REACH Regulations – Your Guide to Chemical Registration, Evaluation, Authorisation, and Restriction

EU REACH and UK REACH provide frameworks for the registration, evaluation, authorisation and restriction of chemicals. EU REACH applies in the EU and EEA, and continues to apply in Northern Ireland, while UK REACH applies in Great Britain.

The two regimes place responsibilities on businesses that manufacture, import, supply or use chemical substances. Companies need to understand their role and obligations, manage the risks associated with substances, maintain appropriate information and communicate relevant risk management measures through the supply chain.

REACH places significant responsibility on industry to understand and manage chemical risks. Depending on their role and the substances involved, organisations may need to generate or obtain data, register substances, assess and manage risks, communicate safe use information, or respond to authorisation and restriction processes.

Following the UK’s withdrawal from the EU, separate EU REACH and UK REACH frameworks now operate. Businesses active across both markets may therefore have obligations under both regimes.

Overview of REACH

Before REACH, European chemicals legislation was fragmented, and many substances that had been on the market for many years had not been subject to systematic assessment.

EU REACH entered into force in 2007, introducing a more comprehensive framework for the management of chemicals. It established the principle of “no data, no market” and placed greater responsibility on industry to understand and manage the risks associated with the substances it manufactures, imports and uses.

REACH covers substances on their own, in mixtures and, in certain circumstances, substances in articles. It requires companies to understand their position in the supply chain and the obligations that apply to their activities.

The framework is built around four main regulatory processes:

• Registration
• Evaluation
• Authorisation
• Restriction

Together, these processes are intended to improve the protection of human health and the environment, improve information on chemicals and their uses, support communication through supply chains and encourage the substitution of substances of concern where appropriate.

Objectives and Rationale

REACH was introduced to address gaps in the information available on chemicals and strengthen the management of risks throughout their life cycle.

Its objectives include:

• safeguarding human health and the environment
• improving information on substances and their uses
• strengthening communication through supply chains
• supporting the identification and management of chemical risks
• encouraging the development and use of safer alternatives
• supporting innovation and the competitiveness of industry

The practical implications of REACH vary considerably between businesses. Obligations depend on factors including the substance, annual tonnage, company role, uses, supply chain and the regulatory status of the substance.

REACH Registration

Registration

Registration is a core element of both EU REACH and UK REACH.

In general, manufacturers and importers of substances at or above one tonne per year must consider whether they have registration obligations in the relevant jurisdiction. The precise requirements depend on factors including the substance, tonnage, company role and supply chain.

A registration process may involve:

• confirming substance identity
• determining the relevant tonnage band
• gathering information on substance properties and hazards
• understanding uses and exposure
• identifying appropriate risk management measures
• preparing and maintaining the required registration information
• communicating and working with other registrants where required

Registration obligations can be particularly important for companies importing substances or mixtures, where it is necessary to understand the identity and tonnage of the individual substances being imported.

Businesses should also consider whether an Only Representative arrangement applies or may provide an appropriate route for managing registration obligations within the supply chain.

Failure to meet applicable registration requirements can affect the ability to manufacture, import or place substances on the relevant market.

RPA supports businesses with EU and UK REACH registration strategy and delivery, including substance and tonnage assessment, registration planning, regulatory submissions and UK REACH Only Representative services.

Evaluation

Evaluation allows registration information and substances of potential concern to be examined in greater detail.

Under EU REACH, evaluation activities include dossier evaluation and substance evaluation. These processes can lead to requests for additional information where existing data are considered insufficient to assess compliance or address potential concerns.

Evaluation can include:

• examination of registration information
• assessment of testing proposals
• compliance checks
• investigation of concerns relating to a substance
• requests for additional information

For businesses, evaluation can create additional technical, regulatory and strategic requirements. Organisations may need to understand the evidence base, respond to requests for information and consider the wider implications for substances, uses and supply chains.

REACH authorisation

The authorisation process applies to substances of very high concern that have been included in the relevant authorisation list.

Substances of very high concern may include substances with properties such as carcinogenicity, mutagenicity, reproductive toxicity, persistence, bioaccumulation or other properties giving rise to an equivalent level of concern.

Where an authorisation requirement applies, companies wishing to continue particular uses after the relevant deadline may need to apply for authorisation.

An application can require detailed technical, economic and strategic evidence, potentially including:

• analysis of alternatives
• assessment of technical and economic feasibility
• socio economic analysis
• assessment of risks and benefits
• substitution planning
• supply chain engagement and evidence gathering

RPA has extensive experience supporting businesses and industry groups with analysis of alternatives, socio economic analysis and the development of applications for regulatory decision making.

REACH restrictions

Restrictions can limit or prohibit the manufacture, placing on the market or use of substances where an unacceptable risk to human health or the environment has been identified.

A restriction can apply to a substance on its own, in a mixture or in an article, depending on the scope of the specific proposal and resulting legal requirements.

Restriction processes can have significant implications for manufacturers, users and wider supply chains. Businesses may need to understand:

• whether their substances and uses are within scope
• how proposed conditions could affect existing operations
• the availability and feasibility of alternatives
• the costs and wider impacts of substitution
• the time required to qualify and adopt alternatives
• the evidence needed to engage effectively with consultations and regulatory processes

Early assessment can help organisations understand potential impacts, identify evidence gaps and decide whether and when engagement with a regulatory process is appropriate.

