Background of EU REACH

The European Union’s REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) entered into force on 1 June 2007. It aims to improve the protection of human health and the environment from the risks posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce animal testing.

In principle, REACH applies to chemical substances used not only in industrial processes but also in everyday products, such as cleaning products and paints, as well as in articles such as clothes, furniture and electrical appliances. The Regulation therefore affects a wide range of companies across the EU.

REACH places the burden of proof on companies. To comply with the Regulation, companies must identify and manage the risks linked to the substances they manufacture and place on the EU market. They must demonstrate to the European Chemicals Agency (ECHA) how their substances can be used safely and communicate appropriate risk management measures to their users.

Where risks cannot be adequately controlled, authorities may restrict the manufacture, placing on the market or use of substances. REACH also aims to progressively substitute the most hazardous substances with suitable alternative substances or technologies where these are economically and technically viable.

Authority

The European Chemicals Agency (ECHA) is an agency of the European Union that manages the technical and administrative aspects of the implementation of REACH. It contributes to a well-functioning internal market and supports innovation and competitiveness in the European chemicals industry.

ECHA develops independent scientific and technical opinions and takes regulatory decisions within its mandate. The Agency plays an important role in protecting human health and the environment from the risks posed by chemicals. Together with the EU Member States and the European Commission, ECHA works to promote the safe use of chemicals by improving, disseminating and assessing information on chemicals and proposing risk management measures where needed. The Agency also contributes to sustainability and the circular economy.

How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register the substances they manufacture or import in quantities of one tonne or more per year by submitting a registration dossier to ECHA.  Registrants of the same substance are required to submit information on the substance jointly to ECHA, following the ‘one substance, one registration’ principle.

The registration dossiers are evaluated by ECHA to verify compliance with the REACH requirements. EU Member States evaluate selected substances to clarify concerns regarding human health or the environment. ECHA's scientific committees and Member State authorities assess whether the risks associated with substances can be adequately controlled.

Where risks need to be addressed, authorities may impose restrictions on the manufacture, placing on the market or use of substances. Certain substances of very high concern (SVHCs) may also be included in the Authorisation List, meaning they cannot be used or placed on the market for a use after a specified date unless an authorisation is granted or an exemption applies.

Who Must Register?

Manufacturers and Importers: REACH registration obligations generally apply to EU manufacturers and importers of substances on their own or in mixtures in quantities of 1 tonne or more per year. Registration may also be required for substances in articles where the substance is present in quantities totalling more than one tonne per producer or importer per year and is intended to be released under normal or reasonably foreseeable conditions of use. Downstream users and distributors do not generally have registration obligations.

Only Representative: A manufacturer, formulator or article producer established outside the EU may appoint an Only Representative (OR) established in the EU to fulfil the registration obligations of importers under REACH.  In this case, the EU importers covered by the OR are regarded as downstream users and do not need to register the imports covered by the OR. More information on the role and responsibilities of an OR is provided in the Only Representative section below.

Third-Party Representative: Manufacturers, importers and, where relevant, downstream users may appoint a third-party representative to represent them in discussions with other manufacturers, importers or downstream users. The company remains fully responsible for complying with its obligations under REACH, but its identity will normally not be disclosed by ECHA to the other participants.

Roles and Responsibilities of an Only Representative

Under Article 8 of REACH, an Only Representative (OR) assumes the obligations of importers for the substances covered by the appointment. The OR is responsible for fulfilling the applicable REACH requirements, including:

• Maintain up-to-date information on the substances and quantities covered by the OR appointment and the relevant registration information submitted to ECHA through REACH-IT.
• Communicate with the EU importers covered by the OR appointment and with ECHA or national enforcement authorities, as required.
• Represent the non-EU company in communications with ECHA and co-registrants, including data-sharing and joint-submission activities.
• Fulfil applicable supply-chain communication obligations, including those relating to Safety Data Sheets (SDSs), where relevant.
• Maintain up-to-date information on the EU importers covered and the quantities imported by each importer, retain the required information for at least 10 years and make it available to enforcement authorities upon request.

