EU REACH Compliance: What You Need to Know About The Chemical Safety Regulation

EU REACH compliance is a mandatory requirement under Regulation (EC) No 1907/2006 for any business that manufactures, imports, or uses chemical substances in the European Union above one metric ton per year. Introduced in 2007, REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is the world’s most comprehensive chemical safety regulation, covering over 22,000 registered substances. Non-compliance can result in significant fines, market access bans, supply chain disruptions, and reputational damage — while achieving and maintaining compliance unlocks trust, market access, and a demonstrable commitment to sustainability under frameworks such as the EU Corporate Sustainability Due Diligence Directive (CSDDD) and the Corporate Sustainability Reporting Directive (CSRD).

In this guide, we break down everything you need to know about REACH compliance — from its key components and registration process to practical implementation steps and how it interconnects with broader supply chain due diligence obligations. Whether you’re a manufacturer, importer, or downstream user, this comprehensive overview will help you navigate the regulation confidently in 2025–2026.

What Is REACH Compliance?

REACH — Registration, Evaluation, Authorization, and Restriction of Chemicals — is the European Union’s flagship chemical safety regulation, enacted under Regulation (EC) No 1907/2006. It applies to all chemical substances manufactured, used, or imported into the EU in quantities exceeding one metric ton per year, including substances used in industrial processes as well as those found in everyday products such as paints, cleaning agents, clothing, and furniture. The European Chemicals Agency (ECHA) administers REACH with over 95,000 substance notifications on record as of 2025.

The REACH regulation is built around several pivotal goals:

1. Identifying and Managing Hazardous Chemicals
   REACH mandates companies to collect data on the properties of the chemicals they produce or import, enabling the identification of hazardous substances. These risks must be adequately managed to minimize their impact on human health and the environment — a principle directly aligned with the human rights and environmental due diligence requirements of the EU CSDDD.
2. Promoting Safer Alternatives
   REACH encourages the use of non-hazardous or less hazardous substances, driving innovation in developing safer materials and chemical substitutes — supporting the broader decarbonization and sustainability goals embedded in CSRD Scope 3 reporting.
3. Transparency and Accountability
   REACH fosters open communication across the supply chain, ensuring that all parties — from manufacturers to end users — are informed of chemical risks and safe handling practices. This supply chain transparency directly supports due diligence obligations under Germany’s LkSG (Lieferkettensorgfaltspflichtengesetz) and the EU CSDDD.
4. Improved Risk Management
   Through its stringent evaluation and authorization processes, REACH ensures that high-risk substances are either phased out or used under strictly controlled conditions, reducing liability exposure and strengthening supply chain resilience.

Who Needs to Comply with REACH Regulations?

REACH applies broadly across industries and supply chains. Understanding whether your business is affected is the first step toward compliance. The regulation covers any enterprise that manufactures, imports, uses, or distributes chemical substances within the EU — whether as standalone substances, as part of mixtures, or contained in articles (finished goods).

Manufacturers

Businesses producing chemical substances in the EU must register them with the European Chemicals Agency (ECHA). This involves extensive testing, compiling technical dossiers, and ensuring that substances meet safety standards. Under aligned due diligence frameworks such as the CSDDD, manufacturers in complex supply chains are also expected to demonstrate visibility and control over hazardous substance use throughout their supplier network.

Manufacturers also have a duty to:

• Inform downstream users about safe handling procedures and potential restrictions.
• Conduct chemical safety assessments for substances classified as hazardous, including preparing Chemical Safety Reports (CSRs) for substances above 10 tonnes/year.

For example, a chemical manufacturer producing solvents must provide comprehensive documentation of the solvent’s properties, intended uses, and risk mitigation measures — documentation that also feeds into ESG reporting under CSRD.

Importers

Importers bring chemical substances, mixtures, or products containing chemicals into the EU. They are responsible for registering these substances if the manufacturer outside the EU has not already done so. Importers must work closely with their suppliers to gather the necessary data and ensure compliance. Given the supply chain due diligence requirements of the LkSG and CSDDD, importers sourcing from non-EU suppliers bear particular responsibility for verifying chemical safety and environmental standards upstream.

