UK REACH: Joint registrations and data sharing
How companies or individuals based in Great Britain should share data and information on the same chemical substance and jointly submit that information to the ‘Comply with UK REACH’ service.
Applies to England, Scotland and Wales
If you manufacture in, or import into, Great Britain a chemical substance at or over one tonne per year, you must register the substance through the ‘Comply with UK REACH’ service. This applies to substances:
- on their own
- in mixtures (formulations)
- in articles - only in limited cases
If you are registering a substance and there are other registrants of the same substance, then you must jointly submit certain information about the intrinsic properties of that substance. By doing this you can:
- avoid repeating studies
- reduce costs to your business
- avoid unnecessary testing on animals
Substance groups
Companies or individuals registering the same substance are matched to a substance group in the ‘Comply with UK REACH’ service. This allows members of the group to access each other’s contact details to:
- organise a registration strategy
- create a cost-sharing model
- share data
Sharing data within your substance group
Members of a substance group need to share study summary data to submit a joint registration. This allows members to:
- find out what studies are available
- assess any data gaps within the group
- consider other publicly available data
New members of the group can request any study summary data from existing group members, if it’s needed for their registration. If the summary data involves testing on vertebrate animals, then members must request this information.
If a study is not available, then members of the group will need to agree how to meet the information requirement for the joint registration. Members can do this by:
- obtaining new studies
- applying the principles of grouping and read across from publicly available data on analogous substances and providing a scientifically robust justification for this.
The group members need to agree how they will share the costs for both existing and new studies. Members should all agree on a process for sharing data before doing so.
Data sharing agreement
A legal agreement or a ‘letter of access’ (LOA) can formalise a data sharing agreement. An agreement can also give group members and new members access rights to the data that will be used in the lead dossier, so they can complete their registration.
Data sharing obligations
All group members must make every effort to:
- reach an agreement on data sharing
- make sure the costs of data sharing are determined in a fair, transparent and non-discriminatory way
All registrants must comply with competition law.
Data sharing disputes
You can contact the Health and Safety Executive (HSE) if you consider that you have made every effort to reach an agreement on data sharing acting in a fair, transparent and non-discriminatory way and:
- a data owner refuses to provide details of the costs of study summary data or a copy of a study summary
- there’s a failure to reach an agreement about data sharing
You must provide evidence to show that negotiations took place in good faith and were fully pursued. The group member that you are making the claim against will also be asked to provide evidence.
HSE will assess the evidence and decide whether both sides have made every effort to reach a negotiated settlement. This decision will not be based only on the costs of study summary data.
If you or the other party do not agree with the final decision, they can appeal the decision to the First-tier Tribunal.
Appoint a lead registrant
Members of a substance group must agree who will be lead registrant. The lead registrant will:
- submit the lead joint registration dossier for that substance on behalf of all group members
- approve members into the joint registration group in the ‘Comply with UK REACH’ service - this links the registrant member dossier to the lead dossier
The information in the lead dossier will support the registrations of all members of the joint registration. It should contain the full information requirement for the group’s highest tonnage band
The lead registrant role can be claimed within the ‘Comply with UK REACH’ service once the lead dossier is ready to be submitted.
Submitting member dossiers
All members of the group need to submit their own member dossier containing information about their manufacture and uses of the substance they are registering.
Opt out of a joint data submission
You can fully or partially opt out of submitting certain information via a joint registration if:
- it would be costly to your company or as an individual
- it discloses commercially sensitive information and is likely to cause substantial commercial damage
- there was a disagreement over the selection of information to be submitted in the lead dossier
You must provide a clear and reasoned justification which of these apply and submit it with your member dossier in the ‘Comply with UK REACH’ service.
If you opt out of a joint data submission, you will still need to include the information to meet your registration requirements when you submit your member dossier.