Q&As

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REACH

Pre-registration

Is it possible to modify the data entered in a pre-registration?

You can change all information in your pre-registration except the envisaged deadline for registration and the substance identity (EC number, CAS number and chemical name): you can update the contact information (i.e. change the contact person in your company or change/add your third party representative), the ‘similar substances’ and the ‘remarks’ for the pre-SIEF.

You can also update the remarks for the pre-SIEF directly in the pre-SIEF page, and it will be updated in your pre-registration.

If you pre-registered your substance with wrong identifiers, see Q&A 377 and Q&A 1142 for advice and instructions on how to proceed. You should still list the pre-registration number in the registration dossier when you register your substance with the correct identifiers.

Detailed instructions on how to deactivate a pre-registration if you want to signal to the pre-SIEF participants that you will not register the substance are provided in Q&A 346.

REACH-IT

Pre-registrations

What should I do if I am in the wrong pre-SIEF?

If during pre-registration of your substance, you entered your substance name in a different way than the other manufacturers and importers, or if you realise during discussions on the sameness of your substance that you do not have the same substance as the other pre-registrants in the pre-SIEF, you may want to look for and join another SIEF. Whether you find a more suitable SIEF or not, you must register your substance with the correct identifiers, which have to be consistent with the analytical data on your substance.

A useful tool when looking for a more suitable SIEF is the list of pre-registered substances. This list contains all pre-registered substances, with the available identifiers, such as EC number, CAS number and chemical name with synonyms. The list is available at:

http://echa.europa.eu/information-on-chemicals/pre-registered-substances. You can also search the list of registered substance available at https://echa.europa.eu/information-on-chemicals/registered-substances.

Once you have examined the list of pre-registered and/or registered substances, the following scenarios are possible:

1) You found a more suitable pre-SIEF for your substance

You can find the lead registrant in the list of lead registrants on the ECHA website. Contact the lead to join the SIEF. If the substance is not listed or no lead is mentioned, you can use REACH-IT to update your pre-registration. If you add the more suitable substance as a similar substance you will have access to this substance pre-SIEF page. As you will not be listed as a member of this pre-SIEF, you will have to take the initiative and get in contact with the pre-registrants therein to explain that you wish to join the SIEF. It is also possible for you to set up the joint submission and to become the lead registrant. For instructions on how to update your pre-registration to view a different pre-SIEF in REACH-IT, see Q&A 1142.

2) You did not find a suitable pre-SIEF for your substance

Most likely you will have to become the lead registrant for the substance. In any case, you should include your pre-registration number in Section 1.3 of your IUCLID dossier, even though it previously corresponded to different substance identifiers (see Q&A 293)In addition, you should keep any relevant documentation that demonstrates the phase-in status of your substance in case it is requested by the enforcement authorities.

How can I join a more suitable pre-SIEF in REACH-IT?

Once you have found a more suitable or more specific identifier for your substance, you can find the pre-SIEF of your substance (here bismuth tetroxide) in REACH-IT and use the functionality ‘Edit pre-registration’ to update your pre-registration (as advised in Q&A 377). 

In the next step of the wizard, you should add the more suitable substance in the ‘Similar substances’ tab.

When this is done, you will be able to navigate from the pre-SIEF page of your substance to the pre-SIEF page of the similar substance using the ‘Read across to’ tab. You will not be listed as a member of this pre-SIEF, which means that you will be able to see the members of the pre-SIEF, but they will not be able to see you. For this reason, you will have to take the initiative and get in contact with them to explain that you wish to join the SIEF.

The ‘Similar substances’ functionality was designed for pre-registrants to list substances with similar chemistry, for which data may be used for grouping or read-across in the registration, in accordance with Annex XI of REACH. So not all substances listed in the ‘Similar substances’ tab concern registrants that want to refine their substance identity.

The ‘Similar substances’ functionality should not be used to fulfil the registration obligations for a substance other than the substance originally intended to be covered in the registration. The new identifier can therefore only refine the identity of the substance initially concerned; it cannot correspond to an entirely different substance.

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