Appointing an Only Representative (OR) to manage compliance obligations on their behalf is a common strategy for non-EU manufacturers exporting to the EU market.

Downstream Users

These are businesses that use chemicals in production but do not manufacture or directly import them — such as formulators producing paints or adhesives, or industrial users incorporating chemicals into finished goods. As supply chain traceability requirements intensify under CSDDD and CSRD, downstream users increasingly need robust data management systems to demonstrate that the substances they use are compliant.

Downstream users must:

• Ensure the substances they use are registered.
• Implement recommended risk management measures provided by upstream suppliers.
• Report new uses of substances to ECHA if they fall outside registered uses.

Other Sectors

REACH’s scope extends to industries such as electronics, automotive, cosmetics, and textiles. Even if chemicals are not your business’s primary focus, compliance is critical if your products contain regulated substances. In 2025–2026, sectors with complex global supply chains face heightened scrutiny as CSDDD enforcement timelines approach, making REACH compliance a foundational element of broader ESG and human rights due diligence programs.

For instance, an electronics manufacturer using flame retardants in circuit boards must ensure those substances are REACH-compliant — and, increasingly, must document this compliance for ESG disclosures under CSRD.

Key Components of the REACH Regulation Framework

To simplify REACH, it’s helpful to break the regulation into its four core pillars — Registration, Evaluation, Authorization, and Restriction — each of which interacts with a company’s broader chemical substance management and supply chain due diligence obligations:

Registration

Companies must register substances they manufacture or import in quantities over one ton annually. This involves submitting a registration dossier to ECHA, detailing the substance’s properties, uses, and potential risks. By 2025, ECHA has processed registration dossiers for over 23,000 unique substances, covering billions of tonnes of chemicals across the EU market.

• Example: A fragrance company registering essential oil extracts must document their chemical composition, physical properties, and potential hazards — data that also underpins Scope 3 emissions and environmental impact disclosures under CSRD.

Evaluation

ECHA and EU member states evaluate the submitted dossiers to ensure data quality and assess whether the substance poses a risk to human health or the environment. ECHA’s Community Rolling Action Plan (CoRAP) systematically evaluates substances of concern — in 2024–2025, over 50 substances were under active evaluation. This process may result in requests for additional testing or restrictions, making proactive data management essential.

Authorization

Substances of Very High Concern (SVHCs) are added to the Candidate List — which contains over 240 substances as of early 2025 — and may require authorization for specific uses. Businesses must demonstrate that risks are adequately controlled or that socio-economic benefits justify their use. Companies with significant SVHC exposure in their supply chains should map this risk as part of their CSDDD and LkSG due diligence assessments.

• Example: A cosmetics company using phthalates must provide a compelling case for continued use or find safer alternatives — a substitution imperative that aligns with both REACH and the EU Green Deal’s Chemicals Strategy for Sustainability.

Restriction

Certain substances are restricted entirely or in specific applications. Annex XVII of REACH outlines these restrictions and is updated regularly — in 2024 alone, new restrictions were added for per- and polyfluoroalkyl substances (PFAS) and several microplastic precursors. Supply chain compliance officers must monitor these updates to avoid inadvertent violations.

How Does REACH Compliance Affect Businesses?

Achieving REACH compliance impacts business operations across several critical areas — and in 2025–2026, these impacts are amplified by intersecting obligations under CSDDD, CSRD, and LkSG:

• Supply Chain Management: Companies must trace and document the chemical substances used throughout their supply chains. This often involves collaborating closely with Tier 1, 2, and 3 suppliers to ensure accurate reporting — a requirement that directly overlaps with supply chain due diligence mandates under the LkSG and EU CSDDD.
• Manufacturing Processes: Compliance may necessitate process changes, especially when substituting hazardous substances with safer alternatives. This substitution activity feeds directly into CSRD environmental disclosures and GRI 301 (Materials) reporting.
• Market Access: Non-compliance can result in losing access to the EU single market — representing over €16 trillion in GDP — affecting revenue, growth, and investor confidence. As ESG due diligence requirements tighten globally, REACH compliance is increasingly a prerequisite for contract awards and supplier approval.
• Costs: Registration fees, testing requirements, and potential production changes represent significant costs, particularly for SMEs. However, companies that invest in proactive compliance management typically reduce long-term risk exposure and strengthen their ESG credentials, supporting better access to sustainable finance instruments.

