Route for REACH Registration
When needing to Register a substance, there is a process to follow, starting with determining if full Registration is required, establishing identity and deciding the type of Registration required.
The process is not simple start-to-finish and options are open and when there is a need to submit as a Joint Registration, the outcome (and especially costs) are dependant on external factors.
1 Check if exempt from Registration (eg
Annex IV and Annex V criteria)
2 Confirm tonnage exceeding 1 tonne per
annum import or manufacture
3 Prepare rough plan for registration to
estimate approximate costs
4 Identify substance correctly and
prepare analytical evidence
5 Submit Inquiry to confirm formal
6 IF already Registered, make contact
with Lead Registrant, go to 7
IF NOT already Registered, start
planning for solo Registration, go to 14
7 Obtain Letter of Access cost from LR
and confirm substance sameness
8 IF acceptable cost, make arrangements
to join Registration (go to 9)
IF unacceptable costs, go to 10
9 Complete personal Joint Submission and
submit, paying fees as needed
10 Negotiate with LR / consortium and make
proposal for 'fair' cost
11 IF negotiations successful, revert to
IF no acceptable deal, prepare for 'opt-out'
12 Prepare data gap analysis to check if
opt out is feasible and cost effective
13 Perform testing as needed and submit opt
14 Conduct data gap analysis to obtain more
accurate costs and time-scale
15 Perform laboratory testing as needed and
prepare full dossier and submit
See below for notes or links to other pages from the guidance tab (guidance)
1 Specific substances are listed in
Annex IV of REACH and Annex V describes more generic exemptions, such as fatty
acids, natural substances (if not chemically modified and non-hazardous),
incidentally formed substances (eg result of neutralisation) etc.
Polymers do not
need Registration, but check whether the monomers / starting reagents need
pharmaceuticals, plant protection products etc will not need REACH Registration
if Approved under other regulatory frameworks.
are intermediates (ie used in further chemical reactions to synthesise other
chemical substances) and handled under strictly controlled conditions are not
exempt, but may have reduced requirements.
2 Tonnage is per-annum per importer / manufacturer
and excludes water or other solvents (eg for hydrated salts check tonnage of
Note that if
importing, the non-EU manufacturer can designate an 'Only Representative' (OR)
to cover imports into the whole REACH area.
[At the time of writing these notes, there is uncertainty whether the UK
will remain in the EU-REACH area. If a separate UK-REACH is established without
any formal links to the EU-REACH, then UK manufacturers can appoint an OR in
the EU-REACH zone and EU-27 manufacturers can appoint an OR in the UK]
Also note that
the PPORD option (production and process orientated research and development)
allow manufacture or import if it can be justified that the substance is for
use in trials. Under such conditions of
supply, all those handling or using the substance need to be identified and
clearly, supply to the general public or for professional use is not possible;
use is limited to industrial processes.
3 Rough costs can often be worked out if
there is good certainty as to the substance identification and if it is known
to be a unique substance not registered by others. Even if registered by
others, a rough idea of cost is possible by looking up the number of other registrants
listed; the more listed, then the costs will have been shared by more
Many consortia or
lead registrants (LR) will provide costs for letters of access on request
without any formal process being started.
4 Full analysis will typically include
NMR, UV-Vis and IR spectra with some chromatography-mass spectrometry. Clearly,
inorganic substance will need different techniques, including elemental, X-ray
needs to include evidence of the substance identity and purity and details of
composition put into the Registration dossier will need justification by this
analysis. The report is submitted with
5 The Inquiry is submitted through the
REACH-IT account (this is easy to set up, if not already done so) and the
dossier can be prepared on-line or using the free IUCLID software. IUCLID is recommended as more flexible than
the on-line portal and the Inquiry dossier can form the basis of the full
dossier to be prepared later.
takes a few hours only and no fees are taken by ECHA
A response will
be obtained typically after 3 - 4 weeks, but many Inquiries are questioned by
ECHA and re-submissions may be needed.
Inquiry is accepted, work can start on the full registration; it is illegal to start
animal testing without confirmation from ECHA that no other registration has
been made or is in progress by other organisations.
6 If an existing (or in-progress)
Registration exists, it is expected that the new registrant makes contact with
the LR to allow the dossier to be shared.
The LR must share and a 'fair and equitable' cost share must be
If there is no
other registrant involved, then the new registrant is the de-facto LR and must
start the dossier from basics.
7 The LR will provide a substance identity
profile (SIP) and this will hopefully confirm a mutual specification of the
substance between the registrants. If not, the SIP can be changed, but only if
minor changes not impacting on the original registrations.
8 The LR will provide a cost for the
access to the Joint Registration and provide a Letter of Access ('token') to
allow submission of the personal dossier through REACH IT. If over 10 tonnes and
a Chemical Safety Report (CSR) is needed, then the cost may include this. When agreeing a cost, it is essential to know
what you get for the price.
If no agreement
can be reached over the SIP, ask ECHA for help; if they have said it is the sufficiently
close in identity for the Inquiry, then it is likely that the LR is just being
awkward. Any perceived anti-competitive action must be reported to the European
9 If agreement is reached, then the LR
needs to be paid for the access and a personal dossier prepared; this is little
more than the original Inquiry, but now includes proposed uses. This personal
dossier if confidential to the submitter and only takes a couple of hours to
complete if using the Inquiry dossier as a starting point.
payable to ECHA; the amount levied depends on the tonnage band and the size of
the company making the Registration; however, fees are slightly lower for Joint
Submissions than if a solo Registration is made.
10 If the cost appears very high and unreasonable,
this needs to be questioned and a counter offer made; any counter offer needs
to be reasonable and explained based on, for example, the value of the test
data, plus dossier preparation effort etc and divided by the number of
co-registrants. All correspondence should be retained in case it goes to a
11 If resolution is not reached, then an
opt-out dossier is needed. This is where a potential co-registrant provides all
the data endpoints themselves and presents to the LR a fully completed dossier,
demonstrating that there is no need to buy into the dossier created by the LR
12 As an opt-out dossier is a significant
amount of work and some testing may be needed (noting that repeating animal
tests is illegal), it is recommended that the cost of an opt-out (time and
money) is considered and if the economics and timing means that the opt-out is
not viable, negotiations need to be resumed and ultimately, a formal dispute
can be attempted.
A data gap
analysis is therefore needed. This is a
review of existing data, published data, data from similar substances that can
be used in the assessment etc and if any gaps exist in the existing data
knowledge, then these will need filling by test work. This exercise helps confirm costs. Time is
13 Once the data set is complete, the full
dossier can be prepared and submitted.
There are procedures and protocols to follow for opt-out dossiers and it
is not always easy.
14 Solo-registrants (effectively the LR)
need to perform the data gap analysis and use the outcome to improve the
accuracy of costs and to plan testing.
ECHA provide a lot of guidance.
15 Once testing is completed, the full
dossier is prepared and submitted. This
can take a significant amount of time. A
Chemical Safety Report (CSR) may also be required.
payable to ECHA; the amount levied depends on the tonnage band and the size of
the company making the Registration.