When talking about the need to register, attention generally focuses on the need for data review, new testing, deciding on classification and filling in all those fields in IUCLID. Even when considering the Chemical Safety Report (CSR) and Exposure Scenarios (ES), guidance is presented as if the reader needs to start from scratch. Most of the guidance and what is presented at meetings is based on the assumption that registrant is a potential lead registrant or is at least taking an active role in the proceedings.
In reality, many registrants will have a minor role in a SIEF that is run by larger organisations or pre-existing consortia or when substances have already been registered in 2010, and lower volume registrations are now needed. Also, in the future when pre-registrations are a thing of the past, new importers or manufacturers will need to make Inquiries and then join up with the Lead Registrant to be part of the Joint Submission.
These (majority of) registrants will only need to do conduct the minimal work to be part of a joint registration process. And of course pay data holders for access.
This short guide covers some of the main issues faced by those who are not being active towards registration, but who will still need to do some work for their own registration.
As a minimum, all those planning to register (even if paid-up members of a consortium letting the consortium do the bulk of the work) will need to prepare their own personal dossiers on IUCLID 5 and submit with REACH IT. Their submission will need to include supporting analysis (section 1 of IUCLID) and descriptions of their own, production, use and processes (Section 3) together with their Exposure Scenarios and Chemical Safety Report.
Hopefully, members of a SIEF can work together to agree on suitable methods of analysis to help demonstrate substance ‘sameness’ and can support each other in the production of the Exposure Scenarios and CSR, but all registrants will need to provide their own personal reports in their own personal submission.
Establishing ‘sameness’ is in practice difficult. The basic position is that members of a Joint Submission need to demonstrate that the following conditions have been met with respect to ‘sameness’:
• The substance description in Section 1 of IUCLID of all joint registrants is effectively the same in terms of the agreed substance identity for the substance; for example, the generic molecular weight spread, isomeric distribution, isotopic content etc. are comparable.
• The spectra, chromatography and other analysis methods need to be supplied by each registrant in their own section 1 of IUCLID 5. This must relate to their substance that they are responsible for. Analysis performed by a consortium or the lead registrant is not sufficient.*
• The substance identified by each registrant that has been confirmed by personal analysis, corresponds to the substances used for evaluating hazards and physical properties.
• If read across has been used, the substance identity must be sufficiently close to allow such read-across
Note that ‘sameness’ or ‘equivalence’ is not the same as ‘identical’ and the system allows for flexibility. However, if the agreed substance specification is a range of molecular weights and a mix or isomers or isotopes, then all data used to support the registration must be valid for all samples within that specified range.
Even if the ‘sameness’ of the substance can be established within a SIEF, ECHA will have a final decision if the dossier is reviewed. This includes situations where some members of a SIEF may try to exclude other registrants by claiming that their substance is not the same. If ECHA disagree, the two sets of registration will still be considered a single substance and if there is evidence of major suppliers using a ‘dominant’ position in the market to exclude others, they could be in breach of anti-competition laws.
It is recommended that the SIEF agrees ideal methods for analysis and that the lead registrant communicates these to other SIEF members to facilitate the sameness discussion after registration. Even passive members need to be part of this process.
*More details of analysis requirements can be provided on request
It is in the collective interest of the SIEF to come to an agreement, but it is apparent that the main justification to keep someone out of a joint registration process is that their ‘impure’ substance may impart hazardous properties not present in the agreed specification. Ultimately, this decision is one that ECHA will need to make and this is why all registrants are asked to specify purity in their own personal part of the registration process (section 1 of IUCLID 5). A compromise may be that if the known impurities a likely to cause a hazard, that registrant will classify their supply based on the impurity, but still enjoy access to the lead registration. Any known impurity found at levels of over 0.1% may need identification on the SDS and label of the supplier if a SVHC or sensitiser, or at over 1% of otherwise hazardous.
If no compromise can be reached and the suppliers of low purity material cannot demonstrate that their substance is within the hazard assessment agreed by the SIEF, then it is possible they will need to make their own separate registration.
There is a danger that some less responsible registrants will use samples of competitors material to pass off as their own if sending samples to independent laboratories; for this reason, molecular marking is being considered by some manufacturers and if a potential registrants tries to submit a non-representative sample, this could lead to severe penalties. Inspecting CAs are aware of this issue.
There is also the danger that exclusion of others from a SIEF could be considered as anti-competitive behaviour; this is deemed to take place when companies, or groups of companies, use their ‘dominant market position’ to make decisions that have a commercial impact on customers or competitors. In other words, if forced out of a SIEF without good reason, the company not given access to the SIEF discussion process or the lead registration may have legal grounds to insist on this
Exposure Scenarios, Chemical Safety Report and Safety Data Sheet
In section 3 of IUCLID, details of production and use (including tonnage details) need to be entered and Exposure Scenarios to cover these attached. The Exposure Scenarios then need to be combined with the chemical identity data in Section 1 and the hazard endpoints prepared by the lead registrant to make the Chemical Safety Report (CSR). The CSR is required for registrations > 10 t and for all substances of very high concern (SVHC)
The first part of the CSR (Part A) is a summary of risk management measures and declarations that these are being implemented by the registrant and a declaration that they are being communicated to customers. These declarations need to be made by each registrant and the CSR attached to IUCLID 5 in Section 13 – however, joint CSRs are possible and in these cases each registrant needs to agree to the conditions of the CSR.
