Introduction on the Chemical
Management Policy in Japan
November 11, 2015
The 9th Tripartite Policy Dialogue on Chemicals
Management among CJKTakehiko FUKUSHIMA
Director,
Chemicals Evaluation Office,Ministry of the Environment, JAPANTable of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
2

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
3Basic Environment Plan
• 㻸㼛㼚㼓㻙㼠㼑㼞㼙㻌㼏㼛㼙㼜㼞㼑㼔㼑㼚㼟㼕㼢㼑㻌㼚㼍㼠㼕㼛㼚㼍㼘㻌㼜㼘㼍㼚㻌㼒㼛㼞㻌㼑㼚㼢㼕㼞㼛㼚㼙㼑㼚㼠㼍㼘㻌㼏㼛㼚㼟㼑㼞㼢㼍㼠㼕㼛㼚㻘㻌㼎㼍㼟㼑㼐㻌㼛㼚㻌㼠㼔㼑㻌䇾㻮㼍㼟㼕㼏㻌㻱㼚㼢㼕㼞㼛㼚㼙㼑㼚㼠㻌㻸㼍㼣䇿㻌• 㼀㼔㼑㻌㼘㼍㼠㼑㼟㼠㻌㻠㼠㼔㻌㻮㼍㼟㼕㼏㻌㻱㼚㼢㼕㼞㼛㼚㼙㼑㼚㼠㻌㻼㼘㼍㼚㻌㼟㼠㼍㼞㼠㼑㼐㻌㼡㼜㼛㼚㻌㼠㼔㼑㻌㻯㼍㼎㼕㼚㼑㼠㻌㻰㼑㼏㼕㼟㼕㼛㼚㻌㼛㼚㻌㻭㼜㼞㼕㼘㻌㻞㻣㻘㻌㻞㻜㻝㻞㻌• 㻥㻌㼒㼛㼏㼍㼘㻌㼍㼞㼑㼍㼟㻌㼕㼚㼏㼘㼡㼐㼑㻌㻧㻌䇾㻱㼒㼒㼛㼞㼠㼟㻌㼠㼛㼣㼍㼞㼐㼟㻌㼑㼟㼠㼍㼎㼘㼕㼟㼔㼕㼚㼓㻌㼏㼛㼙㼜㼞㼑㼔㼑㼚㼟㼕㼢㼑㻌㼙㼑㼍㼟㼡㼞㼑㼟㻌㼍㼚㼐㻌㼜㼞㼛㼙㼛㼠㼕㼚㼓㻌㼠㼔㼑㼟㼑㻌㼙㼑㼍㼟㼡㼞㼑㼟㻌㼒㼛㼞㻌㼏㼔㼑㼙㼕㼏㼍㼘㻌㼟㼡㼎㼟㼠㼍㼚㼏㼑㼟䇿㻚㻌㻌㻵㼠㼟㻌㼜㼛㼘㼕㼏㼥㻌㼓㼛㼍㼘㼟㻌㼍㼞㼑㻌㻧㻌䐟䐠䐡䐢㻭㼏㼔㼕㼑㼢㼕㼚㼓㻌㼃㻿㻿㻰㻌㻞㻜㻞㻜㻌㻳㼛㼍㼘㻌㻾㼑㼐㼡㼏㼕㼚㼓㻌㼞㼕㼟㼗㼟㻌㼠㼔㼞㼛㼡㼓㼔㼛㼡㼠㻌㼘㼕㼒㼑㼏㼥㼏㼘㼑㻘㻌㼠㼍㼏㼗㼘㼕㼚㼓㻌㼣㼕㼠㼔㻌㼡㼚㼑㼤㼜㼘㼍㼕㼚㼑㼐㻌㼜㼞㼛㼎㼘㼑㼙㼟㻌㼑㼠㼏㻚㻌㻌㻱㼟㼠㼍㼎㼘㼕㼟㼔㼕㼚㼓㻌㼍㼚㼐㻌㼜㼞㼛㼙㼛㼠㼕㼚㼓㻌䇾㼏㼛㼙㼜㼞㼑㼔㼑㼚㼟㼕㼢㼑㻌㼙㼑㼍㼟㼡㼞㼑㼟䇿㻌㼁㼚㼐㼑㼞㼟㼠㼍㼚㼐㼕㼚㼓㻌㼍㼚㼐㻌㼏㼛㼚㼒㼕㼐㼑㼚㼏㼑㻌㼒㼛㼞㻌㼍㼘㼘㻌㼍㼏㼠㼛㼞㼟㻌㼑㻚㼓㻚㻌㼏㼛㼚㼟㼡㼙㼑㼞㼟㻘㻌㼕㼚㼐㼡㼟㼠㼞㼕㼑㼟㻘㻌㻺㻳㻻㼟㻘㻌㼓㼛㼢㼑㼞㼚㼙㼑㼚㼠㻌㼍㼓㼑㼚㼏㼕㼑㼟㻧㻌㼍㼚㼐㻌㼍㼏㼠㼕㼛㼚㼟㻌㼎㼥㻌㼍㼘㼘㻌㼍㼏㼠㼛㼞㼟㻌㻵㼚㼠㼑㼞㼚㼍㼠㼕㼛㼚㼍㼘㻌㼏㼛㼛㼞㼐㼕㼚㼍㼠㼕㼛㼚㻌㼍㼚㼐㻌㼏㼛㼛㼜㼑㼞㼍㼠㼕㼛㼚㻌• 㻯㼔㼑㼙㼕㼏㼍㼘㻌㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠㻌㼕㼚㻌㼘㼕㼚㼑㻌㼣㼕㼠㼔㻌㻿㻭㻵㻯㻹㻌4

