Question: Do European Union (EU) regulations such as the Restriction of Hazardous Substances Directive (RoHS) and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) apply to businesses that only operate in the U.S.? After finding the bill of materials (BOM), are International Material Data System (IMDS) breakdowns an acceptable way to determine the breakdown of materials?
Answer: Many U.S.-based companies are interested in supporting demand generation and market access for their goods. Additionally, if any of your customers are selling into the EU or any of your goods are used in international supply chains, the need to support EU RoHS and EU REACH could be passed on to your company as a condition of doing business, even if there are no direct EU sales.
If an EU-based company buys a product that will eventually be introduced to the European Economic Area (EEA) from a U.S.-based company, the U.S.-based company is brought into scope. To meet its clients’ EU REACH and EU RoHS requirements, U.S.-based companies in scope need to provide an Article 33 declaration when importing a Substance of Very High Concern (SVHC) within any article at 0.1 percent weight over weight (w/w). They also must not use any substances restricted under EU RoHS, unless an exception has been explicitly granted. Where declarations are required, IMDS reporting may be acceptable provided a full material breakdown of homogeneous materials is included, however, acceptability should be determined on a case-by-case basis.
This information is accurate as of July 5, 2019.