2018 sees the final registration deadline for lower tonnage substances to be registered under REACH. Here are five key recommendations from the consortium management specialists in WSP | Parsons Brinckerhoff.
1. Don’t assume someone else is going to take the lead
Our experience shows it’s wrong to assume your trade association or the larger manufacturers will be taking the lead. This is especially the case if your use is extremely niche or specialised. There may be progress, but get on the front foot and start checking now.
2. Set up consortia to share data and effort between users
REACH effectively mandates the formation of Substance Information Exchange Forums (SIEF) to manage joint registrations. A SIEF agrees the appointment of a lead registrant, agrees a Substance Identity Profile, and can exchange and agree the valuation of data. However, a SIEF is not a legal entity, so cannot spend money or hold funds. A consortium is a group of organisations that come together to achieve common objectives and typically forms around one substance, a group of substances, and/or specific registration objectives. Consortia can often be more efficient than SIEFs in managing registration programmes.
If there is no consortium, the lead registrant may have to carry all costs until Letters of Access (LoAs) are sold. For SMEs, this can be an impossible burden. Furthermore, consortia offer an opportunity for shared work and to avoid the need for registrants to invoice their competitors. A consortium facilitates substance grouping or read across for multiple substances, reducing testing costs.
3. Use independent managers to run your consortia
Independent consortium management draws on experience of registering previous substances, the legal requirements of cost sharing mechanisms and gives a clear, independent overview. This makes the process quicker, less expensive and not subject to unexpected issues. It also helps avoids competition concerns with sharing confidential data.
4. Commission a scoping study at the outset
There’s considerable uncertainty on just how much toxicology and use data is likely to be already available for smaller tonnage chemicals. Carrying out a scoping study at the outset will help identify the likely registration costs at the outset, helping budgeting, planning and resource management. Costs can also be reduced by grouping substances together, drawing on the results of testing of similar chemicals, intelligent waiving of tests and by challenging LoA prices where appropriate. An independently-commissioned REACH “scoping study” can be valuable in tabulating all of the likely costs of registration.
5. Start work now
Decide whether the expertise or time exists in house to manage required REACH compliance programmes. Either way, although there’s still three years until registration is needed, now is the time to start planning and acting.
Alan Ritchie
alan.ritchie@wspgroup.com,
+44 (20) 7314 4413
WSP | Parsons Brinckerhoff
Alan has 25 years of chemical regulatory and REACH and consortium management. He is happy to provide informal advice on REACH and consortia management.
