The European and US markets have always been a “promised land” for electronics manufacturers due to high demand and spending levels. For OSUNO, accessing these markets is not just about product quality, but also about meeting a complex system of regulations and strict safety and environmental standards. A minor omission in documentation or certification can cause an entire shipment to be returned, leading to significant losses. Therefore, understanding and complying with European and US export standards is a crucial factor for the survival of any Vietnamese electronics company.
1. Regulations on Hazardous Substances: RoHS & REACH
1.1. RoHS (Restriction of Hazardous Substances)
RoHS is an EU directive aimed at restricting the use of hazardous substances in electrical and electronic equipment (EEE). The goal is to reduce risks to human health and the environment from product disposal.
Key points of RoHS:
- List of restricted substances: includes lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr⁶⁺), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and 4 phthalates: DEHP, BBP, DBP, DIBP.
- Content limits: typically ≤ 0.1% (1000 ppm) by weight of each homogeneous material. For cadmium, the limit is stricter at 0.01% (100 ppm).
- Exemptions: some specific components and applications may apply for temporary exemptions if no viable alternatives exist. Exemptions are reviewed periodically.
- Scope of application: most electrical and electronic equipment that uses electricity or electromagnetic fields, excluding products listed as exempt, such as military equipment, large-scale fixed installations, research equipment, railway systems, and renewable energy under certain conditions.
- Requirements for technical documentation & Declaration of Conformity: manufacturers must maintain documentation proving compliance, lab test results, risk assessment calculations, circuit diagrams, drawings, BOM with chemical composition, and provide it upon request from regulatory authorities.
- CE Mark: RoHS is part of the CE Marking for electronic equipment—meaning a product must be RoHS compliant to bear the CE mark if it falls within the scope.
Impact & risks of non-compliance:
If a device exceeds the hazardous substance limits or lacks proper documentation, the product may be blocked at import into the EU, recalled from the domestic market, and the business may face fines or lose credibility with partners. Redesigning and changing materials can incur significant costs and disrupt the production chain.
1.2 REACH (Registration, Evaluation, Authorization, Restriction of Chemicals)
REACH is the EU’s chemical regulation, with a broader impact than RoHS. While RoHS controls hazardous substances in electronic products, REACH manages the registration, evaluation, authorization, and restriction of chemicals across all industries. Highlights include:
- Registration & evaluation of substances: substances manufactured or imported into the EU in quantities over 1 ton/year must be registered with the European Chemicals Agency (ECHA). If exceeding 10 tons/year, a chemical safety report is required.
- Substances of Very High Concern (SVHC): such as carcinogenic, mutagenic, reproductive toxicity, PBT (Persistent, Bioaccumulative, Toxic) substances will be thoroughly evaluated and may be subject to authorization or restriction.
- Restriction: if a substance is identified as high-risk, its use may be restricted or it may be removed from the market.
- Labeling and providing Safety Data Sheets (SDS): for hazardous substances used in components and materials, and communicating this information throughout the supply chain.
Relationship between RoHS & REACH:
RoHS restricts a specific list of substances in electronic equipment; REACH manages many more substances, covering both the production process and materials. A substance on the RoHS list is often also within the scope of REACH (but REACH has a much broader scope).
Compliance with RoHS does not guarantee compliance with REACH (and vice versa), so businesses must evaluate both standards.
Application suggestions for OSUNO:
- OSUNO needs to integrate material assessment from the component selection stage, requiring suppliers to provide SDS / MSDS / chemical composition tables.
- During product development, OSUNO should maintain a “chemical control checklist,” flagging at-risk components for timely replacement.
- When a customer requests export to the EU, OSUNO can assist in preparing RoHS / REACH documentation, preparing for technical testing, and archiving records within the product project.
2. Energy Efficiency, Electrical Safety & Electromagnetic Compatibility (EMC / EMI / Immunity)
Besides materials, electronic devices are also bound by standards for electrical safety, electromagnetic interference (EMC), and energy efficiency—ensuring the device is safe to use, does not interfere with other systems, and saves energy.