SAICM National Implementation Plan (NIP)䛆㻯㼡㼞㼞㼑㼚㼠㻌㼜㼞㼛㼓㼞㼑㼟㼟㻌㼍㼚㼐㻌㼕㼟㼟㼡㼑㼟䛇㻌l 㻼㼞㼛㼙㼛㼠㼕㼚㼓㻌㼏㼔㼑㼙㼕㼏㼍㼘㻌㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠㻌㼜㼛㼘㼕㼏㼕㼑㼟㻌㼕㼚㻌㼘㼕㼚㼑㻌㼣㼕㼠㼔㻌㻿㻭㻵㻯㻹㻌Ø 㻵㼙㼜㼘㼑㼙㼑㼚㼠㼍㼠㼕㼛㼚㻌㼕㼟㻌㼛㼚㼓㼛㼕㼚㼓㻌㼕㼚㻌㼞㼑㼘㼍㼠㼑㼐㻌㼍㼞㼑㼍㼟㻌㼑㻚㼓㻚㻌㼑㼚㼢㼕㼞㼛㼚㼙㼑㼚㼠㻌㻔㻮㼍㼟㼕㼏㻌㻼㼘㼍㼚㻘㻌㼚㼑㼣㻛㼑㼤㼕㼟㼠㼕㼚㼓㻌㼏㼔㼑㼙㼕㼏㼍㼘㼟㻌㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠㻕㻘㻌㼣㼛㼞㼗㼑㼞㼟㻌㼟㼍㼒㼑㼠㼥㻘㻌㼏㼛㼚㼟㼡㼙㼑㼞㻌㼟㼍㼒㼑㼠㼥㻌㼑㼠㼏㻚㻌l 㻹㼑㼍㼚㼣㼔㼕㼘㼑㻘㻌㼙㼛㼞㼑㻌㼏㼛㼛㼞㼐㼕㼚㼍㼠㼕㼛㼚㻌㼍㼙㼛㼚㼓㻌㼠㼔㼑㻌㼐㼕㼒㼒㼑㼞㼑㼚㼠㻌㼜㼛㼘㼕㼏㼥㻌㼍㼞㼑㼍㼟㻌㼕㼟㻌㼚㼑㼑㼐㼑㼐㻌㼕㼚㻌㼞㼑㼟㼜㼛㼚㼐㼕㼚㼓㻌㼠㼛㻌㼏㼕㼠㼕㼦㼑㼚㼟䇻㻌㼏㼛㼚㼏㼑㼞㼚㼟㻘㻌㼞㼕㼟㼗㻌㼍㼟㼟㼑㼟㼟㼙㼑㼚㼠㻛㼙㼍㼚㼍㼓㼑㼙㼑㼚㼠㻚㻌㻼㼍㼞㼠㼕㼏㼕㼜㼍㼠㼕㼛㼚㻌㼛㼒㻌㼐㼕㼒㼒㼑㼞㼑㼚㼠㻌㼍㼏㼠㼛㼞㼟㻌㻔㼜㼛㼘㼕㼏㼥㻌㼐㼕㼟㼏㼡㼟㼟㼕㼛㼚㼟㻌㼞㼑㼓㼍㼞㼐㼕㼚㼓㻌㼏㼔㼑㼙㼕㼏㼍㼘㼟㻌㼍㼚㼐㻌㼑㼚㼢㼕㼞㼛㼚㼙㼑㼚㼠䠅㻌㻌㻾㼑㼒㼘㼑㼏㼠㼕㼚㼓㻌㼐㼕㼒㼒㼑㼞㼑㼚㼠㻌㼘㼍㼥㼑㼞㼟㻌㼛㼒㻌㼏㼕㼠㼕㼦㼑㼚㼟㻌䠄㼜㼡㼎㼘㼕㼏㻌㼔㼑㼍㼞㼕㼚㼓㼟䠅㻌㻌㻭㼐㼛㼜㼠㻌㻿㻭㻵㻯㻹㻌㻺㻵㻼㻌䇾㻯㼛㼙㼜㼞㼑㼔㼑㼚㼟㼕㼢㼑㻌㻿㼠㼞㼍㼠㼑㼓㼥㻌㼒㼛㼞㻌㻲㼡㼠㼡㼞㼑䇿㻌䠘㻻㼞㼓㼍㼚㼕㼦㼍㼠㼕㼛㼚䠖㻌㻌㻵㼚㼠㼑㼞㻙㻹㼕㼚㼕㼟㼠㼑㼞㼕㼍㼘㻌㻹㼑㼑㼠㼕㼚㼓㻌㼛㼚㻌㻿㻭㻵㻯㻹䠚㻌l 㼀㼛㻌㼜㼞㼛㼙㼛㼠㼑㻌㼟㼏㼕㼑㼚㼠㼕㼒㼕㼏㻌㼞㼕㼟㼗㻌㼍㼟㼟㼑㼟㼟㼙㼑㼚㼠㻌 l 㼀㼛㻌㼕㼚㼏㼞㼑㼍㼟㼑㻌㼟㼍㼒㼑㼠㼥㻌㼍㼚㼐㻌㼍㼟㼟㼡㼞㼍㼚㼏㼑㻌l 㼀㼛㻌㼞㼑㼐㼡㼏㼑㻌㼞㼕㼟㼗㻌㼠㼔㼞㼛㼡㼓㼔㼛㼡㼠㻌㼘㼕㼒㼑㼏㼥㼏㼘㼑㻌l 㼀㼛㻌㼜㼞㼛㼙㼛㼠㼑㻌㼕㼚㼠㼑㼞㼚㼍㼠㼕㼛㼚㼍㼘㻌㼏㼛㼛㼜㼑㼞㼍㼠㼕㼛㼚㻌㻒㻌l 㼀㼛㻌㼠㼍㼏㼗㼘㼑㻌㼣㼕㼠㼔㻌㼡㼚㼑㼤㼜㼘㼍㼕㼚㼑㼐㻌㼜㼞㼛㼎㼘㼑㼙㼟㻌㼏㼛㼛㼞㼐㼕㼚㼍㼠㼕㼛㼚㻌㻌l 㼀㼛㻌㼕㼐㼑㼚㼠㼕㼒㼥㻌㼒㼡㼠㼡㼞㼑㻌㼕㼟㼟㼡㼑㼟㻌䖃㻌㻌㻌㻾㼑㼜㼛㼞㼠㻌㼠㼔㼑㻌㻺㻵㻼㻌㼑㼢㼍㼘㼡㼍㼠㼕㼛㼚㻌㼜㼞㼕㼛㼞㻌㼠㼛㻌䖃㻌㻌㻌㻾㼑㼢㼕㼟㼑㻌㻺㻵㻼㻌㼕㼒㻌㼚㼑㼏㼑㼟㼟㼍㼞㼥㻘㻌㼒㼛㼘㼘㼛㼣㼕㼚㼓㻌㻵㻯㻯㻹㻌㻠㻌㼕㼚㻌㻞㻜㻝㻡㻌㻵㻯㻯㻹㻌㼍㼚㼐㻌㼛㼠㼔㼑㼞㻌㼐㼕㼟㼏㼡㼟㼟㼕㼛㼚㼟㻌㻌㻭㼏㼔㼕㼑㼢㼕㼚㼓㻌㼃㻿㻿㻰㻌㻞㻜㻞㻜㻌㻳㼛㼍㼘㻌5

SAICM National Implementation Plan (NIP)• September 2012, compiled by Inter-Ministerial
Meeting on SAICM.

