ISO 37301
International certifiable standard for compliance management systems
REACH
EU regulation for chemicals registration, evaluation, authorisation, restriction
Quick Verdict
ISO 37301 provides a certifiable framework for compliance management systems across organizations globally, while REACH mandates chemical registration, evaluation, and restrictions for EU market access. Companies adopt ISO 37301 for integrated governance and certification; REACH to legally place chemicals on the EU market.
ISO 37301
ISO 37301:2021 Compliance management systems – Requirements
Key Features
- Certifiable requirements replacing guidance-only ISO 19600
- High-Level Structure alignment for IMS integration
- Risk-based compliance obligations assessment and planning
- Top management commitment and compliance culture mandate
- Confidential whistleblowing channels with anti-retaliation protections
REACH
Regulation (EC) No 1907/2006 (REACH)
Key Features
- Industry-shifted responsibility for chemical risk data
- Registration dossiers required above 1 tonne/year
- SVHC authorisation to drive substance substitution
- Annex XVII restrictions on unacceptable risks
- Supply-chain SDS and SVHC communication duties
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 37301 Details
What It Is
ISO 37301:2021 – Compliance management systems – Requirements with guidance for use is a certifiable international standard for establishing, implementing, maintaining, and improving effective compliance management systems (CMS). It applies to all organization sizes and sectors, using a risk-based approach and Plan-Do-Check-Act (PDCA) cycle aligned with the ISO High-Level Structure (HLS).
Key Components
- Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
- Emphasizes leadership commitment, compliance culture, whistleblowing protections, risk assessment, and continual improvement.
- Built on HLS for integration with ISO 9001, 14001, 27001.
- Supports certification via accredited bodies like ANAB.
Why Organizations Use It
- Demonstrates systematic compliance to regulators, investors, partners.
- Reduces risks of fines, litigation, reputational damage.
- Enhances stakeholder trust, supports ESG/SDGs, enables market differentiation.
- Drives cultural integrity and operational efficiency.
Implementation Overview
- Phased: gap analysis, obligation register, training, audits, certification.
- Scalable for SMEs to enterprises; 3-year certification cycles.
- Global applicability; 2024 amendment adds climate action changes. (178 words)
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 protects human health and the environment by shifting responsibility to industry for generating and managing chemical risk data. Scope includes substances, mixtures, and articles manufactured or imported into the EU/EEA, using a risk-based lifecycle approach.
Key Components
- Four pillars: Registration (>1 tonne/year dossiers), Evaluation (dossier/substance checks), Authorisation (SVHC permission regime), Restriction (Annex XVII bans/limits).
- Tonnage-scaled data requirements (Annexes VII-X); SVHC Candidate List, Annex XIV.
- Built on industry-led data generation, ECHA coordination, national enforcement; no certification, continuous compliance model.
Why Organizations Use It
- Mandatory for EU market access, avoiding fines/market bans.
- Mitigates risks, ensures supply-chain transparency.
- Drives substitution/innovation, boosts competitiveness.
- Builds stakeholder trust via SDS/SVHC communication.
Implementation Overview
- Phased: scoping/inventory, gap analysis, dossier submission, monitoring.
- Cross-functional for chemical-dependent firms all sizes, EU-focused.
- Ongoing workflows; national inspections, no central audit.
Key Differences
| Aspect | ISO 37301 | REACH |
|---|---|---|
| Scope | Compliance management systems across all obligations | Chemical substances registration and risk management |
| Industry | All sectors, all sizes worldwide | Chemicals, manufacturing, EU/EEA focused |
| Nature | Voluntary certifiable standard | Mandatory EU regulation |
| Testing | Internal audits, certification audits | Dossier evaluation, substance evaluation |
| Penalties | Loss of certification | Fines, market bans, enforcement actions |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 37301 and REACH
ISO 37301 FAQ
REACH FAQ
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