2013,Nov.15th International Open Seminar on Chemicals Management Policies among China, Japan and Korea

Latest Trends on the Enforcement ofChemical Substances Control Law
in Japan
Ministry of the Environment, Japan
Chemicals Evaluation Office
Masanobu Kimura

Table of Contents
１．The Chemical Substances Control Law (CSCL)
・Overview
・Evaluation/ verification of new chemicals
・Risk assessment under CSCL
・Response to Class I specified chemical substances
２．Pollutant Release and Transfer Register Law 〜PRTR〜
３．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 Countries2１．Implementation of the
Chemical Substances Control Law(CSCL)

3

Chemical Regulations on chemical exposure via
environment in Japan
Exposure

HazardVia the environment

Waste

Discharge・stock

Poisonous and Deleterious Substances Control Law
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

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

※4Chemical Substances
Control Law (CSCL)
CSCL<Purpose> 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>
Jointly authorized by Ministry of Health, Labour and Welfare (MHLW), Ministry of
Economy, Trade and Industry (METI), and Ministry of the Environment (MOE)<Primary Measures>

Persistence

Bioaccumulation

Toxicity

Prohibits in principle manufacturing or use of substances of PBT Restricts manufacturing or use of substances of persistence and long-term
toxicity and requires them to be labeled Notifies the production volume of substances that could meet any of above Evaluates persistence, bioaccumulation, long-term toxicity, etc. of new
chemical substances5Chemical Substances Control Law (CSCL)＜Approach＞＞(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.
6

Chemical Substances Control Law (CSCL)
Chemical Substances Control Law(CSCL)

Persistent andbioaccumulative

Monitoring
ChemicalSubstances*

Long-term toxicity
for humans or for
higher-orderpredators

Class I Specified
ChemicalSubstances
Manufacturing orimport must be
prohibited* Notify manufacturing / import quantity

Risks are notproven to be
sufficiently low

Priority
Assessment
ChemicalSubstances(PACSs)*Long-term toxicity
for humans or
animals / plants
in livingenvironment, or
persistence inenvironment inextensive areas

Class II Specified
ChemicalSubstances
Manufacturing orimport must be
restricted as
required

Types of Chemicals regulated under CSCL
Enforced in 2012

38
140

8

Overview of CSCL
Existing Chemical
Substances

New Chemical Substances> 1 ton/year

Screening Assessment

Screening Assessment

Monitoring Chemical
Substances

Priority Assessment
Chemical Substances

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

if necessary

Evaluation of PBT*

if necessary

General Chemical Substances

Instruction to report
the state of handlingSpecified Cases

Polymers≤ 1 ton/year (e.g.,intermediates) of Low Concern

Instruction to report
the state of handling

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 business9Evaluation/ verification of new chemicals
Prior evaluation and judgement is conducted to confirm whether the new chemical
substances have following properties, based on report submitted by a manufacturer orimporter at the time of manufacturing or importing. New chemical substances is definedas substances which have not been manufactured or imported in Japan.

①Degradable:

Whether or not it is easily affected chemically in natural process②Accumulative: Whether or not it is easily accumulated within organisms③Long-term toxicity to humans: Whether or not it may affect human healththrough continuous intake④Eco-toxicity: Whether or not it will affect the habitats or growth of animals
and/or plants10Pre-Evaluation ① New Chemical Substances○The notification number of new chemical substances is in increasing trend.
The notification number was 835 in FY2012.
Number of notifications

Paper and pulp
agent1.9%※ Includes notifications for same substance
900
800

Operating oil, insulating oil,process oil and lubricant
agent 1.9%

Synthetic textile andtextile treating agent
2.9%

700
600

Glue, adhesive andsealant 3.7%

Others12.0%

500

Printing ink andcopying agent(e.g. toner) 5.1%

400
300

Plastic, plastic additiveand processing aid
6.3%

200
100

Paints andcoating
Interme agent
diates 17.4%
13.2%

Annual trend of notification numbers of
new substances

24

23

22

21

20

19

18

17

12

7

H2

60

55

50

Photoresist, photographs andprinting matrix materials‘74 ‘75 ‘80 ‘85 ‘90 ‘95 ‘00 ‘05 ‘06 ‘07‘08 ‘09 ‘10 ‘11 ‘12
6.9%
S49

0

Electric andelectronicmaterials
28.9%

Primary usage of new substances（2011)reference：METI Chemical Substances Council (1st Council, FY2012)

