So, once pre-registered,
what happens next ? We know what to do about those chemicals you wish you had pre-registered, but had no
customers in 2008 (late pre-registration), but the big unknown is how will industry behave when it comes to co-operating to
share data and agree classification end points ?
Ironically, the biggest thing we now need to worry about is in our own hands – if a culture of helping
others in the industry evolves, SIEFs and joint registrations will be far less painful than if we do not work together.
If we try to play games and attempt to make competitive gains from the SIEFs or if we are too cautious due to legal
departments being unhappy about working with competitors, we will find costs and time commitments being much worse. However,
we do have anti-competition laws to follow as well.
This short guide is a bit of a crystal ball in that we only have the legal text and some limited guidance to help
us through the next period. We can draw some experience from how the plant protections industry and biocide
manufacturers coped with their respective legislation, but the scale in terms of numbers of chemicals and number of registrants
is massive.
What happens at Pre-registration
?
The first real practical
activity with REACH is ‘Pre-registration’. The basic aim of is to identify at an early stage
of REACH exactly which substances are in Europe and will need Registration and subsequent evaluation.
A major reason for the ritual of pre-registration is to
bring members of industry together who are interested in supplying the same substances so they can get together and avoid
duplicating animal testing – the SIEF (substance information exchange forum).
If you miss the pre-registration deadline or have
new substances to import or supply (as long as they are phase-in substances), you can pre-register late and join a SIEF late.
The limit on this is that you may not have this facility if it is only a short time before the registration is about
to go in; again, this is sensible as a new SIEF member could disrupt and delay a registration which would not be fair on other
suppliers.
In
January 2009, a list of pre-registered substances will be published with limited information on tonnage bands and expected
registration dates – if a substance you buy in is not on this list, it is your chance to chase your EU supplier or to
make your own late pre-registration. Due to commercial confidentiality, it will not be possible to check
who has pre-registered what, unless you have pre-registered yourself and in which case, you will have access to the pre-SIEF
lists.
Do not want to register
?
There are many substances
being pre-registered that will not be fully registered. This may be because volumes do not currently exceed
1 tonne per annum or that once pre-registered, the importer or user finds that is has been correctly pre-registered by their
supplier and they have been assured that full registration will follow.
In such cases, it is important to let fellow SIEF members know quickly that you do not intend to play
an active part in the registration process. This is not only helpful to other members, but could save yourself
incurring costs within the SIEF; for example, if the SIEF decides to hire a consultant to manage the project, you may be included
in the cost share structure unless it is made clear quickly that you do not want to be involved.
The easiest way to do this is to use the e mail contact details
you will receive as a SIEF member and simply e mail the other pre-registrations. It may be that your SIEF
of 15 quickly becomes a SIEF of 3 once contacts are made with other members.
Substance Identity – pre-SIEF activity
Pre-registration is open to all EINECS listed (and other valid) substances and although EINECS is considered
a more accurate guide to chemical identity than CAS, there are errors and misunderstandings in it. Therefore,
when entering your EC number into the pre-registration system in good faith, there is a chance that others who have entered
the same number have actually got a different substance.
It has been noted that non-eligible substances such as those Notified as new substances pre-REACH and
have an ELINCS number, or those never been supplied (legally) before in Europe can be successfully entered into the REACH
IT system for pre-registration and have not [yet] been rejected by ECHA. It is expected that these may
get flagged up after 30 November when the lists of pre-registered substances are published.
Once pre-registered, and it is found that there are apparently other
organisations who have pre-registered the ‘same’ substance, you need to first decide amongst the embryonic SIEF
(proto-SIEF or pre-SIEF, or other term frequently used) exactly what substance it is you intend to register. This
is the first and probably the most difficult step when a SIEF forms.
In some cases this may not be an issue, but in many instances, you may find that others in your SIEF
have used the same EC number to describe a different isomer or a material with a wider molecular weight spread than your own.
These differences do not invalidate a SIEF and you may decide to work within a very broad product description to save
time an money with testing, but conversely, you may decide that your substance is not equivalent to the others described by
your colleagues in the SIEF. You may decide that the SIEF is valid, but that you will pursue different
registrations, each with its own substance definition. Or it may be decided that the EC number used for
pre-registration in fact refers to two different substances that need completely different registrations.
In the cases where the SIEF splits into two or more groups
and members go their separate ways to pursue their own registrations, there may still be opportunities for the interested
parties to work together; even if some end points in the data set vary, others may still be close enough to allow some read
across and importantly, animal testing could be reduced.
SIEF formation – legal considerations
As a SIEF, you will need to work with competitors and there are
certain key points to consider. Firstly, commercial laws are in force in Europe to prevent activities of
an ‘anti-competitive nature’ – this could include discussing the identity of customers, pricing, excluding
other organisations from activities they have a right to take part in etc. One area that is close to this
restriction is the need to share tonnage bands with other SIEF members – it is accepted that you will need to indicate
your tonnage band (eg. 10 – 100 tonnes or > 1000 tonnes), but it is not considered appropriate to discuss precise
figures such as 56 tonnes or 2500 tonnes.
