Material Compliance worldwide

SUBSTANCE RESTRICTIONS THROUGHOUT THE WORLD

Legal provisions governing combinations of materials in products are just as relevant for companies as other product safety provisions. Meeting material compliance requirements is of great importance, not only in the European Union, but also globally. There are hundreds of sets of rules worldwide that restrict or prohibit the use of certain substances in products.

In the US states alone, for instance, there are about 377 sets of material compliance rules. As well as federal laws (e.g. the Toxic Substances Control Act (TSCA) in the USA), there can also be sub-federal provisions in individual states (e.g. USA), provinces, and territories (e.g. Canada). So researching requirements can be very challenging.

Adhering to material provisions is not only difficult due to international supply chains, different approaches, and different limits in substance lists, but also because of the many exemptions and, in some cases, wildly differing interpretations.

The prerequisite for product manufacturers is to inform themselves about the requirements that apply in their target markets and ensure that the goods they produce adhere to the corresponding provisions. They must monitor international legislation carefully, cooperate with suppliers, and then implement effective material compliance systems throughout the supply chain.

By adhering to internationally applicable material compliance provisions, companies can fulfill their customers’ requirements, avoid legal consequences, build a positive image, and at the same time make a positive contribution to human health and environmental protection. Companies that ensure today that their products do not contain any prohibited substances will be twice as competitive tomorrow, while securing a considerable head start over their international competitors.

Regulations similar to REACH

Some countries have introduced regulations similar to the EU’s REACH Regulation. Turkey, for instance, has enacted a regulation called KKDIK (Registration, Evaluation, Authorization, and Restriction of Chemical Substances), which controls the registration process and monitoring of chemicals in the country. Additional countries are:

  • USA
  • China
  • Australia
  • Canada
  • South Africa
  • South Korea
  • Taiwan
  • Malaysia
  • Thailand
  • Vietnam

and many others.

Even though the requirements are similar to those of the EU REACH Regulation, in very many countries it remains a challenge to determine what specific obligations they involve for foreign product manufacturers.

Provisions similar to RoHS

When it comes to restricting dangerous substances in electrical and electronic devices, the EU RoHS Directive is a global role model. Countless countries (including China, Japan, South Korea, Vietnam, India, Turkey, Saudi Arabia, etc.) have enacted RoHS-like provisions that usually refer to the same substances.

However, although these regulations seem similar at first glance, the details can vary widely when it comes to implementing the requirements. Sometimes material analyses and certifications by third parties are required. And there can be just as many differences between affected products. Since, in addition, there is frequently no labelling required in this context, background knowledge is paramount.

Material Compliance in the USA

TSCA & California Proposition 65

In the USA alone, there are 377 different legal provisions around material compliance.

EXPERT TIP

In the USA, requirements for material compliance and environmental topics vary widely from state to state. California is known for being the most regulated. But this (unfortunately) does not mean that if you fulfill the requirements in California you will automatically also cover all requirements in all the other states.

Material compliance is of great significance in the popular target market USA, too, and is subject to various legal requirements, including in particular the federal or cross-state Toxic Substances Control Act (TSCA) and, in the state of California, Proposition 65.

TSCA

Adopted back in 1976, TSCA is the main law regulating chemical substances in the USA. The Frank R. Lautenberg Chemical Safety for the 21st Century Act updated the law and equipped the Environmental Protection Agency (EPA) with new powers to perform risk assessments for existing and new chemicals and enact corresponding provisions to ban or restrict “high risk substances”. At the beginning of 2021, this resulted in the enactment of new regulations for five persistent, bioaccumulative toxic substances (PBTs) (including PIP 3:1, a substance frequently occurring in electrical components, which was previously unregulated around the world). In the near future, we can expect further regulations that will affect all companies exporting products to the USA.

California Proposition 65

California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act 1986, is a Californian law that aims to protect against harmful chemicals that are known to cause cancer or reproductive damage. The current substance list includes more than 1,000 substances. Exposure to these chemicals can occur when products are used (e.g. through skin contact, inhalation, etc.). Exposure can also arise in apartments, in the workplace, or in other environments (e.g. theme parks, hotels, gas stations, etc.). Clear and appropriate warnings aim to give Californian citizens the option of deciding whether to accept the exposure or not. Manufacturers of components, too, may have to pass on warning messages to the manufacturers of end products. Are staff exposed to listed chemicals during assembly? Is it necessary to have a warning on the finished product? The risks to companies are immense, as any public institution, but also any Californian citizen, can bring an action against them in a court of general jurisdiction.

In addition, sector-specific material compliance regulations may also apply in the USA. For example, the electronics industry has specific requirements for the use of lead, mercury, cadmium, and other hazardous substances in electronic devices. The automobile industry is subject to strict provisions with regard to materials used in motor vehicles, to ensure the safety of drivers, passengers, and the environment. To guarantee material compliance in the USA, companies should stay informed about applicable laws and provisions and ensure that their products meet the relevant requirements. This requires them to collaborate closely with suppliers, provide documentation, and implement effective systems to monitor and control the materials used.

PRACTICE-DRIVEN MATERIAL COMPLIANCE EXPERTISE

Legal Specialist Inken Green

Senior Product & Material Compliance Consultant

and a member of IPA Fraunhofer’s Expert Forum on Global Environmental Compliance

B.A. Linda Kritzler

Material & Environmental Compliance Consultant

and a member of IPA Fraunhofer’s Expert Forum on Global Environmental Compliance

Questions we’ve advised companies on in the past:

Is there a list for the TSCA that you can go through with suppliers?

Doe the TSCA also apply if you’re just a supplier?

Can you tell us the restrictions for lead worldwide simply and understandably?

Expert tips

In the USA, the requirements relating to material compliance and environmental topics can vary greatly from state to state. California is known for being the most regulated. Unfortunately, however, this does not mean that if you meet the Californian requirements you have automatically covered all the requirements in the other states.

It is important to know the different requirements of different countries. A device that complies with RoHS China does not necessarily comply with EU RoHS, and the other way round.

“Globalnorm’s expertise and commitment regarding all material compliance matters have significantly advanced our company and helped us understand the regulatory requirements in this area. The material compliance consulting provided goes far beyond merely fulfilling requirements. It creates trust and certainty.”


A. Rösslein, Expert Product Compliance, Stäubli Electrical Connectors AG

HERE’S HOW WE SUPPORT YOU WITH EVERYTHING RELATED TO MATERIAL COMPLIANCE

Efficient knowledge management:
We help you determine and understand the statutory requirements that apply in your target markets and keep them up to date.

Material check and substance inventory:
We support you in identifying and documenting the materials used in your products.

Targeted decision-making:
We advise you on risk assessment and how to develop a material compliance strategy.

Effective process optimization:
We guide you through the implementation of helpful material compliance processes, including documentation and staff training.

Smart supplier management:
We help you execute efficient supplier surveys and handle customer requests.

CONTACT OUR MATERIAL COMPLIANCE EXPERTS

USE OUR COMPREHENSIVE MATERIAL COMPLIANCE EXPERTISE

Don’t hesitate to get in touch with our material compliance experts if you have questions or want to discuss a particular concern.

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Legal Specialist
Inken Green

Product & Material Compliance Expert

B.A.
Linda Kritzler
Material & Environmental Compliance Consultant

Dipl.-Ing. (FH)
Michael Loerzer

Regulatory Affairs Specialist

LET US HANDLE IT!

Our team of experts can also provide specialist support for your material compliance challenge.

Please send your request using the form here, or give us a call:

+49 30 3229027-50

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