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 identity

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 '8' above.

            IF no acceptable deal, prepare for 'opt-out' process.

12        Prepare data gap analysis to check if opt out is feasible and cost effective

13        Perform testing as needed and submit opt out dossier

 

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)

 

           


Notes


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 Registration

Finished pharmaceuticals, plant protection products etc will not need REACH Registration if Approved under other regulatory frameworks.


Substances that 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 anhydrous material). 


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 registrants.

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 diffraction etc.

The report 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 the dossier.


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.

The dossier 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.


Once the 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 agreed. 


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 Commission.


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.


Fees are 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 dispute.


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 or consortium.


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 also needed.


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.


Fees are payable to ECHA; the amount levied depends on the tonnage band and the size of the company making the Registration.

Denehurst Chemical Safety Ltd

REACH Registration process