Pre-Evaluation ②
Low Volume New Chemical Substances○ The notification number of low volume new chemical substances was 31,673 in
FY2012.
Coloring agent (dye, pigment,
colorant, color materials) 2.6%

Number of notifications※ Includes notification for same substances
35,000Glue, adhesive and sealant
2.9%

30,000

Other materials
and additives 3.0%

25,000

Others
その他
13.8%
13.8%

Chemical processregulator 3.3%

20,00015,000

Plastics, plastic additive andprocessing aid 3.6%

10,000Electric andelectronicmaterials
28.0%Intermediates
中間物
17.9%
17.9%

Fragrance and deodorant 6.2%
5,0000Annual trend of notification number

24

23

22

21

20

19

18

17

12

7

H2

60

55

50

S49

‘74 ‘75 ‘80 ‘85 ‘90 ‘95 ‘00 ‘05 ‘06 ‘07 ‘08 ‘09 ‘10 ‘11 ‘12

Photoresist, photographs andprinting matrix materials
12.0%

Primary usage of low volume newchemical substances (FY2011)reference：METI Chemical Substances Council (1st Council, FY2012)

Pre-Evaluation ③
Low Production Volume/ Polymers of Low Concern○ The confirmed number of new chemical substances of low production volume is also in increasing trend.
The confirmed number was 1,316 in, FY2012.
○ The confirmed number of polymers of low concern, implemented from April 2010, was 80 in FY2012.
Confirmed number

Confirmed number

140
120
100
80
60
40
20
0
2010

Confirmed number of new chemical
substances of low production volume

2011

2012

Confirmed number of polymersof low concern
13Step-wise Risk Assessment Based on CSCL
CSCL Chemical Inventory

Industry’s role

Existing Chemicals + Evaluated New Chemicals
Notified Chemical Substances-Notify annual quantity of manufactureetc. (mandatory)- Submit hazard information (voluntary)

Screening Assessment
Designation of PACSs- Notify annual quantity of manufactureetc. with detailed usage (mandatory)- Submit requested hazard information- Report requested for handling situations

Risk Assessment (1st)
Risk Assessment (2nd)Class II Specified Chemical Substances**Risk Assessment Scheme is under consideration in external committee of 3 Ministries- Conduct administratively instructedhazardous properties study (long-term
toxicity tests) (mandatory upon instruction)-Notify planed annual quantity of
manufacture etc.
-Technical guidance for use etc.

14

(1) Screening Assessment【HumanHuman Health】
Health・Classified into hazard class by general toxicity, reproductive and developmental
toxicity, mutagenicity, and carcinogenicity.
【Ecological】
・Classified into hazard class by eco-toxicological test data (algae, crustacean, fish).

Class1

Class2

Class3

Class4

Class1

High

High

High

High

Class2

High

High

High

MediumClass3High

High

MediumMediumClass4High

MediumMediumDesignated as Low Risk

Class5

MediumMediumDesignated as PACSs【Physicochemical】
・Notify annual quantity of manufacture etc.
・Estimation of Total annual quantity of manufacture(every
year update)

Remain toGeneralChemicalSubstances(Exposureclass will be
Update andscreening
every year)

Designation of PACSs

Exposure Class

Hazard Class

① Screening Assessment Result by Exposure Class
Evaluated substances of 7,819(Substance over 10 t of manufacturing & import quantity, among 11,979
substances that have been reported)
In respect to
Human HealthEcological(number of substance)(number of substance)
hazard assessment

Exposure class(Definitive value ofthe FY2012)

１

14

11

２

67

48

３

322

220

４

744

551

５

1,336

988

out

5,336

6,001

○ Exposure Class is attributed, by adding degradability to the National Total
Discharge, which is estimated from the amount of manufacture/importnotified by business entities, usage classification, and emission factor of16
screening assessment.

② Collection of Hazard Information &Attribution of Hazard Class Toxicological information of general chemical substances are collectedfrom 7,819 substance exceeding 10t of import and manufacturing volumes.

 Based on the “Screening assessment methods in CSCL", hazard class are
attributed. Confirmation of reliability is based on the following documents.
・”The Reliability evaluation of hazard data on the human health effects in the CSCL”
・”The reliability evaluation of hazard data on the ecological effect in the CSCL”

 So far, the government has conducted information-gathering on generalchemicals for screening assessment, but a call for hazard information fromthe business entities will be asked, further.
17

③ 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
18

④ Designated Priority Assessment Chemical
Substances• Designated Priority Assessment Chemical
Substances are 140 (As of March 2013)
In deliberation of July 2013, 40 substances have been prepared for public notice aspriority determination corresponds.