Despite these challenges, businesses that embed REACH compliance into their broader supply chain sustainability strategy position themselves as leaders in chemical safety, environmental responsibility, and stakeholder trust.

Step-by-Step Guide to Achieve REACH Compliance

1. Identify Substances in Scope: Catalog all chemical substances used, manufactured, or imported by your business. Use ECHA’s database and the Candidate List to identify substances subject to REACH obligations — including any SVHCs that may require disclosure or authorization.
2. Assess Roles and Responsibilities: Determine whether you’re a manufacturer, importer, or downstream user, as obligations vary by role. In complex supply chains, multiple roles may apply to the same entity.
3. Conduct a Risk Assessment: Analyze the hazards associated with your substances, document safe use practices, and prepare Chemical Safety Reports where required. Align this assessment with your CSDDD and LkSG due diligence risk mapping for chemicals and environmental impacts.
4. Compile Registration Dossiers: For substances requiring registration, prepare and submit dossiers with detailed technical data using IUCLID software. Engage with SIEF partners to share data and reduce duplication.
5. Monitor the Candidate List: Stay updated on SVHCs to ensure ongoing compliance with authorization and restriction requirements. ECHA typically updates the Candidate List twice per year.
6. Engage with Supply Chain Partners: Collaborate with suppliers to obtain accurate substance data, verify compliance, and align REACH efforts with your broader supplier due diligence programs under LkSG, CSDDD, and CSRD.
7. Utilize Compliance Management Software: Leverage purpose-built platforms to track and document REACH compliance activities, automate SVHC monitoring, and generate audit-ready reports that satisfy both regulatory and ESG disclosure requirements.

How to Register for REACH

Registering for REACH involves a detailed and structured process to ensure compliance with the regulation’s requirements. Companies must take the following key steps:

1. Substance Identification

Begin by thoroughly identifying the chemical composition and properties of each substance you manufacture or import. This includes physicochemical, toxicological, and ecotoxicological characteristics, which are essential for completing the registration process. Accurate substance identification is also foundational for CSRD environmental impact disclosures and CSDDD supply chain risk assessments.

2. Pre-registration or Inquiry

• For Phase-In Substances: Companies should have completed pre-registration via the REACH-IT portal.
• For Non-Phase-In Substances or Missed Pre-registration Deadlines: Submit an inquiry dossier to the European Chemicals Agency (ECHA) to determine the next steps.

3. Data Collection and Sharing

• Gather Data: Compile detailed information about the substance, including safety data such as physicochemical, toxicological, and ecotoxicological properties. This data collection effort can be coordinated with supplier ESG assessments to maximize efficiency.
• Join a SIEF: Participate in a Substance Information Exchange Forum (SIEF) to collaborate with other companies registering the same substance. This allows for data sharing and reduces duplication of testing — reducing both cost and the need for animal testing.

4. Dossier Preparation

• Use the IUCLID (International Uniform Chemical Information Database) software to prepare a technical dossier.
• For substances manufactured or imported in quantities above 10 tonnes per year, prepare a Chemical Safety Report (CSR) to demonstrate safe usage scenarios across the entire lifecycle — information that can also be leveraged for Scope 3 environmental disclosures under CSRD.

5. Joint Submission

• REACH follows the “one substance, one registration” principle, which requires registrants of the same substance to submit data jointly.
• Coordinate with other registrants, typically through a lead registrant, to ensure a unified submission that minimizes cost and regulatory burden.

6. Submission to ECHA

• Submit the registration dossier via the REACH-IT portal. Ensure all required documentation is complete and that your dossier meets ECHA’s 2025 quality requirements, which have been strengthened following the Chemicals Strategy for Sustainability.
• Pay the applicable registration fee, which varies based on company size and the volume of the substance. SME fee reductions are available.

7. Evaluation

• ECHA will evaluate your dossier for completeness and scientific quality.
• Additional information may be requested if necessary. Companies must be prepared to respond promptly — delays can trigger enforcement action and affect supply chain continuity.

