Executive Summary
- What's new: A U.S. Commerce Department interim final rule vastly expands the number of entities subject to export control restrictions by extending the Entity List and MEU List restrictions to non-U.S. entities 50% or more owned, directly or indirectly, by listed parties effective as of September 29, 2025.
- Why it matters: Greatly increasing the number of entities subject to these restrictions and requiring comprehensive ownership analyses as part of due diligence will make it more complicated and time-consuming for exporters to ensure compliance with the law, and increases the risk of violations. The rule applies to all transactions subject to the U.S. Export Administration Regulations, including companies with U.S. parts or technologies in their supply chains, whether based in the U.S. or not.
- What to do next: Exporters will want to rescreen customers, suppliers and distributors for their ultimate ownership, and possibly wind down sales if end users are now subject to the widened restrictions. Contracts may also need to be reviewed for compliance with the new rule, and internal red flag mechanisms may need to be established.
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On September 29, 2025, the U.S. Department of Commerce's Bureau of Industry and Security (BIS) released a long-anticipated interim final rule (IFR) that will result in the most dramatic expansion of U.S. export control regulations in years. The IFR, “Expansion of End-User Controls To Cover Affiliates of Certain Listed Entities,” extends export restrictions to any company owned 50% or more, directly or indirectly, by any of the thousands of entities already designated on several Commerce and Treasury Department lists.
The IFR would also impose a new duty on exporters to investigate the ownership of an end user where there is reason to believe a designated entity holds a minority stake, or is affiliated with, the end user, subject to a strict liability standard for violations.
Summary of the Restrictions
The IFR applies to entities 50% or more owned by parties designated on the BIS Entity List and the Military End User (MEU) List. Until now, the Entity List and the MEU List were considered “entity-specific” lists, so that export control restrictions for a listed party did not extend to “legally distinct” affiliates owned by the listed party. The IFR overturns the existing framework, so the Entity List and MEU List restrictions now extend to any non-U.S. entity that is owned 50% or more, directly or indirectly, by one or more listed parties (the Affiliates Rule or BIS 50% rule).
The new restrictions apply to transactions subject to the U.S. Export Administration Regulations (EAR) involving any of the nearly 3,500 parties on the Entity List and MEU list, as well as thousands of parties on the Department of Treasury’s Office of Foreign Assets Control’s (OFAC’s) List of Specially Designated Nationals and Blocked Persons (SDN List).
Given the aggressively extraterritorial dimensions of the EAR, the IFR imposes significant obligations on any company with U.S. parts or technologies in its supply chain. In particular, the Affiliates Rule will apply to the Entity List Foreign-Direct Product (FDP) Rule and the Russia/Belarus MEU and Procurement FDP Rule, which means that the end-user scope of these extraterritorial FDP rules now include affiliates.
Where a non-listed affiliate is more than 50% owned in aggregate by multiple entities on the Entity List, MEU List or SDN List, BIS will apply the “rule of most restrictiveness,” in which the affiliate will be subject to the most restrictive license requirements, license exception eligibility and license review policy applicable to any of its owners under the EAR.
Due diligence obligation. While the Affiliates Rule is based on OFAC’s 50% rule for parties on the SDN List, the diligence obligations imposed by the Affiliates Rule are in some ways more complex and more prescriptive, and leave less room for individual judgment, than those imposed by OFAC.
The IFR indicates that “significant minority ownership” or “other significant ties to” an Entity List or MEU List party presents a “red flag” triggering the need for additional due diligence. The IFR adds one new Red Flag 29 to the EAR: If an exporter cannot determine the ownership percentage of a foreign party, and the exporter knows (or has reason to know) the foreign party is owned in part by an Entity List or MEU List party, the EAR now creates an “affirmative duty” on the exporter to ascertain the ownership percentage (or obtain a license or identify an applicable license exception) before proceeding.
Because compliance with EAR licensing requirements is subject to a “strict liability” standard, even careful diligence may fall short of the mark and result in violations. By contrast, OFAC regulations do not impose explicit diligence obligations with respect to entities that appear to be minority-owned by parties on the SDN List. Rather, OFAC expects parties to take a risk-based approach to compliance, including when navigating sanctioned party interests.
