Nov 13th, 2014 Open Seminar on Chemicals Management Policies

Latest Development ofChemical Substances Control Law
in JapanNovember 13th, 2014
Open Seminar on Chemicals Management Policies

Ryosuke TAKAHASHI
Chemical Evaluation Office
Ministry of the Environment, JAPANTable of Contents
1. Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/ verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
2

Table of Contents
1. Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries3Chemical Regulations on chemical exposure via
environment in Japan
Exposure

HazardVia the environment

Discharge/stock

Waste㻌 Poisonous and Deleterious Substances Control Law

Ozone Layer
Protection Law*㻌 Measures are undertaken to collect fluorocarbons from particular products under Law Concerning
the Recovery and Destruction of Fluorocarbons.

Waste Disposal and Public
Cleansing Law

Soil Contamination
Countermeasures Act

Water Pollution Control Law

ChemicalSubstances
Control Law

Air Pollution Control Law

Ozone layer
destruction

Agricultural
Chemicals
Regulation Law

Effect on human health
Effect on
environment

LivingEnvironment(w/effect onplants &animals)

Pollutant Release andTransfer Register Law / PRTR Law*
4

Chemical Substances
Control Law (CSCL)
CSCL<Purpose>l To prevent environmental pollution caused by chemical substances that are
persistent and pose a risk of impairing human health or interfering with the
inhabitation and/or growth of flora and fauna.

<Authority>l Jointly authorized by three Ministries• Ministry of Health, Labour and Welfare (MHLW),• Ministry of Economy, Trade and Industry (METI), and• Ministry of the Environment (MOE)<Primary Measures>

Persistence

Bioaccumulation

Toxicityl Prohibits in principle manufacturing or use of substances of PBTl Restricts manufacturing or use of substances of persistence and long-term
toxicity and requires them to be labeledl Notifies the production volume of substances that could meet any of abovel Evaluates persistence, bioaccumulation, long-term toxicity, etc. of new
chemical substances

5Enactment and Revision of CSCL
1973 enacted㻌 㻌 㻌 Restriction on manufacture/import, etc. of persistent, bioaccumulative, and longterm toxic (human health) substances such as PCB-like substances.
1986 revised㻌 㻌 㻌 Revised due to the necessity in restricting persistent and long-term toxic but are
not bioaccumulative substances (such as trichloroethylene, etc.), depending on
the residual status within environment.
1999 revised
Joint jurisdiction by three ministries including Ministry of the Environment to thejoint jurisdiction by former Ministry of Welfare and Ministry of Ministry ofInternational Trade and Industry, due to the reorganization of government andministries in January, 2001.
2003 revised㻌 㻌 㻌 Introduction of evaluation/verification system focusing on the effect on animals
and plants (i.e., added ecological effect to toxicity), and evaluation system taking
environmental emission into account.
2009 revised㻌 㻌 㻌 Fundamental revision on examination and verification system for thoroughchemical substances (safety evaluation, etc. through notification obligation of
manufacturing/importing entities for all chemicals including existing chemicals
above certain volume, and narrowing down to Priority Assessment Chemical
6
Substances).

Overview of CSCL
Prevent environmental contamination by chemicals through continual
management before and after placing on market.
*as of October 2014

Obtaindetails on
usage䞉Notification duty on manufacture/import
volume and usage details

Roughly obtainusage, etc.

General Chemical
Substances(approx. 28,000 substances)

Obtaindetails on
toxic effects
and usage

Priority Assessment Chemical
Substances(164 substances)

Controlenvironment
emission

Potential risk on human healthand environment

Government conducts the risk
assessment

Existing chemicals

Avoid
environment
emission

Polymers of low concern

Monitoring Chemical
Substances(37 substances)

䞉License on manufacture/ import(prohibitted besides essential use)䞉Import prohibition on products specified by law
䞉Recovery order, etc.

Class II Specified
Chemical Substances(23 substances)marketIntermediates, etc(usage specified by law)

Persistent, bioaccumulative, longterm toxicity for humans or for
higher-tier predators

Persistent, bioaccumulative, but
toxicity properties unknown

Prior assessment, etc.

Small quantity, notbioaccumulative(below 1 t/yr)
Small quantity new
chemicals(below 1 t/yr)

marketPrior
assessment

New
ChemicalsClass I Specified Chemical
Substances(30 substances)䞉 Notification of
Manufacture/import (present
and prospect) and usage, etc.
䞉 Order to change prospectvolume as necessary.
䞉 Technical guidance䞉 Indication of products
specified by law, etc.
䞉 Notification of
manufacture/import volume,
shipment by detailed usage,etc.
䞉 Instruction toxicity
investigation
䞉 Obligation to making effort indata sharing

䞉 Notification of
manufacture/import
volume, usage, etc.

7

Types of Chemicals regulated under CSCL(As of Oct. 2014)

NAME

Definition

Quantity

Class-I Specified
Chemical Substances

Persistent, bioaccumulative, and toxicity (long-term toxicity forhumans or predator animals at higher trophic level)

30

Class-II Specified
Chemical Substances

Toxicity (long-term toxicity for humans or long-term toxicity forflora and fauna in the human living environment) with concern for
a considerable amount of the chemical substance remaining in
the environment over a substantially extensive area

23

Monitoring Chemical
Substances

Persistent and bioaccumulative, but toxicity properties unknown

37

Priority Assessment
Chemical Substances• Not found that it is clear chemical substance does not pose longterm toxicity• Considerable amount of chemical substance remains in theenvironment• Not thought to pose a risk

(Candidates for the Class-I Specified Chemical Substances)164(Candidates for the Class-II Specified Chemical Substances)

General Chemical
Substances

Industrial chemical substances other than those above8

Chemical Substances Control Law (CSCL)㸺Approach㸼(1) Risk
 Risk of chemicals are assessed comprehensively fromhazard and exposure concentration.

HazardExposure

RISK(2) Optimization of the process A “stepwise assessment” is implemented, due to a great
number of substances subject to assessment.
9

Overview of CSCL
Existing Chemical
Substances

New Chemical Substances> 1 ton/year≤ 1 ton/year

Specified Cases(e.g.,intermediates)

Evaluation of PBT*

General Chemical
Substances

Monitoring Chemical
Substances

Priority Assessment
Chemical Substances

Instruction to report
the state of handling
Order to investigate
long-term toxicity

Class I Specified
Chemical Substances

if necessary

Screening Assessment

if necessary

Screening Assessment

Instruction to report
the state of handling

Polymersof Low Concern

Prior verificationand monitoring*P:Persistent
B:Bioaccumulation
T:Toxicity

Step-wise
Risk
Assessment

Order to investigate
long-term toxicity
Class II Specified
Chemical Substances

Obligatory reporting of hazard information obtained by business10Restriction of Manufacture/import, etc.
of Chemicals substances (1)<Specified Chemical Substances: two types>
Class-I Specified Chemical Substances㻌• Persistence, bioaccumulative, long-term toxicity for humans or for highorder predators• Restriction on license of manufacture/import and usage (virtuallyprohibited)• Import restriction on products designated by law• Recovery order in case substance is designated, etc.㻌
• Usage besides essential use (Compliance to technical standards;
labelling obligation)• 30 substances:㻌 㻌 Polychlorinated biphenyl㻌 㻌 Polychlorinated naphthalene (above three chlorines)㻌 㻌 Hexachlorobenzene㻌 㻌 Aldrin
Endrin㻌 㻌 Dieldrin DDT
㻌 㻌 Chlordanes㻌 㻌 㻌 etc.

