UK Reach Regulation for Various Sectors

The legal framework for regulating chemicals in the UK is the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (UK-REACH). The EU-REACH Regulation was brought into UK law under the European Union (Withdrawal) Act 2018 (Brexit) on 1 January 2021. UK-REACH regulates chemicals placed on the market in Great Britain (i.e. England, Scotland, and Wales), as EU-REACH continues to apply in Northern Ireland under the terms of the Northern Ireland Protocol. The key principles of the EU-REACH Regulations were retained in UK-REACH, but some changes were made to make it operable in the UK. UK-REACH provides for comprehensive transitional arrangements to assist the many importers likely to be affected by the repeal of EU-REACH in the United Kingdom.

UK-REACH applies to the majority of chemical substances manufactured or imported into Great Britain in quantities of 1 TPA or more. This can be a substance on its own, a substance in a mixture (for example ink or paint), or a substance that makes up an ‘article’ (for example a car, furniture or clothes). UK-REACH requires manufacturers, importers, or distributors of chemicals to register their substances otherwise they cannot legally be imported, manufactured, or supplied. There are however some substances that are specifically exempted under UK-REACH. These include:

• Radioactive substances

• Substances under customs supervision

• Non-isolated intermediates

• Waste

• Some naturally occurring low-hazard substances

Some substances that are covered by more specific legislation, have tailored provisions under UK‑REACH. These include:

• Human and veterinary medicines

• Food and foodstuff additives

• Plant protection products and biocides

• Isolated intermediates

• Substances used for research and development.

The Great Britain Classification, Labelling and Packaging (GB CLP) Regulation came into effect on 1 January 2021. The GB CLP requires manufacturers, importers, and downstream users of substances and mixtures to classify, label, and package chemicals appropriately before placing them on the GB market. This requirement ensures that information on hazards is passed efficiently along the supply chain. In order to make GB CLP fully operable in Great Britain the EU CLP Regulation has been amended and some requirements have therefore changed. An example of this is the arrangements that make the EU harmonised classifications legally binding within GB as mandatory classifications. This means that Great Britain will be able to make its own decisions on mandatory hazard classification and labelling, including whether or not to align with decisions made in the EU.

The authority that enforces UK-REACH in England, Scotland, and Wales is the Health and Safety Executive (HSE). The HSE is a UK government agency responsible for the regulation and enforcement of workplace health, safety, and welfare. It is a non-departmental public body meaning that the HSE carry out their work largely independently from ministers and answer to the public through Parliament. The HSE is the relevant authority overseeing the classification, labelling, and packaging of substances and mixtures placed on the GB market.

The United Kingdom has not yet implemented their own chemical inventory, instead they still refer to the European Community (EC) Inventory which contains 106,212 unique substances. The EC Inventory is a combination of three EU inventories (European Inventory of Existing Commercial Chemical Substances (EINECS), European List of Notified Chemical Substances (ELINCS), and the No-longer Polymers (NLP) List) and was published in 2008 when the European Chemicals Agency (ECHA) was founded. The chemical substances within the EC inventory are governed by the provisions of the European Union’s REACH regulation (Registration, Evaluation, Authorisation, and restriction of Chemicals).

Companies that manufacture or import 1 TPA or more of any substance must register that substance with the Health and Safety Executive (HSE). Substances in articles will also require registration if these substances are intended to be released during use. An example of such an article is scented children’s toys, where the fragrance substances contained in the toy are released with the intention to make the article more attractive by providing a pleasant smell.

The compliance obligations under UK-REACH depend on the role in the supply chain. Manufacturers that produce or extract a substance either through chemical synthesis, smelting or extraction are required to hold a valid registration for these substances under UK-REACH.

Importers that bring chemical substances into Great Britain from the EU, the EEA, Northern Ireland, or the rest of the world are required to hold registrations for these substances unless their suppliers have appointed and Only Representative (OR) to fulfil the obligations. This also applies to importers who were downstream users under EU-REACH, i.e. GB-companies that imported chemicals from the EU/EEA before the end of the transition period and relied on an EU-REACH registration further up the supply chain. These companies are now importers under UK-REACH and must ensure a valid registration for the substances they import.

Downstream users (DU) are companies or individuals (such as dry cleaners, car washers, and makers of household appliances, toys, and textiles) who directly handle chemical substances (such as paint, adhesives, and cleaning agents) and that are not manufacturers or importers of the substances. Companies who import substances directly from the EU/EEA will find that they are classed as importers under UK-REACH while they were classed as downstream users under EU-REACH. This means that they may have to apply for New Registration of Existing Substances (NRES) or Downstream User Import Notification (DUIN) to continue importing. The role of Only Representatives (ORs) is described in Article 8 of UK-REACH. A non-GB manufacturer who wants to import their substances into Great Britain can appoint an OR to fulfil the obligations under UK-REACH. The OR helps to maintain access to the GB market by reducing the responsibilities for the importers. An Only Representative must be:

• A natural or legal person established in Great Britain.

