Essentially all products imported and manufactured in the European Union are subject to one or more product regulations, directives, or safety standards. In this guide, we provide a comprehensive overview of product regulations covering chemicals and heavy metals, general safety, toy safety, electrical safety, energy efficiency, and much more.
Note: This guide does not cover all product regulations and directives in the EU. Our main focus is listing product regulations and directives applicable to consumer products.
REACH restricted chemicals, heavy metals, and other toxins in essentially all consumer products importer or manufactured in the European Union. Such substances include lead, cadmium, formaldehyde, phthalates, and many others.
Materials that contain a restricted substance above a certain limit are non-compliant. Verifying compliance often requires third-party lab testing, and the majority of manufacturers outside the EU cannot provide reliable and up-to-date substance documentation.
Some substances are banned or limited. That said, some substances are classified as Substances of very high concern (SVHC) – which require notification if above a certain limit.
Further, different substance restrictions and limits apply depending on the material and the product category.
- Clothing textiles
- Children’s products
- Kitchen products
- List of Products Covered by REACH (Link)
- REACH Product Lab Testing (Link)
- List of REACH Lab Testing Companies (Link)
- List of REACH Consulting Companies (Link)
Persistent Organic Pollutants (POPs) Regulation
The POPs regulation restricts chemical compounds classified as Persistent Organic Pollutants. These can sometimes be found in everything from textiles to electronics. Some POPs are prohibited, while others are restricted. Further, release reduction provisions apply to some types of POPs.
Third-party lab testing is often required in order to verify if a certain product or material is compliant with the regulation.
Annex I: Prohibited POPs
Annex II: Restricted POPs
Annex III: Substances that are subject to releases reduction provisions
- Polychlorinated naphthalenes
- Dyes in the textile, leather, footwear industry
- Surface coatings for carpets, furniture, waterproof apparel, and paper goods
- Flame retardant in furniture, upholstered products, and foam-based packaging
- Persistent Organic Pollutants (POPs) Regulation in the European Union (Link)
General Product Safety Directive (GPSD)
While some product directives and regulations apply to specific product types, the General Product Safety Directive (GPSD) sets general safety requirements for essentially all consumer products in the European Union.
Its purpose is to ensure that all products sold in the EU are safe – regardless of whether there are product-specific standards or other requirements in place or not.
The GPSD also covers product traceability, manufacturer and importer labeling, and documentation requirements. Further, some EN standards are harmonised under the GPSD.
- Children’s products
- Fitness products
- General Product Safety Directive For EU Importers (Link)
- Buying EN Standards Online: A How-To Guide (Link)
- Children’s Clothing Regulations in the European Union (Link)
Textile Regulation (EU) No 1007/2011 covers textile labeling requirements for apparel and other textile products in the European Union. The regulation requires that the fiber composition (e.g. 100% Polyester) is stated on a permanently affixed label. It also requires the disclosure of leather and other animal-origin materials.
That said, it does not cover sizes or country of origin labeling.
- Home textiles
- Children’s clothing
- Clothing and Textiles Regulations in the European Union (Link)
Food Contact Materials Framework Regulation
Regulation (EC) No 1935/2004 covers food contact materials such as kitchen utensils, appliances, and food packaging. The regulation sets limits and bans on certain substances, such as Bisphenol-A. Further, it covers migration limits, compliance documentation (e.g. Declaration of Compliance), and labeling requirements.
Third-party lab testing is often required in order to verify compliance. Further, the framework regulation references other regulations that apply to specific materials – such as plastics or ceramics.
- Regulation (EU) No 10/2011: Plastic FCM
- Regulation (EC) No 1895/2005: Epoxy Derivatives Restriction
- Regulation (EC) No 282/2008: Recycled Plastic FCM
- Directive 84/500/EEC: Ceramics FCM
- Regulation (EC) No 450/2009: Active and Intelligent Materials
- Directive 2007/42/EC: Regenerated Cellulose Film
- Plastic lunch boxes
- Electronic kitchen appliances
- Stainless steel drinking bottles
- Paper cups
- Food packaging
- EU Declaration of Compliance (DoC) for Food Contact Materials (Link)
- Food Contact Materials Regulations in the European Union (Link)
- List of EU Food Contact Materials Testing Companies (Link)
Toy Safety Directive
The Toy Safety Directive covers all products defined as toys. This definition can be found on the EU website, but can broadly be said to cover all products with play features intended for 14-year-olds or younger. There are also certain less ‘obvious’ product types that also fall within the scope of the Toy Safety Directive.