(as of Oct, 2014)11

Restriction of Manufacture/import, etc.
of Chemicals substances (2)Class-II Specified Chemical Substances• Long-term toxicity for humans or animals / plants in living
environment• Considerable amount remaining in the environment over a
substantially extensive area
• Notification of volume of manufacture/import of present and prospect• Order to change prospect volume when restriction on
manufacture/import is necessary• Publication of technical guidance to prevent environmental
contamination, and recommendation as necessary• Labelling obligation and compliance to technical guidance• 23 substances:㻌 㻌 Trichloroethylene㻌 㻌 Tetrachloroethylene㻌 㻌 Carbon tetrachloride㻌 㻌 Organic tin (20 compounds)(as of Oct, 2014)12

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
13Evaluation/ verification of new chemicals
Prior evaluation and judgment is conducted to confirm whether
the new chemical substances have following properties, based onreport submitted by a manufacturer or importer at the time of
manufacturing or importing. New chemical substances is definedas substances which have not been manufactured or imported inJapan.
I. Degradable: Whether or not it is easily affected chemically in naturalprocess
II. Accumulative: Whether or not it is easily accumulated within organisms
III. Long-term toxicity to humans: Whether or not it may affect humanhealth through continuous intake
IV. Eco-toxicity: Whether or not it will affect the habitats or growth ofanimals and/or plants
14

Exception of Notification or Evaluation
for New Chemical Substances
Content
Small Quantity New
ChemicalSubstances

Confirmed by the three ministers that the prospect national yearly
manufacturing and importing volumes are below 1 ton, and are notconsidered to contaminate the environment and harm humanhealth or animals and/or plants in living environment.

Intermediates, etc.*

Confirmed by the three ministers that the substances falls undersuch designated by the law (intermediates, closed usage,
exclusively for exports) that environmental contamination by the
new chemical substances is not likely to occur from the planned
usage.

Polymers of Low
Concern

Substances confirmed by the three ministers that the substances
are polymers and do not contaminate the environment and harm
human health or animals and/or plants in living environment

Low Production
Volume of New
ChemicalSubstances

Substances that may be manufactured/ imported on a condition offollow-up supervision (hearing of report and/or on-site inspection),through prior confirmation by the three ministers that the volume isbelow 10 tons; in a case when the new chemical substances
below national yearly manufacturing and/or import volume below
10 tons are judged/notified that they are persistent but are notbioaccumulative, after specified as subject to pre-evaluation.

*Implementation of “Confirmation system of small quantity intermediates, etc. of new chemical substances”
15
from Oct, 2014 (to p.24)

Pre-Evaluation of new chemical substances (1)l The notification number of new chemical substances is in increasing
trend. The notification number was 702 in FY 2014.
l The application number of Small Quantity New Chemical Substances
was 31,672 in FY2014.
Notification
number

Notification number of New
chemical substances

Application
number

Application number of Small
Quantity New Chemical Substances

35,000

30,000

25,000

20,000

15,000

10,000

Fiscal year





















+

6    +          1974 1975 1980 1985 1990 1995 2000 2005 2006 2007 2008 2009 2010 2011 2012



0





6

5,000



1974 1975 1980 1985 1990 1995 2000 2005 2006 2007 2008 2009 2010 2011 2012

Fiscal year

16

Pre-evaluation of new chemical substances (2)lThe percentage of electric/electronic materials are high in both the newchemical substances and Small Quantity New Chemical Substances.
<Usage of new chemical substances (FY2012)>

Battery material(primary battery,
second battery) 2%
Synthetic textile
and textile treating
agent 2.9%
Glue, adhesiveand sealant 3.7%

Solvents forpaint, varnish,coating, printing
ink, copy,
biocides 2%

Glue, adhesiveand sealant 3%

Other 13%
Paints and coating
agent 26%

Printing ink andcopying agent(e.g. toner) 5%

Electric andelectronicmaterials 18%

Plastic, plastic
additive andprocessing aid
7%
Photoresist,photographs andprinting matrix
materials 8%<Usage of Small Quantity New Chemical
Substances (FY2012)>

Intermediates
13%

Other
materials andadditives 3%

Coloring agent(dye, pigment,
colorant, color
materials) 2%

Other 13%
Electric andelectronicmaterials 29%

Chemical processregulator 3%
Plastic, plastic
additive andprocessing aid
4%
Fragrance anddeodrant 6%
Paints and coating
agent 6%

Photoresist,photographs andprinting matrix
materials 12%

Intermediates
19%17Pre-evaluation of new chemical substances (3)l The application number of Low Production Volume of New Chemical
Substances is also in an increasing trend. The application number
was 1,316 in FY2012.
l The confirmed number of Polymers of Low Concern, implemented from
April 2010, was 80 in FY2012.
Application number of Low Production
Application Volume of New Chemical Substances
numberConfirmation
number

1500

㻝㻜㻜㻌

1200

㻤㻜㻌

900

㻢㻜㻌

600

㻠㻜㻌

300

㻞㻜㻌

0

㻜㻌
2008
+

2009


2010

Fiscal year

2011


2012


Confirmation number ofPolymers of Low Concern

㻴㻞㻞㻌
2010

㻞㻟㻌
2011
Fiscal year

㻞㻠㻌
2012

18

Pre-evaluation of new chemical substances (4)l The confirmed number of intermediates etc. was 263 in FY2012.
l The number of on-site inspection at intermediate producing industries
was 33 in FY2012.
Confirmed
numberConfirmed number of Intermediates etc.

Inspection
numberOn-site inspection of intermediates etc.


















2008
+

2009


2010

Fiscal year

2011


2012



2008
+

2009


2010


2011


2012


Fiscal year19Confirmation system of new chemical substances of
Small Quantity Intermediates etc. (1)䕔 Council for Regulatory Reform
Backgroundl Working Group for Business Establishment, etc., a subsidiarycommittee to Council for Regulatory Reform established within Cabinet
Office (January 23, 2013), adopted “evaluation system of new chemical
substances” as one of the topics to be discussed as a subject ofregulation rationalization.
l As a result of necessary consideration, reconsideration of chemical
substances evaluation system was adopted in the report of Council for
Regulatory Reform and in Regulatory Reform Implementation Plan.
May 14, 2013

The 6th Working Group for Business Establishment (public
hearing)

May 27, 2013

The 7th Working Group for Business Establishment (draft report)

June 5, 2013

Draft “Report for Regulatory Reform” Council for Regulatory
ReformJune 14, 2013 Cabinet decision of “Regulatory Reform Implementation Plan”
20Confirmation system of new chemical substances of
Small Quantity Intermediates etc. (2)䕔 Regulatory Reform Implementation Plan
Regulatory Reform Implementation Plan (June 14, 2013 Cabinet Decision)
Implementa
Jurisdiction
-tion

Item

Content of regulatory reform

Chemical substances
evaluation reform (1)The confirmation system of new chemicals of small quantity is to bea system to secure predictability related to manufacture and/or
import of new chemicals by industries, through ensuring the safetyof human health and ecology based on scientific discussion. Thus,a discussion shall be made to reach a conclusion to confirm by perindustry (enterprise) unit, taking into consideration the exemption(10 tons) of low production volume of new chemical substances.

