗ࡟ᨺฟࡉࢀࡿ≀㉁࡟ࡘ࠸࡚ࡣணഛⓏ㘓ཬࡧⓏ㘓ࡢᚲせࡀ࠶ࡿࡀࠊᙜヱᡂᙧရࡣࡑࡢ㝈ࡾ࡛ࡣ࡞࠸ࠋ࣭ ࣏࣐࣮ࣜ࡟ࡘ࠸࡚ࡣணഛⓏ㘓࠿ࡽ㝖እࡍࡿࠋࡋ࠿ࡋࠊ࣏࣐࣮ࣜࡢ〇㐀࡟౑⏝ࡍࡿࣔࣀ࣐࣮ཬࡧࡑࡢ௚ࡢ≀㉁࡟ࡘ࠸࡚ࡣࠊⓏ㘓ࡀᚲせ࡛࠶ࡿࠋ·ணഛⓏ㘓ࢆ⾜࠺௻ᴗྡࠊఫᡤཬࡧᢸᙜ⪅ྡὀ㸸࣭ ணഛⓏ㘓ࢆ⾜࠺௻ᴗࡀ」ᩘࡢἲே㸦⤌⧊㸧࡛ᵓᡂࡉࢀࠊࡇࢀࡽࡀྠ୍≀㉁ࢆEUᇦෆ࡛〇㐀ࡍࡿࠊཪࡣࡇࢀࢆ㍺ධࡍࡿሙྜࠊྛἲே㸦⤌⧊㸧ࡀಶู࡟ணഛⓏ㘓ࢆ⾜࠺ࡇ࡜ࠋ࣭ ணഛⓏ㘓ࢆ⾜࠺௻ᴗࡣࠊ௚ࡢ〇㐀⪅ࠊ㍺ධ⪅ཬࡧᕝୗ౑⏝⪅࡜ࡢ༠㆟ࢆక࠺ࡍ࡭࡚ࡢᡭ⥆ࡁࢆ㐍ࡵࡿࡓࡵࠊ➨୕⪅ࡢ௦⌮ேࢆᣦྡ࡛ࡁࡿࠋ஦ᴗ⪅ࡀࡑࡢ㐃⤡ඛヲ⣽ࢆ௚ࡢணഛⓏ㘓⪅࠿ࡽ⛎༏ࡋࡓ࠸ሙྜࠊ➨୕⪅ࡢ௦⌮ே5ࢆ฼⏝ࡍࡿࡇ࡜ࠋ

⏝ㄒ၏୍ࡢ௦⌮ேࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋ
⏝ㄒᡂᙧရࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋ
5 ⏝ㄒ➨୕⪅ࡢ௦⌮ேࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋ
3
4

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu࣭ ௨ୗ࡟ࠊⓏ㘓⥾ࡵษࡾணᐃࠊཬࡧࢺࣥᩘᖜ㸦ᖺ㛫1㹼10ࠊ10㹼100ࠊ100㹼1000
ཪࡣ1000ࢺࣥ௨ୖ㸧ࢆグ㍕ࡍࡿࠋ࣭ ணഛⓏ㘓ࡢ῭ࢇࡔ≀㉁࡟㛵㐃ࡍࡿ≀㉁᝟ሗࢆᣢࡘ௚ࡢ≀㉁ࡢIUPAC࿨ྡἲࠋࡇࢀ࡟ࡼࡾࠊㄞࡳྲྀࡾἲࠊ㸦ᐃ㔞ⓗ㸧ᵓ㐀άᛶ┦㛵㸦(Q)SARs㸧ཬࡧ≀㉁⩌ࢆ฼⏝ࡋ࡚ࠊ࡝ࡢࢹ࣮ࢱࡢඹ᭷ࡀྍ⬟࠿ࡀ♧ࡉࢀࡿࠋணഛⓏ㘓࡟ࡼࡿ౽ᐅணഛⓏ㘓࡟ࡼࡾࠊⓏ㘓ࡢ⥾ࡵษࡾࢆᘏᮇ࡛ࡁࡿࠋREACH࡛ࡣࠊ࠸ࢃࡺࡿࠕẁ㝵ⓗᑟධ≀㉁ࠖ
6࡟ࡘ࠸࡚ࠊࢺࣥᩘᖜ࡜≀㉁ࡢ᭷ᐖᛶ࡟ᇶ࡙࠸ࡓⓏ㘓ࡢẁ㝵ⓗ⥾ษࡾࢆタࡅ࡚࠸ࡿࠋ

·2010ᖺ11᭶30᪥

·

2013ᖺ5᭶31᪥·

2018ᖺ5᭶31᪥ࡇࡢẁ㝵ⓗᡭἲ࡟ࡼࡾࠊ⏘ᴗ⏺ࡣ᪂ไᗘ࡬ࡢ㐺ᛂࢆẁ㝵ⓗ࡟㐍ࡵࡿࡇ࡜ࡀ࡛ࡁࡿࠋணഛⓏ㘓࡟ࡘ࠸࡚ࡣࠊ௨ୗࡢ౽ᐅࡀ࠶ࡿࠋ

·ẁ㝵ⓗᑟධ≀㉁ࡢ〇㐀ཪཪࡣ㍺ධࢆࠊᙜヱࡢⓏ㘓⥾ษࡾࡲ࡛⥅⥆࡛ࡁࡿࠋ·฼⏝ྍ⬟࡞ࢹ࣮ࢱࡢ཰㞟ཬࡧホ౯ࠊ᪤Ꮡࢹ࣮ࢱࡢඹ᭷ࠊཬࡧḞዴࡍࡿ᝟ሗࡢసᡂࡢ
ࡓࡵ࡟᫬㛫ࢆ☜ಖ࡛ࡁࡿࠋ