Ensuring compliance with the Toy Safety Directive often requires product compliance with one or more EN 71 standards. These standards cover a wide range of toy safety aspects:
- Physical and mechanical properties
- Chemicals and heavy metals
- Small parts
Third-party lab testing is required in order to verify compliance with the applicable EN standards.
Further, the Toy Safety Directive requires CE marking and the related documentation:
- Declaration of Conformity (DoC)
- User instructions
- Technical file
- Plush toys
- Educational toys
- Plastic toys
- Chemistry kits
- Toy Safety Directive: Guide for EU Importers (Link)
- List of Products Covered by the Toy Safety Directive (Link)
- EN 71 Toy Safety Lab Testing (Link)
- List of EN 71 Lab Testing Companies (Link)
Restriction of Hazardous Substances Directive (RoHS) sets limits on heavy metals, flame retardants, and phthalates in electronic components, solder, and other materials used to manufacture electronics. Here’s an overview:
- Lead (Pb)
- Mercury (Hg)
- Cadmium (Cd)
- Hexavalent chromium (Cr6+)
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ether (PBDE)
- Bis(2-ethylhexyl) phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)
Third-party lab testing often is required in order to verify if the components and materials are RoHS compliant. Further, many components in the electronics industry today are specifically manufactured to comply with RoHS.
Further, products that fall within the scope of RoHS requires CE marking and the related documentation:
- Declaration of Conformity (DoC)
- User instructions
- Technical file
- Printed Circuit Boards (PCBs)
- Electronic motors
- Lighting products
- Tablets and computers
- Quartz watches
- RoHS Product Lab Testing (Link)
- List of Products Covered by RoHS (Link)
- List of RoHS Lab Testing Companies (Link)
Low Voltage Directive (LVD)
The Low Voltage Directive mainly covers electrical safety and applies to all electronic products with input or output voltage of between
- 50 and 1000 V for alternating current
- 75 and 1500 V for direct current
As such, the LVD applies to products that can be plugged into a power socket.
Ensuring compliance with the Low Voltage Directive requires an understanding of the many harmonised EN standards under this directive – and implementation during a product development stage.
Third-party lab testing is often necessary to verify compliance. In addition, the Low Voltage Directive also requires CE marking, DoC, and a technical file.
- AC adapters
- Low Voltage Directive (LVD) Guide For EU Importers (Link)
- List of Products Covered by the Low Voltage Directive (Link)
- List of Low Voltage Directive (LVD) Lab Testing Companies (Link)
Electromagnetic Compatibility (EMC) Directive
The EMC directive aims to ensure that electronic products do not interfere with other devices as a result of electromagnetic disturbance. Ensuring compliance with the EMC directive starts at the drawing board, as the engineer must have an understanding of EMC design principles.
It broadly covers all electronic products, with some products classified as inherently benign equipment. The latter category includes, for example, quartz watches.
Third-party lab testing is often necessary to verify compliance. In addition, the EMC Directive also requires CE marking, DoC, and a technical file.
- Lighting Products
- LED Displays
- Kitchen Appliances
- Lithium Batteries
- AC Adapters
- Electrical Motors
Examples of inherently benign equipment
- Quartz watches
- Passive antennas
- Corded speakers or headphones
- Electromagnetic Compatibility (EMC) Directive (Link)
- List of Products Covered by the EMC Directive (Link)
- List of EMC Directive Testing Companies (Link)
Radio Equipment Directive (RED)
The Radio Equipment Directive (RED) applies to radio equipment, which includes WiFi, Bluetooth, 5G, LTE, GPS, and other devices with wireless communications. The RED covers network usage, emergency service access, privacy and user data, anti-fraud measures, and more.
Third-party lab testing is often necessary to verify compliance. In addition, the Radio Equipment Directive requires CE marking, DoC, and a technical file.
