UK Regulatory News

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 a...

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 ...

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

In a letter of 9 February 2021, Steve Elliott, Chief Executive of the UK’s Chemical Industries Association called upon the UK government to repeal the UK REACH requirement for duplicate registra...

In a letter of 9 February 2021, Steve Elliott, Chief Executive of the UK’s Chemical Industries Association called upon the UK government to repeal the UK REACH requirement for duplicate registration datasets. Under the current situation, companies seeking to register substances under UK REACH must replicate the data used to register under EU REACH or purchase it again. This, according to the industry representatives, may result in a 1 billion pounds extra cost for chemical manufacturers and importers.

To mitigate such extra costs in response to the industry’s concerns, George Eustice, the UK’s Secretary of State for Environment, Food and Rural Affairs, announced on December 6th that the government is considering an amendment of UK REACH. The solutions under consideration mostly coincide with those put forward by industry representatives: which only requires registrants to submit already publicly available data for most substances, and full datasets for the most hazardous ones.

To secure additional time for the industry while exploring the feasibility of this new model, the UK government announced that it will hold a consultation on whether to extend the deadlines for providing full registration data on substances that have been notified via the Downstream User Import Notification (DUIN).  

Under the current regulatory framework, substances that have been DUIN-notified need to be fully registered by 27 October 2023, 2025, or 2027 depending on their tonnage band and risk profile (see table below).

However, subject to the outcome of the consultation, the government might extend the 27 October 2023 deadline to 27 October 2025. Similar plans are also being considered for the 2025 and 2027 deadline.

Last update: 2021-12-15

The deadline to submit a Downstream User Import Notification (DUIN) officially expired on October 27, 2021. However, HSE recently updated its online guidance on UK REACH and announced that DUINs can s...

The deadline to submit a Downstream User Import Notification (DUIN) officially expired on October 27, 2021. However, HSE recently updated its online guidance on UK REACH and announced that DUINs can still be notified, although a clear timeframe was not provided for late notifications.

Consequently, eligible GB-based importers and non-GB-based exporters should take appropriate measures to submit their DUIN as soon as possible.

DUIN is a transitional arrangement set out under UK REACH. It allows GB-based importers and non-GB-based exporters to maintain access to the GB-market for their substance provided that:

1. Their substances are registered within EU REACH
2. They have placed their substances into the GB market between January 1, 2019 and December 31, 2020.

After submitting a DUIN, notifiers have 2, 4, or 6 years to comply with the requirement to register their substances (depending on the risk profile and the tonnage band).

Lastly, manufacturers and importers placing substances into the GB market should keep in mind that Safety Data Sheets (SDS) must now be prepared in accordance with UK REACH. SDS needs to be provided for hazardous chemicals being supplied for use at work, whether packaged or not. SDS also needs to be provided for chemicals that are not classified as hazardous but contain hazardous substances.

Last Update: 2021-11-12

On 31st August 2021, the United Kingdom’s Health and Safety Executive (HSE), in charge of implementing UK REACH, published a draft recommendation for the inclusion of&nb...

On 31st August 2021, the United Kingdom’s Health and Safety Executive (HSE), in charge of implementing UK REACH, published a draft recommendation for the inclusion of two substances into the Authorization List: Dicyclohexyl phthalate (CAS 84-61-7) and Disodium octaborate (CAS 12008-41-2). These substances that were found to have reprotoxic properties, are part of the seven substances previously proposed by ECHA for inclusion in the EU Authorisation list. The other five substances were not selected by HSE for inclusion in the UK Authorisation List, thus showing a significant divergence from ECHA. 

This move raises questions about HSE’s capacity to assess substances and handle applications at the same pace as ECHA. It is also a source of concern both for the industry, for whom regulatory divergences will lead to increased costs, and for NGOs who fear that the UK may not be able to keep up with the EU’s level of chemical safety.

The 27th October 2021 deadline for submitting a Downstream User Import Notification is approaching fast.   As a reminder, your substances are eligible for DUIN if:  They are re...

The 27th October 2021 deadline for submitting a Downstream User Import Notification is approaching fast.  

As a reminder, your substances are eligible for DUIN if: 

1. They are registered under EU REACH; and  
2. They were placed on the GB market between 1st January 2019, and 31st December 2020. 

Once your substances have been notified via DUIN, you may continue to place them on the GB-market, while postponing the registration deadline by 2, 4 or 6 years (depending on the substances’ tonnage band and hazard profile). 

Past 27th October 2021, DUIN will not be applicable anymore. This means that, to place your substances into the GB, you will first need to fully register your substances under UK REACH before you may place them on the GB market.  

As a non-GB substance manufacturer, you may not submit the DUIN yourself. Instead, you should either:  

• Let your GB-based importer submit the DUIN; or 

• Appoint a GB-based Only Representative to submit the DUIN on your behalf.   

Via our London office, GPC (UK) may gladly assist you as your GB-based Only Representative to meet your DUIN requirements within the above deadline! 

In a private communication with GPC, UK’s Health and Safety Executive (HSE) provided some clarification on the UK REACH compliance procedures currently available for importers and manufacturers....

In a private communication with GPC, UK’s Health and Safety Executive (HSE) provided some clarification on the UK REACH compliance procedures currently available for importers and manufacturers.

A great number of GB-based importers and non-GB-based manufacturers are now taking advantage of the Downstream User Import Notification (DUIN) to maintain access to the GB market for their EU REACH registered substances, while postponing the registration deadline of these substances by 2, 4, or 6 years from 28 October 2021. Once they have submitted a DUIN, manufacturers and importers may submit an art. 26 Inquiry to HSE right away if they seek to claim the role of Lead Registrant (LR) or to simply be involved in the discussion to select a LR.

Following the successful submission of a DUIN and an art. 26 Inquiry, importers and manufacturers face two options:

• Option 1: They may decide to register their substances right away. In this case, they must pay the HSE registration fee and submit a registration dossier. If all the substance information required in the dossier is not yet available to them, they may include a waiver explaining why they were not able to submit a full registration dossier (HSE is yet to publish guidance on acceptable justifications). They will them need to submit the full data by the relevant DUIN deadline (2, 4 or 6 years)
• Option 2: They may continue to place their DUIN-notified substances on the GB market and wait to complete the full registration by the relevant deadline.

Despite its positive outcome (i.e., avoiding major disruptions on existing EU-UK supply chains), DUIN has had a tricky consequence for companies who seek to place EU-REACH registered substances into the GB market but who did not themselves place the substances on the GB market during the Brexit transition period (from 01/01/2019 to 31/12/2020). Indeed, new GB-based importers and non-GB-based manufacturers are required to register their substances within UK REACH before they may place them on the GB market. However, they are often unable to gather the substance information needed in the HSE registration dossier, because DUIN may have put the joint registrations and data sharing on hold.

Therefore, in order to provide parity between new registrants and DUIN beneficiaries, HSE recently introduced the concept of New Registration of an Existing Substance (NRES). If you are a non-GB based manufacturer or a GB-based importer and you seek to place an EU REACH-registered substance in the GB-market, then your substance qualifies as a NRES. Provided that you comply with a simplified registration process, you may place your substance on the GB-market and postpone the full registration deadline of your substance by 2, 4 or 6 years from 27 October 2021.

The simplified registration process is as follows:

1. Submit an art. 26 Inquiry to HSE,
2. Submit an alleviated registration dossier, including a waiver explaining why you were not able to submit a full registration dossier,
3. Pay the HSE registration fee for your substance,
4. You must then submit the full substance data by the relevant deadline (2, 4 or 6 years).

Last update: 2021-05-31