- What is RoHS?
- Is RoHS Compliance Mandatory?
- Who Needs RoHS Compliance?
- What Are the RoHS Product Categories?
- What Were the Hazardous Substances in RoHS Directive (2002/95/EC)?
- What Makes a Product RoHS Compliant in EU CE Marking?
- How to Get a RoHS Certificate?
- What is REACH?
- What Does REACH Cover?
- Which Countries Does EU REACH Apply To?
- What Are the REACH Compliance Requirements?
- What is the Difference Between REACH and RoHS?
- REACH Certificate: How to Obtain It?
- What is SASO?
- What is a SASO Certificate of Conformity?
- What Are the SALEEM and SABER Systems?
- What Products Need a SASO Certificate?
- What Is SALEEM?
- How to Get a SASO Certificate via SABER Platform?
- What is Proposition 65?
- What Types of Chemicals Are on the Proposition 65 List?
- What Does a Proposition 65 Warning Mean?
- Who Administers and Enforces Proposition 65?
- What Are the Penalties for Violating Proposition 65?
- Summary & Why Choose Welle Inspection?
- FAQ: Global Product Compliance
Exporting products globally means navigating a complex mix of regulations. RoHS and REACH in the EU, Proposition 65 in the US, and SASO standards in the Middle East each have their own restricted substances, certification requirements, and documentation. For many businesses, it can be difficult to know which products need compliance and how to prove it.
Limited access to proper testing facilities or expertise makes it challenging to verify RoHS compliance, meet REACH SVHC requirements, provide Proposition 65 warnings, or obtain a SASO Certificate of Conformity. These steps often require lab testing, chemical analysis, and careful documentation, which can be time-consuming and resource-intensive.
Non-compliance can lead to shipment delays, fines, product recalls, or reputational damage, emphasizing the need for professional guidance and reliable testing solutions to ensure smooth market access.
What is RoHS?
RoHS, or the Restriction of Hazardous Substances, is an EU directive (2002/95/EC, updated to RoHS 2 and 3) that limits hazardous materials such as lead, mercury, cadmium, hexavalent chromium, PBB, and PBDE in electrical and electronic equipment (EEE). Its goal is to reduce environmental and health risks and promote safer, eco-friendly electronics.
RoHS applies to manufacturers, importers, distributors, and authorized representatives of EEE, covering consumer electronics, appliances, and industrial equipment. Compliance is mandatory in the EU and recognized in regions including the UAE, China, Singapore, Turkey, Saudi Arabia, and some U.S. states like California. Non-compliance can result in legal penalties, shipment delays, or recalls, making proper RoHS testing, certification, and documentation essential.
Is RoHS Compliance Mandatory?
Yes. RoHS compliance is mandatory for all electrical and electronic equipment (EEE) sold in the European Union. Any product that falls within the scope of Directive 2011/65/EU must meet the substance restriction limits before entering the EU market.
Manufacturers, importers, and distributors are legally responsible for ensuring that their products do not contain restricted hazardous substances above allowable thresholds. Non-compliant products may be refused entry at customs, recalled from the market, or lead to fines and brand damage
Who needs RoHS compliance?
RoHS compliance applies to manufacturers, importers, and distributors of electrical and electronic equipment (EEE) covered by the directive. This includes consumer electronics such as smartphones, tablets, laptops, TVs, and digital cameras, as well as household appliances like refrigerators, washing machines, and microwave ovens. Industrial equipment with electronic components, medical devices including diagnostic and imaging systems, telecommunication devices, automotive electronics, and lighting products such as LED bulbs and fluorescent lamps must also comply. Certain aerospace and defense electronics and scientific instruments are included as well.
Some equipment may be exempt, particularly items for military purposes, space applications, or devices designed solely for research and development on a business-to-business basis. Compliance ensures products meet legal requirements, reduce environmental and health risks from hazardous substances, and avoid shipment delays, fines, or recalls. Products like FC RoHS wireless chargers, motherboards, and earphones illustrate the wide range of items requiring RoHS adherence.
What Are the RoHS Product Categories?
RoHS applies to a broad range of electrical and electronic equipment, including household appliances, IT and communication devices, consumer electronics, lighting products, electrical tools, toys, and automated dispensing equipment. In the EU market, almost all products that contain electrical or electronic components fall under RoHS, which means items such as refrigerators, washing machines, computers, smartphones, televisions, LED lighting, electric toys, and similar devices must comply with the substance restrictions. Medical devices and monitoring instruments have also been included since July 22, 2021. In general, any product with electrical functionality that fits into these regulated categories is required to undergo RoHS testing before it can be sold in Europe. For more detailed information, you can refer to our RoHS Guide or explore common questions related to RoHS compliance.
