Status of Chemical SubstanceManagement Policy in Japan
November 2, 2017
The 11th Tripartite Policy Dialogue on Chemicals
Management among China, Japan, Korea

Akira Nitta
Director,
Chemicals Evaluation Office,Environmental Health Department,
Ministry of the Environment, Government of Japan1

Table of Contents① Outline of the Chemical Substances Control
Law (CSCL)② Evaluation & Confirmation of New
Chemical Substances③ Risk Assessment of Existing Chemical
Substances④ Amendment of CSCL
2

① Outline of the Chemical Substances Control
Law (CSCL)

3

Role of the Chemical Substances Control Law in Japans Chemical Substance Control○In Japan, chemical substances are regulated by a variety of laws according to their exposure routes
and the life cycle stages, etc.
○The objective of CSCL is to evaluate the long-term toxicity to human via the environment, and theeffect on the living environment and ecosystem.
Exposure

HazardUse

Emissions/Discharge

Disposal

Waste Management andPublic Cleaning Act

Water Pollution Control Act

Air Pollution Control Act

Law Concerning Pollutant Release
and Transfer Register(PRTR)

Agricultural Chemicals Control
Act

Chemical Substance Control Law(CSCL)

Building Standards Act(sick building syndrome, etc.)

Household Goods Regulation Act

Household Goods Quality
Labeling Act

Pharmaceutical Medical Devices Law

Food Sanitation Act

Greenhouse
EffectAgricultural Chemicals Control Act

Ozone Layer
Depletion
Potential

Agricultural Chemicals Control Act

Effects on Living
Environments(Including animals
and plants)

Manufacture

Poisonous and Deleterious
Substances Control Act
Industrial Safety and Health Act

Impact on Human Health

Chronic(Long-Term)
Toxicity

via Environment

Consumer

CrisisManagement
Law on the Prohibition of Chemical Weapons
and the Regulation of Specific Chemicals

Acute Toxicity

Working
Environment

Act on Preventing Environmental
Pollution of Mercury

Ozone Layer
Protection Law

Law Concerning the Recovery and Destructionof Fluorocarbons

4Outline of the Preliminary Evaluation System for New Chemical Substances Under the CSCLNew Chemical Substances
Exception System
Regular Screening System
of New Chemical Substances

Manufacture Import volume
within 10t/Year(Individual Company)

Businesses submit data on① degradability, ② accumulative
property, ③ toxicity on human healthand the environment

Manufacture Import volume
within 1t/Year(Individual Company)

Intermediates · Closed
Applications · Export Only Items

Low Concern Polymer
CompoundPrior confirmationby the Government

Prior confirmationby the Government

Prior confirmationby the Government

Businesses submit data on ①
degradability, ② accumulative
property

Evaluation by theGovernment

Evaluation by theGovernment※Amended frommanufacturing/import amounts toenvironmental emissions

Low Accumulation※Amended from imported manufacturing
volume to environmental emissions

National
Pre-Confirmation

Environmental Emissions within 1t/Year(Nationwide)

Manufacture/Import
Permitted

Environmental Emissions within 10t/Year(Nationwide)※Number of substances as of October 2017
Requirement 1
・ Persistent・ High accumulation property・Long-term toxicity to humans or high-order predators

Class 1 Specified Chemical Substances (31 Substances)· Manufacturing / import permission system (virtuallyprohibited)· Prohibition of importation of ordinance-designatedproducts· Prohibition of use outside ordinance-designated use· Conformity to handling standards for substances andordinance-designated products (substance-using
products)/labeling duty
· Administrative orders for recall from the market.

