REACHࢹ࣮ࢱせ௳ཬࡧࡤࡃ㟢ࢩࢼࣜ࢜Kees van Leeuwen
TNOᛂ⏝⛉Ꮫ◊✲ᶵᵓࢡ࢜ࣜࢸ࢕࣭࢜ࣈ࣭ ࣛ࢖ࣇ㒊㛛

ෆᐜ

1.
2.
3.

ࡣࡌࡵ࡟ࢹ࣮ࢱせ௳REACH࡜ヨ㦂ື≀ࡢ౑⏝4.
5.
6.

ࡤࡃ㟢ࢩࢼࣜ࢜ཬࡧࣜࢫࢡ⟶⌮⤖ࡧࡢゝⴥ᭦࡞ࡿ࢞࢖ࢲࣥࢫཬࡧࢶ࣮ࣝࢹ࣮ࢱ: ⌧ἣ141ඃඛ≀㉁2767 HPVCs
㸦㧗⏕⏘㔞≀㉁㸧
> 100,000 EINECS ≀㉁HPVCs࡟㛵ࡍࡿࢹ࣮ࢱࡢබ㛤≧ἣ
(Allanou, Hansen and van Der Bilt, 1999)! 14 %㸸࣮࣋ࢫࢭࢵࢺࢹ࣮ࢱ! 65%㸸࣮࣋ࢫࢭࢵࢺࢹ࣮ࢱᮍ‶86%! 21%㸸බ㛤ࡉࢀ࡚࠸ࡿࢹ࣮ࢱࡀ↓࠸໬Ꮫ≀㉁Ᏻ඲ᛶホ౯㸦CSA㸧ࡢ┠ⓗࡣఱ࠿?
໬Ꮫ≀㉁࡟㛵ࡍࡿCSAࡢ┠ⓗࡣࠊࣛ࢖ࣇࢧ࢖ࢡࣝࡢ඲ẁ㝵ࢆ㏻ࡌ࡚≀㉁ࡢ〇㐀ཬࡧ౑⏝ࡢᏳ඲࡞≧ἣࢆ☜❧ࡍࡿࡇ࡜࡛࠶ࡿࠋ ≀㉁ࡑࡢࡶࡢཪࡣㄪ๣
࡟ྵ᭷ࡉࢀࡿ≀㉁ࡢ〇㐀⪅ࠊ㍺ධ⪅ཬࡧᕝୗ౑⏝⪅ࡣࠊᙜヱ≀㉁ࡀேࡢ೺ᗣ࡜⎔ቃ࡟ᝏᙳ㡪ࢆཬࡰࡉ࡞࠸ࡼ࠺࡟〇㐀ࡉࢀࠊ౑⏝࡛ࡁࡿࡇ࡜ࢆಖドࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ2. ࢹ࣮ࢱせ௳㝃ᒓ᭩ VII 㸦ᖺ㛫1 ࢺࣥ௨ୖ㸧! ≀⌮໬Ꮫⓗᛶ≧! ே೺ᗣ㸸 in vitroヨ㦂ࠊឤసᛶࠊኚ␗ཎᛶࠊ ᛴᛶẘᛶ㸦1⤒㊰㸧! ⎔ ቃ㸸 ᛴᛶỈᛶẘᛶ㸦࣑ࢪࣥࢥࠊ⸴㢮㸧ࠊ⏕ศゎᛶ㝃ᒓ᭩ VIII 㸦ᖺ㛫10ࢺࣥ௨ୖ㸧! ே೺ᗣ㸸 in vitroヨ㦂ཬࡧ28᪥㛫཯᚟ᢞ୚ヨ㦂ࢆྵࡴ! ⎔ ቃ㸸 㨶ᛴᛶẘᛶࠊ 㐠࿨ヨ㦂㸦ຍỈศゎࠊ྾╔/⬺╔㸧㝃ᒓ᭩ IX 㸦ᖺ㛫100 ࢺࣥ௨ୖ㸧! 㛗ᮇࠊ཯᚟ᢞ୚ࠊ៏ᛶẘᛶࠊ㐠࿨ヨ㦂࡞࡝㝃ᒓ᭩ X 㸦ᖺ㛫1000 ࢺࣥ௨ୖ㸧! ࡉࡽ࡟㛗ᮇࠊ཯᚟ᢞ୚ࠊ៏ᛶẘᛶࠊ㐠࿨ヨ㦂࡞࡝REACHࢹ࣮ࢱせ௳㝃ᒓ᭩VII୍ᘧᩥ᭩ᙜࡓࡾࡢぢ✚ࡾ㈝⏝᥎ᐃࡉࢀࡿᑐ㇟≀㉁ᩘ

」ᩘࢯ࣮ࢫ࠿ࡽࡢ୍⯡ⓗ࡞᥎ᐃ㝃ᒓ᭩VIII㝃ᒓ᭩ IX

㝃ᒓ᭩X~30 k!

170-330 k!

400-875 k!

400k-2 M!