FY 2013
Discussion/conclusion

MHLW
METI
MOE

A discussion shall be made to reach a conclusion to increase
acceptance frequency of notification for confirmation of small
quantity new chemical substances, taking into consideration thesituation of enterprises, from the perspective of enhancing thecompetitiveness of enterprises without losing business opportunity.

FY 2013
Discussion/conclusion

MHLW
METI
MOE

A discussion shall be made to reach a conclusion on individual
issues necessary for rationalization regarding the assessment
system for new chemical substances to evaluate the effect onhuman health and on ecology through usage and/or exposure
potential of the chemical substances, by attempting to balance thesafety and optimization of cost and time required for thedevelopment of new chemical substances.

FY 2013
Discussion/conclusion

MHLW
METI
MOE

(on total volume
regulation of small
quantity new chemical
substances confirmation
system)Chemical substances
evaluation reform (2)(on acceptance frequency
of small quantity new
chemical substances
confirmation system)

Chemical substances
evaluation reform (3)(on constructing
assessment system
based on usage, etc. ofchemical substances)21

Confirmation system of new chemical substances of
Small Quantity Intermediates etc. (3)n Purpose(CSCL Item 4, Paragraph 1, Article 1)• In accordance with Regulatory Reform Implementation Plan (Cabinet Decision, June 14,2013), “ Ministerial Ordinance to revise a part of ministerial ordinance regarding notification
for manufacturing and/or importing new chemical substances” was proclaimed, and“Confirmation system for small quantity intermediates etc. of New
Chemical Substances” was newly established. (Enacted Oct. 1st, 2014)• For manufacturing and/or importing of new chemical substances used exclusively asintermediates or for export, if the annual planned manufacturing and/or importing
volume per enterprise is below 1 ton, the appendix documents for application is simplified.

n Flow diagram(1) Prior application
Enterprise(Ministerial Ordinance Article 3)(2) Confirmation

MHLW
METI
MOE

(CSCL Item 4, Paragraph 1, Article 3)(3) Submit report(4) On-site investigation
Enterprises could manufacture and/or import new chemical substances after being confirmed (2)by the three ministers.

䞉 Application accepted: as required (no expiration date)䞉 Documents for application: Overview of countermeasures for prevention of environmental
22
contamination, management system, and information, etc. of users (exporter).

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
23POPs Convention(Stockholm Convention on Persistent Organic Pollutants)
POPs (Persistent Organic Pollutants)
཰ToxicཱHardly decomposableིAccumulatedཱིLong-distance transferable    International effort isrequired for pollution
prevention.

To prevent contamination by POPs, elimination and reduction of POPs is required through international
cooperation,
ႼAdopted in May 2001; Japan concluded in August 2002. It entered into force in May 2004.
ႼThe conference of the parties has been held six times so far, every two years.
ႼProfessional and technical issues are discussed at Persistent Organic Pollutants Review Committee (POPRC).

Object substance (12 materials, initially)
Byproducts generated unintentionallyDioxin, Dibenzofuran
Pesticide

Hexachlorobenzene,

Aldrin, Dieldrin
Endrin, Clordane, Heptachlor,
DDT, Mirex, Toxaphene,

Industrial chemicals

PCB
Agreed to add 9 substance group in May 2009

Japan has developed a national implementation planfor implementing the Convention.

24

Overview of the 6th ordinary meeting of the Conference of
the Parties (COP6)to the Stockholm Convention on POPsl Date & Location: April 30 to May 2, 2013 at Geneva (Switzerland)l Outcome of the meeting:㻌 䞉㻌 Listing of chemicals in Annex A to the convention (new POPs)㻌 㻌 㻌 -> Hexabromocyclododecane (HBCD) was listed to Annex A to the convention.
㻌 䞉㻌 Assessment of alternatives to the use of PFOS, its salts, and PFOSF㻌 㻌 㻌 -> Further evaluation of alternatives to PFOS, its salts, PFOSF at the POPRC.
㻌 䞉㻌 Work Plan for specific exemptions and acceptable purposes㻌 㻌 㻌 -> Process for the evaluation of the continued need for the various acceptablepurposes and specific exemptions is adopted (PFOS andBromodiphenylether).
㻌 䞉㻌 Effectiveness evaluation㻌 㻌-> Revised framework for effectiveness evaluation and the global monitoringplan for persistent organic pollutants were adopted .
l COP7䠖May 2015 in Geneva (Switzerland)㻌 䞉㻌 Stockholm Convention, Basel Convention, Rotterdam Convention (three COPs)
will be held jointly.
25

Substances that had been added toAnnex A of COP5 and COP6
Matters determined in COP5
Substance
Endosulfan and its isomerPrimary use
Pesticide

Remarks•

Prohibition of the manufacture, use, etc.

(Exception: production and use of pesticides
for insect pests to in a particular crop)

Matters determined in COP6
SubstancePrimary use

Hexabromocyclododecane,
Flame
1,2,5,6,9,10–hexabromocyclododecane retardants
and its main isomerRemarks•

Prohibition of the manufacture, use, etc.

(Exception: production and use of beads
method-expanded polystyrene foam andextruded polystyrene foam for construction)l 2 substances above is designated as a Class I Specified Chemical Substance of
CSCL, and manufacture, import and use are prohibited.(Enforced in May
1st 2014)*
l Import of products in which HBCD is used (flame-proof fabric flame
curtain textiles flame-retardant treatment drug, and flame-retardant EPS beads) arealso prohibited. (Enforced in October 1st 2014).

26

Based on Agricultural Chemicals Regulation Law, the production and sales of Pesticide are already prohibited for endosulfan.

The risk assessment of PCB as a byproductin the organic pigments
It was identified that organic pigments contain a small amount of
unintentional byproduct-PCB, on February, 2012.
lPBC contents included in organic pigments (Survey of 588 items)
PCB
(ppm)

<0.5

0.5-1

1-5

5-10

10-15

15-20

20-25

25-50

>50

Total

Items

359

51

89

29

13

7

10

13

17

588

*Organic pigments which contain over 50ppm of PCB was found in 17 items. For these items, shipping
manufacturing, and import was already stopped.

lStudy on environmental pollution and impact on consumer

Risk Assessment Study Group on the PCB as a by-product in the organic pigments (Mar, 2012 -- Mar,2013)
ዘThe experts discussed about the impact of the health on consumers due to the continued use of the productin which the pigment and the impact on the ecosystem and people through the pollution of the environmenthas been used.
ዘIt was concluded that risk to ecological and human health via the environment is low except for extreme
cases.

l Study on the level capable of reducing PCB, industrially and economically (Jul,2013--)
ዘThe level capable of reducing PCB as a by-product in organic pigments, industrially and economically, will
be considered by referring to the expert opinion.
27

Environmental Survey and Monitoring of Chemicals
p Aim: To understand the state of residual chemical substances in the generalenvironment, basic data to promoting chemical substances countermeasures.
p Subject: Multiple media (water, sediment, air, biota, etc.)
p Survey commencement: Started from FY1974 when CSCL was first established.