·Ⓩ㘓࡟㛵ࡍࡿ᝟ሗࢆᚲせ࡜ࡍࡿ஦ᴗ⪅ࡀࠊ≀㉁࡟㛵ࡍࡿ᪤Ꮡ᝟ሗ㸦౛㸸㠀ヨ㦂᝟ሗࠊ≀㉁㛫ㄞࡳྲྀࡾἲࠊヨ㦂ࢹ࣮ࢱ㸧ࢆධᡭྍ⬟࡜࡞ࡿࠋ·≀㉁ࢆ౑⏝ࡍࡿᕝୗ౑⏝⪅࡬ࡢ౪⤥ࡀࠊ㞀ᐖ࡞ࡃ⾜ࢃࢀࡿࡼ࠺࡟࡛ࡁࡿࠋ6 ⏝ㄒ᪤Ꮡ໬Ꮫ≀㉁ࠊẁ㝵ⓗᑟධ≀㉁ࠊ㠀ẁ㝵ⓗᑟධ≀㉁ࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋEuropean Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.euணഛⓏ㘓ࡣ↓ᩱ࡛࠶ࡿࠋࡲࡓணഛⓏ㘓ᚋࡶࠊ≀㉁ࡢ〇㐀ཪࡣ㍺ධࢆ⥔ᣢࡍࡿ⩏ົࡣ࡞࠸ࠋ
ࡓࡔࡋࠊணഛⓏ㘓᏶஢஦ᴗ⪅ࡣࠊ2018ᖺ6᭶1᪥ࡲ࡛≀㉁᝟ሗ஺᥮ࣇ࢛࣮࣒ࣛ㸦SIEF:Substance Information Exchange Forum㸧ࡢ୍ဨ࡜࡞ࡾࠊ✚ᴟⓗ࡟SIEFࡢάື࡟ཧຍࡍࡿᚲせࡀ࠶ࡿࡇ࡜ࢆ␃ពࡍࡿࡇ࡜ࠋࡇࢀ࡟ຍ࠼ࠊ஦ᴗ⪅ࡣ⮬ࡽࡀᢅ࠺≀㉁࡟㛵ࡍࡿ㔠㖹ୖ
ࡢ㈐ົࢆ㈇࠺ࠋࢹ࣮ࢱࢆඹ᭷ࡍࡿ஦ᴗ⪅ࡣࠊබṇ࠿ࡘ㏱᫂ᛶࢆᣢࡕබᖹ࡞᪉ᘧ࡛᝟ሗඹ᭷ࢥࢫࢺࢆỴᐃࡍࡿດຊࢆᅗࡿࡇ࡜ࠋ୍⯡࡟ࠊ㈝⏝ࡢඹྠ㈇ᢸ࡟ࡘ࠸࡚ࡢྜពࡣࠊ฼⏝ྍ⬟࡞᝟ሗࢆཧຍ⪅ࡀ㛤♧ࡍࡿ๓࡟⾜࠺ࡇ࡜ࡀࡼ࠸࡜ࡉࢀࡿ7ࠋணഛⓏ㘓ࢆ⾜ࢃ࡞࠸ሙྜ≀㉁࡟㛵ࡍࡿணഛⓏ㘓ࢆ⾜ࢃ࡞࠸ሙྜࠊ஦ᴗ⪅ࡣ⛣⾜ᮇ࡟࠾ࡅࡿᜠᜨࢆཷࡅࡿࡇ࡜ࡀ࡛ࡁ࡞࠸ࠋࡑࡢሙྜࠊ2008ᖺ௨㝆࡟ᖺ㛫1ࢺࣥ௨ୖࡢ≀㉁ࡢ〇㐀ཪࡣ㍺ධࢆ⥅⥆ࡍࡿ๓࡟ࠊ஦ᴗ⪅ࡣᙜヱ≀㉁࡟㛵ࡍࡿⓏ㘓୍ᘧᩥ᭩ࢆᥦฟࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋࡍ࡞ࢃࡕࠊ஦ᴗ⪅ࡀECHA࠿ࡽⓏ㘓␒ྕࢆཷ⌮ࡍࡿࡲ࡛ᙜヱ≀㉁ࡢ〇㐀ཪࡣ㍺ධࢆ୰Ṇࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࡇ࡜ࢆព࿡ࡍࡿࠋⓏ㘓␒ྕࢆཷ⌮ࡍࡿࡓࡵ࡟ࡣࠊ௨ୗࡢᡭ⥆ࡁࢆ⾜࠺ࡇ࡜ࠋ·ྠ୍≀㉁࡟㛵ࡋ࡚Ⓩ㘓ཪࡣ↷఍ࡀᥦฟࡉࢀ࡚࠸ࡿ࠿ࢆࠊECHA࡟↷఍ࡋ☜ㄆࢆ⾜࠺ࠋ·Ⓩ㘓㛵㐃᭩㢮ࡢసᡂ࡟ᚲせ࡞㛵㐃≀⌮໬Ꮫࢹ࣮ࢱࠊ೺ᗣ࣭⎔ቃࢹ࣮ࢱࠊཬࡧ౑⏝᝟ሗࢆධᡭ࣭ホ౯8ࡍࡿࠋ·ECHA࡟୍ᘧᩥ᭩ࢆᥦฟࡋࠊᙜヱᩱ㔠ࢆᨭᡶ࠺ࠋ

2008ᖺ6᭶1᪥࠿ࡽ2008ᖺ12᭶1᪥ࡲ࡛ࡢ▷࠸ணഛⓏ㘓ᮇ㛫ࢆ㏨ࡉ࡞࠸ࡇ࡜ࠋ
ணഛⓏ㘓࡟ࡼࡾࠊREACHࡢ᫬௦࡬ࡢẁ㝵ⓗ⛣⾜ࡀྍ⬟࡜࡞ࡿࠋ

ணഛⓏ㘓ࢹ࣮ࢱࡢ౑⏝7Guidance on Data Sharing㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ8ᡤ᭷ࡍࡿཪࡣࠊ౑⏝ࡍࡿᶒ฼ࢆᣢࡘࠋEuropean Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.euணഛⓏ㘓ࡉࢀࡓ≀㉁ࡢࣜࢫࢺࡣࠊ2009ᖺ1᭶1᪥ࡲ࡛࡟ECHA࢙࢘ࣈࢧ࢖ࢺ࡛බ㛤ࡍࡿࠋࡇࡢࣜࢫࢺ࡟ࡣࠊྛ≀㉁ࡢྡ⛠ࢆᥖ㍕ࡍࡿࠋࡶࡋᙜヱ≀㉁࡟ࡘ࠸࡚ࠊEINECSཬࡧCAS␒ྕࡀᏑᅾࡍࢀࡤࡇࢀࡽࡶᥖ㍕ࡍࡿࠋࡲࡓࠊ➨୍ᅇⓏ㘓⥾ࡵษࡾணᐃࡶᥖ㍕ࡍࡿࠋࡇࡢࣜࢫࢺ࡟ࡣࠊணഛⓏ㘓⪅ࡀᡤ᭷ࡍࡿ㛵㐃≀㉁ࡢྡ⛠ཬࡧࡑࡢ௚ࡢ㆑ู᝟ሗࠊࡍ࡞ࢃࡕࠊㄞࡳྲྀࡾἲࠊ㸦ᐃ㔞ⓗ㸧ᵓ㐀άᛶ┦㛵ཬࡧ㸭ཪࡣ≀㉁ࡢࢢ࣮ࣝࣉศࡅࢆ౑⏝ࡋࡓࠊヨ㦂せ௳ࡢ㐺ྜ࡟㛵㐃ࡍࡿ฼⏝ྍ⬟࡞᝟ሗࡶᥖ㍕ࡍࡿࠋECHAⓎ⾜ࡢࣜࢫࢺ࡟ࡣࠊணഛⓏ㘓⪅ࡢ㆑ู᝟ሗࡣᥖ㍕ࡋ࡞࠸ࠋࡑࡢ᝟ሗࡣྠ୍≀㉁ࢆணഛⓏ㘓ࡋࡓ஦ᴗ⪅ࠊཬࡧㄞࡳྲྀࡾἲࡢࡓࡵ࡟㛵㐃≀㉁ࢆணഛⓏ㘓ࡋࡓ஦ᴗ⪅࡟ࡢࡳ࡟㛤♧ࡍࡿࠋணഛⓏ㘓᝟ሗࡣࠊྠ୍ࡢࠕẁ㝵ⓗᑟධ≀㉁ࠖࡢ〇㐀⪅ཬࡧ㍺ධ⪅㛫࡛ࡢ᝟ሗඹ᭷࡜ࠊࡑࡢศ㢮ཬࡧ⾲♧࡟㛵ࡍࡿྜពࢆ┠ⓗ࡜ࡍࡿSIEFᙧᡂࡢᇶ♏࡜࡞ࡿࠋSIEF࡟ࡣࠊᙜヱ≀㉁ࡢ᝟
ሗࢆಖᣢࡍࡿᕝୗ౑⏝⪅࡜ࠊࡑࡢ௚ࡢ฼ᐖ㛵ಀ⪅ࡀཧຍࡍࡿሙྜࡀ࠶ࡿࠋ

