Ref. Ares(2014)78300 - 15/01/2014

Chemical Safety Assessment and Report“Guidance on Information Requirements andChemical Safety Assessment”
Frans M. Christensen and ECHA colleagues
European Commission, DG JRC
Institute for Health and Consumer Protection (IHCP)
European Chemicals Bureau (ECB)
REACH Workshop: Final countdown
14 April 2008, Brussels

Overview - issues
••
•
••
•

Starting point: REACH Registration
Generation of information
Control of risks
Documentation
Downstream User (DU) perspective and supply
chain communication
Guidance and supporting IT tools

RegistrationAIM:Îmanufacturers and importers obtain information on theirsubstances andÎuse this knowledge to enable well-informed management of therisks these substances may present throughout their life cycle

Registration Dossier = Documentation
Î Technical Dossier: starting at 1 tonnes per yearÎ Chemical Safety Report: starting at 10 tonnes per year
No formal acceptance - industry retain responsibility

Aims of the Chemical Safety Assessment process• Collect/generate/assess information on uses, exposures and intrinsic
properties. Based on this:• Identify the conditions under which the risks arising from manufacture
and use(s) of a substance are controlled.
• Prepare a set of corresponding information on operational conditions
and risk management measures (= Exposure Scenarios) to becommunicated to the users of the substance (for dangeroussubstances).
• Document the assessment in a Chemical Safety Report (CSR) for thecompanies’ own documentation.
• Submit CSR to the authorities as part of the registration.

What is the Chemical Safety Report (CSR) ?
• The CSR is the documentation of the Chemical Safety Assessment(REACH Annex I) covering:– Hazard Assessment of the inherent properties• Human Health• Physicochemical• Environmental– PBT and vPvB assessment*• and when substance is dangerous or PBT/vPvB– Development of Exposure Scenarios for controlling risks– Exposure estimation quantifying human and environmental exposure levels– Risk Characterisation* PBT: Persistent, Bio-accumulative and Toxic* vPvB: very Persistent and very Bio-accumulative

Registration dossier - content

Technical Dossier•Identify of the manufacturer/importer•Identity of substance•Info- manufacture and use of the substance•Classification and labelling•Guidance on safe use of the substance•Study summaries – substance properties•Test proposals (if relevant)•Exposure information

Substance to beregistered> 10 tonne/year

Also

Chemical Safety Report•Hazard and PBT Assessment

Chemical Safety Report

Substance dangerous
or PBT/vPvB

Also•Hazard and PBT Assessment•Exposure Assessment•Exposure Scenarios•Exposure Estimation•Risk Characterisation

Generation of information on intrinsic properties
Hazard and PBT assessment• Generation of information on inherent properties– Collect all available information– Compare with standard information requirements (tonnagedependant) and identify information gaps
• Consider adaptations (triggering or waiving of test)– Generate further information or make a testing proposal• Hazard Assessment– Classification and labelling (C&L)– Dose/concentration-response; No-effect levels (Derived or
Predicted no-effect levels/concentrations DNELs/PNECs) orother measure of potency• Assess whether substance has PBT or vPvB properties

Registration dossier - content

Technical Dossier•Identify of the manufacturer/importer•Identity of substance•Info- manufacture and use of the substance•Classification and labelling•Guidance on safe use of the substance•Study summaries – substance properties•Test proposals (if relevant)•Exposure information

Substance to beregistered> 10 tonne/year

Also

Chemical Safety Report•Hazard and PBT Assessment

Chemical Safety Report

Substance dangerous
or PBT/vPvB

Also•Hazard and PBT Assessment•Exposure Assessment•Exposure Scenarios•Exposure Estimation•Risk Characterisation

What is an Exposure Scenario (ES) ?
– Conditions for use:
• Process description• Operational conditions (incl. quantity used, frequency andduration of specified operations)• Risk Management Measures– process control (e.g. closed system and local exhaust)– emission control– personal protective equipment– good hygiene / working practise– etc.

– Other relevant information

How will the user know?

Exposure Scenarios will be attached to the Safety Data
Sheet (SDS)-> Extended Safety Data Sheets (e-SDS)

Annex:
ESs
ESs
ESs
SafetyDataSheetExposure Scenario Content/Template
Title and covered activities
1

Short title of the exposure scenario

2

Processes and activities covered

Operational Conditions
3

Duration and frequency of use

4.1

Physical form of substance or preparation;

4.2

Concentration of substance in preparation or article

4.3

Amount used per time or activity

5

Other relevant operational conditions of use

Risk Management Measures
6.1

Risk management related to human health (workers, consumers)

6.2

Risk management measures related to the environment

7

Waste management measures

Reference to exposure prediction
8Exposure prediction and reference to its source

9

Guidance to DU to check whether he is working within ES

Overview of CSA process

Information: available

required/needed• substance intrinsic properties• manufacture, use, tonnage, exposure, risk management
Hazard Assessment (HA)

Exposure Assessment (EA)*• Hazard Classification
and PBT conclusion• Build Exposure Scenarios(RMM and OC)• Dose/Concentration-Response
Characterisation• Estimate Exposure Level

nStop

Dangerousor PBT ?

yyDocument
in CSR
Communicate
ES via eSDS

Risk Characterization (RC)**Risk
controlled?

nRequired if substance is dangerous or PBT/vPvB,
or exposure based waiving according to annex XI

