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Das Industrieportal zu REACH-Kommunikation

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(1)

Das Industrieportal zu

REACH-Kommunikation

REACH: Kommunikation in der Lieferkette REACH@Baden-Württemberg

(2)

Substances and Products • • • ---• ....

Dialog between SIEF members

(Registrants)

- Data & cost sharing - Joint compilation &

submission - Evaluation ... REACH-IT SIEFreach Dialog between Registrant (Supplier) and Downstream User (Customer) - Use - Exposure - Risk management …

?

REACH communication requirements

(3)

SIEFreach

Tasks

„ (pre-)SIEF Tasks of the Chemical Industry

z SIEF is formed after agreement on sameness

z Obligation to share data and cost in a SIEF z Fair, transparent and non discriminatory

z „Each SIEF shall be operational until 1 June 2018.“Article 29, 3 „ This platform enables an efficient and consistent process in

the industry

(4)

SIEFreach

Functions / Organizational

„ Functions z polls

z breakout pages (own issues with restricted access) z SIEF moderator (replacing SFF)

z communicate on data availability to non paying companies „ Organizational

z IT-Platform SIEFreach is operated by the company ReachLink

z ReachLink is a new company founded by associations (CEFIC, VCI, CIA, UIC, Federchimica, FEIQUE)

z Online since August 21st. Service Provider is IBM (development, hosting and helpline)

(5)

SIEFreach

Homepage

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Substances and Products • • • ---• ....

Dialog between SIEF members

(Registrants)

- Data & cost sharing - Joint compilation &

submission - Evaluation ... REACH-IT SIEFreach Dialog between Registrant (Supplier) and Downstream User (Customer) - Use - Exposure - Risk management …

?

REACH communication requirements

(9)

TGD DU vs. TGD IR&CSA

RIP 3.5 TGD IR/CSA = RIP 3.2/3.3 Appr. 2000 p ag

(10)

How to deal with thousands of

substances with even more uses?

„ BASF SE with appr. 100 LE and several thousands of substances „ Dossiers for Tier I substances (≥1000 to/a) have to be submitted

until 30 November 2010

„ Detailed communication and consideration of all identified uses according RIP 3.2 is not possible for so many substances due to the tight REACH schedule

„ Pragmatic way is necessary to find an efficient way to communicate with customers and to comply with the comprehensive requirements

(11)

Proposed workflow

Has been revi sed, bec ause work flow not m anag eabl e

(12)

Tiered approach in exposure assessment:

3 steps

1. Step

Basic exposure assessment (e.g. ECETOC TRA)

2. Step

Generic exposure assessment

3. Step

Specific exposure assessment

„ Framework for different detail approaches in Exposure- and Risk-Assessment

„ All 3-steps can be combined z No need to perform all 3 steps

z Step-in in all levels possible

„ “Cascade” can be started

without questioning DU for its uses

z No preparatory work

„ Exposure- / Risk-Assessment gets more detailed and concrete

(13)

Additional information

„ Basic exposure assessment:

z can be performed by ECETOC TRA and / or other tools – due to the specific needs and competences of the user

z can be calculated by list processing for significant number of substances (e.g. „bulk-calculation“ in ECETOC TRA)

z is not needed to be done if generic exposure assessment is available

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Additional information

„ Generic exposure assessment:

z scenarios can be continuously added by e.g. industry sector groups

z a web-based library would allow a industry-wide standard and could be used as reference for all details that should not be given on each CSR or eSDS (“Industry platform”)

(15)

Additional information

„ Specific/Individual exposure assessment: z is still possible in each case

z use of communication templates (e.g. CEFIC ES template) is helpful

z company-specific customer-communication tools can be used

(16)

Iterative approach in exposure assessment:

The 1. Step

1. Step

Basic exposure assessment

2. Step

Generic exposure assessment

3. Step

Individual exposure assessment

ƒ Covering “all targets”

ƒ Easy to use

ƒ Fast results by

high degree of automation

v

#

3

(17)

ECETOC TRA as basic tool –

input parameters in general

„ Tonnage

„ Use category (non-dispersive, wide-dispersive, …) „ Vapor pressure „ Dustiness category „ Log Kow range „ Molecular weight

v

#

3

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ECETOC TRA as basic tool –

additional input for occupational exposure

„ Risk phrase

„ DNEL, OEL, or other limit values

„ Use profile of Process Categories (PROCs)

Î Definition of “duration of activity”, “LEV Y/N” needed for each PROC – BASF is using a standard profile for each

v

#

3

(19)

