REACH vs RoHS Compliance: A Technical Guide to Chemical Regulations in Manufacturing

Introduction

Industries today face a critical challenge: managing the hidden dangers of chemical substances in everyday products. From the electronics industry to healthcare and beyond, harmful chemicals can affect human health, pollute ecosystems, and damage consumer trust.

To address this, the European Union (EU) introduced two cornerstone regulations:

1. RoHS (Restriction of Hazardous Substances): Focused on reducing toxic materials in electrical and electronic equipment (EEE).
2. REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals): Ensures the safe use of chemicals in all products across industries, from electronics to medical devices.

Both regulations aim to safeguard people and the planet while making businesses accountable for their chemical footprint. However, the scope, purpose, and compliance requirements for RoHS and REACH are different.

This article will:

• Distinguish RoHS and REACH scope
• Explain the substances they restrict.
• Discuss their regulations and compliances
• Discuss penalties, challenges, and more.

Let’s dive deeper into these frameworks that bring out globally acceptable products while minimizing risks and developing consumer trust.

Scope & History: REACH vs RoHS Compliance

The RoHS Directive ROHS 1 was first introduced in 2003 as a response to the mounting electronic waste problem. Many materials used in electronic devices, such as lead and mercury, pose severe risks to human health and the environment. The directive restricted the use of certain hazardous substances in EEE, helping reduce these risks. Over the years, updates like RoHS 2 (2011) and RoHS 3 (2015) have expanded the list of regulated substances and refined compliance requirements.

On the other hand, REACH emerged in 2006 as a far-reaching regulation addressing the risks of chemicals in products used across industries. It requires manufacturers and importers to assess and manage the risks posed by substances in their supply chains. Unlike RoHS, which is specific to electronics, REACH applies to a wide range of products, including textiles, plastics, and cosmetics.

These regulations aren’t just limited to the EU. Their influence has shaped policies globally, with countries like China and the U.S. adopting similar frameworks. For manufacturers, understanding these regulations is key to maintaining market access and protecting consumers.

Here's a list of restricted substances under RoHS [1], along with their permissible limits and typical applications:

Restricted Substances in RoHS

1. Lead (Pb)
   • Applications: Solder, glass in CRTs, and electronic components
   • Hazards: Affects the nervous system, causes developmental issues
2. Mercury (Hg)
   • Applications: Fluorescent lamps, switches, and thermostats
   • Hazards: Toxic to kidneys and nervous systems, bioaccumulative
3. Cadmium (Cd)
   • Applications: Batteries, pigments, and plating materials
   • Hazards: Carcinogenic, causes kidney damage and bone fragility
4. Hexavalent Chromium (Cr6+)
   • Applications: Corrosion-resistant coatings, dyes, and pigments
   • Hazards: Carcinogenic, causes respiratory and skin issues
5. Polybrominated Biphenyls (PBBs)
   • Applications: Flame retardants in plastics and electrical components
   • Hazards: Disrupts endocrine systems, bioaccumulative
6. Polybrominated Diphenyl Ethers (PBDEs)
   • Applications: Flame retardants in plastics and electrical equipment
   • Hazards: Affects the liver, thyroid, and reproductive system
7. Bis(2-Ethylhexyl) Phthalate (DEHP)
   • Applications: Plasticizers in cables, connectors, and PVC components
   • Hazards: Reproductive toxicity, endocrine disruption
8. Butyl Benzyl Phthalate (BBP)
   • Applications: Plasticizers in flooring and cable insulation
   • Hazards: Endocrine disruption, developmental toxicity
9. Dibutyl Phthalate (DBP)
   • Applications: Plasticizers in adhesives and printing inks
   • Hazards: Reproductive and developmental toxicity
10. Diisobutyl Phthalate (DIBP)
    • Applications: Adhesives, coatings, and flexible plastics
    • Hazards: Endocrine disruption, reproductive toxicity

Except for Cd, all substances have a maximum permissible limit of 0.1% (1000 ppm). For Cd, it is 0.01% (100ppm).

In comparison, REACH has a broader scope, covering over 2,200 substances identified as SVHCs (Substances of Very High Concern) [2]. 

