Abstract
For a relatively short period between 1 June and 30 November 2008, substances already
on the market in Europe can be pre-registered. Those old enough to remember EINECS being put together in
the early 1980s will have some degree of déjà vu, but pre-registration goes further than the earlier attempt to draw up a list of chemicals on the market in Europe.
The actual mechanics of pre-registration are very
easy; that is once the rules of what you can and cannot pre-register are understood and the question of who can pre-register
is addressed. And finally, once pre-registered, what happens next ? And what if we miss
the deadlines or want to supply something new after 1 December ?
This short guide is to help those having to go through the process
of pre-registration and describes that there is actually some flexibility to meet commercial requirements and how many decisions
will be your own decisions that you will need to justify.
What is 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.
Pre-registration
is not a system to let the Commission spy on industry or to be a rigid system that once on the list you must register; nor
is it a closed system that prevents new supply routes being started or nor does it prevent new companies being set up and
others merging. It is only a system to make sure that when embarking on the REACH process, we have a better
idea of the market place to get interested parties together.
What gets pre-registered
Pre-registration is open to all EINECS listed substances and those that escaped EINECS when it was first prepared
as they were considered polymers at the time – these are known as ‘no longer polymers’ and have NLP numbers.
New substances introduced after EINECS closed had to be Notified and were given ELINCS numbers. Some
chemicals not on EINECS or NLP are possible to pre-register and be phased in; these are described below. However,
there are also many in-valid substances being supplied in the EU at the moment and many will not be possible to pre-register
and will require immediate pre-registration.
RIP 3.10 and guidance on substance identity, polymers etc give good guidance on many issues and even if weak when
describing inorganic substances, salts, derivatives of natural products and by-products with value, the guidelines issues
by ECHA should be the first point of reference. RIP 3.10 is a brave attempt to cover a vast number of scenarios
for chemical identity and each example and recommendation points back to the spirit or REACH – to rationalise the inventory
of chemical substances and to allow comparisons between substances to reduce animal testing.
Use the REACH guidance on substance identity to decide if your substance
is a single consistent, multi-constituent or an unknown, variable chemical or of biological origin (UVCB). The link http://reach.jrc.it/docs/guidance_document/registration_en.htm will take to you help on identifying your substance. Guides are
also available on intermediates and polymers.
A few of the special cases are covered below – but there will be many more examples of ‘borderline’
materials.
Non-EINECS substances
Substances that
were supplied for export only from the EU or were used as isolated on-site intermediates did not need to be on EINECS and
did not need Notification under the pre-REACH system; however, under REACH, these will need registration and manufacturers
can make us of pre-registration and phase in. There is a facility for such materials in the pre-registration
process. There are also substances that were supplied in good faith but it appears that EINECS is imprecise
of isomers were not identified – it is unofficially expect to be an amnesty for such materials, but the absence of an
EINECS number needs justification.
Substances that have been Notified under NONS will be ‘considered’ registered
and will be given a registration number by December 2008. However, only those who Notified will be given
registration numbers and only these ‘registration holders’ can supply the substances – if other suppliers
want to supply the substance, they will need to prepare an immediate registration as a ‘non-phase in’ substance
and share data with the Notifier.
It
is therefore clear that many manufacturers and importers of new substance will need to consider registration in 2008 as pre-registration
is not an option. The act of pre-registration will undoubtedly identify many substances that have
slipped through the regulatory process and should have been Notified – these substances need to be withdrawn from the
market until a registration (after June 2008) is made.
Similar substances
As well as the fun of trying to determine the identity of your substance that is being pre-registered,
you will be prompted to identify other ‘similar’ substances that may allow read-across and help different SIEFs
save time and money on testing – and importantly reduce animal testing requirements.
ESIS is a good place to look, searching for molecular
formula that are ‘similar’ (or the same) as the substance you are pre-registering. Add or take
off a carbon and a couple of hydrogens and search again – is there anything similar. You may also
want to play with the SMILES notation and see what else comes up. For example, C5 H10 brings
up about ten substances on EINECS.
It is not obligatory to fill in ‘similar’ substance, but it could save you a lot of money.
If you are unsure, get someone to help you or hope other members of your SIEF have found some themselves.
Polymers
Polymers are exempt from REACH and do not need pre-registration. However,
anything that goes into the reaction process at > 2% to make the polymer will need pre-registration, including monomers
and other substances. There is a mistaken belief by some that only ‘free polymer’ need pre-registration;
this is wrong !
Mixtures
If supplying a substance that is synthesised
as 70% component A and 30% B (but not mixed after synthesis), you effectively have a choice – make one registration
on the mixed components, by testing the substance as manufactured, or register separately as A and B. The
advantage of two registrations is that if other registrants are supplying A and B separately, you can share data with them.
