IUCLID 6 workshop. Chemical Industry Regulations 9 September Francois Le Goff Computational Assessment and Dissemination Unit

Transcription

1 IUCLID 6 workshop Chemical Industry Regulations 9 September 2016 Francois Le Goff Computational Assessment and Dissemination Unit

2 Agenda Topic 1 Introduction to ECHA new IT tools generation IUCLID 6 REACH-IT 3 Chesar 3 Time 09:00 09:45 2 Use case 1: preparing a REACH registration dossier as a member of a joint submission 09:45 11:00 Coffee break 11:00 11:30 3 Use case 1 finalisation Assessing new ways in which data must be filled in and how 11:30 13:00 the software displays information (for REACH) Q&A on REACH data Lunch 13:00 14:00 4 Use case 2: preparing a BPR dossier 14:00 15:00 5 Conclusions and Q&A 15:00 15:30 2

3 Optional topics Additional topics can be covered during this workshop, for example: Print function Categories Inherited templates Clipboard manager Opt-out Preparation of a lead dossier Information requirements Chemical Safety Report generation 3

4 Survey Experience with: REACH? BPR? IUCLID / REACH-IT? Chesar? 4

5 IT tools for REACH

6 IT tools for REACH Data generation tools Chesar Data preparation Submission and use REACH-IT ECHA Registered substances echemportal 6

7 Introduction to Chesar 19 August 2016

8 Outline What is Chesar? Assessment workflow in Chesar (very) Short demo More information 8

9 What is Chesar? Chesar (CHEmical Safety Assessment and Reporting tool) is a web application developed by ECHA to support registrants carrying out their Chemical safety assessment and generating their Chemical Safety Report (CSR) and generating their Exposure Scenario for communication (annex to extended Safety Data Sheet) It is released as a Desktop and Server version It is free-of-charge and easy to install

10 Assessment workflow under REACH Fulfil information requirements for the various endpoints Derive hazard assessment conclusions (DNELs, PNECs, CnL); Describe the uses of the substance; compile information on the existing conditions of use Exposure assessment: exposure scenario, exposure estimation, risk characterisation CSR to authorities Communicate information on substance properties and conditions of safe use via extended SDS ECHA.EUROPA.EU

11 Characterise the substance: understanding composition, form of the substance during its life cycle (D.2) Assessment workflow Physico chemical/fate properties (D.4.1) Use characterisation Use description (Guidance R.12) Conditions of use (OCs/RMMs) for exposure scenario building (D.3) Hazard assessment (Guidance Part B, R.7b/c and R.10 for environment and R.7a and R.8 for HH ) Guidance D Release /exposure estimation (D.4, Guidance R14, R15, R16) Risk characterisation (quantitative/qualitative) (D.5, Guidance Part E) Scope of the assessment (D.2.3, Guidance Part B) Chemical Safety Report (D.6) Exposure scenario for communication (D.7) Yes Risk controlled? No Use advised Against? No Iteration: refine use conditions, hazard, exposure.. Yes Inform ECHA and downstream users 11

12 ECHA and MS Registrant s IUCLID database ECHA s database Public Substance properties Use description + exposure assessment CSR DU Sector organisations Use maps package (incl. SpERCs, SCEDs, SWEDs) CSA Built-in exposure tools External exposure tools Measured data ESComXML ES for esds DUs ECHA.EUROPA.EU

13 Organisation of Chesar: the Chesar Boxes 1. Substances 2. Uses 3. Exposure assessment 4. CSR 5. ES for extended SDS 6. Library 7. Users 13

14 Physico chemical properties Results of hazard assessment Environment Human health PBT status Import/Export of full CSAs Import substance data from IUCLID Chesar3 workflow Describe uses in life cycle structure Assign tonnage Import/Export of CSA blocks (use maps) Report conditions of use Carry out quantitative exposure assessments and quantitative and/or qualitative risk characterisation CSA elements (library) Conditions of use (determinant) SpERC, SCEDs Standard phrases Import/Export of library objects Generate CSR Section 9 and 10 IUCLID report generator Integration into full CSR Export of uses and exposure data Extract ES for extended SDS Export to companies EHS systems (ESComXML) 14