What Were the Hazardous Substances in Rohs Directive?
The original directive (2002/95/EC) known as RoHS created restrictions for six key hazardous substances:
Substance | Limit |
Lead (Pb) | 0.1% |
Cadmium (Cd) | 0.01% |
Mercury (Hg) | 0.1% |
Hexavalent Chromium (CR VI) | 0.1% |
Polybrominated biphenyls (PBBs) | 0.1% |
Polybrominated Diphenyl Ethers (PBDEs) | 0.1% |
Manufacturers must conduct testing or obtain laboratory reports to prove these substances do not exceed allowed thresholds in any homogeneous material used in the product.
What makes a product RoHS compliant in EU CE marking?
A product is considered RoHS-compliant when it adheres to the requirements and regulations outlined in the RoHS directive. To make a product RoHS compliant, manufacturers, importers, and distributors must take several steps to ensure that it does not contain restricted hazardous substances above the allowable limits and meets the necessary documentation and labeling requirements. Here are the key elements that contribute to RoHS compliance:
Material Assessment
Manufacturers must thoroughly analyze the materials and components used in their products to identify any substances that fall under the RoHS directive’s restrictions. This involves assessing the presence of lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr6+), polybrominated biphenyls (PBBs), polybrominated diphenyl ethers (PBDEs), and the four phthalates (DEHP, BBP, DBP, DIBP) in their products.
Substance Testing
If there is uncertainty about the presence of restricted substances, testing may be necessary to determine their concentrations in the materials and components used in the product. Laboratory testing can provide quantitative data on substance concentrations.
Material Declarations
Manufacturers often require declarations from their suppliers regarding the compliance of materials and components used in their products. These declarations provide information about substance content and help establish compliance.
Documentation
Manufacturers must maintain detailed records of their compliance assessments, including material declarations, test reports, and compliance certificates. These records demonstrate due diligence in ensuring RoHS compliance.
Declaration of Conformity
Manufacturers or their authorized representatives must issue a Declaration of Conformity (DoC) for the product. The DoC confirms that the product complies with RoHS requirements and includes information about the product, the manufacturer, and the substances it restricts.
CE Marking
If the product is also subject to other European Union directives, it may require CE marking to indicate compliance. RoHS compliance is often part of the broader CE marking process.
Labeling
Products may need labeling to indicate RoHS compliance, typically by using a “CE” mark if applicable and by providing information that helps trace the product back to the manufacturer.
Traceability
Manufacturers should establish and maintain traceability of their products to ensure that any non-compliant products can be identified and addressed.
Ongoing Compliance Monitoring
Manufacturers should implement procedures to ensure continuous compliance, including periodic testing, supplier assessments, and updates to product documentation as regulations change.
It’s essential for manufacturers and other stakeholders to stay informed about any updates or changes to RoHS regulations and to regularly review and update their compliance processes to ensure that their products continue to meet RoHS requirements.
How to Get a RoHS Certificate?
Obtaining a RoHS certificate of compliance generally involves a series of steps to ensure that products meet EU RoHS 2 compliance requirements. The process begins with material analysis to detect any restricted substances, followed by RoHS testing in accredited laboratories. After testing, a RoHS compliance statement or Declaration of Conformity is prepared, and finally, a certificate is issued for products that meet the directive. Proper testing ensures that electronics, lighting, and other consumer goods adhere to the substance restrictions, including applicable exemptions and documentation requirements.
Many exporters and manufacturers work with third-party testing and certification providers to streamline this process. These experts can thoroughly evaluate material declarations, guide clients through regulatory requirements, and ensure accurate documentation for RoHS-compliant products. Partnering with experienced compliance services helps businesses navigate the EU regulations efficiently and reduces the risk of delays, fines, or shipment rejections.
Struggling With RoHS Testing or Documentation?
What is REACH?
REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is a European Union regulation (EC 1907/2006) introduced in 2006 to protect human health and the environment from the risks of hazardous chemicals. It applies to substances in products, mixtures, and articles, with a focus on Substances of Very High Concern (SVHCs), which may be carcinogenic, mutagenic, toxic to reproduction, or bioaccumulative.
Under REACH, companies must register all chemical substances they manufacture or import into Europe in quantities above one tonne per year, assess potential risks to human health or the environment, and provide safety information to ensure these chemicals are used safely. The European Chemicals Agency (ECHA) publishes and regularly updates a list of restricted substances, and SVHCs cannot exceed 0.1% of the total product weight without authorization. Compliance helps companies avoid financial and legal penalties, recalls, and ensures safe market access within the EU.
