demonstrating safe use of chemicals - europadata to be submitted jointly/separately recap from...

Demonstrating Safe Use Of Chemicals

Chemical Safety Report – overview of requirements and tools

HelpNet Webinar on Joint Submission – member registrants 28 and 29 April 2010Andreas AhrensAndreas Ahrens ECHA ECHA –– Guidance and Helpdesk UnitGuidance and Helpdesk Unit

Overview

• Purpose of the CSA• Submission of CSR• Control of risks• Exposure Scenario in a nutshell• IT tools supporting CSA/CSR• CHESAR• Further reference

2http://echa.europa.eu

http://echa.europa.eu

When is a CSA required?

• A chemical safety assessment is required when a substance is manufactured or imported at 10 tonnes or more per year.

• The assessment shall be documented in a CSR to be submitted as part of the registration dossier.

• Annex I of REACH sets out the general provision for assessing the substances and preparing CSRs.

3

Purpose of CSA/CSR


Information Requirements (Annex VI-XI) Technical Dossier

Chemical Safety Assessment

Hazard AssessmentExposure assessmentRisk Characterisation

Chemical Safety Report5



Purpose of CSA - 1

• Assess the intrinsic hazards of substances: – determining the hazard classification– further characterizing hazards– where possible derivation of no-effect-levels

• Derived No-effect-Levels (DNEL) for human health• Predicted No-Effect-Concentrations (PNEC) for

environment– assessing properties relating to persistence,

bioaccumulation and toxicity (PBT) – generate new information if needed

6

Purpose of CSA - 2If substance is to be classified dangerous, or is assessed tobe a PBT/vPvB, or in case of exposure based waiving:• Identify the conditions ensuring control of risks arising

from manufacture and use(s) of a substance• Document the assessment in a CSR for the companies’

own records: Exposure scenarios (for CSR), exposure estimates and risk characterisation

• Describe the operational conditions and risk management measures to be communicated to the users of the substance = Exposure Scenario (attached to eSDS)

• Submit CSR to the authorities as part of the registration dossier



Annex 1 standard format for CSR - 1

Part A

• Summary of Risk Management Measures• Declaration that Risk Management Measures are

implemented• Declaration that Risk Management Measures are

communicated

8


Part B1. Substance Identity & Phys/chem. properties2. Manufacture and Uses3. Classification and Labeling 4. ENV fate Properties5. HH Assessment for toxic hazards6. HH Assessment for physical hazards 7. ENV Hazard Assessment 8. PBT/vPvB Assessment9. Exposure Assessment • Exposure Scenarios• Exposure estimation 10. Risk Characterization

Annex 1 standard format for CSR - 2

9

Submission of CSR


Data to be submitted jointly/separately recap from session 1

• Separate submission– Identity of the registrant, identity of the substance– Information on manufacture and uses– Exposure information (1-10 tonnes)

• Joint submissionClassification and labeling of the substanceStudy summaries, robust study summariesTesting proposals

• Free choice– Guidance on safe use– Chemical safety report

• Optional– Information has been reviewed by an assessor


Submission of CSRFour cases may occur• All registrants of the same substance mandate the

lead registrant to submit a CSR on their behalf.• All registrants submit their CSRs separately;

assumption: – The hazard assessment part of CSRs of these

CSRs are similar (if registrant has not opted out).– The parts on use and exposure of these CSRs

are different. • Some registrants submit together, others submit

separately.• Some or all registrants go for a joint CSR but submit

certain parts separately in parallel.12http://echa.europa.eu

Joint CSR - issues• Part B (content)

– Traceability of uses and volumes to be ensured when joint and separate parts are submitted in parallel, in particular regarding environmental assessment.

– Information will need to be dealt by third party due to CBI and competition law

• Description of uses not to be shared with others• Volume information not to be shared with others

– Arrangements needed for updates of joint CSR• Part A

– „Individual“ declaration on implementation of RMM – „Individual“ declaration on communication of RMM


Control of risk



Control of Risk – Risk Characterisation (RC)

Hazard information

Quantitative: PNEC/DNEL

Qualitative

Exposure information

Exposure Estimates

Quantitativeand/or

QualitativeRC

Exposure Scenarios

15


Control of Risk – Risk Characterisation (RC)

Hazard information

Exposure information

RC for combined Routes

Iteration

Conclusion

Quantitativeand/or

QualitativeRC

16


Iteration (if needed)

Initial Exposure Scenarios• Short title

• Operational conditions (OC)

• Risk management measures (RMM)

Final Exposure Scenarios• Short title

• Operational conditions (OC)

• Risk management measures (RMM)

Decisions by M/I• Refine hazard assessment

• Refine exposure estimate

• Modify RMM or OC

• Advise against use

If risk not demonstrated to be controlled

17


Control of risks• includes operational conditions, e.g.