Requirement 2・Persistent・Suspected long-term toxicity to humans
and / or toxicity to animals and plants

Requirement 3
・Does not fall under Requirements 1, 2

Risk is high from the viewpoint of combined
toxicity and environmental emissions

ＮＯ

ＹＥＳ

Priority Evaluation Chemical Substances(201 Substances)· Notification of manufacturing/import volume,detailed use application, etc.
· For handling operators: ① obligation to convey
information, ② guidance / advice from the country
concerning the handling method, ③ reporting on thehandling situation to the government

Significant long-term toxicity to human or living
environment, animals and plants

ＹＥＳ

ＮＯ

※New definition

Specific General Chemical Substances (Not Enforced)※Specific New Chemical Substances before Public
Announcement· Notification of manufacturing/import volume, usage
application.
· For handling operators: ① obligation to convey
information, ② guidance / advice from the country
concerning the handling method, ③reporting on thehandling situation to the government

General Chemical Substances(About 28,000 Substances)※New Chemical Substances before Public
Announcement· Notification of manufacturing/import volume, usage
application

5

Screening Assessment of General Chemical Substances etc. - Risk Assessment
General Chemical Substances (About 28,000 Substances)(Existing chemical substances/newly evaluated chemical
substances/specified general (new) chemical substances, etc.)※Number of substances as of October 2017

Notification of Manufacturing/Import
volume (more than 1 ton/year), useapplication, etc. by business operator

Screening Assessment by
the government
Risk is high from the viewpoint of combined toxicity and environmental emissions

Priority Evaluation Chemical Substances(201 Substances)

Risk Assessment by thegovernment

Persistent and high accumulative property, and long-term
toxicity to humans or high-order predators is unknown

Monitoring Chemical Substances(39 Substances)· Notification of manufacturing, import
volume, detailed use application, etc.
· Obligation to communicate information tohandling businesses

If necessary
Handling Condition
Report Request

If necessary based on
Risk Assessment results

Hazard Information,
handling condition
report request

If necessary based on
Risk Assessment results

If necessary

Hazard Survey
Instructions

Hazard Survey
Instructions
Long-term toxicity to humans or high-tier predators

Risk to human or living environment, animals and plants in considerably wide areas

Class II Specified Chemical Substances (23 Substances)· Notification of manufacture, import (scheduled and actual), volume, use application etc.
· Order for changing the planned manufacturing/import volume as necessary· Publication of substances and handling technical guidelines for designated products· Labelling obligation of designated products specified by the government

Class I Specified Chemical Substances (31 Substances)· Manufacturing / import permission system (virtually prohibited)· Prohibition of importation of ordinance-designated products· Prohibition of use outside ordinance-designated use· Conformity to handling standards for substances and ordinance-designatedproducts (substance-using products)/labeling obligation· Administrative orders for recall from the market

6

② Evaluation & Confirmation of New
Chemical Substances

7

Evaluation and Confirmation of New Chemical Substances
With regard to manufacturing or importing new chemical substances that have never been
manufactured or imported in Japan, the chemical substance are evaluated and judged
prior to the manufacture and import for the following properties, based on notificationfrom the manufacturer/ importer.

① Whether it is difficult for chemical changes to occur under natural processes(degradability)② Whether it is easily accumulated in living organisms (bioaccumulation) [hereand above, Ministry of Economy, Trade and Industry]③ In case of continuous ingestion, whether there is a risk of damage to humanhealth (long-term toxicity to humans) [Ministry of Health, Labour and Welfare]④ Whether there is a risk of interfering with habitats or the growth of animals
and plants (eco-toxicity) [Ministry of the Environment]
8

Judgment of New Chemical Substances (Article 4)
Regular Review and Judgments on New Chemical Substances (FY2016 Results)
No. of
Reviews202

No. of Judgments
No. 1

No. 2

No. 3

No. 4

No. 5

No. 6

0

9

6

43

171

0

※Regular new substances based on polymer flow schemes, as well as those subjected only to the degradation test, are also
included.

