The relatively short period to enable pre-registration is upon us
and we must now look ahead to life after REACH is fully implemented. We have had a sort of phoney period between June 2007
and June 2008 where the legal text has been in place and where that has been a frantic preparation (and arguing over) the
technical implications of the legal text. Pre-registration is working more or less (at the time of writing, there are still
some REACH IT problems, but we have been assured that they will be ironed out. Soon.
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 ?
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.
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.
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.
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.
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:
a purity of > x %
Contains no single impurity > x%
Contains no know substance of very high concern (SVHC)
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.
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.
data can you bring to the SIEF ?
Basically, any data may have value (but you must have rights to access).
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.
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. Examples may be if a data
owner suggests that the rest of the SIEF buys into extensive marine toxicology data that they generated to enable supply to
the off-shore oil industry. However, if you do not supply to this industry, you may not need to demonstrate safety in the
marine environment and there is no point in buying into this data set.
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, next you need to assess what data are available and who has rights to it. Just because it is published
on the internet or in a Government Agency review document (eg HPV programme review on ESIS), it does not mean that it can
be used by anyone. Even if published independently and not by a supplier, it may still be subject to copyright.
ownership has been established, those who have rights are entitled to compensation from other SIEF members to share (see below).
is basically up to the SIEF to decide on how data is valued, but a good starting point is to decide what the cost would be
to the SIEF if that particular report was not already available; in other words, if a key study essential for the registration,
it has a full value, but if a supporting study of passing interest, value will be less. If it has any value. Likewise, some
data may be valuable to one SIEF member, but not others; for example, an inhalation test report is important for those supplying
as a fine dust, but for those making it in a viscous solvent, inhalation data would not normally be relevant.
strongly advised to get external help if any doubt, but remember that a meeting in Brussels with technical experts, accountants
and lawyers could to cost more than the share you are being asked to pay.
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.
you only contribute to the cost of data you need and if you are registering only in the 1 - 10 tonne band, you will not need
to buy into the more extensive data at higher tonnages. And the share of costs? This will often be based on the tonnage band,
but again, it is up to the SIEF to agree.
What if the SIEF cannot agree ?
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.
Action - what should you consider after pre-registration
The first thing to do is to watch for
messages from ECHA in your REACH IT log-in page or to wait for e mails from other SIEF members. Or you may want to take the
lead and pro-actively contact other members once you have their details. Either way, in early 2009 you will need to consider
the SIEF as a body. Also, read guidance on the ECHA website.
For certain substances, consortia may have already formed
with many of the potential registrants already members. The consortia may want to take a lead role, but those not members
of the consortia cannot be excluded. In many cases, it will be worth buying into consortia especially as many will have bought
into consultant toxicologists and chemists to help save work, but do not get bullied into joining a group that it not relevant
to your needs.
Above all, you need to be aware of the legal, chemical, environmental, toxicological and regulatory requirements
of REACH and be a good negotiator and have good meeting skills. There are probably not many about who are skilled in all of
these, but even merely recognising issues in these areas is a good starting point.