Understanding EU REACH: Regulatory Framework

EU-REACH Regulation: A Technical and Regulatory Consultant’s Overview

The REACH Regulation (EC) No 1907/2006 represents the cornerstone of chemical management within the European Union and the European Economic Area (EEA). It establishes a comprehensive, science-driven framework for the registration, evaluation, authorisation, and restriction of chemical substances, fundamentally reshaping regulatory accountability by placing the burden of proof on industry.

This article provides a technical, consultant-level explanation of REACH, intended for regulatory professionals, compliance managers, toxicologists, and companies navigating EU chemical compliance.

Purpose and Regulatory Intent of REACH

REACH is designed to ensure a high level of protection of human health and the environment, while maintaining the efficient functioning of the EU internal market and enhancing the competitiveness of the EU chemicals industry.

A defining principle of REACH is the reversal of the traditional regulatory burden: manufacturers and importers must demonstrate that substances can be used safely, rather than authorities having to prove harm. This is operationalised through mandatory data generation, risk assessment, and risk management obligations.

REACH applies across the full chemical lifecycle, covering substances used as raw materials, intermediates, formulations, and those incorporated into articles.

Meaning and Structure of REACH

REACH is an acronym for:

• Registration – Submission of technical dossiers and, where applicable, Chemical Safety Reports (CSR)

• Evaluation – Scientific and regulatory assessment of submitted data by European Chemical Agency (ECHA) and Member State Competent Authorities

• Authorisation – Controlled use of Substances of Very High Concern (SVHCs) listed in Annex XIV

• Restriction – EU-wide risk management measures under Annex XVII

• Chemicals – Covering substances on their own, in mixtures, and in articles

Together, these elements form an integrated risk-based regulatory system aligned with EU chemical policy objectives.

Legal Scope and Applicability

REACH applies to:

• Substances manufactured or imported in quantities of ≥ 1 tonne per year per legal entity

• Substances on their own or in mixtures

• Substances intentionally or unintentionally released from articles, subject to specific conditions

The regulation impacts:

• EU manufacturers

• EU importers

• Downstream users

• Distributors

• Non-EU manufacturers via Only Representatives (ORs)

Certain exemptions apply (e.g., radioactive substances, non-isolated intermediates, waste), but these must be assessed carefully on a case-by-case basis.

Registration: Technical and Data Requirements

Registration is the entry point to REACH compliance and is governed by the principle of "no data, no market".

Registrants must submit dossiers via IUCLID through the REACH-IT platform, containing:

• Substance identity and analytical information

• Manufacturing and use descriptions

• Physicochemical properties

• Toxicological and ecotoxicological endpoints

• Classification and labelling in accordance with CLP

• Guidance on safe use

For substances ≥10 tonnes/year, a Chemical Safety Report (CSR) is mandatory, including:

• Human health hazard assessment

• Environmental hazard assessment

• PBT/vPvB assessment

• Exposure assessment and risk characterisation

Registrants of the same substance are required to cooperate within a Substance Information Exchange Forum (SIEF) or equivalent data-sharing mechanism.

Evaluation: Dossier and Substance Assessment

Evaluation occurs at two levels:

• Dossier Evaluation: ECHA assesses compliance and examines testing proposals to prevent unnecessary testing

• Substance Evaluation: Member States assess substances of concern under the Community Rolling Action Plan (CoRAP)

Authorities may request additional data if potential risks to human health or the environment are identified.

Authorisation: Managing Substances of Very High Concern

Substances meeting criteria under Article 57 (CMR, PBT, vPvB, or equivalent concern) may be identified as SVHCs and placed on the Candidate List.

Subsequent inclusion in Annex XIV triggers the Authorisation requirement, meaning that:

• Uses are prohibited after the sunset date unless authorised

• Applicants must demonstrate either adequate control of risks or that socio-economic benefits outweigh risks and no suitable alternatives exist

• Substitution plans are strongly encouraged

Authorisation is a use-specific, time-limited approval mechanism.

Restriction: EU-Wide Risk Management

Restrictions under Annex XVII impose legally binding conditions or bans on the manufacture, placing on the market, or use of certain substances.

Restrictions apply to:

• Substances on their own

• Substances in mixtures

• Substances in articles

This mechanism ensures harmonised risk management across all EU Member States.

Supply Chain Communication and Downstream Obligations

REACH places strong emphasis on supply-chain communication. Key obligations include:

• Provision of Safety Data Sheets (SDS)

• Communication of exposure scenarios

• Notification obligations for SVHCs in articles (Article 33)

• SCIP database submissions for SVHC-containing articles

Downstream users must verify that their uses are covered and implement prescribed risk management measures.

Strategic Importance of REACH Compliance

From a regulatory consulting perspective, effective REACH compliance:

• Enables lawful and uninterrupted EU market access

• Reduces enforcement, liability, and reputational risks

• Enhances data governance and product stewardship

• Supports sustainability, substitution strategies, and ESG commitments

Proactive compliance planning and early regulatory engagement are critical to managing long-term obligations.

Conclusion

REACH is a scientifically rigorous and legally binding framework that governs chemical risk management in the EU. For companies operating within complex global supply chains, REACH compliance requires technical expertise, strategic planning, and continuous regulatory monitoring.

A robust understanding of REACH is essential not only for compliance, but for sustaining competitive advantage in the European chemicals market.