20,000≀㉁

4,600≀㉁

2,900≀㉁

2,600≀㉁

3. REACHཬࡧヨ㦂ື≀ࡢ౑⏝! ⬨᳝ື≀ࡢヨ㦂ࡣࠊ᭱ᚋࡢᡭẁ࡜ࡋ࡚ࡋ࠿⾜ࡗ࡚ࡣ࡞ࡽ࡞࠸㸦➨25᮲㸧! ᝟ሗࡣື≀ヨ㦂௨እࡢ᪉ἲࠊ≉࡟in vitroἲࠊ㸦ᐃ㔞ⓗ㸧ᵓ㐀άᛶ┦㛵ᡭἲ㸦(Q)SARs㸧ཬࡧㄞࡳྲྀࡾἲ㸦read-across㸧ࢆ౑⏝ࡍࡿࡇ࡜࡟ࡼࡾࠊసᡂࡍࡿࡇ࡜ࡀ࡛ࡁࡿ㸦➨13᮲㸧э つ๎᮲ᩥཬࡧ࢞࢖ࢲࣥࢫࡣࠊヨ㦂ື≀ࡢ౑⏝ࢆไ㝈ࡋ࡚Ᏻ᫆࡞ุ᩿㸦box-ticking㸧ࢆ㜵Ṇࡍ࡭ࡁ࡛࠶ࡿ㹃㹓࡟࠾ࡅࡿヨ㦂ື≀ࡢ౑⏝㸦2002ᖺ㸧COM(2005)7 final
⑌ᝈ䛾デ᩿
2.12%

ᩍ⫱ཬ䜃カ⦎
3.2%
䛭䛾௚
5.57%

⏕≀Ꮫ䛾ᇶ♏ⓗ◊✲
34.7%

ẘᛶཬ䜃䛭䛾௚䛾
Ᏻ඲ᛶホ౯
9.93%
ື≀⏝་⸆ရ䛾⏕⏘ཬ䜃ရ㉁⟶⌮2.42%ே⏝་⸆ရཬ䜃ṑ⛉་⒪ရ䛾⏕⏘ཬ
䜃ရ㉁⟶⌮
13.6%

ே⏝་⸆ရཬ䜃ṑ⛉་⒪ရ୪䜃䛻ື≀⏝་⸆ရ䛾䛯䜑䛾〇ရཬ䜃ᶵჾ䛾
㛤Ⓨ䞉◊✲
28.4%

2002ᖺࡢ⥲ᩘ = 1,070୓

ື≀ᐇ㦂ࡢ┠ⓗ㸦2002ᖺ㸧COM(2005)7 final⥲ᩘᏳ඲ᛶホ౯㎰⸆ᕤᴗ⏝໬Ꮫရ໬⢝ရ

10,700,000
1,060,000
123,000
136,000
2,700

100 %
10 %
1%
1%
0.025%ヨ㦂ື≀ࡢ㟂せ᥎ᐃ 㸦van der Jagt et al., 2004㸧
ヨ㦂ື≀ࡢホ౯㡯┠ู๭ྜホ౯㡯┠ู䛾ヨ㦂ື≀㟂せ㸦඲ヨ㦂࡟ᑐࡍࡿ๭ྜ㸦㸣㸧㸧䠄ヨ㦂ື≀䛾⥲㟂せ䛻ᑐ䛩䜛๭ྜ䠂䠅஧ୡ௦⦾ṪⓎ⏕ẘᛶヨ㦂㏣ຍࡢኚ␗ཎᛶ
⓶⭵ឤస㛗ᮇ㨶ẘᛶⓎ⏕ẘᛶࢫࢡ࣮ࣜࢽࣥࢢ⵳✚▷ᮇ཯᚟ᢞ୚Ⓨࡀࢇᛶள៏ᛶẘᛶ㛗ᮇ཯᚟ᢞ୚▷ᮇ㨶ẘᛶᛴᛶ྾ධẘᛶᛴᛶ⓶⭵ẘᛶᛴᛶ⤒ཱྀẘᛶ
in vivo║่⃭in vivo⓶⭵่⃭㛗ᮇ㫽
0

5

10

15

20%

25

30

3540

3ࡘࡢヨ㦂࡛㈝⏝ࡀỴࡲࡿ඲యⓗ࡞ヨ㦂ື≀ࡢ㟂せ࡜㈝⏝ࡢ3኱せᅉ࡜࡞ࡗ࡚࠸ࡿୗグヨ㦂ࡢ௦᭰ࡣࠊ⌧ᅾࡢ࡜ࡇࢁᚓࡽࢀ࡚࠸࡞࠸ࠋ
1. ஧ୡ௦⦾Ṫẘᛶヨ㦂
2. Ⓨ⏕ẘᛶヨ㦂
3. ㏣ຍࡢኚ␗ཎᛶ㸦in vivo㸧ヨ㦂ୖグヨ㦂ࡣヨ㦂ື≀ࡢ⥲㟂せཬࡧື≀ᐇ㦂ࡢ⥲㈝⏝ࡢ⣙70%ࢆ༨ࡵ࡚࠸ࡿࠋ⤒㈝⠇⣙㠃㸸 ▱ⓗヨ㦂ᡓ␎(Intelligent Testing Strategies)⏘ᴗ⏺ࡢ㈇ᢸࡍࡿ⤒㈝ࢆ๐ῶࡋࠊື≀ヨ㦂ࢆ᭱ᑠ㝈࡟ᢚ࠼࡞ࡀࡽ᭷ᐖᛶホ౯ཬࡧࣜࢫࢡホ౯ࢆ᭱ࡶຠ⋡ⓗ࡟ᐇ᪋ࡍࡿ᪉ἲࡣࠊ▱ⓗヨ㦂ᡓ␎㸦ITS㸧ࢆ⏝࠸࡚ࠊᚲせ࡞᝟ሗࢆධᡭࡍࡿࡇ࡜࡛࠶ࡿࠋ
▱ⓗヨ㦂ᡓ␎ࡣࠊ」ᩘࡢせ⣲࠿ࡽᵓᡂࡉࢀࡿ⤫ྜⓗ࢔ࣉ࣮ࣟࢳ࡛࠶ࡾࠊ⤒㈝࡜ື≀ヨ㦂ࢆ๐ῶࡋ࡞ࡀࡽࣜࢫࢡホ౯ࣉࣟࢭࢫࡢ㎿㏿໬ࢆ┠ᣦࡍࠋ(Bradbury, Feytel and Van Leeuwen, 2004)

