REACH
Chemical Safety Assessment(CSA)

Dinant Kroese
TNO Quality of Life
Zeist, The Netherlands

CONTENTS
1.

Registration requirements

2.

Core tools under REACH

3.

Procedures for Chemical Safety Assessment
Human Health
Environmental Health4.

Guidance and tools1. Registration requirements:
1. A Technical Dossier
2. A Chemical Safety Report! 1 tonne/y! 10 tonnes/yFormat of the Technical Dossier----------------------------------------------------------------------------------------------------------------------------------

identity of the Manufacturer / Importer
identity of the substanceinformation on its manufacture and use
the classification and labeling of the substanceguidance on its safe use(robust) study summaries of the information on the intrinsic propertiesof the substance derived from applying Annexes VII to XI! an indication as to whether the above issues and/or, if relevant, the Chemical Safety
Report (→) has been reviewed by an assessor! proposals for further testing, if relevant! between 1 and 10 tonnes, the Techical Dossier shall also contain exposure related
information for the substance (main use categories, type of uses, significant routes ofexposure).

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Simplified format of the Chemical Safety Report-----------------------------------------------------------------------------------------------------------------Part ASummary of risk management measures
Declaration that risk management measures are implemented
Declaration that risk management measures are communicatedPart B

Identity of the substance and physical and chemical properties
Manufacture and uses
Classification and labelling
Environmental fate properties
Human health hazard assessment
Human health hazard assessment of physicochemical properties
Environmental hazard assessment
PBT and vPvB assessment
Chemical Safety Assessment
Exposure assessment
Risk characterization

2. Core tools under REACH! The Chemical Safety Assessment is the tool used to determine thesafety of the chemical! The Chemical Safety Report is the tool used to record/document theassessment to EChA
! The Safety Data Sheet is the tool used tocommunicate
safe use to downstream users (DU)Aim of the Chemical Safety Assessment:
To establish the safe conditions of manufacture and use of a substancefor all life-cycle 1stages.
Manufacturers/Importers/Downstream Users:
have to ensure that the manufacture and use is in such a way that humanhealth and the environment are not adversely affected.

1 on their own or in preparations or in articles

Chemical Safety Assessment should describe:
1. The intrinsic properties of the substance
Human Health (Physico-chemical) hazards
Environmental Health hazards
PBT & vPvB properties

2. All manufacturing and use scenarios

PBT = Persistent, Bioaccumulating and Toxic,vPvB = very Persistent, and very Bioaccumulating

Note:
Ifthe substance meets the criteria for classification as dangerous1 or isassessed to be PBT or vPvB,
thenthe Chemical Safety Assessment has to include an exposure
assessment for one or more exposure scenario(s), exposure
estimation and risk characterization.
1 i.e. labeled with any R sentenceChemical Safety Assessment should describe:
1. The intrinsic properties of the substance
HH (PC) hazards
ENV hazards
PBT & vPvB properties

2. All manufacturing and use scenarios
3. Risk Characterisation:comparison of ad 1. with exposures of ad 2. (of scenarios, includingRMM),
showing safe manufacture & safe use

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios
Classificationand labelling
Exposure
assessment

Hazardassessment

Risk characterisation

NOAre risks adequately controlled?

NOYES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios
Classificationand labelling
Exposure
assessment

Hazardassessment

Risk characterisationNO

Are risks adequately controlled?

!10 tpa: DNEL & PNEC

NO

YES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicatedto users
downstream
users via an SDS annex)
DNEL: Derived No Effect Level;
PNEC: Predicted
No(toEffectConcentrationCSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios
if NOT
Hazardous orClassificationand orlabelling
PBTvPvB
Exposure
assessment

Hazardassessment

Document in:
Chemical safety Report & Safety Data
Sheet.
Risk
characterisation
Responsible care principles
applyNOAre risks adequately controlled?

!10 tpa: DNEL & PNEC

NO

YES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios

if hazardous,
PBT or vPvB
Exposure
assessment

ExposuresNO

Hazardassessment

Risk characterisation

Are risks adequately controlled?

!10DNELtpa: DNEL& PNEC
& PNECNO

YES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios

if hazardous,
PBT or vPvBExposure
assessment

Hazardassessment

Exposures

Risk characterisation

NOAreArerisks
adequatelycontrolled?
risks
adequatelycontrolled?

