Graphic Overlay Regulatory Compliance: UL, CE, RoHS, REACH Guide 2026

Overview of Regulatory Compliance for Overlays

Graphic overlays used in consumer electronics, medical devices, industrial equipment, and other applications must comply with regional and industry-specific regulations governing material safety, environmental impact, flammability, and product marking.

Non-compliance can result in product recalls, market access restrictions, legal liability, and damage to brand reputation—making regulatory due diligence essential during material selection and supplier qualification.

This guide explains key regulatory requirements and provides practical guidance for ensuring graphic overlay compliance across global markets.

Common Regulatory Standards

• UL (Underwriters Laboratories): Safety certification and material flame ratings for North American markets.
• RoHS (Restriction of Hazardous Substances): European directive limiting heavy metals and hazardous substances in electrical equipment.
• REACH (Registration, Evaluation, Authorization of Chemicals): European regulation controlling chemical substances and requiring SVHC disclosure.
• CE Marking: European conformity marking indicating compliance with applicable EU directives and regulations.
• FDA (Food and Drug Administration): US regulatory requirements for medical devices and food-contact materials.

UL Recognition and Flame Ratings

UL (Underwriters Laboratories) provides independent safety certification for materials and components used in electrical equipment sold in North America.

UL Material Recognition

• UL Yellow Card: Document certifying material meets UL safety standards; includes flame rating, electrical properties, and application limitations.
• File Number: Unique identifier (e.g., E12345) for tracking material certification in UL database.
• Supplier provides UL Yellow Card as evidence of recognition; verify file number authenticity on UL website.

UL 94 Flame Ratings

UL 94 standard classifies material flammability; higher ratings indicate better fire resistance.

Application Requirements

• Consumer Electronics: UL 94 HB minimum; V-0 preferred for devices near heat sources or high-power components.
• Industrial Equipment: V-1 or V-0 typical for safety-critical applications.
• Medical Devices: V-0 often required; verify with device classification and standards (IEC 60601).
• Automotive: V-0 or equivalent FMVSS 302 compliance for interior components.

Obtaining UL Recognition

Material suppliers submit samples to UL for testing; UL issues Yellow Card upon successful evaluation. Customers verify supplier's UL file number matches material supplied.

Custom formulations or material changes require re-testing and new UL file number.

RoHS and Material Restrictions

RoHS (Restriction of Hazardous Substances Directive 2011/65/EU) restricts use of specific hazardous materials in electrical and electronic equipment sold in European Union and many other jurisdictions.

Restricted Substances and Limits

RoHS Compliance Verification

• Request RoHS Declaration of Conformity from material supplier; document must specify compliance with RoHS 3 (Directive 2015/863 including phthalates).
• Verify supplier conducts material testing via XRF (X-Ray Fluorescence) or ICP-MS (Inductively Coupled Plasma Mass Spectrometry).
• Maintain compliance documentation for regulatory audits and customer verification.

Global RoHS Adoption

• China RoHS: Similar restrictions; requires marking and material disclosure.
• South Korea RoHS: Equivalent substance restrictions.
• California Prop 65: Warning requirements for products containing listed chemicals (overlaps with RoHS substances).

REACH and SVHC Compliance

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is European regulation requiring registration of chemical substances and disclosure of Substances of Very High Concern (SVHC).

SVHC Candidate List

• European Chemicals Agency (ECHA) maintains continuously updated list of SVHCs (currently 200+ substances).
• If SVHC concentration >0.1% by weight in article, supplier must communicate presence to customers and EU authorities.
• Common SVHCs in plastics: certain phthalates, brominated flame retardants, lead compounds, bisphenol A.

REACH Compliance Requirements

• Request REACH Declaration from supplier; must state whether SVHCs are present above 0.1% threshold.
• If SVHCs present, obtain Safety Data Sheet (SDS) and substance identity information.
• Update declarations annually as ECHA adds new substances to Candidate List (2x per year).

SCIP Database Notification

• As of January 2021, companies supplying articles containing SVHCs >0.1% in EU must submit information to SCIP (Substances of Concern In articles as such or in complex objects) database.
• Applies to finished products containing overlay; overlay supplier typically provides SCIP-relevant data to product manufacturer.

CE Marking and European Requirements

CE marking indicates product conforms to applicable EU directives and regulations, allowing free movement within European Economic Area.