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

NITE CHRIP
http://www.safe.nite.go.jp/english/sougou/view/IntrmSrchYusenList_en.faces（Japanese ver.））Website of Chemicals Evaluation Office, MOE
http://www.env.go.jp/chemi/kagaku/kisei/yuusen.html
19

(2) Procedure of
Risk Assessment

Priority Assessment
Chemical Substances
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
Count of Quantityof Manufacture etc.

Hazard Assessment I

Exposure Assessment I

Addition and Inspectionof Hazardous Properties

Estimation ofEnvironmental Release

Hazard Assessment

Exposure Assessment: Hearing of Opinionof Councils (Article 56)･Total annual quantity of
exposure is less than 1t･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
Designation of a Class II specified
Chemical Substance (Article 2(3))

Assessment III

Rescission of Designation
as a PACS (Article 11)

Assessment II based on more correct data

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)

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
manufacture etc. is less than 10t
orTotal annual quantity of exposure isless than 1t

① 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.

21

② Assessment I of Risk Assessment (1st)All Priority Assessment
Chemical Substances
subject to assessment
 Notified information on Priority
Assessment Chemical
Substances under Article 9 (i) of
CSCL (quantity manufactured orimported, applications, etc.)
 Information on hazardous
properties used for screening
assessment

Assessment I of Risk
Assessment (1st)Hazard Assessment
The Hazard Assessment Value for the endpoint subject toscreening assessment is derived using the same uncertainty
factor as that used in screening assessment

Exposure Assessment
Virtual emission sources by prefecture, life cycle stage andapplication are assumed according to a series of assumptions
regarding emissions, on the basis of the quantity manufactured
and delivered that has been notified by business operators=>
The emission factor is estimated by multiplying by detailed use
class=>
Environmental concentration or human intake is estimatedaccording to a series of assumptions concerning exposure<Indices>
Human: Number of emission sources nationwide at possible risk and total affected area
nationwide at possible risk
Ecology: Number of locations at possible risk

③ Assessment Ⅰ of Risk Assessment (1st)＜Result of 2013 FY＞
Priority Assessment Chemical Substances (Specified by FY2011)

95
79

Substance to undertake theAssessment II form 2013 FY
Target for Assessment I
of Risk Assessment (1st)

Total : 8
Human health :1
Ecological : 7

Substance not applicable substance tothe above& continually subjected to Assessment Ⅰ
next year

62

Substance for Assessment Ⅰ next year;
production volume survey conducted forthe time being(National estimate emissions below 1t)

6

Substance for Assessment Ⅰ next year; production volume survey conducted for thetime being(Nationwide total value less than 10t of production and import volume)2

Ref. <Completion result of evaluation Ⅱ>
Substances for Assessment II from FY2012

23
18（HH: 11, Eco:7）

④ Starting Substance of Assessment Ⅱ of
Risk Assessment (1st)18 Substances for 2012 FY＜Human health effects (11 substances)＞
substances)＞○ Hydrazine○ 1,3 - butadiene○ Dichloromethane○ 1,2 - dichloropropane○ Chloro ethylene○ Ethylene oxide○ 1,2 - epoxypropane○ Formaldehyde○ Acrylonitrile○ Benzene○ o-toluidine

8 Substances for 2013 FY＜Human health effects (1substance)＞
substance)＞○ N, N-dimethylformamide<Ecological effect (7 substances)>○ Hydrazine○ Bromomethane(Methyl bromide)<Ecological effect (7 substances)>○ 1,2,4-Trimethylbenzene○ 1,3 - dichloropropene○ Naphthalene○ n-butyl acrylate○ α-(nonyl phenyl)-ω-Hydroxy poly
○ isopropenylbenzene(oxyethylene) (also known as poly
○ p-dichlorobenzene(oxyethylene) nonyl phenyl ether)○ Initiative 2,6-di-tert-butyl-4-methyl phenol○ Hydrogen peroxide○ [3-(2-ethylhexyl) propyl amine] triphenyl boron ○ Acrylic acid(III)
○ 4,4 '- (propane-2 ,2-diyl) diphenol (bisphenol
A)24

⑤ Assessment Ⅱ of Risk Assessment (1st)Assessment I: Risk Assessment (1st)○Prioritization of risk assessment utilize only the
notification of production and import volume, as
exposure information .

