REACH SVHC

Under the European Union's REACH Regulation (EC No 1907/2006), Substances of Very High Concern (SVHC) represent chemical substances identified by the European Chemicals Agency (ECHA) as having hazardous properties that cause severe or irreversible impacts on human health or the environment. When a chemical is formally included on the SVHC Candidate List, specific legal obligations take effect for all importers, manufacturers, and distributors placing physical articles on the European market.

Identifying SVHC presence in consumer products and industrial assemblies requires ongoing supply chain monitoring, material screening, and timely submission of compliance dossiers to ECHA’s centralized SCIP database.

Legal Trigger and the 0.1% w/w Threshold

The presence of an SVHC on the Candidate List triggers statutory duties when its concentration exceeds 0.1% weight by weight (w/w) (1,000 ppm) within a physical item:

• The "Once an Article, Always an Article" (OAAA) Principle: Based on the European Court of Justice ruling (Case C-106/14), the 0.1% w/w threshold is calculated against the weight of each individual sub-component (e.g., a plastic washer, rubber gasket, or circuit board substrate) rather than the overall weight of the assembled product.
• Article 33 Disclosure Obligations: Suppliers must automatically provide commercial customers with sufficient safety data (at minimum, the official chemical name) within 45 days of a request to allow safe use of the product.
• Article 7(2) ECHA Notification: If an SVHC exceeds 0.1% w/w and the total volume imported by an entity exceeds 1 tonne per year across all product lines, a formal chemical notification must be submitted to ECHA.

SCIP Database Mandate under the Waste Framework Directive

To support the EU circular economy and track hazardous chemicals during waste processing, the Waste Framework Directive (Directive 2008/98/EC) mandates SCIP database registration:

• Data Submission Scope: Importers and producers must submit detailed material hierarchy data, primary article identifiers, precise SVHC concentration ranges, and safe-use instructions to ECHA’s SCIP platform prior to placing goods on the EU market.
• SCIP Number Traceability: Generated SCIP submission numbers must be logged in supply chain compliance files and provided to EU retailers and distributors upon request.

Laboratory Screening Protocols for SVHCs

Because the SVHC Candidate List expands twice annually (typically every January and June) and includes over 240+ substances, laboratories utilize targeted screening matrices:

Practical Module: On-Site SVHC Verification & QC Practice

Quality control inspectors conducting Pre-Shipment Inspections (PSI) on goods bound for the European market must execute the following material verification steps on the factory floor:

Step 1: Sub-Component Bill of Materials (BOM) Audit

• Disassemble sample units down to individual homogeneous sub-components to evaluate compliance against the "Once an Article" rule.
• Verify that raw material suppliers have submitted up-to-date Full Material Declarations (FMD) covering the latest ECHA Candidate List iteration.

Step 2: On-Site XRF Heavy Metal Screening

• Scan metallic components (brass inserts, copper connectors, zinc alloy handles) using a calibrated handheld X-Ray Fluorescence (XRF) analyzer to screen for Lead (Pb) exceeding $1,000\text{ ppm}$ ($0.1\%\text{ w/w}$).
• Verify that any sub-components showing trace Lead or Cadmium content are properly flagged in the SCIP dossier file.

Step 3: Material Batch Traceability & Storage Inspection

• Audit factory raw material warehouses to ensure virgin polymers are segregated from unverified recycled plastic resins that could introduce unrecorded SVHC contamination.
• Confirm that outer shipping cartons match batch batch numbers cited on passing third-party laboratory test reports.

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Frequently Asked Questions (FAQ)

Q1: How does the SCIP database requirement differ from a standard REACH test report?

A REACH test report verifies chemical concentrations within test samples at a specific point in time. SCIP registration is a legally mandatory online disclosure database filing required under the EU Waste Framework Directive when an article contains an SVHC above 0.1% w/w, allowing waste operators to track hazardous substances during recycling.

Q2: Can a product with an SVHC content over 0.1% w/w still be legally sold in the EU?

Yes. Unlike REACH Annex XVII restrictions which impose absolute chemical bans, an SVHC candidate listing triggers disclosure and SCIP registration duties. As long as the presence is disclosed under Article 33 and registered in the SCIP database, the product can be imported legally, provided it does not violate specific Annex XVII restriction rules.

Q3: How often is the ECHA SVHC Candidate List updated?

ECHA updates the SVHC Candidate List twice a year, typically in January and June. Importers must continuously review their product lines against new candidate substances added during each update cycle.

Q4: How is the 0.1% w/w threshold calculated for complex assembled products?

Following the "Once an Article, Always an Article" ruling, the 0.1% w/w concentration limit is calculated based on the weight of each individual sub-component (e.g., a single rubber seal or plastic gear), NOT the total weight of the fully assembled machine or device.

Q5: Are packaging materials subject to SVHC screening and SCIP reporting?

Yes. Packaging (such as outer boxes, plastic bags, or blister trays) is treated as a separate article distinct from the product inside. If packaging contains an SVHC exceeding 0.1% w/w, a separate SCIP notification and disclosure must be completed for the packaging item.

References

[1] European Chemicals Agency. Guidance on Requirements for Substances in Articles[R]. Helsinki: ECHA, 2026.   https://echa.europa.eu/

[2] European Parliament and Council. Directive 2008/98/EC on Waste (Waste Framework Directive)[S]. Brussels: Official Journal of the European Union, 2008.  https://eur-lex.europa.eu/

[3] European Court of Justice. Judgment in Case C-106/14: Definition of Articles under REACH[R]. Luxembourg: Court of Justice of the European Union, 2015. https://curia.europa.eu/

Reference Notes

1. ECHA guidelines define statutory responsibilities for managing chemical substances present in finished consumer goods and component parts.
2. The Waste Framework Directive establishes binding requirements for submitting product and SVHC information into the EU SCIP database.
3. The European Court of Justice Case C-106/14 ruling establishes the "Once an Article, Always an Article" precedent for calculating SVHC thresholds on individual sub-components.