What does REACH cover?
REACH compliance applies to all chemical substances manufactured, sold, imported, or used within the European Union. This includes substances on their own, mixtures such as adhesives, paints, and cleaning products, as well as articles like electronics, textiles, and furniture. By covering both raw chemicals and finished products, REACH ensures that potential risks to human health and the environment are managed across the entire supply chain.
Which countries does EU REACH apply to?
EU REACH compliance is required across all European Union member states and extends to countries in the European Economic Area (EEA), including Iceland, Liechtenstein, and Norway. Certain micro-states, such as Andorra, Monaco, and San Marino, are also subject to REACH through bilateral agreements, while Switzerland has adopted some elements of the regulation. Companies exporting to the UK or Turkey must follow similar regulatory frameworks, such as UK REACH, to ensure their products meet local chemical compliance requirements.
What Are the REACH Compliance Requirements?
Assessing Your Supply Chain for Restricted Substances
REACH compliance requires companies to meet several essential obligations throughout the entire supply chain and product lifecycle. The process begins with assessing products and suppliers for the use of chemicals restricted or controlled under REACH. Companies collect data through Full Material Declarations, certificates, safety data sheets, and test reports to determine whether substances of concern are present and in what quantities, as many substances are subject to total bans or threshold limits.
Managing Substances of Very High Concern (SVHC)
Substances of Very High Concern (SVHC) that exceed 0.1% require communication down the supply chain, provision of safety information to customers, and submission of a SCIP notification. Manufacturers and importers who produce or import more than one tonne of a substance per year must register it with the European Chemicals Agency (ECHA), providing information on the substance’s identity, intended uses, chemical safety assessments, and exposure scenarios across production, use, and disposal stages. Certain SVHCs may require authorization or be subject to usage restrictions, and companies must seek authorization or identify alternatives where applicable.
ECHA Evaluation and Dossier Review
Once registration dossiers are submitted, ECHA evaluates them for completeness, accuracy, and risk information, and may request additional testing or data to ensure compliance.
Communicating Down the Supply Chain
Continuous communication within the supply chain is critical, including providing up-to-date Safety Data Sheets (SDS) to downstream users and informing suppliers and customers of any changes in substance composition or classification.
Staying Updated with REACH Regulations
As REACH regulations evolve, companies must stay informed of updates, deadlines, and amendments, often leveraging third-party experts to maintain compliance and ensure all registration dossiers accurately reflect current substance volumes, uses, and compositions.
What is the Difference Between REACH and RoHS?
Category | RoHS | REACH |
Regulatory Type | EU Directive (2011/65/EU) | EU Regulation (EC 1907/2006) |
Scope | Applies only to Electrical and Electronic Equipment (EEE) | Applies to all chemicals in all products (with limited exemptions) |
Assessment Level | Homogeneous material level | Article level |
Main Objective | Restrict hazardous substances in electronic products | Manage chemical safety through registration, evaluation, authorization, and restriction |
Controlled Substances | Lead, mercury, cadmium, Cr6+, PBB, PBDE + 4 phthalates (DEHP, BBP, DBP, DIBP) | SVHCs, restricted chemicals, substances requiring authorization |
Industries Covered | Consumer electronics, household appliances, lighting, some automotive electronics, medical devices | All industries: electronics, textiles, coatings, plastics, furniture, packaging, chemicals, machinery |
Registration Required | No | Yes — required for substances manufactured or imported ≥1 ton/year |
Compliance Process | No fixed procedure—mainly limits and testing | Defined process: chemical registration, safety assessment, documentation |
Overlap Between REACH & RoHS | Yes — most electronics must comply with both | Yes — electronics typically require REACH SVHC screening and RoHS testing |
Typical Products | Computers, smartphones, appliances, lighting products, medical devices | Any product containing chemicals: electronics, furniture, coatings, plastics, automotive parts |
Compliance Evidence | RoHS Test Report, Material Declarations, Declaration of Conformity | REACH SVHC Test Report, REACH Certificate, Substance Registration Documents |
REACH Certificate: How to obtain it？
A REACH Certificate of Compliance verifies that a product meets EU REACH regulations, which regulate chemicals to protect human health and the environment. It applies to industrial chemicals as well as substances in everyday products like electronics, lighting, and consumer goods.
To obtain the certificate, companies must screen products for Substances of Very High Concern (SVHCs) and other restricted chemicals, conduct physicochemical and identity testing, and register substances produced or imported into the EU over one tonne per year. A REACH compliance statement communicates the presence and safe use of chemicals to customers and regulators.
