Late pre-registration - do you qualify?

Pre-registration applies to phase-in substances only.  If you wish to manufacture/import a non-phase-in substance you will need to submit a full registration before you can proceed above 1 tonne per year.

Read more...

You may qualify for late pre-registration provided you can meet both of the following criteria:

  • You manufacture/import a substance above 1 tonne per year for the first time after 1 Dec 2008;
  • You pre-register within 6 months of manufacture/import, and at least 12 months before the relevant registration deadline. 

These criteria will also apply to Only Representatives (ORs) appointed for the first time after the 1 December 2008.  

Late pre-registration may not apply in the following cases... 

  • If you are an importer who has not pre-registered on the grounds that your non-EU supplier has appointed an OR and now find that this is not the case, you are now operating illegally. Contact your National REACH Competent Authority for help.  The approach they take may vary from State to State, but we expect that they will be pragmatic and seek to help you comply with your obligations.  Make sure you have any documentary evidence to support your position.  the longer you leave it, the more severe your Competent Authority is likely to be...ACT NOW!  
  • If you are a non-EU manufacturer who has changed their OR after pre-registration, your new OR must inform ECHA of the change in order to continue to benefit from the extended registration deadlines.  You will also need a letter from your old OR confirming they are no longer acting on your behalf, and granting access to the original pre-registration information.   If your old OR refuses to co-operate, contact ECHA for help.  The rules for ORs are still being debated by ECHA and the Commission, so watch out for further updates.

Please note , it is not advisable to change your OR in the last 12 months before registration. 

If you are a Downstream User you may also wish to refer to the Downstream User Q&A on Pre-registration.  


Why pre-register? 

  • To take advantage of phased-registration deadlines under REACH;
  • To enable full participation in Substance Information Exchange Forums and data-sharing.

Pre-registration is free, and does not commit you to full registration of your substance.   

Pre-registration enables you to take advantage of extended registration deadlines which are based on annual tonnage and classifcation of your substance:

 
 Tonnage band

 Registration Deadline

 > 1000 t/yr

CMR Cat 1 & 2 > 1 t/yr

R50/53  > 100 t/yr

30 November 2010 
 >100 t/yr 31 May 2013
 >1 t/yr 31 may 2018

 

What happens if I don’t pre-register? 

If you do not pre-register you are required to submit a full registration to ECHA in order to manufacture/import above 1 tonne/year.  if you do not you will be in breach of the REACH regulation and may be liable to prosecution by your Competant Authority.    

What information do I need to pre-register? 

The information you need to collate for pre-registration is limited.  It does not include any test data or physical properties. 

As well as your company details and you will need to provide 

  • Substance Identity: EINECS and/or CAS no's, any other identifying code, IUPAC name, other chemical name, and/or other names the substance is know by, e.g. familiar or trade name;
  • Tonnage band and expected registration deadline;
  • *Name and contact details of third party representatives (if appointed) who will represent you in data sharinfg activities.

Optional information:

  • Request for your identity to be withheld form other potential registrants*;
  • The name of other (similar) substances where there may be possiblilities for read-across and data-sharing;
  • Whether you are willing to act as a pre-SIEF facilitator. 

* If you wish to use a third party representative and withhold your identity from other potential registrants you must indicate this at pre-registration.  ECHA will always communicate with you directly, but your details will not appear on any substance or public access websites.

How do I pre-register? 

Pre-registration can only be done on-line via the REACH-IT portal maintained by ECHA.  

Before you can pre-register you will need to create a company account on the REACH- IT system. This will included the provision of invoicing information for use during the later registration phase. 

Your substance pre-registration(s) can be submitted either

  • By direct entry of information on the website, or
  • Using IUCLID 5 or equivalent format files (XML). 

If you do not know the EC number for your substance(s) you can only submit pre-registrations by direct entry, one at a time. It is not a long process.  ECHA estimate a single pre-registration should take around 10 minutes. 

IUCLID 5 is recommended if you have many substances to pre-register, as ‘bulk’ pre-registrations can be submitted in a single REACH-IT session.  In order to this you must know the EC number for each substance, as the system will use this as the identifier in logging each substance pre-registration.

IUCLID 5 can be downloaded for free at http://iuclid.eu/.  You will also need to download the pre-registration plug-in if you wish to use IUCLID 5 for pre-registration.  A user guide is also available, and there are two videos demonstrating the use of IUCLID5 for the the pre-registration of a mon and a multi-constituent substance.    

For more information on how to pre-register visit ECHA's pre-registration , or REACH IT webpages. 

I don't have an EC number can I still pre-register my substance?

Yes, provided your substance meets the definition of a phase-in substance.  It is recognised that there are many substances which do not have EC numbers but have been legally traded on the EU market.  ECHA will examine each such substance on a case by case basis.

You will need to make a single substance pre-registration, as bulk pre-registrations are only accepted with EC numbers.

Please note:  If you pre-register a substance that does not qualify as a phase-in substance you may be liable to prosecution.

What happens next? 

ECHA use pre-registration information to: 

List of pre-registered substances -ECHA maintains the list of pre-registered substances on it's website.  The list identifies the pre-registered substances only. It does not include the identity of the pre-registrants.

Note: the entire EINECS inventory has been pre-registered.  Therefore, it is unlikely that any downstream user of a phase-in substances will not find their substance on the list. 

Data Holders may now register their interest in specific substances for potential data-sharing.

(Pre-) SIEF formation -REACH-IT automatically sets-up a dedicated web-page for each substance on which the details of potential registrants (or their representatives) will be displayed. 

Only potential registrants will be able to access this web-page.  Details of data holders will also be shown, but they will not have access to the web-page. 

ECHA will send an e-mail to all potential registrants when this web-page is updated by the addition of further potential registrants or data holders. 

The term pre-SIEF is used to indicate that it is at this point that the discussion on ‘sameness’ of the substance should begin.  The SIEF is not really formed until this has been achieved. 

It is possible to change SIEF or form a new SIEF by application to ECHA.  A valid justification to do this must be given.

I've pre-registered in error what can I do?

As of 19 September ECHA where offerring to delete any pre-registrations made in error.  This was to remove mistakes from the system.  applicatiosn to remove an invalid pre-registration should be made to ECHA.  As of Jan 2009 it is believed this offer still stands.

ECHA are currently 'cleaning' the pre-registration REACH-IT system to remove invalid pre-registartions.

If you have pre-registered a substance that you later decide not to register you should inform ECHA.  You can also deactivate yourself from (pre)SIEF activity via your REACH-IT account.

Further Guidance on pre-registration

Practical steps for REACH registrationECHAs own guide to pre-paring for registration.  Available to download in several EU languages from ECHAs website

Pre-registration plug-in User Guide

Pre-registration video tutorials

IUCLID 5 guidance on the use of the Pre-registration plug-in. Downloadable at from the IUCLID 5 website

 

Last Updated ( Wednesday, 26 August 2009 )