OEKO-TEX® STANDARD 100 Guide for Importers & Manufacturers

Posted on Leave a comment


OEKO-TEX® STANDARD 100 restrics chemicals, heavy metals, and other harmful substances in textiles. While OEKO-TEX® STANDARD 100 is voluntary, it is based on REACH and other regulations which make the standard a preferred choice for many brands.

In this guide, we explain which regulations STANDARD 100 is based on, and the conditions you must meet to use the label. We also cover product classes, certification, and more.


  • Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
  • Find product requirements
  • Certification and labeling
  • Lab testing



The OEKO-TEX® STANDARD 100 can be used to certify that your textile products have been tested against more than 300 toxic substances, in order to protect the health of the user. Once you obtain the certificate, you can affix the OEKO-TEX® STANDARD 100 label to your products.

Textile products carrying the label are deemed to be safer for human health for the following reasons:

a. Strict criteria catalog – Every part of the product, from the coating and stitching to the application and zipper, has to comply with OEKO-TEX® STANDARD 100’s test criteria

b. Global standardization – OEKO-TEX®’s test criteria are globally standardized and updated at least once every year with new scientific knowledge or requirements

c. Independent test institutes – the OEKO-TEX®’s partner test institutes that issue the test reports and certificates are independent and neutral

d. Label check – The OEKO-TEX® STANDARD 100 label has a certificate number that businesses and consumers can use to check the validity of the product’s certification

Product scope

OEKO-TEX® classifies covered products into four classes based on their intended utilization. Products in each class have to fulfill various requirements. For example, the applicable limit values concerning restricted substances might be different according to the class.

Product class 1

Product class 1 covers textile products for babies and toddlers and has the strictest substance limit values and requirements.

Product class 2

Product class 2 covers products that are in direct contact with the skin to a great extent and includes products such as the following:

  • Blouses
  • Shirts
  • Underwear
  • Mattresses

Product class 3

Product class 3 covers products that have little to no skin contact and covers products like:

  • Jackets
  • Belts
  • Vests

Product class 4

Product class 4 covers decoration materials such as home textile products and furnishing accessories, which includes:

  • Curtains
  • Table cloths
  • Upholstery fabrics

Substance Restrictions

OEKO-TEX®’s partner institutes test every part and element of the final textile product for harmful substances per the test criteria in the standard’s criteria catalog. This might include the following parts:

  • Threads
  • Buttons
  • Zippers
  • Linings
  • The outer material’s prints and coatings

The standard sets limit values that comply with the substance restrictions set by several regulations and hazardous substance lists, such as the ones listed below.

REACH Regulation (EU)

The OEKO-TEX® STANDARD 100’s limit values comply with several substance restrictions set by REACH, which regulates dangerous chemicals – and articles that might contain such chemicals, in the European Union.

Annex XVII

Annex XVII of REACH is a list of harmful substances that are either restricted or banned from use in products for sale in the EU.

Products that comply with the OEKO-TEX® STANDARD 100’s requirements must meet the restrictions set in the annex.

Annex XIV

OEKO-TEX® STANDARD 100 also requires compliances with the substance restrictions listed in Annex XIV of REACH. While REACH requires authorisation in order to use these substances in your products, according to our understanding OEKO-TEX® STANDARD 100 simply forbids the use of these substances in your product.

SVHC Candidate List

According to the European Chemicals Agency (ECHA), Substances of Very High Concern (SVHC) are substances that might be:

  • Carcinogenic
  • Mutagenic
  • Toxic
  • Persistent
  • Bioaccumulative

SVHCs can permanently and irreversibly impact the environment and human health. As such, the ECHA requires importers and manufacturers of articles that contain SVHC in an amount greater than 0.1% to register their product into the SCIP database and inform customers that make an inquiry about SVHC’s content.

The standard covers SVHCs that are relevant to textile products. Specifically, OEKO-TEX® STANDARD 100’s criteria ensure that “no communication duties are necessary along the supply chain regarding the SVHC substances”.

An exception might be made in rare situations. In this case, the exception should be clearly stated in the scope of the certificate.

Persistent Organic Pollutants (POPs) Regulation (EU)

POPs are persistent and bioaccumulative chemical substances that build up through the food web and remain in the environment. The Persistent Organic Pollutants (POPs) Regulation restricts or prohibits using POPs that can endanger the environment and human health.

OEKO-TEX® STANDARD 100 ensures compliance with the POPs Regulation.


Products belonging to Class 1, that is textiles products for babies and toddlers, must also comply with the total lead content restrictions set by the CPSIA (except for glass accessories).

According to the CPSIA’s website, the limit of total lead content is set to 100 parts per million (ppm).

Note that all OEKO-TEX® partner labs are CPSC-accepted, which means that they can provide test reports that are accepted by the Consumer Product and Safety Commission (CPSC) in the United States, for the sake of proving compliance with the CPSIA requirements.

GB 18401 – National general safety technical code for textile products (China)

The National Standards of the People’s Republic of China has published GB 18401 – National general safety technical code for textile products.

It contains methods for testing textile products that fall into one of three categories:

  • Intended for infants aged 36 months and under
  • Directly contact the skin
  • Have little to no skin contact

Products that comply with the OEKO-TEX® STANDARD 100 also need to respect the substance limitations set by the GB 18401 standard.

Zero Discharge of Hazardous Chemicals Manufacturing Restricted Substance List (ZDHC MRSL)

The Zero Discharge of Hazardous Chemicals Manufacturing Restricted Substance List (ZDHC MRSL) lists chemical substances prohibited from intentional use when processing textile materials; it covers formulations such as coatings, dyes, and finishing agents.

OEKO-TEX® monitors the ZDHC MRSL as well.

