Ask The Experts: May 10 Edition

Ask The Experts: May 10 Edition

Our regulatory subject matter experts help a range of stakeholders solve complex 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 the top five questions our Regulatory team has responded to over the past month.

Question: Last year, Restriction of Hazardous Substances (RoHS) Directive Exemption 6c, which allows for the use of lead up to 4 percent weight by weight (w/w) in copper alloy, was extended until July 2021. What is the likelihood of future extensions?

Valerie Kuntz: In 2015, a significant number of contributors requested an extension to Exemption 6c and, as no alternative substance has been developed to replace the use of lead in copper alloys for added strength and corrosion resistance, it is likely a similar number will continue to submit extension requests. If the expected requests materialize, the exemption will be extended until such time that the European Commission can make a decision.

Although Exemption 6c was only extended for two years, it was based on five-year guidance for Categories 1–7, 10 and 11, as noted in the EU RoHS Directive 2011/65/EU Article 5(2). This requires requests be submitted a minimum of 18 months prior to the expiration date. Requests for extension beyond July 2021 must be filed by January 2020 — less than a year away.

Question: The U.S. Defense Federal Acquisition Regulation Supplement (DFARS) prohibits the use of human trafficking and forced labor in the supply chains of contractors and subcontractors doing business with the U.S. Department of Defense. One part of the law stipulates that specialty metals must be melted in the U.S. or qualifying countries. If I am sourcing raw materials that are already DFARS compliant, do I still need to submit a Conflict Minerals Reporting Template (CMRT) to comply with Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act?

Jared Connors: The CMRT asks that organizations take a reasonable approach to identifying materials and their sources of origin, meaning companies conduct due diligence on where the metal is mined, not just where it’s smelted. As such, DFARS compliance does not absolve companies from filing a CMRT.

Question: If I have several parts made of identical materials, do I need a separate declaration for every part, or can I make one declaration concerning the part type?

Neil Smith: In cases such as this, it is common for suppliers to tailor blanket statements to a product line or group of products. If you do this, it is important to ensure (in addition to meeting the standard IEC 63000 declaration acceptance criteria) that the declarations cite a specific identifier associated with a group of products, such as the product line or shared materiality.

Question: The Canadian Environmental Protection Act (CEPA) requires companies to report certain products using quaternary ammonium compounds. What finished products (i.e. articles, not chemicals) are in scope of this requirement?

James Calder: CEPA’s guidance indicates quaternary ammonium reporting requirement targets items “considered to be key sources of exposure to the general population.” Products (non-chemicals) impacted fall into one of three categories, defined as manufactured items:

  • Intended to be used by or for children under the age of six years.
  • Items intended to come into contact with the mucosa of an individual. Mucosa is defined as a group of mucous membranes that line parts of the body that lead to the outside and are exposed to air (i.e. mouth, digestive tract, urogenital tract, respiratory tract and ears).
  • Items intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual.

Question: How long do IPC-1752A standard data submissions regarding parts stay valid, assuming there is no change to the part?

Bruce Jarnot: The IPC-1752A standard does not specify parameters for supply chain outreach or document retention. The guidelines for document management are laid out in the IEC 63000 standard (4.3.5) and state that the manufacturer shall:

  • Perform a periodic review of the documents contained in the technical documentation to ensure that they are still valid.
  • Ensure that the technical documentation reflects any changes to materials, parts or subassemblies in accordance with 4.3.3.

In effect, this means there is no specific time window for data validity to expire, but changes to materiality and design must be accounted for once they are made.

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