Scope of CSCL risk assessments and CSCL risk assessment scheme

CSCL OVERVIEW
2016
1

CSCL objectives
To prevent environmental pollution caused by chemical
substances that can impair human health or damage the inhabitation
and/or growth of flora and fauna.
To implement necessary regulations with respect to the manufacture,import, use, etc. of chemical substances

Exposure pathways

Industrially manufactured
chemical compounds ※Via the environment

Hazard end points

Long-term effects

Usage categories

Usage categories covered by the law

Chemical substances

CSCL: Chemical Substances Control Law※ Article 2 of the CSCL defines chemical compounds. 2

Outside the scope of CSCL risk
assessment

Substances not defined as “artificial chemicals” by law– From natural sources such as volcanoes and foodExposure pathways that are not “via the environment”– Indoor exposure– Workplace exposure– Direct exposure while using consumer products, etc.
Hazardous properties that can be expected to have “long-term effects”– Acute toxicity (human health)– Irritation, sensitization, etc.
Exposure other than “usage categories covered by other laws”– Exposure from usage categories regulated by other laws such as thefood sanitation law, the pesticide control law, the fertilizer control law,and the pharmaceutical affairs law.
Emission sources that are not related to “manufacturing etc.”– Accidental release– Emission sources in foreign countries

3

CSCL risk assessment scheme

Low riskSpecified byriskClass II specified
chemical substances

Risk
assessment(Phase-2)
Investigation of
toxicity directed

Risk assessment(Phase-1)(Tier-I, II, III)
Priority assessment
chemical substances

Screeningassessment

Generalchemical substances

Specified byproperty
Class I specified
chemical substances

Investigation of
toxicity directed

Monitoringchemical Substances

PBT*?

* Persistentbioaccumulative toxic
chemicals

Known long-term toxicity

Screeningassessment

Notification andevaluation

YES

4

Post-marketing
Pre-marketing

If identified as persistent andhighly bioaccumulativeNO

Low risk

New chemical
substances

Low risk

Low risk

Chemical
substances
subject toregulations on
manufacturingetc.

Detailed risk assessment
Screening assessment

Multi-step assessment
General chemical substances
Screening
Priority assessment
chemical substances
Risk assessment (l)Tier lTier llTier lll
Risk assessment (ll)Class ll specified chemicals

Objective

Required
specifications-Selection of priority
chemicals to beassessed- Ensure no
candidate chemicals
are overlooked

Appropriateness-Providing scientific- As a basis forbackground forjudgment“Class II” designation- Reliability

Promoting efficiency requires
the stepwise reduction of the numberof target chemicals
the stepwise expansion of information
to be used.
5

Information to be used in each step
HazardIndividual
handling
information

P
R
T
R

Monitoring

Physical chemical
properties

Bioaccumulation

Degradability(half-life)

Tier III

Degradability

Tier II

Usage amountdetails

Tier I

Usage amount

R
A
(I)

Long-term

Screening

ScreeningRisk
assessment
steps

Exposure● ○●○● ○ ● ○●●
● ○ ●● ●● ○○● ○ ●● ●● ○○ ●Government order to collect data on long-term
effects on humans and the environment

Risk assessment
(II)

●

●

● ● ●○○ ●RED items are newly added to the previous step. ● or ●： Essential, ○ or ○： Use if available.

Exposure
evaluation
Rough

Detailed
Detailed
hazardevaluation

6

Screening and risk assessment
Screening

Risk assessment

Target chemicals• General chemical substances(reported to the government)• Priority assessment chemical
substances (PACSs)

Purpose• Identification of PACSs• Focusing on Class II candidates

Required specifications• Conservative assessment• Appropriateness• Reliability

Number of chemicals(as of FY2015)•11,904 chemicals•163 chemicals• Chemical identity (MITI No., CAS No.
(if available))• Volume manufactured, imported(previous fiscal year)• Usage category and shipped volume• Chemical identity (MITI No., CAS No.
(if available))• Volume manufactured, imported(previous fiscal year)• Usage category (detailed) andshipped volume• 1 ton/year• >10% in mixture• 1 ton/year• >1% in mixture

Annual reportrequirements

Threshold(28,409 reports)(2,178 reports)• Place of production and use• CAS No.
Assessment units• MITI No.
• Former Type II & III monitoringchemicals• PACS registration number
7

CSCL screening approach and results

SCREENING ASSESSMENT

8

Screening
・STEP 1: Classification of exposure• Annual report (manufacture, import, usage category)• Emission factor table