Iteration

Required forall CSAs

Exposure Scenarios from theDownstream User point ofview

The Downstream User
Must:
• Implement Operational Conditions and Risk Management
Measures communicated to him via the exposure scenarios in theSDS Annex• If he uses the chemical outside the conditions described in theexposure scenario(s)– Inform his supplier of this use to make it an identified use– Alternatively:• Conduct a safety assessment for his own use (and for his downstream
uses if he is a supplier)– and implement ES from own safety assessment– and report to the Agency• Switch to another supplier• Communicate further down the supply chain if he is supplier

Guidance• Guidance on Information Requirements and Chemical
Safety Assessment (first version to be published on theECHA web-site before 1 June 2008)– Guidance was, between others, developed based on an arrayof exposure scenario case studies conducted by industryorganisations and companies– Chemicals industry (CEFIC in cooperation with downstream
user organisations) is working on making exposure scenarios
examples based on the case studies available– Risk Management Measures (RMM) library developed as partof the guidance development project is made available via theCEFIC web-site• Guidance on Downstream User requirements (available
via the ECHA web-site)Who will use the CSA Guidance ?
• Manufacturers of substances > 10 t/a• Importers of substances (> 10 t/a) as such (or as part ofpreparations)• Downstream users who need or want to make their own
chemical safety assessment• Producers and importers of articles when they have to register
substances intended to be released• Manufacturers, importers and downstream users preparing or
updating a CSA/CSR as part of applying for an authorisation• Authorities using the Guidance as a reference for activities
related to assessment and control of risks under evaluation,authorisation or restriction procedure.

Guidance on Information Requirements and ChemicalSafety Assessment
Concise Guidance

In Depth Guidance

A: Introduction
R.2-R.7: Information Requirements
B: Hazard Assessment

R.8-R.10: Dose- or ConcentrationResponse Characterisation

C: PBTand vPvB Assessment

R.11: PBT/vPvB Assessment
R.12: Description of Uses

D: Exposure Assessment

R.13: Conditions of Use (RMM,OC)
R.14-18: Exposure Estimation

E: Risk Characterisation
F: Chemical Safety Report
G: Extension of the SDS

R.19: Uncertainty Assessment

R.20: Explanation of Terms

Guidance on Information Requirements and Chemical
Safety Assessment
R7R3,4,6R2R5Information: available – required/needed

Exposure Assessment (EA)

Hazard Assessment (HA)
B

C

R8-10

DR11.1

EnStopDangerous
Or PBT?

F Document in

CSR

G Communicate

ES via eSDS

R12

R13 R11.2 R14-R18

R19Y

Risk Characterisation (RC)yRisk
controlled?

nIteration

Info on intrinsic properties and hazard assessment

Workflow for generation of Exposure Scenarios
Invited orpro-active

1. Map uses of substance (in-house information)
2. Compile available information on conditions of use

Start up information
Map of uses

3. Select appropriate process and product categories

Inventory of information
on OC and RMMs

4. Build initial ES and run first exposure estimation• need for exposure information related to waiving or testing• Chemical-physical properties (driving release and exposure)• dose/concentration – response characterization• Hazard classification and PBT/vPvB

Info packfrom DUs

5. Complete initial ES (short title, covered activity, OCs, RMM )6. Invite and receive feedback from representative DUs
7. Identify additional information (if needed)

Information available
for higher tierassessment

8. Carry out further CSA runs (iterations) with the selected tool
9. Decide whether measured data or higher tier model needed
10. Apply other models or measured data if needed, run CSA
11.Conclude exposure estimation and risk characterization

Final Output

12. Derive integrated ES by linking all OCs and RMMs

• final ESs (no further testing)• final ESs (testing proposed)

13. Merge different ES into a broader ES (= UEC) (optional)• uses advised against

14. Document• CSR, ES for SDS

Building Exposure Scenarios
Initial Exposure Scenarios

If risks are not controlled• Short title• Operational conditions (OC)• Risk management measures (RMM)

Decisions by M/I• Refine hazard assessment• Refine exposure estimate• Modify RMM or OC

Final Exposure Scenarios• Short title• Operational conditions (OC)• Risk management measures (RMM)• Advise against use

IT tools for developing ES, conducting CSA
and preparing CSR•“Analysis and Design” study April 2007 – March 2008–––

Based on the outcome of RIP 3.2
Strong focus on Exposure Scenarios
Existing exposure estimation models and tools are taken into account•

Challenge is that existing tools do not normally (transparently) include or
describe how Operational Conditions and Risk Management Measures areincluded-> Further development needed to make tools REACH compliant•

ECHA is currently preparing a call for tender for building the 1stgeneration of CSA-CSR tool–––

CSR template (1 June 2008)
IUCLID plug in for CSR generation (summer 2008)
First version of ES/CSA/CSR tool (2009)

IT tools for developing ES, conducting CSA
and preparing CSR
Informationon conditionsof use

CSA/CSR Tool
ES work template
Preset Initial Exposure
Scenarios

IUCLIDExposure
estimation
tools

Final Exposure Scenarios

CSRES annexfor SDS

Conclusions – 1
REACH Registration• Manufacturers and importers• Obtain/generate information on their substances and• Use this knowledge to enable well-informed management of therisks that substances may cause throughout their life cycle• Cooperation with Downstream Users

Conclusions – 2• Exposure scenarios play a very important role by giving useconditions for controlling risks• Exposure Scenarios are:– developed in the iterative Chemical Safety Assessment (CSA)– recorded/documented in the Chemical Safety Report (CSR)– communicated to downstream users as annexes to Safety Data
Sheets (SDSs)• Managing risks becomes an integral part of the Chemical Safety
Assessment (new mindset!)• Communication between DU and M/I should take place before
registration.
• Guidance: (Soon) available via ECHA web-site• Supporting IT tools and examples: Under development

Thank you for your attention !