Licenses and modifications. The IFR creates a temporary general license (TGL) that authorizes some export, reexport and transfer (in-country) transactions involving non-listed affiliates until November 28, 2025. Specifically, the TGL authorizes exports, reexports or transfers (in-country) to or within any Country Group A:5 or A:6 countries (i.e., most U.S. allies and partners) when an affiliate is a party to the transaction; and exports, reexports or transfers (in-country) to or within any countries not embargoed by the U.S. (i.e., countries that are not in Country Group E:1 or E:2 countries) when an affiliate is a party to the transaction and that affiliate is a joint venture with a non-listed and non-affiliate entity that is headquartered in the U.S. or Country Group A:5 or A:6.
The IFR also allows for a modification request process, in which non-listed 50% or more owned-affiliates can request that BIS specifically exclude them from the designated party’s listing on the Entity List or MEU List. BIS states that exceptions to the Affiliates Rule may apply if the End-User Review Committee (ERC) determines that the affiliates that are owned by a particular listed party “do not pose a significant risk of being or becoming involved in diversion to the listed entity.” The ERC will make determinations regarding the applicability of these exceptions in accordance with the procedures set out in the EAR.
Impact on Industry
U.S. and non-U.S. companies involved in the export, reexport, or in-country transfer of items subject to the EAR promptly should consider taking action to assess and mitigate the impact of the new rule on their businesses. For example:
- Review the Entity List and MEU List rules, including the FDPs impacting non-U.S. production and sales, to identify any sales and other shipments by the company of items “subject to” the EAR.
- Rescreen existing customers, suppliers, distributors and other third-party vendors of items “subject to” the EAR to check for parties owned 50% or more, individually or in aggregate, by listed entities on the Entity List, MEU List, and/or the SDN List. Where ownership information is not available publicly or other reputable sources (e.g., a third-part screening vendor), seek information directly from customers or other counterparties.
- Where screening reveals a “hit,” wind down relevant shipments and export activity immediately unless the relevant transaction qualifies for the 60-day TGL described above or a license exception. This excludes the shipment of items that were en route on September 29, 2025. pursuant to actual orders for export, reexport or transfer (in-country) to or within a foreign destination, provided that the export, reexport or transfer (in-country) is completed no later than October 29, 2025 — i.e., 30 days after the IFR was published.
- Review contractual clauses and terms to ensure that they account for the new Affiliates Rule.
- Establish new internal red flags to review and conduct diligence in scenarios in which counterparties may have a large ownership stake held by one or more parties on the Entity List, MEU List or SDN List.
- Where a violation of the Affiliates Rule is discovered, consider a disclosure to BIS.
In the IFR, BIS acknowledges that the Affiliates Rule “may require additional analysis by the private sector ... in order to comply.” In our view, this statement by BIS significantly understates the efforts that may be required to comply with this new rule, particularly in light of the potential consequences for any compliance failures.
Expansion of End-User Controls To Cover Affiliates of Certain Listed Entities
Source: Department of Commerce, Bureau of Industry and Security, 15 CFR Parts 732, 734, 736, 744, and 748
TYPES OF ENTITIES | APPLICATION NOTES |
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Listed entities. A foreign entity listed on the Entity List, MEU List, or in SDN designations in § 744.8(a)(1), including any branch or sales office that is not legally distinct from the listed entity |
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Foreign affiliates of listed entities that meet the Affiliates rule. Foreign affiliates of listed entities owned 50 percent or more, directly or indirectly, by one or more listed entities on the Entity List, MEU List, or an SDN identified in § 744.8(a)(1) or by one or more entities subject to restrictions based upon ownership |
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Foreign affiliates of listed entities owned by listed entities where percentage of ownership cannot be determined (unresolvable Red Flag entities) Foreign affiliates of listed entities that have some direct or indirect ownership by listed entities on the Entity List, MEU List, or by SDNs in § 744.8(a)(1), but the exporter, reexporter, or transferor cannot determine whether the listed entity ownership meets the Affiliates rule |
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Foreign companies where there is no “knowledge” that the foreign entity is owned by a listed entity |
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U.S. entities owned by listed entities |
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