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How to complete a UK REACH Registration as a New Registrant of an Existing Substance when there is currently no UK Lead Registrant.

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How to complete a UK REACH Registration as a New Registrant of an Existing Substance when there is currently no UK Lead Registrant.

With the introduction of UK REACH the following situations can occur:

  1. The EU REACH Lead Registrant has decided not to register under UK REACH.

  2. No company has taken on the role of LR under UK REACH.

  3. A company has only now started to supply a substance and needs to comply with UK REACH. This can either be from a new UK manufacturing plant or a new import into the UK, so a Downstream User notification does not apply.

Where a company has just started to supply a substance under UK REACH and it is likely to exceed 1 tonne per annum within 6 months, then the following process needs to be completed:

  1. Submission of an inquiry dossier under Article 26 of UK REACH. This process is the same as under EU REACH and needs to include a full set of chemical analysis so the substance can be correctly identified.

  1. Once the Article 26 Inquiry has been accepted, the registration dossier, including all the required information has to be submitted to UK HSE and the registration fee paid.

However, if the substance was previously registered under EU REACH prior to 1st January 2021, then the registrant will be considered a new registrant of an existing substance (NRES). 

For a NRES, the registration process is slightly different. Although the registrant should submit a registration dossier, to provide parity with grandfathered registrants and former GB-based downstream users, the submission of the full information requirements for registration can be deferred.

The deadline for this information will depend on the tonnage band and/or hazard profile of the substance.

It is understood that registrants may not be in a position to include all test summaries in their registration dossiers as there are currently no lead registrants. Therefore, the dossier submitted for registration should include a waiver statement explaining why the registrant is not currently able to obtain the information.

The waiver should also state that the registrant will make every effort to negotiate with other members of the Substance Group and that they will either provide the data themselves as lead registrant or will become a member of the joint registration.

This waiver statement should be included in Section 13.2 of the IUCLID registration dossier.

Once the dossier containing the waiver statement has been submitted, passed the relevant checks and the relevant registration fee has been paid, a registrant will be issued with their UK REACH registration number.

Consequently, manufacture in UK or import of the substance into UK in quantities equal to or greater than 1 tonne a year is permitted. The full information requirements will then not be required until the relevant registration deadline.

Confirmation of meeting the definition of a NRES will be received after the successful submission of the Article 26 Inquiry.

However, if this substance was not registered under EU REACH before 1 January 2021 (i.e., is a novel substance) then the registrant will not be classed as a NRES and the process detailed above will not apply.

For novel substances, an Article 26 Inquiry will need to be submitted followed by a full registration dossier containing all the information required for the tonnage band (just as under EU REACH). This will need to be submitted before import into GB at or above 1 tonne per year can commence. 

This article was published by REACHReady in their Review Issue 53 - February 2022.

For any issues concerning UK REACH compliance, contact the regulator: UK REACH helpdesk via ukreach.clp@hse.gov.uk

Peter Godfrey

Chemical Regulatory Affairs-REACH Business Manager

Cambridge Environmental Assessments

RSK ADAS Ltd (Boxworth)

Email: Peter.Godfrey@cea-res.co.uk

Office direct line: +44(0) 1263 834806

Mobile: +44 (0) 7791 101246

Peter provides advice and guidance to companies on all aspects of Chemical Regulatory Compliance. He has been involved with the REACH legislation since 2002.

 

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