Advice in this case is to pre-register A/B mixture, A and B then see who is on the SIEFs and decide later how to register.
Effectively, the material to be registered is what you
claim it to be; xylene is often given as an example with ortho- meta- or para- isomers or a blend of bog basic xylene.
The four are listed separately on Annex I to Directive 67/548/EEC – if you are importing ‘xylene’
for use as a solvent, does it matter which isomer ? Your supplier may just send what they have most of
and the isomeric composition may change between batches; as long as the isomeric composition is within limits set out when
the straight xylene was registered, variation is OK. However, if you ask your supplier for o-xylene for
use as a chemical pre-cursor, you will need a registration of o-xylene.
The pre-registration tools will ask if your substance is a single constituent substance or a mixed substance
(noting that UVCB materials are considered ‘single’.
Purity
Purity figures and the identity of impurities do not need to be included in the pre-registration
process. Unless the ‘impurities’ actually have a function and enhance the product. The rough
rule us that if you or your customer would rather that ‘impurity’ was not there, it can be ignored for pre-registration.
If there is residual solvent, such as
toluene, that has the advantage of making the substance into a wet cake that is easier to handle than the powder formed if
without solvent, then you are effectively supplying a mixture of substance and solvent. If you are an EU
manufacturer, and have bought the toluene from an EU supplier, you obviously do not need to pre-register the toluene yourself
and if a 90% substance 10% solvent material, the tonnage supplied of the substance is obviously 90% of the total tonnage.
If you are importing the 90% material and the toluene
is helpful to you for handling purposes, you are an importer of toluene. If you would rather it was not
there and ‘tolerate’ the impurity, you can consider it an impurity.
Salts
It is allowable
to adjust the pH of substances and preparations and in doing so, consider only the substances in the mixture; for example,
adding a little citric acid to reduce the pH of a potassium phosphate solution can be considered a mixture of citric acid,
potassium phosphate and water where the two substances need to be considered individually for pre-registration (water being
thankfully exempt). However, if a claim was made that you were supplying potassium citrate, this would
need registration as a substance; effectively, it is what you claim to be selling and the decision to consider it a mixture
of a new salt would need to be justified to any Competent Authority that asked. More importantly from a
business point of view, you would also need to be able to persuade customers that what they are buying is pre-registered correctly.
The advice is to consider what is claimed
to be supplied and then pre-register that substance or substances.
‘Natural’ products
Substances dug out of the ground or squeezed from plants are considered
‘natural’ chemicals. Some of there are helpfully listed in Annexes IV and V of the Book of
REACH, but most are not. There are also complications if you take a natural material and process it in
some way; what type of process makes it ‘un-natural’ and requiring registration. And how about
the limitation that natural materials are only exempt if non-hazardous ? At pre-registration stage, data
to determine if hazardous or not is possibly not available.
As with many substance identity issues the advice is to see what other suppliers in your industry are
doing and attempt to find a common position (there is safety in numbers). If you can agree a common position,
use this to consider the pre-registration.
Processed natural products are difficult, especially if reacting them with chemicals to product a derivative; for
example, hydrolysing cellulose or adding reactive groups to clays. In these cases, the advice is that all
starting materials going into the reaction should be registered (unless exempt).
By-products and waste
As with impurities, substances only
need pre-registration and subsequent registration if they are intentionally supplied; waste collected for disposal is outside
the scope of REACH and needs considering under Waste Legislation.
Waste materials can fall into two categories; the first includes solvents,
left over starting materials and un-used product. None of these will need pre-registration, even if you
sell them for recovery because they will have already been pre-registered up the supply chain for them to be used on your
site already. The second type of ‘waste’ will be by-products of reaction that are removed during
the process. Sometimes, these have a value to someone and it may be possible to either sell it, give it
away or at worst, pay less to a waste disposal organisation. In order to get paid, or receive a discount
on disposal costs, the material being supplied will normally have a specification and if there is a specification, or a claim
of composition, you will find it hard to justify that this is still waste. An example may be that the waste
stream generates acetic acid in water and do get a cheaper deal from the waste disposal contractor, they insist on a minimum
15% concentration – this now has a product specification and is not waste and needs pre-registration.
If the waste contractor takes waste from a number of sources
that do not have specifications (ie real waste) but finds that they can extract certain substances of value to recycle, the
waste contractor may find themselves liable for pre-registration. Obviously, if these are solvents or left
over starting materials, they do not need pre-registering for a second time in their life.