Assessment II: Risk Assessment (1st)
Request of handling information,
Additional monitoring, etc.

Assessment III: Risk Assessment (1st)
Directions ofhazard survey

Hazard Assessment
Collecting additionalalready-known information,
scrutinying individually,
selecting Keystudy, andevaluating benthic
organisms in addition toaquatic organisms (algae,
crustaceans, fish)

Exposure Assessment
Implement exposure
assessment using
environmental monitoringdata and the PRTR data in
addition to the notification
information, such as
production volume

Risk assessment (2nd)Specification for Class II
Specified Chemical Substances

Cancellation of specifying of Priority
Assessment Chemical Substances

25

POPs Convention(Stockholm Convention on Persistent Organic Pollutants)
POPs…
①Toxic②Hardly decomposable③Accumulated④Long-distance transferable

International effort isrequired for pollution
prevention.

To prevent contamination by POPs, elimination and reduction of POPs is required through international
cooperation,○Adopted in May 2001; Japan concluded in August 2002. It entered into force in May 2004.
○The conference of the parties has been held six times so far, every two years.
○Professional 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.

Substances that had been added to Annex 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 ofpesticides for insect pests to in aparticular crop)

Matters determined in COP6
SubstancePrimary use

Hexabromocyclododecane,
1,2,5,6,9,10 –hexabromocyclododecane andits main isomer

Flameretardants

Remarks•

Prohibition of the manufacture, use, etc.

(Exception: production and use of beads
method-expanded polystyrene foam andextruded polystyrene foam forconstruction)

 2 substances above is designated as a Class I Specified Chemical Substance of CSCL, andmanufacture, import and use are prohibited . （Enforced in April 2014 ）※ Import of products containing HBCD (flame-proof fabric flame curtain textiles flame-retardant treatment
drug, and flame-retardant EPS beads) will be prohibited based on the CSCL Law (Enforced in August
2014 ).
※ Based on Agricultural Chemicals Regulation Law, the production and sales of agricultural chemicals
27
are already prohibited for endosulfan.

Overview of the 6th ordinary meeting of the Conference of theParties (COP6)to the Stockholm Convention on POPs
○Date：April 30 to May 2, 2013
○Location：Geneva (Switzerland)○Outcome of the meeting
・ Listing of chemicals in Annex A to the convention(new POPs substance)→Hexabromocyclododecane (HBCD) was listed to Annex A to the convention.
・ Assessment of alternatives to the use of PFOS, its salts, and PFOSF→Further evaluation of alternatives to PFOS, its salts, PFOSF at the POPRC
POPRC.
・ Work Plan for specific exemptions and acceptable purposes→ Process for the evaluation of the continued need for the various acceptablepurposes and specific exemptions is adopted （PFOS and Bromodiphenylether）
Bromodiphenylether）.
・ Effectiveness evaluation→Revised framework for effectiveness evaluation and the global monitoring planfor persistent organic pollutants were adopted .
○COP7：May 2015 in Geneva (Switzerland)・ Stockholm Convention, Basel Convention, Rotterdam Convention(three COPs)
will be held jointly.
28

Outcomes of The Persistent Organic Pollutants Review Committee（POPRC-9） (Oct.14-18 2013) and Japan’s responses• Chlorinated naphthalenes（CN）and hexachlorobutadiene （HCBD）：
decides to recommend for consideration by the Conference of the Parties for listingin Annexes A and C to the convention.
→In Japan, CN (with more than three chlorine) and HCBD are designated as Class I
Specified Chemical Substances under CSCL.
•

Pentachlorophenol and its salts and esters ：decides to prepare a risk
management evaluation that includes an analysis of possible control measuresfor pentachlorophenol and its salts and esters.
→In Japan, sales and use of PCP as an agricultural chemical is banned

Decabromodiphenyl ether ：decides to fulfill the screening criteria and preparea risk profile to review the proposal further.
→In Japan, Deca-BDE is designated as Class I Designated Chemical
Substance.under the PRTR law.

••

Dicofol：decides to place the proposal on the POPRC-10 agenda for further
consideration.
→In Japan, dicofol is designated as Class I Specified Chemical Substances under29
CSCL.

The risk assessment of PCB as a byproduct in the organic pigments
It was identified that organic pigments contain a small amount of
unintentional byproduct-PCB, on February, 2012.
PBC 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.