- Wireless earphones
- Tablet computers
- Wireless cameras
- Radio Equipment Directive (RED) Guide (Link)
- List of Products Covered by the Radio Equipment Directive (RED) (Link)
- List of Radio Equipment Directive (RED) Testing Companies (Link)
The Ecodesign Directive sets mandatory energy efficiency requirements for various product types. This covers, for example, energy efficiency and household appliances, and insulation characteristics in windows and construction materials.
Compliance with the Ecodesign Directive requires both expertise in terms of designing for compliance, in accordance with the applicable EN standards, and material selection.
The Ecodesign Directive also requires CE marking, DoC, and a technical file.
- Lighting Products
- Electronic Displays
- Washing Machines and Dishwashers
- Air Conditioners and Comfort Fans
- Electrical Motors
- Welding Equipment
- Insulation Materials
- Ecodesign Directive Guide for EU Importers (Link)
- List of Products Covered by the Ecodesign Directive (Link)
Energy Labelling Framework Regulation
The Energy Labelling Framework Regulation states that products covered by Ecodesign Directive come with an energy efficiency label. The label informs consumers of power consumption and other forms of energy efficiency.
As such, it creates an incentive for consumers to buy more energy-efficient products – both for the sake of long-term cost savings and environmental concerns.
Further, the EU website provides a free energy label generator.
- Lighting products
- Kitchen appliances
- Displays and TVs
- Computers and servers
- Washing machines and dryers
- Air conditioners and fans
- Energy Labelling Framework Regulation (Link)
The Battery Directive restricts heavy metals in lithium, alkaline, and other types of batteries. This includes mercury, cadmium, and lead. It also bans certain types of batteries, such as Nickel-Cadmium batteries.
Further, the directive also covers registration and recycling on a national level in each EU member state.
- Lithium-ion batteries
- Lithium metal battery
- Alkaline battery
- Nickel cadmium batteries
- Nickel metal hydride batteries
- Button-cell batteries
- Sealed lead-acid batteries
- Battery Directive Guide for EU Importers (Link)
- List of Products Covered by the Battery Directive (Link)
Personal Protective Equipment (PPE) Regulation
Personal Protective Equipment (PPE) Regulation covers products designed to protect the wearer. For example, PPE products include work gloves, safety goggles, sunglasses, and protective footwear.
PPE products are divided into different categories:
- PPE Category I
- PPE Category II
- PPE Category III
The PPE Regulation requires CE marking and its associated documentation. The latter includes Declaration of Conformity, user manual, and technical file. Further, third-party lab testing is often mandatory.
Some products also require the involvement of a Notified Body.
- Gardening gloves
- Cleaning gloves
- Bicycle helmets
- Safety goggles for skiing and snowboarding
- Fire-protective clothes
- Electrical insulating protective helmets
- Personal Protective Equipment (PPE) Regulation: Guide For EU Importers (Link)
- List of Products Covered by the PPE Directive (Link)
Medical Devices Regulation
The Medical Devices Regulation covers products intended to be used for medical purposes. This includes a wide range of products, including prescription glasses, medical gloves, and laser devices.
Further, the medical devices are categorized depending on the risk the device poses to the body. Here is an overview:
- Class I
- Class Im (measurement)
- Class Ist (sterile)
- Class IIa
- Class IIb
- Class III
The Medical Devices Regulation requires CE marking, DoC, and technical file.
Further, third-party lab testing is often mandatory. You may also need to get the documents and even the manufacturing facility inspected by a Notified Body before you can place the medical device on the EU market.
- Prescription Glasses
- Medical Masks
- Medical Gloves
- Medical Thermometers
- Syringes and Catheters
- Laser Devices
- Tattoo Removal Equipment
- Medical Devices Directive Guide (Link)
- List of Products Covered by the Medical Devices Directive (Link)
- List of Medical Devices Lab Testing Companies (Link)
- Medical Devices EU Authorised Representative (Link)
The Machinery Directive covers machines imported and manufactured in the European Union. The definition of machinery is quite broad. Here is a quote from the EU website:
Machinery consists of an assembly of components, at least one of which moves, joined together for a specific application.
