BPR䛾ᴫせḢᕞ໬Ꮫ≀㉁ᗇ஦ົᒁ㛗䛻䜘䜛໬Ꮫ≀㉁⟶⌮ᨻ⟇᭱᪂ືྥ䝉䝭䝘䞊䠖REACH䚸CLPཬ䜃BPR䛾᭱᪂ືྥ2015ᖺ4᭶3᪥/ᮾி (᪥ᮏ)Ḣᕞ໬Ꮫ≀㉁ᗇ㻌 ᅜ㝿㛵ಀᢸᙜᐁ㻌Petteri Mäkelä᪂䛯䛺つไ•ẅ⏕≀ᛶ〇ရつ๎ (BPR) (EU) 528/2012oẅ⏕≀ᛶ〇ရᣦ௧(98/8/EC)䛻᭰䜟䜛䜒䛾䛷䛒䜛••

2012ᖺ5᭶䛻᥇ᢥ
2013ᖺ9᭶1᪥䚸㐠⏝㛤ጞ•

ECHA䜴䜵䝤䝃䜲䝖⤒⏤䛷䛾つ๎ᮏᩥ䜈䛾䝸䞁䜽
http://echa.europa.eu/regulations/biocidal-products-regulation௨ୗ䛾ἲ௧䛻䜘䜚つไ䛥䜜䛶䛔䛺䛔ẅ⏕≀ᛶ〇ရ䜢ᑐ㇟䛸䛩䜛䠖•o㎰⸆䚸ື≀⏝་⸆ရ䚸໬⢝ရ䛾ἲ௧

PUBLIC2ᣦ௧䛛䜙つ๎䛻䛺䛳䛯⌮⏤• EU䛾ẅ⏕≀๣ᕷሙ䛾ᶵ⬟䜢ᨵၿ䛩⏦ㄳ⪅䜛• ே䛾೺ᗣཬ䜃⎔ቃ䛾㧗Ỉ‽䛾ಖㆤホ౯ࢆ⾜࠺ᡤ⟶ᙜᒁ (ECA)䜢☜ಖ䛩䜛సᴗ㒊఍సᴗ㒊఍సᴗ㒊఍• 䝥䝻䝉䝇䜢⡆␎໬ཬ䜃ຠ⋡໬䛩䜛• ື≀ヨ㦂䜢ῶ䜙䛩ooᙉไⓗ䛺䝕䞊䝍ඹ᭷䠋㈝⏝ศᢸヨ㦂䜈䛾䜘䜚ᰂ㌾䛛䛴㈼᫂䛺ྲྀ䜚⤌䜏䜢ዡບ䛩䜛PUBLICḢᕞጤဨ఍3つ๎ vs ᣦ௧• ᪂䛯䛺ᐃ⩏䛻䛿௨ୗ䛜ྵ䜎䜜䜛䠖ᣦ௧つ๎o䛭䛾ሙ䛷䛾⏕ᡂ

98/8/ECEU 528/2012oୖᕷ㝃ᒓ᭩I཰㍕

ᢎㄆo䝘䝜䝬䝔䝸䜰䝹㝃ᒓ᭩Iᢎㄆࡉࢀࡓ≀㉁
ࡢ୍ぴ⾲㝃ᒓ᭩IA㝃ᒓ᭩Iపࣜࢫࢡ〇ရ⡆␎໬ࡋࡓᡭ㡰ࡀ㐺⏝ྍ⬟࡞〇ရᯟ⤌ࡳࡢබᘧ໬ẅ⏕≀ᛶ〇ရࢢ࣮ࣝࣉ• ฎ⌮䛥䜜䛯ᡂᙧရ䛻㛵䛩䜛せ௳• ༴㝤ᛶ䛻ᇶ䛵䛟㝖እཬ䜃௦⏝• ┦஫ᢎㄆ䛾ヲ⣽䛺ᡭ㡰• ẅ⏕≀ᛶ〇ရ䛾Ḣᕞ㐃ྜㄆྍ䛜ྍ⬟• ㄆྍ䛾䛯䜑䛾ㄪ࿴䛾䛸䜜䛯䛂〇ရᴫせ䛃PUBLIC

4

ECHA䛸BPR•ຍ┕ᅜྛ⮬䛷ᢅ䛖䜘䜚䜒EU䝺䝧䝹䛷ᢅ䛳䛯䜋䛖䛜䜘䛔ᡭ⥆䛾ㄪᩚཬ䜃ᴗົ䛾㞟୰໬ẅ⏕≀ᛶ〇ရጤဨ఍Ḣᕞጤဨ఍ពぢຍ┕ᅜホ౯IUCLID⏘ᴗ⏺

BPC㆟㛗

(BPC)

