ISO 31000
International guidelines for enterprise risk management frameworks
REACH
EU regulation for chemicals registration, evaluation, authorisation, restriction
Quick Verdict
ISO 31000 provides voluntary risk management guidelines for all organizations globally, enhancing decision-making. REACH mandates chemical registration and controls for EU market access, ensuring safety. Companies adopt ISO 31000 for resilience, REACH for legal compliance.
ISO 31000
ISO 31000:2018, Risk management — Guidelines
Key Features
- Non-certifiable guidelines for enterprise-wide risk management
- Risk defined as effect of uncertainty on objectives
- Eight principles emphasizing integration and leadership commitment
- PDCA-aligned framework embedding risk into governance
- Iterative process from assessment to continual improvement
REACH
Regulation (EC) No 1907/2006 (REACH)
Key Features
- Industry-driven chemical registration above 1 tonne/year
- SVHC Candidate List triggers communication obligations
- Authorisation regime for very high concern substances
- Annex XVII restrictions with bans and limits
- Supply-chain SDS and exposure scenario requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 31000 Details
What It Is
ISO 31000:2018, Risk management — Guidelines is a non-certifiable international standard providing principles-based guidance for systematic risk management. Its primary purpose is to help organizations of any size or sector manage uncertainty affecting objectives through a flexible, iterative approach focused on creating and protecting value.
Key Components
- **Three pillarsEight principles (e.g., integrated, dynamic, continual improvement), framework (leadership, integration, design, evaluation), and process (communication, assessment, treatment, monitoring, reporting).
- No fixed controls; emphasizes customization and PDCA cycle.
- Non-certifiable; relies on internal governance and assurance.
Why Organizations Use It
- Enhances decision-making, resilience, and opportunity capture.
- Builds stakeholder trust via transparent practices.
- Supports strategic benefits like better resource allocation and reduced losses.
- Aligns with regulations indirectly; competitive edge in governance.
Implementation Overview
- Phased roadmap: leadership commitment, framework design, process piloting, integration, continual improvement.
- Applicable universally; involves policy, training, tools like risk registers.
- No external certification; internal audits and reviews ensure alignment.
REACH Details
What It Is
REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals. It shifts responsibility to industry for generating and managing chemical risk data across the supply chain, protecting human health and the environment while promoting innovation.
Key Components
- Four pillars: Registration (>1 tonne/year), Evaluation (dossier checks), Authorisation (SVHCs on Annex XIV), Restriction (Annex XVII bans/limits).
- Detailed annexes (I-XVII) for data requirements, SDS, exemptions.
- Core principles: industry burden of proof, tonnage-based info scaling, substitution promotion.
- No certification; continuous compliance via ECHA dossiers.
Why Organizations Use It
- Mandatory for EU market access (fines, seizures for non-compliance).
- Reduces risks (market denial, recalls, penalties).
- Builds supply-chain transparency, ESG advantages, innovation via safer alternatives.
- Enhances reputation, competitiveness in chemicals-intensive sectors.
Implementation Overview
- Phased: gap analysis, inventory, dossiers (IUCLID), SDS/comms, monitoring.
- Applies to manufacturers/importers/downstream users in EU/EEA; all sizes.
- Cross-functional: procurement, R&D, EHS; ongoing audits, no central cert.
Key Differences
| Aspect | ISO 31000 | REACH |
|---|---|---|
| Scope | Enterprise-wide risk management guidelines | Chemical substances registration and control |
| Industry | All sectors, any organization globally | Chemicals, manufacturing, EU/EEA focused |
| Nature | Voluntary non-certifiable guidelines | Mandatory EU regulation with enforcement |
| Testing | Internal audits and continual reviews | Hazard testing, dossier evaluation by ECHA |
| Penalties | No legal penalties, internal consequences | Fines, market bans, criminal sanctions |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 31000 and REACH
ISO 31000 FAQ
REACH FAQ
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