• Future strategy for addressing the WSSD 2020 Goal– Environment area is based on the 4th Basic EnvironmentPlan.
– Other areas (e.g. workers safety) are based on the ongoing
specific policy measures and future trends of each area.

• NIP was presented at ICCM3 (Sept 2012)

• Present the NIP evaluation in ICCM 4 (Sept-Oct,2015), as well as disseminate other Japanesechemical management efforts
6

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(CSCL)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)*
7

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
8

CSCL
Chemical Substances
Control Law (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

9Enactment and Revision of CSCL
1973 enacted㻌 㻌 㻌 Restriction on manufacture/import, etc. of persistent, bioaccumulative, and long-term
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 notbioaccumulative substances (such as trichloroethylene, etc.), depending on the residual
status within environment.
1999 revised㻌 㻌 㻌 Joint jurisdiction by three ministries including Ministry of the Environment to the joint
jurisdiction by former Ministry of Welfare and Ministry of Ministry of International Tradeand Industry, due to the reorganization of government and ministries in January, 2001.
2003 revised㻌 㻌 㻌 Introduction of evaluation/verification system focusing on the effect on animals andplants (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 thorough chemical
substances (safety evaluation, etc. through notification obligation of
manufacturing/importing entities for all chemicals including existing chemicals abovecertain volume, and narrowing down to Priority Assessment Chemical Substances).
10Overview of CSCL
Prevent environmental contamination by chemicals through continual
management before and after placing on market.
*as of November 2015

Persistent, bioaccumulative, long-term
toxicity for humans or for higher-tierpredators

Priority Assessment Chemical
Substances(177 substances)- Existing Chemicals before CSCL (-1973) ca. 20,000- Assessed “New Chemicals” on the market (1973-)
i.e., new “Existing Chemicals” after CSCL ca. 8,000

Roughly obtainusage, etc.

General Chemical
Substances(approx. 28,000 substances)

Obtaindetails on
toxic effects
and usage

Polymers of low concern

Potential risk on human healthand environment

Government conducts the risk
assessment

Intermediates, etc(usage specified by law)

䞉Notification duty on manufacture/import
volume and usage details

Class II Specified
Chemical Substances(23 substances)

Prior verification

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

Persistent, bioaccumulative, but
toxicity properties unknown

Controlenvironment
emission

Prior Evaluation

New
Chemicals

Monitoring Chemical
Substances(37 substances)

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

Obtaindetails on
usage

Substances(30 substances)

Avoid
environment
emission

OCTMGVClass I Specified Chemical

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.

11Overview of CSCL
Existing Chemical
Substances

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

Screening Assessment

Screening Assessment

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

Evaluation of PBT*

if necessary

General Chemical Substances

Instruction to report
the state of handlingSpecified Cases(e.g.,intermediates)

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 business

12Types of Chemicals regulated under CSCL(As of Nov. 2015)

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)177(Candidates for the Class-II Specified Chemical Substances)

General Chemical
Substances

Industrial chemical substances other than those above

Approx.
28,000<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=en13

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 high-orderpredators• Restriction on license of manufacture/import and usage (virtually prohibited)• 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(as of Nov, 2015)㻌 㻌 Chlordanes㻌 㻌 㻌 etc.
Dichrolinated naphthalene and Pentachlorophenol(PCP) etc. will be added according
to the revision of POPs Convention in May 2015.

14

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 substantiallyextensive area
• Notification of volume of manufacture/import of present and prospect• Order to change prospect volume when restriction on manufacture/importis 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 Nov, 2015)15

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
16

Evaluation/ verification of new chemicals
Prior evaluation and judgment is conducted to confirm whether the
new chemical substances have following properties, based on reportsubmitted by a manufacturer or importer at the time of manufacturing
or importing. New chemical substances is defined as substances whichhave not been manufactured or imported in Japan.
I. Degradable: Whether or not it is easily affected chemically in natural process
II. Accumulative: Whether or not it is easily accumulated within organisms
III. Long-term toxicity to humans: Whether or not it may affect human healththrough continuous intake
IV. Eco-toxicity: Whether or not it will affect the habitats or growth of animals
and/or plants

17

CSCL Test Items
Degradation test
Condensation test

1䡚10t

Over 10t

䕿
䕿1)

䕿
䕿1)

Repeated Dose 28-day Oral Toxicity Study on
mammals䕿1)Bacterial reverse mutation assay

䕿1)
䕿1)

In vitro mammalian chromosome aberration test
Mammalian chronic toxicity, fertility/post-generation toxicity,
teratogenicity, mutagenicity, carcinogenicity, toxicokinetics,
pharmacology tests

Algae growth inhibition test㻌䠄equiv. OECD TG201䠅

Daphnia acute immobilization test䠄equiv. OECD TG202䠅
Fish acute toxicity test䠄equiv. OECD TG203䠅

Avian reproductive test䠄equiv. OECD TG206䠅

䕧2)
䕿1)
䕿1)
䕿1)
䕧2)

1) Other tests than degradation test are not required for not persistent substances.
2) These tests are usually not required, as they are designed to identify the Class 1
Specified Chemical Substances in order to determine chronic toxicity for human or
predators.