REACH: ITS࡟ࡼࡿ⠇⣙ぢ㎸ࡳ(Van der Jagt et al., 2004; EUR report 21405)! ヨ㦂㈝⏝:! ື≀ᩘ:! 8൨-11൨3000୓
130୓-190୓

REACH࡟ࡘ࠸࡚ࡢ᭱ࡶྍ⬟ᛶࡢ㧗࠸ࢩࢼࣜ࢜㸦JRC᥎
ᐃ㸧㸸260୓༉ࡢ⬨᳝ື≀ཬࡧ ! 15൨ࡢヨ㦂㈝⏝(http://ecb.jrc.it/ )࢖ࣥࢸࣜࢪ࢙ࣥࢺࢸࢫࢺᡓ␎㸦ITS㸧ㄞࡳྲྀࡾἲ(Q)SARs

In-vitro࢚ࣥࢻ࣏࢖ࣥࢺ᝟ሗ
ࡤࡃ㟢ࢩࢼࣜ࢜
㸦㝃ᒓ᭩ VII/VIII㸧?
ヨ㦂᪤Ꮡ᝟ሗ⌧ᅾࡢẘᛶヨ㦂ࡢᯟ⤌ࡳ㸦paradigm㸧࡛ࡣࠊྍ⬟ᛶࡢ࠶ࡿࡍ࡭࡚ࡢᙳ㡪ࡢ࠺ࡕ࡝ࢀࡀ㛵ಀࡍࡿ࠿ࢆぢࡘࡅฟࡍࡓࡵ࡟ࠊࡑࢀࡒࢀ࡟ࡘ࠸
࡚in vivo ື≀ヨ㦂ࢹ࣮ࢱࢆᚲせ࡜ࡍࡿṚஸ⋡⏕Ṫ㐺ᛂᗘⓎ㐩㞀ᐖ! ඲㌟ẘᛶ
! ⑌ᝈ! ࡀࢇ! Ꮚࡢ⏕Ꮡ⬟! ⦾Ṫ⬟! ወᙧ! ฟ⏘๓Ḟ㝗୍㐃ࡢື≀ヨ㦂(Jones and Bradbury, USEPA, 2005)▱ⓗヨ㦂ᡓ␎㸦ITS㸧ࡢᵓᡂせ⣲(v) ㄞࡳྲྀࡾἲཬࡧ࢝ࢸࢦ࣮ࣜ (USEPA, 2004)ே೺ᗣ⎔ቃᙳ㡪

50%

58%ㄞࡳྲྀࡾἲ࡟ࡼ 44%
ࡿ᥎ᐃ
ヨ㦂
6%35%

㐺ษ࡞◊✲

7%

ࣃࣛࢲ࢖࣒࣭ࢩࣇࢺࡀᚲせつไࣉࣟࢢ࣒ࣛ࡜ࡢ㛵㐃࡟࠾ࡅࡿㄢ㢟ࡣࠊ᭱ࡶ㛵㐃ᛶࡀ㧗࠸in vivo᝟ሗࢆ≉ᐃࡍࡿࡓࡵࡢᯟ⤌ࡳࢆࠊᖜᗈ࠸᭷ᐖᛶヨ㦂ࢆᚲせ࡜ࡍࡿ⌧≧࠿ࡽࠊ௬ㄝཬࡧࣜࢫࢡ୺ᑟࡢ࢔ࣉ࣮ࣟࢳࢆ౑࠼ࡿ᪉ྥ࡬ࠊ⛉Ꮫⓗ࡟ಙ㢗࡛ࡁ࠿ࡘ㏱᫂࡞᪉ἲ࡛⛣⾜ࡉࡏࡿࡇ࡜࡛
࠶ࡿࠋ(Bradbury, Feytel and Van Leeuwen, 2004)

ITSࢆᐇ᪋ࡍࡿ7-R ᡓ␎࡟ྥࡅ࡚
1. ࣜࢫࢡ㸦Risks㸧 ࣜࢫࢡ࡟㔜Ⅼ 㸦ࡤࡃ㟢ࢆྵࡴ㸧
2. ཯᚟㸦Repetitive㸧ᠱᛕࡢప࠸໬Ꮫ≀㉁ࢆ㎿㏿࡟ホ౯ࡋࠊཬࡧື≀ヨ㦂ࢆᢚไࡍࡿࡓࡵ࡟ࠊࢩࣥࣉࣝ࡞࢔ࣉ࣮ࣟࢳ࠿ࡽᚲせ࡛࠶ࢀࡤヲ⣽ཪࡣໟᣓⓗ࡞࢔ࣉ࣮ࣟࢳ࡬㐍ࡴẁ㝵ⓗ࢔ࣉ࣮ࣟࢳࢆ㐺⏝ࡍ࡭ࡁ࡛࠶ࡿࠋ
3. 㛵㐃㸦Relatives㸧 ㄞࡳྲྀࡾἲࠊQSARsཬࡧࡤࡃ㟢࢝ࢸࢦ࣮ࣜࢆ⏝࠸࡚ࠊ໬Ꮫ≀㉁ࡢ⩌ཪࡣ࢝ࢸࢦ࣮ࣜ㸦ࢢ࣮ࣝࣉほⅬࡢ࢔ࣉ࣮ࣟࢳ㸧࡟㔜Ⅼࢆ⨨ࡃ࡭ࡁ࡛࠶ࡾࠊ໬Ꮫ≀㉁ࢆಶู࡟ᢅ࠺࢔ࣉ࣮ࣟࢳ࠿ࡽ⬺༷ࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ
4. ไ⣙㸦Restriction㸧 ே೺ᗣཬࡧ/ཪࡣ⎔ቃ࡬ࡢᦆᐖࢆ㜵ࡄࡓࡵ࡟ࠊྍ⬟࡛࠶ࢀࡤヨ㦂ࢆไ⣙㸦ච㝖㸧ࡋ࡚ࠊᚲせ࡛࠶ࢀࡤin-vivoヨ㦂ࢆᐇ᪋ࡍࡿࠋ
ࡇࡢᡓ␎ࡣ⌧⾜ࡢ௨ୗࡢ3-Rᡓ␎ࡶ⥙⨶ࡍ࡭ࡁ࡛࠶ࡿࠋ
5. ௦᭰㸦Replacement㸧
6. ᨵⰋ㸦Refinement㸧ⱞ③࣭ⱞᝎࢆ㍍ῶࡍࡿࠋ
7. ๐ῶ㸦Reduction㸧