Important Considerations

• Start Early: The registration process can take several weeks to months, depending on the complexity of the substance and the need for collaboration. With ECHA increasing dossier compliance checks in 2025–2026, adequate lead time is critical.
• Seek Expertise: Given the complexity of REACH registration and its interactions with CSDDD, CSRD, and LkSG, consulting specialized experts or using compliance management software can significantly streamline the process and ensure nothing is missed.

Challenges in REACH Compliance and How to Overcome Them

Challenge: Complexity of Regulatory Requirements

REACH regulations involve detailed documentation, chemical testing, and navigating a multi-step registration process. For small and medium-sized enterprises (SMEs), these requirements can seem daunting and resource-intensive — and complexity increases further when REACH obligations must be coordinated with parallel requirements under CSDDD, LkSG, or CSRD.

Solution: Break the process into manageable steps. Use guides and resources provided by ECHA to clarify obligations. Partnering with compliance experts or deploying compliance management software — such as Certainty Software — to integrate REACH tracking with broader ESG and supply chain due diligence workflows can dramatically reduce the burden.

Challenge: Keeping Up with Regulatory Updates

The Candidate List and Annex XVII are updated frequently — ECHA typically adds new SVHCs to the Candidate List twice per year, and Annex XVII restrictions are subject to legislative amendment. In 2024–2025, significant new restrictions were introduced for PFAS and microplastics, affecting hundreds of product categories.

Solution: Implement a system for continuous regulatory monitoring. Subscribing to ECHA’s alerts is a first step. Compliance management software with automated regulatory update feeds ensures your substance library and risk assessments stay current without manual effort.

Challenge: Data Collection Across the Supply Chain

Many businesses struggle with obtaining accurate and complete chemical data from suppliers — particularly for imported goods or complex multi-tier supply chains. This challenge is compounded in 2025–2026 as CSDDD requires businesses to perform environmental and human rights due diligence across their entire value chains, making supplier chemical transparency a legal obligation, not just a best practice.

Solution: Establish structured supplier engagement processes with standardized data request templates. Deploy supply chain management and audit tools to track and verify compliance information across Tier 1, 2, and 3 suppliers — turning fragmented supplier data into a centralized, audit-ready compliance record.

Challenge: High Costs of Compliance

Testing, dossier preparation, and registration fees can be expensive, particularly for smaller businesses. ECHA estimates that REACH compliance costs EU industry approximately €2.3 billion annually, though benefits in avoided health and environmental costs are estimated at five to ten times that figure.

Solution: Pool resources by joining industry consortia to share testing data and registration costs. Explore ECHA’s SME support resources and funding opportunities available for compliance initiatives. Integrating REACH compliance into a broader ESG data management platform also reduces duplicated effort across multiple regulatory programs.

Challenge: Understanding the Technical Aspects of REACH

Technical terms like SVHCs, Annexes, Chemical Safety Reports, and dossier requirements can be overwhelming for non-specialists. The intersection of REACH with newer frameworks like CSDDD and CSRD adds additional layers of complexity for ESG and compliance teams.

Solution: Invest in targeted training for your compliance team, or engage a third-party consultant to clarify technical requirements. Many industry bodies and ECHA itself offer webinars and workshops specifically tailored to REACH compliance in the context of the EU Green Deal and supply chain sustainability regulations.

Exemptions to REACH

The REACH regulation provides several exemptions, categorized into total exemptions, partial exemptions, and substances for which registration is not required. While these exemptions reduce the regulatory burden for certain substances, it remains essential to ensure compliance with any other relevant obligations under REACH or related legislation — including the EU CSDDD’s broader environmental due diligence requirements.

Total Exemptions

The following substances are completely excluded from REACH:

• Radioactive Substances: Regulated under other specific frameworks.
• Substances Under Customs Supervision: Materials in transit through the EEA without entering the market.
• Defence-specific Substances: Used in defence and covered by national exemptions.
• Waste: Classified as waste under EU regulations.
• Non-Isolated Intermediates and Transported Substances: Substances that do not leave the equipment during processing.

