The CE mark is a mandatory conformity marking in the European Union, also serving to inform consumers that the product complies with relevant EU directives. Below are some mandatory directives and regulations that require the use of the CE mark. Products not covered by these directives should not bear the CE mark.
- RoHS Directive
- Low Voltage Directive
- EMC Directive
- Radio Equipment Directive
- Toy Safety Directive
- Personal Protective Equipment Regulation
- Machinery Directive
Here are products that must bear the CE mark:
Examples: wooden toys, electronic toys, plastic toys, educational toys
Toys designed or intended for children under 14 years old fall under the Toy Safety Directive, requiring the CE mark. Additionally, toys must meet EN 71 standards.
Examples of EN 71 standards:
- EN 71-1: Mechanical and physical properties
- EN 71-2: Flammability
- EN 71-3: Migration of certain elements
Examples: Bluetooth speakers, laptops, electric shavers, digital cameras, gaming consoles, shredders, printers
Electronic products must bear the CE mark. The most common CE directives for electronics include:
- RoHS Directive: Regulates certain hazardous substances in electronic and electrical equipment (e.g., lead and mercury).
- LVD (Low Voltage Directive): Applies to products with input or output voltages within these ranges:
- AC: 50 - 1000 V
- DC: 75 - 1500 V
Many household appliances, laser devices, and AC generators fall under LVD.
- EMC (Electromagnetic Compatibility Directive): Regulates electronic products that may cause electromagnetic interference with other devices (e.g., TVs and household appliances).
- RED (Radio Equipment Directive): Covers radio equipment like Wi-Fi, RFID, and Bluetooth devices, addressing safety and electromagnetic interference.
Examples: electronic watches, quartz watches, smartwatches
Electronic watches are covered by the RoHS Directive, which limits heavy metals in components that contact the skin. Additionally, smartwatches fall under the RED Directive. Any watch containing electronic components must have a CE mark. Note that RoHS and RED do not apply to mechanical watches.
Examples: laptop AC adapters, interchangeable medical AC adapters, universal power AC adapters
Many AC adapters are regulated by LVD, EMC, and RoHS directives. LVD applies to most adapters with input voltages typically between 110 - 240 V AC.
Examples: LED billboards, LED lights, smart LED bulbs
LED lighting products must have the CE mark. RoHS applies to all LED lighting products; LVD covers those with voltage ranges of 50 - 1000V AC or 120 - 1500V DC; EMC applies to products that might interfere with other electronic devices. Additionally, the Ecodesign Directive applies to most LED lighting products, while RED covers smart LED lights that include Wi-Fi, Bluetooth, or 3G/4G/LTE.
Examples: LED strips, water heaters, refrigerators, vacuum cleaners, tumble dryers, ventilation equipment, TVs
The Ecodesign Directive covers any of the 28 high-efficiency product groups listed on the EU's official website. Importers and manufacturers must comply with various labeling requirements, including the CE mark.
Examples: safety helmets, safety gloves, goggles, safety shoes
PPE is governed by the Personal Protective Equipment Regulation and must have the CE mark. PPE includes devices designed to protect users from risks like falling objects or chemical hazards.
PPE Categories:
- Category I: Simple PPE to protect against minimal risk (e.g., sunglasses, dust goggles, ski goggles).
- Category II: Intermediate PPE that protects against physical, electrical, and chemical harm (e.g., UV-resistant goggles, work helmets).
- Category III: PPE to prevent irreversible harm or fatal injury (e.g., goggles for high infrared radiation environments, diving respirators).
Examples: polarized sunglasses, sports sunglasses, ski goggles, swimming goggles, diving masks
Sunglasses and other eyewear are classified as PPE, thus requiring the CE mark. Most sunglasses and sports eyewear fall under Category I of the Personal Protective Equipment Regulation.
Examples: treadmills, rowing machines, hot-rolled steel mills, concrete mixer trucks, drilling machines
The Machinery Directive covers most machinery imported and sold in the EU. Machinery is defined as:
A. An assembly of interconnected parts or components with at least one moving part, including a drive system (excluding human or animal power).
B. A set of movable objects or components intended for lifting items with human force.
Examples: electric bicycles, toy bicycles
Most bicycles on the market are considered transportation devices and are not covered by CE directives. However, bicycles with a saddle height below 435 mm are considered toy bicycles under the Toy Safety Directive.
Examples: medical masks, plastic syringes, thermometers, blood glucose meters, oxygen concentrators, ventilators, nebulizers
The Medical Device Regulation applies to medical devices and their accessories in the EU market, requiring the CE mark.
Examples: doors, windows, chimneys, bathroom appliances, wastewater treatment products, construction adhesives, communication cables, fire safety products
Building products are regulated by the Construction Products Regulation (CPR), requiring the CE mark.
Examples: water meters, gas meters, electricity meters, thermal energy meters, automatic weighing instruments, taxi meters, material measuring devices, dimension measuring instruments, exhaust analyzers
The Measuring Instruments Directive (MID) governs instruments sold in the EU market, requiring CE marking.
Examples: cooking equipment, space heating devices, water heaters
The Gas Appliances Regulation mandates CE marking.
Examples: escalators, mechanical walkways, mining hoists, military or police lifts, cable cars, construction site lifts
The Lifts Directive covers lift design, manufacturing, installation, and maintenance, requiring CE marking.
The overview of CE-covered products ends here. Sellers should be aware of the above products when selling to the EU, as incorrect labeling can result in fines or recalls.
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