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なぎさみやまる
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4 USA ChAMP ICCA RC GPS EU WSSD; World Summit on Sustainable Development SAICM; Strategic Approach to International Chemicals Management ChAMP; Chemical Assessment and Management Program GPS; Global Product Strategy JAPAN

5 欧州ＲＥＡＣＨ規則の概要現行化学物質規制の問題点 1. リスク評価が完了した物質が少ない 2. リスク評価の実施責任が行政のみ 3. 公開されている情報が少ない EU環境政策の4原則予防原則未然防止原則発生源での防止優先原則汚染者負担原則ＲＥＡＣＨ規則ＲＥＡＣＨ規則 1 化学品 Chemicals を製造輸入する場合にＥＵ域内にてＥＵ域内にて化学品 Chemicals を製造輸入する場合に 2 ①登録 Registration ②評価 Evaluation を義務付け ①登録 Registration ②評価 Evaluation を義務付け高懸念物質(SVHC)については ③認可 Authorization 高懸念物質(SVHC)については③認可 Authorization さらにリスクの高い物質には禁止等の ④制限 Restriction)を設ける Restriction) さらにリスクの高い物質には禁止等の④制限 Restriction)を設ける化学品産業に必要不可欠な化学品原料製品 1 合成樹脂原料合成繊維原料化学肥料無機原料工業塩合成樹脂電子材料生化学製品など All Rights Reserved, Copyright 2009 JEITA 2 ＳＶＨＣ高懸念物質 Substance Very High Concern 発がん性物質変異原生物質生殖毒性物質内分泌かく乱物質など欧州化学品機構で別途リスト化される

6 Registration Authorization Evaluation Restriction

8 1. a. REACH 7 b. REACH 7 2 c. REACH REACH 33

21 IUPACK name (Chemical name) CAS No. EC No. Residues (coal tar), pitch distn. Distillates (coal tar), heavy oils Distillates (coal tar), heavy oils, pyrene fraction Distillates (coal tar), pitch, pyrene fraction Coal tar pitch, high temperature Tris(2-chloroethyl)phosphate Arsenic and its salts ( ) Index number

22 IUPACK name (Chemical name) CAS No. EC No. Anthracene oil Anthracene oil, anthracene paste, distn. Lights Anthracene oil, anthracene paste, anthracene fraction Anthracene oil, anthracene-low Anthracene oil, anthracene paste Diisobutyl phthalate (BIBP 2,4-Dinitrotluene 2,

25 1. 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 2. Alkanes,C10-13,chloro (short chain chlorinated paraffins; SCCPs) 3. Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified 4. 4,4 -Diamino diphenyl methane (MDA) 5. Bis (2-ethylhexyl) phthalate (DEHP) 6. Benzyl butyl phthalate (BBP) and 7. Dibutyl phthalate (DBP)

26 Guidance on requirements for substances in articles ( Notification according to Article 7(2) The substance concentration threshold of 0.1%(w/w) applies to the article as produced or imported. It does not relate to the homogeneous materials or parts of an article 0.1% 2.3 Obligations according to Article 33 As for the article 7(2) requirements, the substance concentration threshold of 0.1 % (w/w) applies to the article as produced, imported or supplied.. Note 4: Dissenting views ( questioning the application of the 0.1 % threshold to the entire article have been notified by 6 Member States (Austria, Belgium, Denmark, France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.

Main Points 2009 4 26 No registration fine between 15K and 90K Uses or places a

Commission fine up to 120K Neglects to communicate information down the supply chain or

28 Main Points No registration fine between 15K and 90K Uses or places a substance on the market which is included in Annex XIV without authorisation from the Commission fine up to 120K Neglects to communicate information down the supply chain or neglects to keep information (non complete safety data sheet included) fine between 10K and 60K

30 The Enforcement Regulations allow for a breach of a listed REACH provision to be tried summarily (e.g. in Magistrates Courts) or on indictment (e.g. in Crown Courts), and provide that the same potential maximum penalty will apply for each provision, namely up to the maxima permitted under the European Communities Act These are currently: up to 5,000 fine and/or up to three months imprisonment following summary conviction; and an unlimited fine and/or up to two years imprisonment following conviction on indictment. The Enforcement Regulations also provide for a number of supplementary criminal offences. These include obstruction of inspectors, providing false statements, failing to comply with enforcement notices, and so on. These supplementary offences are also the subject of criminal penalties which are consistent with those above.

31 dimetylfumarate (3/17 CAS no.: Einecs No.: DMF 0.1mg/kg DMF UNI CEI EN ISO/IEC17025 DMF DMF

34 ( AIS-1 AC adaptor (detachable) Power cable (detachable) mouse (detachable) manual CD&packaging AIS-2 AIS-3 AIS-4 AIS-6 AIS-7 AIS-7 AIS-8 AIS-9 AIS-10 AIS-11 AIS-12 AIS-13 AIS-14 AIS-15

36 20,000 system/y SVHC=0.5t/y (SVHC 0.1wt%) 200,000 /y 1 Not be included (SVHC 0.1wt%) 5,000 /y SVHC=0.3t/y (SVHC 0.1wt%) 20,000 /y Not be included (SVHC 0.1wt%) 100,000 /y SVHC=0.1t/y (SVHC 0.1wt%) ( ) 150,000 modules /y SVHC=0.05t/y (SVHC 0.1wt%) 200 system /y SVHC=0.2t/y (SVHC 0.1wt%) Total SVHC (Be)=1.15t/y (>1ton) (SVHC >0.1wt%) Cable (SVHC 0.1wt%)

38 EU

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untitled 0 REACH 2009326 REACH 1 REACH Registration(), Evaluation() and Authorisation() of Chemicals (EU) 200761 ECHAEuropean Chemicals Agency) EU EUEU(Only Representative) (OSOR: One Substance, One Registration)