18

Exception of 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”
19
from Oct, 2014 (to p.24)

Notification Trends of New Chemicals‫ ۑ‬Recently, approx. 600 new notifications each year. Regular new chemicals areapprox. 400/year, while low volume new chemicals are approx. 200/year. Main
uses are 䐟paints/coating, 䐠intermediates, 䐡electric/electronic material. Thesemain uses do not change over the years.
㸺1RWLILFDWLRQ7UHQGVRI1HZ&KHPLFDOV㸼㸺0DLQXVHV㸦)<㸧㸼

800

primary batteries,
secondarybatteries, 2%

700

fragrance,
deodorant, 5%䠄notifications䠅chemical processregulator, 2%

others, 13%

600

paints/coating,
21%

500
photoresist
material, photo
printing, printing
plate, 6%

400

300

intermediates,
17%

200

100

0

electric/electronic, 14%‘74 ‘75 ‘80
S49 50 55‘85 ‘90 ‘95 ‘00 2005
60 H2 7 12 17 18
New chemicals ; regular2008
19 20 212011
22 23 24

FY201425 26

䠄calendar year till 2011䠅

New chemicals ; low volume
䠄Low concentration level, and annual
production/import less than 10 tons䠅

printing inks,
toners, 6%
adhesives, sealant,
6%

plastics, plastic
additives, plastic
molding
agents,8%20

Verification Trends of Low Production Volume of New Chemicals䠄=<10t/year䠅‫ ۑ‬Verifications of Low Production Volume of New Chemicals are increasing every
year. Almost 1,600 verifications in FY2014. Main uses are 䐟electric/electronicmaterial, 䐠 intermediates, 䐡photoresist material, photo printing, printing plate.
These main uses do not change over the years.
㸺9HULILFDWLRQ7UHQGVRI/RZ3URGXFWLRQ9ROXPHRI1HZ&KHPLFDOV㸼䠄verifications䠅
1600

colorant, 2%
textile treating agent,
2%

1400

1200

㸺0DLQXVHV㸦)<㸧㸼
chemical processregulator, 2%

others, 10%adhesives, sealant, 3%
plastics, plastic
additives, plastic
molding agents, 3%

1000

800

electric/electronicmaterial,32%

fragrance,
deodorant,4%

600

400
intermediates, 17%200
printing inks,
toners,5%0
1718
FY20051920
21 FY201022
23 FY201224
FY200825 FY201426
FY2005䠄ᖺᗘ䠅

paints/coating, 7%

photoresist material,
photo printing, printing
plate,13%21

Application Trends of Small Quantity New Chemicals䠄=<1t/year䠅‫ ۑ‬Applications of Small Quantity New Chemicals are increasing every year.
Approx. 36,600 applications in FY2014. Main uses are 䐟electric/electronicmaterial, 䐠 intermediates, 䐡photoresist material, photo printing, printing
plate. These main uses do not change over the years.
㸺$SSOLFDWLRQ7UHQGVRI6PDOO4XDQWLW\1HZ&KHPLFDOV㸼㸺0DLQXVHV㸦)<㸧㸼

䠄applications䠅
40,000adhesives, sealant, 3%other materials,
additives, 3%

30,000colorant, 2%

others, 12%

plastics, plastic
additives, plastic
molding agents, 3%

electric/electronicmaterial, 29%

chemical processregulator, 3%

20,000intermediates, 22%
fragrance, deodorant,
6%

10,0000

FY FY
55 ‘85
60
‘80

FY

FY

FY

FY

H2
7 ‘00
12 ‘0517‘90 ‘95

18FY

19 200820 21

FY

22 201123 24

FY

photoresist material,
photo printing,printing plate, 11%paints/coating, 7%

25 2014
26

FY
䠄ᖺᗘ䠅

22

Application Trends for Polymer of Low Concern 䠄PLC䠅
‫ ۑ‬Applications for Polymer of Low Concern 䠄PLC䠅 maintain at a certain level(introduced from the CSCL 2009 revision).

90
80

Exemption for Polymer of Low Concern (PLC)70

Polymers, that are confirmed by the 3 Ministries topose no risk of causing damage to human health or60

the habitat and other matters of plants and animals,
are exempted from mandatory notification of its
manufacture/import.

50
80

40

30

61

54

46

20

36

10
0
FY20102010

22

FY2011
2011

23

FY201224

FY201325

FY201426

ͤImplemented from FY2010
ͤᖹᡂ22ᖺᗘࡼࡾไᗘ᪂タ23

Verification Trends for intermediates, for export only, or used in a closed system‫ ۑ‬Verifications of special exemptions for intermediates etc. were 236 in FY2014.
The great majority are intermediates (approx. 80%). The most of remaining
20% are export-only. Only small numbers are closed-system use.
‫ ۑ‬The operators, which are verified for special exemption, are inspected on aregular basis by the 3 Ministries and NITE (National Institute of Technology and
Evaluation).
9HULILFDWLRQVRILQWHUPHGLDWHVHWF

Import㍺ධ

Inspection ,QVSHFWLRQVIRULQWHUPHGLDWHVHWFInspection
䠄Operators䠅䠄Verification䠅

9HULILFDWLRQV













〇㐀
manufacture











FY2014FY2013
FY2012FY2011FY2010FY2009FY2008FY2007
FY2006
FY2004
FY2003
FY2014FY2013
FY2012FY2011FY2010FY2009FY2008FY2007
FY2006
FY2004
FY2003
FY2014FY2013
FY2012FY2011FY2010FY2009FY2008FY2007
FY2006
FY2004
FY2003᳨ᰝ௳ᩘ䠄☜ㄆ௳ᩘ䠅Inspections (Verifications)
୰㛫≀㛢㙐⣔➼⏝㏵

㍺ฟᑓ⏝ရ

intermediates

Closed-system use

Export only᳨ᰝ௳ᩘ䠄஦ᴗᡤᩘ䠅Inspections (Operators)






FY2008+

FY2009

FY2010

FY2011

FY2012



FY2013



24

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
25

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.
Regulation by properties
Continuous
Prior evaluation and
Persistence,
management ofregulation of new
Bioaccumulation, Long term
existing substanceschemical substances
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.