Partial Exemptions

Some substances are exempt from specific REACH requirements, such as registration or authorization:

Exempt from Registration and Authorisation:

• Substances used in scientific research and development.
• Substances used in food and feedstuffs.
• Medicinal products that are regulated under other legislation.

Exempt from Registration:

• Annex IV Substances: 68 substances known to pose a minimal risk (e.g., nitrogen, corn oil).
• Annex V Substances: Includes by-products and hydrates.
• Substances occurring in nature, provided they are not chemically modified.
• Polymers: However, the monomers used in their production must be registered.
• Recycled or Recovered Substances: If already registered.
• Substances re-imported into the EEA, provided they were previously registered.
• Substances used in product and process-oriented research and development (PPORD) under controlled conditions.

Registration Not Required

Registration is not required for:

• Substances with Minimal Risk: Those listed in Annex IV.
• Substances previously registered, exported, and re-imported into the EEA.
• Naturally Occurring Substances: Provided they are unmodified.
• Recovered Substances: If they have already been registered through a waste recovery process.

How Certainty Software Aligns with and Supports Compliance with the EU’s REACH Regulation

Certainty Software makes it easier to sustain EU REACH compliance by simplifying the collection, management, and reporting of chemical safety audit and inspection data across your entire supply chain.

With tools including custom form building, multi-stage automated workflows, configurable dashboards, and in-depth reporting, you gain complete control over your REACH compliance efforts — while simultaneously building the supplier data infrastructure needed to satisfy due diligence requirements under the CSDDD, LkSG, and CSRD.

Certainty’s automation features and machine learning capabilities don’t just help you meet REACH requirements — they help you demonstrate a systematic, documented commitment to chemical safety, environmental responsibility, and supply chain transparency that satisfies regulators, investors, and customers alike.

Schedule a call with our team today to discover how Certainty Software can work with you to improve your REACH compliance management and integrate it with your broader supply chain sustainability program.

Frequently Asked Questions (FAQs)

What is the difference between REACH and CSDDD?

REACH is a product safety regulation focused on the registration, evaluation, and restriction of chemical substances placed on the EU market. The EU Corporate Sustainability Due Diligence Directive (CSDDD) is a broader human rights and environmental due diligence law requiring large companies to identify, prevent, and mitigate adverse impacts across their entire value chains. REACH compliance feeds directly into CSDDD environmental due diligence obligations, particularly for companies whose supply chains involve hazardous chemicals.

How does REACH relate to CSRD reporting?

The Corporate Sustainability Reporting Directive (CSRD) requires companies to disclose their environmental impact under the European Sustainability Reporting Standards (ESRS). REACH compliance data — including substance hazard profiles, substitution actions, and supply chain chemical transparency — directly informs CSRD disclosures under ESRS E1 (Climate), ESRS E2 (Pollution), and ESRS E4 (Biodiversity). Companies that maintain strong REACH compliance records are better positioned to produce accurate and auditable CSRD reports.

What are Substances of Very High Concern (SVHCs) under REACH?

SVHCs are chemical substances that pose serious and often irreversible risks to human health or the environment. They include carcinogenic, mutagenic, and reproductive toxic (CMR) substances, persistent bioaccumulative and toxic (PBT) substances, and endocrine disruptors. ECHA maintains the Candidate List of SVHCs — currently containing over 240 substances — which must be communicated throughout the supply chain when present above 0.1% by weight in articles.

What are the penalties for non-compliance with REACH?

Penalties for REACH non-compliance are set by EU member states and vary by jurisdiction. They can include significant fines, mandatory withdrawal of products from the EU market, and in serious cases, criminal liability for company directors. Beyond legal penalties, non-compliance can trigger supply chain disruption, loss of major customer contracts (particularly from companies with CSDDD or LkSG obligations), and lasting reputational damage.

How can compliance management software help with REACH?

Compliance management platforms such as Certainty Software help organizations centralize their REACH substance data, automate SVHC monitoring against the ECHA Candidate List, conduct and document supplier chemical audits, and generate audit-ready reports for both REACH regulators and broader ESG disclosures under CSRD and CSDDD. This integrated approach reduces manual effort, minimizes compliance gaps, and strengthens supply chain transparency.

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