A short history of REACH
This short guide is aimed at those who need to know enough about REACH to get on with their ‘day-jobs' of buying or selling chemical products, manufacturing goods or just working with chemicals. It is important that industry believes 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 spirit of the law to find the answers.
It is not possible to give all the answers and if having to work directly with REACH, you will need to investigate areas of interest further.
The topics covered include:
· Legal background
· History of the legislation
· Basics of REACH
· Exempt materials
· Definitions; chemicals, articles
· Pre-registration and late pre-registration
· SIEFs; working together to save time and money
· Substance sameness
· Data evaluation, classification and the robust summary
· Considering new testing
· Exposure scenario
· Risk assessment - the CSR
· Communication; the SDS
· Registration process with IUCLID 5 and REACH IT
· Special cases; intermediate registration, non-phase in, inquiries, PPORD
· Downstream users
· Authorisation and restriction
· After registration
There are three ways to look at REACH.
The first is from a legal perspective that starts by reading and
memorising the legal text of Regulation (EC) No 1907/2006 and this continues
into a check-list of things you must do and those you must not. The problem
with this approach is that the concepts and principles can be lost in the
detail. If attempting to read the Regulation, concentrate on the Recitals in
the opening sections.
A second approach is to follow the spirit of the legislation that sets out,
quite rightly, to ensure that chemicals manufactured, supplied and used are
‘fit for purpose'. This has no set boundaries and without keeping the
regulations and practicalities in perspective, time and money can quickly
disappear while aiming for perfection.
The third approach, favoured by this guide, is to do sufficient to ensure that
adequate hazard and risk communication is taking place and to ensure that you
are doing enough for compliance. To meet this objective, we do need to know a
bit about the legal text and also need to understand the science of why we are
doing all this to ensure that the chemicals are fit for purpose.
The legal background
European legislation is a nightmare for
those in the legal profession as the text is largely written by committees
working to come to a compromise. The good news for industry, is that the
authors of much of the text are scientists and are not lawyers and the
ambiguity that can disturb the legal profession can be a gift to those in
industry wanting an interpretation to meet their practical needs.
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. However, come back to
the question of what you believe to be right and wrong in terms of aiding
hazard and risk communication, and the answer is usually clear to see.
The legal text is found almost entirely in Regulation (EC) No 1907/2006, but
note minor revisions have already been issued.
· The fees Regulation (EC) No 340/2008 describes fees
for registration activities
· Regulation (EC) No 440/2008 covers test methods.
· Annexes IV and V (Regulation (EC) No 987/2008)
describe changes to exempt substances
· Annex XI was revised in February 2009 (Regulation
(EC) No 134/2009) to clarify data waiving.
· Annex II was revised in 2010 to outline SDS
requirements in Regulation (EC) No 453/2010
Other amendments may yet follow, but
the reality is that that these amendments consider details that perhaps go
beyond what to expect in a short guide.
To check on the latest incarnations of the legal text, the ECHA website
is a good place to look http://echa.europa.eu/reach/legislation_en.asp
History of the legislation
to put the legal framework into context, you need
to go back over 40 years. In 1967, the first major piece of European chemical
supply legislation was published which set the framework for the control of
dangerous chemicals. With the exception of finished pharmaceuticals, direct food
additives, radioactive substances, ammunition etc, the dangerous substances
Directive 67/548/EEC, and the myriad of Directives spawned from it, formed the
basis of all subsequent chemical control directives.
The key part of Directive 67/548/EEC was to make suppliers of chemicals submit
a list of substances they manufactured or imported with details of chemical
identity, and the final list was known as EINECS - European Inventory of
Existing Chemical Substances. Effectively, this was the same as the ‘pre-registration'
phase of REACH.
Any substance not listed on EINECS (the list closed in 1983) was considered a
‘new substance' and notification was necessary. The legacy of this with REACH
is that the new substances are now considered registered under REACH and those
on EINECS are the ones that could be pre-registered as phase-in.
Some complications arose from the exemption to
notify if exported from the EU and the exemption if used as an on-site isolated
intermediate (these substances not ‘placed on the market’ did not need to be on
EINECS or notified, but could be considered phase-in under REACH). A further
complication was caused by a change in rules for polymers during the Seventh
Amendment to 67/548/EEC, and substance omitted from EINECS as they were originally
considered polymers, subsequently needed listing as ‘no longer polymers' (NLP);
these were also considered ‘phase-in’ and many were only found in 2008 when
industry looked hard at what substances were actually being made.
