REACH-IT, IUCLID and other IT toolsFollowed by practical examples

IUCLID

REACH 2018 SME workshop – road to successful registration9-10 March 2017, Vienna, Austria

Francois Le Goff

Computational Assessment and Dissemination Unit

European Chemicals Agency

IT tools for REACH

3

IT tools for REACH

Data generation tools

Data preparation

Submission and use

Chesar

REACH-IT

ECHA Registered substances

eChemPortal

5

• IUCLID (International Uniform Chemical Information Database) is a software application to record, maintain and exchange scientific data on chemicals in a regulatory context, e.g., under the EU Biocides and EU REACH

• REACH data shall be submitted in IUCLID format

IUCLID

6

Drivers for changes

• Changes in requirements

• Feedback received

• Interactions with Competent Authorities and Industry IT working groups

• SME visits by ECHA staff and SME workshops

• Helpdesk

• Technological upgrades

• Quality observations on dossiers

• Needs for enhanced dissemination

IUCLID6

https://iuclid6.echa.europa.eu/

7

8

Search by UUID

View your dossiers

Create new or modify your

existing substances here

Store chemical information on particular chemicals

once in the database and link it from there to any

IUCLID section.

Import files: LE, substance datasets, reference substances

Validate the substance datasets and also the final dossiers in order to minimize the risk

for errors

View what information will be published on

the ECHA website

Create a template to reuse same

endpoint data in diferentdatasets.

Embedded Help System (F1)

IUCLID 6 functionalities

How to create specific dossiers (e.g. how to create a registration dossier)

Field by field help

9

Help needed? Press F1

Embedded Help System (F1)

10

11

Create new or modify your

existing substances here

12

Find and open your dataset

13

Dataset content

• Click on ‘TOC’ to display the table of content of the dataset

• By default, the view is ‘REACH Complete’

14

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)

15

IUCLID: section tree

16

IUCLID: general information

• Section 1:• Substance identification

• Composition(s)

17

IUCLID: general information

• Section 2:• 2.1 Classification and Labelling (joint or

individual)

• 2.3 PBT assessment (if CSR is required)

18

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 reportsThe CSR document is attached to this section as a Word or PDF file

19

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 reportsThe CSR document is attached to this section as a Word or PDF file

20

IUCLID: assessment reports

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

Se)

• 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

21

IUCLID: section tree

Mandatory sections are indicated with an asterisk: *

• This is only an indication and the Validation Assistant should be run to verify the completeness of the dossier

22

• IUCLID 6 is record based

• Right-click on a section name to create a new record or an endpoint summary

• Fill-in the information

Filling-in a dataset

23

Filling-in a dataset

• Use free text templates to help you enter the data

24

• 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

Filling-in a dataset: tips

Data entry examples

26

• Section 1.1: Identification

• ‘Other identifiers’ table to capture identifiers used previously, or in other regulatory contexts

Substance identification

27

• Section 1.2: Composition

• Type of composition:

• Legal entity composition = own composition provided by each registrant

• Boundary composition (Substance Identity Profile) = joint submissioncomposition provided bythe lead registrant

Substance identification

28

• Substance identification

profile (SIP)

• The collectively agreed boundaries of the substance in scope of a registration

• Constituents, impurities, additives

• Concentration ranges

• Manufacturing process (UVCB)

• Forms (if applicable)

• Extracted to the REACH-IT joint submission page

Substance identification

29

• Substance identification profile (SIP)

• The ‘glue’ between registrant-specific compositions and the jointly provided hazard data, C&L, PBT assessment.

Substance identification

Registrant 4

composition

Registrant 1

composition Data package:

• Hazard information

• Hazard assessment

• PBT assessment

• C&L

Boundaries:

• Constituents

• Impurities, additives with

C&L impact

• Concentrations

• Forms

• Manufacturing process

Registrant 2

compositionRegistrant 3

composition

30

• Section 1.4: Analytical information• For each row, the ‘Purpose of analysis’ and ‘Analysis type’ (multi-

select) picklist fields must be filled in.

• Either an attachment must exist in the 'Attached methods/results' field, or a reason for not providing it must be indicated in the field ‘Rationale for no results’ combined with an explanation in the 'Justification' free-text field.

• At least one identification and one quantification analysis must be provided (Purpose of analysis); these can be combined in one row.

Substance identification

Use and exposure information

• Section 3.5:

• Describe activities/processes of each use

• Allocate uses into life cycle stages

• Each use is a separate record

31

32

• Section 3.5:• Existing information

migrated

• Each use must contain at least one contributing activity for the environment (ERC) and one for workers/consumers (PROC/PC/AC)

• Technical function and indication of subsequent service life must be provided

Use and exposure information

Opt-out from the joint submission

33

• Provide the data in your own dataset

Opt-out from the joint submission

34

• Select the relevant records and add a justification for each opt-out, in section 14

Validation Assistant

36

• Access the substance datasets list

• Right-click on the dataset and select ‘Validate’

