REACH
EU regulation for chemicals registration, evaluation, authorisation, restriction
ISO 17025
International standard for testing and calibration laboratory competence.
Quick Verdict
REACH mandates chemical risk management for EU market access, requiring registration and restrictions. ISO 17025 accredits labs for competent, impartial testing worldwide. Companies adopt REACH for legal compliance; ISO 17025 for trusted results and credibility.
REACH
Regulation (EC) No 1907/2006 on REACH
Key Features
- Shifts burden to industry for chemical registration above 1 tonne/year
- Four pillars: registration, evaluation, authorisation, restriction
- SVHC Candidate List triggers Article 33 communication duties
- Tonnage-scaled data requirements with read-across adaptations
- Annex XVII enforces EU-wide substance restrictions and bans
ISO 17025
ISO/IEC 17025:2017 General requirements for laboratory competence
Key Features
- Impartiality and confidentiality as core general requirements
- Personnel competence lifecycle management
- Metrological traceability to SI units
- Measurement uncertainty evaluation mandatory
- Risk-based process validation and proficiency testing
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 protecting human health and the environment through industry-led registration, evaluation, authorisation, and restriction of substances, mixtures, and articles. It employs a responsibility-shift approach, requiring manufacturers and importers to generate and submit safety data.
Key Components
- **Four pillarsRegistration (dossiers via IUCLID), Evaluation (dossier/substance checks), Authorisation (Annex XIV for SVHCs), Restriction (Annex XVII bans/limits).
- Tonnage-based info requirements (Annexes VII-X), Chemical Safety Reports (CSRs) for ≥10 tpa.
- Built on precautionary principles, supply-chain communication (SDS, Article 33), national enforcement.
- No certification; continuous compliance via ECHA databases.
Why Organizations Use It
Legal obligation for EU market access; avoids fines, seizures, market bans. Enhances risk management, substitution innovation, supply-chain transparency. Builds stakeholder trust, supports ESG, prevents disruptions from SVHCs/restrictions.
Implementation Overview
Phased: gap analysis, substance inventory, dossiers/CSRs, monitoring Annexes. Applies to manufacturers/importers/downstream users EU-wide; cross-functional (procurement, R&D, EHS). Involves audits, no formal certification but inspection readiness essential. (178 words)
ISO 17025 Details
What It Is
ISO/IEC 17025:2017 is the international standard specifying general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It applies a risk-based, performance-oriented approach integrating management and technical controls to ensure technically valid results.
Key Components
- Eight core elements: general (impartiality/confidentiality), structural, resource, process, and management system requirements.
- Focuses on personnel competence, metrological traceability, measurement uncertainty, method validation, and proficiency testing.
- Built on risk-based thinking; offers Option A/B for management systems (standalone or ISO 9001-aligned).
- Leads to accreditation by bodies like ILAC signatories, attesting scope-specific competence.
Why Organizations Use It
- Enables market access, regulatory acceptance, and international result recognition.
- Mitigates risks from invalid results in safety-critical domains.
- Builds stakeholder trust via demonstrated impartiality and traceability.
- Provides competitive edge through credible, efficient operations.
Implementation Overview
- Phased PDCA: gap analysis, documentation, training, validation, audits.
- Suited for labs across industries; scalable by size.
- Requires accreditation body assessments with witnessed testing.
Key Differences
| Aspect | REACH | ISO 17025 |
|---|---|---|
| Scope | Chemicals registration, evaluation, authorisation, restriction | Laboratory competence, impartiality, testing/calibration validity |
| Industry | Chemicals, manufacturing, import/export across EU/EEA | Testing/calibration labs in all sectors worldwide |
| Nature | Mandatory EU regulation with national enforcement | Voluntary international accreditation standard |
| Testing | Dossier submission, substance evaluation, no routine lab audits | Method validation, proficiency testing, accreditation body assessments |
| Penalties | Fines, product seizures, market bans by Member States | Loss of accreditation, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about REACH and ISO 17025
REACH FAQ
ISO 17025 FAQ
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