DEFRA Closes Consultation on Alternative Transitional Registration Model for UK REACH

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently closed a public consultation on a proposal to introduce an Alternative Transitional Registration model (ATRm) for the UK’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system. The consultation, which was originally set to close on July 11, 2024, was extended to July 25, 2024, to allow for wider stakeholder input. The consultation period has now ended, and DEFRA will analyze the feedback to shape the next steps in refining the UK-REACH framework.

Overview of the Alternative Transitional Registration Model

The ATRm, developed by DEFRA in collaboration with the Health and Safety Executive (HSE) and the Environment Agency (EA), aims to address the challenges faced by businesses transitioning from the EU-REACH system to the UK-REACH system. The model is designed to reduce costs for companies, while ensuring that the high levels of protection for human health and the environment are maintained. Key proposals include:

● Reduced Hazard Requirements: The ATRm proposes a reduction in the hazard information required for substances that were on the market before the end of the EU Exit Implementation Period. However, it maintains full hazard information requirements for new substances entering the market after this period.

● Enhanced Use and Exposure Information: The model aims to improve the level of detail required on the use and exposure of substances within Great Britain (England, Scotland and Wales), thereby providing more accurate data for regulatory oversight.

● Streamlined Chemical Safety Reports: For substances manufactured or imported in quantities above 10 tonnes per year, the ATRm proposes reduced hazard information requirements in Chemical Safety Reports (CSRs).

● Focused Transitional Evaluations and Compliance Checks: The model allows the HSE to request additional data from registrants where necessary to address new or emerging risks. It also suggests that compliance checks should be carried out on at least 20% of registrations, focusing on specific uses, exposures or other critical parameters.

● Organized Data Sharing: Registrants of the same substance are to be organized into Substance Groups to facilitate data sharing and joint submission of information to ensure consistency and efficiency in the registration process.

The consultation received a wide range of feedback from industry stakeholders, regulatory bodies, and non-governmental organizations, which will now be used to refine these proposals.

Proposed Enhancements to UK-REACH

In addition to the ATRm, DEFRA’s consultation also explored potential improvements to the UK-REACH restriction and reporting processes. The proposals aimed to:

● Reduce Redundancy: Streamline regulatory processes to avoid duplication and reduce the administrative burden on businesses.

● Accelerate Decision-Making: Improving the efficiency of statutory consultation requirements to facilitate faster regulatory decisions.

●?Minimizing Animal Testing: Proposing additional safeguards to limit animal testing, reinforcing the principle that such testing should only be used as a last resort.

Next Steps in the Legislative Process

Following the conclusion of the consultation, DEFRA will now analyze the feedback received to shape the development of the necessary legislative changes. These changes will be the subject of a second round of consultation, supported by a Statutory Instrument and a full impact assessment. This second consultation will also be accompanied by an explanation of how the proposed regulations align with Article 1 of UK-REACH, ensuring transparency and adherence to legal standards.

This process is?part of a wider effort to ensure that UK-REACH remains effective and aligned with the objectives set out in the Environment Act 2021, providing a regulatory framework that balances environmental protection with business practicality.

Context and Background

Since leaving the European Union, the UK has developed its own independent chemicals management system, UK-REACH, which retains the core principles of the EU-REACH Regulation. However, the high cost associated with accessing or purchasing EU hazard data has raised concerns about the potential impact on the availability of substances on the UK market. The ATRm was proposed as a solution to these challenges, aiming to reduce costs while maintaining the existing high standards of regulatory protection.

Stakeholder Engagement

Throughout the consultation period, DEFRA encouraged participation from a wide range of stakeholders, including chemical manufacturers, downstream users and environmental organizations. The insights gained from this engagement will be crucial in shaping the future of UK-REACH, ensuring that it continues to protect public health and the environment while supporting the competitiveness of the UK chemical industry.

Confidentiality and Data Protection

Respondents to the consultation were given the option to request confidentiality for their responses, although DEFRA notes that such requests cannot always be honored due to legal obligations under various information access laws. All responses will be carefully considered as DEFRA moves forward with the legislative process.

As the consultation phase draws to a close, DEFRA’s focus will now shift to analyzing and integrating of the feedback received. The results of this consultation will play a key role in shaping the future regulatory landscape for chemicals in the UK, ensuring that the UK-REACH system remains both robust and responsive to the needs of all stakeholders.