The European Chemicals Agency (ECHA) evaluates registrations, assesses risks, and may restrict or ban hazardous substances, suggesting safer alternatives. Manufacturers often maintain detailed chemical databases to track component compositions across suppliers, ensuring proper documentation and enabling dual compliance with RoHS.
Proper REACH testing and certification not only confirm regulatory compliance but also provide transparency, build customer trust, and support environmentally responsible practices.
What is SASO?
The Saudi Standards, Metrology and Quality Organization (SASO) is a government body established in 1972 to oversee standards, quality, and metrology in the Kingdom of Saudi Arabia (KSA). SASO ensures that imported products meet Saudi technical standards and safety requirements through its certification programs, including the SALEEM system.
Certification under SASO is mandatory for a wide range of products, including appliances, electronics, vehicles, and chemicals. By complying with SASO regulations, exporters can ensure that their products are legally marketable in Saudi Arabia and meet the country’s safety and quality expectations.
What is a SASO Certificate of Conformity?
A SASO Certificate of Conformity (CoC) is an official document confirming that a product meets Saudi Arabia’s technical standards and is ready for customs clearance. It serves as a “passport” for imported goods, ensuring compliance with safety and quality regulations. Even with a SASO certificate, customs authorities may perform additional inspections or tests upon arrival.
Products such as electrical appliances, automotive components, and consumer electronics must obtain SASO certification before entering the Saudi market. Under the SALEEM program, integrated with the SABER platform, product registration, compliance documentation, and certificate issuance are managed efficiently. The program requires both a Product Certification of Conformity (PCoC) and a Shipment Certification of Conformity (SCoC) for each shipment, which are only granted once the product meets the applicable technical regulations and standards.
By obtaining a SASO certificate, exporters can ensure their products comply with Saudi requirements, facilitating smooth customs clearance and market entry.
What Are the SALEEM and SABER Systems?
Saudi Arabia’s conformity assessment system is governed by SALEEM, a product safety program established by the Saudi Standards, Metrology and Quality Organization (SASO). SALEEM ensures that imported products meet national safety standards before entering the Saudi market.
To support the SALEEM program, Saudi Arabia introduced the SABER online platform.
On SABER, importers must register their products, apply for certification, and obtain both Product Certificates of Conformity (PCoC) and Shipment Certificates of Conformity (SCoC).
What Products Need a SASO Certificate?
SASO certification is mandatory for certain products before they can be imported into Saudi Arabia. Products that fall under the SASO Technical Regulation List must undergo certification through the SABER platform to ensure compliance with Saudi standards. Typically, products requiring SASO certification include electrical appliances and electronics, lighting products, automotive parts, batteries, building materials, mechanical equipment, children’s products, packaging, and household goods.
In Saudi Arabia, products that need a Certificate of Conformity (CoC) are referred to as “Regulated Products” in the Technical Regulations. These include textiles, mechanical equipment, electrical and electronics products, construction and building materials, and chemicals. Depending on the product’s classification as high-risk or medium-risk under the Product Certification Scheme, additional requirements and controls may apply. Exporters should review the relevant technical regulations for each product category to ensure compliance. Companies exporting food products should refer to the SFDA Certification Guide for specific regulatory requirements.
What Is SALEEM?
SALEEM is Saudi Arabia’s electronic certification and conformity assessment system, established by SASO to streamline product compliance and import procedures. It connects SASO-approved certification bodies, importers, and relevant authorities, serving as the platform to obtain both the Product Certificate of Conformity (PCoC) and Shipment Certificate of Conformity (SCoC) required for regulated products.
Integrated with the SABER platform, SALEEM handles product registration, compliance documentation, and the issuance of certificates for all mandatory imports, ensuring that goods entering Saudi Arabia meet the country’s safety and technical standards.
How to get a SASO Certificate via SABER Platform？
Obtaining a SASO Certificate of Conformity (CoC) for Saudi Arabia involves several steps, which may vary depending on the product’s risk level. The process begins by applying for certification through the SABER platform, where you enter all required product details, materials, and select the appropriate product classification and Saudi HS Code. Next, a SASO-approved Conformity Assessment Body is requested to perform a product conformity assessment. This body will contact you to schedule the necessary testing, inspections, or evaluations as part of the assessment process.
If the products meet the applicable regulations and technical standards, a Product Certificate of Conformity will be issued. After this, shipment details and invoices must be added to the SABER system. Once verified, the Conformity Assessment Body will issue a Shipment Certificate of Conformity, confirming that all exported products comply with Saudi standards.