启呂吮吞吐吆&ẅ⏕≀ᛶ〇ရ叏Ⓩ㘓஦ົᒁ吃叻吗呉吐άᛶ≀㉁䛾ᢎㄆᑂᰝ䝥䝻䜾䝷䝮Ḣᕞ㐃ྜㄆྍ䛭䛾௚⛉Ꮫⓗពぢㄪᩚ䜾䝹䞊䝥ᢏ⾡ⓗ➼౯஦ົᒁ௦᭰౪⤥⪅䝕䞊䝍ඹ᭷⏦ㄳ

ᬑཬ

ୖッጤဨ఍

PUBLIC5ᇶᮏⓗ䛺ᴫᛕ• άᛶ≀㉁䠖᭷ᐖ⏕≀䛻ᑐ䛩䜛䚸䜒䛧䛟䛿཯䛩䜛䚸స⏝䜢᭷䛩䜛≀㉁䜎䛯䛿ᚤ⏕≀ ―㻌 ᢎㄆo᭷ᐖ⏕≀䠖 ே㛫䜔䛭䛾άື䚸䜒䛧䛟䛿ே㛫䛜฼⏝䛧䛯䜚⏕⏘䛧䛯䜚䛩䜛〇ရ䚸ື≀䜎䛯䛿⎔ቃ䛻䛸䛳䛶ᮃ䜎䛧䛟䛺䛔Ꮡᅾ䛷䛒䛳䛯䜚䚸᭷ᐖ䛺ᙳ㡪䜢୚䛘䛯䜚䛩䜛⏕≀ (⑓ཎయ䜢ྵ䜐)• ẅ⏕≀ᛶ〇ရ㻌 ―㻌 ㄆྍo22✀㢮䛾〇ရ䝍䜲䝥䛻ศ䛡䜙䜜䜛 (㝃ᒓ᭩V)

PUBLIC6୺せ䛺䜾䝹䞊䝥ཬ䜃〇ရ䝍䜲䝥ᾘẘ๣

•o䝠䝖⏝⾨⏕〇ရ (1) 䚸බ⾗⾨⏕⏝ (2) 䚸ື≀⏝ (3) 䚸㣗ᩱ䜔㣫ᩱ䛾ศ㔝 (4) 䚸㣧ᩱỈ⏝ (5)ಖᏑ (㜵⭉) ๣•o⨁ワ⏝ (6) 䚸䝣䜱䝹䝮 (⿕⭷) ⏝ (7) 䚸ᮌᮦ⏝ (8) 䚸⧄⥔⏝ (9) 䚸ᘓ㐀ᮦᩱ⏝ (10) 䚸ᾮయ෭༷⏝ (11) 䚸䝇䝷䜲䝮㜵Ṇ๣⏝ (12) 䚸㔠ᒓຍᕤ⏝ᾮయ⏝ (13)᭷ᐖ⏕≀㥑㝖๣•oẅ㰡๣ (14) 䚸㫽㥑㝖๣ (15) 䚸㌾యື≀㥑㝖๣ (16) 䚸ẅ㨶๣ (17) 䚸ẅ⹸๣ (18) 䚸ᚷ㑊๣ (19) 䚸䛭䛾௚䛾⬨᳝ື≀䛾㥑㝖๣ (20)䛭䛾௚䛾〇ရ

