Approaches and tools to facilitate CSA and ES development

Transcription

1 Approaches and tools to facilitate CSA and ES development REACH Implementation Workshop, Brussels, 7 December 2012 Dook Noij, Frank Schnoeder, Mercedes Viñas Dow / DuPont / Cefic On behalf of the Cefic Exposure Scenario Working Group 1

2 Content Development of ES information for substances in mixtures Scaling of RMM/OC s in ES GES and SES template revision Cefic ESCOM Package update (standard Phrase Library + XML) SPERC development CHESAR related activities Inclusion of industry elements into CHESAR: SPERCs, ESCOM Phrase Library, TRA plugged-in phrases Approach for generating systematic titles for ES for communication Under discussion: uploading of ECETOC TRA data sets into CHESAR 2

3 ES Information for Substances in Mixtures Cefic ES Working group: sub-group ES information for mixtures Draft position developed in prepation for ENES3 Reflects the current opinion of Cefic on requirements, options and approaches for developing and communicating Exposure Scenario information for (substances in) mixtures Discusses the legal requirements related to ES information for mixtures and the options for presenting ES information for substances in mixtures (in SDS or as separate attachment) Addresses on a high level the general approach by industry as developed over the past 3 years (stepwise approach; use of flowcharts (refer to Cefic/VCI REACH practical guide); key methodology: DPD+ (scope, application boundaries, further development) 3

4 ES Information for Substances in Mixtures Discusses the applicability and feasibility (pros and cons) of the current specific approaches: GES like approach (sector effort) Builds on use/rmm/oc profiles for groups of mixtures; requires significant preparatory work and relatively well organized sector organisations; independent of registration timelines; delivers consistent info on OC/RMM s and most likely relatively concise ES s Case-by-case approach (company effort) Builds on ES information provided by the suppliers ES for priority and lead substances (via DPD+); applicable for many types of mixtures; requires less preparatory work and can be automated to a significant extent; issue is the availability of ES info for not yet registered substances (particularly but not only until 2018): which surrogate information can be used? Draft position paper will be updated with latest info from ENES and after approval published on the Cefic website in January 2013 (as such will contribute to ECHA s consultations) Further development and refinement needed based on concrete examples; need for more detailed Cefic guidance document? 4

5 Scaling of RMM/OC s in ES Cefic ES Working group: sub-group Scaling of RMM/OC s in ES Draft position paper developed in prepation for ENES3 and as a basis for discussions with ECHA and MS Benefits of scaling clear for industry: Confirmation that the conditions of use by the DU are still resulting in safe use Forces the DU to appreciate the intention of the registrant Requires the DU to scrutinise his activities more closely (improved conditions of use) May result in the generation of meaningful data and information Disadvantages of a very restrictive interpretation of scaling: Most DU s lack the expertise for developing a DU CSA (result: poor quality DU CSA s?) Mass notification of DU CSA to ECHA: significant administrative work with meaningless information Registrants may be flooded by requests for inclusion of DU specific sets of OC/RMM s o Substantial increase in additional supply chain communication o Frequent CSR updates with increase in size/volume o Further increase in size of esdss (reduces transparency and user friendliness) 5

6 Scaling of RMM/OC s in ES ECHA has formed a small Task Group with representatives from ECHA, MS (Germany, Sweden, Finland), DUCC and Cefic ECHA/MS and industry in general have common views on: The definition of scaling (mathematical and quantitative approach) The scaling instructions to be provided by the M/I (method, parameters, RCR-range) Use of RMM hierarchy (which in principle is not scaling, but suitable to prove compliance) The use of measured data in scaling (refining modelling parameters may be related to scaling; use of actual exposure measurements for comparison with reference value is suitable to prove compliance, but NOT scaling) On the actual application and the boundaries of scaling ECHA/MS and industry views differ and discussion is ongoing 6

7 Scaling of RMM/OC s in ES Main elements of the Cefic/industry position for further discussion with ECHA/MS: Scaling tools are based on the logic of the underlying exposure assessment model; newer versions of assessment models can be applied provided changes in the model are correctly addressed in the scaling tools Scaling to RCR higher than the registrant s RCR is possible; however the M/I should indicate the boundaries for scaling in the ES (e.g. RCRrange) It should be possible to remove, not only to compensate a RMM (fits the definition of scaling as the efficiency of the RMM is considered zero) Cefic strives for continuation of the discussion on scaling with ECHA/MS to arrive at a common position on all relevant elements There is a need for further examples to better exemplify the benefits of scaling and the disadvantages of a restrictive approach to scaling 7