Study 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)
・The 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.
・It was concluded that risk to ecological and human health via the environment is low except for extreme
cases.

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

2. Pollutant Release and Transfer
Register Law ～ PRTR ～31

PRTR System
 PRTR (Pollutant Release and Transfer Register) System: Registration / Announcement systems of hazardous chemicals discharged
amount to environment and migration amount contained in waste material.
 It takes much time for the determination of threshold (standard value) andrisk evaluation.
→ Effectively reduce the discharge of [Gray Substance]- Voluntary management by business operators, information disclosure tonations and utilization by the public administration
 Preceded by U.S.A and Netherlands (Framework and main purpose aredifferent depending on countries) → In Japan, Legislated in 1999. (Act on
Confirmation, etc. of Release Amounts of Specific Chemical Substances inthe Environment and Promotion of Improvements to the Management
Thereof): (Co-Jurisdiction by the MOE and METI)
32

PRTR System (continued)
 PRTR System in Japan- Purpose: Promoting the voluntarily management improvement by business operators
Trouble Prevention for Environmental Conservation- Target Chemicals: 354 substances → 462 substances (started since FY2010)- Target Business Operators: Handling Business Operators (Defined by businesscategory / size)- 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 this year Delivery system for MSDS (Material Safety Data Sheet) is also incorporated.

33

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 and City
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 theBusiness

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].
34

Trend of Notified Discharge Amount / Migration Amount,
FY2003 ~ 2011
(Kilo Tons)

600

500

Total of Discharge /Migration Amounts

400

排出量
Discharge300

移動量
Migration
Amount

200

100

0
平成15年
平成16年
平成17年
平成18年
平成19年
平成20年
平成21年
平成22年
平成23年
2003
2004
2005
2006
2007
2008
2009
2010
2011
(Year)
35

Image of the System to Display PRTR Data on Maps
How to publish data
Select filtering / map
Server

Display resultswith a list ofcompanies

User

Display search results on map

Display
results witha map

Emissions and movement of a fiscal year
Change in emissions and movement over the years

36Purpose of PRTR and Data Utilization Examples
Purpose of PRTR

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

 Let the PRTR Discharge Amount Data to be the benchmark toward undertaking thepromotion of chemical sector
 Use as basic data when reviewing various political measures such as system forindustrial waste subject to special control, etc.

[2] Priority Decision for
Chemicals
Countermeasure by
Administration

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

[3] Promotion of voluntary
management by business
operators

 Provision of tools such as the estimation of environment concentration aroundbusiness offices to business operators.
 Used as business operator instruction material at local public entities[4] Provision of information tonationals andenhancement ofunderstanding regarding
chemicals Announce the adding up results of data and post them on the web.
 Prepare map information on discharge amount and estimated atmosphericconcentration and post them on the web.
 Prepare a guidebook for citizens and chemical fact sheet in which PRTR data isutilized.

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

37

Introduction of GHS in Japan
 Promote activities including organizing liaison conferences among
relevant ministries and agencies, setting the JIS standards of GHS
classification methods and providing governments’ classification ofsubstances.
 Classification by governments:- Approx. 2500 substances were classified between FY2005 and FY2011(further classification is currently in action).
- Classification results are made available to the public:
http://www.safe.nite.go.jp/ghs/list.html (Japanese)38

Systematic Revision to Introduce GHS
 Improve Japanese Industrial Standards (JIS)JIS Z7250 (MSDS) and Z7251 (Indication) are integrated to establish JIS Z7253, the commonbase of “communication” on the basis of the GHS with newly added indications inworkplaces (March 25, 2012).
 Revise Ministerial Ordinance of the Act on Confirmation, etc. of Release Amounts of SpecificChemical Substances in the Environment and Promotion of Improvements to theManagement Thereof
 Enlarge items listed in SDS to 16 items appropriate for the GHS (effective on: June 1, 2012
for pure substances and mixtures) Add a new obligation to make efforts for label indication (effective on: June 1, 2012 for puresubstances; April 1, 2015 for mixtures) Add a new obligation to provide SDS and labels by means appropriate for the GHS (effective
on: June 1, 2012 for pure substances; April 1, 2015 for mixtures)•

Revise the Ministerial Ordinance of the Industrial Safety and Health Act, etc. as well. SDS
and labels compliant with relevant laws and appropriate for the GHS may be created andprovided by conforming to JIS.

