This is the third instalment in our series looking at the chemical regulation REACH. We continue with substance identification and the importance of getting it right early.

Substance identification may well be the most important activity to get right in the whole registration process. Before joining a Substance Information Exchange Forum (SIEF) by pre-registering, basic substance identifiers are used (EC number, CAS number, etc.). These are usually found on the Safety Data Sheet provided by your supplier or, if you manufacture the substance yourself, your in-house knowledge of the correct identifiers based on the manufacturing process. Once you are under REACH, however, substance identity means much more than this. It needs to be adequately quantified by analytical and spectral methods and submitted as part of your registration.

Since the June 2016 update to IUCLID 6, the software used to collate all the substance information, and the subsequent update to the submission platform REACH-IT, the European Chemicals Agency (ECHA) manually check every submission to ensure that the correct identification data is submitted. If ECHA deem the data to be insufficient to identify the substance they will give you one opportunity to update this, but ultimately they could fail the submission. If you are submitting your registration close to the deadline in May 2018, a rejected submission could cause you to become out of compliance. This would result in the need to cease manufacture / import until a registration is in place. So, it’s essential to ensure that you have the correct data as soon as possible to avoid any delays to your ability to supply.

Working out what you need to collect

The requirements of REACH Annex VI (2) ‘Identification of the Substance’ stipulate you submit all the following spectral and analytical data as part of your own registration dossier, and the same applies if you are submitting a Duty to Inquire dossier:

• Ultra-violet visible spectroscopy (UV/Vis)
• Infra-red spectroscopy (IR)
• Nuclear magnetic resonance (NMR) and / or Mass spectrum (MS)
• High-pressure liquid chromatogram and / or Gas chromatogram / GC-MS

In addition, the following items must be presented within the substance identification report:

• Name or other identifier of each substance
• Name(s) in the IUPAC nomenclature or other international chemical name(s)
• Other names (usual name, trade name, abbreviation)
• EINECS or ELINCs number (if available and appropriate)
• CAS name and CAS number (if available)
• Other identity code (if available)
• Information related to molecular and structural formula of each substance
• Molecular and structural formula (including SMILES notation, if available)
• Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate)
• Molecular weight or molecular weight range
• Composition of each substance
• Degree of purity (%)
• Nature of impurities, including isomers and by-products
• Percentage of (significant) main impurities
• Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors)
• Description of the analytical methods or the appropriate bibliographical references for identifying the substance and, where appropriate, for identifying impurities and additives. This information needs to be sufficient to allow the methods to be reproduced.

However, sometimes it’s not technically possible, or scientifically necessary, to give information on one or more of the items above, but you must clearly state the reasons why.

Gathering data

Collecting this data can be increasingly difficult, especially if you don’t manufacture the substance and don’t have any in-house facility for substance identification. One way of getting the data is to request it from your supplier, although often the data is considered intellectual property of the owner and they might not be willing to share it. The second option is to order the testing at a reliable external laboratory, which usually costs ca. £3,500 per substance. The biggest drawback of this is if you purchase substances already incorporated within a mixture / product. Data submitted must be on the substance itself – mixture data is not accepted.

Both options above can take more time than expected; it’s not unusual for this data collection to take more than six months. As the title of these blog posts suggest – and it’s worth repeating – the deadline is coming up fast, so you should be in the process of collecting this data, or starting collection, as soon as possible.

I’ve got my data… now what do I do with it?

Once the spectral and analytical data are collected, the next, incredibly important, step is to interpret the result and determine exactly what your substance is. It might sound like a strange statement, as so many companies have been manufacturing / importing certain chemicals into the EU for decades, how could they have been getting substance identity wrong?! Unfortunately, through the collection of the identification data, companies are realizing that their substances are in fact better identified under other, or new, identifiers. ECHA have produced guidance on the naming and identification of substances under REACH, found here. It’s important to understand that REACH substance identification can differ from other global jurisdictions, therefore don’t solely rely on other country identification.

Any changes to substance identification must be communicated with a SIEF. Members will be able to assess what substance they wish to register and align it appropriately with the Lead Registrant (LR). If there is more than one substance identified within a SIEF, it can split into a sub-SIEF but this must be communicated clearly to all members, and any new members who join. If the wrong substance is registered it can be an incredibly costly activity to realign with the correct identifier, as an entirely new registration will need to be completed and the old registration abandoned, with no financial reimbursement.

The LR should provide all SIEF members with a Substance Identification Profile (SIP) which will stipulate what the submitted substance is. It’s important to gain access to this documentation prior to registration. Once you have confirmed that you have the same substance as the LR via the SIP you can move forwards and begin your registration.

In my next blog, I will go through the information requirements for a Joint Registration, assuming that there is already an LR in place. Rather than provide a step by step guide to how to complete a dossier, I will provide some hints and tips on how to collect the data needed, and on submission.

Take a look at other blogs in this series here.