・STEP 2: Classification of hazard• Data gap survey• Reliability evaluation

・STEP 3: Creation of prioritization matrix
Designation of priority assessment chemical substances9Screening characteristics
STEP 1:
Classification of exposure

STEP 2: Classification of hazard
Human health

Notified information
Production/import
volume,usage category

Total nationalemissions

Environment• Repeated dose toxicity• Reproductive toxicity• Mutagenicity• Carcinogenicity

Persistency• Biodegradability• Ecotoxicity(algae, Daphnia, fish)

STEP 3: Priority matrix
Hazard class

Exposure class

1

2

3

4

1

H

H

H

H

2

H

H

H

M

3

H

H

M

M

4

H

M

M

L

5

M

M

L

L

N/A

Out of classification

N/A

H: High
M: Medium
L: Low

10

STEP 1:
Classification of exposure
Sum up the amounts reported by all reporters andassign the total to the following equation
Total amount of environmental release= Emissions from production stage 〈A〉+ Emissions from usage stage 〈B〉

ΣB=

Quantity of shipment for eachusage category (reported) x
emission factors for each usage
category

Exposure classA = Quantity of manufacture (reported) x
production stage emission factors
Σ

Use to assign exposure class1> 10,000 t

21,000 – 10,000 t

3

100 – 1,000 t

4

10 – 100 t

5

1 – 10 t

N/A

<1 t

11

Math formulas for emission amount estimation[Code of reporter, etc. or reference code of reporter, etc.]
2. Quantity of manufacture, quantity of import, and quantity ofshipment(1) Name of chemical substance, etc.

αName of substance[Official gazette reference no.]

Ma = Quantity of manufacturex Emission factor to air during production stage–[Other no.]––Mw = Quantity of manufacturex Emission factor to water during production stage[Applicability to polymer (if polymer, write a circle in the space](2) Quantity of manufacture, import, or shipment

Ua = Quantity of shipment for each usage categoryx Emission factor to air for each usage category(Unit: t)

Fiscal Year’s results–

Quantity of manufacture (t)Uw = Quantity of shipment for each usage categoryx Emission factor to water for each usage category

Quantity of import (t)Fiscal Year’s total
Quantity of shipment (t)Shipment-related use no.
Specific use ()

Specific use ()

Specific use ()

Specific use ()

Total nationwide emission amount for human health assessment = Σ {(Ma + Mw) + Σ (Ua+ Uw)}
Business

Use

Total nationwide emission amount for environment assessment (only for surface water)= Σ { Mw + Σ (Uw)}Business

Use

12

STEP 2: Classification of hazard- human health Hazard class

SevereHazard item

1

General toxicity

4

Out ofclass

0.05< D ≤0.5

D > 0.50.005 < D ≤ 0.05 0.05 < D ≤ 0.5

D > 0.5

2

3

D ≤ 0.005

0.005< D ≤0.05

GHS class 1

GHS class 2

Reproductive/
developmental
toxicityD ≤ 0.005

Mutagenicity

GHS
class
1A

- GHS class 1B, 2- “Highly positive”
in the CSCL
- “Class 1” of
PRTR- Positive withunknownstrength

Carcinogenicity

GHS
class
1A

GHS class
1B, 2Moderate- Positive*1 in all

mutagenicity
tests in the CSCL

D: Hazard assessment value (HAV)= NOEL, etc. / Uncertainty factor (mg/kg/day)- Positive*1 inanymutagenicity
test in the
CSCL- Out of GHS
class- Negative in all
mutagenicity
tests in the
CSCL- Negative in invivo test*2

Out of GHS
class*1: Except for slightly or highly positive cases*2: Individually determine if positive in in vitro tests
13

STEP 2: Classification of hazard- environment Hazard class

SevereCriterion

GHS

Moderate

1

2

3

4

PNEC
≤0.0010.001<
PNEC
≤0.01

0.01<
PNEC
≤0.1

Chronic toxicity
Class 1Chronic
toxicity
Class 2

0.1<
PNEC
≤1
Chronic
toxicity
Class 3using
acute
toxicity

N/A
PNEC
>1

Out ofclass

PNEC: Predicted no-effect concentration (mg/L)= Minimum toxicity value / Uncertainty factor= Deemed chronic toxicity value / 10
14

