ECHA

ECHA is making sure that registrations are up to the expected standard. If you have already registered and suspect that your dossier could be improved, don’t wait to get a letter from us – get your dossier in order.

ECHA is doing three things with existing registrations. First, we are applying the enhanced completeness check to make sure they contain the information that the law requires. Second, we are making sure that companies who have registered the same substance have just one joint registration. Third, we are taking action where companies have taken on the role of lead registrant without the agreement of the other members of the substance information exchange forum (SIEF).

Registrations must be complete

ECHA launched the enhanced completeness check on 21 June 2016. It has since been applied automatically to all new and updated dossiers. But in the interest of fairness, we are also checking in more detail the completeness of existing registration dossiers.

Last July, we wrote to companies who had provided data waivers for hazard data stating that the study was not ready. In total, we requested information for more than 140 endpoints from 39 registrations for 24 substances.

By the November deadline, almost all of the registrations (37 out of 39) had been updated. Registration decisions for the two registrations that were not updated have been revoked. This means that these companies can no longer legally manufacture or import the substances in the European Union.

We are going to continue using this approach to make sure that registrations contain the data required by REACH.

One substance, one registration

Companies who register the same substance must do it jointly. This was reinforced by the European Commission’s Implementing Regulation on joint submission of data and data sharing. We are now pushing companies who breached this obligation when submitting their dossiers to correct their situation as soon as possible. We are checking companies that:

• registered individually even though a joint submission for the same substance and registration type exists;
• registered the same substance individually without forming any joint submission; and
• have formed multiple joint submissions for the same substance.

By mid-February, we had written to 188 individual registrants covering 59 substances. Because submitting jointly is a collective obligation of all registrants of the same substance, letters were also sent to those registrants that are part of the joint registration – increasing the number of companies addressed to about 2 800. The first deadline for individual registrants to join the existing joint submission is May 2017. If they do not, their registration decisions will be revoked.

We are currently looking into dossiers for substances that are registered for general purposes (i.e. non-intermediates), and expect to have contacted all registrants breaching the joint submission obligation by summer 2017.

The new REACH-IT – in place since June 2016 – does not allow dossiers to be submitted individually if a registration for the same substance and same registration type already exists.

An agreed lead registrant

We have been told that some companies have taken on the lead registrant role and submitted joint registrations without having agreed either their leadership or the dossier content with the SIEF members. This is not what REACH demands.

We have written to four companies who have taken the lead without agreement. Their registrations cover 54 substances. We also wrote to all the pre-registrants of the substances in question asking them to give us evidence on how they agreed to the lead registrant. If the agreed lead registrant is not the company in question, we will transfer the joint submission to the agreed lead registrant.

We are currently taking action on eight of these registrations and will soon transfer the lead role. The companies concerned will receive a letter from us. For the other registrations, we have not received evidence from the SIEF members that there is an agreed lead registrant in place.

Our checks also reveal that most of the endpoints in these dossiers were filled with placeholders instead of actual data. So, the registrants of these dossiers have also received letters saying that their registration decisions will be revoked unless they update their dossiers with the missing information.

How you can help yourself

• Have you included all the necessary information in your dossier? Check it with the IUCLID Validation assistant. Remember that ECHA staff will also do a further manual check to see that your data is relevant within the context of REACH. These manual checks apply equally to initial registrations and updates and cannot be replicated by the Validation assistant. More information and tips are available on ECHA’s website.
  If we find that your dossier is missing information, you will get four months to provide it.
• Is you registration up-to-date? Have you generated new information or made changes, for example, in your substance’s composition or its uses? If you have, update your registration as soon as possible with accurate data.
• Follow the registration progress of your substance.
• Keep in mind that the SIEF members need to agree who the lead registrant is – it is not automatically the company submitting first.
• If you think the lead registration has been submitted by a lead registrant that the members did not agree on, let us know through ECHA Helpdesk. If ECHA asks you to confirm who is the agreed lead registrant of a joint submission, please respond.
• Be proactive and resolve issues on joint submission with your co-registrants before ECHA contacts you. You can find all the other registrants for your substance in the Co-registrants page in REACH-IT. Being proactive will give you more time to discuss and share data and agree on forming a joint submission.
• If you do not succeed in negotiating access to a joint submission or sharing data, you can, as a last resort, file a dispute with ECHA.

Beware!   Remember that a joint registration dossier is a joint responsibility and all SIEF members should give their input to it. However, if you decide to rely on the dossier of the lead registrant, for example through a letter of access, you need to make absolutely sure that the lead is a reliable operator.   If the price seems too good to be true, it probably is. Lead registrants who simply fill a dossier with poorly justified data waivers can do it very cheaply, which might be attractive to you. The problem is that a poorly justified dossier will almost certainly not be compliant with REACH and therefore will have legal and probably financial consequences for your business. This is a very big risk for you to take. And a mistake that a small number of companies have made already. So please beware!

Enhanced completeness check   Based on experience since the start of REACH, and the Board of Appeal’s decision on 15 March 2016 (A-022-2013), ECHA revised its completeness check process. We started the enhanced completeness check on 21 June 2016. It improves how ECHA makes sure that all the required elements are included in the registration dossier and that the submitted information is relevant under REACH.   It applies equally to new registrations and updates. It includes additional manual checks by ECHA staff, where completeness cannot be verified automatically by using the IUCLID Validation assistant. Read more about enhanced completeness check and get advice on preparing your registration.

Further information:

REACH 2018

Joint submission

Working together with your co-registrants

Disputes in practice

Ensure that your lead registrant is a responsible operator, 22 February 2016

Registrants of the same substance must be part of the same registration, 25 January 2016

ECHA to review completeness of registrations, 8 April 2016

Decision A-022-2013 of the Board of Appeal, 15 March 2016

Multilingual explanations of terms
 

Text by Hanna-Kaisa Torkkeli
Top image: Fotolia

If you liked this article, you may also like: Want to know about…the completeness check and how it affects every dossier?, Newsletter 3/2016 New generation of IT tools – what changes?, Newsletter 1/2016