Product Lab Testing Requirements in the European Union: An Overview

Posted on Leave a comment

Product Lab Testing Requirements European Union

Product testing can be applied and is often in practice compulsory when importing and manufacturing products in the European Union. In this guide, we explain lab testing requirements applicable to general consumer products, chemicals, and heavy metals, clothing and textiles, toys, electronics, medical devices, and other products.

  • We Help Brands & Importers With Product Compliance (US & EU)

    • Book a free consultation call today with Ivan Malloci to learn how we can help you with:
    • Product Requirements Lists
    • Product Certification
    • Product & Packaging Labeling
    • Lab Testing

    BOOK A FREE CONSULTATION

Which products require lab testing in the EU?

There is no definitive list of products for which lab testing is required. That being said, all products sold in the European Union are subject to REACH – which restricts harmful substances. Further, many products are subject to safety requirements, for which conformance must be properly documented. This is also done through lab testing.

Then there are certain products that are subject to regulations that explicitly state that lab testing is mandatory. This category includes medical devices and personal protective equipment.

Lab testing is essentially always necessary – be it in-house or through an external service provider – to verify and document product compliance.

How do I know which testing requirements apply?

Lab testing companies can help you assess applicable standards and substance restrictions. You will need to share the following information:

  • Product
  • Age group
  • Material

You can also find information on the official European Union website.

REACH Testing

REACH restricted chemicals and heavy metals in all consumer products imported or manufactured in the European Union. Some substances are banned or restricted – meaning that any article containing excessive amounts of such substances cannot be sold. The exact substances and limits can differ depending on the product, age group, and material.

Examples

  • Lead
  • Cadmium
  • Mercury
  • Phthalates
  • PFAS

The only way to verify if a product or material is compliant is through third-party lab testing. In addition, some substances are classified as Substances of Very High Concern (SVHCs).

Articles containing such substances can continue to be sold in the EU – but requires that the company reports the SVHCs content through an EU database.

Learn more: REACH Product Lab Testing: A Complete Guide

General Product Safety Directive (GPSD)

The GPSD essentially states that all products sold in the EU must conform to basic safety requirements. The GPSD does list harmonized standards, which apply to specific product types. However, the general principle applies regardless of whether such standards exist for a certain product.

These standards then inform the testing methods applied to the relevant product.

Examples

EN 581-1 – Outdoor furniture – Seating and tables for camping, domestic and contract use – Part 1: General safety requirements

EN 913 – Gymnastic equipment – General safety requirements and test methods

EN 957 – Stationary training equipment

EN 14764 City and trekking bicycles – Safety requirements and test methods

Lab testing

This is stated in the GPSD:


Within the limits of their respective activities, producers shall adopt measures commensurate with the characteristics of the products which they supply, enabling them to:

(b) in all cases where appropriate, the carrying out of sample testing of marketed products, investigating and, if necessary, keeping a register of complaints and keeping distributors informed of such monitoring.


As you can read in the text above, producers must arrange testing to ensure that the product is safe and compliant.

Learn more: General Product Safety Directive For EU Importers

Clothing and textiles

REACH restricted chemicals and heavy metals in all clothing and other textiles in the European Union. Clothing and textiles containing excessive amounts of, for example, lead or AZO cannot be sold in the EU. Third-party lab testing is necessary unless your supplier can provide verifiable REACH or OEKO Tex Standard 100 (which covers REACH substances) lab test reports.

Clothing and textiles can also be tested according to safety and flammability standards. Here are a few examples:

EN 14682 Safety of children’s clothing — Cords and drawstrings on children’s clothing

EN 1021-1: Upholstered furniture – Ignition source smoldering cigarette

EN 1021-2: Upholstered furniture – Ignition source match flame equivalent

Learn more: Clothing & Textiles Product Lab Testing in the European Union

Toys

Toys sold in the European Union are covered by the Toy Safety Directive, which states the following under manufacturer obligations:


When deemed appropriate with regard to the risks presented by a toy, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls, and shall keep distributors informed of any such monitoring.


The Toy Safety Directive requires that both manufacturers and importers verify that the toy is compliant with certain safety requirements. In turn, this means that the product must be tested according to its harmonized standards, which include the various parts of EN 71.

EN 71 covers a wide range of safety aspects, including the following:

  • Chemicals and heavy metals
  • Physical and mechanical properties
  • Flammability

In practice, third-party lab testing is almost always necessary when importing or manufacturing toys for the EU market. You need documented evidence to support that you have carried out a conformity assessment procedure – which can be demonstrated by a lab test report issued by a reputable testing company.

Learn more: EN 71 Toy Safety Lab Testing: A Complete Guide

Electronics

Electronics imported and manufactured in the EU are subject to various directives. Here is an overview:

Directive Scope
RoHS Directive Chemicals and heavy metals in electronic components
Low Voltage Directive Electrical safety
EMC Directive Electromagnetic compatibility
Radio Equipment Directive Wireless devices
Ecodesign Directive Energy efficiency

The Low Voltage Directive states that importers and manufacturers must “carry out sample testing of electrical equipment made available on the market”. Similar statements can be found in the other directives listed above.