Current and developing REACH regulatory developments

REACH is not a static framework. Regulatory priorities, substance evaluations, authorisation requirements and restriction proposals continue to develop, creating new requirements and strategic questions for businesses.

Examples of substances and substance groups currently subject to significant regulatory attention include PFAS, chromium(VI) substances, certain solvents and bisphenols. The nature and stage of regulatory activity varies, but businesses may need to consider potential impacts on substances, uses, products and supply chains.

Understanding developments early can help organisations assess whether they may be affected, identify evidence gaps, consider the availability and feasibility of alternatives, and decide whether engagement with regulatory processes is appropriate.

PFAS

Per and polyfluoroalkyl substances, commonly known as PFAS, are the subject of significant regulatory attention because of concerns including their persistence in the environment and the potential risks associated with some substances within this broad group.

The proposed universal PFAS restriction under EU REACH has potentially wide implications across numerous sectors and supply chains. For affected businesses, important questions can include whether particular substances and uses are within scope, whether alternatives are technically and economically feasible, the time required for substitution and the potential consequences of restrictions for products and supply chains.

The breadth and complexity of PFAS use means that businesses may need to consider more than direct chemical substitution. Assessment can require understanding functions, applications, performance requirements, supply chains, alternatives, adoption barriers and wider economic impacts.

Chromium(VI) substances

Chromium(VI) substances have been subject to extensive regulatory attention under REACH, including authorisation and restriction activity.

Chromates continue to present complex questions for sectors and supply chains where they perform important technical functions. Regulatory assessment can require detailed consideration of available alternatives, technical performance, qualification and approval requirements, research and development activity, customer requirements, supply chain dependencies and the time needed to achieve substitution.

For affected organisations, engagement with regulatory developments may require a combination of technical evidence, analysis of alternatives, market and supply chain evidence and socio economic analysis.

Other substances and regulatory priorities

Regulatory developments also affect many other substances and substance groups. These include solvents such as n hexane, bisphenols including BPAF, and other substances being considered through evaluation, risk management, authorisation or restriction processes.

The implications differ significantly between substances and sectors. In some cases, the immediate priority is understanding whether a business is within scope. In others, organisations may need to assess alternatives, engage customers and suppliers, develop socio economic evidence or contribute information to a consultation.

RPA supports businesses and industry groups in understanding regulatory developments, assessing potential impacts and developing evidence to inform regulatory processes and business decisions.

REACH Compliance for Businesses

REACH has implications throughout the chemicals supply chain. A company’s obligations depend on its role, the substances involved and the activities it undertakes.

Key roles can include:

Manufacturers, which may have registration and information requirements for substances they manufacture.

Importers, which need to understand the regulatory status of substances brought into the relevant market and whether registration or other obligations apply.

Downstream users, which need to understand the conditions applying to their uses and follow relevant risk management and communication requirements.

Only Representatives, which may be appointed by eligible non domestic manufacturers or formulators to take on specified registration obligations for substances supplied into the relevant market.

Effective REACH compliance can require:

• accurate substance and supply chain information
• clear understanding of company roles and responsibilities
• appropriate registration and regulatory records
• monitoring of tonnages and uses
• communication between suppliers, importers, customers and downstream users
• monitoring of regulatory developments
• assessment of emerging risks and potential business impacts

REACH compliance should therefore be viewed as an ongoing process rather than a one off registration activity

Managing REACH Requirements

A structured approach can help businesses manage both current obligations and emerging regulatory developments.

Important activities can include:

• reviewing substance portfolios and supply chains
• confirming registration and compliance positions
• maintaining accurate and current regulatory documentation
• monitoring changes to substance status and regulatory requirements
• assessing the potential impact of proposed restrictions or other regulatory measures
• engaging suppliers, customers and industry groups where evidence is needed
• planning early for potential substitution, authorisation or restriction requirements
• maintaining clear internal responsibilities for chemicals regulatory compliance

The appropriate approach will depend on the business, substances and markets involved. For some organisations, the priority may be establishing a registration route. For others, it may be responding to an emerging restriction, assessing alternatives or understanding the potential commercial impact of regulatory change.

How RPA can help

RPA supports businesses, trade associations and public sector organisations across EU and UK chemicals regulation.

Our work includes:

• EU and UK REACH registration support
• UK REACH Only Representative services
• regulatory strategy and compliance support
• analysis of alternatives
• socio economic analysis
• supply chain and stakeholder engagement
• impact assessment and policy evaluation
• evidence development for consultations and regulatory processes
• assessment of emerging regulatory developments

Our chemicals regulatory expertise is supported by RPA’s wider experience in economics, policy analysis, stakeholder engagement and the assessment of business and supply chain impacts.

This combination allows us to support clients not only in understanding regulatory requirements, but also in developing the technical, economic and supply chain evidence needed to make informed decisions and engage effectively with regulatory processes.

Contact RPA to discuss EU REACH, UK REACH, registration, Only Representative services, authorisation, restriction or wider chemicals regulatory support.

Assistance, Resources & Further Information

• European Commission – REACH legislation overview and policy guidance
• European Chemicals Agency – Official REACH guidance, registration processes, and regulatory updates
• Source Intelligence – Industry insights and tools for chemical regulatory compliance

RPA Services

If you need support navigating REACH regulations, our experienced REACH compliance consultants are here to help. Get in touch to discuss your requirements and receive tailored advice on achieving and maintaining full compliance across EU and UK markets.