I. Introduction of UK REACH

Under the European Union (Withdrawal) Act 2018, the EU REACH Regulation was brought into UK law on 1 January 2021 and is known as UK REACH. The key principles of the EU REACH were retained in UK REACH.

UK REACH is a regulation that applies to the majority of chemical substances that are manufactured in or imported into Great Britain (GB) (England, Scotland, Wales). This can be:

• A substance on its own
• A substance in a mixture, for example ink or paint
• A substance that makes up an "article"--an object that is produced with a special shape, surface or design, for example, car, furniture or clothes.

Note: EU REACH continues to apply in Northern Ireland.

II. Who Must Complete UK REACH?

• GB-based manufacturers and importers;
• Enterprises based outside of GB should designate a GB-based Only Representative (OR) to complete UK REACH registration.

III. Scope of Exemption

Some substances are specifically excluded:

• Radioactive substances
• Substances under customs supervision
• The transport of substances
• Non-isolated intermediates
• Waste
• Some naturally occurring low-hazard substances

Some substances, covered by more specific legislation, have tailored provisions under UK REACH, including:

• Human and veterinary medicines
• Food and foodstuff additives
• Plant protection products and biocides
• Isolated intermediates
• Substances used for research and development

IV.UK REACH Registration

4.1 Grandfather clause (GB-based enterprises that have registered under EU REACH)

4.1.1 Who is applicable to the grandfather clause? 

The provision of ‘Grandfathering’ is extended to entities holding EU REACH registrations within the UK from 29 March 2017 to 31 December 2020, encompassing those registrations that were either transferred to or from the UK during the specified timeframe.

Note: The Grandfather clause is not applicable to EU legal entities, unless the above situations.

4.1.2 How to complete registration? 

• Open an account on the Comply with UK REACH service;
• You will receive initial information on existing registrations and be issued with a UK REACH registration number by 30 April 2021, the end of the transitional period;  
• Registration must be completed within five, seven or nine years from 28 October 2021, depending on the hazard profile and tonnage band of the substance.

Note: No registration fee will be levied by HSE for grandfathering your registration.

4.2 Submit Downstream User Import Notification (DUIN)

4.2.1 Who are required to submit DUIN?

• GB-based enterprises importing substances or mixtures from EU and want to import those substances or mixtures into Great Britain after the transition period;
• GB-based enterprises importing substances and mixtures into Great Britain from outside of the EU, under an OR agreement held by an EU-based entity and have continued to import after the transition period;
• Non-GB manufacturers, formulators, and article producers who wish to delegate the notification obligation to the OR in GB on behalf of the importer.

4.2.2 How to submit DUIN? 

• Open an account on the Comply with UK REACH service;
• Notify HSE;
• Registration must be completed within five, seven or nine years from 28 October 2021, depending on the hazard profile and tonnage band of the substance.

Note: DUIN submission does not automatically grant membership to the Substance Group.

4.2.3  Information required for DUIN

4.3 Official Registration

• GB-based enterprises manufacturing or importing substances in quantities of 1 tonne or more per year;
• GB-based enterprises that had submitted a registration dossier to ECHA via REACH-IT but did not receive a registration number prior to the date of Exit;
• Manufacturers, formulators or article producers outside the GB can delegate their registration obligations to GB OR instead of importers; and 
• Enterprises that do not meet the conditions for the grandfather clause and DUIN.

4.3.1 Inquiry

The initial step for any new registration entails the submission of an Article 26 Inquiry. The prerequisites for this inquiry are congruent with those stipulated by the EU REACH regulations. Upon the successful submission of your inquiry dossiers, you will be automatically incorporated into the Substance Group. Within this group, members will exchange their contact information, which was furnished at the time of account creation, via the ‘Comply with UK REACH’ service, thereby facilitating their involvement in the data sharing process.

Note: Pre-registration is not required for UK REACH. Any pre-registration submitted to ECHA will not be applicable to UK REACH.  

4.3.2 New Registration of an Existing Substance, NRES

New registrants of existing substances may submit a registration dossier accompanied by a declaration of data exemption, remit the requisite administrative fee, and be assigned a registration number, provided they have fulfilled the EU REACH registration obligations prior to the 31st of December, 2020. It is imperative for NRES registrants to ensure the fulfillment of all data requisites by the stipulated deadline. 

4.3.3 Submit a complete registration dossier

For substances yet to be registered by ECHA, the dossier must be in strict adherence to the data prerequisites corresponding to the current tonnage.

• EU REACH Lead Registrant has data advantage
• Purchase of full data from EU REACH Lead Registrants
• New Substance Registrant

4.3.4 Fees and charges

UK REACH will apply fees to the same processes that were charged under EU REACH. The starting point for the UK REACH fees are the UE REACH fees and these have been converted from Euro to GBP, based on the average conversion rate for 2017. 

e.g. The following are administration fees for large enterprises:

V. Transitional Period

Substances that are eligible for grandfathering, subject to DUIN, or under NRES, contingent upon their tonnage and hazard classification, must provide comprehensive data by the specified deadline for information submission.