2.1. Electrical Safety (Low Voltage Directive, UL / IEC)
In the EU, electrical equipment within a certain voltage range must comply with the Low Voltage Directive (LVD)—ensuring they do not pose electrical hazards (shock, fire, overheating).
Additionally, in many markets (US, Canada), UL / CSA / IEC safety certification is a supplementary or required factor for sales approval.
A device must ensure:
- Proper insulation between high and low voltage parts, suitable insulating materials, and standard creepage and clearance distances.
- Protection against overcurrent, overvoltage, fire, insulation failure, and leakage—if it has a battery, a protection circuit is required.
- Components like insulation, wires, enclosures, and high-voltage parts must be selected according to international standards (IEC 61010, IEC 60950, IEC 62368, depending on the product type).
If a device does not comply with electrical safety, it can be refused for import or recalled if an electrical hazard arises—severely impacting reputation.
2.2. EMC / EMI & Electromagnetic Compatibility
EMC (Electromagnetic Compatibility) ensures that a device does not emit excessive interference (EMI—electromagnetic interference) and can withstand external interference (immunity). The purpose is for devices to operate together without interfering with each other.
In the EU, EMC requirements are specified in the EMC Directive—if a device emits or is affected by electromagnetism, it must meet limits for emitted and withstood interference.
In the US, electronic devices emitting frequencies ≥ 9 kHz must generally comply with FCC Part 15 (for unintentional/intentional radiators)—meaning there are limits on electromagnetic emissions.
This includes:
- Emissions testing: measuring the electric field / magnetic field / radio waves emitted from the device.
- Immunity testing: the device must withstand electromagnetic impacts such as pulses, frequency interference, voltage dips, power supply surges, and lightning “surges”.
- Circuit design: using EMI filters, grounding, signal shielding, twisted-pair wiring, low impedance paths, and partitioning to separate noisy areas.
- In-house pre-compliance testing: to evaluate before sending to a lab, reducing the risk of failure.
If a device fails EMC / EMI testing, it needs to be redesigned, adjusting circuits, insulation, and shielding—costing money and extending timelines.
2.3. Energy Efficiency / Power-saving Regulations
Many markets, especially the EU and the US, require electronic devices to meet energy efficiency standards (Energy Efficiency / Eco-design). For example:
- EU’s “ecodesign” mechanism: electronic devices must meet minimum requirements for power consumption in standby and off modes, and AC/DC power supply efficiency.
- In the US: the Environmental Protection Agency (EPA) or the Department of Energy (DOE) have programs like ENERGY STAR to certify energy-efficient devices.
- For battery-powered devices, there may be requirements for charging efficiency / energy conversion efficiency.
Businesses need to design power supplies and circuits with low loss, complete power cut-off when inactive, and use energy-saving components to meet the requirements of each market.
3. Lifecycle & Product Responsibility: WEEE & EPR
An essential component is managing the product at the end of its life—collection, recycling, and disposal of electronic waste. In the EU, the WEEE Directive (Waste Electrical and Electronic Equipment) imposes obligations on manufacturers.
Key WEEE requirements:
- Registration with the national environmental authority in each member state where the product is sold.
- Periodic reporting of the quantity of electronic equipment placed on the market and the amount collected.
- Organizing or financing a system for collecting, treating, and recycling discarded equipment.
- Affixing the “crossed wheelie bin” symbol on the device to indicate that it should not be disposed of in regular household waste.
WEEE is implemented differently among member states—meaning registration costs and collection regulations will vary. Manufacturers/importers must understand and comply with the laws of that specific country.
There is a more extended model: EPR (Extended Producer Responsibility)—where the manufacturer/importer is responsible for the entire product lifecycle, from production and consumption to collection and recycling.
Failure to comply with WEEE / EPR can lead to fines, sales bans, or being forced to support the collection of previously sold goods.
4. CE Marking & Declaration of Conformity (EU)
CE Marking is a symbol demonstrating that a product complies with the mandatory directives/standards of the EU—ensuring it can circulate freely within the European market.