These include carcinogens, mutagens, and bioaccumulative toxins such as DEHP (Bis(2-ethylhexyl) phthalate) and BBP (Benzyl Butyl Phthalate). The regulation emphasizes transparency, requiring businesses to inform consumers about SVHCs in their products if concentrations exceed 0.1%.

The ECHA (European Chemicals Agency) maintains a dynamic Candidate List, which industries must monitor to stay compliant. Failure to comply with REACH can result in restricted market access and legal consequences.

RoHS Directive

Sign of recycling or Industrial certificate standard safety logo CE, RoHS, FC.

Before RoHS, hazardous substances in electronics posed severe risks to the environment and human health. When disposed of, these materials could leach into soil and water, contaminating ecosystems. RoHS was a necessary step to minimize these effects, helping industries shift toward safer alternatives.

The RoHS Directive (Restriction of Hazardous Substances) is a key regulation in the electronics industry. Designed by the European Union (EU), it limits the use of hazardous materials in electrical and electronic equipment (EEE).

Impact of the RoHS Directive

The directive has reshaped the way the industry operates, encouraging innovation while reducing environmental harm. Here’s how it has made a difference:

• Cleaner Manufacturing Practices: Manufacturers now prioritize sourcing RoHS-compliant materials, leading to greener production methods.
• Innovation: Companies have developed alternatives to banned substances, driving technological advancements.
• Global Standards: The directive has influenced similar regulations worldwide, such as China RoHS and California’s Proposition 65.

The RoHS Directive has a broad scope, impacting numerous categories of electrical and electronic equipment (EEE) as outlined by the WEEE Directive. From household appliances to specialized medical devices, RoHS ensures the reduction of hazardous materials in these products, safeguarding human health and the environment. Here's a breakdown of the affected product categories:

1. Large Household Appliances
   Includes refrigerators, washing machines, stoves, and air conditioners—essential electronics in every home.
2. Small Household Appliances
   Covers vacuum cleaners, hair dryers, coffee makers, and irons, making everyday tasks safer and eco-friendlier.
3. Computing & Communication Equipment
   Encompasses computers, printers, phones, satellite TVs, antennas, and cell tower equipment, critical to modern connectivity [3].
4. Consumer Electronics
   Features TVs, DVD players, stereos, and video cameras—common entertainment devices now adhering to safer standards.
5. Lighting Equipment
   Includes lamps, lighting fixtures, and light bulbs (excluding some exempt fluorescent lamps).
6. Electrical and Electronic Tools
   Covers drills, saws, nail guns, and trimmers, ensuring compliance in equipment used for professional and domestic purposes.
7. Toys, Leisure, and Sports Equipment
   Includes video games, fitness trackers, talking dolls, and treadmills, addressing the safety of recreational products.
8. Medical Devices
   Includes diagnostic tools and in-vitro diagnostic devices (IVDs), ensuring health-related electronics are safer.
9. Monitoring and Control Instruments
   Features smoke detectors, fire alarms, and industrial control systems, highlighting the safety in essential equipment.
10. Automatic Dispensers
    Covers vending machines and ATMs, frequently used in public spaces.
11. Catch-All Category
    Includes products like electric two-wheelers, e-cigarettes, vaporizers, vape pens, and cables with working voltages below 250V.

You can read more on this here [4].

Suggested Readings: NiMH vs Lithium Ion Batteries: A Comprehensive Comparison for Engineers

REACH Regulations

REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is a regulation that governs the use and management of chemicals in the European Union. 

Its primary purpose is to protect human health and the environment by ensuring the safe use of chemicals throughout their lifecycle. Unlike RoHS, which focuses on hazardous substances in electronic products, REACH applies to all chemical substances, whether they are used in manufacturing or consumer products.

The REACH Regulation requires companies to register chemicals with the European Chemicals Agency (ECHA) if they manufacture or import over one ton annually. These chemicals are evaluated for potential risks, and if necessary, specific authorization or restrictions are applied to chemicals that pose significant threats to health or the environment.