Relevant EU Directives for Products with Overlays

• Low Voltage Directive (LVD 2014/35/EU): Electrical safety for products 50–1,000V AC or 75–1,500V DC.
• Electromagnetic Compatibility (EMC) Directive 2014/30/EU: Emission and immunity requirements.
• RoHS Directive 2011/65/EU: Material restrictions (discussed above).
• REACH Regulation (EC) 1907/2006: Chemical substance controls.
• Medical Devices Regulation (MDR 2017/745): For medical device applications.

Overlay's Role in CE Marking

• Graphic overlay is component of finished product; does not carry CE mark itself.
• Product manufacturer responsible for CE marking and Declaration of Conformity.
• Overlay supplier provides supporting documentation: RoHS/REACH declarations, material certifications, test reports enabling product-level compliance.

Technical Documentation Requirements

• Material data sheets and specifications.
• RoHS and REACH compliance declarations.
• UL or equivalent safety certifications if applicable.
• Flammability test reports (UL 94 or equivalent).
• Chemical composition information for risk assessments.

FDA and Medical Device Compliance

Graphic overlays used in medical devices must comply with FDA requirements for material safety and biocompatibility.

FDA Material Requirements

• Biocompatibility: ISO 10993 testing for skin contact or short-term tissue contact (cytotoxicity, sensitization, irritation).
• Master File: Some material suppliers maintain Device Master File (MAF) with FDA containing confidential manufacturing and safety data.
• Change Control: Material changes require FDA notification if device already 510(k) cleared or PMA approved.

Cleaning and Disinfection Compatibility

• Materials must withstand approved cleaning and disinfection protocols without degradation.
• Test compatibility with hospital-standard disinfectants (alcohol, bleach, quaternary ammonium compounds).
• Document cleaning validation data for submission to FDA.

Labeling Requirements

• Medical device overlays often include required FDA labeling: device name, manufacturer, UDI (Unique Device Identifier), warnings, instructions.
• Labels must be durable, legible, and permanent throughout device life.
• Verify ink and print durability through accelerated aging and cleaning cycle testing.

Compliance Documentation and Certificates

Maintaining organized compliance documentation streamlines regulatory audits, customer verification, and supply chain management.

Essential Documents to Request from Suppliers

• ☐ RoHS Declaration of Conformity: Specify RoHS 3 compliance including phthalates.
• ☐ REACH Declaration: Confirm no SVHCs above 0.1% or provide substance list if present.
• ☐ UL Yellow Card: If UL recognition required; verify file number authenticity.
• ☐ Material Safety Data Sheet (SDS/MSDS): Chemical composition and safety information.
• ☐ California Prop 65 Declaration: For sales in California; confirms compliance or provides warning language.
• ☐ Conflict Minerals Declaration: If applicable under Dodd-Frank Act (rare for overlays).
• ☐ ISO 10993 Test Reports: Biocompatibility data for medical device applications.
• ☐ Material Composition Statement: List of materials, additives, and substances for risk assessment.

Document Management Best Practices

• Centralized repository for all compliance documents organized by material and supplier.
• Annual review cycle to update declarations as regulations change (REACH SVHC list updates 2x/year).
• Version control for material specifications; track changes requiring re-verification.
• Supplier audit schedule to verify ongoing compliance and testing programs.

Customer Communication

• Proactively provide compliance declarations with every order or upon request.
• Update customers promptly if regulatory status changes (new SVHC identified, material formulation updated).
• Maintain customer-specific compliance packages for different market requirements (EU, US, China, etc.).

Frequently Asked Questions

Do graphic overlays require UL certification?

Overlays don't require UL certification themselves, but material should have UL recognition (Yellow Card) if used in UL-certified end products. Verify with product manufacturer whether UL-recognized materials required.

What is the difference between RoHS and REACH?

RoHS restricts specific hazardous substances (heavy metals, flame retardants, phthalates) in electrical equipment. REACH is broader regulation governing all chemicals, requiring registration and disclosure of Substances of Very High Concern (SVHCs) above 0.1%.

Both apply to overlays in EU; compliance requires separate declarations.

How do I verify my supplier's compliance claims?

Request compliance declarations and test reports; verify UL file numbers on UL.com; check REACH SVHC list updates on ECHA website; consider third-party testing for high-risk applications. Conduct supplier audits for critical components.

Do compliance requirements differ by country?

Yes—EU has RoHS/REACH; US has FDA for medical, California Prop 65; China has China RoHS; South Korea has K-RoHS. Many requirements similar but not identical. Maintain region-specific compliance documentation for target markets.

What happens if my overlay material doesn't comply?

Non-compliant materials can result in: product recalls; inability to sell in regulated markets (EU, US); legal liability; customs seizures; brand damage. Verify compliance before production; switch to compliant materials if issues discovered.