Ref. Ares(2014)78302 - 15/01/2014

REACH Workshop
Pre-Registration in PracticeHelena Huttunen
ECHA Guidance & Helpdesks
Brussels, 14 April 2008

http://echa.europa.eu

Steps for Pre-Registration
for Phase-in Substances

Learn

PreparePreregister

http://echa.europa.eu

Join
SIEF

RegisterExamples of Actions for
Phase-in Substances

Learn

PreparePreregister

Join
SIEF

1. Know REACH
regulation
2. Know company
and its roles
3. Know substances
4. Know suppliers
and recipients

http://echa.europa.eu

RegisterExamples of Actions for
Phase-in Substances

Learn

PreparePreregister

Join
SIEF1. Pre-registration
strategy
2. Phase-in substanceinventories perlegal entity
3. Identified uses
4. IT tools anddatabases
5. Available data
http://echa.europa.eu

RegisterPre-registration Data
Requirements

Learn

PreparePreregister

Join
SIEF

REACH:
1. Substance identity: EC-#, CAS-#,
names
2. Contact person of the registrant(company and 3rd party if needed)
3. Envisaged deadline for theregistration and the tonnage band
4. Similar substances

http://echa.europa.eu

RegisterOptions to Pre-Register

IUCLID 5offline

REACH-ITonline

PreparedataofflinePreparedatawith
IUCLID 5and/orpreregistration
pluginEnterdataonline

http://echa.europa.eu

Upload XML file to REACH-IT

Othertools
offlinePreregister

Steps for Preparing Data withIUCLID 5 and Pre-Registration Plugin
1. Optional: create substances in IUCLID 5
database for each legal entity (recommendedfor saving the data for later uses)
2. Create a pre-registration list in plugin tool
3. Add/create substances to the pre-registrationlist
4. Validate your data
5. Export the bulk/single xml files (per legal entity)
6. Upload the pre-registration XML files to REACHIT (per legal entity)

http://echa.europa.eu

Example of Substance Inventory
Legal EntityRole

Substance(EC, CAS,name)Envisaged
Deadline andTonnageBand

One company can have several
legal entities and roles

http://echa.europa.eu

Contact

Similar
Substances
for ReadAcrossPurposeExample: Pre-Registration Plugin

Pre-registration plugin

http://echa.europa.eu

Example:Pre-Registration Plugin

Create a new
pre-registration list

http://echa.europa.eu

Example:Pre-Registration Plugin
Create a new substance fromthe EC inventory

http://echa.europa.eu

Example:Pre-Registration Plugin

Fill in tonnage and deadline

http://echa.europa.eu

Example: Pre-registration Plugin

Paste the UUID of 3rd Party
Representative (identicalwith REACH-IT)

http://echa.europa.eu

Example: Bulk Export from
Pre-Registration Plugin
You can bulk export several
substances within one xml file

http://echa.europa.eu

Recommendations for IUCLID 5• Pre-registrations must be submitted per legal entity• A legal entity can identify a 3rd party representative bytyping its UUID (should be equal to REACH-IT)• Bulk pre-registration of several phase-in substances as one
XML file requires EC-#s. Special cases without EC-# can beexported as single XML files from IUCLID or encoded
directly online via REACH-IT.
• Contact information can be entered in REACH-IT or in
IUCLID 5• More detailed user guidance is available on
http://echa.europa.eu/iuclid

http://echa.europa.eu

Steps for Pre-Registering withREACH-IT
1.

2.

Create a company in sign-up–––––

Create a REACH-IT account for your legal entity (login & password)
Import or enter company information
Enter billing informationAdd contact persons
Check the information you have entered and validate it

Add data and submit pre-registration- Encode or upload pre-registration data- Validate and submit- System generates the pre-registration number(e.g. 05-1234567-12-0000)

3.

PRE-SIEF formation

4.

Publication of list of pre-registered substances- Shows pre-registrants of the same substance

http://echa.europa.eu

Example: Upload of XML file toREACH-IT

You can upload single or bulk XML files,or encode information manually

http://echa.europa.eu

Recommendations for REACH-IT• Fill in company contact information (at least) here
• Import/create 3rd Party Representative UUIDs first here (forreference to IUCLID 5 users)• Phase-in substances without EC-# need to be single
imported/encoded online in REACH-IT• Bulk submissions will have one submission # per batch but
one pre-registration # per substance• Any other data than company and substance identity canbe edited later (also in pre-SIEF)• A pre-registration can be de-activated later• In case of uncertain substance identity, a conservative preregistration strategy is recommended (esp. multiconstituent substances)

http://echa.europa.eu

List of Pre-RegisteredSubstances• Will be published by ECHA by 1.1.2009• Data holders join in and start indicating theiravailable data
• They cannot see the participants in the pre-SIEF,
but can be contacted by the participants

http://echa.europa.eu

Options to Pre-Register

IUCLID 5
offline

REACH-IT
onlinePreparedata
offlinePreparedatawith
IUCLID 5

Upload XML file to REACH-IT

Othertools
offlineand/orpreregistration
pluginPreparedata
onlineImport/createcompany
account

http://echa.europa.eu

1.1.2009

Enter/
uploadandsubmit

PreSIEF