The other major legal consideration will need to cover the rules of the SIEF. It has been described
as a bit like having a pre-nuptial agreement among members; it may seem pointless when the SIEF forms as you all agree to
work together for the common good, but sadly, things can go wrong. This pre-nuptial agreement will need
to include management, voting rights for decision making, cost sharing formulae, appeals process and so on. However,
it is good to keep this simple – we have already heard of some consortia spending months and thousands of Euros in legal
agreements just getting starting arrangements sorted. Remember, you may be in many SIEFs with many different
groups of companies; keeping it simple will keep you costs down and let you get on with the interesting (science and safety
related) bits.
Purity
The purity of the substance is not a factor
in the pre-registration phase. However, it can make a difference in full registration and in considering
the validity of data.
The main consideration is if there are
impurities that can affect the properties of the substance. If it is a simple issue of you supplying 98%
purity and your competitor 95%, where the main impurity is water or non-hazardous starting materials, it will save everyone
a lot of time and effort to work together with a stated purity of > 95%. However,
if your competitor’s 95% substance contains 4% of a hazardous impurity, you may prefer not to join the registration
with them; indeed, it will be hard to justify the read across of test data between the materials if a common agreed classification
is not possible.
A possible compromise could be that the
SIEF agrees that the substance:
Has a purity of > x %
Contains no single impurity > x%
Contains no know substance
of very high concern (SVHC) > 0.1%
For example the substance is > 90 % with no solvent impurity > 5%, water < 6% and no SVHC > 0.1%.
The reason to limit known SVHC to 0.1% is that at above this value, the impurity could influence classification and
labelling of the substance being supplied.
Before deciding on the course of action (a commercial decision) you should consider the advantages of registering
jointly as a SIEF and then agreeing to differ on the classification of the material supplied – in other words, the substance
registered has a specific classification, but in the presence of specific hazardous impurities, will carry a different classification
in the same way that you would consider a preparation of substances. The label and SDS would reflect the
presence of the impurity.
SIEF Agenda – who leads ?
The SIEF decides who leads and takes the secretariat role. They may choose to appoint
external help in the form of a technical consultant or legal advisor, but this should be one of the first things the SIEF
does and in many cases, may be before a mutually acceptable substance identity is agreed.
The ‘lead registrant’ (more later in this document) does
not have to be the SIEF ‘leader’. The manager does not have to be from the organisations who
plans to register the largest tonnage and does not need to be from a legal entity who is registering; for example, a SIEF
may agree that the manager is actually from the production site in India who knows more about the substance than the importers
based in Europe. It is the SIEF that decides, although remember that this should be a democratic decision
based on the SIEF agreements that should have been drawn up as it formed.
If there are no volunteers, it could be (as one attendee at a recent training meeting suggested) like
a game of ‘chicken’ where the first company to panic into getting the registration started actually takes the
lead. Hopefully, the SIEF members are sensible enough to get going before it is too late.
Which data to use ?
Ultimately, it is the SIEF that decides which data to use. No reliable data can be ignored in
assessment the substance properties, even if it can be discounted for purposes of classification. The robust
summary will allow a chance to discuss the technical value of data.
The grading of the quality of data from published journals, read-across, computer modelling, old test
reports etc is a skilled job and it is recommended that members of the SIEF with personnel having specific skills take this
on to best suit their abilities; for example, if one company has a specialist in ecotoxicity, they can asses one area whereas
those with chemists may take on another. Using ‘internal’ skills may prove cheaper than hiring
consultants, but consultants and external specialists will need to be used if skills are not found. Likewise,
paying a consultant may be more agreeable collectively in the SIEF as the consultant will be independent and SIEF members
may not have the time to devote to the technical content.
Data owners may therefore present any of their data to the SIEF, but it is important for the other
members of the SIEF that they recognise useful / valuable data; there is no point buying into a data set that you do not need.
The data must be assessed and gaps found
that prevent completion of the robust summary and therefore prevent agreed classification. It the Chemical
Safety Report cannot be completed, it is a good indicator that more work on testing and data evaluation is needed.
Agreeing on data
gaps for new testing
The SIEF will need to agree on data gaps to meet the basic regulatory requirements outlined in Annexes VII –
X and taking into account XI. These Annexes outline data requirements and Annex XI summarises the need
to provide sufficient data. There is a lot of guidance on the ECHA web-site relating to this (see link
below) http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm
Once gaps are identified,
these need to be completed by searching for more data, considering read-across with other substances, running computer modelling
or other predictive assessments and if it is still not possible to meet the requirements, perform more laboratory tests.
If new testing is required, it is necessary to inform ECHA so they can be assured that any proposed animal testing
is essential and cannot be avoided.