Basics of REACH
Registration is only required for those who
manufacture or import > 1 tonne of a chemical substance or if an imported
article deliberately releases a substance at over 1 tonne. If chemicals are
supplied from within the EU, the registration must be taken care of by the
up-stream suppler and not the customer.
Non-EU manufacturers and producers of formulations (or articles releasing
substances) can appoint EU-based legal entities to be their ‘only
representative' (OR) to handle the registration process and to be the official
legal entity. However, even if appointing an OR, much of the actual work of
data evaluation, negotiation on a SIEF, preparation of registration documents
etc. can be done by the non-EU manufacturer as long as the final registration
is in the name of the official EU-based legal entity.
Exempt materials are described in the REACH
Regulation (legal text) in Article 2 and includes pharmaceuticals, food
additive and other specific types of substance. Note that crop protection
products and biocides are not exempt, but are considered ‘registered' under
their own parallel systems. Substances that are used in exempt applications,
but are used in other areas, need registration under REACH; eg food grade
colourants used in inks.
Specific exempt substances, including elements and natural products are
described in Annex IV and V of the legal text. These may change in time and the
Annexes will be updated as adaptations to the REACH Regulation as Regulations
in their own right.
Cosmetics, food contact materials, medical devices and other specific types of
chemical that are covered under their own directives will need registration,
but such materials may be exempt from certain parts of reach, such as end-use
Waste is exempt from registration if it meets the criteria of the waste directive,
but if sold for recovery, may not be exempt. This needs case-by-case
consideration, but recovery from designated waste does not need registration if
the substance is already registered in Europe.
Definitions are described in article 3 of the REACH
Regulation, but some key ones are described below.
A substance : defined chemical with EC
number or registration number
Impurities : unwanted by-products or residual starting materials that do
not enhance the substance. These will not need registration in their own right
if they do not contribute to the nature of the substance (typical accepted
maximum limit of 20% impurities).
Mixed substances : multi-component substances that are synthesised in such a
way that two or more key chemical components form, such as mixed isomers. These
need special pre-registration and cannot be bulk-uploaded and must be
Polymers: at least three repeating unit of monomer unit with no single
constituent at > 50% by weight composition. Therefore, there it needs good
molecular weight spread as well as number of units. Post-reacted polymers are
still polymers, but the substance reacted with them will need registration.
Unknown Variable Chemicals (or of Biological origin) (UVCB): poorly defined
substances or biological extracts and derivatives that need special
consideration for registration. These include reaction products, but where
there is no clear understanding of the actual constituents or the proportions
of such constituents. Some biological materials may be exempt.
Mixtures (preparation) : one or more substances added together after synthesis,
such as solution in solvent or blended product. The mixture does not need
registration, but all components must be registered and if importing, it is
necessary to determine the components in the preparation from the supplier.
If importing mixtures, remember that the tonnage band that triggers
registration is the quantity of the specific component of the mixture; for
example, if importing 10 tonnes of a cleaning fluid with 60% water, 30%
surfactant and < 10% fragrances, colourants, preservatives etc, registration
will only need to consider the 3 tonnes of surfactant. Those less than a tonne
do not need registration and water is exempt.
Article : a material that is supplied primarily to fulfil a function based on
its size or shape and dried paint providing a water proof coloured surface is
considered part of the article it has coated. Polymer supplied as bead to make
plastic cups are ‘chemical' (polymer), but the finished cup is an article.
Even though the definition is easier to work out when the logic is understood,
there are many grey areas, such as metals, where it is necessary for suppliers
to make their own decision, record that decision in case of later questioning,
and then do what is appropriate in terms of hazard assessment and
The metal industry is one where there is confusion, with the best example being
that a lump of iron is a chemical if the user melts and makes steel from it,
but is an article if used to hold a door open as a doorstop. The function and
use of the material is key.
Chemicals delivered by articles, such as pens, printing cartridges, wet-wipes
etc. Are considered as chemical for purposes of registration. These are
delivered by ‘speciality containers' even though the container is an article
(eg. Pen case). This can also apply to some chemicals in serviceable parts of
machinery (eg lubricants) or screen wash in imported cars.
Substances deliberately released from an article: the object has a primary
physical form, but secondary chemical nature. Examples include toys with
special smells (eg toy banana smelling like a banana) where the scent is a
chemical released and will need registration.
