BY BEN MEAD, MANAGING DIRECTOR, HOHENSTEIN INSTITUTE AMERICA, INC.
Q: What is the definition of a restricted substance?
A: A restricted substance is terminology that companies have come up with to identify chemicals that could be used in the manufacturing of their product, and they want to make sure their presence in the finished product is limited so that users of the product have reduced exposure to the chemical. These chemicals could be on the list for a variety of reasons, including hazards such as toxicity, cancer, reproductive concerns, and environmental persistence. Many restricted substances today have been covered by global legislation for many years.
Q: How do most product manufacturers address the use or nonuse of restricted substances?
A: Companies often address restricted substances by publishing their own list or relying on a publicly available third-party list like the one included in the OEKO-TEX® STANDARD 100. The use of this list helps them communicate to their suppliers what they expect from them, and it creates a consistent, systematic way for them to conduct testing of raw materials or finished products. For some companies, the restricted substance list (RSL) is part of a greater chemical management program where they also address how chemicals are purchased, stored, used, treated in wastewater, or otherwise disposed of to protect workers and the environment.
Q: Are restricted substances requirements becoming more common? Why?
A: The concept of restricted substances in textiles and apparel has been around at least since 1992 when OEKO-TEX® published the first version of the STANDARD 100. We also have worked closely with brands and industry groups who have more commonly been relying on restricted substance requirements since the early 2000s. Lately, we have seen an increase in global chemical regulations, which has increased awareness among companies that, especially if they are interested in selling in a global marketplace, they need to know what goes into their product and what remains in the product. The more constantly changing legislation means it’s more challenging for companies to have in-house resources to keep an up-to-date list of chemical requirements and testing approaches so we continue to see companies relying on third-party standards like OEKO-TEX® STANDARD 100 because a team is already constantly making sure the most strict and relevant requirements are maintained.
Q: What is the OEKO-TEX® 100 Standard and why did it come about?
A: The OEKO-TEX® STANDARD 100 was developed in 1992 as an independent way for companies (primarily in Europe) to validate that their products were compliant with new laws that were introduced around dyes and other chemicals in consumer products. When these laws were introduced, it brought about a new level of consumer awareness so the domestic textile industry would look for a positive way to communicate to consumers that even though they were hearing about hazardous chemicals in products—maybe for the first time—this wasn’t unknown to the European textile producers, and it didn’t have to mean that all products were unsafe. The OEKO-TEX® STANDARD 100 quickly became the go-to tool for consumer communication around chemical safety.
Q: How are the restricted substances in the OEKO-TEX® 100 Standard selected?
A: Many of the substances have now been on the list for many years but each year the criteria, limit values, and test methods are reviewed to ensure continued global safety leadership. Substances can get added to the list when new legislation is introduced or when OEKO-TEX testing laboratories identify that production processes potentially leave finished products susceptible to residual levels of hazardous chemicals.
Q: Who determines the limits for restricted substances in products?
A: Limits are determined through cooperation by the OEKO-TEX Association, the independent toxicologists they work with, and member institutes that perform the testing. Some limits can also be influenced by legislation, since many OEKO-TEX certificate holders count on the certification to help them confirm legal compliance. Other organizations have used toxicology and regulatory expertise to help set their restricted substance limits.
Q: How are restricted substance limits reported?
A: Usually, the limit values are reported as a concentration in the material. For example, it is common to report milligrams of chemical per kilogram of the material, which is equivalent to a parts per million concentration. Some volatile substances are also reported as emission concentrations to simulate off-gassing potential.
Q: Which organizations evaluate products for restricted substances?
A: Typically, evaluation is done as a precheck before introducing a product to the market so in addition to being an OEKO-TEX® STANDARD 100 certification provider, we (Hohenstein) operate as an independent lab capable of providing chemical testing according to other lists of restricted substances. There are also other entities like government agencies, nongovernment organizations (referred to as NGOs), and even private lawyers who evaluate products to make sure they comply with legal requirements.
Q: Are the test methods used for the measurement of restricted substances standardized?