Key Elements of REACH:

1. Registration
   All manufacturers or importers must register chemicals with ECHA, providing detailed information on the chemical’s properties, uses, and risks. This process helps authorities evaluate whether a substance could be harmful to health or the environment.
2. Evaluation
   ECHA evaluates the information submitted by manufacturers. If concerns arise regarding a chemical’s safety, further testing may be required. The evaluation helps ensure that harmful chemicals are controlled or substituted with safer alternatives.
3. Authorisation
   Substances of Very High Concern (SVHC) are identified and placed on the Candidate List. If these substances are used in a product, the company must inform consumers and customers, and, in some cases, authorization must be obtained to use these chemicals. Once authorized, the substance is carefully monitored for its continued safe use.
4. Restriction
   Some chemicals may be subject to restrictions under REACH. These are chemicals that pose unacceptable risks to health or the environment, and their use may be banned or restricted in certain applications.

RoHS Compliance

'REACH compliance' and RoHS compliant vector icon set with tick mark, green in colr

Compliance with the RoHS directive isn’t just a legal checkbox—it’s about ensuring your products are safer for users and the planet. For businesses, it’s also a critical step toward building trust and avoiding penalties. With the goal of reducing harmful e-waste and minimize the environmental footprint of modern technology, the RoHS directive (Restriction of Hazardous Substances) primarily limits the use of certain hazardous materials in electrical and electronic equipment (EEE). 

It’s a systematic process requiring careful sourcing, testing, and documentation.

Steps to Ensure RoHS Compliance

1. Product Design and Materials Evaluation
   Manufacturers must assess their products' materials, components, and design to ensure they do not contain any of the restricted substances. This is often the first step in RoHS compliance, as identifying materials early in the design phase reduces the likelihood of using restricted substances.
2. Testing and Documentation
   Products need to be tested for RoHS compliance. Manufacturers typically work with testing labs to analyze the concentration of restricted substances. The results must then be documented and submitted. Compliance documentation should include:
3. Technical documentation that demonstrates the materials and components used do not exceed the limits set by RoHS.
4. Declaration of Conformity (DoC), which is a formal statement that the product meets the RoHS requirements.
5. CE Marking
   The CE mark is a symbol that indicates compliance with various EU regulations, including RoHS. To affix the CE mark, manufacturers must provide evidence that their product meets RoHS standards. This ensures that the product can be legally sold in the EU market.
6. Post-Market Surveillance
   Even after a product is sold, manufacturers and importers must ensure ongoing compliance. This can involve random inspections, internal audits, or further testing, depending on the product category and market regulations.
7. Stay Updated: Monitor changes to the EU directive and adapt your processes as new requirements emerge. Subscribing to updates from the European Commission can help you stay ahead.

By following these steps, manufacturers can prove RoHS compliance, protect consumer health, and support the global push for environmental sustainability. The emphasis on eliminating harmful substances is pivotal in reducing electronic waste and its adverse environmental impact.

REACH Compliance

To achieve REACH compliance, businesses must ensure that their products and chemicals adhere to REACH’s regulatory requirements. Compliance involves multiple steps, including registration, evaluation, and authorisation processes. For companies involved in manufacturing or selling chemicals and products containing chemicals in the EU, adherence to REACH is mandatory.

Steps to Ensure REACH Compliance:

1. Chemical Registration
   Manufacturers must register chemicals used in their products with ECHA, including full details of the chemical’s properties, potential risks, and safe use. Registration is required for any substance manufactured or imported in quantities greater than 1 ton per year.
2. SVHC Notification
   Companies must notify ECHA if they use any Substances of Very High Concern (SVHC). They must inform customers if the substance is present in products in concentrations exceeding 0.1% by weight.
3. Authorization
   If a product contains a substance that requires authorisation under REACH, businesses must apply for permission to continue using it. This is particularly important for high-risk chemicals that are critical for specific applications.
4. Ongoing Monitoring
   Compliance with REACH is not a one-time event. Companies must regularly monitor their use of chemicals and ensure they are up to date with any changes to the REACH regulation or the addition of new substances to the Candidate List.

Failure to comply with REACH can result in product recalls, significant fines, or prohibited market access within the EU. Thus, businesses must prioritize chemical safety and ensure compliance to safeguard both the environment and human health.