Selection of subject
substances for survey

InitialEnvironmental
Review

Survey to determine the state ofenvironmental residue of chemical
substances whose presence of residue
in environment is unknown.

Development ofanalytical method

Detailed
Environmental
Review

Survey to understand the precise
residual state of chemical substances,whose presence of residue in theenvironment was found in the Initial
Environmental Review.

Monitoring
SurveySurvey to understand the transition ofchemical substances, which are
persistent and bioaccumulative toanimal body.

Sampling and analysis(local governments andprivate companies)

CSSL

PRTR

Initial Environmental
Risk Assessment

EXTEND2010

Local
governments

Applied for different measures regarding
chemical substances
EXTEND: Extended Tasks on Endocrine Disruption

28

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
29

Risk Assessment under CSCL
To prevent environmental contamination by chemicals that may
be harmful for human health and/or to the inhabitant or growthAimof animals and plants.
Continuous
Prior evaluation andRegulation by properties
management ofregulation of new
Persistence, Bioaccumulation,
existing substanceschemical substancesLong term toxicity
Step-wise risk assessment
䠘Role of enterprises䠚

General Chemical Substances

CSCL Chemical Inventory
Notified Chemical Substances

Screening Assessment

Designation of PACs
Risk Assessment (1st)
Risk Assessment (2nd)Class II Specified Chemical Substances

Notify annual volume of manufacture etc.
(mandatory)
Submit hazard information (voluntary)
Notify annual volume of manufacture etc. with detailed
usage (mandatory)
Submit requested hazard information
Report requested for handling situations
Conduct administratively instructed hazard properties
study (long-term toxicity tests) (mandatory ujpon
instruction)
Notify planned annual volume of
manufacture, etc.
Technical guidance for use, etc.

30

Screening Assessment
䛆Human Health effect䛇• Classified into hazard class by general toxicity, reproductive and developmental toxicity,
mutagenicity, and carcinogenicity.
䛆Ecological effect䛇• Classified into hazard class by eco-toxicological test data (algae, crustacean, fish).

Exposure Class㻯㼘㼍㼟㼟㻝㻌

㻯㼘㼍㼟㼟㻝㻌

㻯㼘㼍㼟㼟㻞㻌

㻯㼘㼍㼟㼟㻟㻌

㻴㼕㼓㼔㻌

㻴㼕㼓㼔㻌

㻴㼕㼓㼔㻌

㻯㼘㼍㼟㼟㻠㻌
㻴㼕㼓㼔
㻴
㻴㼕㼓㼔㻌
㼕㼓㼔
High (Not thought to pose a risk)㻯㼘㼍㼟㼟㻞㻌

㻴㼕㼓㼔㻌

㻴㼕㼓㼔㻌

㻴㼕㼓㼔㻌

㻯㼘㼍㼟㼟㻟㻌

㻴㼕㼓㼔㻌

㻴㼕㼓㼔㻌

㻹㼑㼐㼕㼡㼙㻌

㻯㼘㼍㼟㼟㻠㻌

㻴㼕㼓㼔㻌㻹㼑㼐㼕㼡㼙㻌

㻹㼑㼐㼕㼡㼙㻌Medium
㻸㼛㼣㻌
& Low

㻯㼘㼍㼟㼟㻡㻌

㻹㼑㼐㼕㼡㼙㻌

㻹㼑㼐㼕㼡㼙㻌

㻸㼛㼣㻌㻱㼤㼜㼛㼟㼡㼞㼑㻌㻯㼘㼍㼟㼟㻌
㻯㼘㼍㼟㼟㻌㻝㻌
㻯㼘㼍㼟㼟㻌㻞㻌
㻯㼘㼍㼟㼟㻌㻟㻌
㻯㼘㼍㼟㼟㻌㻠㻌
㻯㼘㼍㼟㼟㻌㻡㻌

㼀㼛㼠㼍㼘㻌㻱㼟㼠㼕㼙㼍㼠㼑㼐㻌㻱㼙㼕㼟㼟㼕㼛㼚㻌㼂㼛㼘㼡㼙㼑㻌㻌㼛㼢㼑㼞㻌㻝㻜㻘㻜㻜㻜㻌㼠㼛㼚㼟㻌㻝㻘㻜㻜㻜㻌䇵㻌㻝㻜㻘㻜㻜㻜㻌㼠㼛㼚㼟㻌㻌㻝㻜㻜㻌䇵㻌㻝㻜㻜㻜㻌㼠㼛㼚㼟㻌㻝㻜㻌䇵㻌㻝㻜㻜㻌㼠㼛㼚㼟㻌㻝㻙㻝㻜㻌㼠㼛㼚㼟㻌㻹㼑㼐㼕㼡㼙㻌
㻹㼑㼐㼕㼡㼙㻹㼑㼐㼕㼡㼙㻌

㻸㼛㼣㻌

Expert Judgment
Designatedas Low Risk

䛆Physicochemical䛇
• Notify annual quantity of manufacture etc.
• Estimation of Total annual quantity ofemission (updated every year)

Remain toGeneralChemicalSubstances(Exposureclass will be
updated andscreened
every year)

Designation of PACS

Hazard Class

31

Screening Assessment Results2010 FY(deliberation on
January 2011)
Human
Ecological
HealthType II
Type III
Substance
Monitoring Monitoring
Classification ofChemical Chemical
Evaluation
Substance Substance2011 FY(deliberation on
January 2012)
Human
Ecological
Health2012 FY
2013 FY(deliberation on July(deliberation on July 2013)
2012)
Human
Human
Ecological
Ecological
HealthHealthPart of General
Chemicals

General chemical substance of all that had
reported

Exposure
information

Record of 2009 FY

Record of 2010 FY

Record of 2010 FY

HazardInformation

Judgment basis ofType II & III Monitoring
Chemical Substance

Judgment basis of
OECD/HPV

Collected data that the reliability was confirmed

Record of 2011FY

Substance for
evaluation

682

212

109

275

10,792

11,979Quantity ofimports andproduction(over 10 t)

447

166

101

188

7,054

7,819

46

40

Corresponding
Priority
Assessment
ChemicalSubstances

88
75

8
20

6

4

31

21

17

23

32

Designated Priority Assessment Chemical Substances
Designated Priority Assessment Chemical Substances are 164 (As of Oct. 2014)<Public site for notice (English ver.)>
J-CHECK: Japan Chemicals Collaborative Knowledge Database)
http://www.safe.nite.go.jp/jcheck/list7.action?category=230&request_locale=en

About J-CHECK:• J-CHECK is a database developed to provide the information regarding CSCL by theauthorities of the law, MHLW METI and MOE.
• J-CHECK provides the information regarding CSCL, such as the list of CSCL, chemicalsafety information obtained in the existing chemicals survey program, risk assessment, etc.
in cooperation with eChemPortal by OECD.

33

Priority Assessment
Chemical Substances

Procedure of
Risk Assessment

Notification of Quantity, etc. of Manufacture (Article 9)
Reporting of Hazardous Properties (Article 41)
Total annual quantity of manufacture etc. is less than 10t
Preparation for Assessment
Rescission of Designation
as a PACS (Article 11)

Assessment I
Hazard Assessment I

Count of Quantityof Manufacture etc.

