Cooper Companies’ 2025 Conflict‑Minerals Disclosure: 3TG Compliance & FDA‑Safe Medical Devices

Detailed Corporate Disclosure on Conflict‑Minerals Management by The Cooper Companies, Inc.

Overview of the Form SD Filing

The Cooper Companies, Inc. (NYSE: CCO) filed a Form SD on 29 May 2026, pursuant to SEC Rule 13p‑1, to disclose its conflict‑minerals status for the fiscal year ended 31 Dec 2025. The report provides a systematic audit of the presence and sourcing of conflict minerals—tantalum, tungsten, tin, and gold (collectively, 3TG)—in the company’s two principal business units: CooperVision (contact lenses and related ophthalmic products) and CooperSurgical (orthopaedic and neuro‑surgical devices).

The filing details the company’s due‑diligence methodology, highlights current compliance levels, and outlines governance mechanisms designed to mitigate supply‑chain risks. The disclosure is part of an ongoing commitment to transparency, regulatory compliance, and responsible sourcing within the medical‑device sector.

Methodological Framework

1. Supplier Questionnaires

• All Tier‑1 suppliers were surveyed using a standardized questionnaire that captured information on mineral content, processing location, and compliance with the Responsible Minerals Initiative (RMI) guidelines.

2. RMI Reporting Template

• The company adopted the RMI “Responsible Minerals Assurance Process” (RMI‑RAP) to classify suppliers and processing facilities as Conformant, Active, or Non‑Compliant.
• The template facilitated cross‑check of mineral provenance against publicly available databases (e.g., the Open‑Supply Chain project).

3. Engagement with Smelters and Refineries

• Direct contact was established with key processing nodes identified through the supplier questionnaire.
• The company obtained Processing‑Location Statements from 85 % of the smelters and refineries in its supply chain, enabling verification of the compliance status.

4. Data Gaps and Limitations

• While 70 % of Tier‑1 suppliers completed the questionnaire fully, 15 % could not furnish definitive mineral‑source data.
• Consequently, the company acknowledges that the countries of origin for a subset of minerals could not be definitively established.

Findings and Compliance Status

• Conformant/Active Facilities

• 92 % of the identified smelters and refineries were classified as either Conformant or Active under RMI‑RAP.

• These facilities have implemented trace‑ability mechanisms and maintain documentation of conflict‑free sourcing.

• Risk Exposure

• The presence of conflict minerals in medical devices is not intrinsically hazardous to patient safety. However, the supply‑chain risk—including potential legal exposure, brand reputation, and compliance with U.S. Section 1502 of the Dodd‑Frank Act—necessitates rigorous oversight.

• Regulatory Pathways

• By meeting RMI standards, the company aligns with the FDA’s Medical Device Regulatory Guidance on traceability of critical components, ensuring that devices remain eligible for market approval without additional regulatory burden.

• The company’s disclosure satisfies the SEC’s requirement for material information under Rule 13p‑1, thereby avoiding potential liability for non‑disclosure.

Governance and Internal Controls

Cross‑functional teams collaborate to update records, resolve data gaps, and embed conflict‑minerals checks into existing quality systems (ISO 13485). The company’s internal Code of Conduct mandates that all suppliers commit to conflict‑free sourcing, providing a contractual baseline for risk mitigation.

Practical Implications for Healthcare Professionals

1. Patient Safety

• The company’s rigorous due‑diligence processes confirm that the 3TG minerals present in its devices are sourced from conformant or active facilities.
• No evidence suggests that the trace amounts of these minerals pose a direct risk to patient health when used in ophthalmic contact lenses or orthopedic implants.

2. Device Traceability

• Enhanced traceability supports post‑market surveillance. In the event of device‑related complications, manufacturers can quickly identify the mineral source and assess potential impact.

3. Regulatory Confidence

• Clinicians can be assured that the devices meet FDA traceability requirements, thereby avoiding the need for additional clearance or safety notifications.

4. Ethical Procurement

• Hospitals and health systems that prioritize ethically sourced supplies may use the company’s compliance documentation to justify procurement decisions and reinforce corporate responsibility statements.

Outlook and Continuous Improvement

The Cooper Companies commit to:

• Annual Reporting – Publishing a detailed conflict‑minerals audit each year, enabling external stakeholders to track progress.
• Methodology Refinement – Enhancing supplier questionnaire depth, leveraging blockchain for traceability, and exploring third‑party verification services.
• Supply‑Chain Diversification – Expanding the supplier base to reduce concentration risk and improve sourcing resilience.

These initiatives aim to close remaining data gaps, further align with evolving regulatory frameworks, and reinforce the company’s reputation as a leader in responsible medical‑device sourcing.

Conclusion

The Form SD filing underscores the Cooper Companies’ adherence to SEC disclosure requirements, FDA regulatory expectations, and Responsible Minerals Initiative standards. While certain supply‑chain data remain incomplete, the overall compliance landscape indicates a low probability of conflict‑mineral‑related risk to patient safety or regulatory compliance. The company’s structured governance and ongoing refinement of due‑diligence protocols provide healthcare professionals and system administrators with confidence that medical devices sourced from CooperVision and CooperSurgical maintain high ethical and safety standards.