Documentation Requirements

REACH requires detailed dossiers, including substance identification, safety data sheets (SDS), and exposure assessments. RoHS mandates technical documentation such as conformity declarations, test reports, and risk assessments to ensure material compliance.

Technical Comparison Table

Challenges and Penalties for RoHS and REACH Compliance

Challenges in RoHS Compliance

Staying RoHS compliant isn’t as simple as ticking off a checklist. Manufacturers face the challenge of ensuring every component down to the homogeneous material level meets the regulations. Homogeneous materials, by definition, cannot be mechanically separated, which means a product must be tested thoroughly. This complicates sourcing, especially when working with a vast supplier network.

Another major challenge lies in the constant updates to the directive. With the introduction of RoHS 2 and RoHS 3, new restricted substances like phthalates were added to the list. Companies must continuously adapt, which requires significant investment in material testing, redesign, and updating technical documentation. For example, electronics industry leaders often have to phase out entire product lines because certain banned substances cannot be replaced without compromising performance.

For global businesses, dealing with different interpretations of the EU directive across member states also adds complexity. While one state may enforce stricter penalties, others might have a more lenient approach, making harmonization tricky.

Challenges in REACH Compliance

The REACH regulation, governed by the European Chemicals Agency (ECHA), presents a broader scope of difficulties due to its focus on both chemical substances and mixtures. Identifying Substances of Very High Concern (SVHCs) in supply chains requires extensive collaboration with suppliers worldwide.

REACH’s candidate list is updated frequently, and each update can potentially disrupt operations. For instance, a new SVHC designation could trigger bans or usage restrictions, forcing companies to search for safer alternatives. This is particularly difficult for industries relying on specific substances that are hard to substitute without increasing costs or decreasing performance.

Moreover, REACH compliance becomes a significant financial burden for small and medium enterprises. Companies must perform rigorous chemical testing, prepare extensive documentation, and ensure traceability of substances used—tasks that require both time and technical expertise.

Penalties for Non-Compliance

Both RoHS and REACH regulations impose strict penalties for non-compliance, including fines, product recalls, and bans from the EU market.

For RoHS, non-compliance often results in hefty fines or suspension of product sales in member states. Products failing to meet the directive may also face CE marking bans, leading to damaged brand reputation and financial loss. For example, a high-profile tech manufacturer once faced product recalls across Europe due to failing RoHS standards for lead usage, costing millions in lost revenue and legal fees.

Under REACH, companies face even more severe consequences. Penalties vary by member states, but non-compliance can lead to criminal charges, fines reaching millions of euros, and complete bans on product distribution. Additionally, failure to declare SVHCs or report their usage to the ECHA often results in public exposure, tarnishing brand credibility.

Implementation Mechanisms

Testing Methodologies

Substance detection requires advanced analytical techniques such as gas chromatography-mass spectrometry (GC-MS), inductively coupled plasma mass spectrometry (ICP-MS), and X-ray fluorescence (XRF). These methods ensure precise identification and quantification of restricted substances at trace levels.

Sampling requirements dictate representative material extraction to reflect overall compliance. Sampling protocols often follow statistical sampling methods, with samples subjected to homogenization to ensure consistency across tests.

Sampling and testing procedure (ASCII Diagram):

+-------------------+     +------------------+     +--------------------+
| Sample Collection | --> | Homogenization   | --> | Analytical Testing |
+-------------------+     +------------------+     +--------------------+
          |                                |                     |
          v                                v                     v
+-------------------+     +------------------+     +--------------------+
| Visual Inspection |     | Pre-Treatment    |     | Report Generation  |
+-------------------+     +------------------+     +--------------------+

Reporting Process Flowchart

+------------------+     +---------------------+     +---------------------+
| Collect Data     | --> | Validate Accuracy   | --> | Prepare Reports      |
+------------------+     +---------------------+     +---------------------+
          |                            |                              |
          v                            v                              v
+------------------+     +---------------------+     +---------------------+
| Format to Standard| --> | Submit to Authorities| --> | Archive Records     |
+------------------+     +---------------------+     +---------------------+

