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Article related to: REACH
Get your substance identity right – here's how
Identifying your substance is one of the first steps you need to take when preparing a registration dossier under REACH. ECHA Newsletter spoke with Dr Stuart Niven, Senior Regulatory Affairs Manager at Harlan Laboratories Ltd, who gave a presentation on this topic at ECHA's Stakeholders' Day. Here is his advice to small and medium sized enterprises and other REACH registrants on the key aspects in building an accurate substance identity.
Watch the video interview above. The interview in full below.
Dr Niven, how would you advise SMEs or first time registrants to get started with their substance identity?
The key point is to start looking at the general class of the substance that you have, whether it is an organic, inorganic or oligomeric material. Try to get the basic idea of the substance and then tailor an appropriate analytics package with correct analytical techniques for the type of substance, taking into account the scope of substances covered in REACH and what needs to be registered.
The analytical techniques can vary depending on the type of substance that you think you have. It is important to approach the analytics with full professionalism. Fully justify what you have, analyse properly, get the full identity package – only then do you really know what you have and can also justify to the authorities what you have.
Where can companies find help?
If all this sounds too complicated, you can always employ a consultant to give you some guidance. You could also employ a university to give you some help.
You can start discussions with your suppliers and with trade associations who operate on your behalf. Remember that many aspects of analytics are confidential but trade associations often know how to bring these together in a non-confidential way.
The lead registrant for your substance can also help and in many cases will have a substance identity profile. The SIEF is available and potentially substance consortia. There are many places to start.
There is also plenty of ECHA guidance available. You can also search online. I find the online databases, for example ChemSpider and SciFinder to be very useful. These cannot be used as a replacement for analytics performed on a registrant's substance itself. But they can help you with predictive tools for what your substance should look like within its spectral identity to give you some guidance if you are going in the right direction or not.
How much time should companies reserve for building an accurate substance identity?
This is a very difficult question to answer. A standard package, with a fairly easy substance, can take up to a month. However, laboratories tend to be very busy. It could easily take another month of lead time before it can start and it may need further time to finalise reporting, particularly if you are using Good Laboratory Practice (GLP) which is required if you are doing further testing. So you could be looking at a three month package. Time may also be needed to prepare a suitable sample. For example, if the substance is supplied in a solvent, this may have to be removed if it is not considered part of the registration substance.
However, time is key and particularly so if something goes wrong. I am not talking about a test going wrong but rather the situation where your substance is not what you think it was. Or your substance is more complex, a UVCB (substance of unknown or variable composition, complex reaction products or biological materials) rather than a single substance; or something that requires a change in the analytical strategy or even additional tests. These can all take more time, including things like analytical development, for example, the substance may bind to the column of the High Performance Liquid Chromatography (HPLC) and require a complete new methodology.
So, start as soon as you can.
What do registrants need to keep in mind to build a high-quality substance identity?
Good quality testing. This means reproducible quality testing and also traceability. It's no good simply having a spectrum that came from the manufacturer of the substance you have imported. You must be able to relate this back to your quality system, to batch numbers, and to the batch numbers of your suppliers so that you can go back through all of the stages of the manufacturing process. That to me is the key point. It needs to have full traceability in addition to the quality of the actual test itself. If certain information is not included, you also need to justify that, and back it up with evidence.
Stuart Niven is the Head of Regulatory Affairs Switzerland at Harlan, where he leads an expert consulting group in the preparation of dossiers for chemical, agrochemical, pharmaceutical, biocidal, food contact and cosmetics regulations.
For the 2010 and 2013 REACH deadlines, he ran three consortia, had steering committee roles in 11 further consortia and acted as lead registrant for approximately 20 substances. The consortium groups in which he was involved registered more than 100 substances as lead.
- Stakeholders' Day presentations
- Substance identity
- Questions and Answers
- REACH 2018
- Substance Information Exhange Fora (SIEF)
- Guidance on REACH
- Terminology – in 23 languages
Interview by Päivi Jokiniemi
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