The general CE process is as follows:
- Identify applicable standards: which directives apply to the device, such as LVD, EMC, RoHS, Eco-design, RED (Radio Equipment Directive) if it has a radio component, etc.
- Conduct testing at an accredited lab or according to harmonized standards.
- Compile a Technical File: including test results, device diagrams, BOM, risk assessment, and a Declaration of Conformity (DoC)—where the manufacturer declares compliance with the listed directives.
- Affix the CE logo on the product (with clear specifications for size, position, and printing conditions). If a notified body is involved, its identification number must be placed next to the CE mark.
- Keep the file for at least 10 years (depending on the device type) for inspection by authorities when needed.
CE is not a third-party certification (unless the directive requires confirmation from a notified body). In many cases, the manufacturer can self-declare. However, if the product falls into a high-risk category, the involvement of a notified body may be necessary.
CE Marking is the “passport” for a product to be accepted in Europe—if a product lacks a CE mark or has one that does not correspond to the applicable directives, it is considered a violation and may be recalled or have its circulation suspended.
6. Data Protection & Privacy: GDPR & CCPA (if the device collects/processes data)
For “smart” devices (IoT, data collection, network-connected), technical standards alone are not enough—they must also comply with personal data protection regulations.
- GDPR (General Data Protection Regulation, EU): if a device collects, stores, or processes the personal data of European users, the business must ensure privacy, transparency, data security, and have mechanisms for data deletion, complaints, data breach notifications, and keeping data to a necessary minimum.
- CCPA (California Consumer Privacy Act, California, USA): if a device provides services to California residents or processes their personal data, it must comply with regulations on providing information, the right to opt-out, and the right to delete personal data.
Ignoring these can lead to administrative fines, lawsuits from users in the EU / California, and damage to the brand and revenue.
7. Import Procedures and Customs Dossier
During the export process, the customs dossier is the decisive factor for smooth clearance. A basic dossier includes the foreign trade contract, commercial invoice, packing list, bill of lading, certificate of origin, and quality certificate. For electronic products, adding compliance certifications like FCC, CE, or UL is mandatory.
When goods arrive at the port, authorities will inspect several factors. First is electrical safety, ensuring the product is not dangerous to users. Next is labeling, which requires clear indication of origin, voltage specifications, safety warnings, and instructions in the local language. Finally, the import tariff is determined based on the HS Code and may benefit from trade agreements if rules of origin are met.
Inexperienced businesses often face difficulties at this stage. Many have had their goods held for months just because of incorrect labeling or a missing minor certificate.
8. Common Mistakes and Practical Lessons
In reality, many Vietnamese businesses have encountered barriers right at the border. A mechanical keyboard manufacturing company once exported a shipment to Germany without RoHS certification. When the goods arrived at the port of Hamburg, customs requested the additional documentation. Unable to comply, the entire shipment, worth nearly two hundred thousand euros, was returned, causing heavy losses. This is clear evidence that lacking just one small standard can cause a business to lose everything.
Conversely, there are success stories thanks to thorough preparation. A Vietnamese company producing OEM smart locks for a US partner designed the product to FCC and UL standards right from the R&D stage. They then sent samples to the Intertek testing lab in Singapore, at a cost of about $25,000. Six months later, the product achieved both certifications, had the FCC ID printed on its casing, and was quickly listed on Amazon in the US. In the first year alone, revenue reached over four million USD, opening a major door to the North American market.
These stories show that success or failure depends entirely on whether a business views international standards as a barrier or as a foundation for growth.
Conclusion
Meeting the strict export standards of the European and US markets is not only a mandatory condition for the legal circulation of electronic products but also a strategic step to enhance international reputation and competitiveness. With a focus on producing to international standards from the R&D stage, OSUNO commits that all its electronic lock and smart security products strictly comply with safety, environmental, and quality regulations. This is not only the key for OSUNO to conquer the export market but also a testament to its mission: to bring Vietnamese technology products to a global standard.