Apparel and Footwear International RSL (Restricted Substance List) Management (AFIRM)

The AFIRM limits the usage of certain substances in product categories such as the following:

  • Jewelry
  • Apparel
  • Footwear
  • Accessories
  • Sporting goods equipment
  • Wearables
  • Home textiles

AFIRM member brands must comply with such limitations. OEKO-TEX® also monitors the AFIRM.


OEKO-TEX®’s independent test institutes use the standard’s criteria catalog to test textile products, including related accessories such as buttons, for harmful substances.

The tests account for many regulated and non-regulated substances which may harm human health, including the ones restricted by the regulations and standards that we mentioned in the previous section.

OEKO-TEX® updates the catalog yearly and expands upon it to include the latest scientific knowledge or statutory requirements.

The company has 17 independent partner institutes in Europe and Japan. We list a few of those institutes below:

  • Centexbel (Belgium)
  • Hohenstein Textile Testing Institute (Germany)
  • Shirley® Technologies Limited (United Kingdom)
  • Nissenken Quality Evaluation Center (Japan)

You can find the full list on this page.

OEKO-TEX® STANDARD 100 Certificate

Textile manufacturers can apply for a STANDARD 100 certificate by completing an application form and submitting it to their chosen OEKO-TEX® partner institute. The institute then contacts the manufacturer to request relevant documents, and the following occurs:

1. The selected institute examines the manufacturer’s documents and defines the audit’s scope and parameters of success.

2. The institute tests the textile products according to the OEKO-TEX® STANDARD 100’s criteria catalog titled.

3. If the product successfully passes the lab test, the institute provides the STANDARD 100 certificate and test report to the manufacturer

4. An OEKO-TEX® professional visits the manufacturer’s location to confirm the shared information and details. This visitation occurs either before or shortly after the manufacturer receives the certificate, which authorizes the usage of the OEKO-TEX® STANDARD 100 label

Test Report

As explained above, the manufacturer chooses an OEKO-TEX® partner institute to test its products for harmful substances and receives a test report if the product passes the tests.

The manufacturer needs this test report to prove that their textile products comply with relevant substance restrictions such as those in REACH’s Annex XVII and SVHC Candidate List.


The OEKO-TEX® STANDARD 100 label informs consumers that the textile product, including every component of said product, is “harmless for human health”. This is because it indicates that the product has undergone testing for harmful substances at an independent OEKO-TEX® partner institute.

The information on the label contains a certificate number. Businesses and consumers can enter this number into the dedicated field on the OEKO-TEX® Label Check page to check the validity of the product’s certificate.


Below we provide information regarding several frequently asked questions about OEKO-TEX® STANDARD 100.

Is OEKO-TEX® STANDARD 100 mandatory in the EU?

OEKO-TEX® STANDARD 100 is not mandatory in the EU. However, in order to obtain the certificate, you must comply with the substance restrictions set by two EU regulations:

  • POPs Regulation

This means that by fulfilling the requirements of the standard, you also conform to the substance restrictions set by the above-mentioned regulations.

Note, however, that OEKO-TEX® STANDARD 100 is “stricter” than the REACH and POPs regulations, as it also includes additional substance restrictions, such as the ones listed below.

Is OEKO-TEX® STANDARD 100 mandatory in the US?

OEKO-TEX® STANDARD 100 is not mandatory in the United States. However, children’s textiles products belonging to Class 1 must comply with the total lead content restrictions (ie. 100 ppm) set by the CPSIA, which regulates children’s products in the US.

Note that, even if your product complies with the above-mentioned restriction, this doesn’t mean that it complies with CPSIA, which has additional requirements, including the following:

a. Other substance restrictions (which might not all be covered by OEKO-TEX® STANDARD 100)

b. Mandatory safety standards

c. Documentation requirements

d. Labeling requirements

Is OEKO-TEX® STANDARD 100 mandatory in the UK?

OEKO-TEX® STANDARD 100 is also not mandatory in the UK and, according to our knowledge, it doesn’t mandate compliance with any UK regulation.

However, as already mentioned, the standard requires compliance with the substance restrictions set by two EU regulations. After Brexit, the UK has retained these regulations, with amendments.

This means that, by adhering to the standard, you are indirectly complying with some of the substance restrictions set by the following UK regulations:

  • Persistent Organic Pollutants Regulations 2007

Note, however, that with the time these regulations might differ more and more from their EU’s counterpart, as both the EU and the UK are constantly updating the substance restrictions. Thus, they might decide to restrict different types of substances.

What is the difference between REACH and OEKO-TEX® STANDARD 100?

REACH is a substance regulation that restricts and regulates the usage of chemicals in the EU. It mandates importers and manufacturers to ensure that their products don’t contain restricted substances above the set limitation. It also sets covers registration requirements for certain substances.

Conversely, OEKO-TEX® STANDARD 100 is a voluntary standard that covers labeling, documentation, and testing requirements. These include substance restrictions set by REACH (Annexes XVII and XIV, as well as SVHC).

How do I know if an OEKO-TEX® STANDARD 100 label is valid?

You can check the validity of an OEKO-TEX® STANDARD 100 label by entering the certificate number featured on the label on the OEKO-TEX®’s Label Check website.

If the label check does not come up with a result, you can contact OEKO-TEX® regarding this issue by filling out their contact form.

  • (USA & EU)


    • Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
    • Find product requirements
    • Certification and labeling
    • Lab testing


    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

    Full Disclaimer: Link

    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
  • Leave a Reply

    Your email address will not be published. Required fields are marked *

    Free Training Session

    Product Compliance in 2024

    1. United States, EU, and UK

    2. Product examples & case studies

    3. Ask your questions via Live Chat!