Ask the Experts: March 15 (RoHS Edition)

Ask the Experts: March 15 (RoHS Edition)

Our regulatory subject matter experts are always available to educate compliance professionals through content, webinars and events. They also provide advice to Assent clients. With the upcoming restrictions on four new phthalates under the European Union (EU) Restriction of Hazardous Substances (RoHS) Directive, our Regulatory team has been fielding a lot of questions. Here are the answers to the top four they recently received.   

Q: Is there a way to determine whether a component has zero risk of containing a regulated substance, and doesn’t require substance disclosure documentation as a result?

James Calder: Every part and/or material in scope of RoHS, or any similar regulation, requires substance disclosure documentation. A material specification can be used in supporting documentation in conjunction with the contractual requirement that demonstrates how the material is used. A material specification must explicitly determine the presence and/or absence of substances covered by the regulatory need.

Q: Does a part in scope of a RoHS exemption still need to be certified? Is it considered still in scope?

James Calder: If a material is covered by a RoHS exemption, it is still in scope — but it has application-specific uses that may allow the use of restricted substances above threshold. The parts/materials that fall under an exemption must include supporting documentation to meet IEC 63000, just like any other part/materials that are in scope.

Q: Does every single component of an assembly (such as nuts and bolts) need to be certified under EU RoHS?

James Calder: The requirement of meeting the RoHS Directive is to create a technical file that includes all documents on materials, parts and/or sub-assemblies. The acquisition/compilation of the documentation would be related to the materials/parts/sub-assemblies, as provided by the immediate supplier. It would not be expected for every company to directly get documentation from sub-tier suppliers, but it would be expected that direct suppliers have performed the same due diligence on their respective supply chains. The complexity of products/parts should be a factor in assessing the risk of products.

Q: The RoHS category descriptions are not very specific. How can I tell which categories products fall into?

James Calder:

This is a difficult question with no one-size-fits-all answer, but good practice is to review a variety of product or product lines that are representative of your product portfolio. In the review, document the decision process that determines the inclusion/exclusion of scope or RoHS category. The conclusions and documentation can then be used as a reference when applying the same decision process for other products.

For an unclear product category, the conclusion would likely be Category 11, “Other.”

For more questions and answers, visit the last edition of Assent’s Ask the Experts blog.

Assent’s regulatory subject matter experts frequently participate in events such as webinars to educate compliance professionals. They also inform our clients’ regulatory programs. To learn more, contact