SIEFࣉࣟࢭࢫ඲యࡢ㈐௵ࡣࠊ⏘ᴗ⏺࡟࠶ࡿࡇ࡜࡟␃ពࡍࡿࡇ࡜ࠋཎ๎࡜ࡋ࡚ࠊẁ㝵ⓗᑟධ≀㉁1ࡘ࡟ࡘࡁSIEFࡀ1ࡘᙧᡂࡉࢀࡿࠋࡲࡓࠊSIEFཧຍ஦ᴗ⪅ࡣ⩏ົ࡜ࡋ࡚ࡢࠕࢹ࣮ࢱࡢඹྠᥦฟࠖ9ࢆ⤌⧊ࡍࡿࡓࡵ࡟ࠊ௚ࡢ₯ᅾⓗⓏ㘓⪅࡜⠏࠸ࡓ㛵ಀࢆ฼⏝ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋ໬Ꮫ≀㉁Ᏻ඲ᛶホ౯ࡢᐇ᪋࡟ᚲせ࡞ࢹ࣮ࢱࡢ஺᥮ࠊ໬Ꮫ≀㉁Ᏻ඲ᛶ
ሗ࿌᭩ࡢ㉳ⲡࠊཬࡧᏳ඲౑⏝ࡢ࢞࢖ࢲࣥࢫࡢྜព࡜࠸ࡗࡓసᴗࡀࠊඹྠᥦฟ࡟࠾ࡅࡿ㑅ᢥ⫥ࡢ୍㒊࡛࠶ࡿࠋྠ୍≀㉁ࡢ〇㐀ཪࡣ㍺ධࢆ」ᩘࡢ஦ᴗ⪅ࡀ⾜ࡗ࡚࠸ࡿ࠿ࠊ௨ୗࡢ4ẁ㝵ࡢసᴗ࡛Ỵᐃࡍࡿ10ࠋ1.

஦ᴗ⪅ࡣࠊ≀㉁ࡢணഛⓏ㘓ཪࡣⓏ㘓ࢆ⾜࠺ྡ⛠ཬࡧ㸭ཪࡣ㆑ูࢥ࣮ࢻࢆỴᐃࡍࡿࠋ2.

ྠ୍ྡ⛠ཬࡧ㸭ཪࡣ㆑ูࢥ࣮ࢻࡢୗ࡛ணഛⓏ㘓ࢆ⾜ࡗࡓ」ᩘ௻ᴗࡣࠊᙜヱ≀㉁ࡀ
SIEFᙧᡂཬࡧඹྠᥦฟࡢ┠ⓗ࡟↷ࡽࡋ࡚ྠ୍࡛࠶ࡿ࠿࡝࠺࠿ࢆỴᐃࡍࡿࠋ9 ⏝ㄒ」ᩘࡢⓏ㘓⪅࡟ࡼࡿࢹ࣮ࢱࡢඹྠᥦฟࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋ
10 Guidance for identification and naming of substances under REACH 㸦ⱥㄒ㸧ཬࡧ Guidance on DataSharing㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu

3.

ࡇࢀ࡟ຍ࠼ࡇࢀࡽࡢ௻ᴗࡣࠊࡑࡢ≀㉁ࡀ௚ࡢྡ⛠ཬࡧ㸭ཪࡣ㆑ูࢥ࣮ࢻࡢୗ࡛ணഛ
Ⓩ㘓ཪࡣⓏ㘓ࡉࢀ࡚࠸ࡿ࠿࡝࠺࠿ࢆ☜ㄆࡍࡿࠋࡇࡢẁ㝵࡛ࡣࠊ௚ࡢ஦ᴗ⪅ࡀணഛⓏ㘓ࡋࡓ≀㉁ࡀྠ୍࡛࠶ࡿ࡜ࡢྜពࢆᚓࡿࠋ

4.

ୖグ3ẁ㝵࡟ཧຍࡋࡓ஦ᴗ⪅ࡣࠊSIEFࢆᙧᡂࡍࡿࠋྛSIEFࡢάືᮇ㛫ࡣࠊ2018ᖺ6᭶1᪥ࡲ࡛࡛࠶ࡿࠋ㸦ணഛ㸧Ⓩ㘓ࡍ࡭ࡁ≀㉁ࡢ≉ᐃ᪉ἲ
ணഛⓏ㘓࡟ᙜࡓࡗ࡚ࡣࠊ௨ୗࡢணഛᡭ⥆ࡁࢆ᏶஢ࡍࡿࡇ࡜ࠋ

1.

EUᇦෆ࡛〇㐀ࡍࡿ〇ရཬࡧ㠀EUㅖᅜ࠿ࡽ㍺ධࡍࡿ〇ရࡢ୍ぴ⾲ࢆసᡂࡍࡿࠋ

2.

ᙜヱ〇ရࡀ༢୍≀㉁ࠊㄪ๣㸦Ⓩ㘓ᑐ㇟ࡢࡉࡲࡊࡲ࡞≀㉁ࢆྵ᭷㸧࡛࠶ࡿ࠿ࠊཪࡣᡂᙧရ࠿ࡽᨺฟࡉࢀࡿ≀㉁ࡀ࠶ࡿ࠿࡞࠸࠿ࢆ☜ㄆࡍࡿࠋ3.

ࡇࢀࡽࡢ≀㉁ࡀࣔࣀ࣐࣮ࠊ࣏࣐࣮ࣜཪࡣ୰㛫య࡛࠶ࡿ࠿ࠊࡲࡓࠊ〇ရ࣭ࣉࣟࢭࢫᣦྥ◊✲㛤Ⓨࡢ┠ⓗ࡟ἢࡗࡓ≀㉁࠿ࠊREACHࡢⓏ㘓ච㝖࡟㛵ࡍࡿ㝃ᒓ᭩㸦㝃ᒓ᭩IVཪࡣV㸧࡟ᥖ㍕ࡉࢀࡿ≀㉁࠿ࠊREACHࡢୗ࡛≉ู࡞᱁௜ࡅࡢ࠶ࡿ≀㉁࠿࡟ࡘ࠸࡚☜ㄆࡍࡿ11ࠋ

4.