① Items falling under any of the items of Article 2, Paragraph 2 (Class I Specified Chemical
Substances) ... No. 1② When it is persistent in the degradation test, and it is judged that it is not highly accumulativeby the accumulation test or the Pow measurement test ... No. 2 - No. 5
No. 2：Human health toxicity yes, eco-toxicity no
No. 3：Human health toxicity no, eco-toxicity yes
No. 4：Human health toxicity yes, eco-toxicity yes
No. 5：Human health toxicity no, eco-toxicity no③ When judged to be of good degradability by the degradation test … No. 5④ When it is unclear if it falls under No. 1 through No. 4 … No. 6
Review and Judgment on Low Production Volume New Chemical Substances (below 10 tons/year nationwide) (FY2016 results)
No. of
Reviews

No. of Judgments

155

155

※Low production volumes for new chemical substances based on polymer flow schemes are also included.

9

Preliminary Review and Prior Confirmation of New Chemical Substances○ Able to manufacture and import by notification of new chemical substances and undergoing the regular preliminary
examination [Regular New]
○ Regardless of the regular notification, there are cases where substances can be manufactured/imported by priornotification/confirmation. (Special case system, notification exemption system). [New Low Production Volume,
New Small Volume, Low Concern Polymer, Intermediate, etc.]○ While the Japanese chemical industry shifts to small-quantity multi-varieties, on the premise of preventing
environmental pollution from chemical substances, we are adopting a rational system design that takes into
consideration small-volume and multi-product industries. Depending on each procedure, information such as on
hazardous property to be submitted to the government is different.
ProcedureType

ArticleProcedure

Hazard Data
Submitted
at Notification

Other Submitted
Materials

VolumeUpper
Limit

VolumeAdjustment

Application
Frequency

FY 2016
Results

Regular New

Article 3,
paragraph 1

Notification→JudgeDegradability/accumu
lation/human healthand ecological effects

Usage/planned
volume, etc.

NoNo

10 times/year

202

New Small
VolumeArticle 3,
paragraph 1, No. 5

Application→Confirm－

Usage/planned
volume, etc.

Within 1t
Nationwide

Yes

4 times/year

35,841

Degradability/accumu
lation(If there is data on
human health/ecological effect,
submit at time ofreport.)Usage/planned
volume, etc.

Within 10t
nationwide

Yes

Notification: 10
times/year
Application: Any time
( Extension once
/year)

1,678－

Molecular
weight/physicochemical
stability test data, etc.

No

No

Any time

28

Handling method/drawingthat show facility state, etc.

No

No

Any time

124(Simplification)

Within 1t
percompanyNo

Any time

180

New Low
Production
VolumeArticle 5,paragraph 1

Low Concern
Polymer

Article 3,
paragraph 1, No. 6

Notification→JudgeApplication→Confirm

Application→Confirm

Intermediate
Article 3,
paragraph 1, No. 4

Small Volume
Intermediate, etc.

Application→Confirm－

10

③ Risk Assessment of Existing Chemical
Substances11

Screening/Risk Assessment in CSCL※As of October 2017

Risk Assessment by Phase

CSCL Inventory
Reported Chemical
Substances

Screening Assessment
12 Substances
Cancelled※Not including thecancellation of 8
intrusive substances

5 substances
cancelled

Priority Assessment Chemical
Substance Designation

About 28,000

About 20,000 existing chemical substances
Approximately 8,000 new chemical substances examined

About 12,000

For more than 1t/year per company, notification of
manufacture/import volume and simple use

Target Substances: about 8,000201

Target: National manufacture/import
total volume above 10 tons/year

Judgment using priority matrix based on
hazard/exposure class

Risk Assessment (I)Assessment I
Target substances: 55 substances(Assessment II already implemented)
7 human health effects
13 ecological effect

Assessment II

Assessment III

1 substance

Detailed evaluation using PRTR informationand monitoring in addition to
manufacturing/import volume and detailed
use information

Determine exposure information by asking forhandling information, additional monitoring, etc.