Validation Assistant

37

• Select the submission type

Validation Assistant

38

• Fill-in the dossier header information

Validation Assistant

39

• Validation assistant report

Validation Assistant

40

• Right-click on a failure to access the error location

Validation Assistant

41

Validation Assistant

You can (un-)hide the Validation Assistant using this icon

Dossier creation

43

• Select the dataset

• Right-click and create dossier

Dossier creation

44

• Select the correct dossier type

Dossier creation wizard

45

• Fill-in the dossier header

Dossier creation wizard

46

• Fill-in the dossier header for update

Dossier creation wizard

47

Open the dossier

48

Validate the final dossier

49

Export the dossier

Technical Completeness Check

Manual verifications

51

Technical Completeness Check

Technical Completeness Check (TCC) is performedin accordance with Article 20(2) of the REACH Regulation

It consists of:

automated checks that can be replicated usingthe validation assistant

manual verification by ECHA staff which cannotbe replicated using the validation assistant

52

Scope of the manual verifications

• As of 21 June 2016, the automated completeness check is complemented with additional manual verifications by ECHA staff

• To ascertain that all the information required by the legislation has been included

• Both new registrations and updates of existing dossiers

53

Scope of the manual verifications

• The manual checks are integrated in the completeness check process

• These checks cannot be replicated using the Validation Assistant plug-in

• Make sure that your descriptions on substance identification and any deviations from the standard information requirements are justified and reported

• If you receive a communication that your dossier is not complete, carefully follow the advice included in Annex 1 of the letter

54

Areas for manual verification

• Substance identification

• Data waivers

• Chemical safety reports (CSRs)

• Testing proposals on vertebrate animals

• More information on the areas of the additional verifications can be found at: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf

Exercise

56

Exercise

Context

You are the lead of a joint submission of 10-100 tonnes. Prepare your registration dossier.

Tasks

• Log-in to IUCLID and import the substance dataset. Find your substance dataset in IUCLID

• Run the Validation Assistant and correct all the failures

• Create a dossier for lead standard registration of 10-100 tonnes; own tonnage is the same. Lead provides Guidance on safe use and CSR on behalf of the members.

• Export your dossier

57

Section 3.3 Sites

• If you indicated in section 1.1 that your 'Role in the supply chain' is 'Manufacturer', then you must provide at least one production site in section 3.3. To this end, you must create a record in section 3.3 and link a 'Site' to it. The contact address of each site must be provided; as a minimum the fields 'Site name', 'Address', 'Town' and 'Country' must be filled in. In addition, to indicate the site as a production site, you must link it using the field 'Related manufacture/own use' to at least one manufacture record in section 3.5.1.

58

Section 7 summary

59

Amendments to Annexes VII and VIII due tonew or revised OECD test guidelines

Section 7.3.1: Skin corrosion/irritation

Section 7.3.2: Eye irritation

Section 7.4.1: Skin sensitisation

Non-animal testing is now the default approach to gather information.

60

Example: Section 7.4.1 Skin sensitisation

62

Triggers for the initiative and proposed solution

• Triggers

• The need to maintain an operational IUCLID version has been raised as a burden for Small and Medium size Enterprises (SMEs)

• The usage of IUCLID for non-frequent users is seen as complex

• Solution

• Provide IUCLID 6 as a Cloud service

Always work on the latest version of the application

Reduced risks of data loss (backups

managed by ECHA)

Facilitate working anywhere (easier remote access)

and delegation to consultants

Possibilities for better online

support

No cost for managing

installations and hardware

Data is more secure because

of reduced number of local

copies

63

Milestones

1. Infrastructure setup: internal milestone

2. IUCLID Cloud trial• first access to the service

• IUCLID data can be browsed with a web interface and edited with a ‘IUCLID app’

3. IUCLID Cloud services for SMEs available (mid 2017)

4. Easier dossier preparation with the help of tasks (end 2017)

M2M1 M3 M4

64

Conclusions

66

Conditions

Member in a jointsubmission?

No previoussubmission in

IUCLID

Only onecomposition to

register

Provide additionalstudy or own

record

Yes

Yes

Yes

No

No

No

Yes

No

67

IUCLID 6, IUCLID Cloud, online dossiers, how to choose?

Online dossiers

• All substances are registered as a member of a joint submission

IUCLID Cloud

• SMEs

IUCLID 6

• All other cases

All these solutions are based on the IUCLID 6 technology

68

Summary

1

• Find your co-registrants

• Join the joint submission

2

• Create a dataset and fill in the information • Run the Validation Assistant on the dataset

3• Create the dossier

• Run the Validation Assistant on the dossier

4• Submit the dossier to REACH-IT

5

• Read the tasks and messages

• Pay the invoice

• Receive the registration number

Support and guidance

70

ECHA website: support section

71

Useful links

• IUCLID 6 website https://iuclid6.echa.europa.eu/

• ECHA website support section https://echa.europa.eu/support

• REACH 2018 Roadmap: https://echa.europa.eu/reach-2018

• Manuals on preparing dossiers http://echa.europa.eu/manuals

Thank you!

Subscribe to our news at echa.europa.eu/subscribe

Follow us on Twitter

@EU_ECHA

Follow us on Facebook

Facebook.com/EUECHA

francois.legoff@echa.europa.eu