Regulatory Developments

Defra Begins Public Consultation on Extending the UK REACH Transitional Registration Deadlines

July 18, 2022 PRINT

The Department for Environment, Food and Rural Affairs (Defra) has begun a public consultation on extending the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) submission deadlines for transitional registrations -- the registrations under UK REACH of substances that were registered in the European Union (EU) in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition period. Defra seeks comment on two options to extend the current deadlines for registration, as well as a do-nothing option. Defra also requests comment on extending the dates for the Health and Safety Executive (HSE) to carry out compliance checks on at least 20 percent of the registration dossiers. Responses are due September 1, 2022.

UK REACH requires substances that are manufactured in or imported into Great Britain (GB) to be registered with the HSE, the Agency for UK REACH. Registrations include information on the hazards, uses, and exposures to the substance. HSE uses registration information for regulatory purposes, and registrants use the information to identify appropriate risk management measures for themselves and other users down the supply chain.

The UK REACH Regulation contains transitional provisions intended to reduce the disruption to GB businesses as they moved to the new regime from EU REACH. According to Defra, these provisions have allowed companies to submit initial “notification” data to continue trading and then subsequently provide the full registration data. The transitional provisions apply to GB entities that were registrants, downstream users, or distributors under EU REACH before UK REACH came into effect. The current deadlines for completing the transitional registration process, depending on tonnage and hazard profile of the substance, are:

  • October 2023 for substances included on the EU REACH candidate list before UK REACH came into effect; substances that are carcinogenic, mutagenic, or toxic for reproduction (CMR) and manufactured or imported in quantities of one metric ton (MT) or more a year; substances that are very toxic to aquatic life and manufactured or imported in quantities of 100 MT or more a year; and all substances manufactured or imported in quantities of 1,000 MT or more a year.
     
  • October 2025 for substances added to the UK REACH candidate list before the above submission deadline; and all substances manufactured or imported in quantities of 100 MT or more a year.
     
  • October 2027 for all substances manufactured or imported in quantities of one MT or more a year.
     

Defra states that in response to concerns raised by stakeholders around the cost of acquiring the data to complete their registrations, the government is working with stakeholders to explore an alternative transitional registration model. According to Defra, the aim of the model is to reduce costs to businesses of transitioning from EU REACH to UK REACH while maintaining or improving existing human health and environment protections, in line with international commitments. Defra notes that developing a new model is highly technical and complex, and once a suitable model is found, operational and legislative changes would need to be made to implement it.

The public consultation also covers the proposal to extend the legislative timelines for the HSE to carry out compliance checks on at least 20 percent of the registration dossiers required under UK REACH Article 41, which was carried over from EU REACH. According to Defra, the timelines need to be amended “to ensure that they apply after the relevant submission dates have passed, otherwise no data may have been submitted for the Agency to carry out compliance checks on.”

According to the consultation document, the policy options being considered, and which are included in the consultation, are:

  • Baseline -- Do Nothing: Do not change the current submission deadlines (October 27, 2023; October 27, 2025; and October 27, 2027). The consultation document states that with a “do nothing option,” the first deadline of October 27, 2023, will fall before the government has time to develop and legislate for the alternative model. This will cause considerable uncertainty about what companies’ duties are and what steps they should take to meet them. There is also a risk that industry could start making nugatory investment towards acquiring data that may not be necessary under the criteria set out in the alternative transitional registration model being developed.
     
  • Option 1: Extend all the current submission deadlines for each tonnage band by three years to October 2026, October 2028, and October 2030. The public consultation document states that this should give the government time to introduce the alternative model and those subject to the first deadline time to prepare to comply with it. It would also give those subject to subsequent deadlines the same amount of time they have now to take account of what is done by those subject to earlier deadlines. As set out in the Article 1 Consistency Statement, the government considers that this option would be consistent with Article 1 of the UK REACH Regulation. In particular, with the purpose of ensuring a high level of protection for human health and the environment and the free circulation of substances.
     
  • Option 2 (Preferred Option): Extend the first submission deadline by three years to October 2026, the second by two years to October 2027, and the third by one year to October 2028. According to the public consultation document, moving the first submission deadline back by three years should give the government time to introduce the alternative transitional registration model and those subject to that deadline time to comply with it. The public consultation document states that Option 2 has the advantage of the transitional registration data being received by the HSE earlier than under Option 1. Under this option, those subject to the second two submission deadlines would have less time to take account of what those subject to earlier submission deadlines did. Defra “do[es] not consider that there would be any significant impacts to industry as a result of the reduced gaps between submission deadlines, and believe[s] any disadvantages are outweighed by the benefits of the HSE receiving the transitional registration data sooner.”

Commentary

This Defra public consultation shines a bright light on the challenges that the UK government and GB businesses face as the UK’s transition from EU REACH to UK REACH continues. The foundational principles in REACH Article 1(3) are common to both the EU and UK legislative paradigms. These REACH principles place the responsibility on manufacturers, importers, and downstream users to “ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment” and that they are “underpinned by the precautionary principle.” Defra’s proposed alternative model is somewhat problematic with respect to how the information requirements in Article 10 will be fulfilled, particularly the requirement that “the registrant shall be in legitimate possession of or have permission to refer to the full study report summarized under (vi) and (vii) for the purpose of registration.” Even if Defra amends this Article 10 provision, it could face legal challenges from data owners.

Unless the UK amends UK REACH Article 41(5), the HSE will be out of compliance with its provisions by December 31, 2023, when the first deadline for review of “no lower than 20%” of REACH registration dossiers in the 100 MT or higher tonnage band are to be checked for compliance. Defra’s preferred policy option delays compliance with the current provisions of UK REACH Article 41(5) by at least three years, but narrows the delay for completion of compliance checks for tonnage bands of less than 100 MT per year with respect to both UK and EU REACH, which currently require the HSE to meet its compliance check target for the lower tonnage bands by December 31, 2027.

Regardless of the outcome of this public consultation, Defra faces the daunting challenge of meeting the UK’s commitment to a UK REACH Regulation that is no less protective of human health and the environment than EU REACH without placing additional financial burdens on GB businesses.


 
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