Exposure Assessment I

Addition and Inspectionof Hazardous Properties

Estimation ofEnvironmental Release

Hazard Assessment

Exposure Assessment: Hearing of Opinionof Councils (Article 56)

㺃Total annual quantity of
exposure is less than 1t
㺃When Assessment II
isn’t done
Monitoring of Quantity,
etc. of Manufacture

Prioritization
Requesting of Hazardous Properties Study (Article 10(1)) Reporting of Hazardous Properties (Article 41)
Carry out Assessment II in consideration of priority
and collection situation of hazardous properties
Assessment II
Hazard Assessment II

Exposure Assessment II

Investigation ofHazardous Properties

Investigation of monitoring data
(mainly on existing data)

Hazard Assessment

Exposure Assessment
based on monitoring data

Rescission of Designation
as a PACS (Article 11)

Investigation of PRTR data Inspection of presumed amountof environmental release
Exposure Assessment
based on PRTR data

Exposure Assessment
based on notified data

Risk Characterization
Requesting of Hazardous Properties Study (Article 10(1)) Reporting of Hazardous Properties (Article 41)
Requesting of Report on the Status of Handling (Article 42) Voluntary Report on the Status of Handling
Additional Monitoring etc.
Hearing of Opinion of Councils about
Rescission of Designation
Designation of a Class II specified
Assessment III
as a PACS (Article 11)
Chemical Substance (Article 2(3))
Assessment II based on more correct data

General Chemical SubstancesClass II Specified Chemical Substances

Hearing of Opinion of Councils about
Designation of a Class II specified
Chemical Substance (Article 2(3))<More than past three years>
Total annual quantity of manufactureetc. is less than 10t or
Total annual quantity of exposure isless than 1t

Instruction of Hazardous Properties Study (Article 10(2))
Hearing of Opinion of Councils about
Designation of a Class II specified
Chemical Substance (Article 2(3))

Second Risk Assessment
Assessment III based on hazardous properties study

Rescission of Designation
as a PACS (Article 11)34

Risk Assessment (1st) Risk Assessment (1st) is composed of three stages
referred as the Assessment I, II, or III.
<Assessment I >   Hazard assessment uses the same information as the screening assessment.
Exposure assessment uses only the notified information of production and import
volume, etc.. From these results, the priorities for implementing the Assessment II
are determined.
<Assessment II >   The hazard assessment is performed by collecting additional toxicologicalinformation. The risk assessment of Exposure Assessment is performed byincreasing the coverage. The recorded monitoring data and PRTR data in past isalso utilized. From these data, risk assessment is carried out, and the direction of
hazard investigation or the appointment to Class II Specified Chemical Substance isdetermined immediately. If there is no optimal decision, Assessment III is applied.
<Assessment III >   The risk assessment is conducted in detail using handling information andadditional monitoring data. The necessity of direction of hazard investigation isdetermined.
35

Result of Assessment I
l Risk Assessment (1st) has been conducted three times. Among 140 substances designated as Priority
Assessment Chemical Substances by FY 2012, Risk Assessment (1st) was conducted on 116 substances,
exceeding the total national manufacture/import volume of 10 tons. Risk Assessment (2nd) is conducted on 18
substances in FY 2012, 8 substances in FY 2013, and 16 substances in FY 2014
Date/number of target substances

Jul. 2012

Jul. 2013

Jul. 2014㻌 㻌 Priority Assessment Chemical Substances*1

87

95

140

㻌 㻌 Assessment I of Risk Assessment (1st)

86

79

116

Substances to undertake Assessment II(Human health)(Ecological)

18
(11)
(7)

8
(1)
(7)

16
(3)
(13)

Substances not applicable to the above and will continually besubjected to Assessment I next year

63

62

97

5
(-)
(-)

6
(-)
(-)

7
(3)
(4)

1
(-)
(-)

2
(-)
(-)

5
(4)
(1)

National estimate emissions below 1t(Production volume survey conducted for the time being*2, and Assessment
I will be conducted next year)(Cancellation of designation as Priority Assessment Chemical Substances)

National total manufacture/import volume below 10 t
(Production volume survey conducted for the time being*2, and Assessment I
will be conducted next year)(Rescission of designation as Priority Assessment Chemical Substances)*1䞉䞉䞉Target substances for July 2012 assessment were designated substances of Apr. 2011 (of which one substance was cancelled in Jan.
2012). Target substances for July 2013 assessment were substances designated by FY 2011. For June 2014 assessment, the target substanceswere substances designated by FY 2012.
*2䞉䞉䞉Rescission of designation as Priority Assessment Chemical Substances for substances below national total manufacture/import volume of
10 t or national estimate emissions below 1 t , according to Article 11 of CSCL.

36

Starting Substance of Assessment II
18 Substances for 2012 FY
᧸Human health effects (11 substances)᧺
Ⴜ Hydrazine
Ⴜ 1,3 - butadieneႼ DichloromethaneႼ 1,2 - dichloropropane
Ⴜ Chloro ethylene
Ⴜ Ethylene oxide
Ⴜ 1,2 - epoxypropane
Ⴜ FormaldehydeႼ Acrylonitrile
Ⴜ BenzeneႼ o-toluidine

8 Substances for 2013FY᧸Human health effects (1substance)᧺
Ⴜ N, N-dimethylformamide<Ecological effect (7 substances)>Ⴜ Hydrazine
Ⴜ Bromomethane(Methyl bromide)Ⴜ 1,2,4-Trimethylbenzene<Ecological effect (7 substances)>Ⴜ NaphthaleneႼ 1,3 - dichloropropene
Ⴜ α-(nonyl phenyl)-ω-Hydroxy polyႼ n-butyl acrylateႼ isopropenylbenzene*(oxyethylene) (also known as poly
Ⴜ p-dichlorobenzene(oxyethylene) nonyl phenyl ether)Ⴜ Hydrogen peroxide
Ⴜ Initiative 2,6-di-tert-butyl-4-methyl phenolႼ [3-(2-ethylhexyl) propyl amine] triphenyl boron Ⴜ Acrylic acid(III)
Ⴜ 4,4 '- (propane-2 ,2-diyl) diphenol (bisphenol* Substances subject to the evaluation/
discussion at the Joint Council by threeA)*
ministries, held on June 27, 2014.