IUPAC࿨ྡἲࠊEINECS␒ྕࠊCAS␒ྕཪࡣࡑࡢ௚ࡢ㆑ูࢥ࣮ࢻ࡛≉ᐃࡋࡓ≀㉁ྡ
࡟ࡘ࠸࡚ࠊ฼⏝ྍ⬟࡞᝟ሗཬࡧヨ㦂ᡤࡀฟࡍศᯒࢹ࣮ࢱ㸦ᙜヱ≀㉁࡟㛵ࡍࡿᐃᛶⓗཬࡧᐃ㔞ⓗ⤌ᡂ㸧ࢆ཰㞟ࡍࡿࠋ

5. REACH࡟࠾ࡅࡿ≀㉁ࡢ≉ᐃཬࡧ࿨ྡ࡟㛵ࡍࡿ࢞࢖ࢲࣥࢫ࡟ᚑࡗ࡚ࠊᙜヱ≀㉁ࢆ࿨ྡ
ࡍࡿ12ࠋ

6.

≀㉁ࡢẁ㝵ⓗᑟධ࡟㛵ࡍࡿ≧ἣࢆ☜ㄆࡍࡿࠋ௨ୗࡢᇶ‽ࡢ࠸ࡎࢀ࠿1ࡘ࡛ࡶ‶ࡓࡍ≀㉁ࡣࠊẁ㝵ⓗᑟධ≀㉁࡛࠶ࡿ13ࠋ

1112ヲ⣽࡟ࡘ࠸࡚ࡣࠊGuidance on registration㸦ⱥㄒ㸧࡟グ㍕ࡍࡿࠋ
Guidance for identification and naming of substances under REACH 㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu࣭ Ḣᕞ᪤Ꮡၟᴗ໬Ꮫ≀㉁ࣜࢫࢺ㸦EINECS: Substances listed in the European
INventory of Existing Commercial chemical Substances㸧࡟ᥖ㍕ࡉࢀࡿ≀㉁࣭ EUᇦෆ㸦2004ᖺ௨๓ࡢຍ┕ೃ⿵ᅜࢆྵࡴ㸧࡛〇㐀ࡉࢀࡓࡀࠊ1992ᖺ6᭶1᪥௨㝆ࡶEUᕷሙ࡟ୖᕷࡉࢀ࡚࠸࡞࠸≀㉁࣭ ࠸ࢃࡺࡿࠕࡶࡣࡸ࣏࣐࣮ࣜ࡜ࡣࡳ࡞ࡉࢀ࡞࠸≀㉁ࠖ࡜ㄆࡵࡽࢀࡿ≀㉁7.

ᖺ㛫ࢺࣥᩘཬࡧศ㢮ཬࡧ⾲♧࡟ᑐᛂࡋࡓࠊⓏ㘓⥾ࡵษࡾணᐃࢆ☜ㄆࡍࡿࠋẁ㝵ⓗᑟධ≀㉁ࡢⓏ㘓⩏ົࡀ࠶ࡿ஦ᴗ⪅ࡣணഛⓏ㘓ࡢ㈨᱁ࢆᣢࡕࠊREACHⓏ㘓⥾ࡵษࡾࢆᘏᮇ࡛ࡁࡿ࣓ࣜࢵࢺࢆாཷྍ⬟࡛࠶ࡿࡇ࡜࡟␃ពࡍࡿࡇ࡜ࠋ

ணഛⓏ㘓ࡢᐇົ
ணഛⓏ㘓ࡣࠊECHA࢙࢘ࣈࢧ࢖ࢺୖࡢREACH-IT࣏࣮ࢱࣝࢆ௓ࡋ࡚⾜࠺ࡇ࡜ࠋ≀㉁ࡢணഛ
Ⓩ㘓ࢆጞࡵࡿࡓࡵ࡟ࡣࠊREACH-IT࡛஦ᴗ⪅࢔࢝࢘ࣥࢺࢆ࠶ࡽ࠿ࡌࡵసᡂࡍࡿᚲせࡀ࠶ࡿࡇ࡜࡟␃ពࡍࡿࠋ࢙࢘ࣈࢧ࢖ࢺࡢREACH-ITࢭࢡࢩࣙࣥ࡟ࠊணഛⓏ㘓⏦ㄳ⏝ࡢ࢔ࢡࢭࢫ࣏
࢖ࣥࢺࡀ࠶ࡿࠋணഛⓏ㘓⏦ㄳ⏝࢔ࢡࢭࢫ࣏࢖ࣥࢺ࡟ධࡿ࡜ᑓ⏝࣮࣌ࢪ࡟᱌ෆࡉࢀࡿࡢ࡛ࠊ≀㉁ࡢணഛⓏ㘓࡟㛵ࡍࡿ௨ୗࡢ2ࡘࡢ㑅ᢥ⫥࠿ࡽ1ࡘࢆ㑅ᢥࡍࡿࠋ

1. ࢜ࣥࣛ࢖ࣥணഛⓏ㘓㸦2008ᖺ6᭶1᪥㛤ጞ)㸸≀㉁ẖ࡟ᚲせ࡞᝟ሗࢆࠊREACH-ITࢩࢫࢸ࣒࡬┤᥋ධຊࡍࡿ14ࠋ2.

XMLࣇ࢓࢖ࣝࢆ฼⏝ࡋࡓணഛⓏ㘓ฟ㢪㸸ࣇ࢓࢖ࣝࡣࠊᣦᐃࡢ㟁Ꮚࣇ࢓࢖ࣝᙧᘧ࡛≀㉁ẖ࡟సᡂࡋࠊ࢜ࣥࣛ࢖ࣥணഛⓏ㘓᫬࡟࢔ࢵࣉ࣮ࣟࢻࡍࡿࠋࡇࡢ᪉ἲ࡟࠾࠸࡚ࡣࠊ༢୍ཪࡣ」ᩘࡢ≀㉁࡟㛵ࡍࡿᚲ㡲ணഛⓏ㘓᝟ሗࢆグ㍕ࡋࡓࣇ࢓࢖ࣝࢆ1ࡘཪࡣ」ᩘ
ᥦฟ࡛ࡁࡿࠋ13 ⏝ㄒ᪤Ꮡ໬Ꮫ≀㉁ࠊẁ㝵ⓗᑟධ≀㉁ࠊ㠀ẁ㝵ⓗᑟධ≀㉁ࡢヲ⣽࡟ࡘ࠸࡚ࡣࠊᮏᩥ᭩᭱ᚋࡢࠕ㔜せ࡞஦ᐇ㸭ᐃ⩏ࠖࡢࢭࢡࢩ࡛ࣙࣥㄝ᫂ࡍࡿࠋヲ⣽࡟ࡘ࠸࡚ࡣࠊGuidance on registration㸦ⱥㄒ㸧࡟グ㍕ࡍࡿࠋ
14 User guide on REACH-IT㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.euࡇࢀࡽࡢࣇ࢓࢖ࣝ࡟ࡘ࠸࡚ࡣࠊ௨ୗࡢࡼ࠺࡟‽ഛࢆ㐍ࡵࡿࡇ࡜ࡀ࡛ࡁࡿࠋ