REACHࠊⓏ㘓ཬࡧITS! ௦᭰ἲࡢ㐺⏝࣭㛤Ⓨࢆಁ㐍ࡍࡿᅽຊࡀቑ኱ 㸦⌧ᅾࡢᙳ㡪ຊࡣ㝈ࡽࢀ࡚࠸ࡿࡀࠊᑗ᮶ࡢ௦᭰ἲࡢཷධࢀ࡟ᙳ㡪ࡍࡿྍ⬟ᛶࡀ࠶ࡿ㸧! ໬Ꮫ≀㉁ᗇࡣࠊຍ┕ᅜཬࡧ㛵ಀ⪅࡜༠ຊࡋ࡚ࠊ㐺ษ࡞ᣦ㔪ࢆ⟇ᐃࡍࡿ࡭ࡁ࡛࠶ࡿ㸦REACH つ๎๓ᩥ(38) 㸧ITS࡟㛵ࡍࡿ⤖ㄽ
1.

2.
3.
4.

5.

ື≀ヨ㦂ࢆin vitroヨ㦂ཬࡧQSARs࡛⨨ࡁ᥮࠼ࡿࡇ࡜࡬ࡢᮇᚅࡣࠊ
⛉Ꮫⓗ⌧ᐇ࡟ඛࢇࡌ࡚࠸ࡿ࡜ࡳࡽࢀࡿ㸦ཧ⪃ᩥ⊩㸸CSTEE &SCCNFP in Van Leeuwen, Patlewicz, Worth, 2007 ཬࡧ Greim et al.,2006㸧ᖜᗈ࠸ື≀ヨ㦂࠿ࡽࠊ7-R࢔ࣉ࣮ࣟࢳࢆ㐺⏝ࡍࡿຠ⋡ⓗ࡛ⓗࢆ⤠ࡗࡓື≀ヨ㦂࡬ࡢࣃࣛࢲ࢖࣒࣭ࢩࣇࢺࡀᚲせITS࡟ࡣ ື≀౑⏝࡜ヨ㦂㈝⏝ࢆ኱ᖜ࡟⠇ῶࡍࡿྍ⬟ᛶࡀ࠶ࡿࢹ࣮ࢱせ௳࡟㛵ࡍࡿ࢞࢖ࢲࣥࢫ㸦RIP 3.3㸧ࡣⲡ᱌ࡢᙧ࡛ධᡭྍ⬟㸦Ḣᕞ໬Ꮫ≀㉁ᒁ㸦ECB㸧ࡢ࢙࢘ࣈࢧ࢖ࢺࢆཧ↷ࠊᐇ࡟1100࣮࣌ࢪ࡟ཬࡪ㸟㸧᭦࡟㐍ࢇࡔ⛉Ꮫⓗసᴗ㸦2007ᖺ௨㝆㸧࡜つไࡢᐇ᪋ࡀᚲせ4. ࡤࡃ㟢ࢩࢼࣜ࢜ཬࡧࣜࢫࢡ⟶⌮໬Ꮫ≀㉁Ᏻ඲ᛶホ౯㸦CSA㸧ࡣ໬Ꮫ≀㉁ࡀᏳ඲࡟౑⏝ࡉࢀࡿ᪉ἲࢆỴᐃࡍࡿࡓࡵࡢࢶ࣮࡛ࣝ࠶ࡿࡤࡃ㟢ࢩࢼ࡛ࣜ࢜ࡣࠊ࠶ࡿ⏝㏵࡟࠾࠸࡚ࠊࡑࡢ⏝㏵࡟㛵ࡍࡿ௨ୗࡢ≧ἣࢆグ㏙ࡍࡿࡇ࡜࡛ࠊࣜࢫࢡࢆ㐺ษ࡟⟶⌮ࡍࡿ᪉ἲ࡟ᚑ࠸ࠊ≀㉁ࡀ
࡝ࡢࡼ࠺࡟౑⏝ࡉࢀᚓࡿ࠿ࢆ❧᱌ࡍࡿ" ࣉࣟࢭࢫࡢグ㏙ 㸦౑⏝㔞ࢆྵࡴ㸧" సᴗ᮲௳ 㸦≉ᐃసᴗࡢ㢖ᗘཬࡧ⥅⥆ᮇ㛫ࢆྵࡴ㸧" ࣜࢫࢡ⟶⌮ᥐ⨨㸦ࣉࣟࢭࢫཬࡧ᤼ฟไᚚࠊಶே⏝ಖㆤලࠊⰋዲ࡞⾨⏕࡞࡝㸧ࡤࡃ㟢ࢩࢼࣜ࢜ࡣCSAࡢ୍⎔࡜ࡋ࡚సᡂࡉࢀࡿࠋCSAࡣ໬Ꮫ≀㉁ࡀ
Ᏻ඲࡟౑⏝ࡉࢀࡿ᪉ἲࢆỴᐃࡍࡿࡓࡵࡢࢶ࣮࡛ࣝ࠶ࡿREACH࡟ᇶ࡙ࡃࡤࡃ㟢ࢩࢼࣜ࢜ࡣࣜࢫࢡ⟶⌮࡟୙ྍḞ࡞࢔ࣉ࣮ࣟࢳ࡛࠶ࡿබᘧࡢᐃ⩏㸸≀㉁ࡢࣛ࢖ࣇࢧ࢖ࢡࣝ࡟࠾࠸࡚࡝ࡢࡼ࠺࡟
〇㐀ࡉࢀࠊ౑⏝ࡉࢀࡿ࠿ࠊࡑࡋ࡚〇㐀⪅ཪࡣ㍺ධ⪅ࡀேཬࡧ⎔ቃ࡬ࡢࡤࡃ㟢ࢆ࡝ࡢࡼ࠺࡟⟶⌮ࡍࡿ࠿ࠊཪࡣᕝୗ౑⏝⪅࡟ࡑࡢ⟶⌮ࢆ࡝ࡢࡼ࠺࡟᥎ዡࡍࡿ࠿ࢆグ㏙ࡋࡓసᴗ᮲௳ࡸࣜࢫࢡ⟶⌮ᥐ⨨ࢆྵࢇࡔ୍㐃ࡢ᮲௳ࠋࡇࢀࡽࡢࡤࡃ㟢ࢩࢼࣜ࢜ࡣࠊ≉ᐃࡢ୍ࡘࡢࣉࣟࢭࢫཪࡣ⏝㏵ࠊᚲ
せ࡟ᛂࡌ࡚ࠊ࠸ࡃࡘ࠿ࡢࣉࣟࢭࢫཪࡣ⏝㏵ࢆྵࡵ࡚ࡶࡼ
࠸ࠋⓏ㘓࡟ᚲせ࡞ࡶࡢ:1. ᢏ⾡୍ᘧᩥ᭩㸦ᖺ㛫1ࢺࣥ௨ୖࡢ࠶ࡽࡺࡿ≀㉁ࡀᑐ㇟㸧2. ໬Ꮫ≀㉁Ᏻ඲ᛶሗ࿌᭩㸦CSR㸹ᖺ㛫10ࢺࣥ௨ୖࡢ≀㉁ࡀᑐ㇟㸧≀㉁ࡀ༴㝤ᛶࡢศ㢮ࢡࣛ࢖ࢸࣜ࢔࡟㐺ྜࡋ࡚࠸ࡿሙྜࠊཪ
ࡣPBTⱝࡋࡃࡣvPvB࡛࠶ࡿ࡜ホ౯ࡉࢀࡿሙྜ࡟ࡣࠊ㸯ࡘ௨ୖࡢࡤࡃ㟢ࢩࢼࣜ࢜ࠊࡤࡃ㟢᥎ᐃཬࡧࣜࢫࢡ≉ᛶ໬㸦characterization㸧࡞࡝ࢆグ㏙ࡋࡓࡤࡃ㟢ホ౯ࢆCSA࡟ྵࡵ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋࡤࡃ㟢ࢩࢼࣜ࢜ࢆ⟇ᐃࡍࡿ6ࡘࡢẁ㝵
1.
2.
3.
4.
5.
6.