The directives in turn lists harmonized standards which means a product can then be tested according to. Here are a few examples:

EN 50106 – Safety of household and similar electrical appliances

EN 60947 – Low-voltage switchgear and control gear

EN 61995 – Devices for the connection of luminaires for household and similar purposes

EN 61204 – Low-voltage power supply devices

Without testing, it’s impossible to determine if an electronic or electrical product is compliant. Further, you need some sort of test report as part of your technical file to demonstrate compliance.

Learn more: Electronic Product Lab Testing in the European Union

Food Contact Materials

Food contact materials include drinkware, kitchen utensils, electrical kitchen appliances, and food packaging. The EU Food Contact Materials Framework Regulation restricts substance contents in materials. It also covers the migration of substances from the materials to the food or beverage contained.

Lab testing is necessary to determine if the material is compliant. Further, the specific substance restrictions, limits, and test methods differ depending on the material (e.g. plastics or ceramics) and age group.

Examples

Plastic Materials: Regulation (EU) 10/2011

Bisphenol A in Plastic Infant Feeding Bottles: Regulation (EU) 321/2011

Recycled Plastic Materials: Regulation (EC) 282/2008

Ceramics: Directive 2005/31/EC

Regenerated Cellulose Film: Directive 2007/42/EC

Active and Intelligent Materials: Regulation (EC) No 450/2009

Products Originating or Consigned from China or Hong Kong: Regulation (EU) 284/2011

Learn more: Food Contact Materials Regulations in the European Union: An Overview

Furniture

REACH applies to materials used to manufacture furniture. For example, this includes cover materials, paints, and coatings. Materials containing excessive amounts of restricted substances, such as lead and cadmium, cannot be sold in the EU. Lab testing is necessary for the sake of verifying and documenting whether a product contains such substances.

Furniture can also be subject to flammability lab testing. Here are two standards:

EN 1021-1: Upholstered furniture – Ignition source smoldering cigarette

EN 1021-2: Upholstered furniture – Ignition source match flame equivalent

EN 597-1: Mattresses and upholstered bed bases – Ignition source smoldering cigarette

EN 597-2: Mattresses and upholstered bed bases – Ignition source match flame equivalent

Learn more: Furniture Fire Safety Standards in the European Union: An Overview

Medical Devices

Medical devices imported and manufactured in the European Union are covered by Regulation (EU) 2017/745. The regulation provides detailed information about documentation and testing requirements, such as the following:


results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;


Learn more: Medical Devices Directive Guide: By Anssi Ilmari Tynjälä

FAQ

Must lab testing be done within the European Union?

Not in most cases. It’s rather common that consumer products destined for the EU market, such as electronics and textiles, are tested in the manufacturing country. Many of our customers, therefore, arrange lab testing in countries such as China or Vietnam, rather than bringing samples back to the EU for testing.

However, some products require the involvement of a Notified Body which must generally be located in an EU member state.

Is lab testing mandatory in the European Union?

Lab testing is at least in practice mandatory for essentially all consumer products, in the sense that product compliance must be verified and documented. This in turn is achieved through lab testing.

What can happen if we sell non-lab-tested products in the EU?

Selling non-lab-tested products in the EU means that you’re selling products that may or may not be unsafe. Further, the materials may contain excessive amounts of restricted chemicals, heavy metals, and other harmful substances.

This can in turn result in the products being denied entry by the customs authorities. The products may also be subject to a sales ban or recall at a later date.

National market surveillance authorities request test reports as part of their work to monitor products sold in the respective EU member states. Failing to produce a verifiable and legit lab test report upon request can result in a sales ban.

Can we use lab test reports provided by a supplier?

In theory, using lab test reports can help you cut costs as you can therefore skip out on expensive third-party lab testing. In practice, however, it’s extremely rare to find suppliers outside the EU that can provide pre-existing lab test reports that can be used as evidence of your products being safe and compliant.

This is further explained in these articles:

  • How to Verify Lab Test Reports & Product Certificates
  • Test Reports & Product Certificates on Alibaba
  • Fake Product Certificates & Test Reports

How much does EU lab testing cost?

There is no standard price structured for lab testing. The costs depend entirely on the applicable standard or regulation, materials, functionality, age group, and other factors that somehow impact the required testing procedure.

For example, testing a single fabric can cost less than 100 euros – while medical device testing procedures can cost hundreds of thousands of euros.

What are some examples of reputable testing companies in Europe?

Here are some of the more well-known testing companies with facilities in one or more EU member states:

  • TUV Nord
  • TUV SUD
  • TUV Rheinland
  • SGS
  • Eurofins
  • Bureau Veritas
  • Intertek

All of these companies listed above operate facilities outside the EU, including China and the United States.

  • (USA & EU)

    We Help Brands & Importers With Product Compliance (US & EU)

    • Product Requirements Lists
    • Product Certification
    • Product & Packaging Labeling
    • Lab Testing

    BOOK A FREE CONSULTATION


    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
  • Leave a Reply

    Your email address will not be published.