REACH Compliance: Key Requirements for Chemical Manufacturers and Exporters

What is REACH and Who Must Comply

REACH — short for Registration, Evaluation, Authorisation, and Restriction of Chemicals — is a comprehensive EU regulation (EC 1907/2006) that governs production, import, and use of chemical substances. REACH requires companies to register substances they manufacture or import in quantities of one tonne or more per year with the European Chemicals Agency (ECHA), conduct safety assessments, and communicate information throughout supply chain.

Core Principle: No Data, No Market

The REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) (No. 1907/2006) represents a paradigm shift. It mandates that companies, not public authorities, must demonstrate that their chemical substances are safe before market entry. Under EU REACH Regulation, any EU manufacturer or importer of a substance, on its own or in mixtures, in quantities of one tonne or more per year must register it with ECHA (Article 6(1) REACH). Without registration, substance may not be manufactured or placed on EU market (“no data, no market”, Article 5).

Who Has Obligations

REACH applies to manufacturers and importers of substances in EU (and wider EEA), to downstream users who formulate mixtures or use chemicals industrially, and to distributors. Regulation is administered by ECHA and enforced by member states. Companies established outside EU/EEA do not have obligations under REACH directly — their EU importer does, unless they appoint an Only Representative.

Registration: The First Requirement

Main requirements of REACH include Registration: You must register chemical substances with ECHA before you manufacture or import them in quantities of one tonne or more per year.

Tonnage Bands and Dossiers

Manufacturers and importers dealing with substances over one tonne per year must submit comprehensive dossiers to ECHA, including detailed physico-chemical, toxicological, and ecotoxicological data. Registration dossiers submitted to ECHA must include substance ID, safe use data, and chemical safety report (if needed).

Substances manufactured or imported at one tonne or more per year must be registered with ECHA with technical dossier; at ten tonnes or more per year a chemical safety report is also required.

REACH-IT and Joint Submissions

Register substances with ECHA using REACH-IT portal. Most registrations are joint submissions via SIEF / consortia to share data and costs, with lead registrant submitting joint dossier.

Authorisation, Restriction and SVHC

Annex XIV Authorisation List

Annex XIV (Authorisation List) – Substances requiring explicit authorization before use. Substances of Very High Concern (SVHC) placed on Candidate List may move to Annex XIV, after sunset date use requires authorisation.

Annex XVII Restriction List

Annex XVII (Restricted List) – Substances with specific limitations or bans. REACH compliance is ongoing obligation to register substances, screen finished products for SVHCs, respect Annex XVII restrictions, and – when required – submit data to ECHA's SCIP database.

SVHC and SCIP Database

Candidate List (SVHC) – Substances of Very High Concern. Requirement to submit information to ECHA's SCIP database for articles containing SVHC >0.1% w/w, to support Waste Framework Directive.

Requirements for Non-EU Exporters

Only Representative (OR)

To fulfill REACH obligations, non-EU exporters must appoint an Only Representative (OR) based in EU. Non-EU companies are required to register any chemicals imported into EU in quantities exceeding 1 ton per year. This involves providing ECHA with detailed information about chemical's properties, applications, and potential risks.

REACH importer obligations & Supply Chain Compliance: Non-EU companies need an Only Representative (OR). Importers ensure compliance when bringing chemicals into EU, downstream users must also comply.

Articles and Finished Products

Manufacturers of finished products containing chemicals, such as textiles, electronics, or automotive parts, must check SVHC content and Annex XVII restrictions, even if they do not manufacture substance itself.

EU vs UK REACH

Key Differences

If you manufacture, import, supply or use chemical substances in UK, you must comply with REACH Regulations. Register substances you manufacture or import into Great Britain (GB) at one tonne or more per year.

EU REACH continues to apply in Northern Ireland. Businesses must meet all obligations of EU REACH, including registration with ECHA. Companies must register substances with ECHA, assess/manage risks, communicate safety info, and substitute hazardous chemicals. Same duties apply in UK, though registration must be done with UK's Health and Safety Executive (HSE), not ECHA.

Practical Checklist

• Map all substances >1 tonne/year per legal entity

• Appoint OR if non-EU exporter

• Prepare registration dossier / join consortium

• Screen for SVHC Candidate List, Annex XIV, Annex XVII

• Update SDS and labels to GHS/CLP

• Submit SCIP notification for articles with SVHC >0.1%

• Maintain supply chain communication down to downstream users

Sources:

How REACH Affects Non-EU Companies – ComplianceXL – Non-EU exporters must register >1 ton/year, provide ECHA properties, appoint Only Representative based in EU

ECHA: Backbone of Global Chemical Safety – ChemCopilot – REACH 1907/2006 paradigm shift companies must demonstrate safety, manufacturers/importers >1 tonne submit dossiers

How Does Registration Requirement Work – Maak Law – Article 6(1) REACH, one tonne or more must register, no data no market Article 5