15 Chesar aims at supporting Consistency Synchronisation of information between IUCLID (substance properties, uses) and Chesar (CSA) Information for the authorities (CSR) and for the supply chain (ES for communication) consistently developed Standardisation Approach based on workflow Use of (cross) sector-developed elements as input Use maps including: use description, condition of uses (SPERCs, SCEDS, SWEDs) Standard phrases: ESCom catalogue and ESComXML CSR format ES for communication format

16 Chesar aims at supporting Efficient CSA Reuse of information across substances Some integrated exposure estimation tools (ECETOC TRA/EUSES) Actions at substance level (valid for all uses) or at exposure scenario level (use specific) Automated generation of documents (CSR, ES for extended SDS) + IT exchange of data (XML format) Updates facilitated, as all data is in one database in case of: New information on substance -> recalculation of exposure for plugged in exposure estimation tools New ( or change of) use -> integrated with existing assessment

17 More information Chesar 3.0 released end of June Subscribe to stay up-to-date with latest developments Training for trainers organized in Q4

18 Chesar website

19 Chesar website library

20 Webinars Getting familiar with the new Chemical Safety Assessment and Reporting tool (Chesar 3.0) /journal_content/56_instance_ddn5/title/getting-familiar-with- the-new-chemical-safety-assessment-and-reporting-tool-chesar REACH 2018 Assess hazards and risks of your chemicals /journal_content/56_instance_ddn5/title/reach-2018-assesshazards-and-risks-of-your-chemicals

21 IUCLID 6

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23 Simplification Desktop version installation improved IUCLID dossier creation online with REACH-IT Help system reviewed and Dossier Submission Manuals included 23

24 Modernised interface New technological platform IUCLID 6 New format Advanced security IUCLID format update (OHTs, use and exposure, etc.) Annotation inventory Simplification of user interface and key functions Test material inventory Plug-ins redeveloped Not available yet New help system 24

25 IUCLID: dataset content Section 1: Substance identification Composition(s) Section 3: manufacture, use and exposure (CSR sections 9-10 extract - structured fields) Section 3.2 Estimated quantities Section 3.5 Life cycle description: brief description of uses based on the REACH use descriptor system Section 3.7 Exposure scenarios, exposure and risk assessment Sections 4 7 (OECD Harmonised templates) Section 13: assessment reports The CSR document is attached to this section as a Word or PDF file 25

26 Documentation available IUCLID contains an embedded Help System. Press F1 to access it. It contains: Information on the IUCLID functionalities Help text for the IUCLID fields Dossier preparation manuals, e.g. how to prepare a registration dossier The same information is downloadable from the ECHA and IUCLID 6 websites 26

27 Embedded Help System (F1) IUCLID 6 functionalities How to create specific dossiers (e.g. how to create a registration dossier) Field by field help 27

28 Embedded Help System (F1) 28

29 Creating a complete dossier 1 Create the dataset Fill-in the information 2 3 Run the Validation Assistant on the dataset Correct the failures Create the dossier Run the Validation Assistant on the dossier In case of failures, correct the dataset or re-create the dossier 29

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31 REACH-IT EU Member states REACH EU Industry CLP Data (GHS) REACH-IT aspires to be THE innovative, user-friendly, and only submission tool used by Industry and Competent Authorities for REACH and CLP data REACH-IT aims at being the main communication and information hub for Industry in relation to submitted data Regulatory processing Representative for EU Importers

32 Regulatory processing by ECHA Positive decision IUCLID I6Z Upload Preprocessing BRC Invoice TCC OCC Decision sending Negative decision Virus scan File format validation XML validation Load context info Dissemination BRC Business Rules Check TCC Technical Completeness Check OCC Overall Completeness Check Dossier Evaluation Screening 32

33 New in REACH-IT 3.1 Main goals with the new release Simplify and streamline the user experience for industry Integrate help into the application

34 New in REACH-IT 3.1 Account Management Same user account can be used for access to: R4BP3, epic and REACH-IT Possibility to allow users to work on your behalf