37

(4) Starting Substance of Assessment II (cont.)
FY 2014㻌 16 substances
䠘Human health effect (䠏3substances)䠚
䞉Carbon disulfide
䞉Aniline䞉4䠈4䇻-Diamino-3䠈3䇻-dichlorodiphenylmethane㻌 (also known as “4䠈4䇻-methylenebis(2-chloroaniline)”)䠘Ecological effect (13 substances)䠚
䞉 Tetraethylthiuram disulfide (also known as “disulfiram”)
䞉Bis(䠪䠈䠪-dimethyldithiocarbamic acid)䠪䠈䠪䇻-ethylenebis (thiocarbamoyl thiozinc)(also known as “polycarbamate)䞉䠪䠈䠪-dimethylpropane-1䠈3-diyldiamine䞉䠪䠈䠪-dimethyldodecylamine䠙䠪-oxide
䞉1-Dodecanol䞉Trisodium䠙2䠈2′䠈2′′-nitrilotriacetate䞉2-䠷(䠏-dodecaneaminopropane-1-yl)(dimethyl)ammonium䠹acetate
䞉Xylene䞉Benzyl benzoate
䞉(R)-4-isopropenyl-1-methylcyclohex-1-ene㻌 (also known as “䡀-limonene”)
䞉1䠈3䠈5-Trichloro-䠍䠈3䠈5-triazinan-2䠈4䠈6-trione
䞉(䠰-䠐)-bis䠷2-(thioxo-k䠯)-pyridine-1(2䠤)-olato-k䠫䠹zinc(ϩ)
䞉Benzenesulfonic acid, sodium salt(limited to linear alkane with carbons 10 to 14)38Class-II Specified Chemical Substancesl The Class-II Specified Chemical Substances that are manufactured and/or imported forusage other than research purposes are trichloroethylene (TCE), tetrachloroethylene(PCE), and tetrachlorinated carbon (CCl4). However, the shipment quantity (besides export
and for intermediates) are in a decreasing trend.
Trend in shipment quantity of principal Class-II Specified Chemical Substances(besides export and for intermediates)
Yr.㻌
1988㻌
1989㻌
1990㻌
1991㻌
1992㻌
1993㻌
1994㻌
1995㻌
1996㻌
1997㻌
1998㻌
1999㻌
2000㻌
2001㻌
2002㻌
2003㻌
2004㻌
2005㻌
2006
2007㻌
2008㻌
2009㻌
2010㻌
2011㻌
2012㻌

䠰䠟䠡㻌
57,922㻌
46,201㻌
36,762㻌
34,546㻌
34,546㻌
35,002㻌
34,541㻌
34,084㻌
34,396㻌
34,394㻌
33,179㻌
33,340㻌
31,952㻌
27,634㻌
24,863㻌
23,537㻌
22,233㻌
21,889㻌
18,351
18,020㻌
14,284㻌
12,971㻌
13,142㻌
12,437㻌
11,628㻌䠬䠟䠡㻌
45,483㻌
42,760㻌
37,554㻌
30,059㻌
30,009㻌
28,727㻌
27,892㻌
24,648㻌
23,159㻌
21,200㻌
17,585㻌
16,787㻌
14,089㻌
11,153㻌
11,148㻌
10,397㻌
9,191㻌
8,683㻌
7,013
6,270㻌
5,198㻌
5,200㻌
5,703㻌
4,618㻌
4,391㻌

(unit: ton)CCl4㻌
7,736㻌
6,904㻌

6,492㻌
6,420㻌
6,127㻌

3,681㻌
1,747㻌
trichloroethylene
658㻌
89㻌
70㻌

37㻌
44㻌
27㻌
37㻌
tetrachloroethylene
29㻌
22㻌22㻌
30㻌
tetrachlorinated carbon
27
40㻌

20㻌
 ‘93
 ’94
 ’95
 ‘96
 ‘97 ‘98‘99 
‘04‘05‘06‘07‘08 ‘09
’10 ‘11‘12’92‘00 
‘01 
‘02 ‘03
16㻌
17㻌
18㻌
39
15㻌 unit: tonReporting of hazard information
lThe manufacturer and/or importer of chemical substances are obliged to reportwhen hazard such as toxicity is observed for humans and animals/plants at a
certain degree by tests required for assessments of CSCL. (Article 41)<Reporting number of hazard information>
FY 2010㻌

FY 2011㻌FY 2012㻌Degradation㻌

74㻌

101㻌

88㻌

Accumulation㻌

3㻌

3㻌

5㻌

Physical chemical properties㻌

6㻌

4㻌

10㻌

Human toxicity㻌

90㻌

79㻌

113㻌

Ecotoxicity㻌

48㻌

37㻌

51㻌

Total㻌

221㻌

224㻌

267㻌

40

Chemicoco: Chemical Information Retrieval Support System
Chemicoco is a search tool for chemicals information.(Japanese only)
Users can access directly to reliable chemical information of appx. 2200 substances.

Search from
related Laws and how to use

Lists for outside data base
Links for Chemicals commentary

URL: http://www.chemicoco.go.jp/

41

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
42

PRTR System
u PRTR (Pollutant Release and Transfer Register) System㻌 : Registration / Announcement systems of hazardous chemicals discharged
amount to environment and migration amount contained in waste material.

u It takes much time for the determination of threshold (standard
value) and risk evaluation.
->Effectively reduce the discharge of [Gray Substance]->Voluntary management by business operators, information disclosure tonations and utilization by the public administrationu Preceded by U.S.A and Netherlands (Framework and main
purpose are different depending on countries)->In Japan, Legislated in 1999. (Act on Confirmation, etc. of Release Amountsof Specific Chemical Substances in the Environment and Promotion of
Improvements to the Management Thereof): (Co-Jurisdiction by the MOE
and METI)

43

PRTR System (continued)u PRTR System in Japan- Purpose:• Promoting the voluntarily management improvement by business operators• Preventive measures for Environmental Conservation- Target Chemicals: 354 substances -> 462 substances (started since FY2010)- Target Business Operators: Handling Business Operators (Defined bybusiness category / size)㻌㻌- Notification of discharge amount / migration amount by the target business
operators- Estimation of discharge amount from other exhaust sources (small size
business place, non-target business category, family and mobile object) by
the country-> Adding Up and Announcement. Individual notification data has beenannounced since FY2008.

u Delivery system for SDS (Safety Data Sheet) is also incorporated.
44

Institution of PRTR System
Understand the chemical discharge
amount to environment andmigration amount contained inwaste material by individual
business place and target
substances (354 substances)

Businesses

Trouble Prevention forenvironmental conservation bypromoting the voluntarily
management of chemicals

Notify estimated values ofdischarge and migration
amounts to the country

Data Announcement for
Individual Business PlaceVia Prefectural andCity Governments

Government

Evaluation on
Management
StatusDisclosure ofData

The public

Data Disclosure Request for
Individual Business Place
Announcement of Adding Up Results by
Substance, Business Category, Area, etc.

Minister
Responsible for
the Business

Minister of
METI
Minister of
MOE

Adding Up notification data, estimate exhausts other than notification (house,
agricultural land, vehicles, etc.), announce the results as well as inform the results toconcerned government ministries, and prefectural and city governments [MOE, METI].

45

FY2005-2014 Transition of Release and Transfer
(ton)

2005

2006

2007

2008

Release2009

Transfer

2010

2011

Release & Transfer

2012

2013

2014

46

Image of the System to Display PRTR Data on Maps
How to publish data
Server

Select filtering /map
Display
results with alist ofcompanies

User

Display search results on map

Display
results
with amap

Emissions and movement of a fiscal year

Change in emissions and movement over the ye

47

Purpose of PRTR and Data Utilization Examples
Purpose of PRTR

Utilization Examples of PRTR Data (Future utilization schedule included)[1] Basic Data forEnvironmental
Conservation

ü Let the PRTR Discharge Amount Data to be the benchmark toward
undertaking the promotion of chemical sector
ü Use as basic data when reviewing various political measures such assystem for industrial waste subject to special control, etc.

