Ask the Experts: September 13 Edition

Ask the Experts: September 13 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: My company produces fuel delivery modules (FDMs). Because we sell it into India, we need to understand India Restriction of Hazardous Substances (RoHS) lead restrictions. It does not appear that our product is in scope, but we need to be certain. Can you help?

Valerie Kuntz: India RoHS, and the Waste Electrical and Electronic Equipment Directive, include a limited list of products that are considered in scope as defined in Schedule 1 of the updated India E-Waste Management Rules, GSR 338(E), March 2016. It includes the original six RoHS substances, but not the four phthalates added to RoHS 2 (EU 2015/863) this year. The list of products does not make specific reference to FDMs or any similar products, so I would agree that you are not within the scope of India RoHS.

You are, however, in scope of the European Union (EU) RoHS Directive — most likely under Category 11 — and must ensure this product is either compliant with all 10 substance restrictions, or has received an exemption. 

Find out about how Assent can help you acquire the full range of supply chain data with our guide the Assent Compliance Platform: Building Value Into Your Supply Chain Data Management Program.

Question: When a smelter is removed from the known smelter list, is there a grace period before it is formally removed from the certified smelter list? What is a reasonable time period for our suppliers to wait before removing this smelter from their Conflict Minerals Reporting Template (CMRT)?

Jared Connors: Removing a smelter from the known list is very different than removing them from the certified list. If a smelter has been removed from the known list, they no longer refine metals or have never been defined as a smelter or refiner, and the removal is a correction.

However, if the supplier has identified a smelter as a possible upstream source, we don’t recommend removing them from your disclosure, regardless of their compliance status. Often, tin refineries — especially those in Southeast Asia — open and close based on current incoming materials that have yet to be processed. It’s very common for them to shut their doors as they negotiate concessions from various mining sites. If that closure period falls during their audit renewal, they often won’t pay to be re-audited until they have more stock and are ready to re-open.

There may also have been changes to the audit process. Some tin smelters may not be listed because of a recent rewrite to their process. Additionally, oversight could shift toward the International Tin Association before the end of the year. Although this may further delay some smelters, it will strengthen the due diligence process by requiring internationally traded tin brands to comply with best practice auditing standards.

Question: Is there an English version or guidance related to the United Arab Emirates (UAE)  version of the RoHS Directive?

Valerie Kuntz: In the UAE, compliance with the RoHS Directive can be demonstrated in two different ways: If the manufacturing process for the product is complete, submitting your technical dossier will yield the Emirates Quality Mark (EQM) and certificate for a period of three years. If the product hasn’t been manufactured yet, certification can still be obtained for a period of one year in order to mitigate risk during production. Click here for an English version of the text and guidance on its associated requirements. 

Question: Our company sells service replacement parts that can be incorporated into a system we produce, or sold as accessories. In some cases, they are repaired or refurbished units. Customers send us their old units, and we sell them refurbished products at a discount. In order to identify that the unit has been refurbished, we sometimes add a unique suffix to the end of the part number.

If the REACH Regulation applies to service replacement parts, we would include these items in our data export to the Assent platform. In the case of refurbished units, we make the assumption that they have the same components as a new part. If we were to replace a component due to it being non-compliant, we would replace it during refurbishing. We typically don’t set up a bill of materials (BOM) for these refurbished parts. In this case, can we refer to the new part’s BOM as the BOM of the refurbished parts?

James Calder: REACH SVHC communication applies to the Article level, therefore, it does not distinguish between replacement or refurbished parts. If there is a clear and documented process that states a refurbished product has the same BOM as a new product, then one could simply have the suffix identifying it as a refurbished product put in the Assent Compliance Manager, but they would map to the same parts and suppliers just like a non-refurbished product with the same BOM.

In the case of the new component, if it was being imported into the European Economic Area (EEA) to replace part of an assembly, then the component would need to comply with REACH requirements at the point of import (i.e. have part data supporting REACH compliance). If the component was being replaced in a product outside of the EEA and then imported into the EEA, the entire product would need data related to all parts in the product as delivered. If this requires setting up a new BOM or some kind of flat part list to properly account, it would be important to export to the Assent platform.

Question: How should my medical devices company manage new requirements associated with Section 10.4 of the EU MDR 2017/745 and the 0.1 percent threshold for substances that are carcinogenic, mutagenic or toxic to reproduction? Although my company isn’t concerned about the risk for implantable metals, as they are tested and evaluated rigorously, we are concerned about our instruments, especially those produced by outside manufacturers.

Safety Data Sheets don’t provide the required information, and industry standards don’t require testing for trace elements — so they generally aren’t tested. We have relied on certificates of conformity, analysis and requests to vendors for threshold levels on polymers. In the case of metals, it’s more difficult; most manufacturers haven’t had stringent requirements until now and manufacture primarily for other industries.

Raj Takhar: Section 10.4 of the EU MDR requires the identification of substances. The manufacturer placing the finished product on the marketplace has to create a technical file as part of the product approval process. This identifies where any EU MDR substances may be found above the 0.1 percent weight by weight threshold within a medical device, it’s sub-assemblies at the very lowest part and must include appropriate justification. This data should be acquired from your suppliers.

To put this technical file together, your first order of business should be to identify substances in products. If your organization receives a request for information on EU MDR substances, you’ll need to provide data on any reportable substances contained in any articles you supply. The onus is on your suppliers to determine this.

To acquire the data, various conformance certificates may be collated and submitted. The Assent EU Medical Device Regulation module allows for additional documentation to be uploaded. 

Please note that although it may seem like your implantable devices are compliant, under EU MDR implants are under even more scrutiny. When a patient receives an implant, the manufacturer of the implant has to provide an implant passport that identifies the product, the patient receiving an implant and data on materials used in the implant. This is managed from a central database, and used for post-market surveillance (product monitoring and recalls). Therefore, any requests relating to implant materials must be treated in the same manner as all other EU MDR requests.

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