UK Regulatory News

In June, the UK’s Health and Safety Executive (HSE) published Work Programme 2022/23 detailing the UK REACH activities carried out in the last calendar year and the activities HSE will carry out for...

In June, the UK’s Health and Safety Executive (HSE) published Work Programme 2022/23 detailing the UK REACH activities carried out in the last calendar year and the activities HSE will carry out for the UK REACH operation, together with the Environment Agency and other relevant agencies.

HSE is an agency for UK REACH, mainly responsible for handling regulation functions under UK REACH.

The newly published Work Programme includes information about UK REACH activities, multiannual priorities, work plan, dossier evaluation, substance evaluation, risk management and its engagement with the wider regulatory community.

Published by Britain’s Health and Safety Executive, the first opinion on mandatory classifications under GB CLP aligns with the previous technical report in all 23 cases even if it hints at divergen...

Published by Britain’s Health and Safety Executive, the first opinion on mandatory classifications under GB CLP aligns with the previous technical report in all 23 cases even if it hints at divergence from the EU.

In all the cases where there is potential for different classifications to those proposed in the EU, the agency found no significant impact. However, there is potential for different classifications in the case of five opinions on:

• Azamethiphos, an organophosphate insecticide currently under review as a biocidal active substance,
• Mancozeb and trifloxystrobin, two fungicides for crop use
• Cyfluthrin, insecticide approved for use as a biocidal active substance, and
• Beta-cyfluthrin, a pyrethroid insecticide for crop use.

These mandatory classifications would have impacts on moulding downstream legislation, affects if a particular product is available on the market, while the forked opinion as such can be seen from the product azamethiphos. It currently has no entry in the GB MCL list and warranted classification as a category 2 carcinogen, but the Health and Safety Executive in the UK (HSE) disagreed with this aspect of the committee’s opinion.

The disapproval of this biocidal use in the EU dwelled in the previous withdrawal of application for authorization and its use in GB is also still under review. For the other 18 Opinions, the technical reports agreed with the Echa’s Risk Assessment Committee (RAC), and the HSE plans to publish another 82 Opinions by the end of June 2022.

Under the current scheme, within six months of RAC publishing an Opinion on mandatory (harmonised) classification under EU CLP, the HSE have to publish a technical report outlining if it agrees with the scientific assessment. Concerns from many NGOs have been flourishing for this distinct UK chemicals legislation after Brexit, which bears the great potential to diverge from EU laws, and seems to pose great threats to the protection of human health and the environment.

Socio-economic factors are another point to take into consideration in the Opinion adopted by the agency on the proposed changes within 12 months of publication of the technical report, after which the HSE spends another 12 months to give feedback and suggestions on if the proposed classification should be implemented. Lastly, after all these procedures, the governors have three months to decide on the implementation of these recommended changes to the GB legislation as well as to include them in the Mandatory Classification and Labelling (MCL) list.

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