39

３．The Strategic Approach
to International Chemicals
Management (SAICM)

SAICM: History to Adoption• 1992 “Agenda 21” adopted at Earth Summit(Chapter 19: Management of toxic chemicals)• 1994

Intergovernmental forum on chemical safety established•Sep 2002 Implementation Plan on sustainable development for World
Summit-Aim to achieve, by 2020, that chemicals are used and produced in ways that lead to theminimization of significant adverse effects on human health and the environment, usingtransparent science-based risk assessment procedures and science -based risk
management procedures, taking into account the precautionary approach.

→ Decide to develop the strategic approach (SAICM) for the above by 2005
• 2003 ~ 2005 Three times of preparatory meeting, Regional meetings in five regions of theworld, etc.

• Feb 2006 SAICM adopted at International Conference on Chemicals
Management (ICCM)
41

Actions to SAICM (Past and Prospect)・ May 2007 Asia-Pacific regional meeting (Bangkok)
・ 2009ICCM2Review of SAICM implementation→ Further chemicals management indeveloped countries→ Support and fund to developing countries→ Actions to emerging policy issues including
chemicals in products, nano materials, etc.

・ Nov 2009

Settle on further
actions in countries
and internationalorganizations

Sep 2011： Asia-Pacific regional meeting (Beijing)･ 2009 ~ 2012 Chairmen corps meeting (multiple times)
・ Nov 2011 Open-ended working group for preparation of ICCM3
・ Sep 2012 ICCM3・ 2015ICCM4・ 2020ICCM5Follow-up of SAICM implementation

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

42

Japan’s activities related with SAICM
 Domestic activities
・ Promote a variety of individual measures (Revision of Chemical
Substances Control Law and Act on Confirmation, etc. of Release Amountsof Specific Chemical Substances in the Environment and Promotion of
Improvements to the Management Thereof)・ Set up a liaison meeting at relevant Ministries and Agencies
・ Place the 2020 goal and SAICM in the Basic Environment Plan
・ Formulate the SAICM national implementation plan (11th Sep, 2012)
・ Policy dialogue on chemical substances and environment

 International activities
・ ICCM Vice Chairperson as representative of Asia-Pacific Region・ Support Thailand and Bhutan for the Quick Start Program (in-kind QSP)・ Participate in the activities such as workshops related to emerging policy
issues, etc.
43

SAICM National Implementation Plan (Nov.2013)[Conventional measures and issues in chemicals management]
Promotion of chemicals management with international viewpoint pursuant to SAICM
 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
On 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) Promotion of science-based risk assessment
 Risk reduction throughout whole life-cycle
 Response to emerging and uncertain issues
Review of the progress of the Plan and its
announcement prior to ICCM4 to be held in2015

 Strengthening of safety and security
 Promotion of international cooperation andcoordination
 Issues to be examined in the future
Amendment, if necessary, reflecting thediscussion in ICCM

Towards Achievement of WSSD2020 Goal

44

SAICM implementation plan of Japan
6 pillars of Actions (1) 6 main actions ~ Concrete action items(1) Promotion of science-based risk assessment(2) Risk reduction throughout whole life-cycle(3) Response to emerging and uncertain issues(4) Strengthening of safety and security(5) Promotion of international cooperation andcoordination(6) Issues to be examined in the future(1) Promotion of science-based risk assessment
 Promote efficiently scientific risk assessment and develop a new method and make it in practical use.
- Take actions based on Chemical Substances Control Law, Agricultural Chemicals Regulation Act, andIndustrial Safety and Health Act- Utilize QSAR or Category Approach- Perform POPs and monitoring of heavy metals, etc.
- Set the environmental target, upgrade of the quantitative evaluation method for setting the environmental
target, etc.

(2) Risk reduction throughout whole life-cycle
 Further promote the risk reduction measures based on the results of the risk assessment
 Risk reduction in the whole life-cycle of chemicals and a proper combination of various means-

Actions based on Chemical Substances Control Law, Industrial Safety and Health Act, and Act on Controlof Household Products Containing Harmful Substances
Measures against the environmental emission- Operation of the PRTR system
Actions related to the products recycling or the disposal stage, etc. - Actions for accidents and disasters,
etc.
45