A: Now that restricted substance testing has been available for several decades, there are many standardized international methods that are used for the most common chemicals. In some cases, a lab may also optimize a standardized method to try to ensure complete measurement of a chemical in a specific material. When new requirements are introduced—for example, the PFAS requirements, which rely on total fluorine measurements—they have gone through a series of method tweaks as companies try to find the right approach to ensure they are getting the most complete data. In those cases, different labs might focus on creating a method based on their available equipment while other facilities take a different approach. Over time, there generally is consolidation in the methods.
Q: How often are restricted substance requirements updated?
A: For the OEKO-TEX® STANDARD 100, the requirements are updated at least annually. There also are REACH SVHC* changes that can be published every six months, so in some years it is necessary to make a smaller mid-year update. Having complete updates is a lot of work, so we see companies that try to manage their own restricted substances list also trying to keep updates to at least an annual frequency.
Q: How does the PPE Supplement affect restricted substance requirements?
A: The OEKO-TEX® STANDARD 100 PPE Supplement is used for special PPE and military materials that require special manufacturing conditions or functionality that may not meet all the chemical requirements of the traditional STANDARD 100. There are limited exceptions to the chemical requirements, which are designed to enable certification and communication about performance of all the other chemical requirements when only specific parameters can’t be met because of technical limitations.
Q: What justifications are used for providing different limits for PPE?
A: The main justification is the PPE and military materials have a very specific duty to protect the wearer from specific acute hazards. To achieve that performance, specific materials with manufacturing processes that require specific solvents, colorants, or repellency chemistry might be technically required, no alternatives exist, and opportunities to replace are not possible. While these are restricted in the traditional STANDARD 100, the value to the wearers is that they know the majority of the STANDARD 100 requirements are met. Without the PPE Supplement, no consumer label would be possible, and the wearers would not have the confidence that they are protected from nonnecessary hazardous chemicals.
Q: How are the OEKO-TEX® 100 Standard and PPE Supplement applied to PPE?
A: The OEKO-TEX® STANDARD 100 is used on PPE in the same way it is used to label other consumer products like diapers, T-shirts, towels, and sheets. When a company has a product certified and labeled, consumers can clearly see they are protected from hazardous chemicals. The PPE Supplement can be used to certify specific protective materials and also combined with materials certified to the OEKO-TEX® STANDARD 100 to enable labeling of full PPE products.
Q: Can only components used in PPE be evaluated for restricted substances?
A: No, components used in any type of product can be tested for restricted substances. OEKO-TEX certifies all types of apparel products but also diapers; other disposable hygiene products; leather items; shoes; and home textiles like sheets, pillows, and mattresses. Testing is customized depending on the material composition so the restricted substances a company tests for certainly don’t look the same for every material.
Q: Where is the information about compliant products and components found?
A: OEKO-TEX® lists all its information on its website. Anyone can download for free the certification standard and requirements, the list of restricted substances, and the test methods used to perform the testing. You can also find a section of the website called the “Buying Guide,” where a searchable database of certificate holders is available for free. The other useful part of the website is the label check tool, where you can check to see that a certificate is valid and that the scope of the certification includes the product or material you are concerned about.
Q: How are the NFPA 1970 requirements for restricted substances different from those in the OEKO-TEX® 100 Standard and PPE Supplement?
A: Really, the current OEKO-TEX® STANDARD 100 list of substances, limit values, and test methods matches the NFPA 1970 requirements for restricted substances. This is one of the reasons the OEKO-TEX® STANDARD 100 is specifically listed in NFPA 1970 as proof of compliance to the restricted substance requirements. OEKO-TEX® has an annual update process so the requirements get stricter year after year. As we know that NFPA 1970 will not be revised for several years, the annual requirements for OEKO-TEX® STANDARD 100 and the PPE Supplement will get stronger and continue to exceed the requirements through the revisions.
Q: Are there other organizations that can provide restricted substance testing and verification?
A: OEKO-TEX® certification can be provided by any of the 17 member institutes so companies have options for certification no matter what country they are producing in. There are other labs that can also perform restricted substances testing, but companies should make sure that the comprehensive testing according to the described methods is followed to prove compliance to NFPA 1970 restricted substances requirements.
* REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. REACH is a European Union regulation that controls the use and supply of chemicals. It was adopted in 2007 to protect human health and the environment from the risks of chemicals. SVHC stands for substance of very high concern.
