Strategic regulatory guidance to help you plan for UK REACH in the context of global regulations
Proven track record of working as an OR
Vast experience of working with the UK regulator, HSE
The U.K. left the EU on January 31, 2020, and until December 31, 2020, it continued to follow EU REACH. After this date, however, the new U.K.-based regulatory framework (UK REACH), based on EU REACH, for chemicals manufactured or imported into the U.K. should be followed. Initially, the EU and U.K. frameworks are likely to be very similar; however, regulations may diverge over time.
A consultation period in 2022 will be held by DEFRA (U.K. policymaker for UK REACH) to formally review registrants’ need to provide full information requirements, particularly hazard data, as part of their UK REACH full registration. As regulators, they are considering the balance between registrants providing hazard information and more detail on uses and potential exposure to better understand the safe use of chemicals on the U.K. market.
The consultation period is expected to occur in summer 2022. DEFRA has suggested they intend to extend the registration deadlines currently written in UK REACH by two years; however, no time scale can be given at this time as to when a decision will be available until the consulting period is complete.
Only companies with a legal entity based in Great Britain (GB) can register chemicals in UK REACH. If you are not, then you may need a UK-based Only Representative (OR) registrant. The OR takes on the legal responsibility of complying with UK REACH on your behalf.
Appointing an OR alleviates all your downstream customers (GB importers) from the obligation to register in UK REACH; additionally, by having one registration dossier per substance, the need for multiple submissions to HSE and multiple registration fees is eliminated. Appointing an OR can also help you maintain a degree of influence/control on your UK REACH registered substance and sensitive information such as total tonnage volumes being imported.
EU REACH registrations for legal entities based in GB were transferred across into UK REACH; however, to have your transferred EU REACH registration recognized in UK REACH, the same legal entity had to claim their now U.K.-based registration via a process known has “grandfathering.” The deadline to complete this grandfathering exercise was 30 April 2021. Full registration is needed within two, four or six years of October 27, 2021 depending on the tonnage imported and the hazard profile of the substance.
GB-based importers who previously relied on an EU REACH registration further up the supply chain are now required to register their substance in UK REACH. As GB importers of a previously registered substance, they may benefit from a phased-in registration program that allows import to continue before full registration is needed. To confirm their stays as downstream users, they had to submit a DUIN. The deadline for submitting the DUIN was October 27, 2021. If a downstream user did not submit a DUIN before then, it still may be possible to benefit from the phased-in registration program. Labcorp can support with late DUINs on behalf of the downstream user.
Our dedicated regulatory specialist team can take on all legal responsibilities for your UK REACH registration as a U.K.-based OR. We have proven expertise in supplying OR services under EU REACH and now under UK REACH as well. Our regulatory scientists have vast experience working with the U.K. regulator, HSE. Partner with us and we can manage all the technical, scientific, legal and administrative aspects of the OR role for you. Find out more about our OR services.
We can help with substance group communications and data sharing negotiations so you have access to data to support your registrations. We can negotiate access to data owned by EU REACH data owners and prepare both “lead” registrations and co-member registrations.
To access the substance group and communications surrounding who will be the lead registrant, we can prepare and submit article 26 (duty to inquire) dossiers to HSE for registrants new to the GB market or for downstream users who have successfully submitted a DUIN.