[2] Priority Decision for
Chemicals
Countermeasure by
Administration

ü Used for the environment risk evaluation of chemicals
ü Used for the selection of target substance / target place for environment
monitoringü Used for the risk evaluation of monitoring chemicals based on CSCL

[3] Promotion of voluntary ü Provision of tools such as the estimation of environment concentration
around business offices to business operators.
management by business
operators
ü Used as business operator instruction material at local public entities[4] Provision of information
to nationals andenhancement ofunderstanding regarding
chemicalsü Announce the adding up results of data and post them on the web.
ü Prepare map information on discharge amount and estimatedatmospheric concentration and post them on the web.
ü Prepare a guidebook for citizens and chemical fact sheet in which PRTR
data is utilized.

[5] Understanding of effectand progress status ofenvironment
countermeasureü Understand the countermeasure situation regarding the reduction ofpriority undertaking substance of Air Pollution Control Act with
monitoring data and PRTR data.
48

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
49

SAICM: History to Adoption· 1992㻌 “Agenda 21” adopted at UNCED (the Earth Summit)(Chapter 19: Management of toxic chemicals)· 1994 㻌 Intergovernmental forum on chemical safety established· Sep 2002㻌 Implementation Plan on sustainable development forWorld Summit-

Aim to achieve, by 2020, that chemicals are used and produced in ways that lead tothe minimization of significant adverse effects on human health and theenvironment, using transparent science-based risk assessment procedures andscience -based risk management procedures, taking into account the precautionary
approach.

=> Decide to develop the strategic approach (SAICM) for the above by 2005
· 2003 - 2005㻌 Three times of preparatory meeting, Regional meetings in five
regions of the world, etc.

· Feb 2006㻌 SAICM adopted at International Conference on Chemicals
Management (ICCM)
50

Actions to SAICM (Past and Prospect)䞉 May 2007㻌 Asia-Pacific regional meeting (Bangkok)㻌
䞉 2009㻌 ICCM2
Review of SAICM implementation• Further chemicals management in developed countries• Support and fund to developing countries• Actions to emerging policy issues including chemicals in products,
nanomaterials, etc.

䞉 Nov 2009

Sep 2011: Asia-Pacific regional meeting (Beijing)䞉 Sep 2012㻌 ICCM3 (Nairobi)
Review of SAICM implementation• Establish guidance for 2020 goal
• Support and fund to developing countries• Add endocrine disrupting chemicals to action to emerging policy issues

䞉 Mar 2013 Asia-Pacific regional meeting (Geneva)

䞉 Sep – Oct 2015 ICCM4㻌 㻌 㻌䞉 2020㻌㻌㻌

ICCM5

Follow-up of SAICM implementation

Minimize the significant adverse effect of chemicals tohealth and the environment by 2020.
51

SAICM National Implementation Plan (Nov. 2013)[Conventional measures and issues in chemicals management]
lPromotion of chemicals management with international viewpoint pursuant to SAICM
Ø Implementation of chemicals management in each field, such as the environment (Basic
Environment Plan, Law Concerning the Examination and Regulation of Manufacture, etc of
Chemical Substances, Law concerning PRTR, etc.), labor safety and hygiene, and safety measuresfor household appliances
lOn the other hand, measures to deal with anxiety of the citizens for the safety of chemicals, and further
coordination, reinforcement, etc. in each measure of risk assessment and management are demanded.
Involvement of various stakeholders (Discussion
in Policy Dialogue on Chemicals and theEnvironment)

Reflection of opinions from all levels of civilsociety (Implementation of Public
Consultation)

Development of SAICM National Implementation Plan
<Comprehensive strategies regarding chemical substances>(Developed by the liaison meeting among relevant Ministries and Agencies)㻌
l Promotion of science-based risk assessmentl Risk reduction throughout whole life-cyclel Response to emerging and uncertain issues
Review of the progress of the Plan and its
announcement prior to ICCM4 to be held in
2015

l Strengthening of safety and security
l Promotion of international cooperation andcoordinationl Issues to be examined in the future

Amendment, if necessary, reflecting thediscussion in ICCM

Towards Achievement of WSSD2020 Goal

52

Policy Dialogue on Chemicals and Environment All relevant sectors and stakeholders should be involved in the decision-making

processes to ensure transparency and accountability.
 Policy dialogue was set up in March 2012 as a site where the relevant entities
exchange opinions on chemicals and environment for consensus formation. It aims
at making policy proposals for securing the people’s safety and security against thechemicals.

Government
CitizenBusiness

Policy dialogue on
chemicals andenvironment
Academic expert

Workercontinue discussions on progress of the SAICM implementation plan.

53

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
54

Minamata Convention on Mercury (1)Process to adoption
p UNEP started its program for Global Mercury Assessment and Management in2001.
p February 2009, UNEP GC Decision 25 agreed to commence Negotiations in 2010
and aim at the adoption of the Convention by 2013.
p June 2010, Intergovernmental Negotiating Committee (INC1) was held, and held
five times of INC until 2013.
p January 2013 , agreed upon the “Minamata Convention on Mercury” texts in INC5.

n October 2013, The Conference of Plenipotentiaries on the Minamata
Convention was held in Minamata City and Kumamoto City.
Ø More than 1000 people including about 60 ministers and other governmental
representatives from 139 countries and area.
Ø Signed by 125 countries, agreed by 6 countries (USA, Uruguay, Gabon, Djibouti, Monaco),
as of 9th October,obber,er, 2014.
2014.
20

55
5

Minamata Convention on Mercury (2)Outline of the Convention text
Ø Substantial lessons of Minamata Disease in the preamble.
Ø Regulate primary mercury mining, the import and export of mercury,
and artisanal and small-scale gold mining (ASGM).
Ø Regulate manufacture, import or export of mercury-added products(fluorescent tube, thermometer, sphygmomanometer), and regulate
manufacturing processes in which mercury is used.
Ø Promote measures of reducing emissions to the atmosphere, land or
water based on Best Available Techniques / Best Environmental
Practice (BAT/BEP).
Ø Promote appropriate disposal of Mercury wastes while taking existingtreaty (Basel Convention) and consistency.
Ø Establish the fund mechanism to support capacity building and capitalspending of the developing countries.
Ø Will go into effect 90 days after fifty countries approve ratification.
56

Minamata Convention on Mercury (3)Status towards Conclusion of Convention• UNEP secretariat stated at diplomatic conference to set the goal for effectivationof Convention in 2016.
• As a country experiencing Minamata Disease, we are now drafting a relating
law to submit to the Diet in the first half of year 2015, for early conclusion of theConvention.
• Submitted “Countermeasures on Mercury in response to the Minamata
Convention” to Environmental Committee.
㻌 㻌 -> Started review in three subcommittes/ advisory committees mentioned below.
䞉㻌 Environmental Health Committee- Subcommittee on mercury
countermeasures in response to Minamata Convention
䞉㻌 Atmosphere/ Noise and Vibration committee- Subcommittee on mercury
countermeasures on atmospheric emission
䞉㻌 Environment and Sound Material-Cycle Society Committee- Advisory committee
on appropriate countermeasures of mercury waste-> Will compile plans by the end of the year and aim to submit draft law in the first half ofthe year 2015.

Action for the Convention’s effectuation• Contributed 1.6 million dollars to UNEP, the provisional secretariat of Minamata
Convention in March, 2014.
• Plan to conduct supporting project for capacity building in developing countries.
• Conduct a Survey for deployment of our high technology on mercury
57
countermeasure to developing countries.

