REACH
EU regulation for chemical registration, evaluation, authorisation, restriction
ISO 22301
International standard for business continuity management systems
Quick Verdict
REACH mandates chemical risk management for EU manufacturers and importers, ensuring safe substances via registration and restrictions. ISO 22301 provides voluntary BCMS certification for global organizations to build disruption resilience through planning, testing, and audits. Companies adopt REACH for legal compliance, ISO 22301 for operational continuity.
REACH
Regulation (EC) No 1907/2006 (REACH)
ISO 22301
ISO 22301:2019 Business continuity management systems requirements
Key Features
- PDCA cycle for continual BCMS improvement
- Business Impact Analysis (BIA) and risk assessment
- Leadership commitment with policy and roles
- Operational planning and recovery testing
- Integration with ISO 27001 and Annex SL
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
REACH Details
What It Is
REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation establishing a comprehensive framework for managing chemical risks. Its primary purpose is to ensure a high level of protection for human health and the environment from chemical substances, while promoting innovation and alternatives to animal testing. The core approach shifts responsibility to industry for generating and submitting data on hazards, uses, and risk management.
Key Components
- Four pillars: Registration, Evaluation, Authorisation, and Restriction.
- Detailed annexes (I-XVII) defining data requirements by tonnage bands (≥1, ≥10, ≥100, ≥1000 tonnes/year), exemptions, and lists like Annex XIV (SVHC authorisation) and Annex XVII (restrictions).
- Built on principles of precaution, substitution, and industry-led compliance.
- No certification; continuous dossier updates and national enforcement.
Why Organizations Use It
Legal obligation for manufacturers/importers; avoids market bans, fines, and recalls. Enhances supply-chain transparency, risk reduction, and ESG performance. Builds stakeholder trust and competitive edge via safer products.
Implementation Overview
Phased approach: gap analysis, substance inventory, dossier preparation (IUCLID), SDS management, monitoring. Applies to chemicals sector globally trading in EU/EEA; cross-functional teams essential. No central certification; Member State inspections required.
ISO 22301 Details
What It Is
ISO 22301:2019 is the international standard for Business Continuity Management Systems (BCMS), providing a framework to protect against, reduce the likelihood of, and recover from disruptive incidents. It applies to organizations of all sizes and sectors, using a risk-based PDCA (Plan-Do-Check-Act) cycle for resilience.
Key Components
Features 10 clauses, with Clauses 4-10 core: context and scope (Clause 4), leadership and policy (5), planning with BIA and risk assessment (6), support resources (7), operation including recovery strategies (8), performance evaluation via monitoring and audits (9), and improvement (10). Built on Annex SL for integration. Certification lasts 3 years with annual surveillance audits.
Why Organizations Use It
Enhances operational resilience, minimizes downtime and financial losses, ensures compliance with regulations like NIS Directive, builds stakeholder trust, reduces insurance premiums, and provides competitive advantages in procurement and reputation.
Implementation Overview
Starts with gap analysis, BIA, risk assessment, training, testing, and documentation. Two-stage certification audit (6-8 weeks). Applicable globally across industries; tools like software accelerate for SMEs.
Key Differences
| Aspect | REACH | ISO 22301 |
|---|---|---|
| Scope | Chemicals registration, evaluation, authorisation, restriction | Business continuity management system for disruptions |
| Industry | Chemicals, manufacturing, importers EU-wide, all sizes | All sectors worldwide, critical services like finance, utilities |
| Nature | Mandatory EU regulation, directly applicable law | Voluntary certification standard, PDCA framework |
| Testing | Dossier evaluation by ECHA, substance checks | BIA, exercises, internal audits, certification audits |
| Penalties | National fines, effective/proportionate/dissuasive penalties | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about REACH and ISO 22301
REACH FAQ
ISO 22301 FAQ
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