Instruction for hazardous investigation of long-term toxicity

Risk Assessment (II)Class II Specified Chemical Substance

0 Substances

Examining hazard information

0 Substances(Former System: 23)

12

Screening Assessment○Screening assessment (chemical substance selection where the risk can not be said tobe sufficiently small) is conducted by assigning exposure classes (magnitude ofestimated emissions) and hazard class (degree of harmfulness) for each generalchemical substance using the following matrix.
Human Health
Set the toxicity class from hazard information ※ on general toxicity, reproductive developmental
toxicity, mutagenicity, carcinogenicity
Ecosystem
Set the harmfulness class from the hazard information※ related to eco-toxicity test data (algae,
crustaceans, fish) of aquatic organisms※Information reported or submitted
by the CSCL, existing inspection
information carried out by thegovernment, document
information collected by thegovernment, arbitrary report
information from the business
operator, etc.

Hazard Class
StrongClass 1

above 10,000

Class 2

1,000 – 10,000 tons

Class 3100 – 1000 tons

Class 410 – 100 tons

Class 5

1-10 tons

Outside Class

Less than 1 ton

Small

2

3

4

Out

1

H

H

H

H

O

2

H

H

3

H

O
M
H
Cannot judge that the risk is sufficiently low
O
M
M
H

4

H

M

M

L

O

5

M

M

L

L

O

O

O

O

O

O

O

For the priorities "Medium" and "Low", they will be designated as a Priority
Assessment Chemical Substance as necessary by expert judgment.

Priority Assessment
Chemical Substances

Environmental Emissions
Total Estimate

1

General Chemical SubstanceExposure Class

Large

Exposure Class

Total Estimated Environmental
Emissions・ Report information on
manufacturing/import volume, etc.
・Estimate environmental emissions
from decomposition judgment
results, set exposure class (update
yearly)Weak

13

Risk Assessment (1st)
The Risk Assessment (1st) is composed of 3 stages – Assessment I, II, III
Assessment I
Hazard assessment is performed using the same information※ as at screening assessment,
and exposure assessment is conducted using only notification information such as
manufacture/import volume. Through this, priorities for implementing Assessment II are
determined.
※Information reported or submitted by the CSCL, existing inspection
information carried out by the government, document informationcollected by the government, arbitrary report information from thebusiness operator, etc.

Assessment II
For hazard assessment, hazard information is additionally collected, and exposure
assessment is subject to risk assessment by increasing the scope of application. We also
make use of existing PRTR data and monitoring data. Through these measures, risk
assessment is carried out, and designation of Class II Specified Chemical Substances, or thedetermination of a hazard assessment is immediately made. If there is no optimal decision,
Assessment III is applied.
Assessment III
We will also refine risk assessment using handling information and additional monitoringdata. The necessity of direction of hazard investigation is determined.
14

Risk Assessment (1st) Assessment I
Result of Priority Assessment Chemical Substances
As a result of Risk Assessment (1st) Assessment I in FY 2016, there are 13 substances※ (ecologicaleffect) that were initiated for the Risk Assessment (1st) Assessment II in FY 2016.
※Of those, 2 substances have already been included in Assessment II, and 11 substances have been newly added to Assessment II.

FY 2015
Risk Assessment (1st) Assessment I Result
6 substancesin Assessment II

FY 2016
Risk Assessment (1st) Assessment I Result
Target Substances
Newly added to Priority Assessment
Chemical Substances: 1
Newly judged as Priority
Assessment Chemical Substance: 1

ResultQuantity Monitoring: 3 substances
Scheduled for removal from Priority
Assessment :2 Substances

Quantity Monitoring 6 substances

Effect on
Human Health94 Substances in
Assessment I

100
Substances

Risk Assessment (1st)Assessment II Status

94 Substancesin Assessment I

5 Substances Assessment Completed
Scheduled for removal from Priority
Assessment : 3 Substances
Continuing in Assessment II :2 substances(included in 16 substances)

16 Substancesin Assessment II
Quantity Monitoring 2 substances

9 Substances Assessment Completed
Scheduled for removal from Priority
Assessment : 2 Substances
Continuing in Assessment II :7 substances(included in 29 substances)

Ecological Effect

8 substancesin Assessment II

Newly added to Priority
Assessment Chemical
Substances:12
Newly Judged as Priority
Assessment Chemical Substances :9