Foreseeable release : chemicals expected to be released from an article during
normal use by wearing and during re-working, such as metal dust from grinding,
polymers from tyres etc. These do not need registration by importers of the
No foreseeable release : chemicals are considered to be bound tightly in the
matrix of the article, such as plasticisers in plastics where there is no
evidence of leaching or loss from the article. This is an important point when
the chemical is hazardous
Pre-registration (valid up to May 2017)
The first real practical activity
industry faced was ‘pre-registration'. The purpose was to identify at an early
stage of the process exactly which substances we are buying in, producing,
extracting, importing and supplying.
A major reason for the ritual of pre-registration was also 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). Pre-registration had a deadline of December 2008
to allow a line to be drawn and for SIEF formation to start, but ‘late
pre-registration' options are still open in some cases.
Late pre-registration was aimed to allow continued commercial activity of
responding to customer needs to manufacture or import new chemical substances.
SIEF formation; working together to save work
After pre-registration, those who had
pre-registered had access to lists of other potential registrants to see who
else had a potential interest in the same (or similar) substance; SIEF stands
for ‘substance information exchange forum' and this is its primary function -
to facility data exchange.
Substance sameness (Substance Identity Profile -
The initial evaluation of the substance
is essential for all those registering a chemical substance and who need to
demonstrate that their substance has the same identity and purity as other
members of the SIEF or those who have already registered - to file an Inquiry
to ECHA, basic substance identity details are required.
If it is not possible to pre-register
(eg not on EINECS or past the respective deadline for late pre-registration, it
is necessary to file an Inquiry so that ECHA can check if the substance is the
same as other registered or pre-registered substances. If it is the same, any
data already generated to evaluate the substance can be shared; a major reason
for this process is to avoid the risk of repeating animal testing.
The basic requirements are spectral
evaluation (typically IR, UV-Vis, NMR, Mass-Spec) and this can be requested
even in cases where it is not possible to interpret the results to least
provide a ‘fingerprint' for future reference. Chromatography and other analysis
including HPLC, GC, MS etc are required as appropriate for the type of
substance the analysis must be sufficient to demonstrate that the substance you
are registering is equivalent to others in the same Joint Registration.
These need reporting by all registrants as an attachment to section 1of IUCLID.
Data evaluation - classification and labelling and
the robust summary
Having spent time and money gathering,
assessing or generating data, there needs to be a reasonable attempt to do
something useful with it. The minimum is to look at the answers and propose a
classification (the SIEF should make a proposal as part of a joint
registration), but as part of the registration process, it is necessary to make
a ‘robust summary' in IUCLID . The data put into these summaries are being
disseminated by ECHA on their web-site and these provide valuable source of
data for all to see.
The proposed classification and labelling is entered into section 2 of
IUCLID as part of a joint registration and the conclusions will be published in
the classification and labelling inventory. This is done in accordance with GHS
principles, outlined in the CLP Regulation (EC) No 1272/2008.
If the data are not considered adequate for classification or to
complete the robust summary, further data generation (testing, modelling,
read-across etc) is needed.
Part of the conclusion for data evaluation will be the derived no-effect level
(DNEL) or minimal effect (DMEL) for health effects from different routes of
administration and also the predicted no-effect concentration (PNEC) for
environmental endpoints. DNEL / DMEL and PNECs will be established for each
When working in a joint registration, data considered adequate to avoid new
testing will be considered to have a value and the owners of such data will be
entitled to compensation if sharing access to the data. Even if not sharing
access (eg for non-animal testing where sharing access is not compulsory), the
data will still be required to complete the robust summary and classification.
Data for hazardous substances must be made public - even if other members do
not have access to use the data for their registration, the data cannot be kept
Considering new testing
The annexes VII - X of REACH describing
test data are frightening. There were many reports scaring industry of high
costs, but Annex XI tells you how to avoid testing. 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 according to the tonnage being registered. For example, if your
substance is water soluble and biodegrades rapidly, it is most likely
justifiable to avoid most, if not all, of the terrestrial ecotoxicity testing
described in annexes IX and X.
New animal testing not explicitly required in Annex VII or VIII should be
proposed to, and agreed by, ECHA before starting. Even if testing is required,
but there is no capacity at laboratories, it can be stated 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 give it our best effort and then update
as the new data became available.
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. This
is known as the ‘intelligent testing strategy' and guidance on how to approach
testing is provided by ECHA.
The exposure scenario
The life cycle of the substance and any
preparations made from it must be considered in preparing an exposure scenario.