⏝㏵ཬࡧ౑⏝ࣉࣟࢭࢫࡢ≉ᐃ〇㐀ཪࡣ౑⏝ࣉࣟࢭࢫࡢグ㏙ࠕᬻᐃⓗ࡞ࠖࡤࡃ㟢ࢩࢼࣜ࢜㸦ES㸧ࡢ⟇ᐃࡤࡃ㟢᥎ᐃཬࡧࣜࢫࢡ≉ᛶ໬ࠕ᭱⤊ࠖࡤࡃ㟢ࢩࢼࣜ࢜ࡢỴᐃᏳ඲ᛶࢹ࣮ࢱࢩ࣮ࢺ㸦SDS㸧ࡢ㝃ᒓ᭩ࢆ⟇ᐃࢧࣉࣛ࢖ࢳ࢙࣮ࣥ࡟࠾ࡅࡿ᝟ሗఏ㐩౪⤥⪅ࡤࡃ㟢ࢩࢼࣜ࢜ࢆ
ྵࡴSDS㸦᥎ዡࡉࢀࡓ
ࣜࢫࢡ⟶⌮ᥐ⨨㸧Ᏻ඲ᛶࢹ࣮ࢱࢩ࣮ࢺ
㸦SDS㸧

ᕝୗ౑⏝⪅

⏝㏵ࢆ≉ᐃࣜࢫࢡ⟶⌮ᥐ⨨ࡢᙧᘧ
1.
2.
3.
4.
5.
6.
7.

〇ရ̺≀㉁㛵㐃ࡢᥐ⨨≀㉁࣭〇ရࡢୖᕷࡢไ㝈౑⏝ࢆไ㝈ࡍࡿᣦ♧ᣦ♧࣭᝟ሗ࣭㆙࿌ᢏ⾡ⓗᥐ⨨⤌⧊ⓗᥐ⨨ಶேಖㆤᥐ⨨

ฟ඾: RIP 3.2 WP1 development of the concept ofExposure scenarios, 337 pp (ECBࡢ࢙࢘ࣈࢧ࢖ࢺ㸧)᪤Ꮡࡢ▱㆑/ࢹ࣮ࢱ᭷ᐖᛶ≉ᐃࡤࡃ㟢ࢩࢼࣜ࢜᝿ᐃࡋࡓࣜࢫࢡ⟶⌮ᥐ⨨ཬࡧ/ཪࡣసᴗ᮲௳ࢆಟṇศ㢮࡜⾲♧ࡤࡃ㟢ホ౯᭷ᐖᛶホ౯ࣜࢫࢡ≉ᛶ໬࠸࠸࠼ࣜࢫࢡࡣ㐺ษ࡟⟶⌮ࡉࢀ࡚࠸ࡿ࠿?