Quantity Monitoring: 2 substances

20 Substancesin Assessment I

22
Substances

Assessment II: 12 substances

Assessment II: 12 substances(Added)Scheduled for removal from Priority
Assessment: 2 Substances

29 Substancesin Assessment I

29 Substancesin Assessment II
Quantity Monitoring : 2 substances※As of October 201715

Status of Risk Assessment II (1st) for Priority Assessment Chemical Substances○Risk Assessment II (1st) for Priority Assessment Chemical Substances in FY 2016 was implemented for 8 substances by March
2017, and 1 substance by June, for a total of 19 substances so far (7 human health effect, and 13 for ecological effect※1).
○Based on the evaluation so far, the status of 6 substances※2 as Priority Assessment Chemical Substances have beencancelled.※2○In the future, Risk Assessment II will be implemented on 8 substances in FY 2017 and 10 in FY 2018.
※1: Excludes hydrogen peroxide (6.17.2016) which reported the progress status of risk assessment from the viewpoint of ecological impact ※2: Includes cancelled substances from the end of FY 2016
Assessment
Judgment Date

6.17.2016

1.31.20173.24.20176.25.2017

Substance Name

Evaluation

Evaluation Result and Future Measures (Outline)

1,2-dichloropropane

Human
Health· Not applicable as a Class II Specified Chemical Substance in the current handling.
· Designation of Priority Assessment Chemical Substances has been cancelled.

Naphthalene

Ecology· Not applicable as a Class II Specified Chemical Substance in the current handling.
・Collect hazard info on human health effects in the future.

Bromomethane (aka methyl
bromide)Dichloromethane

Ecology
Human
Health· Not applicable as a Class II Specified Chemical Substance in the current handling.
· Designation of Priority Assessment Chemical Substances has been cancelled.

Benzyl benzoate

Ecology· No sufficient information to judge the suitability of Class II Specified Chemical Substances.
· Monitoring is enforced.

Hydrazine

Human/Ecology· As there are several uncertain aspects in regards to exposure assessment,
proceed to Assessment III and conduct investigation.

XyleneEcology· Could not obtain exposure assessment results sufficient for the basis of
judgment for Assessment II.
· Perform monitoring after lowering the detection lower limit value.

Zinc pyrithione

Ecology・Could not obtain exposure assessment results sufficient for the basis of judgment
for Assessment II.
・In the future, examine the method of risk assessment and monitoring after
reviewing the relationship with copper pyrithione.

1,3,5-trichloro-1,3,5-triazinane-2,4,6trione

Ecology・Could not obtain exposure assessment results sufficient for the basis of judgment
for Assessment II.
・In the future, collect actual measured data from environmental monitoring of
isocyanuric acid.

Same as above16

④ Amendment of CSCL

17

Evaluation System for New Chemical Substances (Current System)
1: Regular New Evaluation System Those who intend to manufacture or import new chemical substances shall notify the government in advance.
 The government evaluates the properties of the newly notified chemical substance (degradability, accumulation,
whether it has toxicity to human health/ecology) and regulates according to the result.

Test Items for the CSCL Regular New Evaluation System①Info related to degradability②Info related to accumulativeness ③Effect on Human Health④Ecological Effect

Does substance degrade in naturalenvironment?

Does substance accumulate easily if itenters body of organism?

Is substance toxic to livingorganisms?

CO2
H2O

Is substance toxic to humans?

2: Special Evaluation Scheme In regards to new chemical substances whose manufacturing/import volume is below a certain amount, as a special measure, some or
all of the above-mentioned evaluations will be exempted, and manufacturing and importing can be carried out after the volume isconfirmed.
 A similar special evaluation exception scheme exists in Europe and the United States, but due to the existence of original domestic
gross amount regulation in Japan, adjustment of the confirmation volume by the government may occur occasionally.

