Das Industrieportal zu REACH-Kommunikation
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1 Das Industrieportal zu REACH-Kommunikation REACH: Kommunikation in der Lieferkette 2 Dezember 2008 Dr. Ingo Richter BASF SE REACH-Implementation
2 REACH communication requirements Dialog between SIEF members (Registrants) - Data & cost sharing - Joint compilation & submission - Evaluation... REACH-IT SIEFreach Substances and Products Dialog between Registrant (Supplier) and Downstream User (Customer) -Use - Exposure - Risk management? Dez 2008 Dr. Ingo Richter BASF SE 2
3 SIEFreach Tasks (pre-)sief Tasks of the Chemical Industry SIEF is formed after agreement on sameness Obligation to share data and cost in a SIEF Fair, transparent and non discriminatory Each SIEF shall be operational until 1 June Article 29, 3 This platform enables an efficient and consistent process in the industry storage of SIEF communication for 10 years free of charge area (explore data availability) Dez 2008 Dr. Ingo Richter BASF SE 3
4 SIEFreach Functions / Organizational Functions polls breakout pages (own issues with restricted access) SIEF moderator (replacing SFF) communicate on data availability to non paying companies Organizational IT-Platform SIEFreach is operated by the company ReachLink ReachLink is a new company founded by associations (CEFIC, VCI, CIA, UIC, Federchimica, FEIQUE) Online since August 21 st. Service Provider is IBM (development, hosting and helpline) Dez 2008 Dr. Ingo Richter BASF SE 4
5 SIEFreach Homepage Dez 2008 Dr. Ingo Richter BASF SE 5
6 SIEFreach Dez 2008 Dr. Ingo Richter BASF SE 6
7 SIEFreach Dez 2008 Dr. Ingo Richter BASF SE 7
8 REACH communication requirements Dialog between SIEF members (Registrants) - Data & cost sharing - Joint compilation & submission - Evaluation... REACH-IT SIEFreach Substances and Products Dialog between Registrant (Supplier) and Downstream User (Customer) -Use - Exposure - Risk management? Dez 2008 Dr. Ingo Richter BASF SE 8
9 TGD DU vs. TGD IR&CSA RIP 3.5 TGD IR/CSA = RIP 3.2/3.3 Appr pages Dez 2008 Dr. Ingo Richter BASF SE 9
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 Dez 2008 Dr. Ingo Richter BASF SE 10
11 Proposed workflow Has been revised, because workflow not manageable Dez 2008 Dr. Ingo Richter BASF SE 11
12 Tiered approach in exposure assessment: 3 steps 1. Step Basic exposure assessment (e.g. ECETOC TRA) Framework for different detail approaches in Exposure- and Risk-Assessment All 3-steps can be combined No need to perform all 3 steps 2. Step Generic exposure assessment 3. Step Specific exposure assessment Step-in in all levels possible Cascade can be started without questioning DU for its uses No preparatory work Exposure- / Risk-Assessment gets more detailed and concrete Dez 2008 Dr. Ingo Richter BASF SE 12
13 Additional information Basic exposure assessment: can be performed by ECETOC TRA and / or other tools due to the specific needs and competences of the user can be calculated by list processing for significant number of substances (e.g. bulk-calculation in ECETOC TRA) is not needed to be done if generic exposure assessment is available Dez 2008 Dr. Ingo Richter BASF SE 13
14 Additional information Generic exposure assessment: scenarios can be continuously added by e.g. industry sector groups 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 ) Dez 2008 Dr. Ingo Richter BASF SE 14
15 Additional information Specific/Individual exposure assessment: is still possible in each case use of communication templates (e.g. CEFIC ES template) is helpful company-specific customer-communication tools can be used Dez 2008 Dr. Ingo Richter BASF SE 15
16 Iterative approach in exposure assessment: The 1. Step 1. Step Basic exposure assessment 2. Step Generic exposure assessment Covering all targets Easy to use Fast results by high degree of automation ECETOC TRA: 3. Step Individual exposure assessment Dez 2008 Dr. Ingo Richter BASF SE 16
17 ECETOC TRA as basic tool input parameters in general Tonnage Use category (non-dispersive, wide-dispersive, ) Vapor pressure Dustiness category Log K ow range Molecular weight Dez 2008 Dr. Ingo Richter BASF SE 17
18 ECETOC TRA as basic tool additional input for occupational exposure Risk phrase DNEL, OEL, or other limit values Use profile of Process Categories (PROCs) Definition of duration of activity, LEV Y/N needed for each PROC BASF is using a standard profile for each PROCs Dez 2008 Dr. Ingo Richter BASF SE 18
19 3-step approach: Example of HDDA (HEXANDIOLDIACRYLAT) - CSR 1. Step Basic exposure assessment (e.g. PROCs - ECETOC TRA) 2. Step Generic exposure assessment 3. Step Specific exposure assessment Dez 2008 Dr. Ingo Richter BASF SE 19