•oởᰁ㜵㝖〇ရ (21) 䚸Ṛయཬ䜃๤〇㜵⭉䛾䛯䜑䛾ᾮయ (22)PUBLIC7ἲⓗ≧ἣ• ᑂᰝ䝥䝻䜾䝷䝮o᪤Ꮡ䛾άᛶ≀㉁䛾〇ရ䝍䜲䝥䛾⤌䜏ྜ䜟䛫䜢䚸EU䛾ไᗘ䛻ẁ㝵ⓗ䛻ᑟධ䛩䜛o᪤Ꮡ䛾ẅ⏕≀ᛶ〇ရ䜢ㄆྍ䜢⾜䛖䛣䛸䛻䜘䜚䚸EU䛾ไᗘ䛻ẁ㝵ⓗ䛻ᑟධ䛩䜛• ᮍᢎㄆ䛾άᛶ≀㉁ཬ䜃䛭䛾⤖ᯝ䛸䛧䛶ᮍㄆྍ䛾ẅ⏕≀ᛶ〇ရ䛿඲䛶䚸ᕷሙ䛛䜙㝖ཤ䛧䛺䛡䜜䜀䛺䜙䛺䛔Ø EUᕷሙ䛿䚸ᑂᰝ䝥䝻䜾䝷䝮䛜⤊஢䛩䜛䜎䛷䛿⛣⾜ẁ㝵䛻䛒䜛䚹8ECHA䛾ᙺ๭• 㞟୰ᆺIT䝅䝇䝔䝮Øẅ⏕≀ᛶ〇ရ䛾Ⓩ㘓㻌 R4BP 3 (඲⏦ㄳ䛾୰ᚰ)Øẅ⏕≀ᛶ〇ရ⏝䛾ᶵ⬟䜢ྵ䜐IUCLID 5.6• ẅ⏕≀ᛶ〇ရጤဨ఍ཬ䜃ㄪᩚ䜾䝹䞊䝥ØEU඲ᇦ䛷䛾ྲྀ䜚⤌䜏䛾䛯䜑䛾୰ᚰᶵ㛵Ø䝯䞁䝞䞊䜈䛾⛉Ꮫⓗᨭ᥼ཬ䜃⟶⌮ୖ䛾ᨭ᥼Øရ㉁ཬ䜃୍㈏ᛶ୪䜃䛻㏱᫂ᛶ䛾☜ಖ• ⏦ㄳ⪅ཬ䜃ຍ┕ᅜ䜈䛾ᨭ᥼Ø䜺䜲䝎䞁䝇ཬ䜃ECHA䝦䝹䝥䝕䝇䜽䠋䝦䝹䝥䝛䝑䝖䛾ᥦ౪Øຍ┕ᅜ㛫䛾୍㈏䛧䛯ྲྀ䜚⤌䜏䜢᥎㐍• 䝕䞊䝍䛾ඹ᭷ཬ䜃ᬑཬ୪䜃䛻ᢏ⾡ⓗ➼౯ØREACH䛾⤒㦂䛷ᚓ䛯౽┈• ᝟ሗఏ㐩Ø㔜せ䛺㛵ಀ⪅ཬ䜃฼ᐖ㛵ಀ⪅䛸䛾ព㆑ྥୖ9άᛶ≀㉁䛾ᑂᰝ―୺䛺ᡭ㡰ᡤ⟶ᙜᒁ䛾ሗ࿌බ㛤༠㆟

ពぢ䜢㏙䜉䜛ẁ㝵௦᭰ရ䛾ೃ⿵䛜䛒䜛ሙྜ䛻㝈䜛ຍ┕ᅜཬ䜃⏦ㄳ⪅సᴗ㒊఍䛷䛾ウ㆟
᭷ຠᛶ≀⌮໬Ꮫⓗ᪉ἲ+ศᯒⓗ᪉ἲே䛾೺ᗣ⎔ቃ⥅⥆ㄪᰝẅ⏕≀ᛶ〇ရጤဨ఍ (BPC)
PUBLIC䛾ពぢḢᕞጤဨ఍䛾ពᛮỴᐃ10ᑂᰝ䝥䝻䜾䝷䝮άᛶ≀㉁䛾〇ရ䝍䜲䝥䛾䝗䝅䜶䛾ᩘ:•ooo••⥲ィ: 619
ᢎㄆ: 109EU䝺䝧䝹䛷ᰝㄞ୰: 144ᑂᰝ䝥䝻䜾䝷䝮䛷ᑐᛂ䛧䛶䛔䜛᪤Ꮡ䛾άᛶ≀㉁䛾ᩘᖺ㛫䛷⣙50௳䛾䝗䝅䜶䜢ᑂᰝᮇ㛫䛿2014ᖺ5᭶14᪥䛛䜙2024ᖺ
12᭶31᪥䜎䛷11άᛶ≀㉁䛾ᢎㄆ䛩䜉䛶䛾᪂つ⏦ㄳ䛻ᑐ䛩䜛䜘䜚㎿㏿䛺䝥䝻䝉䝇䠖• ホ౯ẁ㝵䛻1ᖺ㛫• ពぢ䛾ᙧᡂ䛻270᪥㛫• ホ౯ᮇ㛫୰䛻ᮇ㝈䛜ᘏ㛗䛥䜜䜛ྍ⬟ᛶ• ᭱㛗180᪥㛫䜎䛷䚹せồ䛥䜜䜛䝕䞊䝍䛾ᛶ㉁䜎䛯䛿≉ู䛺஦᝟䛻䜘䜚ṇᙜ䛸ㄆ䜑䜙䜜䜛ሙྜ䛿180᪥㛫௨ୖ• ඲య䛷䠖 ⏦ㄳ᭩䛾ᥦฟ䛛䜙BPC䛾ពぢᙧᡂ䜎䛷⣙2ᖺ㛫• Ḣᕞጤဨ఍䛾Ỵ㆟䛾ᒚ⾜䛜⥆䛟

