UK REACH

UK Regulations post-Brexit

Although there is reasonable alignment between the EU and GB (and indeed, Turkey) with regard to most chemical related Regulations, some GB-specific differences are emerging. 

And of course there is confusion over Northern Ireland – there is further consultation happening and for now they are effectively in the EU and GB systems.

Remember, GB is ‘mainland’ England, Scotland and Wales with Northern Ireland joining them as the United Kingdom (UK).  The Isle of Man is not part of this process.

GB REACH

Some of the differences are due to the UK having to ‘catch up’ with the EU in terms of REACH Registrations and how to deal with Grandfathering and how to reduce disruption for business during transition, but some more fundamental differences are likely in time.

The UK legal framework is driven by the Department for Environment, Food and Rural Affairs (DEFRA) and managed by the Health and Safety Executive (HSE) and with the Environment Agency (England and Wales), Scottish Environmental Protection Agency (SEPA) and local Trading Standards also involved.

The policing and enforcement framework has not really chanced post-Brexit.

The main points to consider are:

  • The UK have retained the REACH Regulations with the key differences only with regard to terminology and details of appeals etc. This is published as UK Statutory Instruments.
  • Therefore, there is continuity in terms of REACH implications, including requirements for Registration and SDS and in terms of controlling Substances of Very High Concern (SVHC)
  • The UK Government is determined to minimise expense for industry (and itself).
  • The UK has its own ‘REACH-IT’ portal for submissions (‘Comply with REACH’)
  • A period of time for those importing from the EU or reliant on EU REACH Registrations has been granted for those needed to make GB Registrations; this is a Downstream Import Notification (DUIN)
  • For Registration of substances already covered by equivalent tonnages in EU REACH, a reduced NRES dossier is possible.
  • Some differences are emerging between EU and GB REACH.  More will no doubt follow.
  • UK REACH is still in transition and ‘consultation’ with a new REACH model in preparation.  Part of this is likely to include a simplified fees system.
  •  GB REACH Legal text and guidance

The main UK guidance from the HSE is found on this link

https://www.hse.gov.uk/reach/index.htm

At the time of writing, a number of amendments to the GB REACH legal text are being pushed through as clarification and legal-wording is amended. In time, we can expect a ‘finalised’ consolidated version and perhaps an easier to remember title than ‘ The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020’

Links to the legal texts can be found here

https://www.hse.gov.uk/reach/enforcement-law.htm

Other than trying to work out the legal position of a DUIN or Grandfathering arrangements (and good luck with that), it is still easier to refer to the EU REACH Regulation and ECHA guidance to get answers on most points.

Variations in use of IUCLID for UK / EU

The HSE will still reference EU guidance when helping explain necessary action to UK industry, but slowly, we are seeing some specific GB REACH differences when making submissions in IUCLID

  • There is no ‘official’ legal entity requirement for GB REACH.  In IUCLID Section 1.1, you can create new Legal Entity and add the necessary contact details.  These should of course match the details in ‘Comply with REACH’ portal for submission, but unlike having to import LEOX files from EU REACH IT into IUCLID for EU Registrations, there is no electronic link between IUCLID and the submission portal.
  • The UK is not issuing ‘Index numbers’ for substances.  There is no legal obligation for EC or CAS numbers for GB REACH and no GB Number exists.  At one level, having a third set of numbers is not sensible, but in view of the complexity and variation in naming substances, mistakes will happen without a definitive identity number.  If an EC number is granted for a novel substance for an EU Inquiry, then it is recommended to use this in the GB Inquiry.
  • Contact details are expected in Section1.1 of IUCLID.  This was not needed for EU REACH as the contact details of the key responsible people / departments are in EU REACH IT
  • For PPORDs, names and contact details of the recipients in the UK are expected.  ECHA never demanded this, even though the HSE point out it is in the EU legal text. If exporting to the EU, it is accepted that identifying the EU REACH PPORD holder is sufficient in terms of  ‘recipient’ and this is also recommend if exporting to other regions, such as US, Switzerland etc.
  • For strictly controlled intermediates, details of recipients are also needed.
  • When converting the IUCLID ‘data’ life to ‘dossier’ for UK submission, it is necessary to use the ‘advanced options’ in the dossier creation step and select the tick-box ‘include legal entity’.

Most of GB REACH mirrors EU REACH in terms of Inquiries, PPORDS, Intermediate Registrations etc, but two major (transitory) GB REACH processes need to be considered:

Making UK NRES Registration

If needing to make a UK REACH Registration of a substance already Registered in the EU at an equivalent tonnage, then a ‘New Registration of an Existing Substance’ (NRES) is possible. The HSE will advise on this when accepting the Article 26 Inquiry, a but a check on the ECHA web-site for EU Registrations is a good starting point.

The IUCLID template to use for NRES is the ‘EU REACH Joint Submission General Case’ and means you need to complete the personal information non Sections 1 and 3, make a PBT/vPvB declaration in Section 2, give advice on safe use (Section 11) and provide a ‘waiver statement’ in Section 13 under ‘other reports’.

The waiver statement is important as it is a declaration that you are aware that the NRES is a transitional arrangement and that in due course, it may need updating.  A typical short statement could be:

‘The Registrant will work with other UK Registration holders to provide any required joint data-set supporting the future Registration of the substance.’

It is worth noting that have spent 3 – 4 hours at most working on an Inquiry, upgrading to an NRES will not take much more time.  It is easy and Denehurst can provide advice and training if needed.

If over 10 t, a CSR is needed and this will of course need more time.  See further help on this. [link].