How to comply with the EU and UK REACH chemical regulations when using, making, selling or importing chemicals in the UK and in the EU.
UK REACH is part of the UK’s chemicals regulatory regime. If you sell or distribute chemicals in the UK and the EU, you’ll need to follow both UK REACH and EU REACH rules.
UK REACH maintain EU REACH’s aims and principles. These include:
- the ‘no data, no market’ principle
- the ‘last resort’ principle on animal testing
- access to information for workers
- the precautionary principle
Manage your chemicals on UK REACH
If you’re based in Great Britain (England, Scotland and Wales), you’ll need to follow UK REACH regulations to manufacture, import, sell or distribute chemical substances or mixtures.
Use the ‘Comply with UK REACH’ service to:
- transfer your EU REACH registration into UK REACH (also known as ‘grandfathering’) to continue having access to the GB market
- submit a new registration for a substance
- notify that you’re going to continue importing substances from the EU or European Economic Area (EEA) by submitting a Downstream User Import Notification (DUIN)
- transfer your assets, such as registrations, to another legal entity
Before you start
You’ll need to create a Government Gateway account to sign into the service.
Find out how to. This guidance includes how to create and name your accounts.
If you act on behalf of other legal entities, for example as an Only Representative (OR), you’ll need to set up a ‘parent’ account for yourself and ‘child’ accounts for those legal entities you represent once you’ve signed into the service.
Check that your substance information is in the correct format. The service only accepts substance registrations and other submissions as i6z dossier files. You can use IUCLID 6 or a later version to create the files.
Make sure you understand your regulatory obligations under UK REACH.
You need to contact the Health and Safety Executive (HSE) to:
- validate existing UK-held product and process orientated research and development (PPORDs), known as ‘grandfathering’
- provide information on any authorisation matter, including new authorisation application, grandfathering of existing authorisations, and downstream user notifications of authorised uses
Full UK REACH guidance is available on the Health and Safety Executive website. This includes information on how to move goods between Northern Ireland (NI) and GB.
UK REACH for GB businesses
Under UK REACH, manufacturers and importers must register chemicals that access the GB market.
You must review your:
- role in the EU REACH system
- role in the UK REACH system
- your current supply chains
You’ll need to take certain actions to access the EU or EEA and UK markets.
UK REACH for NI businesses
NI businesses moving goods to and from the EU can continue to use EU REACH.
GB importers need to submit some information on the substances they source from NI in quantities of one tonne or more. They must submit this information within 300 days of the end of the transition period.
GB held registrations: ‘grandfathering’
EU REACH registrations held by GB-based businesses have been carried across directly into UK REACH, legally ‘grandfathering’ the registrations into the new regime.
GB-based holders of existing EU REACH registrations needed to complete the ‘grandfathering’ process by providing basic information to the Health and Safety Executive (HSE) by 30 April 2021 using the UK REACH system ‘Comply with UK REACH’.
The deadline has now closed. If you have any queries about late grandfathered registrations, contact the HSE by email: email@example.com
Depending on tonnage band and hazard profile of the substance, users must comply with the full information requirements for their tonnage band under UK REACH within either 2, 4 or 6 years from 28 October 2021.
The information requirements for registration under UK REACH are the same as EU REACH.
After completing the initial stage of the grandfathering process, registrants of the same substance are placed in a substance group together within Comply with UK REACH.
Registrants can then access the contact details of other group members and start negotiating data access in order to submit a joint registration.
EU held registrations: GB downstream users
GB downstream users (who do not hold an EU REACH registration) currently importing chemicals from an EU or EEA country need to ensure the substances they purchase are covered by a valid UK REACH registration.
Businesses that relied on a registration held by an EU or EEA-based company before 1 January 2021 can continue importing substances as they did before. However, they will need to make sure that the chemical is registered for UK REACH purposes. Find out how GB downstream users can notify the HSE using a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU or EEA by 27 October 2021.
A new registration must then be submitted to the HSE within 2, 4 or 6 years of 28 October 2021. Alternatively, GB downstream users can encourage their EU or EEA supplier to appoint a GB-based Only Representative (OR), or change their source to a GB registered supplier.
It’s possible to submit DUINs if a chemical is covered by a registration held by an EU or EEA-based OR, and then sold into GB.
New registrants include anyone who wants to manufacture or import for the first time, and needs to submit a full registration.
After completing the substance inquiry process, new registrants can view contact details of other members within Comply with UK REACH and start negotiating data access.
An individual registering a new substance that has never been registered under UK REACH will become the lead registrant and need to submit a lead dossier for that substance. This will make joint registration available for any future registrants. If multiple businesses want to register the same substance for the first time, they will be placed in a substance group together and a joint registration should be submitted.
Under UK REACH, new registrants are able to request any information from existing registrants if it’s needed for their registration. However, they must request information if it involves tests on animals.