26

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 Class27

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
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)28

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.
29

Progress of Risk Assessment by CSCL 2009 Revision
Tiered Approach
General Chemical substances

28,000Existing Chemicals before CSCL: ca. 20,000
Existing Chemicals after CSCL: ca. 8,000

11,897

Annual Manufacture Volume Reporting(more than 1 ton per company)

Volume Reporting

Target: 7,699 substances
Hazard classification has been done only
ca. 300 substances for health;ca. 235 for ecotox
due to lack of available hazard information

Screening Assessment
Designation of PACs

*Target: manufacture/import more than 10 ton
per year in total* Collected hazard info
is verified by experts

177

Risk Assessment (Tier I)

140 substances in pipeline

RA 1 - 1

Prioritization by using detailed
sales volume and use category

41 substances
RA 1- 2
RA 1- 3

Risk Assessment (Tier II)- 36 in pipeline;- 5 completed (health: 1; ecotox:4)
Lack of hazard info is a key challenge

0 substances

0 substancesClass-II Specific Chemical Substances

Detailed RA by using PRTR
data and environmental
monitoring data

Request companies for use information; MOE
conducts additional environmental monitoring
Request companies to conduct toxicity testing; Final
RA to make decision

0 substances
䠄23 before 2012 revision)

30

Review of CSCL
CSCL 2009 Revision- has fully come into effect in April 2011
- requests “5-year review” and to take necessary
measures, as needed (“Where five years has elapsed after theenforcement of this law, when the government finds it necessary inconsideration of the state of implementation of CSCL after the revision, it
shall review the provisions and take necessary measures based on the
results.”)• August 2015: METI/MOE’s joint committee has started apreliminary review (MHLW join as an obserber)• March 2016 (tbd): Initial report by the joint committee
METI: Ministry of Economy, Trade and Industry
MHLW: Ministry of Health, Labour and Welfare
MOE: Ministry of the Environment

31

Review of CSCL
METI, MHLW and MOE agrees with 3 discussion points;
consensus to be developed;
Japanese industries seems to request further
international harmonization and further uses of alternative
methods such as QSARs and Category Approach3 discussion points• Speed-up of Risk Assessment of Existing Chemicals
toward WSSD 2020 Goal
• Assessment methods of New Chemicals• Risk Management measures
32

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
33

About PRTR System
䕿 PRTR System㻌 㻌 PRTR, or Pollutant Release and Transfer Register, is a system used to register andprovide public notifications about the amounts of hazardous chemical substances being
released (emitted) into the environment as well as the amount of such substances
contained in waste materials that are to be transferred from one location to another.

䕿 Backgroundl It was necessary to effectively curtail emissions of “grey matter” because setting
thresholds (standard values) and evaluating risks take time.
l Self-management by business operators, availability of information to the public andactivities undertaken by administrations

䕿 Introduction to Japan and Other Countries
l Countries like USA and Netherland took the lead (approach and primary objectives
differ depending on the country) 㻌l Legislation took place in Japan in 1999
Title: Law Concerning Reporting, etc. of Releases to the Environment of SpecificChemical Substances and Promoting Improvements in Thereof (Chemical
Substances Control Law)
Jurisdiction: Joint jurisdiction by Ministry of Environment and Ministry of Economy,
Trade and Industry
34

About PRTR System (Continued)
䕿 Outline of Law Concerning Reporting, etc. of Releases to the Environment ofSpecific Chemical Substances and Promoting Improvements in Thereof㻌 Objectives:

Promote improvements in self-management by business operators
Proactively prevent impediments to environmental conservation
System for delivering PRTR system and SDS (Safety Data Sheet)㻌 Targeted chemical substances:
462 Class I Designated Chemical Substances
100 Class II Designated Chemical Substances
15 Class I Specified Chemical Substances㻌 Targeted Business Premises:
24 business types, Business Premises with 21 or more full-time employees㻌
Business Premises that annually handle 1 ton or more of said chemicals(Class I Specified Chemical Substances is 0.5 ton or more) or BusinessPremises holding said chemicals in facilities that fulfill special parameters㻌 Totaling items: State makes grand totals and date estimated by business operators and outof report data estimated by the State

35

Selection Standards for Targeted Substances
Hazard

1.Carcinogenic
2.Mutagenicity
3.Oral chronic toxicity
4.Inhalation chronic toxicity
5.Inhalation chronic toxicity acquired
from permissible concentration inwork environment
6.Reproductive/developmental
toxicity
7.Sensitizing potential
8.Ecotoxicity
9.Ozone depleting substances㻌

Exposure䕿 Class I Designated Chemical SubstancesØ Pollution detected from multiple areas based onmonitoring results in chemical substances related
environmental pollution investigations held over thelast ten years (commonly known as “Kurohon
studies”)
Ø Amount of annual manufacture and/or import is 100
tons or more
Ø Amount of annual manufacture and/or import ofsubstances and agrochemicals with a hazard rankingof Class I in carcinogenic terms that is 10 tons or
moreØ For ozone depleting substances, past accumulation of
manufacture and/or import amount is 10 tons or more
䕿 Class II Designated Chemical SubstancesØ Pollution detected from one point based on monitoring
results in chemical substances related environmental
pollution investigations held over the last ten years(commonly known as “Kurohon studies”)
Ø Amount of annual manufacture and/or import is 1 ton
or more36

Items targeted for reporting
Emissions
intoatmosphere

Transfers tolocations awayfrom BusinessPremiseEmissions
into soil
Discharging
into public
watersTransfers intosewersOn-site Landfill
disposal atBusiness Premise37Configuration of Releases
Point source

Emissions amount total of 401,000 tons (100%) in
FY2013
Non-point source
Non-targetedbusiness types

Household䕔 Chemical
use is outside
Annuallyof Businesshandled amountPremise䕔
Emissions intandem
withproduct
usage

Targeted business types

䕔 Report Targets

䐟 21 or more employees䐠 Annually handled amount of
1t or more
Chemical industry, steelworks,
machine industry, health industry

䕔 Report
Non-targetsof less than 1t
41,000t (10%)

160,000tons(40%)
Business-operators estimate

䕔 Report Non-targets㻌 20 or less employees(fishing,
construction,
diningindustries, etc.)
81,000t (20%)

51,000t(13%)

METI
estimates

MOE estimates䕔 Mobile 68,000t (17%)
㻌 Automobiles, ships, trains, aircrafts, etc.

