A relief organisation delivering medical supplies into an active conflict zone discovers that its supply chain touches a counterparty connected to a designated entity. Its in-house counsel needs to know, urgently, whether a general licence covers the shipment under OFAC's rules – and whether the export licence position under the EAR (the Export Administration Regulations administered by BIS, the Bureau of Industry and Security) is the same, different, or entirely separate. As of May 2026, humanitarian and NGO authorisations under these two US regulatory regimes operate on parallel but distinct tracks, and assuming they are interchangeable is one of the most consequential mistakes an organisation can make.
Humanitarian and NGO authorisations under OFAC are a distinct body of general licences (standing authorisations permitting defined categories of transactions without a case-by-case application) and specific licences (case-by-case authorisations for transactions outside general-licence scope). BIS provides analogous carve-outs under the EAR through licence exceptions and specific licensing, but the scope, conditions, and enforcement consequences differ materially from OFAC's regime. The two bodies of authority must be assessed independently for every cross-border humanitarian transaction.
This analysis works through the governing authority, the scope and structure of available authorisations, the procedural comparison, the risk flags practitioners see most often, and the circumstances in which early specialist advice protects an organisation's ability to operate.
What is the legal basis for humanitarian authorisations under OFAC and BIS?
OFAC derives its authority to issue both general and specific licences from the International Emergency Economic Powers Act (IEEPA) and, for older programmes, the Trading with the Enemy Act (TWEA). Both statutes authorise the President – and, by delegation, the Secretary of the Treasury and OFAC – to prohibit transactions and to grant exceptions to those prohibitions. Humanitarian carve-outs are embedded in programme-specific regulations and, separately, in Executive Order-level instruments. Because OFAC administers more than a dozen active sanctions programmes, the scope and terms of humanitarian general licences vary programme by programme. A general licence in one programme does not extend to another.
BIS administers the EAR under the Export Control Reform Act (ECRA) and IEEPA. The EAR controls the export, re-export, and transfer of items on the Commerce Control List (CCL – the master list of controlled items, each assigned an ECCN, an Export Control Classification Number). Humanitarian carve-outs under the EAR operate through designated licence exceptions – principally those covering food, medicine, and donated articles – and through BIS-specific licence applications where a licence exception does not extend to the transaction. Critically, BIS jurisdiction attaches to the item, not to the sanctioned party. That distinction defines the structural divergence between the two regimes.
What follows from that divergence? Under OFAC, a transaction is prohibited if a sanctioned party is involved, regardless of what is being transferred. Under the EAR, a transaction requires a licence (or must satisfy an exception) if a controlled item is involved, regardless of whether a sanctioned party is present. A single humanitarian shipment can therefore require OFAC authorisation and an EAR licence exception or BIS licence – and the two cannot substitute for one another.
How do OFAC general licences for humanitarian activities work in practice?
OFAC's programme-specific general licences for humanitarian activity typically authorise NGOs and qualifying organisations to conduct transactions – transfers of funds, movement of goods, provision of services – that would otherwise be prohibited under the relevant sanctions programme. Authorisation is self-executing: if your transaction falls squarely within the licence's defined scope, no application or prior approval is required. The organisation simply documents its reliance, retains records, and proceeds.
The critical discipline is scope-mapping. General licences specify qualifying entities (often limiting coverage to NGOs that meet defined criteria), qualifying activities (personal remittances, medical supplies, food, or activities of specific international organisations), geographic scope, and – frequently – conditions that must be met before the licence applies. A payment processed through a non-US correspondent bank to a local partner may be outside the licence scope even if the underlying goods qualify. In our experience, many organisations read the headline activity – "food and medicine" – and miss the entity-category or conduit restrictions that govern the licence's edges.
Where a transaction falls outside every available general licence, the organisation must apply for a specific licence from OFAC. OFAC will assess the application against its licensing policy for the relevant programme and, for complex humanitarian applications, may request additional information. The processing period is not fixed by statute for most applications, though OFAC's published standards indicate a target period that practitioners should verify against current OFAC guidance before relying on it. Applications that are incomplete or that do not clearly establish humanitarian purpose take materially longer. We regularly advise organisations to treat the specific-licence route as a structured submission process – not a form – and to invest time in the supporting narrative and documentation before filing.
How does BIS treat humanitarian and NGO transactions under the EAR?
