This is part 2 in our series looking at the chemical regulation REACH. We continue with guidance for handling late pre-registration, the Substance Information Exchange Forum (SIEF), and SIEF communication.

After you have completed the evaluation of your substance portfolio, and concluded that under REACH you require a registration in 2018, you must ensure that you have valid pre-registration(s) for all identified substances. As discussed in my last blog post, the pre-registration period has ended, and late pre-registrations can only be submitted if your tonnage (manufactured, or imported in the EU), has historically been less than one tonne per annum, and has exceeded one tonne only within the past 12 months[1]. If you have already pre-registered, you might like to sit back, relax, and take a look at a different blog; but if you need to go through late pre-registration, it’s worth reading on.

1.      Deciding whether to handle your obligations externally or in-house

First off, it’s important to recognize how much time and resource needs to go into getting REACH compliant; hiring an external company to assist you should be seriously considered.

If you are a non-EU manufacturer 

You are not able to register at all under REACH. However, if you wish to protect your supply chain and assist your EU customers, you can appoint an Only Representative (OR) within the EU. The OR will take all responsibility for the REACH obligations associated with importing a substance into the EU, including the legal responsibilities.

If you are an EU manufacturer or importer

You can either appoint a Third Party Representative (TPR) who will act as a ‘mask’ for your pre-registrations and will be shown on the pre-registration and not you, or appoint a general REACH consultant to assist you. In these cases, the legal responsibility of REACH still lies with you.

If you do decide to get external support or keep the work internal, you must ensure that you have an account set up to late pre-register your substance. ECHA and lead registrants routinely contact potential and actual registrants via this system so it’s wise to ensure you have up-to-date contact information within your account. More information on REACH-IT, and how to set up an account, can be found here. Although only basic substance identification (ID) is needed, it’s advised that you identify your substances early, and I will discuss this in my third blog.

2.      Becoming part of a Substance Information Exchange Forum

Once pre-registered, REACH-IT will give you access to a Substance Information Exchange Forum (SIEF), which is a collection of all legal entities that have pre-registered the same substance. A SIEF can be made up of potential registrants, data owners, and companies that do not intend to register but have had to pre-register (i.e. substances are exempt from registration but not pre-registration such as reimports, or excipients).

Within each SIEF, there can be one company that takes the voluntary role of SIEF Formation Facilitator (SFF). The SFF generally takes the role to organize a SIEF and begin the initial communications to identify who will take the Lead Registrant (LR) position. The LR is the legal entity appointed by a SIEF to submit the Lead Registration dossier, and from whom all other registrants will buy access, via a Letter of Access, to complete their own joint, or co-registrant, dossier. Often, but not always, the SFF will become the LR, so the SFF is your best port of call when wanting to find out more information about the registration.

3.      Communicating with your SIEF

When communicating with the SFF and/or the LR, it’s important to ask the right questions. To help, here are some key questions to ask:

• Please provide a Substance Identification Profile (SIP) to confirm substance ID
• What analytical and spectral techniques/methods are recommended for substance ID?
• What is the Letter of Access cost for 1 – 10 / 10 – 100 tonnes?
• How many registrants are there, and how many registrants are expected in 2018?
• Are there any additional future costs expected?

As part of a SIEF, you will also receive communications about any ECHA evaluations on the LR dossier, and any updates in information on the substance or dossier. It’s vital to remain proactive within a SIEF to ensure that you have all the information you need to complete your own registration. If you have not received any emails or news for six months or so, it can be worth sending a reminder email to the LR.

It’s important to note that it’s not always guaranteed that there is an LR in the SIEF. If you find yourself in a SIEF without a LR, or even an SFF, you may have to consider taking on the LR role. As there are both financial and resource burdens for the LR, and also legal responsibilities to a whole SIEF, such a decision should not be taken lightly, but the continuity of the substance may be critical to your business. Ultimately, if you need to become the LR, you must make this decision now, as time is running out to complete the registration in a timely fashion. To complete an Annex VIII (10 – 100 tonnes) LR dossier, including testing, it can take approximately 18 months to complete. Given the registration deadline is now 18 months away (from November, 2016) a decision has to be made by the end of 2016. So, as I mentioned in my last blog, the time really is now!

Now you are in a SIEF, and have established whether you will be part of a joint registration, or will become the LR, substance ID is your next step towards registration. My next blog will be on the importance of substance ID, and some of the pitfalls to avoid.

Take a look at other blogs in this series here.

[1] If your tonnage has been greater than one tonne for more than 12 months, please contact our REACH team using the fill out form below.