35 New in REACH-IT 3.1 Online dossier submission with integrated help Member of joint submission CnL notification Why to submit online? Create simple IUCLID 6 member dossiers with no endpoints directly in REACH-IT It indicates the missing information before the submission (embedded BR and TCC rules) Once submitted, a IUCLID 6 dossier is created and handled by REACH-IT like any other submission It has automatic saving possibility to stop/continue Update your online dossiers online

36 Online submission

37 New in REACH-IT 3.1 Topic help Checklists in wizards Integrated help Page help

38 New in REACH-IT 3.1

39 New in REACH-IT 3.1

40 Use case 1: Preparing and submitting a REACH registration dossier

41 REACH-IT Background information You have all pre-registered your substance and intend to register by 2018 A lead has been selected The substance boundaries and the hazard data have been agreed and all the needed data have been shared The lead has created the joint submission in REACH- IT and will submit the lead dossier once you all have joined the joint submission

42 Preparatory steps in REACH-IT

43 Login or create a new company account REACH-IT

44 REACH-IT When creating a new company account you will be asked to: i. validate your ii. create or import a legal entity

45 Determine the company size REACH-IT

46 REACH-IT In order to join a joint submission you should first find your co-registrants: i. via pre-sief if you have pre-registered your substance ii. via co-registrants page if you have inquired or already registered your substance Negotiate on the substance sameness and agree on the data sharing

47 REACH-IT Members of the joint submission can submit their dossiers after the lead has successfully submitted the dossier, i.e. passed the BRC.

48 REACH-IT Submit your dossier and follow the dossier lifecycle by clicking on the submission number

49 Read your tasks and messages REACH-IT

50 REACH-IT All the annotations are attached in the Key documents folder

51 Dossier creation in

52 Main IUCLID 6 functions

53 IUCLID6 53

54 IUCLID6 54

55 IUCLID6 55

56 IUCLID6 56

57 IUCLID6 57

58 IUCLID substance datasets

59 Import a dataset See the progress of the importing by clicking on the orange circle bottom left on the screen. Once the import is completed you will find your dataset in the substances list. 59

60 Find and open your dataset 60

61 Dataset content Click on TOC to display the table of content of the dataset By default, the view is REACH Complete 61

62 Adapting view to submission types Adapt the view according to your needs (e.g. preparation of a registration dossier as a member of a joint submission) 62

63 IUCLID: section tree 63

64 IUCLID: general information Section 1: Substance identification Composition(s) 64

65 IUCLID: general information Section 2: 2.1 Classification and Labelling (joint or individual) 2.3 PBT assessment (if CSR is required) 65

66 IUCLID: use and exposure data Section 1: Substance identification Composition(s) Section 3: manufacture, use and exposure (CSR sections 9-10 extract - structured fields) Section 3.2 Estimated quantities Section 3.5 Life cycle description: brief description of uses based on the REACH use descriptor system Section 3.7 Exposure scenarios, exposure and risk assessment Sections 4 7 (OECD Harmonised templates) Section 13: assessment reports The CSR document is attached to this section as a Word or PDF file 66

67 IUCLID: hazard information Section 1: Substance identification Composition(s) Section 3: manufacture, use and exposure (CSR sections 9-10 extract - structured fields) Section 3.2 Estimated quantities Section 3.5 Life cycle description: brief description of uses based on the REACH use descriptor system Section 3.7 Exposure scenarios, exposure and risk assessment Sections 4 7 (OECD Harmonised Templates) Section 13: assessment reports The CSR document is attached to this section as a Word or PDF file 67

68 IUCLID: assessment reports Section 1: Substance identification Composition(s) Section 3: manufacture, use and exposure (CSR sections 9-10 extract - structured fields) Se) Section 3.2 Estimated quantities Section 3.5 Life cycle description: brief description of uses based on the REACH use descriptor system Section 3.7 Exposure scenarios, exposure and risk assessment Section 11: Guidance on safe use Section 13: assessment reports The Chemical safety Report document is attached to this section as a Word or PDF file 68

