Introduction
The reality of REACH may be that despite the complaints
and doomsday predictions, life will go on, the world will continue to turn and perhaps REACH is something we can live with.
During a recent seminar, I asked the question what REACH means to those present – among the familiar voices suggesting
extra work, more costs and a decline in the industry was one voice suggesting that REACH may be an opportunity.
Only time will tell for certain.
This short document
attempts to encourage industry to believe that REACH is not an impenetrable tangle of legislation, but a tool to catalogue
the hazards and risks of substances supplied in Europe. REACH appears very complicated and frightening if just reading the
legal texts, but the concepts are simple and we need to continually go back to the ultimate message to find the answers to
our problems.
The Spirit of REACH
European legislation is a nightmare for those in the legal profession.
Much of the text is written by committees working to come to a compromise acceptable by political interests.
The good news for industry, is that the authors of much of the text are scientists with industrial or financial backgrounds
and are not lawyers.
What we end
up with is a text that is full of compromise, vagueness and uncertainty. The letter of the law is not concise
and those who try to work to the black and white text will struggle to find answers to many of the questions facing industry;
or in some cases, will find two answers.
With
the risk of sounding heretical, it is possible to draw a comparison between REACH and religion – in religious texts,
the common message to live in peace and respect others is clear; what is confusing is all the interpretations put on this
fundamental message by scholars and ‘experts’ who suggest complications and details. REACH
is the same in that the spirit of REACH is something no one in the industry can rightly argue against – REACH asks that
industry catalogue their products, assess hazards and advise customers of possible risks. This spirit of
REACH should be our guide and the secondary objective should perhaps be to meet legal requirements.
Pre-registration
The
first real practical activity industry needs to face is ‘Pre-registration’. Among the helpdesks
of Europe, this is currently one of the most frequently asked questions and quite rightly so – the Regulation is ambiguous
on many points and guidance is still limited. The Spirit of REACH is that we need to identify at an early
stage of the process exactly which substances we are buying in, producing, extracting, importing and supplying.
Unfortunately, most of the EU national
helpdesks rely on the black and white Book of REACH to give answers, with lawyers helping to make sure that any response is
within the legal framework. For those of us in the UK, we are lucky to have the pragmatic HSE helpdesk
that has taken the attitude that it should really be helping industry, and not just citing regulations. Alternatively,
REACHReady offers practical advice and a range of services (other helpdesks are available and it should be noted that Denehurst
works closely with REACHReady).
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). The first pre-registration
deadline passed on 1st December 2008, with more than 2 million pre-registrations submitted - about 15 times the expected number,
for over 140,000 substances.
If you 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 this case, the new registrant would be treated as ‘non-phase
in’ and have to share animal data with the SIEF (without the advantage of sharing registration). The
Regulation states the time limit for late pre-registration, but in reality, expect this to be flexible as the spirit of REACH
is for industry to work together to harmonise data sets.
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
other 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.
Identity of
substances
Being associated
with the REACHReady helpdesk, we get to see a flavour of what is really causing problems for industry. Many
questions follow trends, but what is consistently causing angst is chemical identity. This is quite understanding,
as anyone who has tried to read the guidance on substance identification, and does not have a first class degree in chemistry
and law, will be baffled. However, digging into it, this guidance document 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.
Therefore, 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 spirit of REACH
is that you register the chemical required to be fit for purpose and that once registered, use is limited to the uses defined
by that specification. Analysis and identification of components should be sufficient to confirm or dispute
similarity with other substances and to allow a chemical fingerprint to demonstrate a specification of supply.
REACH does not mean we have to conform to strict purity requirements or identify every minor constituent or impurity
to a fraction of a percent – we only need sufficient information to justify that the stuff being supplied is equivalent
to the stuff that was assessed for hazard and risk and that it is fit for purpose in terms of impact on the environment and
on health.
Testing
The Annexes VII – X of REACH describing test data are frightening. There
have been many reports scaring industry of high costs and more worrying, reports stating tests should start now to beat the
rush so you do not miss registration deadlines.
However, if
you close the Book of REACH at Annex X to lie down in a darkened room you may have missed the best Annex – Annex XI
tells you how to avoid testing. And better yet, the guidelines from RIP 3.3 describing data requirements
give even more reasons to justify not doing new tests.
Effectively, the requirement for industry is to do sufficient testing and data assessment (modelling, read across
etc) to justify the end points listed in the respective Annexes VII – X. For example, if your substance
is water soluble and biodegrades rapidly, it is most likely justifiable to avoid most, if not all, of the ecotoxicity testing
described in Annexes IX and X. The higher Annexes in particular allow the registrant to consider exposure
(and subsequent risk) to plan testing.
In terms of
starting work immediately, there are two issues to consider; firstly, animal testing should be proposed to and agreed by ECHA
before starting. Secondly, if we must do some testing, but there is no capacity at laboratories or if ECHA have taken a long
time to agree to proposals, we can state on the IUCLID 5 input that testing is planned or in progress. In
these cases, we would also be unable to complete the CSR, but we can probably give it our best effort and then update as the
new data became available.
Only if registrants
blatantly ignore deadlines or fail to justify why work has not been done (or has not been completed) can they expect to be
penalised and supply stopped.