– duration and frequency of use, – amount / concentration of substance in an activity...– rigorous containment

• includes necessary risk management measures, e.g.– product safety measures, e.g. limit concentration in

mixtures, package design– local exhaust ventilation, or particular waste water

and exhaust gas treatment…– wearing certain types of gloves or respirator

• Manufacturer or importer should determine the most efficient way to control risks and to document this

18

Exposure Scenarios


Four standard formats of ES

• Manufacture or downstream uses by workers– Conditions determining environmental exposure– Conditions determining human exposure

• Uses by consumers– Conditions determining environmental exposure– Conditions determining human exposure

• Article handling/processing by workers– Conditions determining environmental exposure– Conditions determining human exposure

• Article handling by consumers– Conditions determining environmental exposure– Conditions determining human exposure

http://echa.europa.eu 20


Two types of ES

• ES for the CSR (section 9.x.1 of the CSR)– Describes “only” the conditions of use– corresponding to exposure estimates and risk characterization

reported in other sections of the CSR• ES for eSDS

– Contains an extract of information from the ES for the CSR, potentially more phrased as target group specific advice

– Contains an extract of information on exposure estimates, risk characterization and the corresponding assessment method applied by the registrant

– May contain advice to DU on how to establish whether or not they are working within the boundaries assessed to be safe by the registrant.

21

9.x Title of exposure scenario number x• Short free title• List of use descriptors relevant for this ES• Title of contributing ES for environment plus related ERC• Title for contributing ESs for workers plus related PROCs

9.x.1 Exposure scenario9.x.1.1 Conditions determining environmental exposure (contributing scenario 1)9.x.1.2 Conditions determining workers exposure (contributing scenario 2)

9.x.1.3 Conditions determining workers exposure (contributing scenario 3)

9.x.1.n Conditions determining workers exposure (contributing scenario n)

Generic Structure of CSR-ES

Contributing scenario (CS): set of conditions corresponding to one worker’s or consumer’s activity (which can be associated to exposure estimates)



9.1 Industrial spray coating, waterborne• PC9a, ERC 4, PROC3, PROC5, PROC7, PROC 8b, PROC13, SU15, SU17, SU18 • Processing aid in industrial spraying of water born products (ERC4)• closed mixing (PROC 3)• open mixing (PROC5)• transfers with dedicated equipment (PROC8b)• industrial spraying automated (PROC7 )• industrial spraying manual ((PROC 7)• cleaning of equipment automated (PROC 13)• cleaning of equipment manual (PROC 13)

9.1.1 Exposure scenario9.1.1.1 Conditions determining environmental exposure (Processing aid in industrial spraying

of water born products)9.1.1.2 Conditions determining workers exposure (closed mixing )

9.1.1.3 Conditions determining workers exposure (open mixing )

…9.1.1.n Conditions determining workers exposure (cleaning of equipment manual )

Example: Solvent in coating






Generic structure of CSR-ES

24

http://echa.europa.euhttp://echa.europa.eu

Control of environmental exposure

Product characteristicAmounts usedFrequency and duration of use/exposureEnvironmental factors not influenced by risk management Other given operational conditions affecting environmental exposureTechnical measures at process level (source) to prevent releaseTechnical on-site conditions and measures to reduce or limit discharges, airemissions and releases to soil Organisational measures to prevent/limit releases from siteConditions and measures related to municipal sewage treatment plantConditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste

Sub-headlines of CES for the environment

Additional good practice advice beyond the REACH CSA






Generic Structure of CSR-ES

http://echa.europa.euhttp://echa.europa.eu

Control of worker’s exposure

Product characteristic

Amounts used

Frequency and duration of use/exposure

Human factors not influenced by risk management

Other given operational conditions affecting worker’s exposure

Technical measures at process level (source) to prevent release

Technical measures to control dispersion from source towards workers

Organisational measures to prevent/limit releases, dispersion and exposure

Measures related to personal protection, hygiene and health evaluation

Additional good practice advice beyond the REACH CSA

Sub-headlines of CES for workers

1. Title of exposure scenario• Short free title• List of use descriptors relevant for this ES• Title of contributing ES for environment plus related ERC• Title for contributing ESs for workers plus related PROCs

2. Conditions of useConditions determining environmental exposure (contributing scenario)Conditions determining workers exposure (contributing scenario 2)

Conditions determining workers exposure (contributing scenario 3)

Conditions determining workers exposure (contributing scenario n)

3. Exposure estimates and reference to its source

4. Guidance to evaluate actual conditions of use against advice in the ES

Generic Structure of eSDS-ES


IT Tools


IT tools supporting CSA/CSR - 1

IUCLID 5 CSR plug-in• Automatic creation of CSR chapter 1 to 7 from

IUCLID substance data set (not chapter 8 to 10)• Summary/conclusions of hazard assessment

extracted from endpoint study summaries• Facilitates structured reporting and prevents

essential information available in the IUCLID dossier to be missing in the CSR

• Will be released for IUCLID 5.2 and integrated in Chesar


IT tools supporting CSA/CSR-2

CHESAR: Chemical Safety Assessment and Reporting tool (IUCLID plug-in to be rolled out in May)

• Facilitates– PBT assessment– description of identified uses with a view to

exposure assessment– exposure assessment and risk characterization

• Generates – CSR– Exposure scenarios for communication


CHESARChemical SafetyAssessment andReporting Tool


CSA Framework and Chesar

Exposure Assessment (EA)Hazard Assessment (HA)

Risk Characterisation (RC)

Risk controlled ?

