es and csa process - echa · > 10 tonne/year. technical dossier •identify of the...

ES and CSA process

M. Viñas

2

Agenda

Introduction

Cefic proposed processes for ES development

•

Generic Exposure Scenarios

•

Specific Exposure Scenarios

Libraries

3

Guidance on information requirements and chemical safety assessment, Guidance for downstream users

29 documents!

> 2000 pages!

Substance to be registered

> 10 tonne/year

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

Chemical Safety Report•Hazard and PBT AssessmentAlso

Chemical Safety Report•Hazard and PBT Assessment•Exposure Assessment

•Exposure Scenarios•Exposure Estimation

•Risk CharacterisationAlso

Substance dangerousor PBT/vPvB

Registration dossier - content

5

Agenda

Introduction


•


•


Libraries

ES Development & Communication model

LegendM/I = Manufacturer / ImporterDU = Downstream User

For specific products and applications the appropriate (next) steps in the above diagram need to be

determined based on expert judgement: not always all steps are needed and/or the order can be

adapted.

M/I and DU partnershipvia trade associations

Generic ES Development

•

Input of DU Associations•

Development GES library

M/I and selected DU’s

Specific ES development

•

Input of selected customers•

Use of Cefic ES template

DUWait forfinal ES

M/ICommunicate Uses (ES titles, Use Descriptors)

to direct DU for further communicationin the supply chain

DUUse covered?

DU•

Complete feedback

form•

Await decision M/I

Final Exposure Scenario (M/I)

DU•

Prepare CSA/CSR•

Inform Agency

No

Yes

or

M/I and/or M/I‐DU Associations => determine strategy

Systematic assessment of safe uses (use of Tier1 tool)

Map uses and use conditions in supply chain

Initial ESs, ES titles and Use Descriptors

Communication to

direct DUDistributionof e‐SDS

for s

afe

uses

onl

y

7

Agenda

Introduction


•


•


Libraries

8


DUWait forfinal ES



DUUse covered?

DU•

Complete feedback

form•

Await decision M/I

DU•

Prepare CSA/CSR•

Inform Agency

No

Yes

or

Communication to





adapted.



•





•

Input of selected

customers•







for s

afe

uses

onl

y

Generic Exposure Scenarios (GES)‏

• GESs are developed by M/Is in partnership with DU Associations

•

The (composite) GES is aggregated from the ESs for individual tasks/activities and incorporated into a library of GESs for access by relevant stakeholders

•

The GES describes Risk Management Measures & Operational Conditions relevant for safe use of a group of substances with a similar risk profile

• M/I selects relevant GES to support their substance registration

•

GES and supporting documentation is refined as necessary to form the substance-specific ES for demonstration of safe use and

inclusion within their CSR• ES is transferred to the e-SDS for communication to customers

9

Key Characteristics of GESs

•

Determine simple titles (and descriptions) that describe the areas of use and that are understandable across DUs

within and across supply chains

•

Involve the collaboration of M/I (and/or formulator) associations and DU associations

•

Represent a mapping of all (or key parts of) the supply chain for a substance (or groups of substances) ‏

•

Follow a process that aligns with the requirements of the TGD and delivers documentation sufficient to meet these for a CSR and/or eSDS

(subject to confirmation on the part of the registrant) ‏

•

Communicate all relevant OCs

and RMMs

for the identified scenarios

•

Describe the ES according to a library of standard phrases 10

Map the supply chain to compile an inventory of Uses together with likely

circumstances of handling

M/I obtains from internal product stewardship/technical activities; dialogue with representative trade groups (using a pre-populated template)

Characterise typical RMMsand OCs for the intended

uses

Determine the likely exposures (personal and

environmental) for each use for substance life cycle

Confirm adequacy of existing RMMs through

PNEC and DNEL comparisons and iterate

where necessary to define adequate risk control

Aggregate the RMMs for the uses to form the GES

Define domain of reliable application for the GES

As #1 Above

Use ECETOC TRA for human health and EUSES for environmental risks

RMMs communicated reflect, at a minimum, typical practice for the application and enable alignment with language/jargon for the sector

Refer to other sources of RMM efficiencies for the application/sector if these need to be confirmed e.g. COSHH Essentials, BREF documents

Under what circumstances are the advocated RMMs reliable?

1

2

3

4

5

6

M/I selects relevant GES for substance registration

7

M/I matches the specific ES to the M/I product names

M/I matches the substance-specific ES to the relevant M/I product names for communication to customers

8

How is GES developed?

For associationsTemplates available!

For M/I11

13

Agenda

Introduction


•


•


Libraries

14


DUWait forfinal ES



DUUse covered?

DU•

Complete feedback

form•

Await decision M/I

DU•

Prepare CSA/CSR•

Inform Agency

No

Yes

or

Communication to





adapted.



•





•

Input of selected

customers•







for s

afe

uses

onl

y

15

What are Specific Exposure Scenarios ?