STEP 3: Priority matrix
Environment

Human health
Hazard class

High

Low

Moderate

Severe
1

2

3

4

1

H

H

H

H

2

H

H

H

M

3

H

H

M

M

4

H

M

M

L

5

M

M

L

L

1

2

3

4

1

H

H

H

H

2

H

H

H

M

3

H

H

M

M

4

H

M

M

L

5

M

M

L

L

N/A

N/A

Out of classHigh
Medium/Low

Exposure class

Exposure class

SevereHazard class

Further review

High

Low

N/A

Moderate
N/A

Out of class
Out ofclassification

Designated by government
Remain as general chemical substances
as PACSs

15

15

FY2015 screening assessment results• The government has conducted screening assessments forgeneral chemicals every year since 2012.
• The number of PACs reached 196 in April 2016.
＜2015 screening assessment results＞
21 PACSs
newly designatedFY2014reportingPriority
Screeningassessment
assessment
chemicals
7,678 substances
General(PACs)(manufacture/importchemicals
more than 10t/y )11,810 substances(manufacture/import
more than 1t/y)Class II
specifiedchemicals
Risk
assessment

PACs

196 PACSs in April 2016

About 11,000 substances(prioritize as medium or low,and no hazard information)

Generalchemicals

16

Stepwise CSCL risk assessments for PACSRISK ASSESSMENT

17

About PACSs(Priority Assessment Chemical Substances)
Definition

Chemical substances that are found to require priority assessments because of thelikelihood that they may impair human health or damage the inhabitation and/or
growth of flora and fauna in the human living environment through environmental
pollution.
(Since risks are initially unclear, assessments must be made)Overview• There are 196 PACSs (April, 2016).
• Annual reports of manufacture/import volume and usage aremandatory. (≥ 1 ton per year)• Risk assessments are conducted based on the annual reports.
• Manufacturers/importers may be requested to provide
additional toxicity information if necessary.
18

CSCL risk assessment system
Report systemformanufactured
quantity, etc. isa means of
exposure
assessment

Reports of manufactured
quantity, etc.
Name
Material name

Information used for hazard
evaluation by government
Example:Manufacture Pref.
Qty
ABC
**t
ABC
**t
Shipment Pref.
Use QtyABC
XX-X **tDEF
XX-X **tABC
XX-X **t• Toxicity study information
used for reports andevaluations of new
chemical substances• Result of hazard
assessment and evaluation

Exposure
assessment

Hazardassessment

Amount of
exposure

Hazardassessment
value

Hazard level isassessed to acertain degree
by reports andevaluations,etc.

Risk assessment
19

Methods used to assess efficiently
Our approach combines a stepwise reduction in the numberof assessed chemicals with a stepwise expansion of
information to be used
Assessment step
Risk assessment(Phase I)

Tier - lll

Risk assessment(Phase II)

Detailed assessment using
publically available
information.
Newly obtained exposure
information is used to review
the assessment result.
Newly obtained toxicity test
result is used instead ofexisting long-term toxicity
information.

Information
to be used

OutputPriority list
More

Less

Increase

Tier - ll

A minimum amount ofcommon information is used
to determine the priority of
Phase II assessment or
hazard information request.

Number ofchemicals

ReduceTier - lOutline

Less

More

Assessment
reports

Assessment
reports

Usable notification information
For each manufacturer/importer, for each
substance

Report of the Manufactured quantity, etc. ofPriority Assessment Chemical Substances
1. Name and Address
2. Manufacture, Imported and Shipped Quantity(1) Name etc. of Chemical Substance[Material Name]ー[Official Gazette Ref. No.]…

3. Manufacture etc. of Chemical Substance(1) Name of manufacturing business firm and its location(2) Manufactured quantity by prefecture or imported
quantity by country/region for the relevant chemical
substance
Prefecturecode

Manufactured Country/region
quantity (t)codeImported
quantity (t)(3) Shipped quantity by prefecture (or country/region)
Prefecture code

Use code

Shipped quantity (t)――Manufactured
quantity by
manufacturinglocation
Shippedquantity by
prefecture andby useReleased quantity
can be estimatedーIf emission factor
is available[Material Management No.]

