Navigating A New UK REACH Registration For An Existing Substance Without A Lead Registrant

Following the United Kingdom’s (UK) exit from the European Union (EU), any legal entity based in Great Britain (GB) intending to manufacture or import a substance into England, Scotland, and/or Wales at or above one tonne per year is required to submit a registration to the Health and Safety Executive (HSE) for that substance. This process is typically straightforward. What should a company do, however, when a substance is identified as a New Registration of an Existing Substance (NRES) and no Lead Registrant has been assigned? The following steps provide a practical guide for navigating this common scenario:

• Prepare and submit an Article 26 Inquiry (Inquiry) for the substance via Comply with UK REACH;

• Await notification from the HSE via Comply with UK REACH once the Inquiry dossier has passed the Business Rules, Technical Completeness Check, and Completeness Check. The HSE will inform the submitter that the substance is considered a NRES and will place it in the relevant Substance Group with other potential registrants (including registrants that have grandfathered the substance and new registrants that have submitted an Inquiry);

• Prepare and submit a registration dossier. To register, either a Lead or Member Registration dossier with the appropriate data for the tonnage band needs to be submitted. Normally, a Lead dossier would include the relevant test summaries. In the case of NRES dossiers, however, the registrants within the Substance Group will not be in a position to do this. Therefore, ensure that the submitted dossier contains waivers explaining why the submitter is currently unable to provide all relevant test summaries;

• Negotiate with the other members of the Substance Group and determine who will take the role of Lead Registrant; and

• Submit a registration dossier (Lead or Member Registration dossier) via Comply with UK REACH to the HSE which complies with the full information requirement for the submitter’s role within the Substance Group and the tonnage band to continue to manufacture or import into GB. Ensure that the dossier is complete by the applicable transitional deadline for the substance based upon its hazard properties and the tonnage band.

Navigating the NRES registration process can be challenging, particularly when no Lead Registrant has been identified. The Acta Group (Acta^®) closely monitors UK REACH regulatory developments. Acta welcomes opportunities to assist companies in developing practical compliance strategies and managing evolving UK REACH compliance obligations.