•

Specific Exposure Scenarios (SES) describe Exposure Scenarios (ES) for individual substances in specific uses

•

SESs are developed by the M/I in dialogue with DU selected representative customers

•

SESs can cover one task or a set of tasks related to an application

•

The SES process is particularly useful to develop ESs for substances in relatively short supply chains or supply chains lacking well structured sector organizations

16

CEFIC dialogue template for SES building

•

Enables M/I to develop initial ESs, using a harmonised industry format

•

Enables DU to give feedback on uses and use conditions to M/I in a standardized way

•

Enables DU to enter new ES, if he finds his use not covered (art. 37-2) ‏

•

Structured according to ES format in Technical Guidance Document

•

Each section contains the basic information for description of the ES and exposure assessment using the ECETOC TRA tool

•

Template in line with the final version of the ECETOC TRA tool

17

How the dialogue template works1. M/I selects appropriate template:

combined/worker/consumer

2. M/I fills in the use and use informationfrom the drop-downs in the yellow column

3. DU reviews the informationproposed by the M/I

4. Combination ofuse descriptors reflect

DU use?

4.1. DU fills in deviations from the conditionsof use and/or RMMs in the blue column,

where applicable

4.2. DU completely fills in new (orange)column to identify a new useNO

YES

18

Extract out of the dialogue template

The parameters in the yellow column are filled in

by the manufacturer or importer (M/I)

The parameters in the blue column are filled in by the downstream user (DU) if

needed

19

Identification of Sectors of Use(s) (1)

No. Information item Available options Proposed ES1 Deviation from proposed ES1(plus explanatory notes) (to be completed by MI) (to be completed by DU)

0 Product Identification 0 1 10.1 Product name as it appears on SDS General Solvent

1 Short title exposure scenario1.1 Internal name1.2 Sector(s) of Use Selection - multiple SU per ES possible

For a broader ES, please select "All except SU21Private Households"

ALL Except SU21 private house holds

1.3 Product Category(ies). Not applicable for worker exposure scenario, as the product category does not impact the TIER 1 risk assessment for workers

Not Applicable Not Applicable

1.4 Process Category(ies) Selection (preferably use descriptors from dropdown list without an *)

0

1.5 Article Category(ies). Selection1.6 Environmental Release

Category(ies)Selection 0

If the M/I wants to limit the use of the General Solvent to

professional / industrial uses, he can use the dropdown

selection from short list and select “ALL except SU 21

private households ”

20

Identification of Sectors of Use(s) (2)

If the M/I wants to limit the use of the General Solvent to some specific use

sectors, he selects from the drop down detailed list e.g.

SU1 Agriculture, forestry, fishery SU3 Industrial manufacturing

21

Features: Dropdown’s with predefined selection

Example of dropdown of PROC’s

22

Identification of Process Categories

By selecting PROC10, the worker exposure can be linked to ECETOC TRA exposure prediction models,

Process Categories are relevant for worker

exposure assessment and worker risk

management measures

This field should not be changed by t

DU in his feedback as it would be confusing. A new PROC needs a

separate column

23

Identification of Article CategoriesIn the next step, the M/I wants to

limit the use of the General Solvent for using in the production of the

following article categoriesAC 3-1 Electrical and electronic products, e.g. computers, office equipment, video and audio recording, communication equipment

24

Identification of Environmental Release Categories

In the next step, the M/I specifies the Environmental Release Category for

which the General Solvent can be used ERC2 Formulation of preparations

This field should also not be changed by the DU in his feedback

25

Definition of Exposure (Recommended)

The M/I specifies the exposure to workers (1-4 hours)

The M/I specifies that the operation is indoor with LEV present. It also

indicates the use of RPE

26

Inserting a 2nd

Exposure Scenario

By clicking Ctrl n, a new ES 2 blank form “Proposed ES2”

is inserted in the template

The M/I populates the information same as he

did for ES 1

27

The DU worker exposure exceeds 4 hours

The DU has no LEV in placeThe M/I needs to consider the deviations in worker exposure duration and

RMM in place; M/I might reject

The consequence for the DU might be the need to re-

organise work (e.g. limitation

to 4 hours exposure)

The dialogue –

feedback from DU on operational conditions

28

The dialogue –

feedback from DU on measured data

As measured data need to be considered in the risk assessment

process, they should be indicated by the downstream user, if available. In our example the measured exposure

to workers was 5 ppm

29

How are SESs developed?

SES process: stepwise approach, initiated by M/I in dialogue with DU

1. Inhouse collection of informationon uses and use conditions

2. Development of initial SESs (use of SES dialogue template)‏

3. Dialogue with selected customers(feedback, using SES dialogue template)‏

4. Development of draft SESs(based on input by customers)‏

5. Evaluation of draft SESs in the CSAAggregation into final SESs

8. Communication of ESto direct DU customers

7. Transformation of SES for substanceto ES for product (annex SDS) ‏

6. Documentation of SESsin Chemical Safety Report

30

Final remarks on ES development

•

Dialogue template for SES building is aimed at two way communication in an effective and efficient way; it is NOT a questionnaire!

