We are down two deadlines and approaching the third; for many companies this could be your first foray into REACH registration and the start of a journey that impacts your future ability to operate.
So assuming you want to operate then it is essentially a “Return on Investment” analysis heavily influenced by the regulatory and capacity issues discussed in the article. So where to start?
Know your substance(s) – ECHA’s wording is “unambiguous” substance identification. Sounds simple but this has been a cause of major problems in the previous deadlines. This will determine if you can be part of an existing joint registration SIEF (Substance Information Exchange Forum) or whether there may be more work ahead as a potential LR (Lead Registrant). The data you need for a single substance (>80% of one component) may be more than you currently hold including impurity identification. For a UVCB substance (Unknown or Variable composition, Complex reaction products or Biological materials) the identification process can be even more complicated.
If you are assured of your substance identification and you have established that it is registered then you can contact the LR (or Consortia) to purchase a LOA (Letter of Access). You should be aware of how the SIEF agreement relates to the status of a legal entities or affiliates. With the LoA you should be able to register with a simplified co-member dossier. The LoA allows you to “refer to data”; you do not own the data and the price can vary greatly – confirm that it covers your uses and exposure scenarios. There may also be continued costs associated with being part of a SIEF, for example if additionally data needs to be generated.
If your substance has not been registered then you or another supplier will need to take the LR role. The contact details of your potential co-registrants can be found in the pre-SIEF pages of REACH-IT. The LR has greater responsibilities as well as upfront costs to develop the data you need to fulfil the Annex VII (1 tonne or more) and/or Annex VIII (10 tonne but less than 100 tonne) registration requirements. As LR you have a legal obligation to share (required) data with other companies but importantly to be compensated.
Additionally, if you are LR you should complete your IUCLID dossier and submit ideally at least three months in advance of the 31st May 2018 deadline so any joint registrants can also meet the legal submission deadline.
The Annex VII and VIII are mandatory data sets and unlike the higher tier studies do not require testing proposals. Potentially data can be filled by read across, modelling and literature but if not you will need studies most of which will need to be to GLP (Good Laboratory Practice) standards. ECHA is expecting anywhere between 25,000 to 50,000 substances and around 70,000 dossiers for 2018. So even looking at the lower end this is still a lot of substances and laboratory space will be a major factor.
Act now to secure your business -“No data, no market.” If you have not pre-registered, late pre-registration may still be an option until 31st May 2017.
Dr Sean McCarthy
Head of Regulatory Affairs for Harlan Laboratories Ltd
smccarthy@harlan.com