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
58

Japan Environment and Children’s Study(JECS)Core Hypothesis ⊦⊦⊦Chemical exposure during the fetal and infant stages adversely
effects children’s health and development.

Method⊦Target≝Birth cohort study, 100,000 subjects.
Term≝16 years (recruitment 3 years, data collection 13 years)
possibly longer.

Funding≝‒ ‒ ‒ ‒ ‒ ‒3.1 billion yen ($ 31 million) in FY 2010
4.6 billion yen ($ 46 million) in FY 2011

Reached 100,000 *on 20th March, 2014.
(*) number of mothers

6.1 billion yen ($ 61 million) in FY 2012
6.1 billion yen ($ 61 million) in FY 2013

Prospective Results :(1) Identify environmental factors impacting children’s health and development.
lopm
ment.
(2) Develop better risk management specifically addressing children’s health.

(3) Ensure a sound environment where future generations lives.
(4) Promote children’s environmental health studies.

59Chemical exposure during the fetal and infant stages adversely
effects children’s health and development.
(Exposure)Chemicals in the Environment
POPs (dioxins, PCBs, organofluoric
compounds, flame retardants, etc.),
heavy metals (mercury, lead, arsenic,
cadmium, etc.), endocrine disruptors(bisphenol A, etc.), agrichemicals, VOC(benzene, etc.), etc.

Genetics(Effect)
Physical Development:
Low birth weight, development after birth, etc.

Congenital Anomalies:
Hypospadias, cryptochidism, cleft lops,
cleft palate, spina bifida, etc.

Sexual Differentiation :Sex ratio, genital development impairment,
sexual differentiation of the brain, etc.
Psychoneuro developments:
Autism, learning disorders, AHDH (attentiondeficit hyperactivity disorder), etc.
Compromised Immune System:

Socioeconomics㻌 㻌 Pediatric allergies, atopic eczema, asthma,
etc.
Endocrine / Metabolic Abnormalities:

Lifestyle㻌 㻌 Lowered glucose tolerance, obesity, etc60ᛦỉ්ủ Research Flow
Enrollment 100,000 pregnant women

Early Pregnancy

Mid to latepregnancy

䞉Informed consent
䞉Questionnaire䞉Collect mother’s blood and urine
samples

At birth䞉Evaluate health condition of baby
at birth䞉Collect cord blood samples
䞉Collect parent’s blood samples andmother’s hair䞉Collect baby’s dried blood sample

1 month old䞉Collect breast milk
䞉Collect baby’s hair *2

6 months to
12 years old

䞉 Questionnaire (every 6 months)
䞉 Interviews (every few yrs.) *䠍䞉 Environmental measurements *䠍Long-term Storage(Specimen Bank)
Measure Chemical
Substances

Analyze Results

Statistical Analysis

㻌 Identify environmental factors affecting children’s health*1㻌 for a part of subjects㻌 㻌 㻌 *2㻌 small cuts using scissors

61Organization
Ministry of
the Environment

䖃OverallPlanning䖃Budegeting

cooperation
Ministry of Health,
Labor and Welfare
Ministry of
Education,Culture,
Sports,Science andTechnology
United States andother countries

National Center (National Institutefor Environment Studies)䖃 Implementation body䖃 Data systems management, specimen
storage, and accuracy control
䖃 Support and oversight of Unit Centers

Medical Support Center(National Center for Child
Health and Development)

Local Governments
䖃 Outreach to increase citizens awarenessand participationcooperation
䖃 Assist recruitment through the MotherChild Health Handbook
䖃 Provide administrative data based on applicable laws

Cooperating Local
Medical Institutions(Hospitals and Clinics)
䖃 Register study participants (expectant mothers)
and collect biological specimens at the request of
the regional centers.

Call foparticipation

䖃 Providing medical support
䖃 Support protocol writing relating to theoutcome measurement㻌䖃 Guidance and support for health care
professionals involved in the study

Regional Centers
ᴾ (15 locations nationwide)䖃 Recruit study participants and conduct follow-up
until 13 years old
䖃 Collect biological specimens and implement
questionnaire program䖃 Communicate with participants through individual
62
consultation services

Table of Contents
1. The Chemical Substances Control Law (CSCL)
࣭Overview
࣭Evaluation/verification of new chemicals
࣭Response to Class I specified chemical substances
࣭Risk assessment under CSCL

2. Pollutant Release and Transfer Register Law -PRTR3. The Strategic Approach to International Chemicals
Management (SAICM)
4. Minamata Convention on Mercury
5. Japan Environment and Children’s Study (JECS)
6. Cooperative Enterprise with respect to ChemicalsManagement in Asian Countries
63

Workshop on Environmental Chemical Risk/
Pollution and Challenge in Asia
䛆Summary䛇
Purpose䠖㻌 To promote an improvement of capacity ofchemical management and to strengthenchemical management in Asia.
Agenda䠖• Current status and issues of environmental
pollution in Vietnam• Knowledge and experience of Japan on
chemicals management• Risk assessment methods of chemical
substances
Place: Hanoi, Vietnam
Date: 1st, 16th February, 2012 
2nd, 7th March, 2013
   3rd, 21st January, 2014
Participants:
MONRE (Ministry of Natural Resources and Environment),
DONRE (Natural Resources and Environment from local gov.),
MOIT (Ministry of Industry and Trade),
VINACHEMIA, etc.

64Project for the Development of Basic Schemes for
PRTR System in Kingdom of Thailand
Project by䠖 JICA, MONRE, MOI
Place䠖㻌 㻌 Kingdom of Thailand Rayong provinceTerm䠖㻌 㻌
2011 - 2014
Contents䠖㻌 the Development of Basic
Schemes for PRTR System

PROJECT Website:
http://www.jica.go.jp/project/english/thailand/013/index.html

65

The Network for Strategic Response to International
Chemical Management
Purpose㻌 The Network for Strategic Response to International Chemical Management wasestablished on July 26, 2007. All organization can participate in the network as longas they agree with the terms of network’s objectives.
Activities• Sharing of information andstrengthening of cooperation.
• Hold seminars consisting of
lectures and presentationfrom administrator fromoverseas, column, mailmagazine, etc.
Participants• As of October 2nd, 2014
Number of organizations: 315
66

POPs
Monitoring Project in East Asia
ᮾ䜰䝆䜰POPs䝰䝙䝍䝸䞁䜾䝥䝻䝆䜵䜽䝖Started in FY 2002 in response to Stockholm Convention on Persisting Organic Pollutants (POPs).
Purpose䠖To establish monitoring system and collect monitoring data continuously in East Asia㻌 㻌 [1] Collect and analyze environmental samples in East Asian Countries㻌 㻌 [2] Hold workshops for monitoring data quality check, information exchange, etc.

Republic of Korea(Jeju Island)

Vietnam (Tam Dao)Japan
(Cape Hedo)

Participating countries
Cambodia
IndonesiaJapan
Lao PDR
Malaysia
Mongolia
Philippines
Republic of Korea
Singapore
Thailand
Vietnam

Besides frequent monitoring at above three focal survey sites, corroborative
support monitoring was conducted, and provided important information for theeffectiveness evaluation to the Stockholm Convention as a Monitoring Report in
67
Asia-Pacific Regions.

Thank you for your attention.

68