•

SES and GES development processes are complementary; both processes on their own or in combination offer the flexibility needed to develop ESs that suit M/I needs and the needs of DU customers

•

Cefic strongly supports and recommends the use of both ES development methods and accompanying tools to achieve optimal information exchange on uses in the supply chain

Single substance with specific or general applications

Groups of substances with similar applications

May have limited knowledge of substance handling in the supply chain by M/I

Assumes some knowledge of substance handling by M/I

Limited supply chain Dispersive application

Specialised Uses, e.g. fine chemicals

Common Uses, e.g. commodity chemicals

M/I and Key customer iteration M/I and DU Partnership via Trade Associations

Main FocusMain Focus

Specific ES approachGeneric ES approach

Selecting the Approach

Available tools on Cefic web



•





•

Input of selected customers•


DUWait forfinal ES

DUUse covered?

DU•

Complete feedback

form•

Await decision M/I

Final Exposure Scenario (M/I)‏

DU•

Prepare CSA/CSR•

Inform Agency

No

Yes

or





Communication to


•

Newsletter: guidance on Use and ES development and Supply Chain Communication VCI Practical guide CSR eSDS

•

DUCC UseR template:

Use and ES communication

•

IT tool requirements

•

Guidance on GES process + templates

•

Guidance on SES process + template

Preparation phase•

Use communication standard reply

Stric

tly C

ontr

olle

d |In

term

edia

tes

ES for preparations, DPD+

33

Agenda

Introduction


•


•


Libraries

Cefic libraries TF

34

What?• Generic Exposure Scenarios• Standard Phrases for SDS/ES• RMM and associated efficiencies• Use Mapping including Use Descriptors.• Reference latest guidance material

When?• Ongoing 2010

Where?http://cefic.be/en/reach-for-industries-libraries.html

Cefic libraries TF: overview

35

28 sectors included including paints, plastics, silicons,

catalysts, etc.

Description of available

information: operational

conditions, GES, etc.

Links to available information

Updated monthly with new information, sectors, etc…http://cefic.be/en/reach-for-industries-libraries.html

Cefic libraries TF: use mappings

36

User of Cefic libraryEntry field: CEPE

Database in Cefic server

List of Links:Manuf of powder and coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022AE&DWNLD=ajns0163b - descriptors of use -coatings and inks manufacture (powder products).xls

Manuf of other coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022AC&DWNLD=ajns0162b - descriptors of use -coatings and inks manufacture (all, except for powder products).xls

Industrial application of coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=101DC5&DWNLD=ajns0164final - descriptors of use -coatings and inks application (industrial).xls

Professional application of coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=101DC7&DWNLD=ajns0165afinal - descriptors of use - coatings and inks application (professional).xls

E.g.

Cefic libraries TF: use mappings

37Use mapping library soon available!

Download from Associations’ websites the excel file

Reduced list of Links:Manuf of powder and coatings:http://cepe-

myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022

AE&DWNLD=ajns0163b -

descriptors of use -

coatings and inks manufacture (powder products).xls

Manuf of other coatings:http://cepe-

myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022

AC&DWNLD=ajns0162b -

descriptors of use -

coatings and inks manufacture (all, except for powder products).xls

Merge information into a single tableUpload to company’s

supply chain communication tool

Or upload to Chesar or other assessment tool (manual / XML if available)

Cefic libraries TF: Standard phrases

38

Cefic is

working

in cooperation

with

BDI/BusinessEuropein order

to make

available

a catalogue of standard phrases

to be

used

in the preparation

of ES.

• Current

version available

at:www.euphrac.eu

• Both

general

and sector-specific

phrases

• It will

be

regularly

updated

•

It is

foreseen

that

Chesar

will

allow

to work

with downloaded

catalogue

Abbreviations

39

•DPD: Dangerous Preparations Directive•ES: Exposure Scenario•GES: Generic Exposure Scenario•M/I: Manufacturer/Importer•SES: Specific Exposure Scenario

•BDI: Federation of German Industries•Cefic: European Chemical Industry Council•DUCC: Downstream Users of Chemicals Co-ordination•FECC: European Association of Chemical Distributors

Useful links

Cefic website:http://cefic.org/templates/shwPublications.asp?HID=750

DUCC UseR

template:http://www.aise.eu/reach/documents/DUCC_Use_and_E

S_MappingTemplate_revisedFinal15072009.xls

Ecetoc

TRA:https://www.ecetoc-tra.org/public/login/index.asp

ECHA:http://echa.europa.eu/reach/software_en.asp

Thank you for your attention!

http://cefic.org/templates/shwPublications.asp?HID=750

http://www.aise.eu/reach/documents/DUCC_Use_and_ES_MappingTemplate_revisedFinal15072009.xls

http://www.aise.eu/reach/documents/DUCC_Use_and_ES_MappingTemplate_revisedFinal15072009.xls

https://www.ecetoc-tra.org/public/login/index.asp

http://echa.europa.eu/reach/software_en.asp

es and csa process - echa · > 10 tonne/year. technical dossier •identify of the...

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