DNEL & PNEC

NOYES
YES!
ESs with RMM and operational conditions to adequately control the risks, to be:
DocumentDocumented
in Chemicalin theSafety
ChemicalReportSafetyandReport
Safety(CSR)
Data Sheets(+)
Communicated to users (to downstream users via an SDS annex)

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios

Revise RMM and/or
operationalconditions

if hazardous,
PBT or vPvB
Exposure
assessment

Exposures

NONOHazard
assessment

Risk characterisation

AreArerisks
adequatelycontrolled?
risks
adequatelycontrolled?

DNEL & PNEC

NONO

YES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios
Revise assumed RMM
and/or operational
conditions

Classificationand labelling
Exposure
assessment

Hazardassessment

Risk characterisation

NOAre risks adequately controlled?

NOYES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

CSA / describe intrinsic propertiesof the substance

1. Human health hazard assessment
2. Human health hazard assessment of phys-chem properties
3. Environmental hazard assessment
4. PBT and vPvB assessment

CSA / describe intrinsic properties
Objectives:
1. Human health hazard assessment
1. determine Classification & Labeling in accordance with 67/548/EEC
2. derive Derived No Effect Level (DNEL)2. Human health hazard assessment of phys-chem properties
3. Environmental hazard assessment
4. PBT and vPvB assessment

CSA / describe intrinsic properties
Objectives:
1. Human health hazard assessment
2. Human health hazard assessment of phys-chem properties
1. determine Classification & Labeling in accordance with 67/548/EEC

3. Environmental hazard assessment
4. PBT and vPvB assessment

CSA / describe intrinsic properties
Objectives:
1. Human health hazard assessment
2. Human health hazard assessment of phys-chem properties
3. Environmental hazard assessment
1. determine Classification & Labeling in accordance with 67/548/EEC
2. derive Predicted No Effect Concentration (PNEC)

4. PBT and vPvB assessment

CSA / describe intrinsic properties
Objectives:
1. Human health hazard assessment
2. Human health hazard assessment of phys-chem properties
3. Environmental hazard assessment
4. PBT and vPvB assessment
1. determine if criteria Annex XIII are fulfilled
2. if yes: characterize emission potential

CSA / evaluate intrinsic properties

1. Human health hazard assessment
2. Human health hazard assessment of phys-chem properties
3. Environmental hazard assessment
4. PBT and vPvB assessment
Same basic approach for all 4 assessments:

CSA / evaluate intrinsic properties(Annex VI)
1.

Gather and share available information

2.

Consider information needs

3.

Identify information gaps

4.

Generate new data / propose testing strategy

CSA / evaluate intrinsic properties
1.

Gather and share available information
All Available Health & Environmental Information:- physico-chemical data- human data
- in vitro / in vivo data-read-across, SAR, QSAR&Exposure characteristics

CSA / evaluate intrinsic properties
1.

Gather and share available information

2.

Consider information needs! ! 1 tpa

: Annex VII! ! 10 tpa: Annex VIII:! ! 100 tpa: Annex IX:! ! 1000 tpa: Annex X:

Annex XICSA / evaluate intrinsic properties
1.
2.

Gather and share available information
Consider information needs

3.

Identify information gaps
Conclude on whether information is adequate to:Assess:Allow the derivation of:Classification & Labeling,

DNEL and PNEC

PBT, vPvB

CSA / evaluate intrinsic properties
1.
2.
3.

Gather and share available information
Consider information needs
Identify information gaps

4.

Generate new data / propose testing strategy

1 Conclude on what exactly is unclear or insufficient
2 Is testing technically possible?
Yes

3 Is exposure-based waiving possible?

! 1 tpa: rules in Annex column 2! 10 tpa: rules in Annex column 2 and Annex XICSA / evaluate intrinsic properties
1.
2.
3.

Gather and share available information
Consider information needs
Identify information gaps

4.

Generate new data / propose testing strategy

1 Conclude on what exactly is unclear or insufficient
2 Is testing technically possible?

NoYes

3 Is exposure-based waiving possible?

Yes

Providejustification for
no testing

CSA / evaluate intrinsic properties
1.
2.
3.

Gather and share available information
Consider information needs
Identify information gaps

4.

