Companies that import or manufacture more than 1 tonne per year of a substance, on it’s own or in a mixture, into Great Britain (England, Scotland, Wales and associated islands) must make a UK REACH registration with the UK Health and Safety Executive (UK HSE) unless an exemption applies.
The UK REACH regulation has transitional arrangements that will give companies time to meet their registration obligations. These processes are called grandfathering, DUINs and Article 26 Inquiries. Please refer to the UK HSE guidance to find out more on these processes;
The UK HSE does not charge for these notifications and the next step is to create and submit the registration dossier before the appropriate regulatory deadline.
For substances that were not imported or manufactured before 31st December 2020, then an Article 26 Inquiry is required before that activity starts. For grandfathering and DUINs, the registration deadlines are shown in Table 1.
|28th October 2023||1000 tonnes or more per year||Carcinogenic, mutagenic or toxic for reproduction (CMRs) – 1 tonne or more per year|
Very toxic to aquatic organisms (acute or chronic) – 100 tonnes or more per year
Candidate list substances (as at 31st December 2020)
|28th October 2025||100 tonnes or more per year||Candidate list substances (as at 27th October 2023)|
|28th October 2027||1 tonne or more per year|
Companies that grandfather or submit a DUIN on time can have unfettered market access (i.e. continue to import or manufacture) until the appropriate registration deadline, without any additional costs.
UK REACH registration costs
There are 4 cost categories for a UK REACH registration, assuming that a Letter of Access is available for the necessary information requirements;
- Substance identity analytical data
- Letter of Access
- UK HSE fees
- Your time
1. Substance identity analytical data
In order to prove the identity of the substance that you are importing or manufacturing you will be require to send the correct analytical data to the UK HSE. The type of data required depends on the substance that you are dealing with.
Your company may already have this data in-house or it may be available from your supplier.
Estimated cost; From less than £1,000 to over £2,500
2. Letter of Access
In order to make a successful registration, a submission must meet the full information requirements mandated by the UK REACH regulation. The amount of data required correlates to the volume of substance imported or manufactured by the registrant but can also depend on other factors. The information includes simple studies such as melting/freezing point through to studies such as in vitro skin irritation/corrosion and pre-natal developmental toxicity in one species (i.e. vertebrae testing).
Testing of substances to generate all the information required may be costly. However, this information may have already been created for other regulations, such as EU REACH, and may be made available to UK REACH registrants via a Letter of Access.
Estimated cost; From less than £1,000 to over £100,000
Note; Companies that have have already paid for a Letter of Access for an EU REACH registration may receive UK REACH access at a reduced price. However, this is a commercial decision set by the data owner(s).
3. UK HSE fees
Upon submission of a registration dossier, the UK HSE will issue an invoice for their registration fees.
Estimated cost; From less that £60 to over £30,000
Note; Companies that have grandfathered their registration will not have to pay UK HSE registration fees.
4. Your time
We estimate that it will take from 25 to over 50 hours of time to create and submit a UK REACH registration dossier. This includes obtaining a Letter of Access for the required data, creating an IUCLID dossier and submitting via a Comply with REACH account.
A report by the European Commission estimates that companies spent an average of €33,300 per substance registration under EU REACH.
Based on this, we estimate that a UK REACH registration would cost from around £15,000 to £30,000 per substance. Costs will be lower for companies that have already held an EU REACH registration for the same substance.
However, as there are no charges for initial notifications and registration costs are only incurred ahead of the appropriate deadline, it may be possible to spread costs. We recommend that you create a registration plan to reduce compliance costs and risks.
Need help with chemical legislation compliance?
Speak with a regulatory expert for FREE.
Pingback: What are the UK HSE fees for UK REACH submissions? | REACH Compliance
Pingback: New Registration of an Existing Substance (NRES) | REACH Compliance