Tonnage band deadlines
Under UK REACH, deadlines for the full submission of data to underpin registration dossiers will be staggered over a period of 6 years. These deadlines start from 28 October 2021, the end of the DUIN submission period. Find out tonnage band deadlines and hazard profiles on the HSE website.
EU market access for GB business
GB-based businesses previously registered with EU REACH can no longer sell into the EEA market unless they have transferred their registrations to an EU or EEA-based organisation.
GB businesses who have not done so are able to appoint an OR to assume registration obligations under EU REACH or support their EU or EEA-based importers to become registrants.
They will also need a valid UK REACH registration to maintain access to the GB market.
Importing from the EU to GB
EU or EEA based businesses who import chemicals into GB must ensure that they are covered by a valid UK REACH registration.
These businesses can register the substance under UK REACH either through a GB-based OR, or an affiliate GB importer.
Joint registrations are a way of reducing costs to business and avoiding testing on animals.
Registrants share data to ensure the information needed for a registration is submitted to the HSE. They must share data on a substance’s properties in a fair, transparent and non-discriminatory way. ‘Comply with UK REACH’ enables data sharing through the formation of substance groups.
Registrants under UK REACH should jointly submit information on the intrinsic properties of the substance in a lead dossier. The information in the lead dossier will support the registrations of all members of the joint registration and contain the full information requirement for the group’s highest tonnage band. All members of the group will need to submit a separate member dossier containing certain information.
The lead registrant is responsible for approving members into the joint registration group in ‘Comply with UK REACH’. This links their member dossier to the lead dossier.
Substance groups are the way that ‘Comply with UK REACH’ organises registrants. They are made up of multiple businesses that all want to submit a registration for the same substance. Members of the group are able to contact each other to start the data sharing process.
Registrants of the same substance are automatically matched and put in a substance group. This is done after either:
- submitting the initial substance identification information - in the case of grandfathered registrations
- submitting a substance inquiry if you are a new registrant - including those who wish to register, having submitted a Downstream User Import Notification
Once a substance group is formed, members of the group can access each other’s contact details to organise a registration strategy, a cost-sharing model and group data sharing. A lead registrant should be appointed by the group to submit the joint registration dossier for that substance on behalf of all group members. The lead registrant role should be claimed on ‘Comply with UK REACH’ once the dossier is ready to be submitted.
If a substance group is already formed, new registrants should communicate directly with the lead registrant to negotiate data sharing. If the group is still forming, new registrants should communicate with the group as a whole.
Sharing the data needed to submit a joint registration is an important task for substance groups. If the substance group is in the process of forming, members must:
- find out what studies are available
- assess any data gaps within the group
- consider other publicly available data
If a study is not available in the group, members will need to agree how to get the missing data. The group members need to agree how they will share the costs for both existing and new studies.
Businesses should agree on a process for sharing data before doing so. If members of the substance group are data owners, they may want a non-disclosure agreement. A legal agreement or a ‘Letter of Access’ (LOA) can formalise the data sharing agreement and give co-registrants and new members access rights to the data to be used in the lead dossier, for the purpose of completing their registration.
All parties must make every effort to reach an agreement on data sharing and to ensure the costs are determined in a fair, transparent and non-discriminatory way
All registrants must comply with competition law.
UK REACH includes a dispute process to help resolve issues around data sharing within the service.
Businesses can lodge a dispute with the HSE as a last resort when negotiations over data access have failed. The party submitting the dispute must provide evidence to demonstrate those negotiations took place in good faith and were fully pursued. The party the claim is being made against will also be asked to provide evidence.
The HSE assesses this evidence and decides whether both parties have made every effort to reach a negotiated settlement. This decision will not be based on the issue of cost. Parties can appeal the decision to the First-tier Tribunal.
A registrant can opt out of submitting certain information within a joint registration and do so separately. There are 3 scenarios where this is possible.
- Where the costs of submitting information jointly would be too costly.
- Where submitting the information jointly would disclose commercially sensitive information and is likely to cause substantial commercial detriment.
- If there is a disagreement over the selection of information to be submitted in the lead dossier.
If any of these scenarios apply, you must submit, along with the dossier, an explanation of why that is the case.
Authorisation is the process under UK REACH that phases out the use of particularly hazardous substances. It allows the use of the substance to continue in specific circumstances, where it’s deemed necessary.
The Secretary of State makes decisions to add substances to the authorisation list and grant authorisations. These decisions are based on the scientific opinion of the HSE. We will publish these decisions on GOV.UK.
UK REACH uses a restriction process to regulate the manufacture, placing on the market or use of dangerous substances, either on their own or in mixtures or articles, within GB.
Such activities may be limited or banned, if they pose an unacceptable risk to human health or the environment. The restriction process is designed to manage risks that are not addressed by the other UK REACH processes or by other legislation.
The Secretary of State makes decisions to restrict substances, based on the scientific opinion of the HSE. We will publish these decisions on GOV.UK.
For help using the Comply with UK REACH service call the UK Chemicals helpline.
Telephone: 0330 159 1985
Monday to Friday, 9am to 5pm (except public holidays).