·࢜ࣥࣛ࢖ࣥணഛⓏ㘓 ― ᡭື࡛ᚲ㡲ࢹ࣮ࢱࢆ⦅㞟ࡍࡿࠋ·IUCLIDணഛⓏ㘓 ― IUCLID 5ࡢணഛⓏ㘓ᶵ⬟ࢆ౑⏝ࡋ࡚ࠊᥦฟ⏝XMLࣇ࢓࢖ࣝࢆసᡂࡍࡿ15ࠋ·XML࡟ࡼࡿணഛⓏ㘓 ― ࡑࡢ௚ࡢITࢶ࣮ࣝࢆ฼⏝ࡋࠊREACH-ITࢆ௓ࡋ࡚ணഛⓏ㘓ࣇ࢓࢖ࣝࢆ⏕ᡂࡋࡓᚋ࡟ᥦฟࡍࡿࠋXMLࣇ࢓࢖ࣝࡢ௙ᵝ࡟ࡘ࠸࡚ࡣࠊECHA࢙࢘ࣈࢧ࢖ࢺࡢIUCLID 5ࢭࢡࢩࣙࣥ࠿ࡽධᡭ࡛ࡁࡿࠋⓏ㘓ࡍ࡭ࡁ≀㉁ࡀᑡ࡞ࡃIUCLID 5ࢆ⌧ᅾ฼⏝ࡋ࡚࠸࡞࠸ሙྜࡣࠊREACH-ITࢆ௓ࡋࡓ࢜ࣥࣛ࢖ࣥணഛⓏ㘓ࡀ⡆౽࡛࠶ࡿࠋIUCLID 5ࡶࡋࡃࡣXMLࡢ฼⏝ࡣࠊከ✀ࡢ໬Ꮫ≀㉁࡟ࡘ࠸࡚
ணഛⓏ㘓ࢆ⾜࠺ሙྜ࡟㐺ࡍࡿࠋࡇࢀࡽࡢ᪉ἲ࡛ࡣࠊ༢୍ࡢࣇ࢓࢖࡛ࣝ」ᩘࡢ≀㉁࡟㛵ࡍࡿணഛⓏ㘓ࢆ⏦ㄳ࡛ࡁࡿ࠿ࡽ࡛࠶ࡿࠋࡑࡢሙྜࠊXMLࣇ࢓࢖ࣝࡢᥦฟ᫬࡟EINECS␒ྕࡀ฼⏝࡛ࡁࡿࡇ࡜ࡀ๓ᥦ࡜࡞ࡿࠋ

2008ᖺ12᭶1᪥௨㝆ࡢணഛⓏ㘓ࡣྍ⬟࠿ࠋ1ࢺࣥ௨ୖࡢẁ㝵ⓗᑟධ≀㉁ࡢ〇㐀ཪࡣ㍺ධࢆึࡵ࡚⾜࠺஦ᴗ⪅ࡣࠊ௨ୗࡢ᫬ᮇ࡟ணഛⓏ㘓ࢆ⾜࠺࡞ࡽࡤࠊ2008ᖺ12᭶1᪥௨㝆ࠊⓏ㘓⥾ࡵษࡾࡢᘏᮇࡢᜠᜨࢆཷࡅࡽࢀࡿࠋ
·ึࡵ࡚1ࢺࣥࢆ㉸࠼࡚〇㐀ཪࡣ㍺ධࢆ⾜ࡗ࡚࠿ࡽ6ࣨ᭶௨ෆࠊཬࡧࠊ·ヱᙜࡍࡿⓏ㘓⥾ࡵษࡾࡢᑡ࡞ࡃ࡜ࡶ12ࣨ᭶๓〇㐀ཪࡣ㍺ධࡢᐇ᪋ึᅇ࡜ࡣࠊREACHࡢຠຊⓎ⏕᪥㸦2007ᖺ6᭶1᪥㸧௨㝆ࡢ᭱ึࡢ᫬ࢆ
࠸࠺ࠋヲ⣽᝟ሗ࡟ࡘ࠸࡚15

IUCLID 5 tutorial㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋEuropean Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu

ECHA࢙࢘ࣈࢧ࢖ࢺ࡟ࡣࠊREACH᝟ሗ࡬ࡢ࢔ࢡࢭࢫ࣏࢖ࣥࢺࡀᥖ㍕ࡉࢀ࡚࠸ࡿࠋ
·ࠕGeneral information about the RegulationࠖࡀࠕAbout REACHࠖࢭࢡࢩࣙࣥ࡟
࠶ࡿࠋ·

ࠕNavigator toolࠖཬࡧ⏝ㄒ㞟ࡀᥖ㍕ࡉࢀ࡚࠾ࡾࠊREACHୗ࡟࠾ࡅࡿ㈐ົࡢࡼࡾ῝࠸⌮ゎࢆᚓࡿ㝿࡟ᙺ࡟❧ࡘࠋ·ᑓ⏝ࡢணഛⓏ㘓࢙࢘ࣈࢧ࢖ࢺ࡟ࡣணഛⓏ㘓ࡢ㝿࡟฼⏝࡛ࡁࡿ㔜せ࡞᝟ሗ࡜ࠊ௨ୗࡢ஦㡯ࢆᥖ㍕ࡍࡿECHA࢙࢘ࣈࢧ࢖ࢺୖࡢ㛵㐃࣮࣌ࢪ࡬ࡢࣜࣥࢡࡀᥖ㍕ࡉࢀ࡚࠸ࡿࠋ

࣭ ணഛⓏ㘓㸦REACHࠊIUCLID 5ཬࡧREACH-IT㸧࡟㛵ࡍࡿQ&A࣭ ணഛⓏ㘓࡟㛵ࡍࡿ࣮࣮࢟࣡ࢻ᳨⣴௜ࡁࡢ࢞࢖ࢲࣥࢫᩥ᭩࣭ ࣮ࣘࢨ࣮࣐ࢽࣗ࢔ࣝ㸦IUCLID 5ࣉࣛࢢ࢖ࣥཬࡧREACH-IT㸧

࣭ IUCLID 5ཬࡧREACH-ITࢆ౑⏝ࡋࡓணഛⓏ㘓ࡢ᪉ἲ࡟ࡘ࠸࡚ࡢࣅࢹ࢜ࢳ࣮ࣗࢺ
ࣜ࢔࣭ࣝ ணഛⓏ㘓ࣉࣛࢢ࢖ࣥࡢ౑⏝᪉ἲࠊཬࡧREACH-ITࢆ౑⏝ࡋࡓࣇ࢓࢖ࣝ〇సࡢ᪉ἲ࡟㛵ࡍࡿࢺ࣮ࣞࢽࣥࢢࣉࣞࢮࣥࢸ࣮ࢩࣙࣥ

ணഛⓏ㘓࡟ࡘ࠸࡚㉁ၥࡀ࠶ࢀࡤࠊ௨ୗࢆཧ⪃࡟ࡍࡿࡇ࡜ࠋ·ྛᅜࡢREACH࣊ࣝࣉࢹࢫࢡ࠿ࡽࠊᙜヱᅜෆࡢ஦ᴗ⪅ࡢᙺ๭ࠊ㈐ົࠊཬࡧ࢞࢖ࢲࣥࢫ
ࢆᚓࡽࢀࡿࠋࡲࡎࠊ࣊ࣝࣉࢹࢫࢡ࡟ၥ࠸ྜࢃࡏࡿࡇ࡜ࠋECHA࢙࢘ࣈࢧ࢖ࢺ࡟ࡣࠊᅜẖࡢ࣊ࣝࣉࢹࢫࢡࡢ㐃⤡ඛࡀᥖ㍕ࡉࢀ࡚࠸ࡿࠋ