࠸࠸࠼ࡣ࠸ࣜࢫࢡࢆ㐺ษ࡟⟶⌮ࡍࡿࡓࡵࡢࣜࢫࢡ⟶⌮ᥐ⨨㸦RMM㸧ཬࡧసᴗ᮲௳ࢆྵࡴࡤࡃ㟢ࢩࢼࣜ࢜㸦ES㸧ࡣ௨ୗࡢ᮲௳ࢆ‶ࡓࡍ࡭ࡁ࡛࠶ࡿ㸸໬Ꮫ≀㉁Ᏻ඲ᛶሗ࿌᭩㸦CSR㸧࡟グ㍕
౑⏝⪅࡟㸦SDS㝃ᒓ᭩ࢆ㏻ࡌ࡚ᕝୗ౑⏝⪅࡟㸧ఏ㐩!

ࡤࡃ㟢ࢩࢼࣜ࢜ࡢ௦⾲ⓗ࡞≉ᚩࡤࡃ㟢ࢩࢼࣜ࢜㸦ES㸧ࡢ≉ᚩࣃ࣓࣮ࣛࢱࡢ౛㸦㠀⥙⨶ⓗ㸧ESࡀゝཬࡍࡿ≀㉁ཪࡣ〇ရࡢࣛ࢖ࣇࢧ࢖ࢡࣝ〇㐀⪅ཪࡣ㍺ධ⪅ࠊྜᡂࠊ໬ྜࠊㄪྜࠊ⏝㏵ࠊ⪏⏝ᖺᩘࠊᗫᲠẁ㝵඲ᶆⓗ㞟ᅋࢆᑐ㇟࡟㛵㐃ࡤࡃ㟢ࢆ≉ᐃࡋ࡚ࠊ㐺ษ࡞ᗈ⠊ࡢ
ESࡢ㑅ᢥࢆᨭ࠼ࡿ

ࣉࣟࢭࢫࡢ≉ᛶ⏘ᴗ༊ศࠊ⏝㏵༊ศ

〇㐀ཪࡣ౑⏝άືసᴗ᮲௳

άື/౑⏝ࡢ✀㢮άື/౑⏝ࡢ⥅⥆ᮇ㛫άື/౑⏝ࡢ㢖ᗘᗘࠊ pH, ࡞࡝ࣉࣟࢭࢫࡢ㛢ࡌ㎸ࡵ [㛤ᨺ/㛢㙐]ࡤࡃ㟢ࢱ࢖ࣉ㸦▷ᮇ vs. 㛗ᮇ㸧ࢆỴᐃࡋࠊ ண ↓ᙳ㡪⃰ᗘ㸦
PNEC㸧ཪࡣ᥎ᐃ↓ᙳ㡪ࣞ࣋ࣝ
㸦DNEL㸧ࢆ㑅ᢥࡍࡿㄪ๣≉ᛶ≀㉁ࡢ㔜㔞๭ྜ⛣ື㏿ᗘㄪ๣ཪࡣ〇ရ࡬ࡢேཬࡧ⎔ቃࡢࡤࡃ㟢ࢆỴᐃࡍࡿ౑⏝㏿ᗘ [ࢺࣥ/ᖺ]ྲྀᢅ㔞 [kg/᪥࡞࡝]᫬㛫ᙜࡓࡾࡢࡤࡃ㟢ྍ⬟ᛶࢆ☜ᐃࡍࡿᒁᡤ᤼Ẽ⿦⨨⌧ሙ࡛ࡢᗫᲠ≀㸦᤼Ỉ㸧ฎ⌮ಶே⏝㜵ㆤලࣉࣟࢭࢫࡢ୍㒊࡜ࡋ࡚ࠊཪࡣᕝୗ౑⏝⪅ࡢ┤᥋⤫ไୗ࡛ࡢࣜࢫࢡ⟶⌮ᥐ⨨౑⏝㔞ࣜࢫࢡ⟶⌮ᥐ⨨㸦⤫ไ⠊ᅖෆ㸧ഛ⪃

ESsཬࡧRMMs࡟㛵ࡍࡿ⤖ㄽ
1.
2.
3.
4.

5.
6.

ࣜࢫࢡ⟶⌮ᥐ⨨㸦RMM㸧ࡣࣜࢫࢡホ౯㸦RA㸧ࡢฟⓎⅬ࡛࠶ࡾࠊࡤࡃ㟢࡟㔜Ⅼࢆ⨨ࡃ㛤ጞ᫬Ⅼ࠿ࡽศ㔝ᶓ᩿ⓗ࠿ࡘ⤫ྜⓗ࡞ᛮ⪃࡜ᑓ㛛▱㆑ࡀᚲせ࡜࡞ࡿࢧࣉࣛ࢖ࢳ࢙࣮ࣥ㛵ಀ⪅ࡢ㛫࡛⾜ࡁ᮶ࡍࡿᑐヰࡀᡂຌࡢ㘽㸟௨ୗࡢࣃࣛࢲ࢖࣒ࢩࣇࢺࡀᚲせ㸸! ᙳ㡪࣮࣋ࢫ → ࡤࡃ㟢୺ᑟ! ࣜࢫࢡホ౯ → ࣜࢫࢡ⟶⌮୍⯡࡟㛵ಀᙜᒁࡀධᡭ୙ྍ⬟࡞㸦〇ရ୰ࡢ㸧≀㉁ࡢ౑⏝࡜ࡤࡃ㟢࡟㛵ࡍࡿヲ⣽᝟ሗࡀᚲせ (Haigh and Bailly, 1992!)⏘ᴗ⏺ෆእࡢᑓ㛛▱㆑ࡀ୙㊊ࡋ࡚࠸ࡿ 㸦㧗㱋໬ࡍࡿேཱྀ㸧5. ⤖ࡧࡢゝⴥࢺࣞࣥࢻ࡜ࣃࣛࢲ࢖࣒ࡢࢩࣇࢺࡀᚲせ1.
2.
3.
4.