Generate new data / propose testing strategy! 1 & < 10 tpa: conform test Annex VII
1 Conclude on what exactly is unclear or insufficient! 10 tpa: conform endpoint-specific ITS(RIP 3.3)

2 Is testing technically possible?
Yes

3 Is exposure-based waiving possible?
No

4 Consider if in vitro testing may be adequateNo

5 Conduct or Propose an appropriate in vivo test

CSA / evaluate intrinsic properties
1.
2.
3.

Gather and share available information
Consider information needs
Identify information gaps

4.

Generate new data / propose testing strategy

1 Conclude on what exactly is unclear or insufficient
2 Is testing technically possible?
Yes

3 Is exposure-based waiving possible?
No4 Consider if in vitro testing may be adequate

Yes

No

5 Conduct or Propose an appropriate in vivo test

Yes

Perform testorawait approval

CSA / evaluate intrinsic properties(Annex VI)

New information

1.

Gather and share available information

2.

Consider information needs

3.

Identify information gaps

4.

Generate new data / propose testing strategy

Gaps filled?

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios?
How toExposure
assessment
assessthis

if hazardous,
PBT or vPvB
Hazardassessment

Risk characterisation

NOAre risks adequately controlled?

!10 tpa: DNEL & PNEC

NOYES
ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

Hazardous?
Apply Classification & Labeling Criteriain accordance with Dir 67/548/EEC
RIP 3.6 1

REACH

Globally Harmonised Systemof Classification and Labeling of Chemicals(GHS)(reclassification deadline December 1st 2010)

1 not yet started

PBT or vPvB ?
Apply assessment criteria:
Parameter

PBT criteria

1vPvB criteria

PHalf-life:> 60 d in marine water, or> 40 d in fresh- or estuarine water, or> 180 d in marine sediment or> 120 d in fresh- or est. sediment, or> 120 d in soil

Half-life:> 60 d in marine, freshor estuarine water, or>180 d in marine, freshor estuarine sediment> 180 d in soil

B

BCF > 2000

BCF >5000

T

Chronic NOEC < 0.01 mg/l or C (cat. 1, 2) M (cat.
1, 2) R (cat. 1-3) or ED-effects T-R48 or Xn-R48

1 developed by TGD RIP 3.2

Not applicable

CSA:

Existing
knowledge/data

Hazardidentification

Exposure scenarios

if hazardous,
PBT or vPvB
Exposure
assessment

Hazardassessment!10 tpa: DNEL & PNEC?
How toassessNO
Are risks adequately controlled?
theseRisk characterisation

NOYES

ESs with RMM and operational conditions to adequately control the risks, to be:
Documented in the Chemical Safety Report (CSR)
Communicated to users (to downstream users via an SDS annex)

DNEL derivation
DNEL =NOAEL
1(lowest)

Overall1Assessment factor

NOAEL (No Observed Adverse Effect Level) from Repeated Dose Toxicity studies(28-day, 90-day, 2-year) or Reproductive Toxicity studies
Assessment Factor (AF) are to address various uncertainties in extrapolation fromanimals to humans
AF1AF2interspecies
intraspecies

AF3AFnAFmduration
dose-response (e.g. LOAEL only)
database quality

1 Overall Assessment Factor = AF1 " AF2 " AF3 " ""

value
"10"
5 (worker)
10 (general population)
2 to 6
1 to about 3!1

PNEC derivation (water)
L(E)C50PNEC =or
Assessment Factor

NOEC
HC5or
AF
AF(lowest)

L(E)C50 (Lethal Effect Concentration to 50% of population) from appropriate studies
NOEL (No Observed Effect Concentration) from appropriate studies
Assessment factor value
Short-term L(E)C50 from each of three trophic levels ofthe base-set (fish, daphnia, algae)
Additional
One long-term NOEC (either fish or Daphnia)
Two long-term NOECs from species representing two
trophic levels (fish and/or Daphnia and/or algae)
Species sensitivity distribution: HC5
Field data or model ecosystems

1000

100
505-1
case by case

6. REACH guidance and tools! RIP 1: Process description! RIP 2: Development of REACH-IT! RIP 3: Guidance documents for Industry- 3.1 TGD on preparing the Technical Dossier- 3.2 TGD on preparing the Chemical Safety Report 1- 3.3 TGD on Information requirements on Intrinsic properties- 3.6 GD on Classification & Labeling under Global Harmonised System 2! RIP 4: Guidance documents for Authorities! RIP 5/6: Setting up the Agency
1 not yet finalized
2 not yet started

Thank you for your attention!