PUBLIC12άᛶ≀㉁䛛䜙䛿㝖እ䛥䜜䜛䛂SVHC䛃• ௨ୗ䛾≀㉁:o

CMR (Ⓨ䛜䜣ᛶ䚸ኚ␗ཎᛶ䚸⏕Ṫẘᛶ䛻ศ㢮䛥䜜䜛) 1A䜎䛯䛿1B䛾≀㉁o

PBT (㞴ศゎᛶ䚸⏕య⵳✚ᛶ䚸ẘᛶ) 䜎䛯䛿vPvB (ᴟ䜑䛶㞴ศゎᛶ䛷㧗䛔⏕య⵳✚ᛶ) 䛾≀㉁oED (ෆศἪ䛛䛟஘) 䛾ᛶ㉁䜢ᣢ䛴≀㉁• ౛እⓗ䛻άᛶ≀㉁䛸䛧䛶ᢎㄆ䛥䜜䜛䛂SVHC䛃:o᭚㟢䛜ᴟ䜟䛪䛛䛺≀㉁oே䜒䛧䛟䛿ື≀䛾೺ᗣ䚸䜎䛯䛿⎔ቃ䛻ᑐ䛩䜛῝้䛺༴㝤ᛶ䜢⟶⌮䛩䜛䛯䜑䛻୙ྍḞ䛺≀㉁oᢎㄆ䛧䛺䛔䛣䛸䛷䚸♫఍䛻㐣ᗘ䛾ᝏᙳ㡪䜢䜒䛯䜙䛩≀㉁

PUBLIC13άᛶ≀㉁䛾௦᭰ရ• άᛶ≀㉁䛜௦᭰䛾ೃ⿵䛷䛒䜛ሙྜè ẅ⏕≀ᛶ〇ရ䛜┦ᑐホ౯䛾ᑐ㇟䛻䛺䜛• ECHA䛻䜘䜛60᪥㛫䛾බ㛤༠㆟䠖
o➨୕⪅䛜㛵㐃᝟ሗ䜢ᥦ౪o୺䛻䚸ணᮇ䛥䜜䜛฼⏝ྍ⬟䛺௦᭰ရ䛻㛵䛩䜛᝟ሗ• ᡤ⟶ᙜᒁሗ࿌᭩䛻䛚䛡䜛ᇶ‽䛾᫂♧ⓗ䛺ホ౯oᇶ‽䛜‶䛯䛥䜜䛶䛔䜛䛛䛹䛖䛛䛿䚸ホ౯䛾᭱⤊⤖ᯝ䛾䜏䛻䜘䜚☜ㄆ䛥䜜䜛
PUBLIC

14䝕䞊䝍ඹ᭷䛿⩏ົ䛷䛒䜛• R4BP䜢㏻䛧䛶ECHA䜈ᥦฟ• άᛶ≀㉁䛾ື≀ヨ㦂ཬ䜃౪⤥⪅䛾⊂༨≧ែ䜢᭱ᑠ㝈䛻ᢚ䛘䜛• ௨ୗ䛻㐺⏝䛥䜜䜛䠖o᪤Ꮡ䛾άᛶ≀㉁䛾䛩䜉䛶䛾ẘᛶཬ䜃⏕ែẘᛶ◊✲䛻㛵䛩䜛⬨᳝ື≀ヨ㦂䛾䝕䞊䝍o௦᭰౪⤥⪅䛻㛵䛩䜛䝕䞊䝍• ᑗ᮶䛾⏦ㄳ⪅ཬ䜃䝕䞊䝍ᡤ᭷⪅䛿ྜពⅬ䜢᥈䛥䛺䛡䜜䜀䜀䛺䜙䛺䛔• 䝕䞊䝍䛻ᑐ䛩䜛⿵ൾ䛿බṇ䛷㏱᫂ᛶ䛜䛒䜚ᕪูⓗ䛷䛺䛔᪉ἲ䛷Ỵᐃ䛧䚸ᮏつไ䛾䛯䜑䛻ᥦฟ䛥䜜䜛᝟ሗ䛻䛛䛛䜛㈝⏝䛿ศᢸ䛩䜛• ஺΅䛜ኻᩋ䛧䛯ሙྜ䛻䛿䚸ECHA䛿ᑗ᮶䛾⏦ㄳ⪅䛻ཧ↷䛩䜛ᶒ฼䜢୚䛘䚸ᅜ䛾⿢ุᡤ䛻䜘䜚Ỵᐃ䛥䜜䛯┦ᛂ䛾㈝⏝䛾㈇ᢸ䛜ᨭᡶ䜟䜜䜛䜒䛾䛸䛩䜛

