Ask the Experts: June 21 Edition

Ask the Experts: June 21 Edition

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


Question: We follow the same manufacturing process as a coated wire company, but use 1-methyl-2-pyrrolidone (NMP) for the manufacture of medical tubing. Does the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation Restriction List (Annex XVII) apply to the substance, or the manufacturing process in which it is used?

Neil Smith: The REACH restriction on NMP applies to the substance, and the implementation date and exemption until 2024 are for the specific process of wire coating. Manufacturing companies that use the same process but are not manufacturing wire coating are not in scope.

It should be noted that the restriction of NMP as a process chemical only applies to manufacturing processes that occur within the EU. If NMP is used in the manufacture of a product outside the EU, but it is no longer present once the product enters the European Economic Area (EEA), it cannot be regulated against.

Question: What products commonly contain formaldehyde? 

Bruce Jarnot: Formaldehyde is often present in automotive dashboards, plastics and rubber hoses. Urea formaldehyde glue is also commonly used to bond wood fibers in products such as plywood, particle board and resins such as delrin, which are polymers of formaldehyde.

Question: Are compounds containing cobalt considered out-of-scope of responsible sourcing best practices, and should products with trace amounts of cobalt be included in our outreach to suppliers?

Jared Connors: The scope of regulations governing a compound is dependent on whether cobalt was intentionally added, including where it is left as residue after processing.

When communicating with customers, the best practice is specifying that “no cobalt has been intentionally added for use within the products or the production process, but trace amounts may be contained within certain metal materials.”

Where cobalt is present, companies can use the Cobalt Reporting Template to report on it. This is a free, industry-standard template developed by the Responsible Mineral Initiative (RMI) to collect cobalt data from the supply chain, and facilitate smelter and refiner identification.

Question: For a full material disclosure (FMD), how should I proceed when a supplier has determined the percentage of a substance is confidential?

Raj Takhar: If the client accepts FMDs with proprietary substance declarations, they should engage the supplier that provided the FMD for REACH and RoHS any time there is a regulation update. The Assent Supplier Portal can be configured by the client to accept any percentage of proprietary information, including zero percent, in order to maintain confidentiality.

Question: Can European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) declarations also meet the requirements for EU Restriction of Hazardous Substances (RoHS) Directive substances?

Raj Takhar: REACH Substances of Very High Concern (SVHC) levels are calculated based on the mass of the definition of an article, whereas EU RoHS is set at the homogeneous level, meaning at any point of measurement within the product. Additionally, REACH and RoHS have different exemptions, and the more common ones are calculated differently. It is possible to be compliant with RoHS exemptions, but not be compliant with REACH exemptions, and vice versa.


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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