The
Spirit of REACH is that we take a scientific approach to testing and we should have sufficient justification to meet the objectives
of each Annex. We must be able to confidently classify the substance and propose risk
management. If our dossier is one of those reviewed in detail, ECHA may disagree with our justifications
– in which case more testing may be required. If we can justify our actions, we have done what is
legally required of us and we can expect continued supply to be permitted.
Chemical Safety
Assessment – Robust Summary
Having spent several hundreds / thousands / tens of thousands in generating data, there really should be a reasonable
attempt to do something useful with it. The minimum is to look at the answers and propose a classification,
but as part of the Registration process, it is necessary to make a ‘Robust Summary’ ; the basics are handled by
the IUCLID 5 Software in that there is an option to filter key studies you want to make up a Robust Summary, but to give it
real value, it is necessary to tie together the test data – the physic-chemistry, toxicology and environmental data
are all linked and cannot be considered in isolation.
However daunting
this may seem, a fairly basic understanding of these studies will enable a lay reader to add some value to the data –
ideally, a friendly passing toxicologist or chemist could come in handy, but the key part is that the reviewer must understand
the bigger picture and understand all disciplines. Training is available for this by Denehurst and also
through Hull University Post Graduate training and through the Chemical Hazard Communication Society.
The end result is a ‘Chemical Safety Assessment’ (CSA) that
is the culmination of hazard data review. There is no formal requirement to produce a CSA in report format
for submission (although it is a fair part of the Risk Assessment, CSR), but having spent all that time reviewing data, you
are best keeping a report on file in case you are ever asked about the hazards in the future. Or are asked
why you classified something a particular way.
The CSA can (or
must) taker into account data from all sources – not just testing, but read-across, modelling, published and best guesses.
Likewise, if producing an SDS for a mixture (preparation) it is necessary to justify the hazards and the CSA is effectively
required for that – it is not a Registration requirement, but is good management and follows the Spirit of REACH.
Exposure Scenarios
Once the hazard has been assessed, this needs to be compared with exposure and the mechanism
for describing this is the Exposure Scenario. Any type of exposure assessment should include consideration of the life cycle
of the product including how it is synthesised, handled, formulated, used and how much waste is produced. This
also needs to consider the routes of exposure that in turn will relate to the physico-chemical properties (volatile, dusts,
soluble in water etc). More details are given on the CSR page on this web-site.
It is accepted that suppliers
cannot know every detail of use by their customer and likewise, customers, or Downstream Users (DU) may not want to divulge
their specific uses to suppliers. Therefore, it is possible for DUs to prepare their own ES and subsequent
CSR. This is especially applicable to mixtures in cases where such formulation details are commercially
confidential.
The CSR
A whole page is devoted to this on the web-site, but the CSR is nothing more than a formatted
Risk Assessment. The most important part from a legal point of view are the declarations in Part A –
making the declaration that you have communicated risk management measures to your customer means that it is then their problem
if they have done something with the material outside you own recommendations.
EUSES is worth a mention here – it is complex bit of software that will hopefully
be replaced / improved and linked to IUCLID 5 (this is promised). However, running the model and not understanding
the science is dangerous. Unfortunately, many regulators put a lot of faith into EUSES without adding much
science and like it or not, we need to understand the science behind the model.
Extensive guidance on the CSR has been developed under RIP report 3.2 that attempts
to flesh out the basic requirements outlined in the REACH Regulation 2006/1907/EC – however, those who have downloaded
the 30 separate parts and tried to read this to make sense of requirements will probably now be more confused than
before. The RIP reports are not designed for the non-specialist reader, but set the technical framework
for the regulators and there is a need for simple guidance to help understand the RIP.
Training is given by Hull University and CHCS.
The SDS
The
SDS is not changing much. Again, there is a whole page on SDS on this website and training is available
from the CHCS on all aspects of the SDS. There are some formatting changes (sections 2 and 3 are changing
over for some reason that no-one has yet given me a good reason for) and to reflect the change in the times, e mail contact
is now considered more important than a fax number. Of more importance is the expectation that the hazard
and risk conclusions will be reports, such as comment on vPvB / PBT or CMR and also a DNEL (see the CSR page).
This is still the ultimate communication tool and writers
should be less worried about the format and headings and instead concentration on communication skills – the SDS must
take into account the conclusions of the CSA and the Exposure Scenarios used to write the CSR. The SDS
must therefore consider who is reading the SDS and under the conditions of their use.
Downstream User obligations
Most of industry will be a Downstream User (DU) as this covers anyone buying in , handling
or supplying chemicals that are already Registered. And how do you know they are Registered ? This is something
deeply worrying DUs – how do they know that the material they buy in is registered for their use and what is their legal
obligation. You can ask your supplier and if they answer, they could just say ‘yes’ to keep
you as a customer – what then ? Fortunately, just asking your supplier covers your obligations but
it is important to keep the question on file !
If you supplier
has not covered your use (and odes not want to), the DU can prepare their own CSR using the Robust Summary from the Registrant.
This sounds easy, but communication routes will be complex and one only hopes that the Regulators are understanding.
A problem could arise though if your use
is unsuitable for the substance and it is restricted for certain uses – in this case you may need an authorisation.
This is such a complicated issues, that unless your market and profit is substantial, substitution for other chemicals
may be the pragmatic way forward
More information
This is just a short overview – please contact Denehurst
if you have any specific questions.