BIS approaches humanitarian transactions through a different analytical gate. The starting point is whether the goods, software, or technology being exported are controlled – that is, whether they carry an ECCN on the CCL, or whether they are EAR99 items (items subject to the EAR but not listed on the CCL and therefore generally exportable without a licence to most destinations). EAR99 status removes the BIS licensing question almost entirely for most humanitarian shipments, though destination controls and end-use rules can still apply.
For controlled items, the EAR provides licence exceptions specifically designed for humanitarian contexts. The relevant exceptions cover donated articles intended for use by the recipient-country population, food and agricultural commodities, and medicine and medical devices. Each exception carries its own conditions: limits on the value of a single shipment, restrictions on the items covered, record-keeping requirements, and – in some cases – prior notification obligations. The exceptions are not blanket permissions; they require careful mapping of the shipment against the exception's exact conditions.
Where licence exceptions do not reach the transaction – for instance, because the items are controlled for reasons beyond what the exception covers, because the end-user is subject to a denial order or Entity List restriction, or because the destination country faces a regime-specific control – a specific BIS licence is required. BIS licensing for humanitarian purposes follows a case-by-case review. Processing times are qualitative in the current environment; organisations should build realistic lead times into operational planning and not assume that humanitarian purpose accelerates approval as a matter of right.
One additional BIS-specific risk deserves emphasis. The Entity List (BIS's list of parties subject to specific licence requirements due to proliferation or other national-security concerns) is independent of OFAC's SDN List (OFAC's list of Specially Designated Nationals and blocked persons). An end-user or local distribution partner that does not appear on the SDN List may still appear on the Entity List. An NGO that screens only against OFAC lists and assumes BIS compliance will miss this exposure entirely.
Where do OFAC and BIS diverge most sharply for cross-border humanitarian operations?
Four points of divergence define the practical difference for organisations operating across borders.
The first is the trigger for the restriction. OFAC's trigger is the identity of the counterparty – a designated person or entity. BIS's trigger is the nature of the item and its destination or end-user. An NGO can move EAR99 goods to a location subject to OFAC sanctions without a BIS licence, but still requires OFAC authorisation. Conversely, an NGO can pay a counterparty not on any OFAC list but still require a BIS licence if the goods are controlled and the destination is subject to EAR controls.
The second is programme specificity. OFAC's general licences are programme-by-programme. An NGO delivering aid in a context where the relevant OFAC programme has a broad humanitarian general licence will operate under materially lighter compliance burdens than an NGO operating in a context where the programme is more restrictive or the general licence is narrowly drawn. BIS controls apply by item and destination across all contexts, without the programme-by-programme variation that characterises OFAC.
The third is the treatment of financial flows versus goods. OFAC's primary scope covers financial transactions and dealings with designated persons. General licences in the humanitarian context often address both money transfers and goods, but the financial-transaction element is distinctly an OFAC question. BIS does not regulate payments; it regulates the physical movement of controlled items. An NGO sending funds to a local partner to purchase food locally may need OFAC authorisation but will not require BIS engagement at all if no controlled items cross a US-jurisdiction threshold.
The fourth is the enforcement architecture. OFAC enforces against parties who engage in prohibited transactions with sanctioned persons or entities. BIS enforces against parties who export controlled items without the required licence or in violation of an exception's conditions. Both agencies can impose significant civil penalties. Both have criminal referral routes for wilful violations. In our cross-border practice, we see organisations that manage OFAC compliance carefully but underinvest in BIS classification and export-licence management, leaving a structural gap in their risk profile.
One critical cross-border point: neither OFAC nor BIS authorisations substitute for authorisations required by other regimes. The UK's OFSI, the EU Council's sanctions regime, and the export-control regimes of third-country jurisdictions each operate independently. An OFAC general licence authorises the OFAC-regulated element of a transaction; it says nothing about whether the UK arm of an NGO's operation is authorised under OFSI's general licences, or whether the EU entities involved are covered by the relevant Council regulation authorisation. In multi-entity NGO structures operating across UK, EU, and US jurisdictions, the compliance assessment must run each leg of the transaction through its own regime.
The position above covers the standard analytical framework. Your organisation's specific facts – the counterparty structure, the goods being shipped, the destination, the financial channels, and the regime in play – will change the analysis materially.
To assess the authorisation position for a specific humanitarian programme or transaction, contact Calder & Vance at info@caldervance.com.
