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The Department for Environment, Food and Rural Affairs (DEFRA), UK in March 2022 published guidance for data and information sharing of the same chemical substance. This guidance will help companies and individuals understand their obligations pursuant to UK REACH.

This applies to anyone who manufactures or imports chemical substances over one tonne per year into Great Britain. During substance registration, registrants who register the same substance have to jointly submit information to avoid repeated studies, and unnecessary animal testing and to reduce costs. These joint registrants are matched to a substance group where the substance group members are expected to share details like registration strategy, cost-sharing model, and data.

This published guidance states that members must share study summary data (about available studies, data gaps, and publicly available data) for joint registration submission. If a new member joins, they can request any study summary data from existing members, if needed for registration. However, if the summary data involves vertebrate animal testing, the information has to be requested. And members must agree on how to meet information requirements for their joint registration when the study is not yet available. 

Group members should agree on how to share the costs for existing and new studies, and appoint a lead registrant. The lead registrant holds the responsibility of submitting the lead joint registration dossier and approving members into the joint registration group. This role can be claimed once the lead dossier is ready to be submitted. Furthermore, members will also submit their member dossier, which should provide information about the manufacture and uses of the substances they are registering.

The guidance also includes information on the grounds based on which members of the substance group may trigger a data-sharing dispute. Accordingly, such disputes may be initiated when:

• 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

Disputes may only be initiated if the members submit evidence that they have tried to reach an agreement in good faith.

Lastly, the guidance provides that group members can opt-out of a joint data submission partially or fully under certain conditions like:

• If it is costly for you or your company
• If there is a disagreement when selecting what to be submitted in the lead dossier
• If it discloses sensitive information that might cause commercial damage

There must be a justified reason when opting out of joint registration which will be submitted alongside your member dossier.

When UK REACH entered into force, all substances included in the EU REACH candidate list were ipso facto (by the fact itself) transferred into the new UK REACH candidate list. As to the substances added to the EU REACH candidate list after UK REACH entered into force, the UK regulators committed to assess whether these substances should also be added into the UK REACH candidate list.

On December 10, 2021, the UK’s Health and Safety Executive (HSE) and Environment Agency (EA) announced having conducted an assessment of the substances placed into the EU REACH candidate list by ECHA since the entry into force of UK REACH. Out of those, HSE and EA have identified four substance groups that should undergo further assessment:

ü  dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives, and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety

ü  1,4-dioxane

ü  small brominated alkylated alcohols (SBAA)

ü  phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/or combinations thereof (PDDP)

Following the assessment, the UK regulators will recommend the most appropriate course of action for managing the risks identified from these four substance groups. Such actions may consist in adding the substances into the UK REACH candidate list, although according to the official statement “HSE and EA may make other recommendations.”

Source: Approach to including substances of very high concern on the UK REACH candidate list