Ask the Experts: August 2 Edition

Ask the Experts: August 2 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, and to provide Assent’s clients advice. Here are the top five questions our Regulatory team has responded to over the past month.

Question: How have regulations and laws improved the transparency of conflict minerals reporting? What progress has been made in determining material point of origin, and how have these regulations affected the Democractic Republic of the Congo (DRC)?

Jared Connors: There are two sides to due diligence on this issue. On one side, most conflict minerals programs focus on the downstream collection of smelter source information from suppliers and the assessment of tier 1 supplier programs. This is primarily what Assent’s Corporate Social Responsibility Suite supports. We’ll refer to this as the “downstream” side of due diligence.

The “upstream” aspect of due diligence focuses on the smelter and the mine. While upstream due diligence differs from typical corporate social responsibility efforts, it addresses the source of nearly all questions concerning supply chain transparency in the DRC.

Prior to the passage of Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act,  the only concerns smelters had were about the amount, purity and price of minerals. While smelters knew where minerals were mined, few downstream companies concerned themselves with the origin of resources.

Today, however, smelters have to demonstrate greater transparency to pass conflict minerals audits. Smelters also require greater levels of verification from the mines supplying their minerals. Smelters are more concerned with the legitimacy and condition of the mine, as well as details concerning material transportation and the exchange of money.

What does this mean for the DRC? For one, more stringent mineral point of origin requirements make it harder for illicit materials to enter the legitimate trade. While illicit trade still occurs, companies (upstream and down) tracking mineral sourcing makes it harder for illicit trade to continue.

Within the DRC, there is now more legitimate traceable material sourced from small villages than ever before thanks to the influx of organizations supporting legitimate trade. The impact on larger industrial cities in the DRC has been minimal, however, because of existing obligations to monitor sources.

Question: Are silica gel packets within scope of the European Union (EU) Medical Device Regulation (MDR)?

Raj Takhar: Silica gel packets are an interesting case. According to the EU MDR:

Article 10.4.1

Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.

Devices, or those parts thereof or those materials used therein that:

  • are invasive and come into direct contact with the human body,
  • (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
  • transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.

In theory, if a device meets these criteria, it is within the scope of the EU MDR.

Silica gel packets may not look as though they are in scope of EU MDR because they keep product containers dry and prevent moisture build-up. However, section 11.7 of the EU MDR, Infection and microbial contamination,  stipulates the following: “Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimize the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.”

In essence, if a product meets the criteria for Article 10.4.1, then section 11.7 is applied and the packaging, including silica gel packets, would be considered part of the finished device until it is opened and used. The same logic applies to section 11.4, which concerns plastic packaging on sterile devices.

Question: What’s the difference between the EU MDR and the In Vitro Diagnostic Regulation (IVDR)? How do they affect each other?

Raj Takhar: The EU MDR and IVDR are different regulations with different thresholds and substance lists that are applied to different product types. While some confusion arises from EU MDR’s applicability to certain diagnostic devices, these separate regulations can be thought of as two sides of the same coin.

EU MDR applies to medical devices that come into direct contact with humans. It covers everything from bandages and catheters to implants and colored contact lenses. Some diagnostic and monitoring devices are also within scope.

In contrast to the EU MDR, the IVDR covers diagnostic and monitoring devices that may attach to a person, but are specifically used for monitoring human functions. A heart rate monitor, for example, would likely be in scope of the IVDR. The IVDR has a longer implementation period and affects a smaller product range (the EU MDR affects around 500,000 devices, while the IVDR affects approximately 50,000).

Question: Because of the substances they contain, batteries are outside the scope of the Restriction of Hazardous Substances (RoHS) Directive. However, are batteries and battery packs impacted by the REACH Regulation?

Raj Takhar: Batteries are indeed outside the scope of the RoHS Directive due to Battery Directive 2006/66/EC, which regulates the manufacture and disposal of batteries.

However, batteries are still within the scope of the REACH Regulation, as an individual battery (or battery cell) is classified as an article.

Battery packs, meanwhile, are defined as “any set of batteries or accumulators that are connected together and/or encapsulated within an outer casing so as to form a complete unit that the end user is not intended to split up or open.” Assuming the pack is sealed, it would fall under Battery Directive 2006/66/EC, but the pack itself would be in scope of the REACH Regulation.

In short, Battery Directive 2006/66/EC labeling is applicable to batteries and potentially for sealed battery packs, while the REACH Regulation applies to all in-scope items, including a case and its components.

Question: Hexavalent chromium (chromium 6) is restricted from use in electronic equipment in the EU under the RoHS Directive, but it’s commonly formed during stainless steel welding. Does welding wire therefore need to comply with the RoHS Directive?

Valerie Kuntz, Bruce Jarnot & Neil Smith: No, stainless steel welding wires and rods are considered consumable items outside the scope of the RoHS Directive, but that doesn’t mean there is no potential for chromium 6 exposure.

Chromium 6 is a harmful substance when touched directly or inhaled as a fume. Elemental chromium is often used to strengthen stainless steel during the alloying stage. As such, welding steel components or welding with steel wires and rods could potentially produce chromium 6 temporarily.

While chromium 6 can be produced through “hot” work such as welding, it is not present in stainless steel. Chromium 6 will not typically be the reason the RoHS Directive applies to electrical and electronic equipment (EEE), but that doesn’t mean it should be dismissed entirely.

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

Assent’s regulatory subject matter experts frequently provide actionable insight into regulatory programs through webinars and other events. To learn more, contact