REACH IT tools training: - Regulatory processing - IUCLID 6 - Completeness Check

Transcription

1 REACH IT tools training: - Regulatory processing - IUCLID 6 - Completeness Check May 2017 Directorate of Registration European Chemicals Agency

2 Agenda Overview of the IT tools for REACH Regulatory processing, i.e., from dossier submission to registration IUCLID 6: creating a complete dossier IUCLID 6: technical completeness check ECHA cloud services Exercise

3 IT tools for REACH

4 IT tools for REACH Data generation tools Data preparation Submission and use Chesar ECHA Registered substances echemportal 4

5 Regulatory processing

6 Regulatory processing by the Agency IUCLID I6Z 6

7

8 Creating a complete dossier in IUCLID Go to IUCLID 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 In case of failures, correct the dataset or re-create the dossier 8

9 Sign in and download the application Download data, e.g. reference substances; FAQ regarding installation, migration from IUCLID5 to IUCLID6, etc. Technical manuals 9

10 Main functionalities Create new or modify your existing substances here Create a template to reuse same endpoint data in diferent datasets. View your dossiers Search by UUID Store chemical information on particular chemicals once in the database and link it from there to any IUCLID section. Validate the substance datasets and also the final dossiers in order to minimize the risk for errors Import files: LE, substance datasets, reference substances View what information will be published on the ECHA website 10

11 Datasets list Find your dataset from the list of all the substance datasets 11

12 Dataset s content Click on TOC to display the table of content of the dataset By default, the view is REACH Complete Select the relevant view from the black arrow 12

13 Section tree Mandatory sections are marked with a red asterix * 13

14 Data requirements Lead data requirements compared to the member data requirements 14

15 Filling-in a dataset Right-click on a section to create a new record or a new endpoint summary 15

16 Tips for filling in a dataset 1/2 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 16

17 Tips for filling in a dataset 2/2 Use free text templates as guideline 17

18 Help needed? Press F1 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 18

19 Validation assistant

20 Creating a complete dossier Create the 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 In case of failures, correct the dataset or re-create the dossier 20

21 Validation Assistant Access the substance datasets list Right-click on the dataset which you want to check and select Validate 21

22 Validation Assistant Select the submission type 22

23 Validation Assistant Provide the dossier header information to get the correct outcome 23

24 Validation Assistant Correct all the submission checks: both business rules (BR) and technical completeness check rules (TCC) Quality checks are recommendations to improve the quality and consistency of your data; not subject to completeness check 24

25 Validation Assistant Rule identifier Location of the failure Section name Name of the table Number of the row in that table Error description 25

26 Validation Assistant Refresh the Validation Assistant report after correcting a failure. Click Re-check. Right-click on a TCC failure to be automatically directed to the error location in IUCLID 26

27 Validation Assistant You can (un-)hide the Validation Assistant clicking on this icon 27

28 Dossier creation

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

30 Dossier creation Select the dataset Right-click and create dossier 30

31 Select the correct dossier type Dossier creation wizard 31

32 Fill-in the dossier header Dossier creation wizard 32

33 Fill-in the dossier header for update Dossier creation wizard 33

34 Open the dossier 34

35 Validate the final dossier 35

36 Export the dossier 36

37 Technical Completeness Check

38 Technical Completeness Check The technical completeness check ensures that all the required elements are in the registration dossier as per Article 20(2). It is performed on each registration dossier submitted to ECHA both initial and update submissions. It consists of automated checks that can be replicated by the Validation Assistant and manual checks performed by ECHA staff. echa.europa.eu 38

39 Technical Completeness Check outcome Technical completeness check (TCC) passes: Message from ECHA in REACH-IT. If the payment (if invoice was issued) is received on time, your submission is complete and a positive decision is sent to you via REACH-IT. Initial submission: registration number assigned. Update of existing registration: ECHA will accept the updated information in the database. 39

40 Technical Completeness Check outcome Failure of technical completeness check 1 st time: Letter in the REACH-IT task box. Both initial submission and update of existing registration: Only one possibility to submit a complete dossier. Deadline specified in the letter. 40

41 Technical Completeness Check outcome Failure of technical completeness check 2 nd time: Negative decision in the REACH-IT task box, informing that submission is rejected. Initial submission: Registration number not granted. Fee is not refunded (if invoice was issued). Update of existing registration: The updated information is not accepted into the ECHA database and subsequent processes. You keep your registration number. 41

42 Manual checks at completeness check As of 21 June 2016, the automated completeness check was complemented with additional manual checks by ECHA staff of certain elements of the registration dossier that cannot be checked automatically. Not displayed by the Validation assistant. Document with information on manual checks published on the ECHA website, under Support > Manuals: 42

43 Areas for manual checks 1. Substance identification (IUPAC name, composition, manufacturing process description of UVCB substances, analytical information). 2. Justification for waiving of standard information requirements (physicochemical, environmental fate and hazard information, toxicological and ecotoxicological information). 3. Testing proposals on vertebrate animals (presence of considerations for adaptation possibilities). 4. Justification for waiving of Chemical safety report. 43

44 Key points for completeness Be clear and transparent. When providing a justification, always summarise the main points of the justification in the expected field, and if needed refer to a section/field where more details are given note that reference alone is not enough Use the correct field to provide the information In case your submission has failed TCC, refer to the letter and read through the failure message in Annex 1 carefully. 44

45

46 What service is provided? A new platform for delivery of Business Information systems in ECHA The first service focuses on IUCLID IUCLID Cloud Trial (April 2017) IUCLID Cloud for SMEs (Summer 2017) 46

47 IUCLID Cloud for SMEs Aimed for SME users to prepare registration dossiers under REACH for 2018 deadline Work fully on a web browser without installing anything locally Automated backup and data recovery in case of data loss Immediate subscription activation Up to 1 GB of secure data storage Target 24/7 availability except for pre-defined maintenance periods occurring outside the working hours Controlled service updates with every new release Facilitate working anywhere (easier remote access) and delegation to consultants IUCLID Helpdesk support during office hours Integrated help and support for dossier preparation (End 2017) 47

48 Summary

49 Creating a complete dossier in IUCLID 1 Fill in the information in your IUCLID substance dataset 2 Run the Validation Assistant on the dataset and also on the final dossier. Correct the failures. 3 Export your dossier and submit it to ECHA via REACH-IT. 49

50 Support and guidance

51 Useful links IUCLID 6 website: ECHA website support section: ECHA website on 2018 deadline: Manuals on preparing dossiers: More information on the manual verification areas of the completeness check: k_en.pdf Webinar on completeness check: 51

52 Thank you! Subscribe to our news at echa.europa.eu/subscribe Follow us on Follow us on Facebook Facebook.com/EUECHA