Templates for Technical Documentation

Example REACH Registration Dossier Template

1. Substance Identification
   1. CAS number
   2. Molecular structure
2. Manufacturer Information
   1. Company details
   2. Production volumes
3. Hazard Assessments
   1. Toxicological data
   2. Ecotoxicological data
4. Exposure Scenarios
   1. Risk control measures

Example RoHS Declaration of Conformity Template:

1. Product Identification
   1. Model and serial number
2. Compliance Standards
   1. Directive 2011/65/EU
3. Testing Evidence
   1. Laboratory reports
   2. Material certifications
4. Manufacturer’s Signature
   1. Name and date

Practical Implementation Guide

Compliance Testing Procedures

Step-by-step testing protocols for compliance include:

1. Identify relevant materials or components subject to regulation.
2. Conduct a preliminary review of supplier-provided data and material certifications.
3. Perform laboratory testing using approved techniques such as GC-MS or XRF.
4. Document all findings, ensuring results are traceable to specific batches.
5. Cross-reference test results with regulatory concentration thresholds.

Technical Checklist for Compliance Verification

• Verify that all materials meet regulatory thresholds.
• Ensure supplier documentation aligns with test results.
• Confirm testing was performed at certified laboratories.
• Review the completeness of documentation for traceability.

Laboratory Requirements and Standards

• Laboratories must be ISO 17025 accredited.
• Testing equipment must undergo regular calibration.
• Standard operating procedures must align with regulatory requirements.

Quality Control Measures and Tolerances

• Implement batch-specific quality control checks.
• Define tolerances for measurement uncertainty based on regulatory standards.
• Ensure all deviations are documented and investigated.

Supply Chain Integration

Technical Requirements for Supplier Documentation

• Require certificates of conformity and test reports for all supplied materials.
• Mandate declarations of compliance for regulatory thresholds.
• Ensure suppliers provide documentation in an accessible format.

Supplier Assessment Framework

• Evaluate supplier compliance history.
• Conduct on-site audits to verify documentation and practices.
• Establish criteria for performance monitoring and improvement.

Data Collection and Verification Procedures

• Implement centralized data collection systems.
• Validate data against independent testing results.
• Ensure all data is retained in a secure, auditable format.

Communication Protocols and Standards

• Establish clear channels for supplier communication regarding updates and requirements.
• Use standardized formats for reporting and feedback.
• Schedule regular compliance status meetings with suppliers.

Conclusion

REACH and RoHS differ fundamentally in their scope and focus. REACH regulates all chemicals in the EU market, requiring detailed assessments for substances of very high concern (SVHC) and full lifecycle evaluations. RoHS specifically targets hazardous substances in electrical and electronic equipment, enforcing strict concentration limits and material-specific exemptions.

Critical compliance requirements include thorough testing and documentation for both regulations. REACH mandates the preparation of safety data sheets, exposure scenarios, and registration dossiers, while RoHS focuses on declarations of conformity and material compliance testing. 

Frequently Asked Questions

1. What are the key techniques for detecting restricted substances?

Gas Chromatography-Mass Spectrometry (GC-MS), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), and X-Ray Fluorescence (XRF) are widely used for accurate substance detection.

2. Are non-destructive methods acceptable?

XRF is commonly used for preliminary screening due to its non-destructive nature, but confirmatory tests may require destructive methods.

3. How is compliance verified?

By conducting material tests, reviewing supplier documentation, and maintaining traceable records of compliance data.

4. What role do supply chain audits play?

Audits ensure suppliers adhere to regulatory requirements and provide valid documentation.

5. What documents are necessary for REACH compliance?

Safety Data Sheets (SDS), exposure scenarios, and registration dossiers.

6. What is required for RoHS compliance?

Declarations of conformity, test reports, and risk assessments.

References

[1] ECHA. ROHS Directive - Restricted Substances as per Article 4(1), Annex II. Link

[2] REACH 2025 Restricted Chemical List (Annex XVII). Link

[3] Wevolver. Duplexer vs Diplexer: A Technical Guide to RF Signal Management Components. Link

[4] iLenSys. RoHS Directive. Link