8 SES Template Updates Specific Exposure Scenario (SES) template is aimed at structuring the exchange of use/es information at individual company level (M/I DU), first levels of supply chain SES template updated and aligned with modifications in ECETOC TRA version 3 Only worker/env and consumer/env templates 4-section structure of ES and following the "contributing scenario" concept i.e. each column is an ES with a minimum of one environmental CS and one worker or consumer CS (can be extended to N worker or consumer CS s) After final approval to be published on the Cefic website in December

9 Extract SES template Proposed by M/I Deviations by DU New ES s proposedby DU Use Description OC/RMM s worker or consumer OC/RMM s environment 9

10 GES Template Update Replaces Cefic GES Worker CSA Template (Feb 2010) Can be used to develop specific ES s from a GES Separate templates for liquids and solids Full alignment with ECETOC TRA version 3 Increased functionality: Incorporates basic set of standard phrases as pick lists (ESCOM library) Auto population with ECETOC TRA exposure estimates Option for increased exposure estimates for elevated temperature; an approach for assessing aerosols Standard phrases for RMM/OC directly pulled for each TRA modifying factor Option to include RMM phrases based on qualitative assessment (autopopulation) Generates automatically the ES for communication Option to populate exposure estimates and RCRs in ES for communication After final approval to be published on the Cefic website in December

11 Extract GES template (1) Title Phys/chem properties DNELS Settings Qualitative assessment based on classification Use description 11

12 Extract GES template (2) Contributing Scenarios (CS) Use mapping Exposure and risk charactization PROC related to CS Modifying factors (auto-population) 12

13 Cefic ESCOM standard Phrase Library update/xml Last ESCOM Phrase Library version released in April 2012 Update and consolidation of ES Phrase Library almost completed Removal of duplications Increasing consistency by restructuring of phrases according to set of phrase rules Alignment of format for variable values/units Assignment of metadata to all phrases to enhance searching Includes new SPERCs Includes all plugged-in phrases for assessment with CHESAR (aligned with TRA exposure determinants in CHESAR) Updated ESCOM Phrase Library to be released in December 2012 XML activities (to operationalize electronic ES info exchange): Refinement of XML: 90 % complete; to be finalized in Q Mapping of standard phrases to XML: planned for Q

14 SPERC development SPERC s are used in environmental risk assessment and describe realistic default values for environmental emissions based on typically applied OC/RMM s within a sector SPERC s are developed and made publicly available by sector organisations SPERCs are / will be available in environmental exposure assessment tools such as in ECETOC TRA, Petrorisk and CHESAR An updated Cefic guidance document describing the approach and the minimum quality requirements has been published on the Cefic website in October 2012 sectors to update / prepare new SPERCs with this updated Guidance A SPERC library will be made available for import into CHESAR 14

15 CHESAR related activities Inclusion of SPERC library in CHESAR SPERC library submitted to ECHA ECHA will create an XML for importing the SPERC library into CHESAR Inclusion of TRA plugged-in phrases in CHESAR Phrases selected from ESCOM Library to link to TRA determinants in CHESAR Phrases will be implemented in next version of CHESAR Inclusion of ESCOM Phrase Library in CHESAR After completion the ESCOM Phrase Library will be submitted to ECHA ECHA will create an XML for importing the ESCOM Library into CHESAR XML can be downloaded from Cefic website (together with ESCOM package) Will facilitate the creation of the ES for communication Approach for generating systematic titles for ES for communication May solve issues with translations of free text titles Consists mainly of Use Descriptors (plus descriptor from other coding systems) Comparison of approaches by ECHA and industry showed high similarity Will facilitate the generation of socalled Table of Content for the extended SDS Under discussion: uploading of ECETOC TRA data set into CHESAR 15

16 We are not ready yet. Both industry and authorities are working on hard on further CSA and ES development Common aim is to improve the quality of CSA/ES whilst simultaneously increasing efficiency and consistency Good cooperation between industry and authorities; ENES proves to be a good platform for discussing ideas, approaches, tools for CSA/ES What can you do? Liaise with your sector association and actively participate in these activities, provide feedback to newly developed/updated approaches, tools, methodologies! DO NOT ONLY ASK WHAT CEFIC CAN DO FOR YOU, ALSO ASK WHAT YOU CAN DO FOR INDUSTRY!! 16

17 Questions??? 17