PUBLIC15άᛶ≀㉁䛾㈝⏝ศᢸ• 䛩䜉䛶䛾άᛶ≀㉁〇㐀ᴗ⪅䜎䛯䛿㍺ධᴗ⪅䛿䚸2013ᖺ9᭶1᪥䛾᫬Ⅼ䛷䚸ECHA䛻䝗䝅䜶䜎䛯䛿฼⏝≧䜢ᥦฟ䛧䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔• ECHA䛿䚸䛣䛾⩏ົ䛻ᚑ䛳䛯〇㐀ᴗ⪅䜎䛯䛿㍺ධᴗ⪅䛾୍ぴ⾲䜢సᡂ䛩䜛• 2015ᖺ9᭶1᪥䛛䜙䠖 άᛶ≀㉁䛾䝸䝇䝖໬䛥䜜䛯᝟ሗ※䛾䛒䜛ẅ⏕≀ᛶ〇ရ䛾䜏䛜ᕷሙ䛷ධᡭྍ⬟䛻䛺䜛• ᑂᰝ䝥䝻䜾䝷䝮䛻䛚䛡䜛᪤Ꮡ≀㉁䛾䝕䞊䝍ಖㆤ䛿䚸㐜䛟䛸䜒2025ᖺ12᭶31᪥䛻⤊஢䛩䜛PUBLIC

16ẅ⏕≀ᛶ〇ရ―2ẁ㝵䛾᪉ἲẅ⏕≀ᛶ〇ရάᛶ≀㉁Ḣᕞጤဨ఍ຍ┕ᅜ1ຍ┕ᅜ2ຍ┕ᅜ3EUEU䝫䝆䝔䜱䝤䝸䝇䝖䝇䝔䝑䝥1

䝇䝔䝑䝥2〇ရ䝍䜲䝥䛾⤌䜏ྜ䜟䛫䛤䛸䛻άᛶ≀㉁䜢ᢎㄆᅜ䜎䛯䛿Ḣᕞ㐃ྜ䝺䝧䝹䛷䛾〇ရㄆྍ

PUBLIC17Ḣᕞ㐃ྜ䛾ㄆྍ• Ḣᕞጤဨ఍䜘䜚୚䛘䜙䜜䜛䚸Ḣᕞ㐃ྜᕷሙ඲య䛷᭷ຠ䛺ㄆྍ• EU඲ᇦ䛾౑⏝᮲௳䛜㢮ఝ䛧䛶䛔䜛༢୍䛾ẅ⏕≀ᛶ〇ရ䜎䛯䛿〇ရ䜾䝹䞊䝥䛜ᑐ㇟• ௨ୗ䛿㝖እ䠖ooo㝖እᇶ‽䜢‶䛯䛩≀㉁䜢ྵ䜐〇ရ䛢䛳ṑ㢮䚸㫽㢮䚸㨶㢮䚸䛭䛾௚䛾⬨᳝ື≀䜢ᢚไ䛩䜛䛯䜑䛾〇ရ (〇ရ䝍䜲䝥14䚸15䚸17䚸20)
㜵ở〇ရ (〇ရ䝍䜲䝥21)18Ḣᕞ㐃ྜ䛾ㄆྍኚ㑄
1. 䝇䝔䝑䝥

2013ᖺ
9᭶1᪥䠖

〇ရ䝍䜲䝥1䚸
3䚸 4䚸5䚸18䚸
19
᪂䛯䛺άᛶ≀㉁䜢ྵ䜐ẅ⏕≀ᛶ〇ရ

2. 䝇䝔䝑䝥
2017ᖺ
1᭶1᪥䠖〇ရ䝍䜲䝥2䚸6䚸13䝍䜲䝮䝷䜲䞁
3. 䝇䝔䝑䝥
2020ᖺ
1᭶1᪥䠖஦๓ᥦฟ㐺᱁ᛶ☜ㄆ - 180᪥㛫ᥦฟṧ䜚䛩䜉䛶䛾〇ရ䝍䜲䝥 (㝖እ䛥䜜䜛䜒䛾௨እ)᳨ド - 30᪥㛫ホ౯ - 365᪥㛫
ECHAጤဨ఍䛾ẁ㝵 - 180᪥㛫