This includes how it is synthesised, handled, formulated, used and how much
waste is produced. This also needs to consider the routes of exposure that
relate to the physico-chemical properties (volatile, dusts, soluble in water
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
The ES is primarily a tool to help describe potential anticipated points of
exposure to workers, consumers and the environment and must be usable and
understandable to those who need to use the ES to help evaluate potential for
For hazardous substances and mixtures and for mixtures containing hazardous
substances above thresholds of concern (ie when SDSs are compulsory), then the
ES needs to be provided with the SDS as a technical appendix (the extended
Risk assessment; the CSR
The CSR is a formatted risk assessment
and the template and guidance is available in the ECHA guidance. Part A
includes making the declaration that you have communicated risk management
measures to your customer.
EUSES and the ECETOC TRA tools together with the CHESAR tool linked to IUCLID
provide support in estimating exposure, but it is important not to rely on
models without understanding the science behind them. The conclusions to the
CSR are numerical ‘risk characterisation ratios' (RCR) that consider the level
of exposure vs. the estimate no-effect levels. If exposure level is lower than the
effect level, then risk is considered acceptably low.
Communication - the SDS
The SDS has not changed much with
REACH, with the most obvious changes being that Sections 2 and 3 have changed
over. Of more importance is the expectation that the hazard sections will be
based on the robust summaries of substances and that the PNEC and DNEL / DMEL
will be included together with vPvB / PBT or CMR assessments. A glossary is
provided below, but the the authors and recipients will be faced with a more
The SDS is still the ultimate communication tool and writers should be less
worried about the format and headings and instead concentrate 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.
The key conclusions to the CSR are the proposed risk management measures (RMM)
and these needs putting into plain language in the SDS. The ES used to
construct the CSR must also be provided in the case of hazardous substances.
registration is made through reach it using the free software, IUCLID.
The REACH IT portal can be accessed through the ECHA web-site, with the
With a basic level of it skill, IUCLID can be installed onto a
reasonable desktop or laptop computer by following instructions and guidelines
given by ECHA. As well as being the source for download, there is help and
support available from the ECHA web-site.
On-line submissions are also possible.
If making a non-phase in registration,
it is first essential to make an inquiry using IUCLID . These needs a
comprehensive set of analysis data on your production / import material so that
ECHA can compare with other registered substances. If the same as other
substances or similar (eg. Substance notified under NONS with an ELINCS number)
then you will be asked to work with the data holder to share animal data. If
the data was submitted over 12 years before your inquiry, the data will be
The production and process orientated
research and development exemption is very much the same as the PORD under
NONS, but allows a longer period of supply (normally up to 5 years) and has no
real limit for volume. There are no formal test requirements for PPORDs, but
remember that classification and labelling is required and an SDS is needed.
Notification under CLP is also needed.
Substances that are used exclusively
for conversion to other chemicals and which are closely controlled (ie no
supply to the general public and limited exposure to workers or the environment
at named sites) need less testing for registration. Non-isolated intermediates
do not need registration. The term ‘strictly controlled’ is not precisely
defined and is open to discussion, ultimately, local inspectors need to be
assured that there is minimal (or zero) exposure to workers and the environment
and will vary for region to region depending on local inspection policy.
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. If you supplier has not covered your, the du can
prepare their own ES and can even prepare their own CSR using the robust
summary from the registrant. This sounds easy, but communication routes will be
The only legal obligation of the DU is to inform the supplier of any adverse
effects noted, such as health problems with workers exposed to the substance.
The du does not have to inform their supplier of the use patterns and can keep
commercial applications secret. However, if using for a non-registered use, the
DU will need to inform ECHA using REACH IT.
It is recommended that DUs provide basic use information to suppliers,
following guidance in chapter R-12 of the technical guidance.
Authorisation and Restriction
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 issue, that
unless your market and profit is substantial, substitution for other chemicals
may be the pragmatic way forward.
Annex XVII of reach lists substance already considered to be substances of very
high concern (SVHC) and many of these are already restricted under pre-reach
legislation. In addition, chemicals as to be periodically added to the
‘candidate list' of substances to be added to Annex XIV. These will be
effectively banned in Europe and special authorisation is needed or industry
exemptions applied for. Intermediates will be exempt from this if controlled
If mixtures or articles contain SVHC at levels of over 0.1%, then customers
(DUs) must be informed on the labelling with a suitable warning.
After registration ?
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.
this is just a short overview - please contact
Denehurst if you have any specific questions.
This guide was first prepared in 2008 and interestingly, has needed few