At a Glance
• RoHS restricts 10 hazardous substances in electrical and electronic equipment across EU
• REACH regulates over 30,000 chemicals with Annex XVII containing fully banned substances
• SVHC candidate list requires disclosure when substances exceed 0.1% by weight in articles
• 2025 updates include new exemptions for cadmium and lead in specific PVC applications
• Compliance requires testing, certification, and ongoing monitoring of regulatory changes
Understanding REACH and RoHS-compliant materials becomes critical for manufacturers selling in European markets. Both regulations address hazardous substances, but through different approaches and scopes. The RoHS chemicals list contains ten specific restricted substances, while REACH covers broader chemical safety. Professional manufacturers must navigate both frameworks to ensure market access and avoid penalties.
REACH vs RoHS: Understanding the Key Differences
Regulatory Scope and Objectives
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulates all chemicals manufactured or imported in quantities of one tonne or more per year. The regulation affects virtually all industries including chemicals, textiles, electronics, and furniture. REACH aims to improve protection of human health and environment through better identification of chemical properties.
RoHS (Restriction of Hazardous Substances) specifically targets electrical and electronic equipment. The RoHS Directive currently restricts lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). The directive promotes sustainable manufacturing in electronics.
Application Methods and Compliance
The RoHS hit the market on July 1, 2006 with a list of 6 chemicals (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ether). Four additional phthalates were added in 2019. RoHS compliance requires concentration limits below maximum threshold values.
REACH operates through multiple mechanisms including registration, authorization, and restriction. Annex XIV (Authorisation List): Businesses can apply for approval to use listed substances. Annex XVII (Restriction List): Certain uses are completely prohibited or allowed only under strict conditions. Compliance complexity varies by substance classification.
Key Regulatory Differences:
| Aspect | REACH | RoHS |
| Scope | All chemicals, all industries | Electrical/electronic equipment only |
| Substances | 30,000+ chemicals | 10 specific substances |
| Approach | Registration, authorization, restriction | Concentration limits |
| Penalties | Up to €500,000 | Product withdrawal, fines |
RoHS Chemicals List: The 10 Restricted Substances
Heavy Metals and Their Limits
By setting strict limits on substances like lead, mercury, and cadmium, RoHS is driving the global shift toward safer, more sustainable manufacturing. Heavy metal restrictions address toxicity concerns in electronic waste streams.
Lead (Pb) concentration must remain below 1000 ppm in homogeneous materials. Mercury (Hg) limits also stay at 1000 ppm except for specific applications. It also sets limits of 5 ppm mercury and 20 ppm cadmium to batteries except those used in medical, emergency, or portable power-tool devices. Cadmium (Cd) maintains the strictest limit at 100 ppm.
Hexavalent chromium (Cr6+) poses carcinogenic risks requiring 1000 ppm maximum concentration. Testing protocols verify concentration levels in final products. Supplier certification programs ensure upstream compliance.
Flame Retardants and Plasticizers
These restricted substances include heavy metals, flame retardants or plasticizers. Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) face complete prohibition above 1000 ppm. Alternative flame retardant technologies replace these banned substances.
Four phthalate plasticizers joined the restricted list in 2019. DEHP, BBP, DBP, and DIBP must stay below 1000 ppm concentration. These substances affect reproductive health and endocrine systems. Material suppliers develop phthalate-free formulations.
Complete RoHS 10 Substances List:
| Substance | Chemical Symbol | Limit (ppm) | Primary Concern |
| Lead | Pb | 1000 | Neurological damage |
| Mercury | Hg | 1000 | Kidney/brain damage |
| Cadmium | Cd | 100 | Cancer, bone damage |
| Hexavalent Chromium | Cr6+ | 1000 | Cancer, allergies |
| PBB | – | 1000 | Endocrine disruption |
| PBDE | – | 1000 | Developmental toxicity |
| DEHP | – | 1000 | Reproductive toxicity |
| BBP | – | 1000 | Reproductive toxicity |
| DBP | – | 1000 | Reproductive toxicity |
| DIBP | – | 1000 | Reproductive toxicity |
Also Read: Supply Chain Issues Every Chemical Buyer Should Watch—and How to Avoid Them
REACH Compliance Framework
Substances of Very High Concern (SVHC)
REACH requires that manufacturers and importers selling products containing more than 0.1% by weight of substances in the SVHC Candidate List, must provide sufficient information on the safe use of the products. SVHC identification triggers communication obligations throughout supply chains.
If you handle these substances (in any quantity or form), you must: Notify recipients if articles contain SVHCs above 0.1% w/w and provide safe use information. Notification requirements apply within 45 days of customer requests.
The SVHC Candidate List contains over 240 substances requiring ongoing monitoring. Regular updates add new substances based on scientific evidence. Supply chain communication ensures downstream user awareness.
Annex XVII Restricted Substances
The Restriction List, which is also known as Annex XVII of REACH, comprises specific limitations on manufacturing, marketing, or using certain hazardous chemicals. Complete prohibition applies to many consumer product applications.
Typical hazardous substances that are restricted in products include lead, AZO dyes, DMF, PAHs, Phthalates, PFOS, the nickel release and so on. Restrictions vary by application and concentration levels.
Any substance on its own, in a mixture or in an article, subject to a restriction under Annex XVII of REACH, cannot be manufactured, placed on the market or used unless it complies with the conditions of the restriction. Legal compliance becomes mandatory for market access.