What are the most common risk flags in humanitarian authorisation work?
Practitioners in this space see a recurring set of errors that convert a well-intentioned humanitarian operation into an enforcement exposure.
The most common is over-reliance on a general licence without mapping the transaction to the licence's precise conditions. An NGO reads that a general licence covers "the exportation of food" and proceeds without checking whether its local distribution partner is a qualifying entity under the licence, whether the financial channel for paying that partner is authorised, or whether any component of the shipment falls outside the licence's item description. The general licence covers what it covers. It does not extend by analogy.
The second is failure to classify goods under the EAR. Many humanitarian organisations do not maintain an internal export-classification programme because they assume their goods – food, clothing, basic medical supplies – are not controlled. For most standard humanitarian commodities that assumption is correct. But medical devices, communications equipment, and certain software can carry ECCNs and require licence exceptions or specific licences even in humanitarian contexts. Failure to classify means failure to identify the gap.
The third is local-partner screening limited to OFAC's SDN List. A comprehensive screening process covers the UN Security Council Consolidated List, the EU consolidated list, OFSI's consolidated list, and BIS's Entity List and Denied Persons List, as well as OFAC's full listing infrastructure. An organisation that screens only the SDN List may miss a counterparty that is restricted under a separate BIS-administered list or under a UN Security Council resolution.
The fourth is inadequate record-keeping. Both OFAC and BIS impose record-keeping requirements for transactions conducted under general licences or licence exceptions. Records must be maintained for a prescribed period – practitioners should verify the current period applicable to their specific authorisation before relying on it – and must document the basis for the authorisation claimed. If an enforcement review later questions whether the general licence applied, contemporaneous records are the defence. Organisations that self-certify compliance but do not document it have the same exposure as organisations that failed to consider the question at all.
The fifth – and one we see with particular frequency in multi-entity structures – is failure to apply the 50 percent rule (OFAC's rule treating entities owned 50 percent or more in the aggregate by blocked persons as themselves blocked) to local implementing partners. A local partner that is not itself designated may nonetheless be captured if a blocked person holds a controlling interest. The general licence covering the activity does not authorise dealings with a captured entity unless it specifically says so.
A common misconception about humanitarian authorisations – and why it matters
A persistent view among NGO compliance teams is that the existence of a humanitarian general licence means the operation is "covered" – that the general licence is a broad safe harbour that removes most of the detailed compliance work. This is incorrect, and the consequences of acting on it can be severe.
General licences define their scope with precision. They specify the activities authorised, the entities that can rely on them, the geographic scope, the conditions that must be satisfied, and – frequently – the transactions that remain prohibited even within the licence's broader grant. The breadth of the authorisation is determined by the text of the licence, not by the category heading. An NGO providing emergency food aid is not, by virtue of being an NGO providing food aid, covered for all its transactions. It is covered for the transactions that fall within the specific terms of the applicable licence.
In our practice, we have seen organisations assume that once they have identified a relevant general licence, no further compliance work is required. The enforcement records across OFAC and BIS indicate that this assumption has led to violations in contexts where the organisation believed it was operating lawfully. The standard of care is not satisfied by identifying an applicable licence; it is satisfied by documenting that each element of each transaction meets the licence's conditions.
If a transaction has already been flagged by a compliance system, or if an organisation has identified a past transaction that may not have been within the authorisation it relied upon, an early review preserves options that narrow quickly. Contact Calder & Vance at info@caldervance.com for a confidential review.
When should an NGO or humanitarian organisation involve sanctions counsel?
Early involvement of specialist counsel is not a sign of an operation in trouble. It is a decision that experienced compliance teams make before committing to an operational model in a restricted jurisdiction – not after the first enforcement inquiry arrives.
The question of timing is often framed as: "How serious does the problem need to be before we call a sanctions lawyer?" The better framing is: "At what point in the transaction or programme lifecycle does the cost of getting it wrong exceed the cost of getting a proper authorisation assessment?" For most humanitarian operations in a context where OFAC, BIS, OFSI, or EU sanctions are engaged, the answer is early in the planning phase.