❧ἲ㔜ど࠿ࡽ᪋⾜㔜ど࡬බⓗᙜᒁ࠿ࡽ⏘ᴗ⏺࡬㸦❧ド㈐௵㸧཯Ⓨ࠿ࡽ⋡ඛ࡬㸦ែᗘ㸧඲㠃ⓗヨ㦂࠿ࡽ㑅ᢥⓗヨ㦂࡬ (ITS 7-R)

5. ᙳ㡪୰ᚰ࠿ࡽࡤࡃ㟢୺ᑟ࡬
6. ࣜࢫࢡホ౯㔜ど࠿ࡽࣜࢫࢡ⟶⌮ᥐ⨨㔜ど࡬
7. ᪋⾜࡟ࡣ⌧ᅾண ࡉࢀ࡚࠸ࡿࡼࡾࡶ㐶࠿࡟ከࡃࡢ᫬㛫ࢆせࡍࡿぢ㎸ࡳ6. ᭦࡞ࡿ࢞࢖ࢲࣥࢫཬࡧࢶ࣮ࣝ"Ḣᕞ໬Ꮫ≀㉁ᒁࡢ࢙࢘ࣈࢧ࢖ࢺ㸸http://ecb.jrc.it/reach/"Ḣᕞ໬Ꮫ≀㉁ᗇࡢ࢙࢘ࣈࢧ࢖ࢺ㸸
http://ec.europa.eu/echa/home_en.html"Ḣᕞጤဨ఍ࡢ࢙࢘ࣈࢧ࢖ࢺ㸸
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
http://ec.europa.eu/enterprise/reach/index_en.htm"http://ecb.jrc.it/DOCUMENTS/REACH/REACH_in_brief_020
7.pdf"EUຍ┕ᅜࡢ࣊ࣝࣉࢹࢫࢡ㸸
http://www.reachright.ie
http://www.senternovem.nl/reach""""Haigh N Baillie A. 1992. Final report on chemicals control in the European Community in the 1990s.
Institute for European Environmental Policy, London, UK.
Allanou R, Hansen BG, Van Der Bilt Y. 1999. Public availability of data on EU high production
volume chemicals. Report EUR 18996 EN, European Commission, Joint Research Centre, Ispra,Italy.
Van der Jagt K, Munn S, Tørsløv J, De Bruijn J. 2004. Alternative approaches can reduce the use of
test animals under REACH. Addendum to the report "Assessment of additional testing needs underREACH. Effects of (Q)SARs, risk based testing and voluntary industry initiatives#. Report EUR
21405. European Commission,Joint Research Centre, Ispra, Italy. Bradbury S, Feijtel T, VanLeeuwen K. 2004. Meeting the scientific needs of ecological risk assessment in a regulatory context.
Environ Sci Technol 38/23, 463-470a.
Jones, J. 2006. National Pesticide program. A new toxicological testing paradigm: meeting commonneeds. Presentation to the National Research Council Committee on toxicity testing and assessmentof environmental agents on January 19. Irvine, CA. USEPA-OPP, Washington DC.

"""
""""

Greim, H. et al. 2006. Toxicological comments to the discussion about REACH. Arch Toxicol 80:121-124
Commission of the European Communities. 2007. Corrigendum to Regulation (EC) No 1907/2006 of theEuropean 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 (OJ L 396, 30.12.2006). OJ L136, volume 50, 29
May 2007.
Guidance document on data requirements (RIP 3.2). See website ECB
Van Leeuwen, C.J., G.Y. Patlewicz, and A.P. Worth. 2007. Intelligent Testing Strategies In: Risk
Assessment of Chemicals. An Introduction (2nd edition). Van Leeuwen, C.J. and T.G. Vermeire,eds. Springer Publishers, Dordrecht, The Netherlands, pp 467-509.
Van der Poel, P, Brooke, D and Van Leeuwen, C.J. 2007. Emissions of chemicals. In: Risk assessment ofchemicals. In: Risk Assessment of Chemicals. An Introduction (2nd edition). Van Leeuwen, C.J. and T.G.
Vermeire, eds. Springer Publishers, Dordrecht, The Netherlands, pp 37-72.
Van Leeuwen, C.J., B.G. Hansen and J.H.M. de Bruijn. 2007. Management of industrial chemicals in theEuropean Union (REACH). 2007. In: Risk Assessment of Chemicals. An Introduction (2nd edition). VanLeeuwen, C.J. and T.G. Vermeire, eds. Springer Publishers, Dordrecht, The Netherlands, pp 511-551.
National Research Council, 2007. Toxicity Testing in the Twenty-first Century: A Vision and a Strategy.
The National Academic Press, Washington DC.