·ECHA࣊ࣝࣉࢹࢫࢡࡣࠊREACH-ITࠊIUCLIDཬࡧⓏ㘓࡟㛵ࡍࡿ㉁ၥ࡬ࡢຓゝࢆ⾜࠺ࠋ㉁ၥࡣࠊECHA࢙࢘ࣈࢧ࢖ࢺ࡟ᥖ㍕ࡋ࡚࠶ࡿ᝟ሗせồࣇ࢛࣮࣒࡟グධࡋ࡚㏦௜࡛ࡁࡿࠋ·ࢭࢡࢱ࣮≉᭷ࡢ㉁ၥ࡟ࡘ࠸࡚ࡣࠊᡤᒓࡍࡿᕤᴗ఍࠿ࡽᅇ⟅ࢆᚓࡽࢀࡿࠋEuropean Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu㔜せ࡞஦ᐇ㸭ᐃ⩏᪤Ꮡ໬Ꮫ≀㉁ࠊẁ㝵ⓗᑟධ≀㉁ࠊ㠀ẁ㝵ⓗᑟධ≀㉁ẁ㝵ⓗᑟධ≀㉁㸦㑄⛣㐣⛬ࡀ㐺⏝ࡉࢀࡿ㸧ࡣࠊ௨ୗࡢ≀㉁࡛࠶ࡿࠋ
·EINECS࡟ᥖ㍕ࡉࢀ࡚࠸ࡿ≀㉁ࠋḢᕞ᪤Ꮡၟᴗ໬Ꮫ≀㉁ࣜࢫࢺࡢ඲ࣜࢫࢺࡣࠊḢᕞ໬Ꮫ≀㉁᝟ሗࢩࢫࢸ࣒㸦ESIS : European chemical Substances Information
System㸧࠿ࡽධᡭ࡛ࡁࡿࠋEINECS࡟࠾ࡅࡿ1௳ࡢⓏ㘓㡯┠ࡀ」ᩘࡢ≀㉁࡟ᑐᛂࡍ
ࡿሙྜࠊཪࡣ」ᩘࡢEINECSⓏ㘓㡯┠ࡀ1ࡘࡢ≀㉁࡟ᑐᛂࡍࡿሙྜࡀ࠶ࡿࡇ࡜࡟␃ព
ࡍࡿࡇ࡜ࠋ·EUᇦෆ㸦2004ᖺ௨๓ࡢຍ┕ೃ⿵ᅜࢆྵࡴ㸧࡛〇㐀ࡉࢀࡓࡀࠊ1992ᖺ6᭶1᪥௨㝆ࡶEUᕷሙ࡟ୖᕷࡉࢀ࡚࠸࡞࠸≀㉁ࠋࡇࡢࡇ࡜ࢆࠊὀᩥ᭩ࠊᅾᗜရ┠㘓ࠊཪࡣ1992ᖺ5᭶31᪥௨㝆ࡢ᪥௜ࢆ☜ㄆ࡛ࡁࡿ᭩㢮࡟ࡼࡾド᫂ࡍࡿᚲせࡀ࠶ࡿࠋ·࠸ࢃࡺࡿࠕࡶࡣࡸ࣏࣐࣮ࣜ࡜ࡣࡳ࡞ࡉࢀ࡞࠸≀㉁ࠖ࡜ㄆࡵࡽࢀࡿ≀㉁ࠋࠕࡶࡣࡸ࣏
࣐࣮ࣜ࡜ࡣࡳ࡞ࡉࢀ࡞࠸≀㉁ࠖࡢ୍ぴࡣࠊESIS࠿ࡽධᡭ࡛ࡁࡿࠋ≀㉁ࡀẁ㝵ⓗᑟධ≀㉁࡛࠶ࡿࡇ࡜ࢆド᫂ࡍࡿࡓࡵ࡟ࡣࠊᙜヱ≀㉁ࢆヱᙜᇦෆ࡛ୖᕷࡋࡓࡇ࡜ཬࡧࡑࡢ≀㉁ࡀࠕࡶࡣࡸ࣏࣐࣮ࣜ࡜ࡣࡳ࡞ࡉࢀ࡞࠸≀㉁ࠖ࡜⪃࠼ࡽࢀࡓࡇ࡜ࢆ♧ࡍࠊ᭩㠃࡟ࡼࡿドᣐ㸦ὀᩥ᭩ࠊᅾᗜရ┠㘓ࠊࣛ࣋ࣝࠊᏳ඲ᛶࢹ࣮ࢱࢩ࣮ࢺࠊཪࡣࡑࡢ௚1981ᖺ9᭶18᪥࠿ࡽ1993ᖺ10᭶31᪥ࡲ࡛ࡢ᪥௜ࡀ☜ㄆྍ⬟࡞᭩㠃㸧ࡀᚲせ࡛࠶ࡿࠋࡇࢀࡽ3Ⅼࡢᇶ‽ࡢ࠸ࡎࢀࡶ‶ࡓࡉࡎࠊ࠿ࡘREACHࡢᑐ㇟࡜ࡉࢀࡿ≀㉁ࡣࠊẁ㝵ⓗᑟධ≀㉁࡛ࡣ࡞࠸ࡓࡵ㑄⛣㐣⛬ࡢᜠᜨࢆཷࡅ࡞࠸ࠋ≀㉁ࠊㄪ๣ࠊᡂᙧရ
REACHࡢᴫᛕࡣࠊ≀㉁࡟ᇶ♏ࢆ⨨ࡃࡶࡢ࡛࠶ࡿࠋ࡯࡜ࢇ࡝ࡢ㈐ົࡣࠊ≀㉁࡟㛵ࢃࡿࡶࡢ࡛࠶ࡿࠋࡑࡢ㝿ࡢ≀㉁࡜ࡣࠊ≀㉁ࡑࡢࡶࡢࠊཪࡣㄪ๣࡟ྵࡲࢀࡿ≀㉁ࠊཪࡣᡂᙧရෆ࡟Ꮡᅾ
ࡍࡿ≀㉁ࡢ࠸ࡎࢀ࠿ࢆᣦࡍࠋ≀㉁࡜ࡣࠊ໬Ꮫඖ⣲ཬࡧ⮬↛ࡢ≧ែ࡛ࡢཪࡣ࠶ࡽࡺࡿ〇㐀ࣉࣟࢭࢫ࠿ࡽᚓࡽࢀࡿ໬Ꮫඖ⣲ࡢ໬ྜ≀ࢆ࠸࠸ࠊᏳᐃᛶࢆಖࡘࡢ࡟ᚲせ࡞࠶ࡽࡺࡿῧຍ≀ࡸࠊ౑⏝ࡍࡿࣉࣟࢭࢫ࠿ࡽ⏕ࡌEuropean Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.euࡿ࠶ࡽࡺࡿ୙⣧≀ࡀྵࡲࢀࡿࠋࡋ࠿ࡋࠊ≀㉁ࡢᏳᐃᛶ࡟ᙳ㡪ࢆཬࡰࡉ࡞࠸࡛ࠊཪࡣࡑࡢ⤌ᡂࢆኚ࠼ࡎ࡟ศ㞳ࡍࡿࡇ࡜ࡢ࡛ࡁࡿ࠶ࡽࡺࡿ⁐๣ࢆ㝖ࡃࠋ2ࡘཪࡣࡑࢀ௨ୖࡢ≀㉁ࡀΰྜࡉࢀࡿሙྜࠊ⏝ㄒࠕㄪ๣ࠖࢆ౑⏝ࡍࡿࠋ≀㉁ཬࡧΰྜ≀ࡢศ㢮ࠊ⾲♧ࠊཬࡧᲕໟ࡟฼⏝ࡉࢀࡿୡ⏺ㄪ࿴ࢩࢫࢸ࣒㸦GHS: Globally Harmonised System㸧࡛ࡣࠊࠕㄪ๣࡛ࠖࡣ࡞ࡃࠊ⏝ㄒࠕΰྜ≀ࠖࢆ౑࠺ࡇ࡜࡟␃ពࡍࡿࡇ࡜ࠋᡂᙧရ࡟ྵࡲࢀࡿ≀㉁ࡢREACHࡢୗ࡛ࡢⓏ㘓࡟ࡣࠊ≉ูᥐ⨨ࡀ㐺⏝ࡉࢀࡿࠋᡂᙧရ࡜ࡣREACHࡢୗ࡛౑⏝ࡍࡿἲᚊ⏝ㄒ࡛࠶ࡾࠊ≉ᐃࡢ┠ⓗ࡛౑⏝ࡍࡿࡓࡵ࡟≉ᐃ࡞ᙧ≧ࠊ⾲㠃ཪࡣࢹࢨ࢖ࣥࢆ୚࠼ࡽࢀࡓ≀యࢆ࠸࠺㸦౛㸸㌴ࠊ⧄⥔ࠊ㟁Ꮚࢳࢵࣉ࡞࡝ࡢࡼ࠺࡞〇ရ㸧ࠋ≀㉁ࡀ〇㐀⪅ཪࡣ㍺ධ⪅ᙜࡓࡾ࡛ᖺ㛫1ࢺࣥࢆ㉸࠼ࡿ㔞࡛〇㐀ཪࡣ㍺ධࡉࢀࠊ㏻ᖖࡢཪࡣண
ྍ⬟࡞౑⏝᮲௳ୗ࡛ពᅗⓗ࡟ᨺฟࡉࢀࡿሙྜࠊREACH࡛ࡣࡑࢀࡽࡢ≀㉁ࡢ㏻ᖖつ๎࡟ᚑࡗࡓⓏ㘓ࢆ⩏ົ࡙ࡅ࡚࠸ࡿ16ࠋ≀㉁≉ᐃࡢᇶᮏ
REACH࡟࠾ࡅࡿ≀㉁ࡢᐃ⩏ࡣࠊ༴㝤≀㉁ᣦ௧ᨵṇ➨7∧㸦ᣦ௧92/32/EECࠊᨵṇᣦ௧
67/548/EEC㸧࡟࠾ࡅࡿ⌧⾜ᐃ⩏࡟➼ࡋ࠸ࠋ࠸ࡎࢀࡢᐃ⩏ࡶࠊ༢୍ศᏊ17࡟ࡼࡾᐃ⩏ࡍࡿ⣧⢋࡞໬ྜ≀ࡢ⠊ᅖࡼࡾᗈࡃᐃ⩏ࢆࡋ࡚࠸ࡿࠋ≀㉁ࢆ≉ᐃࡍࡿ᪉ἲࡣࠊ≀㉁ࡢࢱ࢖ࣉ࡟ࡼࡾ␗࡞ࡿࠋ≀㉁ࡣࠊ௨ୗࡢࡼ࠺࡟୺࡟2✀㢮࡟ศ㢮࡛ࡁࡿࠋ1.