38Program Implementation System䕿 Concerned Parties and Their Rolesin Program
Implementation
Business operators report
estimated amount of emissions

Estimates checked and totaled by
local governments

Report data

Reporting methods䠖
Written report (paper)
Disk report (CD, etc.)㻌 㻌 㻌 㻌 㻌 㻌Electronic report (online)㻌

Non-point source emission
amount estimates (MOE)
Exempted business-operator
emission estimates (METI)
Data outside of reports

MOE and METI make grand totals for report data and data outside ofreports and then publish grand figures

Japanese public
39

Main schedule in a year
䠐᭶
APR

䠑᭶
MAY

䠒᭶
JUN

䠓᭶
JULY

䠔᭶
AUG

䠕᭶
SEPT 䠍䠌᭶
OCT 䠍䠍᭶
NOV 䠍䠎᭶
DEC

䠍᭶
JAN

䠎᭶
FEB

䠏᭶
MAR

Reporting䠄Business operators э Local governments 䠅

The report㻌 submission from the business operators, and the confirmation.
Report to the ministries*

Data confirmation by Ministries, local governments, NITE

䠆 Ministries and government officers
㻌 䞉Ministry of Agriculture, Forestry and Fisheries (Food manufacturing, etc.)㻌 䞉Ministry od Land, Infrastructure, transport and Tourism 䠄Rail road Industry, etc.䠅㻌 䞉Ministry of Health, Labour and Welfare (Medical businesses, etc.)㻌 䞉Ministry of Education, Culture, Sports, Science (University, etc.)㻌 䞉Ministry of Economy, Trade and Industry (Jurisdiction of regulations,
Manufacturing industry such as machines)
䞉Ministry of the Environment (Jurisdiction of regulations, Waste treatment
businesses, etc.)

Online submission

Drafting of data processing
Data check by local government

Data processing of final version

Publication

Online Submission for the next fiscal year

40Transition of Reported Amount of Chemicals Released andTransferred for fiscal year 2001 to 2013
Number of Target Chemicals

50

1.4

1.3

2.1

new target chemical substances
substance exempt from report since FY2010
continued target substances

2.0 1.6
1.6 1.6

40

1.4
1.2

4.5 4.3 4.0 3.9

47.3 45.4 44.1

38.9

34.0 34.3 35.8 34.5 33.7

2009

20

51.6 48.8 50.7 47.9

2008

30

10

2013

2012

2011

2010

2007

2006

2005

2004

2003

2002

0
2001

Releaseand Transfer (ten thousand ton/year)ᒆฟ᤼ฟ㔞䞉⛣ື㔞[୓䝖䞁/ᖺ]60-2009 : 354
2010- : 462

41

Overview of PRTR㻌 Data for FY2013
Report Circumstances: 㻌l Total number of nationwide Business Premises which
made reports:㻌 㻌 㻌 㻌35,974 Business Premises• Paper submission㻌

15,403 (42.8%)• Disk submission㻌 㻌 㻌

374 ( 1.0%)• Online submission㻌 㻌

20,197 (56.1%)

42

Configuration of Overall Reported Releases and Transfers(FY2013)
Transfers tosewers0.3%
Emissions into
atmosphere
39%

Reported㻌 transfer
amounts㻌 57%

Transfers as
waste goingoutside ofBusiness
Premise57%

Overall reported
release & transfer
amounts: 376,000
tons/year

Reported㻌 releaseamounts㻌 43%

Discharges topublic waters2%

Landfill disposal
inside BusinessPremise2%

Releases intosoil
0.001%

43

Top Industry Types to Report Releases and Transfers (FY2013)

Generalmachinery/equipment
manufacturing industry
3%

Publishing, printing andrelated industries
3%

Other industry types
12%

Chemical industry
27%

Ceramic, stone and clay
production industries
4%
Electric
machinery/equipment
manufacturing industry
5%

Overall reported
release & transfer
amounts: 376,000
tons/year

Non-ferrous metal
production industry
5.1%
Steel industry
16%

Metal production
manufacturing industry
6%
Plastic productmanufacturing industry
8%

Transportation
machinery industry
10.562%44

Top 10 Substances in terms of Amounts Reported as
Released/Transferred (FY2013)
Targeted Chemical Substance Name

Total
Reported(Tons/Year)

Percentage
Reported

Toluene89,39323.8%

Manganese and its compounds

49,932

13.3%

Xylene㻌36,0699.6%

Ethyl benzene

17,378

4.6%

Methyl chlorides

17,241

4.6%

Chromium and chromic compounds

16,797

4.5%

n-Hexane

14,031

3.7%

Hydrogen fluoride and its water soluble salt

12,161

3.2%

N, N-dimethylformamide

9,304

2.5%

Ferric chlorides

9,297

2.5%

Total of Top 10 Substances

271,604

72.3%

Total

375,668

100.0%

45

Publicly Available PRTR Data
䕿Business Premise Data (Original Reporting Data)• Available from MOE homepage, downloadable in csv format (Japanese
only)• “PRTR map display system,” also available from MOE homepage(Japanese only), can search reporting Business Premises and show thereporting data.

䕿 Reporting Data Summary㻌 㻌 Available from MOE homepage,㻌 㻌 downloadable in PDF format㻌 㻌 (Japanese only (Note))㻌 㻌 㻌 㻌 (Note) Some summary data,㻌 㻌 㻌 㻌 as well as the PRTR release㻌 㻌 㻌 㻌 estimation manuals are also㻌 㻌 㻌 㻌 available in English, down㻌 㻌 㻌 㻌 loadable from the English㻌 㻌 㻌 㻌 PRTR homepage.
http://www.env.go.jp/en/chemi/prtr/prtr.html
46

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
47

Purpose of PRTR and Data Utilization Examples (1/3)
Purpose of PRTR

Utilization Examples of PRTR Data
ü Use the PRTR data as the benchmarks forpromoting chemical management policies[1] Basic Data forü Use the PRTR data as basic data in
Environmental
reviewing various regulatory measures
Conservationsuch as system for industrial waste subject
to special control, etc.
ü Use the PRTR data for environment risk
[2] Priority Decision assessment of chemicals (based on CSCL,
etc.)
for Chemicals
Countermeasure ü Use the PRTR data in selecting theby Administration
environmental monitoring substances andmonitoring points
48

Purpose of PRTR and Data Utilization Examples (2/3)
Purpose of PRTR

Utilization Examples of PRTR Data

[3] Promotion of ü Provide business operators with the tools toestimate the environmental concentration
voluntary
management by levels in their surroundings
business
ü Use the PRTR data by local agencies as
operators
materials for business operator instructions

ü Publish the PRTR data summary on the web.
[4] Public
information and ü Prepare map information on release amountpromotion ofand estimated atmospheric concentration,
understanding
and publish on the web.
regardingü Prepare citizens’ guidebooks and chemical factchemicals
sheets by using the PRTR data.
49

Purpose of PRTR and Data Utilization Examples (3/3)

