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In today’s regulatory landscape, maintaining up-to-date product compliance data is crucial. Regulations like the Restriction of Hazardous Substances Directive (RoHS) and the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) are regularly updated, impacting manufacturers worldwide. For instance, REACH’s substances of very high concern (SVHC) list is revised biannually, while California’s Proposition 65 frequently adds new substances.

Newer regulations, such as the Toxic Substances and Control Act (TSCA) Section 6(h) and the PFAS reporting rule under TSCA Section 8(a)(7), further complicate compliance efforts. Companies must ensure their product documentation is always current to avoid non-compliance. Collecting Full Material Declarations (FMDs) from suppliers streamlines this process by providing a comprehensive overview of product composition, reducing the need for multiple, time-consuming requests for updated data.

What is a Full Material Declaration (FMD)?

An FMD provides a detailed disclosure of a product’s chemical composition down to the homogenous material level. Ideally, FMDs include every substance’s Chemical Abstract Service (CAS) number and concentration, though some FMDs may exclude details due to proprietary concerns or unavailable data.

FMDs come in multiple formats, from industry-standard schemas to PDFs and Excel sheets. While this diversity can complicate collection and analysis, FMDs remain a reliable tool for ensuring compliance across various regulatory frameworks.

How FMDs are used for product compliance

Many industries have standardized FMD collection. For example, the automotive sector uses the International Material Data System (IMDS), aerospace and defense rely on IPC-1754, and electronics manufacturers use IPC-1752 and IEC-62474.

These systems and industry standards enable companies to manage compliance with regulations like RoHS and REACH efficiently, reducing administrative burdens and enhancing supply chain transparency.

The expanding role of FMDs in supply chains

As substance restrictions increase across all industries, the need for FMDs is becoming more widespread. The EU’s Medical Devices Regulation (MDR), for instance, places greater emphasis on material transparency, and the EU’s Critical Raw Materials Act (CRM Act) requires manufacturers to better understand the materials and sourcing behind their products.

Environmental, Social, and Governance (ESG) requirements, like the Uyghur Forced Labor Prevention Act (UFLPA) and the Corporate Sustainability Due Diligence Directive (CSDDD), emphasize the need for detailed material data. Collecting FMDs equips companies to stay ahead of these changes and assess potential risks more effectively.

Best practices for collecting FMDs and ensuring data quality

To ensure high-quality FMD data, effective communication with suppliers is key. Set clear expectations for timelines and data formats, and provide templates to streamline the process. Incorporating FMDs into contracts or statements of work ensures data collection remains part of the supplier relationship.

Data quality is equally critical, as common errors in FMD submissions include incorrect CAS numbers, mismatched material weights, and undeclared substances. A clear process for reviewing and correcting these errors ensures that the FMD data is accurate and fit for purpose. Utilizing standardized formats like IPC-1752 reduces inconsistencies and simplifies analysis. Both automated and manual reviews are essential to ensure material declarations align with the product’s components.

When collecting FMDs, obtaining the exact CAS number and chemical name for every substance is the ideal scenario, as represented by the bullseye in the image below.[AL2] However, due to confidentiality concerns or the absence of a CAS number, this isn’t always possible. In such cases, it’s still valuable to gather as much information as you can, even if it’s not directly in the center of the bullseye.

For instance, knowing that a substance is a flame retardant is more useful than labeling it as a “confidential substance.” By narrowing down the classification further—to a halogenated or even brominated flame retardant—you equip your compliance team with more specific data that can be quickly evaluated when regulations change. The more precise the data, the fewer suppliers you’ll need to query for updates, and the lower your costs for verification testing. This approach balances compliance, confidentiality, and efficiency while maintaining the accuracy required for regulatory reporting.

Leveraging FMDs for product compliance and supply chain initiatives

FMDs go beyond product compliance. While they are critical for managing restrictions like REACH and SCIP, they also support conflict minerals disclosures, lithium and cobalt usage tracking, and eco-label certifications.

In addition to regulatory compliance, FMDs are instrumental in ESG reporting. By providing insights into the materials used in products, they help companies identify risks, track sourcing, and align with sustainability goals. This transparency ensures ongoing compliance and demonstrates a commitment to ethical supply chain practices.

If your organization isn’t yet collecting FMDs, now is the time to start. As regulatory scrutiny and transparency demands grow, FMDs provide a clear pathway to future-proofing compliance processes. They simplify reporting, support sustainability, and help protect your supply chain from emerging risks, making FMDs indispensable in navigating an ever-changing regulatory environment.