Companies that operate internationally are subject to numerous regulations that are sometimes similar and sometimes quite different from one another. When marketing products around the world, it is necessary to comply with the specific legal requirements that are imposed in each country. The aim of these laws is always to protect health and the environment. One example is the European chemicals regulation (REACH), which applies in the 27 Member States and exists in a similar form in both the USA (TSCA) and Canada (CEPA). Other regulations that restrict the use of certain substances or require special due diligence are the RoHS Directive, California Proposition 65, the European Medical Device Regulation, and the conflict minerals regulations. Some of these regulations still tolerate a certain percentage of the respective regulated substances in products. In contrast, the Stockholm Convention on Persistent Organic Pollutants (POPs Regulation) completely bans substances such as PFOAs (perfluorooctanoic acid) and PFOS (perfluorooctanesulfonic acid) and its derivatives as well as greenhouse gases. Products containing any of the substances listed in this regulation may not be imported into the EU. If any of the banned substances are discovered during an inspection, the affected part must be immediately reworked or replaced.

The company TE Connectivity recently highlighted regulatory requirements to its suppliers. Using an Excel document, the company lists all substances that are banned in materials, parts, components, and/or products supplied to TE.  Suppliers are asked to fill out a questionnaire about these substances. TE is currently investigating over 550 substances and the list may grow longer. It currently includes substances restricted by TSCA or CEPA as well as those defined in the POPs Regulation. The company encourages its suppliers to report these substances as accurately and completely as possible.

Both TE Connectivity and imds professional recommend the use of a Full Materials Declaration (FMD) using systems such as the IMDS, the CDX or the IPC1752A Class D standard. The advantage of using an FMD is that it covers current and future declarations of prohibited substances and you do not have to re-test and re-declare your parts every time.

Need help managing your compliance obligations?

Then look no further than imds professional! We can help you get up to speed with all the regulatory requirements through our easily accessible training courses. We will provide you with all the background information you need to know about the individual regulations. And we will show you how to set up your reporting and explain which systems are available to you.

We can also provide immediate assistance to IMDS users who need to quickly determine which substances are being used through our training course “IMDS Analysis Functions” (No. 6191), which is taking place on November 23, 2021.

We understand that identifying and reporting affected substances can be very time-consuming. We can take this weight off your shoulders with our fully flexible range of support services. Simply get in touch with us to arrange a free initial consultation when we will evaluate your current situation and develop a support package that meets your needs and frees up your time to focus on your core business.