Purpose of PRTR

Utilization Examples of PRTR Data

[5] Monitoringü Use the PRTR data, combined withtheenvironmental concentration data, ineffectivenessmonitoring the policy impact to reduce theand progress ofpriority substances of Air Pollution Control
environmentalAct.
policy measures

50

Using PRTR Data in Chemicals Risk Assessment
PRTR Data→Release amount by grid/river basin→Concentration level

Reporting Data

Data outside
reporting䠖Mobile source䠖Household䠖Construction
sites

Grid data are
attributedAiraccording to theBusiness Premises’
addresses

Water
Grid data arecomputed(1km x 1 km;
3rd order mesh)

Soil

Release amounts
to Air are
regrouped into
2.5-order meshdata (5km x 5km;
about 40,000
grids in Japan)
Release amounts
to water and soil
are regrouped
according to theriver basin model(about 38,000
grids in Japan)

51

Using PRTR Data in Chemicals Risk Assessment (Continued)
PRTR Data→Release amount by grid/river basin→Concentration level
Simulation model: G-CIEMS䠄Grid-Catchment Integrated
Environmental Modeling
System䠅River concentration (μg/L)

Output

input

input

(Imaging)

Physio-chemical
property, persistence

G-CIEMS output example

52

Using PRTR Data in Chemicals Risk Assessment (Continued)

Assessment Result;
Exposure
Concentration
䠄mg/L䠅
Estimated from
Simulation Model

Comparison

Assessment Result;
HazardPNEC䠄mg/L䠅
䠄Predicted No
Effect Concentration䠅

53

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts54

Laws and Regulations to Implement the Minamata Convention in Japan
Emissions / releases to the environment

Primary mercury
mining(para 3 of Art. 3)
Amendment of Mining
Act & Establishment of
the new act(No practice)

Emissions to air

Releases to water and soil

(Art. 8)(Art. 9䠅Amendment of Air Pollution Control Act

Development of inventories (para 7 of Art. 8, para 6 of Art. 9)
Mercury use

Mercury trade

Trade of mercury(paras 6 & 8 of Art. 3)
Amendment of the orderunder Foreign Exchange andForeign Trade Control Law,
etc.

Water Pollution Prevention Act

Disposal

Manufacture of mercury-added products(Art. 4)
Establishment of the new act

Interim storage of mercury(Art. 10)

Trade of mercuryadded products(Art. 4)
Amendment of the order under
Foreign Exchange and Foreign
Trade Control Law, etc.

Implementation plan
(Art. 20)
Establishment of the new act

Establishment of the new act

Mercury use in manufacturing
processes

ASGM(Art. 5)

Establishmentof the new act(No practice)

Establishment of the new act(No practice)

Mercury wastes(Art. 11)
<Wastes covered by theexisting law>
Amendment of regulations
under Waste Management
and Cleansing Act<Wastes not covered by theexisting law>
Establishment of the newact(Art. 7)

Contaminated sites(Art. 12)
Soil Contamination
Countermeasures Act & Water
Pollution Prevention Act

Financial resources and mechanism (Art. 13), Capacity-building, technical assistance and technology
transfer (Art. 14), Health aspects (Art. 16), Information exchange (Art. 17), Public information,awareness and education (Art. 18), Research, development and monitoring (Art. 19)55

Requirements under the Minamata Convention addressed by the new act(Act on Prevention of Environmental Pollution of Mercury)Art.

Requirement

Former/Current Status

Additional Action

3

Not allow primary
mercury miningl No primary mercury miningl No legal basis to prohibit
primary mercury mining

Prohibition of primary
mercury mining by the newact

4

Not allow the
manufacture of
mercury-added
products listed in
Annex Al The manufacture of someproducts (e.g. cosmetics,
agrochemicals) listed in
Annex A has been banned.
l No legal basis not to allow
the manufacture of the otherproducts listed in Annex A

l Prohibition of the
manufacture of
specified mercuryadded products by the
new actl Early phase out of some
mercury-added
products

4

Take measures toprevent theincorporation into
assembled
products ofmercury-added
productsl Some mercury-added
products (e.g. switches andrelays) are incorporated into
assembled productsl No legal basis to prevent theincorporation

Prohibition ofincorporation into
assembled products ofmercury-added productsby the new act
56

Requirements under the Minamata Convention addressed by the new act(Act on Prevention of Environmental Pollution of Mercury)Art.

Requirement

Former/Current Status

Additional Action

4

Discourage the
manufacture and the
distribution incommerce of new
mercury-added
products

No legal basis to discourage the
manufacture and the distribution
in commerce of new mercuryadded products

Prohibition of the
manufacture of new
mercury-added
products by the newact

5

Not allow the use of
mercury or mercury
compounds in the
manufacturing
processes listed in
Annex Bl No practice of using mercury
or mercury compounds in theprocesses listed in Annex B
l No legal basis to prohibit theuse of mercury or mercury
compounds in the processes

Prohibition of the useof mercury or mercury
compounds in thespecifiedmanufacturing
processes by the newact

7Take steps to reduce
the use of mercury
and mercury
compounds in ASGM

No practice of ASGM

Prohibition of gold
mining using mercury
or mercury
compounds by the
new act
57

Requirements under the Minamata Convention addressed by the new act(Act on Prevention of Environmental Pollution of Mercury)Art.

Requirement

10

Ensureenvironmentallysound interim
storage of mercury
or mercury
compounds

Former/Current Status

Additional Actionl Development ofl Poisonous and Deleterious
Substances Control Act
technical standards
regulates mercury and somefor storage of undermercury compounds as
the new act
Poisonous or Deleteriousl Introduction of a
Substances.
reporting system onl The Act aims to ensure healthstorage by the new
hygiene by sound management
actof chemicals having acutetoxicity but does not provide
storage standards andprocedures.

58

Requirements under the Minamata Convention addressed by the new act(Act on Prevention of Environmental Pollution of Mercury)Art.

Requirement

11

Take appropriate
measures that
mercury waste is
managed in anenvironmentallysound manner

Former/Current Status

Additional Action

Waste Management andCleansing Act covers most of themercury waste but not those
traded with value for reuse or
recycling (e.g. flue gas treatment
sludge from non-ferrous metal
production).

l Development oftechnical standards
for the managementof recyclable
materials containing
mercury under the
new actl Introduction of areporting system on
management by the
new act

59

Requirements under the Minamata Convention addressedby the amendment of existing laws and regulations
Art.