Released qty =Handled qty×
Emission factor

Have it selectablefrom reported
information―

Business Operator A
Business Operator B
Business Operator C

For each usage

Emission factors
Emission factors are specified by life-cycle stage (manufacturing, postshipping), by medium released into (air, water), by usage subcategory, andby vapor pressure/water solubility category
Vapor pressure

Air

Water solubility

Water

Production

Shipment Usage category
Lifecycle stage

Formulation

Industrial use,or private use
Service life oflong-life particles
Waste treatment

Water solubility category (mg/L)
Usage
category01

About 6,000
emission factors

02

Usage subcategory

≤10

10100

1001,000

100010,000≥10,000

a

0.02

0.02

0.05

0.05

0.05

b

0.1

0.1

0.1

0.1

0.1

a

0.5

0.5

0.75

0.75

0.9

http://www.meti.go.jp/policy/chemical_management/english/cscl/ra_emissionfactor-v03_131101.html

“Hypothetical emission source” concept
Method for using available information to judge the necessity of nextstep assessments while avoiding underestimations
Manufacturers
Importers

Manufacturer(1)

Manufacturer(2)

Importer(3)

Total shipped amount
HypotheticalemissionsourceBy usagesubcategory, byprefecture

Formulation

Industrial use

The actual number of emission
sources may be significantly larger
Concept whereby, when no actual emission source information exists, a“hypothetical emission source” is situated nearby and assumptions are made using
reported information, such as manufactured quantity(Because the quantity released from actual emission sources becomes smaller than thequantity released from hypothetical emission sources) [UNCLEAR]

Target of risk assessment- Environmental pathways of human exposure Emission
sourceFactories etc.
that usechemical
substances

Emission
media

Environmental media andenvironmental fateAir
DepositionAir

Diffusion

Livestock

Soil
Partition

Water in soil

Intake media

Exposed route

Air
Meat

Inhalation

Dairy products
GrassAbove-ground crop
Migration

River

Oral

Underground crop

Drinking water
Concentration

DilutionRiver

Freshwater fish

Freshwater fish

Ocean
Concentration

Saltwater fish

Saltwater fish24

Target of risk assessment- Ecological effect -EmissionsourceEmission
media

Environmental media andenvironmental fate

Target species

Exposure group

Algae
Crustacea
Fish

Aquaticorganisms

Benthos

Benthicorganisms

Factories etc.
that usechemical
substancesRiver
sedimentation

River

Sediment

25

Risk assessment under the CSCL
Manufactured quantity
or shipped quantity

Estimation of released
quantity

Quantity releasedAirto the environment
Estimation of environmental concentration

water

Environmental
concentration

Notification of Manufacture
Quantity etc.
Name
Chemical name

Hazard information used forhazard evaluation by
government
Example:Manufacture Pref.
Qty
ABC
**t
ABC
**t
Shipment Pref.
Use QtyABC
XX-X **tDEF
XX-X **tABC
XX-X **t• Toxicity study information
used for reports andevaluations of new chemical
substances

Exposure
assessment

Hazardassessment

Amount of
exposure

Hazardassessment
value• Result of hazard assessmentand evaluation

Estimation of intake

Amount of exposure(Human intake)
Risk assessment
Distribution of areas withrisk concern

Risk assessment
26

Current status of risk assessment(FY2015)
Risk assessment
Phase I – Tier I

Risk assessment
Phase II – Tier II

14 substances

14 substances※ Noticeable risks based on

PACSs

・6 human health concerns
・8 ecotoxicity concerns

reported annual data in 2013107 substances※ Lower risk based on reported

annual data in 2013

2 substances

Keepconducting
risk
assessments
based onreported data
in 2013.

（import/manufacture is less than 10 ton)

6 substances(estimated emission is less than 1 ton)Cancel the designation basedon three-year record

General chemicals

36 substances※ Under assessment at present.
※ Include one double countboth for health andenvironmental concern.
Result of assessment in 2015

(Assessment reportconcluded)
・2 for human healthconcern・6 for environmental
concern27

References
・Technical guidance documents for PACS risk assessments (Japanese
only)

http://www.meti.go.jp/policy/chemical_management/kasinhou/information/ra_1406_te
ch_guidance.html

・Notification of the Manufacturing Amount, etc. of General Chemical
Substances and Priority Assessment Chemical Substances (English)

http://www.meti.go.jp/policy/chemical_management/english/cscl/files/publications/fori
mporters/procedure_dec2010.pdf

・Japanese Use Category under amended CSCL (English)

http://www.meti.go.jp/policy/chemical_management/english/cscl/information.html

・Emission Factor Tables for Risk Assessment Under the CSCL (English)

http://www.meti.go.jp/policy/chemical_management/kasinhou/information/ra_emissio
nfactor-v03_131101.html

28