ࠕ᫂☜࡟ᐃ⩏ࡉࢀࡓ≀㉁ࠖ㸸ᐃᛶⓗ⤌ᡂཬࡧᐃ㔞ⓗ⤌ᡂࢆᣢࡘ≀㉁࡛ࠊREACH㝃ᒓ᭩VIࢭࢡࢩࣙࣥ2ࡢ≉ᐃࣃ࣓࣮ࣛࢱ࡟ᇶ࡙ࡁ༑ศ࡟≉ᐃࡀྍ⬟࡞ࡶࡢࠋ≉ᐃ࡜࿨ྡつ๎ࡣࠊ1ࡘࡢ୺せᡂศ㸦࠾࠾ࡴࡡ80%௨ୖ㸧ࢆᣢࡘࠕ᫂☜࡟ᐃ⩏ࡉࢀࡓ≀㉁ࠖ࡜ࠊ1ࡘ௨ୖࡢ୺せᡂศ㸦࠾࠾ࡴࡡྛᡂศࡀ10%௨ୖ࠿ࡘ80 %ᮍ‶㸧ࢆᣢࡘ≀㉁࡛ࡣ␗࡞
ࡿࠋ࠸ࢃࡺࡿࠕ༢୍ᡂศ≀㉁ࠖ࡜ࠕከᡂศ≀㉁ࠖࡢ㐪࠸࡛࠶ࡿࠋ

16
17

Guidance on requirements for substances in articles 㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ
Guidance for identification and naming of substances under REACH㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu

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ࠕUVCB≀㉁ࠖ㸸⤌ᡂࡀᮍ▱࠿ཪࡣ୙ᐃ࡞ᵓᡂせ⣲ࢆࡶࡘ≀㉁ࠊ」㞧࡞཯ᛂ⏕ᡂ≀ࠊཪࡣ⏕య≀㉁ࡢࡇ࡜ࠋࡇࢀࡽࡢ≀㉁ࡣࠊࡑࡢ⤌ᡂࡢࡳ࠿ࡽ᫂☜࡟≉ᐃࡍࡿࡇ࡜ࡣᅔ㞴࡛࠶ࡿࠋ⏤᮶ཪࡣ〇㐀ࣉࣟࢭࢫ࡞࡝ࠊูࡢ㆑ูᏊࡢ⪃៖ࡀᚲせ࡛࠶ࡿࠋ➨୕⪅ࡢ௦⌮ே࠸࠿࡞ࡿ〇㐀⪅ཪࡣ㍺ධ⪅ࡶࠊࢹ࣮ࢱ࡟㛵㐃ࡍࡿసᴗཬࡧ㈝⏝ࡢඹྠ㈇ᢸࡢࡓࡵ࡟ࠊ➨୕⪅ࡢ௦⌮ேࢆ௵࿨ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋ஦ᴗ⪅ࡀ≉ᐃࡢ≀㉁࡬ࡢ⯆࿡ࢆ㛤♧ࡋࡓࡃ࡞࠸ሙྜࠊࡇࡢᥐ⨨ࡀ⾜ࢃࢀࡿࠋ⯆࿡ࡀ㛤♧ࡉࢀࡿ࡜ࠊ➇ྜ♫࡟〇㐀ཪࡣ௻ᴗ⛎ᐦ࡟ࡘ࠸࡚ࡢ♧၀ࢆ୚࠼ࡿྍ⬟ᛶࡀ࠶ࡿࡓࡵ࡛࠶ࡿࠋணഛⓏ㘓᫬࡟㛤♧ࡉࢀࡓ㐃⤡ඛࡣࠊྠ୍㆑ูࢥ࣮ࢻࡢୗ࡛ணഛⓏ㘓ࡉࢀࡓ≀㉁ࡢࡍ࡭࡚ࡢ₯ᅾⓗⓏ㘓⪅ࠊཬࡧㄞࡳྲྀࡾἲࡢྍ⬟ᛶࡀ♧ࡉࢀ࡚࠸ࡿࡍ࡭࡚ࡢ≀㉁ࡢ₯ᅾⓗⓏ㘓⪅࡟㛤♧ࡉࢀࡿࠋࡇࢀࡽࡢ᝟ሗࡀᶵᐦ஦㡯࡛࠶ࡿ࡜⪃࠼ࡿሙྜࠊ➨୕⪅ࡢ௦⌮ேࢆ฼⏝࡛ࡁࡿࠋ၏୍ࡢ௦⌮ேḢᕞඹྠయ࡟㍺ධࡉࢀࡿ≀㉁ࡑࡢࡶࡢࠊㄪ๣࡟ྵࡲࢀࡿ≀㉁ཪࡣᡂᙧရ࡟ྵࡲࢀࡿ≀㉁ࢆ
〇㐀ࡋࠊㄪ๣ࢆㄪ〇ࡋཪࡣᡂᙧရࢆ⏕⏘ࡍࡿḢᕞඹྠయእ࡟ᡤᅾࡍࡿ⮬↛ேཪࡣἲேࡣࠊ㍺ධ⪅ࡢ⩏ົࢆᯝࡓࡍࡓࡵ࡟ࠊ┦஫ࡢྜព࡟ࡼࡗ࡚Ḣᕞඹྠయෆ࡟ᡤᅾࡍࡿ⮬↛ேཪࡣἲேࢆࠊ၏୍ࡢ௦⌮ே࡜ࡋ࡚ᣦྡࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋ၏୍ࡢ௦⌮ேࡣࠊ௨ୗࡢ᮲௳ࢆ‶ࡓࡍ⮬↛ேཪࡣἲே࡛࠶ࡿࠋ
·EUᇦෆ࡟ᡤᅾࡋࠊ࠿ࡘࠊ·≀㉁ࡢᐇ㝿ⓗ࡞ྲྀࡾᢅ࠸࡟㛵ࡍࡿ༑ศ࡞⤒Ṕཬࡧࡑࢀࡽ࡟㛵ࡍࡿ᝟ሗࢆᣢࡘࠋ၏୍ࡢ௦⌮ே࡟㛵ࡋ࡚ࡣࠊⓏ㘓࢞࢖ࢲࣥࢫࢆཧ↷ࡍࡿࡇ࡜ 18ࠋ

」ᩘࡢⓏ㘓⪅࡟ࡼࡿࢹ࣮ࢱࡢඹྠᥦฟ

ྛ〇㐀⪅ࠊ㍺ධ⪅ཪࡣ၏୍ࡢ௦⌮ேࡣࠊ≀㉁ࡈ࡜࡟Ⓩ㘓ࢆᥦฟࡍࡿ⩏ົࢆ㈇࠺㸦ἲேࡈ࡜㸧ࠋࡋ࠿ࡋ≀㉁ࡀ」ᩘࡢ஦ᴗ⪅࡟ࡼࡾ〇㐀ࡉࢀཪࡣ㍺ධࡉࢀࡿሙྜࠊࡇࢀࡽࡢ஦ᴗ⪅ࡣ≉ᐃࡢ᝟ሗࢆඹྠ࡛ᥦฟࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋࡇࢀࢆࢹ࣮ࢱࡢඹྠᥦฟ࡜࠸࠺ࠋⓏ㘓⪅ࡣࠊ≀㉁ࡢ᭷ᐖ≉ᛶࠊ≀㉁ࡢศ㢮ཬࡧ⾲♧ࠊヨ㦂ᥦ᱌㸦Ꮡᅾࡍࡿሙྜ㸧࡟㛵ࡍࡿ᝟ሗࢆඹྠ࡛ᥦฟ

18

Guidance on registration㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.euࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋࡲࡓⓏ㘓⪅ࡀྜពࡍࡿሙྜࠊ໬Ꮫ≀㉁Ᏻ඲ᛶሗ࿌᭩ཬࡧᏳ඲౑⏝ࡢ࢞࢖ࢲࣥࢫࢆඹྠ࡛ᥦฟࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸19ࠋ

㛵㐃㈨ᩱ࡬ࡢࣜࣥࢡ
REACHつ๎EC No 1907/2006
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2007:136:SOM:EN:HTML

REACH࢞࢖ࢲࣥࢫᩥ᭩
http://reach.jrc.it/guidance_en.htmⓏ㘓࡟ࡘ࠸࡚ࡢ࢞࢖ࢲࣥࢫ
http://reach.jrc.it/docs/guidance_document/registration_en.htm

ࢹ࣮ࢱඹ᭷࡟ࡘ࠸࡚ࡢ࢞࢖ࢲࣥࢫ
http://reach.jrc.it/docs/guidance_document/data_sharing_en.htm

REACH࡟࠾ࡅࡿ≀㉁ࡢ≉ᐃཬࡧ࿨ྡ࡟㛵ࡍࡿ࢞࢖ࢲࣥࢫ
http://reach.jrc.it/docs/guidance_document/substance_id_en.htmᡂᙧရ࡟ྵࡲࢀࡿ≀㉁ࡢせ௳࡟㛵ࡍࡿ࢞࢖ࢲࣥࢫ㸦2008ᖺ6᭶1᪥Ⓨ⾜㸧REACH-IT࣮ࣘࢨ࣮࢞࢖ࢻ㸦2008ᖺ6᭶1᪥Ⓨ⾜㸧IUCLID 5࣮ࣘࢨ࣮࢞࢖ࢻ㸸http://ecbwbiu5.jrc.it/ECHA࢙࢘ࣈࢧ࢖ࢺ㸸http://echa.europa.eu

19

Guidance on data sharing㸦ⱥㄒ㸧ࢆཧ↷ࡍࡿࡇ࡜ࠋ

European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu

ECHA࣊ࣝࣉࢹࢫࢡ㸸http://echa.europa.eu/reach/helpdesk_en.html

ESIS㸸http://ecb.jrc.it/esis/

IUCLID 5㸸http://echa.europa.eu/iuclid

REACH-IT㸸http://echa.europa.eu/reachitணഛⓏ㘓㸸http://echa.europa.eu/pre-registration㸦4᭶୰᪪࡟ᥖ㍕㸧

REACH࢞࢖ࢲࣥࢫ ࣇ࢓ࢡࢺࢩ࣮ࢺ㸦ࡲࡶ࡞ࡃⓎ⾜ணᐃ㸧European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, FinlandTel.: +358 9 6861 80 | Fax +358 9 6861 8210 | http://echa.europa.eu | info@echa.europa.eu