Articles or not
The article vs substance debate still continues with many substances in the grey area
between the two. In such cases, the importer needs to make a decision whether it is a substance or article
and then justify that decision. If you are a manufacturer, the chemical vs article dilemma is less critical
as the substances going into it would need pre-registration for you to have it on site to start with.
If there is any doubt, you should consult with trade
groups or competitors and perhaps seek advice from the Competent Authorities; as with all these cases, you should be able
to demonstrate that your decision whether to pre-register or not is based on sound consideration.
Justification
As indicated above, your final decision will need to be within the scope of the legal text, hopefully
following the guidance documents (RIPs) and be justifiable. The simple rule is if it is not implicit in
the legal text or guidance, put your reasons in writing in case you are asked by a regulatory agency or customer to justify
why you are not pre-registering or ultimately registering a substance. Put this on file somewhere to cover
your decision in case of dispute at a later date; even if you are in hindsight wrong, at least it demonstrates you acted in
good faith with the best available information at that time.
Who makes the pre-registration
There are four ‘entities’ described in the legal text who can make the pre-registration.
However, anyone can physically make the pre-registration if they have the log in details of any of these entities.
There is flexibility in the system to allow commercial decisions to be made. However, once the pre-registration is
made, it is fixed in that name and
Manufacturer
An EU based manufacturer can make the
pre-registration in their name or they can do it in the name of a Third Party Representative (TPR). The
advantage of using a TPR is that the manufacturer’s details are not publicised and they can retain some confidentiality
– not even other members of the SIEF know who it is.
As a manufacturer, pre-registration is in your control.
Importer
As an
importer, you need to ensure that all eligible substances are pre-registered. However, with any luck, the
non-EU supplier may have appointed an Only Representative to make the pre-registration, but to ensure that this is the case,
there will need to be formal communication between the importer and Only Rep to prove that both parties are aware of their
position in the REACH system. If you have not been given the Only Rep details by the supplier by 1 December,
it is possible they have not done the pre-registration – it is not too late to make a ‘late pre-registration’
yourself.
It is also worth noting that if
buying from more than one non-EU supplier, there will probably need to be more than one OR involved as well and the exchange
of communication needs to be with all ORs involved.
Only Representative
As an OR, you have roughly the same responsibility as an importer that makes a registration, but need to be appointed
by the non-EU supplier.
The OR must be appointed by the non-EU producer and their role must be agreed by the importers. Drawing
a parallel with the Sole Representative under New Substance Notification, three stages are involved:
1 Letter
from supplier naming their OR
2
Letter from importers covered by the OR arrangement recognising
the OR
3
Letter from OR to supplier and importers agreeing to their role
The concept of writing ‘letters’ is not explicitly implied in the Regulation, but there
needs to be a defined recognition of roles between the relationships.
The OR must be formally in place by 30 November 2008 and importers
contacted.
Sacking an Only Rep
An OR can be easily ‘sacked’ as their status is entirely
as a representative of the non-EU supplier. However, if sacked, another OR would need appointment in their
place for supply to continue and to do this, the new legal entity would be pre-registering late or going straight into a registration.
This is obviously quite troublesome and the advice is to make sure you are satisfied with the OR before pre-registration
take place.
Third party representatives
If you
are relying on your sales agent to be the formal OR, and the good reason for this is that they are part of your organisation
or if they are trusted agent and you already have a good relationship with them, they can appoint a ‘third party representative’
to actually do the pre-registration and represent your organisation on the SIEF. They can be easily sacked
and replaced if not performing well, whereas changing the OR is more completed.
Therefore, if you have an established and trusted agent or a sales office with employees, it is strongly
recommended that they are the OR and if they do not have the time or feel that they have the skills required for REACH support,
an external consultant / support organisation can be appointed to do the work as a third party rep. The
added advantage is that the true registrant, the OR, can keep their position confidential from the rest of industry as only
the contact details of the third party rep is published in the SIEF after pre-registration.
EU manufacturers can also appoint Third Party Reps to retain some
confidentiality.
Consultant
As already indicated, anyone with access to the internet anywhere in the World can physically
make the pre-registration as long as it is in the name of a recognised EU legal entity or recognised TPR and assuming they
have the log-in details of the organisation they represent.
Tonnage bands and predicted date of registration
Part of the pre-registration process involves predicting when you expect to register.
This mainly relates to the tonnage band, but also if the substance is a Category 2 CMR (carcinogen, mutagen or toxic
by reproduction) or is R50/53 (Very toxic to aquatic organisms and may cause long term adverse effects in the aquatic environment).
The R50/53 is an indicator that the substance may be vPvB or PBT and should be assessed at an earlier stage.