Action Items (2)(3) Response to emerging and uncertain issues
 Right actions for the unsolved problems including the following problems that require the efforts based on
the thought of preventive measures
 Actions considering the influence of the exposure to chemicals on the health of the group who arevulnerable or have great sensitivity to chemicals.
- Ecology children survey- Actions for endocrine disruption of chemicals- Study on the complex influence of chemicals- Actions for nanomaterials- Research for the influence of the minimum amount of chemicals on human health(4) Strengthening of safety and security
 Continual performance of various monitoring, etc. as a basis for ensuring safety and security on chemicals- Conduct various environmental surveys and monitoring- Further promotion of risk communication- Promotion of taking actions for chemicals in products46Action Items (3)(5) Promotion of international cooperation and coordination
 Management of chemicals in line with SAICM from the global aspect in collaboration among the relevant
Ministries and Agencies and contribution to the international performance of SAICM- Promote actions based on POPs (Stockholm convention on Persistent Organic Pollutants)- Participate in OECD, etc.
- Collaborate globally on the Ecology and Children survey.
- Cooperation with the regions in Asia.

(6) Issues to be examined in the future With regards to the various topics we take its emergency and social requirement into consideration, inlight of the discussions in “Policy Dialogue on Chemicals and Environment” where various entities
participate and exchange their opinions, examine them in their priority levels, and promptly implement it
once it becomes possible for that.
- Actions for emerging policy issues of SAICM (chemicals in products, nanomaterials, e-waste, lead inpaints)- Actions for the so-called “sick-house” issues- Biocide47

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.
48

Chemicoco: Chemical Information Retrieval Support System
Chemicoco is a search tool for chemicals information.(Japanese only)
Users can access directry to reliable chemical information! app.2200 substances linled.

Search from
related Laws and how to use

Lists for outside data base
Links for Chemicals commentary

URL: http://www.chemicoco.go.jp/49

Manufactured Nanomaterials• MOEJ’s activities– Publication of MOEJ’s guidelines for preventing environmental
impacts from manufactured nanomaterials (MNs) (March 2009)– Projects for attempts to verify the validity of current control
measures (FY 2009-2010)– Refocused to hazard identification and monitoring of MNs in theenvironment (FY 2011- )• Evaluation of existing studies on ecotoxicity of MNs• Development of methodology for measurement of MNs aiming
at monitoring MNs in the environment• Association with activities by OECD
– Participation into discussion under the Working Party on
Manufactured Nanomaterials (WPMN) of OECD programme50

４．Minamata
Minamata Convention on Mercury

51

Minamata Convention on Mercury
Process to adoption○ UNEP started its program for Global Mercury Assessment and Management in 2001
○ February 2009, UNEP GC Decision 25 agreed to commence Negotiations in 2010
and aim at the adoption of the Convention by 2013
○ June 2010, Intergovernmental Negotiating Committee(INC1) was held, and held fivetimes of INC until 2013
○ January 2013 , agreed upon the “Minamata Convention on Mercury” texts in INC5
○ October 2013, The Conference of Plenipotentiaries on the Minamata Convention
was held in minamata and kumamoto
 more than 1000 people including about 60 ministers and other governmental
representatives from 139 countries and area
 adopt Minamata Convention on Mercury unanimously and start a signature. 92
countries and area signs the Convention .

Outline of the Convention text
○ the substantial lessons of Minamata Disease in the preamble○ regulate primary mercury mining, the import and export of mercury, artisanal and small-scale
gold mining (ASGM）○ regulate manufacture, import or export of mercury-added products
products（fluorescentfluorescent tube,
thermometer, sphygmomanometer), and regulate manufacturing processes in which mercury
is used○ promote measures of reducing emissions to the atmosphere, land or water based on Best
Available Techniques / Best Environmental Practice（BAT/BEP）
reduce emissions to the atmosphere for coal-fired power plants, the non-ferrous metal
mining industries○ promote appropriate disposal of Mercury wastes while taking existing treaty (Basel
Convention) and consistency.
○ establish the fund mechanism to support the ability development and capital spending of thedeveloping country

Action for the Convention’s effectuation○ enter into force on the ninetieth day after the date of deposit of the fiftieth instrument
ratification, acceptance, approval or accession.
○ hold the first Conference of the Parties (COP1) within one year.
○ The UNEP secretariat mentioned aiming at the Convention’s effectuation of 2016, in the
Conference of Plenipotentiariesof５．Japan Environment andChildren’s Study （JECS）

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
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.
(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.
1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.

（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.