We regularly advise humanitarian organisations at four distinct stages. The first is programme design: structuring the funding flows, procurement channels, and local-partner arrangements to maximise the protection available under existing general licences and exceptions. The second is transaction-level review: confirming that a specific shipment, payment, or contract is within scope before execution. The third is voluntary self-disclosure (VSD – a voluntary report to a regulator of a potential violation): advising organisations that have identified a past transaction that may have been outside the applicable authorisation, and preparing the disclosure that mitigates enforcement consequences. The fourth is enforcement defence: representing organisations in response to agency inquiries or investigations.
The VSD route merits particular emphasis. OFAC and BIS both operate voluntary disclosure programmes under which prompt, complete, and accurate disclosure of a potential violation is a significant mitigating factor in any penalty determination. Organisations that self-discover a compliance gap and disclose it proactively are treated materially differently from those whose violations are uncovered through agency investigation. The window for disclosure to be treated as voluntary is not unlimited; acting promptly matters.
Related practices
- Frozen account management under BIS and the EAR – asset-freeze management, account review, and licence applications for frozen-property situations under US export-control rules.
- OFAC vs BIS / EAR: humanitarian authorisations – further analysis – extended analysis of edge cases, multi-jurisdiction structures, and complex partner arrangements in humanitarian operations.
- Humanitarian authorisations: OFAC vs EU compared – comparative analysis of US and EU humanitarian carve-outs, including divergences in scope, conditions, and enforcement posture.
Frequently asked questions: humanitarian and NGO authorisations under OFAC and BIS
Where do the regimes diverge on humanitarian and NGO authorisations?
The principal divergence is the trigger for restriction: OFAC's rules are counterparty-based (the identity of a designated person or entity triggers the prohibition), while BIS's rules are item-based (the classification of the goods, software, or technology on the CCL triggers the licence requirement). A transaction can require OFAC authorisation without requiring BIS engagement, and vice versa. Programme-level variation under OFAC – where general-licence scope differs from programme to programme – has no direct parallel under the EAR, where controls apply uniformly by item and destination. Financial flows are an OFAC question; physical exports of controlled items are a BIS question. Both regimes can engage simultaneously, and both must be assessed for any cross-border humanitarian transaction.
Which regime is stricter on humanitarian and NGO authorisations?
Neither regime is categorically stricter; the analysis depends on the specific programme, the goods, and the operational context. OFAC programmes vary significantly in how broadly their humanitarian general licences are drawn. Some programmes authorise a wide range of NGO activities without a licence application; others are narrowly drawn and require specific licensing for transactions that might appear routine. BIS licence exceptions for food and medicine are generally accessible for EAR99 and lightly controlled items but do not extend to all items or all end-users. The stricter prohibition governs in any given transaction: where OFAC restricts a transaction that BIS would permit, OFAC's restriction applies, and the reverse is equally true.
What should a cross-border business do about humanitarian and NGO authorisations?
The starting point is a structured authorisation assessment for each operational leg of the transaction: identify the relevant OFAC programme and any applicable general licence; classify the goods under the EAR and identify any applicable licence exception; screen all counterparties against OFAC, BIS, UN, UK, and EU lists; document the authorisation basis for every element; and maintain records for the period required by each regime. Where a transaction cannot be mapped cleanly to an existing general licence or exception, a specific licence application should be prepared and filed before execution. For cross-border structures involving UK or EU entities, the same assessment must run through OFSI and the relevant EU Council regulation. Specialist counsel should be engaged at the programme-design stage rather than at the point of an enforcement inquiry.
About the author
J. M. Aldridge advises multinationals and financial institutions on US sanctions and export controls, with a focus on OFAC licensing, secondary-sanctions risk, and BIS classification. Calder & Vance – International Sanctions & Export Control Counsel.
About Calder & Vance
Calder & Vance is an independent international sanctions and export-control boutique. We advise multinationals, financial institutions, exporters, and individuals on the major regimes – OFAC and BIS in the United States, OFSI and ECJU in the United Kingdom, the EU Council regulations and the EU General Court, the United Nations Consolidated List, and the regimes of Switzerland, Canada, Australia, the UAE, Singapore, and Japan. Our work is limited to lawful compliance, licensing, delisting, enforcement defence, and due diligence. To discuss a matter, contact info@caldervance.com.
Disclaimer: This material is general information, not legal advice, and is not a substitute for advice on your specific facts. Sanctions and export-control rules change frequently and differ by regime; verify the current position before relying on anything stated here. Calder & Vance does not advise on circumventing or evading sanctions. For advice on your situation, contact info@caldervance.com.