3-step approach: Example of HDDA

(HEXANDIOLDIACRYLAT) - CSR

1. Step

Basic exposure assessment (e.g. PROCs - ECETOC TRA)

2. Step

(20)

Step 1- result of exposure assessment

9 Exposure Assessment 9.1 Exposure Scenarios

(21)

3-step approach: Example of HDDA CSR

1. Step

Basic exposure assessment (e.g. PROCs - ECETOC TRA)

2. Step

(22)

Step 2 - result of exposure assessment

(23)

3-step approach: Example of HDDA CSR

1. Step

Basic exposure assessment (e.g. PROCs - ECETOC TRA)

2. Step

(24)

3-step CSR: Easy transfer into eSDS

1. Basic use conditions (no / minimal RMM)

2. Generic uses (specific OC / RMM)

3. Specific uses (individual OC / RMM)

(25)

Interpreting an eSDS as DU:

„Are the processes I use defined as safe?“

? OK, but make sure

the OC used in ECETOC TRA meet DU‘s OC.

NOT OK without any RMM, NOT OK, please contact the manufacturer.

(26)

Mapping of TGD CSA vs. ECETOC TRA

1 Short Title of ES

2 Processes + activities covered by ES 3 Duration + frequency of use

4.1 Physical form of substance or prep. 4.2 Concentration of substance in prep.

8 Exposure estimation

6.2 RMM related to environment 6.1 RMM related to human health

5 Other relevant OCs (pH, T, water flow..)

7 Waste management measures 4.3 Amount used per time or activity

PROC or ERC or PC PROC or ERC or PC

Dustiness

Fraction of substance in product

Standards in step 1, refinement in 2 + 3 LEV and upcoming RMM in v 2.0

STP. River flow, amount used Added manually if appropriate MoE, RCR calculated by ECETOC TRA

Duration Tonnage ES from TGD CSA ECETOC TRA

(27)

Consequences from this tiered framework

„ Advantages for DU:

z Broad range of uses (PROCS) are covered from the beginning z Maximal CBI-protection

z Standardized system – clear instructions, easy to follow / adapt „ Advantages for M / I:

z Iterative process as recommended in the TGD (iterative RMMs) z Efficient communication with DU for risk assessment

z Use of eSDS as the main communication tool

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2. Step Generic exposure assessment 3. Step Specific exposure assessment 1. Step Basic exposure assessment IT-platform: • background, • default values, • guidelines, • details etc. IT-platform: • scenario library, • RMMs, • questionnaires, • default values, • details etc. IT-platform: • questionnaires, • examples, • RMMs, • details etc.

Overview – integration of all parts

AISE

Bauchemie Substance specific (e.g. from EU RAR) VCI VEK

...any generic scenario:

UV/EB

Nano

Company-specific M/I-customer-communication tools can be used

...any specific scenario:

questionnaires communication

templates

...any basic tool:

ECETOC TRA Stoffenmanager RiskofDerm ConsExpo E-Fast EUSES

(29)
(30)

CEFIC?, B‘EU? Ind. Platform ECHA-Template BASF-Tool, tentative BASF

„The Big Picture“ – BASF solution

How to organise the processes of

CSA/CSR/eSDS?

CSR Customer Customer Comm. Tool Step 1 ECETOC TRA Step 2 GES Step 3 individual ES Use / Expo &

Risk Hazard (IUCLID 5) CSA / CSR eSDS (BASIS) Standards, Ref. (e.g. GES) PBT-Tool

(31)

CEFIC?, B‘EU? Ind. Platform

ECHA

BASF

„The Big Picture“ – BASF solution

How to organise the processes of

CSA/CSR/eSDS? (expected from 2010)

CSA / CSR Hazard

(IUCLID 5)

Use / Expo & Risk Customer Customer Comm. Tool Step 1 ECETOC TRA Step 2 GES Step 3 individual ES eSDS (BASIS) Standards, Ref. (e.g. GES) BASF? ECHA? PBT-Tool

(32)

2. Step Generic exposure assessment 3. Step Specific exposure assessment 1. Step Basic exposure assessment IT-platform: • background, • default values, • guidelines, • details etc. IT-platform: • scenario library, • RMMs, • questionnaires, • default values, • details etc. IT-platform: • questionnaires, • examples, • RMMs,

Industry portal(s)

AISE

Bauchemie Substance specific (e.g. from EU RAR) VCI VEK

UV/EB

Nano

Company-specific M/I-customer-communication tools can be used

questionnaires communication ECETOC TRA Stoffenmanager RiskofDerm ConsExpo E-Fast EUSES Authorities Authorities Associations Associations B2B B2B

(33)

Thank you for your attention

and the invitation!

References

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