Ḣᕞጤဨ఍䛾Ỵᐃ

19Ḣᕞ㐃ྜㄆྍ䛾฼Ⅼ• ౑⏝᮲௳䛜㢮ఝ䛧䛶䛔䜛ẅ⏕≀ᛶ〇ရ䜢䚸EUᕷሙ䛻ฟ䛩䛣䛸䜢ಁ㐍䛩䜛o」ᩘ䛾ຍ┕ᅜᕷሙ䜢ᑐ㇟䛸䛧䛶䛔䜛஦ᴗ⪅䛾䛯䜑䛾⡆␎໬䛥䜜䛯ᡭ⥆䛝o඲యⓗ䛺⟶⌮ୖ䛾㈇ᢸ䛾㍍ῶ

oḢᕞ㐃ྜ䛾ᕷሙ඲య䛻ᑐ䛧༢୍䛾ㄆྍ䜢⾜䛖䛣䛸䛷䚸〇ရ䛾Ᏻᐃ౪⤥䛻䜘䛔ᙳ㡪䜢୚䛘䜛oᮇ㝈䜢ᐃ䜑䜛䛣䛸䛷䚸⏦ㄳ⪅䛻ᑐ䛧䜘䜚☜ᐇᛶ䜢୚䛘䜛䛣䛸䛻䛺䜛oㄪ࿴໬䛥䜜䛯ᡭ⥆䛝䛻䜘䜚䚸䝗䝅䜶䛾ホ౯䛻䛚䛡䜛୍㈏ᛶ䛜ᨵၿ䛥䜜䜛20ẅ⏕≀ᛶ〇ရ䛾┦஫ᢎㄆ• 䜘䜚䜘䛔᪋⾜䛾䛯䜑䛻␗㆟⏦䛧❧䛶䜔䚸ᶒጾኻቒ䛻ᑐฎ䛩䜛௙⤌䜏䜢ྵ䜣䛰᫂☜䛺ᡭ㡰• 㑅ᢥ⫥䠖o㡰␒䛻䠖 〇ရ䛜䜂䛸䛴䛾ຍ┕ᅜ䛷䛩䛷䛻ㄆྍ䛥䜜䛶䛔䜛ሙྜ䛾⏦ㄳo୪⾜䛧䛶䠖 〇ရ䛜䜎䛰ㄆྍ䛥䜜䛶䛔䛺䛔ሙྜ䛾⏦ㄳ• ຍ┕ᅜ䛿90᪥㛫䛷ㄪᩚཬ䜃ྜព䜢⾜䛖• ྜព䛻⮳䜙䛺䛔ሙྜ䚸Ḣᕞጤဨ఍䛜Ỵᐃ䛩䜛oḢᕞጤဨ఍䛻ゝཬ䛥䜜䜛ពぢ䛾୙୍⮴䛻䛴䛔䛶䚹䛷䛝䜜䜀ECHA䛾ពぢ䛻ᇶ䛵䛟䜒䛾䚹PUBLIC

21ẅ⏕≀ᛶ〇ရ䛾⡆␎໬䛥䜜䛯ᡭ⥆䛝• ೺ᗣཬ䜃⎔ቃ䛻㛵䛧䛶పᠱᛕ䠋䜘䜚㧗Ỉ‽䛾〇ရ䛾ᕷሙྲྀᘬ䜢ಁ㐍䛩䜛䠖o㝃ᒓ᭩I䛻グ㍕䛾䛩䜉䛶䛾άᛶ≀㉁oᠱᛕ≀㉁䜎䛯䛿䝘䝜䝬䝔䝸䜰䝹䜢ྵ䜎䛺䛔o༑ศ䛺᭷ຠᛶo

PPE (ಶே⏝ಖㆤල) 䜢╔⏝䛩䜛ᚲせ䛜䛺䛔• 〇ရㄆྍ䛾฼Ⅼoᡭ⥆䛝䛜䜘䜚㎿㏿䛻䛺䜛䠖ຍ┕ᅜ䛻䜘䜛ホ౯䛿90᪥㛫䛷⾜䜟䜜䜛o䜂䛸䛴䛾ຍ┕ᅜ䛻䜘䜚ㄆྍ䛥䜜䜛䛸䚸ECHA䜈䛾㏻▱ᚋ䚸䛭䛾〇ရ䜢EUᕷሙ඲య䛻ฟ䛩䛣䛸䛜ྍ⬟䛻䛺䜛

PUBLIC22〇ရ䛾┦ᑐホ౯• ㄆྍ䛾ホ౯ᮇ㛫୰䠖oẅ⏕≀ᛶ〇ရoㄆྍ䛾᭦᪂ (ຍ┕ᅜ䝺䝧䝹䜎䛯䛿EU䝺䝧䝹䛾䛹䛱䜙䛛䛷)• ௨ୗ䛾௦᭰ရೃ⿵䛜䛒䜛〇ရ䛿䚸ㄆྍ䛥䜜䛺䛔䠖oⴭ䛧䛟ప䛔䝸䝇䜽o༑ศ䛻ຠᯝⓗ䛷䛒䜛o⤒῭ⓗ䜎䛯䛿ᐇົⓗ䛺୙฼┈䛜䛺䛔o᢬ᢠ䜢᭱ᑠ㝈䛻䛩䜛䛾䛻㐺ษ䛺໬ᏛⓗከᵝᛶPUBLIC