This definition includes washing machines, treadmills, and even electric bikes.
The Machinery Directive has a broad scope, in the sense that it covers general design safety, airborne hazardous substances, noise levels, emergency stop functionality, and other aspects.
Further, the Machinery Directive requires CE marking, Declaration of Conformity, and technical files. Warning labeling and operational instructions are also required.
- Electronic Gym Machinery
- Commercial Dishwashers and Washing Machines
- Injection Molding Machinery
- Woodworking Machines
- Sawing Machinery
- Wheel Loaders
- Machinery Directive: Guide for EU Importers (Link)
- List of Products Covered by the Machinery Directive (Link)
Construction Products Regulation (CPR)
The Construction Products Regulation (CPR) applies to construction and building materials. This includes doors, windows, thermal insulation, flooring, and other products. More specifically, the CPR covers fire safety, noise protection, energy savings, durability, stability, and mechanical safety.
Third-party lab testing is often required in order to verify compliance.
Construction Products Regulation (CPR) also requires CE marking, Declaration of Conformity, and a technical file.
- Door locks
- Sanitary appliances
- Thermal insulation products
- Curtain walls
- Construction adhesives
- Concrete products
- Construction Products Regulation (CPR): Guide for EU Importers (Link)
Regulation (EC) No. 1223/2009 on Cosmetics Products
The Cosmetics Product Regulation covers substance bans and limits, notification, user instructions, packaging, and other compliance requirements for cosmetic products. This product category includes everything from body cream and make-up to perfumes and deodorant.
Further, third-party lab testing is required in order to verify compliance. The regulation applies both to EU-based manufacturers and importers of cosmetic products produced outside the EU.’
- Body creams or lotions
- Facial masks
- Haircare products
- Suncare products
- Shaving products
- Makeup products
- Cosmetics Regulations in the European Union: An Overview (Link)
Waste from Electrical and Electronic Equipment (WEEE) Directive
The Waste from Electrical and Electronic Equipment (WEEE) Directive directive sets EU-level rules for registration, recycling, and collection of electrical waste. Importers and manufacturers in the EU must register with national electrical waste collection and waste schemes.
The specific requirements, fees, and procedures differ between different EU member states.
The WEEE directive also includes product and packaging labeling requirements.
- Waste from Electrical and Electronic Equipment (WEEE) (Link)
Directive 94/62/EC on Packaging and Packaging Waste
Directive 94/62/EC on Packaging and Packaging Waste restricts heavy metals in packaging materials in the European Union. The list of heavy metals includes lead, cadmium, mercury, and hexavalent chromium. Further, the directive sets heavy metals limits that are reduced over time.
- Product packaging
- Packaging inserts
- Corrugated cartons
- Packaging Materials Regulations in the European Union (Link)
EU Timber Regulation (EUTR)
The EU Timber Regulation (EUTR) sets traceability requirements for certain types of wooden products. This includes wooden furniture, particle boards, plywood, cases, and decorative boxes.
Importers of timber and certain types of wooden products must do a risk assessment and monitor their supply chain – with the ultimate aim of reducing the illegal harvesting of certain types of wood species.
Some importers choose to follow the FSC certification system, which is EUTR compliant.
- Wooden furniture
- Wooden frames
- Particleboard, fibreboard, plywood
- Wooden cases, boxes, crates, and decorative gift boxes
- Timber Regulation (Link)
Regulation (EU) 2016/2031 (Wooden Packaging Materials)
Regulation (EU) 2016/2031 requires that wooden pallets, crates, and other wooden packaging materials are heat treated or fumigated in accordance with ISPM 15 requirements.
Note that wooden packaging with a thickness of 6 mm or less is exempt. Exemptions also apply to plywood and some other types of pressed and heated wooden packaging materials. This is also one reason why many freight forwarders and suppliers in China and other countries prefer to use plywood pallets.
Further, wooden packaging materials must also be labeled with an ISPM 15 mark to demonstrate compliance. The regulation aims to prevent the importation of plant pests into the EU.
- Wooden pallets
- Wooden crates
- Wood and Bamboo Product Regulations in the European Union (Link)