UK Regulatory News

On June 14, 2022, the United Kingdom’s Secretary of State implemented Statutory Instruments (SIs) which impose the ban on some chemicals in cosmetics and toys. This is in accordance with the EU deci...

On June 14, 2022, the United Kingdom’s Secretary of State implemented Statutory Instruments (SIs) which impose the ban on some chemicals in cosmetics and toys. This is in accordance with the EU decision and based on the assessments done by the scientific advisory body that was set up after Brexit.

The new SIs adds some carcinogenic, mutagenic, or reproductive toxicants (CMRs) to Annex II (the list of prohibited substances in cosmetic products) of the cosmetic regulation in the UK. Deoxyarbutin is banned and salicylic acid is added to Annex III of the cosmetics regulation, although restricting its uses to being used as a preservative at the following concentrations:

• Maximum 3% in rinse-off cosmetics
• Maximum 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick, and roll-on deodorant
• Maximum 2% in other products

The amendment also limits the use of aniline and formaldehyde in toys meant for children under 36 months and other toys that might get placed in the mouth. The rule regarding salicylic, aniline, formaldehyde, and deoxyarbutin and salicylic acid in cosmetics are expected to come into force on December 15, 2022. While other rules in the SIs will enter into force on October 15, 2022.

Consolidated versions of UK REACH and Classification, Labelling and Packaging (CLP) legislation were published, including the incorporation of amendments made to EU regulations covering post-Brexit na...

Consolidated versions of UK REACH and Classification, Labelling and Packaging (CLP) legislation were published, including the incorporation of amendments made to EU regulations covering post-Brexit national laws. The concern about the effectiveness brought by consolidated texts used in legislation prompted the new versions of legislation release.

To increase the legislation readability for different stakeholders, the “re-organized" UK REACH text is updated by the National Archives on the UK government legislation website. This regulation entered into force on January 1, 2021, compiling five Statutory Instruments (SI) that amends the EU REACH regulation. The updated version successfully merged several amendments into a single piece of legislation.

The newly published text on April 28, 2022, is expected to make it more accessible and available for concerned readers to check the regulation without any required consultation. In a similar fashion, GB CLP and the British cosmetics law, which referred to the EU Regulation for cosmetics products, also have their consolidated texts published.

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.