Even though amendment of existing chemical regulations
is anticipated, the adoption of amendments to the Law on
the Control of Examination and Manufacture of Chemical
Substances (Kashinho) on 20 May 2009 was much earlier
than expected. In the amended Law of 20 May 2009, for
the manufacture or import of chemicals, manufacturers or
importers are required to submit an annual report on the
chemicals to the Ministry of Economy, Trade and
Industry. Through screening of reported existing
chemicals, the Ministry of the Environment, the Ministry
of Health, Labour and Welfare and the Ministry of
Economy, Trade and Industry will determine "priority
chemicals for assessment" and may require further hazard
and risk assessment studies from industries. Also the
amended Law of 20 May 2009 provides framework for the
stricter control of internationally controlled
chemicals, in particular, chemicals in semiconductors
(e.g. perfluorocompounds) or fire extinguishers. The key
point of the amended Law of 20 May 2009 is that the Law
will transform the Japanese chemical control system from
hazard-based to risk-based approach. The implementation
date of the amended Law of 20 May 2009 is not yet
specified and will be designated by a Government
Ordinance soon. It is anticipated that provision s of
the amended Law of 20 May 2009 would be implemented in a
phase-in manner, e.g., hazard communication requirement
by 1 April 2010, introduction of new chemical
classification system by 1 April 2011.
Under the Law on the Control of Evaluation and
Manufacture of Chemical Substances (“Kashinho” - 化学物質の審査及び製造等の規制に関する法律),
Japan has established a sound chemical control system
for new and existing chemicals as well as classification
of chemicals since 1973. Together with Kashinho, the
pollutant release and transfer register (PRTR) system,
which has been operated under the Law on the Reporting
of Releases of Specific Chemical Substances to the
Environment and the Improvement of Chemical Management
(“Kakanho”) since 1999, allows Japanese Ministries to
trace the presence of chemicals in the environment.
Through the Japan Challenge Program (JCP), Japan started
existing chemical data collection and sharing for high
production volume (HPV) chemicals together with 47
companies and 2 industry associations in October 2005.
Launched by the Ministry of Health, Labour and Welfare
(MHLW), the Minis-try of Economy, Trade and Industry
(METI), and the Ministry of the Environment (MOE), JCP
aims to facilitate safety information collection of high
production volume chemicals. Collected safety
information of HPV chemicals has been published online
for the public. The chemical hazards at workplace have
been controlled by the Industrial Safety and Health Law
and its subsidiary legislation.
Japan Chemical Laws, Regulations and Standards
The list of Japanese chemical regulations below contains
selective chemical regulations and content. They are not
comprehensive and is only selective. Young & Global
Partners do preliminary review of the English
translation. The full list of Japanese EHS legislation
(including chemical regulations), original Japanese
legal texts and English translation are only available
from the Global EHS Law Library of Young & Global
Partners.
For further information, please contact:
Mr. Tomas YOON
Young & Global Partners
101 Avenue Louise
B-1050, Brussels
Belgium
E-mail:
dc.yoon@ynpglobal.com
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Japanese |
English |
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法律
(Law)
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化学物質の審査及び製造等の規制に関する法律 |
Law on the
Evaluation of Chemical Substances
and Regulation of Their Manufacture,
etc. |
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|
政令
(Government Ordinance)
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化学物質の審査及び製造等の規制に関する法律の一部を改正する法律の施行期日を定める政令(平成15年9月19日) |
Government Ordinance on the
Designation of Implementation Date
for
Enforcement Ordinance of Law on the
Evaluation of Chemical Substances
and Regulation of Their Manufacture,
etc. (Cabinet
Order No.418 of 19 September 2003) |
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|
化学物質の審査及び製造等の規制に関する法律施行令
(最終改正:平成19年10月31日) |
Enforcement
Ordinance of Law on the Evaluation
of Chemical Substances and
Regulation of Their Manufacture,
etc. (31 October 2007) |
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省令
(Ministerial Ordinance)
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|
新規化学物質の製造又は輸入に係る届出等に関する省令
(最終改正:平成17年1月11日) |
Ministerial
Ordinance on the Notification of the
Manufacture or Import of New
Chemical Substances (11
January 2005) |
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新規化学物質に係る試験並びに第一種監視化学物質及び第二種監視化学物質に係る有害性の調査の項目等を定める省令(最終改正:平成15年11月21日) |
Ministerial
Ordinance on the Designation of
Toxicity Test Items for Type I
Monitoring Chemical Substances and
Type II Monitoring Chemical
Substances related to New Chemical
Substances (21 November
2003) |
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|
第三種監視化学物質に係る有害性の調査の項目等を定める省令
(平成15年11月21日) |
Ministerial
Ordinance on the Designation of
Toxicity Test Items for Type III
Monitoring Chemical Substances
(21 November 2003) |
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新規の化学物質による環境の汚染を防止するために必要な措置が講じられている地域を定める省令
(平成16年3月18日) |
Ministerial Ordinance on the
Designation of Areas requiring
Environmental Pollution Prevention
Measures from New Chemical
Substances (18 March 2004) |
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化学物質の審査及び製造等の規制に関する法律第４条第４項に規定する新規化学物質の名称の公示に関する省令(平成16年3月18日) |
Ministerial Ordinance on the
Announcement of Names of New
Chemical Substances in accordance
with Article 4, Section 4 of
Law on the
Evaluation of Chemical Substances
and Regulation of Their Manufacture,
etc. (18 March 2004) |
