Denehurst Chemical Safety Ltd

steps towards joint submission

 Most registrants under REACH will not be leading their SIEF and will not be involved in the data input process or chemical safety assessments.  Instead, these registrants will be following the Lead Registrant (LR) as part of the Joint Submission process.

 

First, there are a number of activities that the LR must complete, including all the data input into IUCLID (a long and rather dreary process), estimation of DNELs / PNECs, classification and labelling criteria and in most cases, preparation of a CSR based on use patterns agreed by the SIEF together with guidance for safe use (phrases and transport classification found on the SDS).

 

Joint submitters (‘secondary registrants’) have the choice of opting out of some of these steps, but unless there is a good reason, it is recommended to join in with as many parts of the joint submission as possible.  Advice can be provided on these steps if needed.

 

The key steps to registration are:

 

1. Initiation of the ‘Joint Submission’. This is performed by the Lead Registrant (LR) through REACH IT. Once this is done, it is possible for the joint registrants to sign up themselves in REACH IT. To sign up, it is necessary to have a ‘token’ and to get this, joint registrants will need to have paid for the letter of access (consortia may have arranged this as part of consortium membership).

What you pay and if it is 'fair' will vary from SIEF to SIEF - so far, most estimates seem 'fair', although in some cases, administration costs appear high. See cost sharing guidance on this.

 

2. Joint Submission token. When setting up the Joint Submission, the LR will receive an electronic ‘token’ which is effectively a very long PIN. This must be entered on REACH IT by each joint registrant. To get into REACH IT, where the pre-registrations were made, it is necessary to log in with your correct name and password. If you have not been on REACH IT for some months, then the password will need to be reset by ECHA and even if it worked last time, it is likely a new one will be requested as they ask for new passwords every few months.

If you do need a password to be reset, you need to remember your login name and send a message from REACH IT to ECHA using the link provided. It usually takes a couple of days.

It is strongly recommended that you do this now to avoid possible delays later.

 

3. Download IUCLID. A guidance document is available [link to page]

With reasonable IT skills, allow a couple of frustrating hours to get this set up. To download all the extras will take longer, but most of these are not needed.

It is suggested that those interested meet go through the process together in a workshop environment. REACHReady have held many public meetings and have also worked with consortia to help members to do this and from experience, it will be possible to input the required information and even make the submission within a day’s meeting.

As with REACH IT, do not delay downloading IUCLID until the last minute in case of problems. However, you will need your LEOX (legal entity file) from REACH IT to start creating the submission in IUCLID, so it is essential that you can access your REACH IT account as soon as possible.

 

4. Review analysis. Every registrant needs to have some confirmation that their substance is equivalent to the material assessed and entered into the lead dossier by the LR. The completed analysis report will need to be attached to your personal IUCLID dossier and will be supporting the substance identity, purity and impurity details on your personal (confidential) part of the dossier.

Analysis details are covered on the guidance for joint registrants

 

5. Consider use patterns and know tonnage of production / imports to EU. This is confidential, and is needed to complete the IUCLID personal sections. Normally, the LR or consultants putting together the dossier for the LR will have asked for this information to ensure the SIEF is fully covered. Check which codes were used by the LR to ensure yours fit into this pattern.

You personal tonnage must be known; note it is not sufficient to state ‘over 1000 t’ in the dossier, but a real number needs to be entered.

 

6. Prepare personal dossier. Completing Sections 1 and 3 of IUCLID is not difficult, but there are some tricky steps in the dossier creation steps that need to be done carefully (especially step 6 ‘dossier header’). It is important that the correct dossier (joint submission, general case) is selected; more help can be provided on this if needed.

Note that it is the policy of Denehurst to help registrants understand how to do this for themselves and we do not create the dossiers for others; after being shown how to do the first one or two, even the most computer-phobic individuals can do most of it for themselves. However, there are always specific issues that may need to be covered and support is offered if needed.

Submission is made by simply up-loading to REACH IT (takes a few minutes)

 

7. After submission. On REACH IT, it is possible to follow progress of the review over the first hour or so after submission. The first steps are all electronic and if the TCC tool is used, most of the checking can be done by the registrant before submission.

If passing the initial electronic check, an invoice will be raised for the ECHA fees. This needs to be paid quickly in Euros by electronic transfer.

The declaration concerning SME status is in REACH IT when it was set up. Check that it is correct before submission; if you have set your size too high, you will pay unnecessary fees, and if set too low, and you are found out, you will be prosecuted and fined.

After fees are paid, you will hopefully hear nothing until a registration number is received.

If the LR dossier is incorrect, there may be more work collectively for the SIEF (now known as the ‘Joint Submission’ to do, but it is most likely that ECHA will give time for improvements to allow supply to continue.

 

 

At a larter date, updates to the dossier may be needed, either in response to questions from ECHA, due to new data, new uses to be reported or due to errors first time around.  Some updates need only be made by the LR, but others need updating by all registrants.  For more help on updates, see    'dossier updates'

 

For more information, contact info@denehurst.co.uk

SIEF of One ?

 

If no other organisation makes contact to take the lead in a registration (for example, leading to 2013 or 2018 deadlines), do not wait until it is too lete to realise that you may be alone.  There were a few organisations who waiting until late in 2010 before realising that there was no-one else planning on a registration and that they would be on their own - a SIEF of one.

 

In REACH IT, it is possible to contact other pre-registrants and find out if others plan to register.  Unfortunately, the act of initiating such contact may make others think you are offering to take the lead and then thank you for doing so. 

 

Taking the lead is not perhaps as bad as is thought - the time spent on administration and form filling and initiating new testingif  needed can all be charged back to the SIEF

 

Denehurst can help in the planning and in the preparation of SIEF agreements and help ensure fair and transparent costs sharing mechanisms.