2025 Regulatory Updates and Changes
RoHS Exemption Updates
The new directive includes an exemption for cadmium and lead in plastic profiles in electrical and electronic windows and doors containing recovered rigid polyvinyl chloride (PVC). Directive 2024/232 went into effect on January 30, 2024, and the exemption expires on May 28, 2028. Temporary exemptions address recycling challenges.
Building materials containing recovered PVC benefit from extended transition periods. Recycling infrastructure development requires time for compliance alternatives. Exemption expiration dates create deadline pressures for material substitution.
REACH List Expansions
ECHA seeking comments on 6 proposed additions to EU REACH SVHC Candidate List and 2 substances proposed to be added to Annex XVII. Regular updates reflect emerging scientific evidence and risk assessments.
Public consultation processes allow industry input on proposed restrictions. Scientific evaluation supports regulatory decision-making. Implementation timelines provide transition periods for affected industries.
Testing and Certification Requirements
Laboratory Testing Protocols
Accredited laboratories conduct RoHS compliance testing using standardized methods. X-ray fluorescence (XRF) screening provides rapid preliminary results. Wet chemistry analysis confirms final concentration levels. Material decomposition may be required for complex products.
Sample preparation affects testing accuracy significantly. Homogeneous material identification determines testing scope. Non-destructive testing methods preserve product integrity. Chain of custody procedures ensure sample traceability.
Certification and Declaration Requirements
As of July 22, 2019, all businesses in the applicable electrical or electronic value chain that sells indirectly to RoHS-directed countries must limit the use of the 10 hazardous restricted material listed below. Supply chain compliance extends beyond direct manufacturers.
CE marking demonstrates RoHS compliance for electronic products. Technical documentation supports compliance declarations. Declaration of conformity statements verify regulatory adherence. Third-party certification provides additional assurance.
Testing Requirements Summary: • XRF screening for metals detection • Wet chemistry confirmation testing • GC-MS analysis for organic compounds • Sample preparation per IEC 62321 standard • Documentation per EN 50581 requirements
Supply Chain Management for Compliance
Supplier Qualification Programs
Material suppliers must provide compliance documentation. Substance declarations identify potential restricted materials. Supply chain audits verify compliance programs. Alternative material development addresses restriction requirements.
Supplier training ensures understanding of requirements. Regular communication maintains compliance awareness. Contract terms establish compliance responsibilities. Performance monitoring tracks supplier adherence.
Raw Material Controls
Incoming material inspection verifies supplier claims. Batch testing confirms ongoing compliance. Change control procedures address material substitutions. Supplier notifications alert to formulation changes.
Documentation and Traceability
Bill of materials (BOM) management tracks all components. Material composition records support compliance demonstration. Version control maintains current information. Audit trails provide regulatory evidence.
Risk Management and Cost Implications
Compliance Cost Analysis
Testing costs vary by product complexity and material count. Initial certification requires comprehensive material analysis. Ongoing monitoring maintains compliance status. Supply chain qualification adds procurement expenses.
Non-compliance penalties include product withdrawal and market access loss. Reputation damage affects long-term business prospects. Legal costs accumulate during violation proceedings. Insurance coverage may exclude non-compliance claims.
Supply Chain Risk Mitigation
Alternative material development reduces dependency on restricted substances. Supplier diversification prevents single-source risks. Inventory management addresses transition periods. Contingency planning prepares for regulatory changes.
Cost Planning Framework:
| Activity | Typical Cost Range | Frequency |
| Initial Testing | $500-5,000 per product | One-time |
| Ongoing Testing | $200-1,000 per batch | Regular |
| Certification | $1,000-10,000 | Annual |
| Supply Chain Audit | $5,000-25,000 | Biennial |
Global Market Impacts and Harmonization
International Adoption
Many countries adopt RoHS-equivalent regulations following EU precedent. China RoHS, California RoHS, and other regional laws create similar requirements. Harmonization efforts reduce compliance complexity. Global supply chains benefit from consistent standards.
Technical differences between regions require careful evaluation. Testing requirements may vary between jurisdictions. Certification mutual recognition agreements reduce duplicate costs. Professional expertise navigates regional variations.
Market Access Benefits
Compliant products access premium European markets without restrictions. Brand reputation benefits from environmental responsibility. Consumer preference increasingly favors compliant products. Regulatory compliance enables global expansion.
Future Regulatory Trends and Preparations
Emerging Substance Concerns
Scientific research identifies new substances of concern regularly. Endocrine disrupting chemicals receive increased attention. Persistent organic pollutants face growing restrictions. Nanomaterials present novel assessment challenges.
Proactive monitoring identifies potential future restrictions. Research and development focuses on safer alternatives. Supply chain engagement prepares for regulatory changes. Investment planning addresses long-term compliance needs.
Technology and Innovation Opportunities
Green chemistry principles guide safer material development. Advanced analytical methods improve detection capabilities. Digital systems enhance supply chain traceability. Artificial intelligence supports regulatory monitoring.
Conclusion
Achieving reach and rohs compliant status requires comprehensive understanding of both regulatory frameworks and their intersection. The rohs chemicals list provides specific substance restrictions while REACH addresses broader chemical safety concerns. Understanding rohs vs reach differences enables effective compliance strategies that address both requirements simultaneously.
Professional manufacturers benefit from proactive compliance programs that anticipate regulatory changes. Successful compliance requires ongoing investment in testing, supplier management, and alternative material development. Supply chain collaboration ensures comprehensive coverage throughout the value chain.
Elchemy provides comprehensive regulatory compliance support including substance testing, supplier qualification, and alternative material sourcing to help manufacturers achieve and maintain REACH and RoHS compliance across global markets.