23〇ရㄆྍ䛾ᴫせ᭱㛗10ᖺ㛫䛾ẅ⏕≀ᛶ〇ရ䛾ㄆྍࡑࡢ௚ࡢຍ┕ᅜᅜࡢㄆྍ㡰␒࡛ࡢ┦஫ᢎㄆࡑࡢ௚ࡢຍ┕ᅜ୪⾜࡛ࡢ┦஫ᢎㄆࡍ࡭࡚ࡢEUຍ┕ᅜḢᕞ㐃ྜࡢㄆྍ

PUBLIC24ฎ⌮䛥䜜䛯ᡂᙧရᐃ⩏•o≀㉁䚸ΰྜ≀䜎䛯䛿ᡂᙧရoẅ⏕≀ᛶ〇ရ䛷ฎ⌮䛥䜜䜛䚸䜎䛯䛿ពᅗⓗ䛻ẅ⏕≀ᛶ〇ရ䛻ໟྵ䛥䜜䛶䛔䜛•ᡂᙧရ䛾ฎ⌮䛻౑⏝䛩䜛ẅ⏕≀ᛶ〇ရ୰䛾άᛶ≀㉁䛿䚸EU䛻䛚䛔䛶ᢎㄆ䛥䜜䜛ᚲせ䛜䛒䜛•ᢏ⾡ⓗ䛺䜺䜲䝎䞁䝇䛿సᡂ୰

PUBLIC25ฎ⌮䛥䜜䛯ᡂᙧရୖᕷ䛩䜛䛯䜑䛾᮲௳•oᡂᙧရ䛿䚸άᛶ≀㉁䛾ᢎㄆ䛻㛵㐃䛩䜛䛩䜉䛶䛾᮲௳䛻ᚑ䛳䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔ᮍᢎㄆ䛾≀㉁䠋〇ရ䝍䜲䝥䛾⤌䜏ྜ䜟䛫䛿䚸௨ୗ䛾ሙྜチྍ䛥•䜜䜛o⤌䜏ྜ䜟䛫䛜䜎䛰ᑂᰝ䝥䝻䜾䝷䝮䛻䛒䜛ሙྜoᢎㄆ⏦ㄳ䛜2016ᖺ9᭶1᪥௨๓䛻ᥦฟ䛥䜜䛶䛔䜛ሙྜ

PUBLIC26ฎ⌮䛥䜜䛯ᡂᙧရ―䝷䝧䝹⾲♧• ௨ୗ䛾ሙྜ䚸せồ䛥䜜䜛ooᡂᙧရ䛾ẅ⏕≀≉ᛶ䛻㛵䛧䛶ⱞ᝟䛜ᐤ䛫䜙䜜䛶䛔䜛≀㉁䛾ᢎㄆ᮲௳䛻せồ䛥䜜䛶䛔䜛• ᝟ሗ䛿䚸ᅜ䛾බ⏝ㄒ䛷ᥦ౪䛩䜛䛣䛸oᡂᙧရ䛜ẅ⏕≀๣䜢ໟྵ䛧䛶䛔䜛䛸䛔䛖グ㏙oᡂᙧရ䛾ẅ⏕≀≉ᛶo䛩䜉䛶䛾άᛶ≀㉁ཬ䜃䝘䝜䝬䝔䝸䜰䝹䛾ྡ⛠oDMF (䝣䝬䝹㓟䝆䝯䝏䝹) 䜢ໟྵ䛧䛶䛔䜛㠐䜢ᒚ䛔䛶䛛䜙23᪥ᚋ䛾⓶⭵⅖ே䜎䛯䛿⎔ቃ䜢ಖㆤ䛩䜛䛯䜑䛻ᚲせ䛺ሙྜ䛿౑⏝ㄝ᫂

PUBLIC

27

BPR⏝IT䝒䞊䝹ຍ┕ᅜ┘╩ᙜᒁ (MSCA)