The entire certification process can take a month or more, depending on the product category and the Conformity Assessment Body used. Testing and certification ensure that products meet SASO requirements and are ready for market access without regulatory delays. Exporters should follow SABER’s guide for regulated products for detailed instructions on submitting product information, test reports, technical documentation, and obtaining both the Product CoC and Shipment CoC.
Need Help Getting a SASO Certificate on SABER?
What is Proposition 65?
Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide warnings about significant exposures to chemicals that can cause cancer, birth defects, or other reproductive harm. These chemicals, including lead, BPA, phthalates, and other substances of very high concern (SVHCs), may be present in products Californians purchase, use in their homes or workplaces, or that are released into the environment.
The law also prohibits businesses from knowingly discharging significant amounts of these chemicals into drinking water sources. California maintains and updates a list of harmful chemicals at least annually, which has grown to around 900 substances since the law’s enactment. By mandating transparency, Proposition 65 helps consumers make informed decisions about their exposure to hazardous chemicals.
What Types of Chemicals Are on the Proposition 65 List?
The Proposition 65 list includes a broad range of naturally occurring and synthetic chemicals. It covers heavy metals like lead and cadmium, endocrine disruptors such as BPA and phthalates, and substances that may be byproducts of manufacturing or packaging processes. These chemicals can appear in everyday items including household products, food, drugs, dyes, and solvents, as well as in construction materials or industrial processes, such as motor vehicle exhaust. By maintaining this list, California helps consumers understand potential chemical exposures in products and the environment.
What Does a Proposition 65 Warning Mean?
A Proposition 65 warning indicates that a product contains one or more listed chemicals at levels exceeding safe exposure thresholds. These warnings allow consumers to make informed choices about potential risks. They can appear on product labels, at workplaces, in businesses, or in rental housing. By issuing a warning, the business acknowledges that individuals may be exposed to the listed chemicals.
The law requires warnings unless the exposure is low enough to pose no significant risk of cancer or is well below levels known to cause birth defects or other reproductive harm. Products that commonly carry such warnings include clothing, furniture, food, electronics, and household goods.
Who Administers and Enforces Proposition 65?
The Proposition 65 program is administered by the Office of Environmental Health Hazard Assessment (OEHHA), part of the California Environmental Protection Agency (CalEPA). OEHHA evaluates chemicals to determine if they meet the scientific and legal criteria for listing under Proposition 65 and oversees the regulations governing warnings and compliance. Enforcement is carried out by the California Attorney General, local district attorneys, or private citizens who can take legal action to ensure businesses adhere to the law.
What are the penalties for violating Proposition 65?
Failure to provide warnings can result in fines up to $2,500 per day per violation.
Proper testing and Proposition 65 labeling help ensure products are safe for California consumers.
Unsure Whether Your Product Needs a Proposition 65 Warning?
Summary & Why Choose Welle Inspection？
Global product compliance involves navigating a complex landscape of regulations, including RoHS and REACH in the EU, SASO standards in Saudi Arabia, and Proposition 65 in the United States. Each regulation imposes specific limits on hazardous substances, requires proper documentation, and often mandates testing or certification before products can enter the market. Non-compliance can result in shipment delays, fines, recalls, or reputational damage, making professional guidance essential.
Welle Inspection is a trusted partner for businesses seeking global export compliance. We provide end-to-end solutions to simplify regulatory challenges, including material analysis, laboratory testing, SVHC verification, and preparation of accurate Declarations of Conformity. For Saudi exports, Welle assists with SASO certification via the SABER platform, ensuring both Product and Shipment Certificates of Conformity are efficiently obtained. For U.S. markets, we provide Proposition 65 compliance support, including chemical screening and labeling guidance to meet California standards.
By partnering with Welle Inspection, companies gain reliable expertise, streamlined compliance workflows, and actionable insights to ensure products meet international standards. This enables exporters to confidently enter global markets, minimize the risk of fines or shipment delays, and maintain a strong reputation for product safety, quality, and regulatory compliance.
Simplify Global Compliance With One Expert Partner
FAQ: Global Product Compliance
Q1: What are the consequences of non-compliance with REACH?
A1: Companies may face fines, product recalls, restricted market access, or reputational damage.
Q2: Can REACH restrict or ban substances?
A2: Yes. REACH can restrict certain substances or ban them entirely. Authorization or alternatives may be required.
Q3: Is a SASO certificate enough for importing a shipment?
A3: No. A SASO CoC is essential but customs may still inspect shipments. Proper registration and documentation through SABER are also required.
Q4: What are RoHS exemptions?
A4: Exemptions allow restricted substances in specific cases where alternatives are not feasible, such as in medical or industrial electronics.