RoHS
EU directive restricting hazardous substances in EEE
FSSC 22000
GFSI-benchmarked certification scheme for food safety management.
Quick Verdict
RoHS restricts hazardous substances in electronics for EU market access, while FSSC 22000 certifies food safety systems globally. Companies adopt RoHS to comply with law and sell EEE; FSSC for GFSI recognition, retailer approval, and supply chain trust.
RoHS
Directive 2011/65/EU (RoHS 2)
Key Features
- Restricts 10 hazardous substances at homogeneous material level
- Open scope: all EEE unless explicitly excluded
- Time-limited exemptions reviewed via delegated acts
- Requires technical file and EU Declaration of Conformity
- Tiered verification using IEC 62321 testing methods
FSSC 22000
Food Safety System Certification 22000
Key Features
- GFSI-benchmarked certification across food chain categories
- Integrates ISO 22000 with sector-specific PRPs
- Additional requirements for food defense and fraud
- Mandatory allergen management and environmental monitoring
- Food safety culture and quality control objectives
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
RoHS Details
What It Is
RoHS (Directive 2011/65/EU, recast as RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE) to protect health and environment during waste management. It applies an open-scope approach to all EEE unless excluded, using homogeneous material thresholds (0.1% for most substances, 0.01% for cadmium).
Key Components
- Restricts 10 substances (Pb, Hg, Cd, Cr(VI), PBB, PBDE, DEHP, BBP, DBP, DIBP).
- **Annex III/IV exemptionstime-limited for specific applications.
- Compliance via technical documentation, EU Declaration of Conformity (DoC), and CE marking.
- Aligned with IEC 63000 for evidence and IEC 62321 for testing.
Why Organizations Use It
Ensures EU market access, reduces e-waste risks, supports WEEE recycling, and provides level playing field. Mitigates fines, recalls, and liabilities; enhances sustainability reputation and supply chain resilience.
Implementation Overview
Risk-based: scope analysis, BoM review, supplier declarations, tiered testing (XRF screening, lab confirmation), exemption tracking. Applies to manufacturers/importers of EEE globally selling to EU; 10-year documentation retention. No formal certification, but market surveillance enforced by Member States.
FSSC 22000 Details
What It Is
FSSC 22000 (Food Safety System Certification 22000) is a GFSI-benchmarked certification scheme for Food Safety Management Systems (FSMS). It applies across food chain categories like manufacturing, packaging, and logistics, using a risk-based PDCA approach integrated with HACCP principles.
Key Components
- **Three pillarsISO 22000:2018 (FSMS clauses 4-10), sector-specific PRPs (e.g., ISO/TS 22002 series), and FSSC Additional Requirements (e.g., food defense, fraud, allergens).
- Over 100 requirements across governance, operations, and verification.
- Built on ISO harmonized structure; certification via licensed bodies per ISO 22003-1.
Why Organizations Use It
- Meets retailer mandates and enables global market access.
- Reduces recalls, enhances supply-chain trust, and supports SDGs.
- Manages risks like adulteration and contamination; boosts reputation.
Implementation Overview
- Phased: gap analysis, FSMS design, training, audits.
- For food chain organizations worldwide; 6-12 months typical.
- Requires Stage 1/2 audits, surveillance, recertification every 3 years.
Key Differences
| Aspect | RoHS | FSSC 22000 |
|---|---|---|
| Scope | Hazardous substances in EEE materials | Food safety management systems |
| Industry | Electrical/electronic equipment manufacturers | Food chain processing, packaging, storage |
| Nature | Mandatory EU directive for market access | Voluntary GFSI-benchmarked certification scheme |
| Testing | XRF screening, IEC 62321 lab analysis | Internal audits, CB surveillance audits |
| Penalties | Fines, recalls by Member States | Loss of certification, market exclusion |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about RoHS and FSSC 22000
RoHS FAQ
FSSC 22000 FAQ
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