VI. Joint Registration

UK REACH retains the 'one substance, one registration' principle. If there is more than one registrant for a substance, co-registrants should agree between themselves who the 'lead registrant' will be.

Responsibilities of LR:

• The lead registrant (LR) is the lead contact for substance registration with HSE.
• LR is responsible for approving members into the joint registration group.
• On request, and where sharing of cost for data has been agreed in a fair, transparent and non-discriminatory way, the lead registrant should also share the data from the joint dossier with potential new registrants.
• Co-registrants can request that LR submits guidance on safe use, CSRs, and other relevant topics on their behalf.
• If co-registrants ask for jointly submitted data to be treated as confidential, LR is required to maintain confidentiality.

Note: UK REACH only accepts joint submissions for registration data to the HSE, rather than individual submissions.

VII. Data Requirement

Data requirement under UK REACH are similar to the requirements under EU REACH. However, the Department for Environment, Food and Rural Affairs (DEFRA) and HSE are delving into the Alternative Model for Transitional Registration (ATRm) to reduce costs and to safeguard human health and the environment. UK HSE does not require to have copies of registration data under EU REACH. DEFRA is proposed to discuss all details of data requirements in the early 2024.

VIII. Product and Process Orientated Research and Development (PPORD)

Where 1 tonne or more per year of a substance is to be used for Product and Process Orientated Research and Development (PPORD), the manufacturer or importer can apply for a 5-year exemption from the obligation to register.

In the PPORD notification, companies should include:

• information on the substance identity,
• its classification,
• information related to the PPORD programme, and
• the quantity of the substance expected to be manufactured or imported during the period of exemption.

How to submit the PPORD notification?

• Open an account on the new UK REACH IT system "Comply with UK REACH” ;
• Prepare and submit PPORD dossiers;
• Pay the registration fee;
• Get a PPORD number;
• Unless informed otherwise by the Agency, the applicant should wait two weeks before manufacturing or importing the substance at 1 tonne or more.

IX. Substance Evaluation

Substance evaluation aims to clarify the potential risk of the manufacture or use of a substance/substance group to human health or the environment. Risk-based criteria (introduction of substance risk, potential exposure, and supply quantity) are used to prioritize substance evaluation, with those selected included in the rolling action plan (RAP). All registrations involving the same substance or group of substances will be assessed during the risk evaluation. Other relevant sources of information will also be considered. Specific hazards or uses are not evaluated. The initial reason for RAP inclusion does not limit the scope of evaluation. 

The evaluation will determine if a conclusion can be drawn from the available data. If not, HSE will require the registrant to provide additional information, which may increase fees or charges.

If the evaluation concludes that there are risks requiring control, additional measures may be introduced. These can include:

• risk management measures under UK REACH, including a restriction or SVHC identification;
• action such as mandatory classification and labelling under GB CLP;

Regulatory Management Options Analysis (RMOAs) will be used to determine the appropriate course of action in GB where necessary.

X. Authorisation

The UK implementation of REACH retains the authorisation provisions in full. GB-based businesses must comply with the authorisation aspects of UK REACH to continue to use substances on the UK REACH Authorisation List (Annex XIV).

If an authorisation application had been submitted by the user or their supplier whilst the UK was a member of the EU, the one of the transitional measures may apply (https://www.hse.gov.uk/reach/authorisation.htm.)

If an application is being submitted for a use that was not previously covered by an existing application, or the user was not an existing downstream user (a user before the end of the transition period) of a non-GB held authorisation then the full authorisation process must be followed.

XI. List of Substances of Very High Concern (SVHCs)

SVHCs are substances that have hazards with serious consequences. In accordance with Article 57 of UK REACH, substances with the following properties may be identified as SVHCs:

• Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the GB CLP regulation;
• Substances which are persistent, bio-accumulative, and toxic (PBT) in accordance with the criteria in Annex 13 of UK REACH;
• Substances which are very persistent and very bio-accumulative (vPvB) in accordance with the criteria in Annex 13 of UK REACH;
• Substances giving rise to an equivalent level of concern to substances meeting the above criteria. Such substances may have endocrine disrupting properties or have properties, that although not meeting the criteria for being a CMR, PBT or vPvB, there is scientific evidence of probable serious effects to human health or the environment. Such substances will be identified on a case-by-case basis.

Substances meeting these criteria may be added to one or both of these lists:

• the UK REACH Candidate List
• the UK REACH Authorisation List (Annex 14).

The Candidate List is a list of substances of very high concern (SVHCs) that may be prioritized for inclusion on the Authorisation List (Annex 14) of UK REACH.

When UK REACH came into force, all substances on the EU REACH Candidate List were carried over onto the UK REACH Candidate List.

Inclusion of a substance on the UK REACH Candidate List brings the following obligations for suppliers of the substance:

• Duty to notify information on substances in articles;
• Notification of substances in articles (submit SVHC notification);
• Duty to notify information on substances in mixtures;
• Duty to notify information on substances (provide SDS to downstream users); and
• Authorisation.

XII. Restriction

The list of restrictions is available here: Restrictions - HSE.

Like EU REACH, substances in the list of restrictions under UK REACH will be banned, limited or set conditions on the manufacture, placing on the market or use.