㸺1ࢺࣥ௨ୖࡢ≀㉁㸼
REACH㝃ᒓ᭩VII࡟ᇶ࡙ࡃࢹ࣮ࢱせ௳ẘᛶᏛⓗ᝟ሗ
8.1
8.2
8.3
8.4.1
8.5.1

⓶⭵่⃭ᛶཪࡣ⓶⭵⭉㣗ᛶ║่⃭ᛶ⓶⭵ឤసᛶኚ␗ཎᛶ㸦ࣂࢡࢸࣜ࢔ࡢ㑇ఏᏊ✺↛ኚ␗㸧ᛴᛶẘᛶ㸦⤒ཱྀ⤒㊰㸧⏕ែẘᛶᏛⓗ᝟ሗ9.1.1↓⬨᳝ື≀㸦࣑ࢪࣥࢥ㸧ࡢ▷ᮇẘᛶ
9.1.2
᳜≀㸦⸴㢮㸧ࡢ⏕㛗㜼ᐖ
9.2.1.1 ⏕ศゎᛶ㸺10ࢺࣥ௨ୖࡢ≀㉁㸼
REACH㝃ᒓ᭩VIII࡟ᇶ࡙ࡃࢹ࣮ࢱせ௳ẘᛶᏛⓗ᝟ሗ
8.1.1
8.2.1
8.4.2
8.4.3
8.5.2
8.5.3
8.6.1
8.7.1
8.8.1

⓶⭵่⃭ᛶ (in vivo)║่⃭ᛶ (in vivo)့ங㢮⣽⬊ࢆ⏝࠸ࡿ⣽⬊㑇ఏᏛヨ㦂㸦in vitro㸧့ங㢮⣽⬊࡟ࡼࡿ㑇ఏᏊ✺↛ኚ␗ヨ㦂㸦in vitro㸧ᛴᛶẘᛶ㸦྾ධ㸧ᛴᛶẘᛶ㸦⤒⓶⤒㊰㸧཯᚟ᢞ୚ẘᛶ㸦28᪥㛫㸧⏕Ṫ/Ⓨ⏕ẘᛶ࡟㛵ࡍࡿࢫࢡ࣮ࣜࢽࣥࢢ㸦OECD 421ཪࡣ422㸧
ࢺ࢟ࢩࢥ࢟ࢿࢸ࢕ࢵࢡࢫ⏕ែẘᛶᏛⓗ᝟ሗ
9.1.3
9.1.4
9.2.2.1
9.3.1

㨶㢮ࡢ▷ᮇẘᛶヨ㦂άᛶởἾ࿧྾㜼ᐖヨ㦂pHࡢ㛵ᩘ࡜ࡋ࡚ࡢຍỈศゎ྾╔/⬺╔ࢫࢡ࣮ࣜࢽࣥࢢヨ㦂㸺100ࢺࣥ௨ୖࡢ≀㉁㸼
REACH㝃ᒓ᭩IX࡟ᇶ࡙ࡃࢹ࣮ࢱせ௳ẘᛶᏛⓗ᝟ሗ
8.6.1
8.6.2
8.7.2
8.7.3

཯᚟ᢞ୚ẘᛶヨ㦂㸦28᪥㛫㸧ள៏ᛶẘᛶヨ㦂㸦90᪥㛫㸧ฟ⏕๓Ⓨ⫱ẘᛶヨ㦂㸹OECD 414
஧ୡ௦⏕Ṫẘᛶヨ㦂⏕ែẘᛶᏛⓗ᝟ሗ9.1.5
9.1.6.
9.1.6.1
9.1.6.2
9.1.6.3
9.2.1.2
9.2.1.3
9.2.1.4↓⬨᳝ື≀㸦࣑ࢪࣥࢥ㸧ࡢ㛗ᮇẘᛶヨ㦂㨶㢮ࡢ㛗ᮇẘᛶヨ㦂㨶㢮ึᮇ⏕άẁ㝵㸦ELS㸧ヨ㦂⬇ཬࡧ⬇ᄞẁ㝵ࡢ㨶㢮▷ᮇẘᛶヨ㦂⛶㨶ᡂ㛗ヨ㦂
⾲ᒙỈ୰࡛ࡢ✲ᴟⓗศゎᅵተࢩ࣑࣮ࣗࣞࢩࣙࣥヨ㦂ሁ✚≀ࢩ࣑࣮ࣗࣞࢩࣙࣥヨ㦂

9.2.3
9.3.2
9.3.3
9.4.1
9.4.2
9.4.3

ศゎ⏕ᡂ≀ࡢ≉ᐃỈ⏕⏕≀✀㸦㨶㢮㸧ࡢ⏕య⵳✚ᛶ྾╔/⬺╔࡟㛵ࡍࡿ㏣ຍ᝟ሗ㝣⏕⏕≀㸦↓⬨᳝ື≀㸧࡬ࡢ▷ᮇẘᛶᅵተᚤ⏕≀࡬ࡢᙳ㡪㝣⏕᳜≀࡬ࡢ▷ᮇẘᛶ㸺1000ࢺࣥ௨ୖࡢ≀㉁㸼
REACH㝃ᒓ᭩X࡟ᇶ࡙ࡃࢹ࣮ࢱせ௳ẘᛶᏛⓗ᝟ሗ
8.6.3
8.7.2
8.7.3
8.9.1

㛗ᮇ཯᚟ᢞ୚ẘᛶヨ㦂㸦12ࣨ᭶௨ୖ㸧Ⓨ⫱ẘᛶヨ㦂㸹OECD 414
஧ୡ௦⏕Ṫẘᛶヨ㦂
Ⓨࡀࢇᛶヨ㦂

⏕ែẘᛶᏛⓗ᝟ሗ
9.3.4
9.4.4
9.4.6
9.5.1
9.6.1

≀㉁ཬࡧ/ཪࡣศゎ⏕ᡂ≀࡟ࡘ࠸࡚ࡢ᭦࡞ࡿ⎔ቃ୰㐠࿨ཬࡧᣲື↓⬨᳝ື≀࡬ࡢ㛗ᮇẘᛶ᳜≀࡬ࡢ㛗ᮇẘᛶሁ✚≀୰ࡢ⏕≀࡬ࡢ㛗ᮇẘᛶ㫽㢮࡬ࡢ㛗ᮇẘᛶ