20 Step 1- result of exposure assessment 9 Exposure Assessment 9.1 Exposure Scenarios Basic Exposure Scenarios by ECETOC TRA Dez 2008 Dr. Ingo Richter BASF SE 20
21 3-step approach: Example of HDDA CSR 1. Step Basic exposure assessment (e.g. PROCs - ECETOC TRA) 2. Step Generic exposure assessment 3. Step Specific exposure assessment Dez 2008 Dr. Ingo Richter BASF SE 21
22 Step 2 - result of exposure assessment Generic / Sector group- / branch-specific Exposure Scenarios Dez 2008 Dr. Ingo Richter BASF SE 22
23 3-step approach: Example of HDDA CSR 1. Step Basic exposure assessment (e.g. PROCs - ECETOC TRA) 2. Step Generic exposure assessment 3. Step Specific exposure assessment Dez 2008 Dr. Ingo Richter BASF SE 23
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) Dez 2008 Dr. Ingo Richter BASF SE 24
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, please contact the manufacturer. NOT OK without any RMM, have a look for the following chapter table 2. Dez 2008 Dr. Ingo Richter BASF SE 25
26 Mapping of TGD CSA vs. ECETOC TRA 1 Short Title of ES ES from TGD CSA ECETOC TRA PROC or ERC or PC 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. 4.3 Amount used per time or activity 5 Other relevant OCs (ph, T, water flow..) 6.1 RMM related to human health 6.2 RMM related to environment 7 Waste management measures 8 Exposure estimation PROC or ERC or PC Duration Dustiness Fraction of substance in product Tonnage Standards in step 1, refinement in LEV and upcoming RMM in v 2.0 STP. River flow, amount used Added manually if appropriate MoE, RCR calculated by ECETOC TRA 9 Guidance to DU IT-platform to provide guidance / step 2 Dez 2008 Dr. Ingo Richter BASF SE 26
27 Consequences from this tiered framework Advantages for DU: Broad range of uses (PROCS) are covered from the beginning Maximal CBI-protection Standardized system clear instructions, easy to follow / adapt Advantages for M / I: Iterative process as recommended in the TGD (iterative RMMs) Efficient communication with DU for risk assessment Use of esds as the main communication tool Structured system easy to transfer into IT-functionality / esds Integration of the broad know how of sector groups possible Dez 2008 Dr. Ingo Richter BASF SE 27
28 Overview integration of all parts 1. Step Basic exposure assessment IT-platform: background, default values, guidelines, details etc. ECETOC TRA E-Fast ConsExpo...any basic tool: Stoffenmanager RiskofDerm EUSES 2. Step Generic exposure assessment 3. Step Specific exposure assessment IT-platform: scenario library, RMMs, questionnaires, default values, details etc. IT-platform: questionnaires, examples, RMMs, details etc. Bauchemie Substance specific (e.g. from EU RAR)...any generic scenario: UV/EB Nano AISE VCI VEK Company-specific M/I-customer-communication tools can be used...any specific scenario: communication templates questionnaires Dez 2008 Dr. Ingo Richter BASF SE 28
29 Concept ECHA CSA/CSR Tool Dez 2008 Dr. Ingo Richter BASF SE 29
30 The Big Picture BASF solution How to organise the processes of CSA/CSR/eSDS? esds (BASIS) Ind. Platform Standards, Ref. (e.g. GES) CEFIC?, B EU? Hazard (IUCLID 5) Customer Customer Comm. Tool BASF CSA / CSR Step 1 ECETOC TRA Use / Expo & Risk Step 2 GES Step 3 individual ES BASF-Tool, tentative PBT-Tool ECHA-Template (expected 12/2008) CSR Dez 2008 Dr. Ingo Richter BASF SE 30
31 The Big Picture BASF solution How to organise the processes of CSA/CSR/eSDS? (expected from 2010) esds (BASIS) Ind. Platform Standards, Ref. (e.g. GES) CEFIC?, B EU? Hazard (IUCLID 5) Customer Customer Comm. Tool BASF CSA / CSR BASF? Step 1 ECETOC TRA Use / Expo & Risk Step 2 GES Step 3 individual ES ECHA? PBT-Tool CSR ECHA CSA/CSR-Tool (expected 2010) Dez 2008 Dr. Ingo Richter BASF SE 31
32 Industry portal(s) 1. Step Basic exposure assessment IT-platform: background, default values, guidelines, details etc. ECETOC TRA E-Fast ConsExpo Authorities Stoffenmanager RiskofDerm EUSES 2. Step Generic exposure assessment IT-platform: scenario library, RMMs, questionnaires, default values, details etc. Bauchemie Associations AISE Substance specific (e.g. from EU RAR) UV/EB VCI VEK Nano 3. Step Specific exposure assessment IT-platform: questionnaires, examples, RMMs, details etc. B2B communication templates Company-specific M/I-customer-communication tools can be used questionnaires Dez 2008 Dr. Ingo Richter BASF SE 32
33 Thank you for your attention and the invitation! Dez 2008 Dr. Ingo Richter BASF SE 33
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