• Equipped with sufficient background in the practical handling of substances and the information related to them.

• Appointed by a mutual agreement with a manufacturer, formulator, or article producer, established outside Great Britain.

• Responsible for complying with the legal requirements for importers under UK-REACH.

Companies that import or manufacture a substance in Great Britain in quantities of more than 1 Tonnes per Annum (TPA) must comply with UK-REACH requirements for registration. There are no provisions for pre-registration under UK-REACH and pre-registrations previously submitted to ECHA are no longer valid in Great Britain.

Transitional Provisions and Deadlines

UK-REACH contains transitional provisions for importers who were accessing the GB market with an EU-REACH registration prior to 1 January 2021, with the purpose of limiting disruptions for already existing business.

Substances previously registered under EU-REACH

Downstream User Import Notification (DUIN)

Downstream User Import Notification (DUIN) is for non-UK companies who have previously exported the substance to the GB market. EU/EEA based holders of an EU-REACH registration number can submit a Downstream User Import Notification (DUIN) to the HSE. This will allow them to maintain access to the GB while postponing the UK-REACH registration by 2, 4, or 6 years. The registration deadline is dependent on the tonnage and/or hazard profile of the substance (see Table 46). To submit a DUIN, the EU/EEA based companies need to appoint a GB-based Only Representative (OR) or let their GB-based downstream user (i.e. importer), distributor, or formulator submit it. The deadline for submission of DUINs was 27 October 2021 however the deadline has been extended for an undisclosed period of time. If a notification is not submitted to the HSE import above 1 TPA of the substance must cease or full registration must be submitted for the substance.

New registration of an Existing Substance (NRES)

Non-GB based manufacturers and GB-based importers that are seeking to place an EU-REACH-registered substance on the GB market for the first time can submit a New Registration of an Existing Substance (NRES). This only applies to substances that were registered with EU-REACH before 31 December 2020. NRES requires the submission of an Article 26 inquiry, submission of a simplified registration dossier, and payment of the HSE authority fee. When these steps are completed, the company can start placing the substances on the GB-market. However, a full registration must be completed before the 2-, 4-, 6-year deadline.

Deadlines for Registration after DUIN and NRES

The deadline for Full Registration after submission of DUIN or NRES depends on the tonnage and/or the hazard profile of the substance. On 20 April 2023, the UK Department for Environment, Food and Rural Affairs (DEFRA) laid a draft Statutory Instrument (SI), REACH (Amendment) Regulations 2023, before Parliament. The SI will formally extend the submission deadlines under UK-REACH by 3 years. The changes will come into force after approval by each of the Houses of Parliament. This SI is expected to be enacted and in force by the third quarter of 2023. The original deadlines as well as the new extended deadlines can be found in the table below.

Substances not Registered under EU-REACH

Companies who wish to access the GB-market with a substance that was not registered under EU-REACH before 1 January 2021 must submit a complete registration before the manufacture or import into GB reaches 1 TPA. In such circumstances, no transitional provisions apply.

Registration

The registration process consists of an Article 26 Inquiry and the registration. The Inquiry Dossier must contain information about the company and the specific substance that is intended to be manufactured or imported into GB. The requirements for compiling the Inquiry Dossier are the same as under EU-REACH. Under UK-REACH registrations must be submitted jointly as the concept of ‘one substance, one registration’ has been retained from EU-REACH. However, each legal entity must still submit their own registration dossier and pay the registration fee. If there is more than one registrant for a substance, the co-registrants will have to choose a Lead Registrant. The Lead Registrant is responsible for submitting a lead join registration dossier and for approving members into the joint registration group.

Fees under UK-REACH apply to the same processes as fees under EU-REACH. Fees for full registration are given below both for individual and joint submission. For Micro, Small and Medium Enterprises (MSMEs) reduced fees apply. The categorisation of MSMEs is the same under UK-REACH as under EU-REACH. The categories are defined by the company’s turnover and the number of employees and can be found in the table below.

Criteria for MSMEs under UK-REACH (NOTE: Exchange rates as of March 2023)

Fees for individual submission (NOTE: Exchange rates as of March 2023)

Fees for joint submission (NOTE: Exchange rates as of March 2023)

It is an offence to not comply with or cause others to not comply with their duties under UK-REACH. Other offences include obstructing an inspector, providing a false statement, and failing to comply with a notice served by an inspector. Compliance with UK-REACH does not excuse a failure to comply with another law (or vice versa) such as other general chemical laws such as the CB CLP or the General Product Safety (GPS) Regulations. Non-compliance with UK-REACH can lead to a fine or up to 2 years of prison. The HSE does not specify the size of the fine but states that there is ‘no limit on the amount’.