Hazardous Items Requiring
Evaluation

New Scheme for Small Volume

None

New Scheme for Low
Production Volume

Degradability/Accumulativeness(No Toxicity Required)Individual Company’s Nationwide Maximum
Maximum Volume
Volume
1 ton

1 ton

(Manufacture/Import Amount) (Manufacture/Import Amount)
10 tons

10 tons(Manufacture/Import Amount) (Manufacture/Import Amount)18

Proposed Review of the Special Evaluation Scheme Utilize the "emission factor" for each use, and review it as a more rational regulatory system on the premise of ensuring safety.
 Specifically, the domestic gross amount regulation of the special evaluation exemption scheme from the manufacture/import volume tothe environmental emissions (manufacture/import volume multiplied by the emission factor for each use).
Before Change: Domestic Gross System(Manufactured/Imported Volume)●New Chemical Substance A→１ ton (planned volume/manufacture)→333kg (after confirming volume/manufacture)

After Change: Domestic Gross System(Environmental Emissions)●New Chemical Substance A→ １ ton (planned volume/manufacture)→ Use: electrical and electronics materials→１ ton (after confirming volume/manufacture)

Manufacture/Import
Volume●New Chemical Substance A→１ ton (planned volume/manufacture)→333kg (after confirming volume/manufacture)●New Chemical Substance A→ １ ton (planned volume/manufacture)→ Use: electrical and electronics materials→１ ton (after confirming volume/manufacture)

Environmental Emissions
Amount●New Chemical Substance A→ １ ton (planned volume/manufacture)→ Use: electrical and electronics materials→１ ton (after confirming volume/manufacture)●New Chemical Substance A→１ ton (planned volume/manufacture)→333kg (after confirming volume/manufacture)<Expected Result>・With an emission coefficient of 0.0012 for electric and electronic materials,
the volume of production is 1 ton, the environmental discharge amounts to
1.2 kg, and the total discharge of the three companies is 3.6 kg, so there isno need to adjust the quantity.

 Utilizing emission factors that take into account its use, volume adjustment will decrease, andproduction and import volume will increase.
 The uncertainty due to volume adjustment is eliminated, and business predictability will improve.

19

Necessity to review Chemical Substance Management with strong toxicity○In recent years, in regards to the new chemical substances review, occasionally,
there are chemical substances that pose a serious risk when released into theenvironment due to strong toxicity to human health and the habitat of animals
and plants, while the emission is extremely small.

○However, even with such chemical substances, if emission to the environment issmall, it does not correspond to the Priority Assessment Chemical Substances towhich certain regulatory measures are imposed, and as a general chemical
substance, there is only a notification obligation for the manufacture/import
volume, making it impossible to take sufficient measures under the current CSCL.
○Therefore, it is necessary to take measures to encourage businesses to handle
appropriate chemical substances that are highly toxic so that they are notaccidentally discharged.
20

Proposed Review of Chemical Substances with Strong Toxicity
In order to call attention to businesses that deal with highly toxic chemical substances, we will establish jurisdiction,such as the obligation of business operators to communicate information, and national guidance and advice tobusiness operators.

Image Diagram
Notification

Notify the business operator about thehighly toxic chemical substance

Administration

Duty to Communicate Info

Reporting Business Operator+

Report on Handling Info

※For example, a business operator handling a highly toxic
chemical substance should keep records of the state ofdelivery and stock status of the chemical substance inadvance, in the form of a document, for a certain periodof time, so that it can respond when asked for reports.

Property
Info,
Etc.

Primary Downstream Operator+
The minister in charge may request abusiness operator handling highly toxic
chemical substances to report on thehandling situation.

Duty to communicate the info that it is ahighly toxic chemical substance

Property
Info,
Etc.

Guidance & Advice

Secondary Downstream Operator+
3rd Downstream Operator

Property
Info,
Etc.

Guidance and advice on the handling
method for highly toxic chemical
substances, according to the actual
situation of each business※For example, in order to prevent environmental
pollution, instruct and advise to provide
information such as improvement measures forthe management method along the supply chain.

21

Thank you for your attention!

22