Exemptions under EU REACH 

REACH provides a number of exemptions from its requirements. Certain substances and activities are fully or partially exempt from REACH, including:

• Radioactive substances
• Substances under customs supervision
• Substances used in the interest of defence and covered by national exemptions
• Waste
• Non-isolated intermediates
• The transport of dangerous substances and mixtures

REACH also provides a number of exemptions specifically from the registration requirements. These include:

• Substances included in Annex IV of the REACH Regulation: Annex IV lists a number of substances for which sufficient information is available to consider them as causing minimum risk to human health and the environment. These substances are typically of natural origin and include, for example, water and nitrogen.
• Substances covered by Annex V of the REACH Regulation: Annex V covers categories of substances for which registration is considered inappropriate or unnecessary, such as certain substances occurring in nature that are not chemically modified, by-products, hydrates, compost and biogas.  The exemption applies where the conditions specified for the relevant category in Annex V are met.
• Polymers are exempt from registration. However, the monomer substances and other substances used to manufacture the polymer may need to be registered under REACH.
• Recovered substances may be exempt from registration if the same substance has already been registered under REACH and the recovery operator has access to the required information on the registered substance.
• Re-imported substances may be exempt from registration where the substance has already been registered under REACH and the conditions for the exemption are met.
• Substances manufactured or imported for product and process orientated research and development (PPORD) may qualify for a time-limited exemption from registration, subject to notification to ECHA and certain conditions.

REACH Registration Process

REACH registration is based on the “one substance, one registration” principle. Registrants of the same substance are required to work together to share relevant data and submit their registrations jointly. This helps avoid unnecessary animal testing and reduces costs for registrants.

Before registering a substance, a potential registrant must submit an inquiry to ECHA to determine whether the substance has already been registered. The inquiry is prepared in IUCLID and submitted through REACH-IT. Following a successful inquiry, ECHA provides access to information on existing and potential co-registrants of the same substance, enabling them to share data and organise the joint submission.

Where several companies register the same substance, the co-registrants agree on a lead registrant. The lead registrant creates the joint submission in REACH-IT and submits the joint part of the registration first, with the agreement of the other co-registrants. The other companies then submit their own registration dossiers as member registrants. All co-registrants remain responsible for the jointly submitted information as well as for the information in their own registration dossiers.

Registration Dossier

A REACH registration dossier consists of a technical dossier and, for substances manufactured or imported in quantities of 10 tonnes or more per year, a Chemical Safety Report (CSR).

The technical dossier includes information such as:

• Identity of manufacturer or importer
• Substance identity
• Information on manufacture and identified uses
• Classification and labelling
• Guidance on safe use
• Information on the physicochemical, toxicological and eco-toxicological properties of the substance
• Study summaries or robust summaries, where required
• Proposals for further testing, where relevant

The information required on the properties of the substance depends on the quantity manufactured or imported per year. The standard information requirements increase with the tonnage band and are set out in Annexes VII–X of REACH:

• 1–10 tonnes/year – Annex VII: Basic physicochemical, toxicological and ecotoxicological information.
• 10–100 tonnes/year – Annexes VII and VIII: Additional information requirements, including further toxicological and ecotoxicological data. A Chemical Safety Assessment (CSA) and Chemical Safety Report (CSR) are also required from 10 tonnes/year.
• 100–1,000 tonnes/year – Annexes VII, VIII and IX: Further information requirements, including additional data on repeated-dose toxicity, reproductive/developmental toxicity, environmental fate and long-term aquatic toxicity.
• 1,000 tonnes/year or more – Annexes VII–X: The most extensive standard information requirements, including further long-term toxicity and environmental information and, where triggered, carcinogenicity testing.

A Chemical Safety Report (CSR) is required for substances manufactured or imported in quantities of 10 tonnes or more per year. The CSR documents the chemical safety assessment carried out for the substance and includes:

• Human health hazard assessment
• Physicochemical properties assessment
• Environmental hazard assessment
• Assessment of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties
• Exposure assessment, including exposure scenarios where required
• Risk characterisation

Where an exposure assessment is required, it covers the identified uses of the substance and includes exposure scenarios describing the operational conditions and risk management measures needed to adequately control risks.

REACH Registration Costs

The overall cost of a REACH registration may include data-sharing costs and the applicable ECHA registration fee. Data-sharing costs may include the cost of obtaining a Letter of Access (LoA), which gives a registrant the right to refer to data needed for the registration. These costs vary depending on the substance, available data and applicable tonnage band.

ECHA registration fees are payable to the European Chemicals Agency (ECHA). The applicable fee depends on whether the registration is submitted individually or jointly, the tonnage band and the size of the company. Qualifying micro, small and medium-sized enterprises (SMEs) benefit from reduced fees. The current registration fees, applicable from 5 November 2025, are shown in the tables below.

ECHA registration fees – standard (individual submissions)

ECHA registration fees for joint submissions

To qualify for the reduced fees, companies must meet the applicable SME criteria. The criteria for medium, small and micro enterprises are shown in the table below.

Criteria for SMEs under EU REACH

At present, SME status is verified ex post, meaning that companies can claim reduced fees when submitting a registration dossier, with ECHA verifying the supporting documentation afterwards. From 5 February 2027, an ex ante SME verification system will apply. Under this system, companies claiming reduced fees must apply to ECHA for recognition of their SME status at least two months before submitting the registration dossier.  Once recognised, SME status will remain valid for three years.