REACH
EU regulation for chemical registration, evaluation, authorisation, restriction
AS9100
International standard for aerospace quality management systems.
Quick Verdict
REACH mandates chemical risk management across EU supply chains for health/environment protection, while AS9100 certifies aerospace quality systems emphasizing product safety and traceability. Organizations adopt REACH for legal compliance, AS9100 for market access and reliability.
REACH
Regulation (EC) No 1907/2006 (REACH)
Key Features
- 1. Shifts burden of proof to industry for registrations
- 2. Tonnage-triggered escalating data requirements from 1 tpa
- 3. Authorisation regime for SVHCs promoting substitution
- 4. EU-wide restrictions via dynamic Annex XVII
- 5. Mandatory SVHC communication down supply chain
AS9100
AS9100D Quality Management Systems Requirements
Key Features
- Configuration management for product integrity
- Product safety processes across lifecycle
- Counterfeit parts prevention controls
- Operational risk management in Clause 8
- Enhanced supplier evaluation and controls
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 on Registration, Evaluation, Authorisation and Restriction of Chemicals. It protects human health and environment by requiring industry to generate and submit safety data on substances. Scope covers manufacture, import, and use of chemicals in substances, mixtures, and articles. Uses a risk-based, tonnage-driven approach with escalating requirements.
Key Components
- Four pillars: Registration (>1 tpa threshold), Evaluation (dossier checks), Authorisation (SVHCs on Annex XIV), Restriction (Annex XVII bans/limits).
- 17 annexes detailing data (Annexes VI-X), lists, SDS rules (Annex II).
- Supply-chain duties: SDS, Article 33 SVHC notifications.
- Managed by ECHA; no certification, continuous compliance via dossiers.
Why Organizations Use It
- Mandatory for EU market access; avoids fines, seizures, bans.
- Reduces supply-chain risks, enables substitution innovation.
- Builds trust via transparency; competitive edge in ESG.
- Manages enforcement variability across Member States.
Implementation Overview
- Phased: inventory, gap analysis, dossiers (IUCLID), monitoring.
- Cross-functional for manufacturers/importers/downstream users in EU/EEA.
- Ongoing; national audits/enforcement, no central certification.
AS9100 Details
What It Is
AS9100D (AS9100:2016) is the international quality management system (QMS) standard for aviation, space, and defense (ASD) organizations. It builds on ISO 9001:2015 with over 100 aerospace-specific requirements, using a risk-based, process-oriented approach to ensure product safety and supply chain integrity.
Key Components
- 10-clause Annex SL structure covering context, leadership, planning, support, operation, evaluation, and improvement.
- Aerospace additions: configuration management (8.1.2), product safety (8.1.3), counterfeit parts prevention (8.1.4), operational risk (8.1.1), enhanced supplier controls (8.4).
- Built on PDCA cycle; certification via accredited third-party audits (Stage 1/2, surveillance, recertification).
Why Organizations Use It
- **Market accessRequired by OEMs/primes for supplier qualification.
- **Risk reductionPrevents safety incidents, defects, counterfeit risks.
- **Efficiency gainsImproves delivery, reduces rework, enhances traceability.
- Builds stakeholder trust via OASIS database visibility.
Implementation Overview
- Phased: gap analysis, process design, training, internal audits, certification (6-18 months).
- Applies to ASD designers/manufacturers/suppliers globally; suits all sizes with scaled complexity.
Key Differences
| Aspect | REACH | AS9100 |
|---|---|---|
| Scope | Chemicals registration, evaluation, authorisation, restriction | Aerospace quality management system processes |
| Industry | Chemicals, manufacturing, EU-wide all sectors | Aviation, space, defense supply chains globally |
| Nature | Mandatory EU regulation, legally binding | Voluntary certification standard based on ISO 9001 |
| Testing | Dossier submission, substance evaluation by ECHA | Third-party audits, Stage 1/2 certification cycles |
| Penalties | National fines, effective/proportionate/dissuasive | Certification loss, no direct legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about REACH and AS9100
REACH FAQ
AS9100 FAQ
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