UK Regulatory News

On 10 May 2023 the British government presented an amendment to the Retained EU Law (Revocation and Reform) Bill removing the sunset clause that would automatically revoke most retained EU law on 31 D...

On 10 May 2023 the British government presented an amendment to the Retained EU Law (Revocation and Reform) Bill removing the sunset clause that would automatically revoke most retained EU law on 31 December 2023.

Originally the Retained EU Law (REUL) was established by the European Union (Withdrawal) Act 2018 to guarantee legal certainty and continuity in the period after Brexit by keeping all EU and EU-derived law as it was on 31 December 2020 when the UK left the EU.  On 22 September 2022 the Government presented the Retained EU Law (Revocation and Reform) Bill to Parliament. The Bill contains a sunset clause that would revoke the majority of REUL on the 31 December 2023 unless positive steps were taken by the government to keep it. REUL consists of around 4,800 pieces of legislation that must be reviewed before it can be decided if they should be preserved, reformed, or revoked.

The amendment to the Retained EU Law (Revocation and Reform) Bill presented on 10 May removes the sunset clause from the Bill. Instead it presents a list of approximately 600 retained EU laws that the government intends to revoke at the end of 2023. The list contains REUL that is obsolete now that the UK has left the EU. The remaining legislation will be retained but can be revoked or reformed later after proper assessment and consultation. The full list can be found here. It contains a variety of legislation concerning biocides, persistent organic pollutants (POPs), import and export of substances subject to the prior informed consent (PIC) regulation, CLP Annex VIII obligation related to poison centers, food additives and environmental permits. 

On 20 April 2023, the UK Department for Environment, Food and Rural Affairs (DEFRA) laid a draft Statutory Instrument (SI), REACH (Amendment) Regulations 2023, before Parliament. The SI will formally ...

On 20 April 2023, the UK Department for Environment, Food and Rural Affairs (DEFRA) laid a draft Statutory Instrument (SI), REACH (Amendment) Regulations 2023, before Parliament. The SI will formally extend the submission deadlines under UK-REACH by 3 years.

The table below shows the original and new deadlines for the various tonnage bands and hazard categories.

The changes will come into force after approval by each of the Houses of Parliament. This SI is expected to be enacted and in force by the third quarter of 2023.

The UK's Health and Safety Executive (HSE) has recently published a regulatory management options analysis (RMOA) – a technical document examining the risks posed by the use, import and manufact...

The UK's Health and Safety Executive (HSE) has recently published a regulatory management options analysis (RMOA) – a technical document examining the risks posed by the use, import and manufacture of PFAS and ways to control these risks. The analysis outlines the scope of its possible restrictions on PFASs, which could target "hundreds" of substances that are most persistent and relevant to the GB market.

The HSE's RMOA focuses on a smaller number of substances than the EU's proposal, which aims to ban the entire class of chemicals. The HSE report recommends prioritizing a restriction dossier this year for PFAS use in firefighting foams.

Furthermore, there are recommendations on preparation of Annex XV dossiers under UK REACH to support restrictions on certain uses, such as firefighting foams, coatings, cleaning agents, and consumer articles. Other recommendations include further evaluation of specific substances, a review of F-gas regulations, and the development of statutory standards for PFASs in drinking water in England and Wales.

Moreover, the HSE has defined PFASs more narrowly than the EU and recommends a number of risk management measures to limit the use of PFAS and control exposures to people and the environment in the country.

The next stages of regulatory action will be set out in the UK REACH work program for 2023-24, followed by a detailed risk assessment and legislative proposal.

The UK Department for Environment, Food and Rural Affairs will publish its chemicals strategy later this year (no date announced). The UK's chemicals strategy is intended to replace the EU's R...

The UK Department for Environment, Food and Rural Affairs will publish its chemicals strategy later this year (no date announced). The UK's chemicals strategy is intended to replace the EU's REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation, which the UK no longer has access to as a result of Brexit. 

The strategy will set out a risk-based approach to regulation diverging from the hazard-based approach taken by the EU. This means that the strategy will focus on managing priority and emerging chemicals of concern, including per- and polyfluorinated substances (PFASs), endocrine-disrupting chemicals (EDCs) and combination effects of different substances. In addition to managing priority and emerging chemicals of concern, the strategy will also focus on improving the department's understanding of the uses and exposures of chemicals across the UK. 

 The strategy will also map out a new UK REACH alternative transitional registration model and improve understanding of chemicals in the environment by continuing to develop monitoring methods. The strategy will utilize the department's prioritization and early warning system to inform decision-making and regulatory activities.

On 29 November 2022, the UK government published the results of a consultation process on extending the UK REACH deadlines. This consultation was conducted from 5 July to 1 September this year by the ...

On 29 November 2022, the UK government published the results of a consultation process on extending the UK REACH deadlines. This consultation was conducted from 5 July to 1 September this year by the Department for Environment, Food and Rural Affairs (DEFRA). In total, 289 responses were submitted to the consultation, with the majority coming from the industry. One of the major concerns by the stakeholders was the registration deadline. The DEFRA had put forward the following three options for the consultation:

• Baseline – do not change the current submission deadlines (27 October 2023, 27 October 2025, and 27 October 2027)
• Option 1 – extend all the current submission deadlines of each tonnage band by 3 years to October 2026, October 2028, and October 2030
• Option 2 (option preferred by the government) – extend the first submission deadline by 3 years to October 2026, the second by 2 years to October 2027, and the third by 1 year to October 2028

82% of respondents selected Option 1, which would mean that the three registration deadlines (October 2023, 2025, and 2027) should be extended by 3 years.

The DEFRA acknowledges that Option 1 could lessen burdens on SMEs and downstream users without reducing levels of protection of human health and the environment. The next step is a request for administration consent and introduction legislation on extension of the submission deadlines across all tonnage bands by 3 years.  

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.