Many substances have not been fully evaluated (which
is why we have REACH !) and you may not know if the substance is CMR or R50/53 and you can therefore be forgiven if in 2018
when tested for registration you find it is very toxic in the environment. To qualify for early registration,
you need to check Annex I of Directive 67/548/EEC to see if it falls in these categories and the best place is to search the
ESIS web-site under classification and labelling. http://ecb.jrc.it/esis/index.php?PGM=cla
Pre-registration ‘to be safe’
Some organisations plan to pre-register many substances that they do not have to definitely register ‘just
to be safe’. This is ultimately a commercial decision, even though you may want to note the wording
in the legal text as to what is eligible for pre-registration.
Although free and relatively quick to perform, pre-registration of substances you probably do not need
to register may be a long term mistake as you may find yourself on countless SIEFs explaining that you do not want to share
any costs they are building up. Certainly, if you can safely anticipate exceeding 1 t production or import
in the period before registration is due, then pre-registering may be a good move as it gets you on the
SIEF and you can play an active role in a process that
you may have a long-term interest in.
The
‘to be safe’ part should be considered in the light of the possibility to pre-register late if you are manufacturing
or importing for the first time after November 2008; therefore, if your supplier does not pre-register and you have to find
an alternative non-EU source, you can pre-register late to ensure continued supply. And this does not have
to be done before the import take place. Therefore, the ability to pre-register late takes away most of
the risk of not pre-registering ‘to be safe’.
How do we pre-register ?
Once you have gone through the decisions on what you need to pre-register and who will do it, the actual process
of preparing the pre-registration and submitting is easy. Using the pre-registration plug in, for example,
will take a few minutes per substance and to do so, you will only need to know the CAS number or the EC number – putting
one into the reference substance list on IUCLID 5 will bring up a list of substances to select from. Care
should be taken as many errors are known on the EINECS and CAS lists and it is recommended you check against the chemical
name.
There are three ways to actually pre-register
and the choice is yours as to how you do it; there is good support and guidance on the ECHA web-site.
REACH IT
Probably the easiest method, this is done on line and is suitable for single substances where
bulk up-loads have not advantage and especially if you do not want to be creating IUCLID files at an early stage.
The system should be ready from June 2008 on the REACH IT web site http://echa.europa.eu/reach/software/reachit_en.asp
IUCLID Plug-in
This was available from March 2008 and
can be easily added to the IUCLID 5 package to act as a portal between IUCLID 5 and the pre-registration process.
In this, you simply create the substance file through the normal references substance process and upload into the pre-registration
plug-in field. Several batches of pre-registration files can be created and subsequently uploaded to REACH
IT after June 2008.
This is good for bulk uploads and if you
are planning on creating IUCLID
Other bulk uploads
Other proprietary software has been
developed that allows bulk uploads in XML format. The warning about these is that some appear to create
more work than just using the free REACH IT software, but if such systems fit into your existing inventories of substances,
it may save some time.
What happens next
?
Pre-registration is just
the beginning of the REACH process. Once a successful pre-registration has been made, the registrant (or
Third Party Rep) will get a message on REACH IT and a portal for a web-page with the substance on it. This
will in time be populated with the contact details of other potential registrants and once the list is completed, and by January
2009, the list of names will be the ‘SIEF’.
Further guidance will be issued on SIEFs later, but note the difference between the terms ‘consortium’
and ‘SIEF’; a SIEF is the legally listed group of organisations that have pre-registered a substance, but a consortium
is a group of organisations working together – the difference is subtle, but members of a SIEF do not have to work in
a consortium.
Paying for consortia
Some consortia are already forming and
incurring costs as they take on staff and arrange meetings for members. To recover costs, they will charge
for membership and it is a commercial decision whether to join the consortium or not. Being named in a
SIEF is free, but as work takes place, it is justifiable for those working for the common good to expect to recover some costs
and expenses – quite what is justifiable is up to the consortia.
The warning is whether you are paying for services you do not need, especially if you only pre-registered
to ‘be safe’ and do not need a registration. Make sure you do not sign up for costs you may
not need.
Conclusions
As the pre-registration process continues and experience is gained on pitfalls and issues
that may not be possible to predict in May 2008, this guide will be updated. It is unlikely to get shorter.
It must be remembered that the software input is
easy, and the difficulties are in deciding what to pre-register and justifying what not to pre-register. There
will be duplications in EINECS to resolve and SIEFs will find that they actually have more than one substance on their list
once analysis is conducted. There will be many discussions among pre-registrants and a lot of late pre-registrations
when users find that their supplier has not pre-registered after all.
We all have a sharp learning curve over the coming months;
industry, advisors and regulators are all in the same position.
For additional support, contact REACHReady www.reachready.co.uk or the ECHA web site http://reach.jrc.it/guidance_en.htm
