UK Regulatory News

The UK Health and Safety Executive (HSE), as the implementing agency for UK REACH, is currently consulting on different potential options for a UK REACH restriction on substances to be used in tattoo ...

The UK Health and Safety Executive (HSE), as the implementing agency for UK REACH, is currently consulting on different potential options for a UK REACH restriction on substances to be used in tattoo inks and permanent make-up. 

The proposed restriction would be in line with a similar restriction introduced in the EU through Commission Regulation (EU) 2020/2081, which entered into force in January 2022. 

According to the HSE, uncertainties about the substances causing tattoo-related complications and their prevalence, it is difficult to quantify the level of risk that is associated with substance use for tattoo inks and permanent make-up. The restriction is therefore proposed on a precautionary basis, and it seeks to address the lack of UK regulations on the topic. 

In line with the existing EU restriction, the UK restriction proposal would address the following groups of substances, imposing conditions on their use in tattoo inks and permanent make-up: 

• Substances that have a harmonized hazard classification under the UK CLP for one of the following hazards: 
  • Carcinogenic, mutagenic, or toxic to reproduction (categories 1A, 1B or 2) 
  • Skin sensitising (categories 1, 1A or 1B) 
  • Skin irritant or corrosive (categories 1A, 1B, 1C or 2) 
  • Eye damaging and irritant (categories 1 or 2) 
• Substances that have been prohibited under the EU Cosmetics Regulation (listed in Annex II therein) 
• Colorants subject to use conditions under the EU Cosmetics Regulation (as specified in its Annex IV)

For these substance groups, HSE is proposing three alternative restriction options. While the restriction proposal contains several exceptions, the overarching approaches are depicted in the table below. A further point of differentiation is the automatic implementation of changes to the EU Regulation.
 

Additionally, the restriction would also introduce some labelling requirements to complement existing regulations on the topic: 

• The labelling of all ingredients that would not be identified under the UK CLP 
• The highlight of the presence of nickel and chromium VI if applicable 
• The provision of a manufacturer’s reference number
• The identification of the intended use of a mixture as tattoo ink or in permanent make-up, and instructions for use 

Consultation on the scope of the restriction and on the proposed restriction options is open until November 6, 2022. An additional consultation will be held at a later stage on the socioeconomic impacts of the restriction. 
 

On August 17, 2022, the UK’s Environment and Health Security Agencies released a report reviewing potential approaches to the management of risks arising from unintentional mixtures. While this is i...

On August 17, 2022, the UK’s Environment and Health Security Agencies released a report reviewing potential approaches to the management of risks arising from unintentional mixtures. While this is in keeping with the discussions on chemical management in the European Union, the Agencies’ findings point – if implemented – to the risk of regulatory divergence between the UK and the EU. 

The issue of unintended mixtures is one of the key points raised in the European Union’s Chemical Strategy for Sustainability, which outlines the framework for a far-reaching reform of the bloc’s chemical legislation framework. In the context of the ongoing revision of Regulation (EC) 1907/2006 (the REACH Regulation) in the European Union (EU), the introduction of a Mixtures Assessment Factor (MAF) when conducting substance risk assessments has been proposed. 

Now, the report released by the two UK Agencies proposes the partial use of MAF when conducting risk assessments. However, it proposes limiting it to environmental risk assessment in aquatic media. Therefore, other media and human health risk assessment would not include this approach to tackling unintentional mixtures. 

Changes requiring businesses to include a MAF would need to be implemented in the UK through specific reform of UK REACH. In the EU, the Commission’s formal proposal to amend REACH is still in the works, and has not been officially presented yet. Therefore, the potential for divergence on this topic across both regulatory regimes will be clarified in the future. 
 

The UK Department for Environment, Food, and Rural Affairs (DEFRA) has begun consultation on the extension of UK REACH registration deadlines. UK REACH established a transitional system whereby substa...

The UK Department for Environment, Food, and Rural Affairs (DEFRA) has begun consultation on the extension of UK REACH registration deadlines. UK REACH established a transitional system whereby substances registered under EU REACH could continue to be marketed in Great Britain with only minimal compliance obligations, and full registration would only become necessary at later dates (in October 2023, 2025, or 2027, depending on the substance).
 

However, the industry has raised concerns about the adjustment costs, and work is currently being carried out to provide an alternative framework. Given the proximity of the earliest deadline (October 2023) and the difficulty of developing such a new framework, DEFRA sees it as necessary to extend the deadlines.

Consultations are being held on two options. In both options, the initial registration deadline would be pushed forward by three years, to October 2026. Under the first option, the second and third deadlines would likewise be extended by three years (to October 2028 and 2030, respectively). DEFRA’s second (and preferred) option would only delay these by 2 and 1 years (to October 2027 and 2028, respectively).

Current registration timeline and options under consideration

The Consultation closes on September 1, 2022. After that date, DEFRA will analyse the submissions and choose one of the options.

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.