However politicians play their cards in the weeks ahead, preparations are being made across UK industry and the supporting regulatory sector for the possibility of an abrupt “hard” Brexit departure from the EU. This includes REACH, writes Jon Herbert.
REACH is the European Regulation 1907/2006 covering chemicals and their safe use. At present it applies to all 28 EU Member States, plus Iceland, Liechtenstein and Norway in the European Economic Area (EEA). However, that will change with Brexit.
The REACH Regulation is designed to improve the protection of both human health and the environment through a system of registration, evaluation, authorisation and restriction of chemicals.
Since 31 May 2018, companies producing or importing chemical materials — known generally as substances — falling under the REACH Regulation in volumes of between 1 and 100 tonnes per annum have had to complete the European Chemical Agency’s (ECHA’s) registration process.
However, if there is no orderly EU exit this autumn, the REACH Regulation will be brought into UK law via the European Union (Withdrawal) Act 2018. The regulation and related legislation will then be retained in the UK with changes needed to make it work within a domestic context.
Key principles remain
Leaving the EU and being outside the Single Market will take the UK out of the scope of the ECHA. In this scenario, UK chemical companies wanting to work in the EU will be seen as part of a non-EU country and non-EU manufacturers.
Instead of registration taking place in the UK, this will be replaced by registrations carried out by EU importers, or “only representatives” (ORs) in the EEA. UK-based ORs will no longer be able to make registrations for non-EU manufacturers. This represents an estimated 40% of UK registrations.
The Government says the UK will keep the key principles of the REACH Regulation, including the fundamental concept of “no data, no market”, plus its provision for ORs. For clarity, the amended REACH Regulation is now referred to as the UK REACH Regulation; in parallel the regulatory system it creates is known as UK REACH. The new regulatory framework will allow new chemicals to be registered through a UK digital system similar to the existing EU digital registration system.
In the event of a “no deal”
In the case of a “no-deal” scenario, the UK and the EU regulatory agencies will operate independently from each other. As a result, if companies are supplying, purchasing or importing substances, mixtures or articles between the EU/EEA and the UK, they must ensure that these are registered separately with both the ECHA and the UK Agency (effectively the Health and Safety Executive (HSE)) by a Lead Registrant (LR) in their supply chain to keep or gain access to both markets.
At the same time, the UK will increase its ability to carry out the functions currently performed by ECHA to monitor and evaluate chemicals in the UK to reduce risks to human health and the environment. A parallel aim will be to minimise disruption to the supply of chemicals. Existing standards of protection of human health and the environment will be maintained.
HSE and Defra guidance
As soon as the UK leaves the EU, the HSE will become the UK’s lead regulatory authority. It already plays a key role in the UK’s chemicals regulatory process, working closely with the Department for Environment, Food and Rural Affairs (Defra) and the Environment Agency (EA). As a responsible regulator, the HSE provides support and guidance for all possible Brexit outcomes, including a “no deal”, see www.hse.gov.uk.
Defra has also published guidance updated in 2019 on both UK REACH and UK REACH IT in the case of a “no deal”, although it points out that this is not a definitive statement of the law or its interpretation and could be tested in the courts.
The HSE and EA will have sufficient regulatory and enforcement powers to recommend controls in response to the hazards and risks of substances. Defra and the devolved administrations will have necessary policy powers.
Implications for individual businesses
The role of businesses within REACH may change with Brexit, in some cases significantly. A phased approach for the UK market is designed to minimise disruption and ensure continuity. However, to help individual companies make the transition and take actions needed, the HSE provides detailed information in the following categories.
- UK-based REACH registrant.
- UK-based downstream user or a distributor of an EU REACH registered chemical.
- Existing UK-based importer or distributor of substances sourced from outside the EU/EEA.
- UK-based REACH authorisation holders.
- UK downstream users of a REACH authorisation held by an EU/EEA-based company.
- Exempt for the purposes of product and process-orientated research and development (PPORD).
- Awaiting an ECHA or EU Commission decision for a registration or authorisation application.
In March 2019, the HSE also published a scenario summary table explaining what companies need to do, depending on their objective, and the timeframe allowed.
Reasons for REACH
REACH is a continuously evolving process designed to guarantee a high level of human health and environment protection from possible risks posed by chemicals. It applies to both industrial and domestic substances and promotes non-animal testing methods.
In addition to the free circulation of fully compliant substances in the EU internal market, further goals include a focus on innovation, commercial needs and competitiveness. REACH makes it the responsibility of industries and individuals to assess and manage risks, and provide safety information to all handlers, storers and users. Extra precautionary measures can be taken for highly dangerous substances.
REACH legislation text is organised into 15 titles: the first eight refer to REACH processes; the next seven detail REACH administration elements such as the ECHA’s roles, data confidentiality and enforcement issues. Within each title are chapters with 141 Articles setting out legal obligations. Many amendments have been added to the regulations.
There are also 17 Annexes outlining technical details to the obligations which are updated and adapted as legal positions change and are interpreted, plus new or amended legislation. Legal text is supplemented by guidance documents, factsheets, guides and extensive user manuals; unless an organisation has an in-house expert, specialist advice is strongly recommended.
REACH affects phase-in substances used in quantities of 100 tonnes per annum or more, or those carcinogenic, mutagenic or toxic to reproduction (CMRs) supplied in quantities of 1 tonne per annum or more.
REACH, the European Regulation covering chemicals and their safe use in EU Member States plus European Economic Area (EEA) countries, will change after Brexit. The Government will keep REACH principles post-Brexit. However, in the event of a “no-deal” departure, to continue buying and selling with Europe and the EEC, UK companies must follow new procedures for both EU and UK registration.
The HSE will become the UK’s lead regulatory authority post-Brexit. Working closely with Defra and the Environment Agency, the HSE has made extensive detailed guideline REACH information available for businesses.