REACH (EC 1907/2006)
Registration, Evaluation, Authorisation and Restriction of Chemicals
Standard Introduction
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is EU Regulation (EC) No 1907/2006, one of the most comprehensive chemical regulations in the world. It governs the manufacture, import, and use of chemical substances across the European Union, placing the burden of proof on companies to demonstrate that their chemicals and products are safe. REACH is administered by the European Chemicals Agency (ECHA) and applies to virtually all products placed on the EU market.
REACH operates through four key mechanisms: Registration (manufacturers and importers must register substances above 1 tonne per year), Evaluation (ECHA evaluates testing proposals), Authorisation (Substances of Very High Concern on Annex XIV require authorisation), and Restriction (Annex XVII lists specific conditions or bans). For article producers and importers, the primary obligation is SVHC communication — if an article contains a Candidate List substance above 0.1% by weight, the supplier must inform customers on request. The Candidate List currently includes over 240 substances and is updated at least twice yearly.
Registration Required
Manufacturers and importers must register substances produced or imported above 1 tonne/year with ECHA, providing safety data based on tonnage band.
SVHC Candidate List
Substances of Very High Concern (SVHCs) — carcinogenic, mutagenic, persistent, bioaccumulative — are placed on the Candidate List with special communication and authorization requirements.
No Data, No Market
Core REACH principle: substances cannot be manufactured or imported into the EU without registering safety data with ECHA. The burden of proof is on industry, not regulators.
list_alt Key Processes
- Registration — substance safety dossiers to ECHA
- Evaluation — ECHA reviews dossier quality and substance risks
- Authorisation — SVHC substances require use-specific authorization
- Restriction — limits or bans on hazardous substance use
- SVHC Candidate List communication obligations
- Safety Data Sheets (SDS) in supply chain
- Downstream user obligations
Who Needs to Comply?
EU manufacturers and importers of chemical substances above 1 tonne/year. Also applies to producers/importers of articles containing SVHCs above 0.1% w/w and downstream users of registered substances.
Key Requirements
Substance Registration
Register all substances manufactured or imported above 1 tonne/year with ECHA. Submit a technical dossier with physicochemical, toxicological, and ecotoxicological data. Higher tonnages require more extensive data.
SVHC Communication
If an article contains an SVHC from the Candidate List above 0.1% w/w, provide sufficient information to allow safe use to downstream recipients. Notify ECHA if total quantity exceeds 1 tonne/year.
Safety Data Sheets
Provide Safety Data Sheets (SDS) to downstream users for hazardous substances and mixtures. SDS must include 16 mandatory sections covering identification, hazards, handling, exposure controls, and disposal.
Authorisation Applications
Substances on the Authorisation List (Annex XIV) cannot be used after the sunset date without an authorization. Apply to ECHA demonstrating adequate control or that socio-economic benefits outweigh risks.
Implementation Roadmap
Prepare scope, obligations and evidence model
Define the chemicals registration and product substance compliance program scope across substances, mixtures, articles, imported products, suppliers, SVHC candidate list screening, authorisation, restriction, safety data sheets, and customer communication. Identify applicable legal, product, customer, certification, or market-access obligations and agree how evidence will be owned, updated, and retained.
Gap analysis and risk classification
Assess current practices against EU REACH requirements and risk context. Review substance inventory, registration obligations, SVHC screening, Article 33 communication, restriction checks, authorisation needs, SDS management, supplier declarations, and product change control, then prioritize gaps by market-access impact, safety or environmental risk, customer exposure, and documentation readiness.
Implement controls, testing and documentation
Deploy required controls, supplier workflows, testing or assessment activities, labeling or communication steps, and technical documentation. Build traceable evidence around substance inventories, supplier declarations, SDS files, SVHC screening records, Article 33 responses, restriction assessments, authorisation decisions, testing evidence, and customer communication logs.
Review, maintain and respond to changes
Complete readiness reviews and corrective actions before the chemical compliance review or regulator/customer inquiry. Keep the program current after product, supplier, substance, design, regulatory, market, or incident changes.
Compliance Checklist
checklist Scope and obligations
checklist Controls and evidence
checklist Monitoring and maintenance
Penalties & Enforcement
Enforcement varies by member state. Penalties include market bans, product recalls, and significant fines. In Germany, fines can reach EUR 50,000 per violation. In the UK (pre-Brexit), fines were unlimited with up to 2 years imprisonment for serious offences.
Frequently Asked Questions
Who needs EU REACH?
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EU REACH is relevant for organizations whose products, services, or activities fall within substances, mixtures, articles, imported products, suppliers, SVHC candidate list screening, authorisation, restriction, safety data sheets, and customer communication. It is commonly driven by market access, safety, environmental, customer, or regulatory obligations.
What is the main purpose of EU REACH?
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The practical purpose is to create a repeatable program for substance inventory, registration obligations, SVHC screening, Article 33 communication, restriction checks, authorisation needs, SDS management, supplier declarations, and product change control. The program should make obligations visible, define accountable owners, and maintain evidence that remains current as products and rules change.
What should be done first?
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Start with scope. Identify which products, components, sites, suppliers, markets, and activities are covered before writing procedures or commissioning tests.
How long does implementation take?
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Implementation can take weeks for a narrow product family or many months for complex multi-market portfolios. Timing depends on testing, supplier evidence, technical documentation quality, and whether third-party assessment is needed.
What evidence is most important?
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Important evidence includes substance inventories, supplier declarations, SDS files, SVHC screening records, Article 33 responses, restriction assessments, authorisation decisions, testing evidence, and customer communication logs. Authorities, auditors, customers, and test labs usually expect traceable records that connect requirements to decisions, tests, labels, and declarations.
How should suppliers be managed?
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Suppliers should provide declarations, test reports, change notifications, and traceable material or component data. High-risk suppliers need periodic review and contractual flow-down of compliance requirements.
When should the file be updated?
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Update the file after regulatory changes, design changes, supplier changes, material changes, incidents, complaints, or new market launches. Static files quickly become unreliable in product compliance.
Can this be integrated with other programs?
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Yes. EU REACH can share supplier management, document control, risk management, test planning, labeling review, and corrective-action workflows with related quality, safety, environmental, or product-compliance programs.
Official Documentation
REACH Regulation (EC) 1907/2006
EUR-Lex • Full Regulation Text • All EU Languages
ECHA REACH Portal
External Link • echa.europa.eu • Understanding REACH
REACH Guidance Documents
External Link • echa.europa.eu • Implementation Guidance