Communication of the risk management measures is through the Safety Data Sheet (SDS) and this obviously need to be personalised for each registrant and onward supplier. The bulk of the information in the SDS needs to be entered into the lead dossier in Section 11 (Guidance on safe use) and this includes first aid, fire fighting, accidental release, handling, transport classification, stability and disposal – effectively, the lead registrant writes most of the SDS for the other members of the Joint Submission, and all registered substances will therefore have almost identical SDSs.
However, if joining in on the CSR and basic SDS content, the uses of the substance need to match. As of July 2011, reports of inspections of ES are being received and regulatory agencies in member states are asking for ES on the SDS to be amended to match reality.
More information on ES, CSR and SDS can be provided on request, including personalised in-house training.
Inclusivity in a SIEF
Non-active members may not find themselves included in all discussions taking place in the SIEF or be invited to meetings if being held; by being passive, the registrant has effectively surrendered their participation in the SIEF activities – the advantage to the registrant is that this means they are not wasting time on SIEF work and can get on with their day job. There is also the advantage to the active SIEF members that there are less potential registrants to consult and therefore the SIEF processes hopefully become more streamlined and efficient.
However, being passive, or even dormant, does not mean that the registrant has no right to be involved and can ask for progress updates or even start taking a more active role if progress does seem to be slow.
Note that there are organisations who are trying to mislead registrants into using web-based systems by implying that such systems must be used to join a SIEF. Although some of these are very good and sincerely aim to help registrants work together, some are clearly a scam to make money. The use of any such system should be done with caution and care taken not to reveal commercial information. It is not necessary to pay to join a SIEF and you cannot be excluded for refusing to enter details into a software system.
Costs in a SIEF
Separate guidance has been provided on cost sharing, but it is essential that this should be ‘fair’. There is considerable concern from secondary registrants who are passive in the SIEF that the calculations will be transparent and indeed fair. The lead registrant having to complete the bulk of the IUCLD 5 dossier will obviously need to put in considerable time and effort and recovery of these costs is considered acceptable, but there is also debate about recover of costs by other active members; the point here is whether those who have put in effort to steer test programmes and attend meetings have the right to recover some of their direct and indirect costs from passive member who just pay a fee for access at the end. The SIEF will need to decide.
Ultimately, it must also be remembered that time can be wasted arguing over small variations in shares and if legal advice is needed, costs incurred may be higher than potential savings.
Guidance on cost sharing is available on request.
Most registrations will be ‘joint’ in that one lead registrant will submit a complete dossier and others , the ‘secondary’ registrants will only need to submit a reduced registration containing only personal information relating to their own substance identity and describing their proposed industry and process types. The technical information making up the bulk of the IUCLID on the substance that covers hazards, the derived no effect levels (DNEL / DMEL and PNEC) and proposals for classification will only be completed by the lead registrant.
This leads to the justified concern for many whether the lead registrant has got it right and the ‘master’ dossier is accepted; if taking a ‘passive’ role, the secondary registrant may not have had much input into this dossier and the counter argument is that if the passive member is that concerned, they should have taken a more active role). If the lead registration is rejected, those following may face a delay in their registration under some circumstances. The main risk is that the substance identity in the lead registration is incomplete and it is not possible to link the substance identity of the secondary registrants with that of the leader and this reinforces the importance of good analysis using comparable methods that allow sameness to be assessed.
The lead registrant will make the first submission and obtain a ‘token’ in the form of an electronic reference number to pass to other SIEF members for them to use in their joint submissions. The lead IUCLID 5 dossier must also include the names of those who are part of the joint submission and include the UUID details (ie. Official legal entity details).
Conclusions to REACH in Practice
Understanding the legal text and the official guidance will only give a framework in which to work. In practice, there are many examples of substances and articles that will not be covered in generic text and the methods for testing or how to register will need to be considered on a case-by-case basis.
Likewise, human nature will ensure that no two SIEFs will work the same way and what is considered appropriate, or fair, in one SIEF will be discounted in another.
Knowing the legal position and working to the spirit of REACH will help provide answers in more cases, but ultimately much of it is commons sense and good business and personal skills.
Finally, extreme caution is needed when entering any type of legal or financial agreement. Aiming for a win-win solution is essential, but there are some out there seeking to take advantage of other’s misfortune.
For more information contact firstname.lastname@example.org
REACH in Practice
Life as a passive member of a SIEF or as a later registrant
This page contains an extract of guidance provided for those in a SIEF. It is important to stress that the level of involvement in a SIEF while planning for registration will depend on the registrant's concerns that it will be done properly; if being led by a large consortium or a well established group of companies, there is a good chance it is being organised well and you may be able to take a back-seat (passive) role. In other cases, you may have less confidence in other SIEF members and want to take an active role or even lead the registration.
This decision will be largely commercial and will need to be taken on a case by case basis.
Many lessons have been learnt and are still being learnt.
Denehurst Chemical Safety Ltd
Advice for those having to work in a SIEF for joint registration