This is the fourth and final instalment in our series looking at the chemical regulation REACH. We continue with the information requirements for a Joint Registration and ensuring that your submission is compliant.

Once you have completed your substance identification, and established that you are in the correct SIEF with a Lead Registrant (LR)[1], it’s time to start your Joint Registration dossier. Before looking at the tools used for dossier creation, ensure that you have all the information needed to complete the registration dossier…

Hints and tips for information collection

Make sure that you have joined the Joint Submission in REACH-IT: your LR should provide you with a Joint Submission Token as part of the Letter of Access. Your dossier will automatically fail submission if the token is not submitted. And beware: the token has a one-month shelf life, so if you do not submit it within the expiry date, a new token will need to be requested from the LR. For this reason, it’s best to submit your token immediately upon receipt.

Double check your tonnage (something you should have been checking annually since your pre-registration) to confirm which tonnage band you want to register in. The final REACH deadline (May 31, 2018) covers ≥1 - <10 (Annex VII) and ≥10 - <100 (Annex VIII) tonnes. If you find that your tonnage crept over 100 tonnes (within the last 12 months) then an immediate registration may need to be submitted.

Get information on your use(s) of the substance within the EU, regardless of whether it is manufactured or imported on its own or as part of a product/mixture. The use information submitted is broken down into codes:

• Sector of Use (SU);
• Environmental Release Categories (ERC);
• Chemical Product Categories (PC);
• Process Categories (PROC); and
• Article Categories (AC).

Ensuring these codes are accurate compared to your actual use is essential, especially if you need to submit a Chemical Safety Report (which you do for >10 tonne registration) as these codes are linked to the exposure calculations. Your LR should provide you with a list of the use codes covered in their registration, and often the Chemical Safety Report will be shared, although it is not mandatory. You should also check whether your uses and codes are indeed covered by the LR; if not, you will need to submit a full separate Chemical Safety Report (I’ll touch on this more later in this blog). Use codes can be found here in ECHA guidance.

Your tool options

So, once you have all your information ready, it’s time to complete your dossier. There are two options for how to do this:

Via your REACH-IT account

Using the REACH-IT account created when you submitted your pre-registrations, you can use a dossier wizard to create and submit the registration. If you have a small substance portfolio and limited IT support within your company, it may be easier to use the REACH-IT online dossier tool as you do not need to install IUCLID. Only Joint Registration submission can be created this way, and there is little flexibility for data entry (which can be beneficial for individuals who do not have a substantial REACH background).

IUCLID 6

Since June 21, 2016, dossiers created using IUCLID (International Uniform ChemicaL Information Database) must be done with the latest version – IUCLID 6. IULICD 6 can be installed either on a network/server or standalone. IUCLID is beneficial as it can be used to save a lot of information on your substance – especially useful when you have a larger substance portfolio. However, if you opt to use IUCLID, I recommend that that you have had appropriate training as it is an extensive system.

IUCLID 6 does have a validation tool available which checks your dossier before it is submitted. This is useful to avoid any submission failures for sometimes very minor errors in your dossier.

One last thing… got your Chemical Safety Report?

As mentioned earlier in the blog, for substances >10 tonnes, if your uses are not covered by the Lead Registration, or if the LR is not providing a Chemical Safety Report, you will need to generate one yourself. The Chemical Safety Report documents the intrinsic hazards of the substance and uses, if hazardous, in a formatted report. It can be generated using data collected in the IUCLID 6 dossier, including (eco)toxicological data provided by the LR via the Letter of Access. The Chemical Safety Report can often be 150+ pages, especially if there is a lot of data available, and can take anywhere from 25 – 100 hours to complete – so it is not a simple activity!

Submission (and decision!) time

Once you have completed your dossier, and you are satisfied with the information presented, you can submit it via REACH-IT. Within about five working days after submission, ECHA will conduct a manual substance identity check, which is why it is essential that you submitted the correct analytical and spectral data, as well as included detailed composition information. If ECHA deems the information is not adequate, they will fail your submission and a new submission will be needed with the correct information.

If the substance data is adequate, an ECHA invoice will be generated for your registration fee. The fee is determined by tonnage band and company size (costs can be found here). You must pay the invoice as soon as possible, so it’s best that you have the funds available before submission. If the invoice is not paid within the specified time, ECHA can fail your submission.

Once the invoice is paid, you will be issued with a Registration Number. The Registration Number is unique to your registration and should be used to communicate your REACH compliance.

One final reminder…

I cannot stress enough that you need to get your registration ready and submitted well in advance of the May 31, 2018 registration deadline! As is hopefully clear from my blog series, the registration process can be complicated, and gathering the data and completing the dossier can take more time than you may realise.

If you have any questions, or find that your substance has not been registered and no other SIEF member is taking the lead, then do get in contact via our contact form below to find out how Anthesis can help you meet with your REACH obligations.

Take a look at other blogs in this series here.

^{[1] Remember this might not always be the case. Always check the ECHA substance database to see whether a registration has already been submitted. Always ask the SIEF who the Lead Registrant is too.}