Requirement

Former/Current Status

Additional Action

3

Not allow the exportof mercury except incases where certain
conditions are metl Japan exports mercury toother countries.
l Foreign Exchange andForeign Trade Control Law
regulates the export ofgoods, but its order does
not provide procedures
necessary to confirm theconditions provided by theConvention.

l New policy to prohibit
export of mercury andmercury compounds for
ASGM
l Introduction of a permit
system for the export ofmercury and mercury
compounds by theamended Export Trade
Control Orderl Introduction of areporting system on theuse of mercury or
mercury compounds
exported from Japan60

Requirements under the Minamata Convention addressedby the amendment of existing laws and regulations
Art.

Requirement

Former/Current Status

Additional Action

4

Not allow theexport/import ofmercury-added
products listed in
Annex Al Japan exports/imports
mercury-added productsl Foreign Exchange and Foreign
Trade Control Law regulates
the export/import of goods but
its orders allow theexport/import of mercuryadded products listed in Annex
A

Introduction of a permit
system forimport/export specified
mercury-added
products by theamended Export Trade
Control Order andImport Trade Control
Order

8

Take measures tocontrol emissions
from sources listed
in Annex D (require
BAT/BEP for new
sources, implement
measures for existingsources

Air Pollution Control Act
designates mercury and mercury
compounds as possible toxic air
pollutants and requires emission
monitoring and control but does
not set emission standards.

Introduction of aregistration system offacilities emitting
mercury and mercury
compounds andemission standards by
the amendment of Air
Pollution Control Act
61

Requirements under the Minamata Convention addressedby the amendment of existing laws and regulations
Art.

Requirement

Former/Current Status

Additional Action

11

Take appropriate
measures that
mercury waste is
managed in anenvironmentallysound mannerl Waste Management andCleansing Act and relevant
order/ordinance:
l do not provide special
standards for wastes
consisting of mercury or
mercury compounds
l do not provide special
standards for wastes
containing mercury
compounds
l provide standards fortransportation andtreatment and disposal ofwastes contaminated withmercury or mercury
compounds

By amendment oforder/ordinancel Addition of a new
category “wastes
consisting of mercury
or mercury
compounds” tospecially controlledwastes andestablishment ofstandards for
management of such
waste categoryl Addition of special
requirements for
wastes containing or
contaminated withmercury or mercury
compounds

62

Table of Contents
1. Chemical Management Policy in Japan
2. Chemical Substances Control Law (CSCL)•••

Overview of CSCL
Evaluation/verification of new chemicals
Risk assessment under CSCL

3. PRTR Law••

Outline of PRTR system
Data Utilization Examples

4. Laws and Regulations to Implement the
Minamata Convention in Japan
5. Other Efforts
63

Overview of the Japan Environment & Children’s Study (JECS)Core Hypothesis:
Exposure to environmental chemicals in utero and in the㻌 early childhood
adversely effects children’s health

Method: Birth cohort study
Sample Size: 100,000 participants nationwide
Study Duration: Recruitment 3 years(2011-2014),㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 follow up for 13 years(2011-2028)

Objectives:㻌 㻌 (1) Identification of environmental factors impacting on children’s health㻌 㻌 (2) Development of risk management systems that reduce children’s㻌 㻌 㻌 㻌 exposure to the harmful environment㻌 㻌 (3) Creation of a sound environment for future generations㻌 㻌 (4) Establishment of the foundation for children’s study64

Policy Dialogue concerning Chemicals and the Environment
Setting subjects byrelevant parties

Exchange opinions and building
consensus among the relevant㻌 parties

Government
Citizens/Consumer
Groups and NGOs/NPOs

Industrial Associationsand Labor
Organizations

Policy Dialogue concerning
Chemicals and the Environment
AcademicPursuit of cooperation
among the relevant
parties

Local Government

Contribute to reduction of the environmental risks
associated with chemicals and building of a society
where citizens can live safely in peace

Members• Academia• Ministries (Environment, Industry, Health, Labor , Agriculture)• Local government (Osaka)• Industry Associations (Chemical, Automobile, Electronics)• Labor Unions• NGO
Policy Dialog was held 8 times since 2012

The relevant parties
commit to their own
efforts

65

Local Governments
Gifu Prefecture
The Agricultural Management Section of the
Gifu Prefectural government has beenworking on R&D of a small weeding robot for
paddy fields, nicknamed “Aigamo Robot”.
The Aigamo Robot is a moving mechanism
equipped with crawler belts.
The crawler belts “stamp and pull weeds andmuddy the water” to impede their growth.

Sapporo City
Sapporo City takes stock of
the amounts of chemicals
released by businesses andencourages them toproperly manage chemicals
and voluntarily reduce theirreleases with two systems:
the PRTR system under the
PRTR Law, and the systemfor proper management ofchemicals under its
ordinance on the protectionof the living environment.
66

Local Governments
Kumamoto Prefecture
Kumamoto Prefecture has been
taking the initiative in creating a“ mercury-free society” thatshuns the use of products
containing mercury as much as
possible and properly disposesof such products at the ends oftheir lives.

Osaka Prefecture
Osaka Prefecture works with Osaka City,
Sakai City, and other municipalities toorganize a seminar on chemicals
management once a year.
Good practices in risk communication bybusinesses are presented at the seminar,
which is usually attended by about 400500 people.

67Industrial Associations and Labor Organizations• Responsible Care
• GPS/JIPS: new chemical management initiative• JCIA BIGDr: Web portal for collecting various
information for risk assessment and learning• SCRUM: Project of Supply chain Chemical Risk
management and Useful Mechanism discussion• Publishing easy-to-understand leaflets on GHS• Use of the International Material Data System(IMDS): Designed to communicate environmental
information throughout the supply chain.
• Initiative to Elucidate the Mechanism of the Sickbuilding Syndrome68

Citizens/Consumer Groups and NGOs
pServe as mediators for the activities by citizens,businesses, national and local governments,and other actors
pUndertaking their own missions, most notably
providing objective and lucid information andadvice, on the risks of chemical substances.
Ø Brochures providing information on the risks ofchemical substancesØ Workshops and seminars for citizens
Ø Questionnaires surveys for citizens
etc.
69Thank you for your attention.

70