Ask the Experts: July 5 Edition

Ask the Experts: July 5 Edition

Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain data management. We compile these insights to help educate compliance professionals through content, webinars and events. They also provide advice to Assent clients. Here are the top five questions our Regulatory team has responded to over the past month.


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? 

Raj Takhar: 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. 

Question: What are the Stockholm Convention and the Conference of the Parties (COP 9)? What is perfluorooctanoic acid (PFOA)?

Neil Smith: The Ninth Meeting of the Conference of the Parties to the Stockholm Convention, known as COP 9, is the most recent conference in which decisions pertaining to the Stockholm Convention were addressed. It took place from April 29–May 10, 2019. The Stockholm Convention on Persistent Organic Pollutants is an international environmental treaty that is meant to encourage the elimination or restriction of the production and use of persistent organic pollutants.

Once substances are formally listed in the Stockholm Convention, signatory countries are obliged to restrict it within their national or regional hazardous chemical regulations, such as the European Chemicals Agency (ECHA) in the EU. Perfluorooctanoic acid (PFOA), including its salts and related compounds, was one of the two substances proposed for listing at the COP 9 meeting. 

Question: I have an instruction manual that is associated with one of our products. Are the paper and ink in scope of REACH? 

Valerie Kuntz: Nearly everything is in scope of EU REACH. That means the instruction manual would need to be evaluated for SVHCs over threshold and potentially any Annex XVII substances if the condition requires it be restricted. 

The inks would be evaluated as a mixture, but the threshold would be considered at the article level. When doing the threshold calculation for the inks, you would examine the entire manual for SVHC(s) within the ink and complete the necessary reporting.

Question: Should we be concerned with substances used for cleaning products during the coating process of industrial equipment since it is not part of the final product?

Travis Miller: For product compliance purposes, if the material is not present in the finished good, then it does not need to be declared. However, many companies prefer to collect information on processing chemicals in case chemicals, substances or materials become restricted from use or are discontinued. This foresight protects them against line of business disruptions and the possibility of price spikes. In addition, the use of cleaning products has been known to remain on the finished products. For example, dimethylformamide (DMF), a REACH SVHC, was found on many polyurethanes after it was used as a solvent during production and was not properly removed. The presence of DMF then triggered reporting requirements under REACH.

Question: I have a customer that has not purchased materials from us since 2013. Am I required to provide them with a declaration or response for EU REACH, EU RoHS and/or the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)? 

James Calder: If the contract or original purchase agreement addressed the need to provide data for a certain period of time, failure to provide data may reduce the potential for future business.

However, the obligation to provide information is purely based on a business to business relationship. If there is no defined contractual or regulatory requirement for information to be provided, then it’s up to the company to re-engage if they require additional declarations or responses. 


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 info@assentcompliance.com.  

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