Genetics

Psychoneuro developments:
Autism, learning disorders, AHDH (attentiondeficit hyperactivity disorder), etc.
Compromised Immune System:

Socioeconomics

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

Lifestyle

Lowered glucose tolerance, obesity, etc2

調の流れ Research Flow
Enrollment 100,000 pregnant women

Early Pregnancy
Mid to latepregnancy

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

At birth

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

1 month old・Collect breast milk
・Collect baby’s hair

6 months to
12 years old

・ Questionnaire（every 6 months)
・ Environmental measurements

Long-term Storage（Specimen Bank）
Measure Chemical
Substances

Analyze Results

Statistical Analysis

Identify environmental factors affecting children’s health3

Organization
Ministry of
the Environment●Overall Planning●Budegeting

cooperation
Ministry of Health, Laborand Welfare
Ministry of
Education,Culture,
Sports,Science andTechnology
United States and othercountries

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

Cooperating Local
Medical Institutions(Hospitals and Clinics)● Register study participants (expectant mothers) andcollect biological specimens at the request of theregional centers.

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

Medical Support Center（National Center for Child
Health and Development）● Providing medical support● Support protocol writing relating to theoutcome measurement● Guidance and support for health care
professionals involved in the study

Regional Centers（15 locations nationwide）● Recruit study participants and conduct follow-up
until 13 years old● Collect biological specimens and implement
questionnaire program● Communicate with participants through individual
consultation services
4６．Cooperative Enterprisewith respect to Chemicals
Management in Asian Countries

日中韓化学物質政策ダイアローグ○2006, December
In 8th Tripatite Environmental Ministries Meeting among Japan, China, Korea
Upon receiving the agreement on “ promotion of information exchange on policiec andregulations on chemical management.
○2007,The First Tripartite Policy Dialogue on Chemicals Management
among China, Japan, and Korea
Purpos：・ Different situation in three countries should be recognized;
・ Long-term co-operation should be set up based on common interests; and・ Co-operative activities should include the elements of capacity building, collaborationand efforts for harmonization

The 7th Dialogue has been held since Fiscal year 2007.
H19
JAPAN
（Tokyo）

H20
H21
H22
KOREA
CHINA
JAPAN
（Seoul） （Beijing） （ Tokyo ）

H23
H24
H25
KOREA
CHINA
JAPAN
（Jeju） （Hangzhou） （Kyoto）
60

For the harmonization of the chemical substancepolicy among China, Japan and Korea
We has been a dialog about chemical management with China and Korea
which are closely related to Japan about chemical management.
The export and import of the chemical substance are performed frequently with in the
East Asia area ( Mainly, China, Japan and Korea). Especially, proper management of thechemical substance within East Asia is important for each country.

Policy dialog
Transmit information about results of
dialog to the business and the public

Exchange of
opinions andInformation＜Expected outcom＞○Rationalisation and facilitationof the export and import of achemical substance○Rationalisation of the chemical
management in whole East Asia

Cooperation and harmonization of the chemical management system

61

Training Seminar in Asia (Viet Nam) for Enhancing
the Ability of Handling Chemicals【Summary】
Ｐuｒｐｏｓｅ:
To promote an improvement of a capacity ofchemical management and to strengthen chemical
management in Asia.
Major agendas:- Current status and problems ofenvironmental pollution in Viet Nam- Knowledge and experience of Japan on
chemicals management- Risk assessment methods of chemical
substances
Place:

Hanoi, Viet Nam

Date:

1 st, 16 th February, 2012

/ 2 nd, 7 th March, 2013

Participants: Departments of Ministry of Natural Resources andEnvironment, Department of Natural Resources and Environment
from local governments, etc.
Approximately 30 peopleProject for the Development of Basic Schemes for
PRTR System in Kingdom of hailand
Project by：
by：JICA、
JICA、MONRE、MONRE、MOI
Place：
Kingdom of Thailand Rayong province
Place：
Term：
2011〜
Term：
2011〜2014
Contents：
Contents： the Development of Basic
Schemes for PRTR System

プロジェクトのホームページ：
http://www.jica.go.jp/project/english/thailand/013/index.html

63

The Network for strategic Response to
International Chemical Managemant
PurposeThe Network for strategic Response to International Chemical Managemant wasestablished on July 26, 2007. All organisation can participate in the network as longas it arranges to network’s objectives.
Activities○Sharing of information andstrengthening of cooperation.
Hold a seminars was consistedof lectures from administrator
from overseas, column, mailmagazine.
Participants○As od October 2nd, 2013
Number of organizations:313
64

Thank you for your attention.