௻ᴗ䝗䝅䜶
AS/BP䝩䝇䝖㞟୰ᆺẅ⏕≀๣⏝IT䝒䞊䝹Ḣᕞጤဨ఍䝕䞊䝍䝉䝑䝖
AS/BP⏘ᴗ⏺
௻ᴗᙜᒁ

䝗䝅䜶
AS/BP

IUCLIDᙜᒁ䝗䝅䜶
AS/BPAS䠙άᛶ≀㉁
BP䠙ẅ⏕≀ᛶ〇ရ

R4BP3ཬ䜃IUCLID䠖ඹ㏻䛾䝝䝤ཬ䜃䝨䞊䝟䞊䝺䝇䝅䝇䝔䝮
PUBLIC28

http://echa.europa.eu/regulations/biocidal-products-regulation
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ECHA䝦䝹䝥䝕䝇䜽䛾BPR䛻㛵䛩䜛䜰䝗䝞䜲䝇฼⏝⪅䠖 ⏦ㄳ⪅䚸≉䛻୰ᑠ௻ᴗ䝖䝢䝑䜽䠖 άᛶ≀㉁䛾ᢎㄆ䚸㝃ᒓ᭩I䜈䛾཰㍕䚸Ḣᕞ㐃ྜ䛾ㄆྍ⠊ᅖ䠖 䜰䝗䝞䜲䝇ఏ㐩ᡭẁ䠖 䝦䝹䝥䝕䝇䜽⏝䝁䞁䝍䜽䝖䝣䜷䞊䝮

http://echa.europa.eu/contact/helpdesk-contact-form
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ẅ⏕≀๣䜺䜲䝎䞁䝇

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-legislation
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31

BPRཬ䜃PIC䛾ᡂᯝẅ⏕≀๣••••••

R4BP3䛻䜘䜚ẅ⏕≀๣㛵㐃䛾⏦ㄳ⏝IT䝒䞊䝹䜢᭦᪂㟁Ꮚᥦฟ䞉ಖ⟶䝅䝇䝔䝮つไ䝅䝇䝔䝮䛾ኚ᭦䜢⩏ົᡤ᭷⪅䛻᫂☜䛻ᥦ♧᪂䛯䛺つไ䝥䝻䝉䝇䛜䛖䜎䛟ᶵ⬟䛩䜛䛣䛸䜢ド᫂άᛶ≀㉁ᑂᰝ䝥䝻䜾䝷䝮2014ᖺ䛾ពぢᩘ䠖34௳

PIC (஦๓㏻ሗ䞉ྠព)• つ๎䛾෇⁥䛺ᘬ⥅䛞• ㍺ฟཬ䜃㍺ධ䛾㏻▱⏝䛾᪂䛧䛔ePIC IT䝒䞊䝹• 䛖䜎䛟⾜䜟䜜䛯㏻▱⟶⌮• 2014ᖺ䠖⣙4,600௳

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32

ECHA䛸⏘ᴗ⏺䛾ㄢ㢟 (2015ᖺ)ẅ⏕≀๣• άᛶ≀㉁౪⤥⪅䛾㈨᱁䜢ᚓ䜛䛯䜑䛾௻ᴗ䛾⏦ㄳ䛿9᭶1᪥䜎䛷• ᑐ㇟䛻ྵ䜎䜜䛺䛔〇ရ䛿ᕷሙ䛻ฟ䛫䛺䛟䛺䜛• ⏦ㄳᩘཬ䜃䛭䜜䛻క䛖ᡭᩘᩱ཰ධ㢠୪䜃䛻୙☜ᐇ䛺≧ἣ䛻䛚䛡䜛ẅ⏕≀๣䛻㛵㐃䛩䜛άື䛾ィ⏬

• Ḣᕞ㐃ྜ䛾ㄆྍ• ௻ᴗ䛻䛸䛳䛶䛾᪂䛯䛺ᶵ఍
• ECHA䛜⟶⌮䛩䜛᪂䛯䛺䝥䝻䝉䝇
PUBLIC33

ぬ䛘䛶䛚䛟౯್䛾䛒䜛䛣䛸• BPR䛿䚸䝥䝻䝉䝇䜢ຠ⋡໬䛧䚸ពᛮỴᐃ䜢ᙉ໬䛩䜛• 䝡䝆䝛䝇䛾ᶵ఍䛷䛿䛒䜛䛜䚸௻ᴗ䛿⮬䜙䛾⩏ົ䛸䝍䜲䝮䝷䜲䞁䜢Ꮫ䜃䚸⌮ゎ䛩䜛ᚲせ䛜䛒䜛• ECHA䛿௻ᴗ䛻䚸ᨭ᥼䚸IT䝒䞊䝹䚸䜺䜲䝎䞁䝇䜢ᥦ౪䛩䜛• ฎ⌮䛥䜜䛯ᡂᙧရཬ䜃௦᭰౪⤥ရ䛾せ௳䛻ὀព䛩䜛䛒䜚䛜䛸䛖䛤䛦䛔䜎䛧䛯!