The SIEF will need to agree on the test laboratory, the sample to be used (purest grade, the least
pure grade, a mixture of samples from SIEF members?), the division of costs and the ownership of data generated.
These issues are up to the SIEF to agree, but it would perhaps be helpful if they were decided on at the formation
stage.
How do you determine the value of data ?
Having agreed the identity of the substance, who is to be the lead registrant and the
structure of the SIEF, the quality of existing data and plans for testing, the next big discussion likely to cause argument
is agreeing the value of data.
Guidelines are available from ECHA, but it is suggested that standard EU testing laboratory prices are
today’s rates are used. This means that a complicated biodegradation study done to Japanese guidelines
at the best Japanese laboratory costing € 30 000 is actually only worth the € 5000 it may have cost to meet standard
EU guidelines in the EU; conversely, the toxicity study performed for £ 250 and 10 shillings in the UK many years ago
is now worth €2500 as it meets the criteria and new animal testing needs to be avoided where possible
You will only need data relevant to your Registration; for example,
if you only sell to the building trade, do you need to buy access to marine toxicity data that was conducted by another SIEF
member so they can sell to the offshore oil industry. Therefore, the marine data has no value to you.
The value of data will depend on its saleability to other
members of the SIEF but guidance on this makes it clear that this should be fair and equitable. However,
the real monetary value may ultimately depend on the skill of negotiators.
Fair share of costs
The words ‘fair’ and ‘REACH’ do not always fit comfortably in
the same sentence. However, if industry works with ‘fairness’ in mind, those negotiating should
get close to the win-win situation where all parties are satisfied. It is very likely that those organisations
who either try to take advantage of weaker members of the SIEF or those that are so cautious that avoid getting involved in
negotiation end up doing more work and spending more money that those who quietly get on with the work and aim to minimise
work.
It
may be a naive or simplistic view, but organisations who work together to get a fair deal will al benefit – lawyers
and technical consultants are expensive and if you try to carefully scrutinise the sharing of costs, the time and effort required
may cost more than simply trusting your fellow SIEF members.
It is also important to agree on what sharing means in practice – are you buy access to the data
for REACH or are you buying a share of a report that you can use at any time in the future (eg for US TSCA Notification) ?
What if new registrants ask you to share later – can you enter a private deal with them to share the reports
you just bought a half share in or must the new registrant go to the whole SIEF ?
These are commercial decisions, but ones that must be
considered at the start of negotiation.
What if the SIEF cannot agree ?
There are many things that the SIEF may
not agree on. The substance identity, management, fair distribution of costs etc. There
is guidance on this on the ECHA web-site http://reach.jrc.it/docs/guidance_document/data_sharing_en.htm but it is effectively up to the members to agree to work together. As
already stressed, it will lead to a win-win situation if members can work sensibly together; in training exercises conducted,
it is clear that those willing to work together will reach an agreement more quickly, efficiently and equitably than those
who do not co-operate. In the bigger picture, you may feel that you could have negotiated harder and save a few hundred Euros,
but by not upsetting you ‘colleagues’ in the SIEF, you may in turn get a better and easier deal on another SIEF.
To quote a very old guidance document, those who live by the sword, die by the sword; in other words those who take
advantage of others may find that they are in turn taken advantage of later.
Registration – how much or how little do you need to do ?
If you decide to submit a joint registration
(strongly recommended), one of the SIEF members will need to take the role as ‘lead registrant’. This
would normally be one of the SIEF members in the higher tonnage bands, but if more than one member has similar tonnages to
register, then it is a simple challenge of finding a volunteer. The good news for the volunteer, is that
additional costs incurred in preparing the full dossier can be off-set within the SIEF (to be agreed in the SIEF formation
process).
The secondary registrants will only need
to complete sections 1 and 3 on IUCLID 5 relating to their substance identity and their manufacturing and use details (including
tonnage supplied). These details will obviously remain confidential to the specific registrant and not
shared among the SIEF.
The Robust Summary of hazard data will
be part of the hazard classification agreement, but the Exposure Scenarios (ES) and Chemical Safety Report (CSR) will be specific
to individual registrants – obviously, if all members of the SIEF have similar uses, generic ES and CSR will be a good
idea as it will avoid duplication of effort.
The simple rule is that the more you can work together, within limits set by commercial company law covering anti-competitive
practices, the less work you will have collectively.
After
Registration ?
Remember
that the SIEF will formally cease once all members are registered, but all registration holders have a duty to maintain their
CSR and SDS and alert customers of new safety issues. And if new data emerge to suggest a previously unknown
hazard, all registrants will be affected as the classification will need to reflect all supplies of the substance.
If a new supplier wants to register the
substance, the existing registrants will need to share data and the easiest mechanism for this is to revert back to the SIEF
agreement. For the SIEF members, this present an opportunity to recover back a share of the value of shared
data – if the SIEF agreement covers this.