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監視化学物質／特定化学物質の規制等 |
Control on Monitoring
Chemical Substances / Specific
Chemical Substances |
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経済産業省関係化学物質の審査及び製造等の規制に関する法律施行規則
(最終改正:平成17年3月4日) |
Enforcement
Regulation of Law on the Evaluation
of Chemical Substances and
Regulation of Their Manufacture,
etc. (4 March 2005) |
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第一種監視化学物質及び第二種監視化学物質の有害性の調査の指示及び第二種特定化学物質に係る認定等に関する省令
(最終改正:平成16年3月18日) |
Ministerial Ordinance on Toxicity
Studies for Type I and Type II
Monitoring Substances and on the
Recognition of Class II Specific
Chemical Substances (19 March 2004) |
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第三種監視化学物質の有害性の調査の指示に関する省令(平成16年3月18日) |
Ministerial Ordinance on Toxicity
Studies for Type III Monitoring
Substances (18 March 2004) |
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有害性情報の報告 |
Reporting of Toxicity
Information |
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有害性情報の報告に関する省令(最終改正:平成17年4月1日) |
Ministerial Ordinance on the
Reporting of Toxicity Information (1
April 2005) |
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告示
(Public Notice)
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新規化学物質に係る試験法並びに第一種監視化学物質及び第二種監視化学物質に係る有害性の調査等を定める省令第2条の2の規定により厚生労働大臣、経済産業大臣及び環境大臣が別に定める試験成績
(平成16年4月30日) |
Public Notice on Testing Results in
accordance with Article 2-2 of
Ministerial
Ordinance on the Designation of
Toxicity Test Items for Type I
Monitoring Chemical Substances and
Type II Monitoring Chemical
Substances related to New Chemical
Substances (30 April 2004) |
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化学物質の審査及び製造等の規制に関する法律施行令第３条の日本国内において生産される同種の製品により代替することが困難であり、かつ、その用途からみて輸入することが特に必要な製品
(平成16年5月6日) |
Public Notice on Import Products,
which No Alternative Products Exist
in Japan, in accordance with Article
3, Enforcement
Ordinance of Law on the Evaluation
of Chemical Substances and
Regulation of Their Manufacture,
etc. (6 May 2004) |
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二種特定化学物質の取扱事業者が環境の汚染を防止するためにとるべき措置に関する技術上の指針
(平成二年三月二十日付厚生省・通商産業省告示第三号) |
Public Notice on Technical Guidance
on Environmental Pollution Measures
required for Facilities handling
Class II Specific Chemicals
Substances (20 March 1990) |
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通知・その他
(Circular and Others)
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|
化学物質の審査及び製造等の規制に関する法律の運用について
(平成19年10月15日) |
Circular on the
Implementation
of Law on the Evaluation of
Chemical Substances and Regulation
of Their Manufacture, etc.
(15 October 2007) |
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有害性情報の報告に関する運用について(最終改正:平成17年4月1日) |
Circular on the Implementation of
Reporting of Toxicity Information (1
April 2005) |
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通常新規化学物質の届出 |
Notification of New Chemical
Substances |
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化審法に基づく新規化学物質の届出等に係る資料の作成・提出等について(平成18年1月23日) |
Circular on the Preparation and
Submission of Data for the
Notification of New Chemical
Substances (23 January 2006) |
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中間物等に係る事前確認の申出 |
Preliminary Confirmation on
Intermediate Substances |
|
|
確認基準(平成20年3月24日) |
Confirmation Standards (24 March
2008) |
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|
中間物等に係る事前確認の申出手続きについて(平成20年3月24日) |
Circular on the Preliminary
Confirmation Procedure for
Intermediate Substances (24 March
2008) |
|
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中間物等の確認を受けた申出内容を変更する場合の手続き(平成20年3月24日)
|
Circular on the Modification of
Preliminary Confirmation for
Intermediate Substances (24 March
2008) |
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中間物等に係る管理の際の注意事項及び立入検査の実施状況等について(平成20年3月24日) |
Circular on the Enforcement Status
on the Control of Intermediate
Substances (24 March 2008) |
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試験方法 |
Test Methods |
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新規化学物質等に係る試験の方法について(最終改正:平成18年11月20日) |
Circular on Test Methods of New
Chemical Substances (20 November
2006) |
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第三種監視化学物質に係る有害性の調査のための試験の方法について(平成20年7月4日) |
Circular on the Test Methods for the
Toxicity of Type III Monitoring
Chemical Substances (4 July 2008) |
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既に得られているその組成、性状等に関する知見としての取扱いについて(高分子フロースキームはこちら)(最終改正:平成16年9月16日) |
Circular on the Handling of
"Existing
Available Information on
Compositions and Properties of
Chemical Substances" (16
September 2004) |
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|
監視化学物質への該当性の判定等に係る試験方法及び判定基準(最終改正:平成18年7月21日) |
Circular on the
Test Methods
and Judgment Criteria for the
Designation of Monitoring Chemical
Substances (21 July 2006) |
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|
Good Laboratory Practice
(GLP) |
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新規化学物質等に係る試験を実施する試験施設に関する基準について(最終改正:平成20年7月4日) |
Circular on the
Standards for
Chemical Test Laboratories of New
Chemical Substances (4 July 2008) |
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新規化学物質の審査等に際して判定の資料とする試験成績の取扱いについて(最終改正:平成16年4月30日) |
Circular on the Handling of Test
Results for the Evaluation of New
Chemical Substances (30 April 2004) |
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化学物質GLP制度の運用方針について(平成16年4月1日改正) |
Circular on the Implementation of
GLP System (1 April 2004) |
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輸入通関の手続き |
Import Procedure |
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化学物質の審査及び製造等の規制に関する法律に係る化学物質の輸入通関手続等について(平成19年10月31日)
|
Circular on the Import of Chemicals
in accordance with Law
on the Evaluation of Chemical
Substances and Regulation of Their
Manufacture, etc. (31 October 2007) |
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