Communicate ES with extended SDS (eSDS)

Document in Registration Dossier, including CSR n

Iteration of hazard and/or exposure

assessment

y

EBW?Dangerous?

PBT?stop

y

Information: available required/needed

n


A: Introduction

B: Hazard Assessment

R.2-R.7: Information Requirements

C: PBTand vPvB Assessment R.11: PBT/vPvB Assessment

D: Exposure Scenario Building

R.14-18: Exposure Estimation

E: Risk Characterisation R.19: Uncertainty Assessment

F: Chemical Safety Report

G: Extension of the SDS

R.12: Description of Uses

Chesar translates existing guidance into practical steps

R.8-R.10: Dose- or Concentration-Response Characterisation

R.13: Conditions of Use (RMM,OC)

R.20: Explanation of Terms

Aim and Scope of Chesar (1)• It is largely flexible in order to support the variety of

emerging working practices under REACH. • It nevertheless aims to support standardisation as far

as possible, e.g.– expressing risk management measures and

operational conditions– format for CSR and format for ES to be

communicated to DU• It provides a workflow support for the CSA• It supports sharing of assessment or parts of it within

and across companies, in order to gain overall efficiency.


• It allows reporting exposure assessment results from different sources – from built-in exposure estimation tools– from external exposure estimation tools and – from sets measured data characterising certain

conditions of use • It generates Exposure Scenarios and Risk

Characterization Ratios (RCRs)• It compiles the Chemical Safety Report

Aim and scope of Chesar (2)


37

Chesar Concept

Chesar

IUCLID

External ES libraries

CSR ES for eSDS

External Exposure Estimation Tools

PBT assessment

Maps of Uses

Substance properties info Use info

Exposure info

Internal library

ECETOC TRA EUSES

Prerequites:• harmonised structure of info• xml exchange format


38

Organisation of Chesar (1)

1. Manage substances2. Reporting of uses 3. Manage assessment4. ES building and CSR generation 5. Generation of ES for eSDS6. Administration tools


Release plan (1)

• First release on 12 May 2010, containing all functionalities to prepare a “standard” CSA (except waste life stage) and initial reporting in a CSR:– Import of substance data from IUCLID – Use reporting – Assessment – Exposure Scenario building – CSR generation in an initial stage – Initial user manuals


Release plan (2)

• Second release (1st upgrade) planned for end of June :– Bug fixing, if needed – CSR generation – ES generation (for eSDS) - initial stage.

• Further releases not planned yet


Key Messages


Key messages (1)• Each registrant needs to know i) when a CSR is required

and ii) which information is required for a CSA/CSR.• The lead registrant should communicate whether or not

he intends to prepare a joint CSR.• A member registrant needs to take a decision whether to

go for a joint CSR or for an own CSR. • A member registrant mandating the lead registrant to

prepare a joint CSR needs – to provide all necessary information on manufacture

and condition of manufacture – to provide all necessary information on uses and

condition of use – to identify which parts of the joint CSR are relevant to

him (own conditions and supply chain). 42


Key messages (2)• Chesar will be available as tool to help registrants to

carry out the CSA/CSR in a transparent and harmonised manner.

• Chesar will facilitate exchange and re-use of CSA elements in order to gain efficiency in the assessment and communication across industry.

• Chesar’s internal library will be empty on roll out. Imports from external sources depend on xml format.

• Working with Chesar will need a basic understanding on risk assessment and training to use the tool.

• In order to successfully work with Chesar, registrants need to i) fill the IUCLID database with the required information and ii) to collect essential information on uses and conditions of use. 43


Further reference

• Guidance documents on the ECHA website– Guidance on Information Requirements and Chemical

Safety Assessment– Guidance for Downstream Users

• Webinars– Chemical Safety Assessment (CSA) and CSR

• Part I: Overview• Part II: Reporting tool (Chesar)


Abbreviations

• CES: Contributing Exposure Scenario• CHESAR: Chemical Safety Assessment and Reporting tool• CSA: Chemical Safety Assessment• CSR: Chemical Safety Report• ECETOC TRA: European Centre for Ecotoxicoloy and Toxicology of

Chemicals Targeted Risk Assessment tool• ES: Exposure Scenario• EUSES: European Union System for the Evaluation of Substances• M/I: Manufacturer/Importer• PBT: Persistent, Bio-accumulative and Toxic• SDS: Safety Data Sheet


Thank you for your attention


demonstrating safe use of chemicals - europadata to be submitted jointly/separately recap from...

Documents