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 continually updated to include new substances and requirements, which directly impact manufacturers worldwide. For instance, the REACH SVHC list is updated biannually, while California’s Proposition 65 sees updates at least once per year, often adding new substances that require disclosure.
Beyond these existing frameworks, newer regulations such as Section 6(h) of the Toxic Substances and Control Act (TSCA) and the per- and polyfluoroalkyl substances (PFAS) reporting rule under TSCA Section 8(a)(7) further illustrate the growing complexity. Companies must ensure their product documentation is always current to avoid non-compliance. Collecting Full Material Declarations (FMDs) from suppliers can significantly streamline 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)?
A Full Material Declaration (FMD) is a detailed disclosure of the chemical composition of a part or product, listing substances down to the homogenous material level. Ideally, FMDs provide complete information, including each substance’s CAS number and concentration. However, due to proprietary concerns or the unavailability of certain substance data, some FMDs may exclude specific details.
FMDs come in many formats, ranging from industry-standard schemas to PDFs or Excel sheets. The diverse formats, while useful, can complicate the collection and analysis of data. Nonetheless, obtaining an FMD provides a deeper level of transparency into a product’s material content, offering a more reliable tool for compliance reporting across multiple regulatory frameworks.
How FMDs are used for product compliance
Various industries have developed systems to standardize the collection and use of FMDs. For example, the automotive industry utilizes the International Material Data System (IMDS), which enables manufacturers to gather, analyze, and archive material data for compliance purposes. Similarly, the aerospace and defense sectors use IPC-1754, while electronics manufacturers rely on IPC-1752 and IEC-62474 to manage FMD data.
These systems and industry standards enable companies to collect detailed information that supports compliance with regulations like RoHS, REACH, and other material restrictions. By leveraging standardized FMDs, companies can reduce the administrative burden of compliance and improve supply chain transparency.
The expanding role of FMDs in supply chains
FMDs are not just relevant for the automotive and electronics sectors. As substance restrictions increase across all industries, the need for FMDs is becoming more widespread. The EU’s Medical Devices Regulation, for instance, places greater emphasis on material transparency, and the EU’s Critical Raw Materials Act requires manufacturers to better understand the materials and sourcing behind their products.
Additionally, growing environmental, social, and governance (ESG) requirements such as the U.S. Uyghur Forced Labor Prevention Act (UFLPA) and the EU’s Corporate Sustainability Due Diligence Directive (CSDDD) are pushing the need for more detailed material data. Companies collecting FMDs will be better equipped to comply with these new demands, ensuring they can swiftly assess their products for risks and stay ahead of regulatory changes.
Best practices for collecting FMDs from suppliers
Effective communication with suppliers is critical when collecting high-quality FMD data. Before initiating a request, inform suppliers about the data you require and set clear expectations for submission timelines and formats. Providing sample templates can help streamline this process and improve data consistency.
Another key best practice is incorporating FMDs into contracts or statements of work with suppliers, ensuring that data collection becomes an ongoing part of the business relationship. This can be reinforced by evaluating supplier performance based on their responsiveness and ability to meet compliance requirements.
Ensuring data quality with FMD collection
Data quality is vital for ensuring compliance, and FMDs must be collected and reviewed with attention to detail. Utilizing standardized formats like the IPC-1752 schema can reduce inconsistencies and allow for easier data analysis. It’s also essential to have both automated and manual oversight in place to review declarations, ensuring the data aligns with the product’s materials and components.
When collecting FMDs, obtaining the exact CAS number and chemical name for every substance is the ideal scenario—represented by the bullseye in the image below. However, due to confidentiality concerns or the absence of a CAS number, this isn’t always possible. In such cases, gathering as much information as possible is still valuable, 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.
Targeted generic substances help balance confidentiality, compliance, and efficiency. By aiming to get as close to the bullseye as possible, companies can streamline the FMD collection process and ensure compliance without misrepresenting the product. This approach also protects supplier interests by ensuring that sensitive information is handled with care, while maintaining the level of accuracy needed for regulatory reporting.
Common errors in FMD submissions include incorrect CAS numbers, mismatched material weights, and undeclared substances. Having a clear process for reviewing and correcting these errors helps maintain accuracy and ensures that the FMD data is fit for purpose.
Leveraging FMDs for product compliance and supply chain initiatives
FMDs are powerful tools that extend far beyond product compliance. While they are essential for managing substance restrictions like REACH and SCIP, their value spans a broader range of reporting and supply chain initiatives. FMDs support conflict minerals disclosures, assist with lithium and cobalt usage tracking, and help companies meet evolving eco-label criteria.
In addition to regulatory compliance, FMDs play a crucial role in ESG reporting. By providing a detailed understanding of the materials used in your products, FMDs enable companies to identify potential risks, track the sourcing of materials, and align with sustainability goals. This transparency helps businesses stay compliant and demonstrate their commitment to ethical supply chain practices.
If your organization isn’t already collecting FMDs, now is the time to start. With ever-increasing regulatory scrutiny and growing demands for supply chain transparency, FMDs offer a clear pathway to future-proofing your compliance processes. They simplify compliance reporting across a range of frameworks and provide the foundation for more informed, sustainable decision-making. In an era where regulations constantly evolve, FMDs are indispensable for ensuring agility and protecting your supply chain from unforeseen risks.
Simplify compliance through powerful FMD capabilities
Source Intelligence’s C-Map software is built to efficiently collect, store, and process FMDs, enabling quick identification and reporting of hazardous substances and other ESG data. Our software simplifies and streamlines compliance management with industry-leading capabilities such as:
- Regulation Coverage: Generate compliance declarations for all global requirements using a single FMD, reducing the need for multiple data entries.
- Chemical Analysis: Identify and flag regulated substances with precise CAS number processing, ensuring compliance with global standards.
- Data Completeness: Even with partial data (e.g., 80%), C-Map can analyze and compare chemical data across regulations to assess compliance.
- Format Compatibility: Seamlessly integrate and process data from multiple industry-standard FMD formats, including IPC 1752a, IPC 1752b, IPC 1754, and IEC 62474 XML formats.
By leveraging FMDs through Source Intelligence’s advanced software, you can build stronger supplier relationships, improve risk management, and stay ahead in the dynamic world of global compliance. Our solution ensures your company remains resilient, adaptable, and ready to meet evolving regulatory demands.