69 IUCLID: section tree Mandatory sections are indicated with a red star: * This is only an indication and the Validation Assistant should be run to verify the completeness of the dossier 69

70 Filling-in a dataset Right-click on a section name to create a new record or an endpoint summary Fill-in the information 70

71 Filling-in a dataset Every value must be followed by a unit Every other must be followed by a justification in the designated free text field Every justification must be (scientifically) meaningful 71

72 Dossier creation

73 Dossier creation Select the dataset Right-click and create dossier 73

74 Select the correct dossier type Dossier creation wizard 74

75 Dossier creation wizard Fill-in the dossier header 75

76 Fill-in the dossier header for update Dossier creation wizard 76

77 Validation Assistant

78 Validation Assistant To assist users in the preparation of IUCLID dossiers so that they can be successfully submitted to and processed by the relevant authority. The outcome of the validation is a report, which lists all the rules for which the validation failed. The Validation assistant currently supports the validation of all dossier types that industry can submit to the European Chemicals Agency (ECHA) under the REACH and CLP regulations. 78

79 Validation Assistant Access the substance datasets list Right-click on the dataset and select Validate 79

80 Validation Assistant Select the submission type 80

81 Validation Assistant Fill-in the dossier header information 81

82 Validation Assistant 82

83 Right-click on a failure to access the error location Validation Assistant 83

84 Validation Assistant You can (un-)hide the Validation Assistant using this icon INTERNAL 9/7/

85 Preparation of a registration dossier Main steps

86 Summary Create a substance dataset Fill-in the information Run the Validation Assistant on the dataset Correct the failures Create the dossier Run the Validation Assistant on the dossier 4 Export the IUCLID 6 dossier for submission to ECHA, via REACH-IT 86

87 Exercise Preparation of a registration dossier as a member of a joint submission

88 Context A REACH-IT account has been created You are a member of a joint submission You will now start preparing the IUCLID registration dossier containing the information required Substance identity information (in line with the boundary composition defined by the lead registrant) Use information 88

89 First steps Download the training materials from the IUCLID 6 website Open the downloaded file and extract the content to your Desktop (drag and drop) This presentation One dataset to be used as a starting point for the dossier preparation 89

90 What you need to do 1. Download the IUCLID 6 installer 2. Install IUCLID 6 and launch IUCLID 6 3. Import the dataset 4. Complete a dataset as a member of a joint submission (general case, i.e. not intermediate) tonnage band t/y mono-constituent substance Pre-registration number to be added to section 1.3 The lead provides the Chemical Safety Report and the Guidance on safe use 5. Completeness check failures to be corrected 6. Create a dossier that will pass the Technical Completeness Check 90

91 BPR dossiers in IUCLID INTERNAL 9/7/

92 Biocides IT tools To manage your data and prepare dossiers SPC Editor To create and edit your SPC R4BP 3 To submit and manage your dossiers 92

93 IUCLID 6 release 93

94 What do I need to put in my IUCLID 6 dossier?

95 Your biocidal product Your product

96 Table of contents of your product

97 Starting point for each submission type Representative biocidal product: Biocidal product to be authorised: one active substance one or more active substances other substances and mixtures

98 Biocidal product - where to fill in data BPR active substance application (representative product) BPR biocidal product authorisation

99 Biocidal product - where to fill in data

100 Biocidal product Data for your product: Study summaries Endpoint summaries Attachments BPR Annex III requirements

101 Biocidal product composition

102 Biocidal product components Your active substance

103 Biocidal product components Substance datasets Active substance information Substance of concern Basic information (substance) Mixture datasets Basic information (mixture)

104 Biocidal product components Data for your active substance Study summaries Endpoint summaries Attachments BPR Annex II requirements

105 Biocidal product Your product

106 Biocides dossier IUCLID dossier

107 What s in a biocides dossier? Before submission, all data is copied to a dossier

108 Update of biocides data in IUCLID All these elements can be edited, updated with additional information

109 Dossier creation

110 Export Export your IUCLID dossier as a file and submit it using R4BP 3

111 Exercise Create a BPR dossier for Product Authorisation Product composition One active substance One solvent 111

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