Since January 1, 2026, covered steel, aluminum, cement, fertilizer, electricity and hydrogen entering the European Union carries a carbon cost that the EU importer has to report and pay for, unless its imports stay within the 50-tonne annual exemption, which does not apply to electricity or hydrogen. The Carbon Border Adjustment Mechanism, known as CBAM, puts the legal obligation on the EU importer, not on the US mill or plant. In practice the cost and the data burden travel back up the supply chain. EU buyers now ask their US suppliers for installation-level emissions data, and a supplier that cannot provide it leaves the buyer to fall back on the Commission’s default values.

This guide is for US exporters of CBAM goods and the logistics and compliance teams that support them. It covers what the definitive period changed, which goods are in scope and who pays, the exact data EU importers will request, how verification works, and the CBAM dates that matter through 2027.

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What the Definitive Period Changed on January 1, 2026

CBAM was introduced in two phases under Regulation (EU) 2023/956. The transitional period ran from October 1, 2023 to December 31, 2025 and was a reporting exercise: importers filed quarterly reports on embedded emissions but paid nothing, and verification was optional. The definitive regime has applied since January 1, 2026. EU importers above the threshold now need authorization as CBAM declarants. From February 2027 they buy CBAM certificates priced off the EU Emissions Trading System, and each year they surrender certificates against the emissions embedded in what they imported the year before.

Regulation (EU) 2025/2083, the simplification package adopted in 2025, amended the original text before the financial phase started. Its most visible change is a single mass-based threshold that takes small importers out of scope, discussed below. The annual declaration requirement in Article 6(1) now applies as amended by that regulation. The Commission publishes a consolidated version of Regulation (EU) 2023/956 as amended by 2025/2083, and that consolidated text is the one EU buyers’ compliance teams work from.

The policy logic explains the data demand. CBAM exists to put the carbon price of imports on par with EU production, which pays under the EU ETS. Free allocation of ETS allowances to EU producers in the same sectors is being phased out between 2026 and 2033 while CBAM is phased in, and from 2034 the embedded emissions of CBAM goods are fully covered by certificates. Every year of that phase-in raises the stakes of the emissions number attached to a US shipment.

Covered Goods, the 50-Tonne Threshold and Who Pays

CBAM covers imports from six sectors: iron and steel, aluminum, cement, fertilizers, electricity and hydrogen. The precise scope is the list of Combined Nomenclature codes in Annex I to the CBAM Regulation, which includes some precursors and some downstream products of those sectors. CN codes share their first six digits with the HS, so a US exporter can screen the first six digits of its Schedule B numbers against Annex I as a first pass. Where Annex I lists fewer than eight digits, every CN code beginning with those digits is covered.

The de minimis exemption is set at 50 tonnes of net mass. Per the Commission’s Guidance No. 1 of August 2026, the threshold applies to the aggregate net mass of all CBAM goods, across all CN codes, imported by the same importer in the same calendar year. It is not per shipment and not per product. If an importer crosses 50 tonnes during the year, it becomes subject to all CBAM obligations for that year, including for goods imported before the threshold was crossed. The exemption does not apply to electricity or hydrogen.

The party that pays is the authorised CBAM declarant, which the Commission describes as the person lodging the customs declaration, usually the importer and in some cases the indirect customs representative. Each tonne of imported goods is the responsibility of exactly one declarant. For a US exporter selling on terms where the EU buyer clears customs, the buyer is the declarant. If the US seller takes on EU clearance, the question of who acts as declarant has to be settled before the first shipment, and it belongs in the same conversation as who pays EU import duties and taxes under the chosen Incoterm.

How the CBAM Obligation Is Calculated

The number of certificates an EU declarant must surrender starts with the embedded emissions of the imported goods, in tonnes of CO2 equivalent per tonne of product. Two reductions follow. The first is a free allocation adjustment that reflects the free ETS allowances an EU producer of the same good would still receive, based on a CBAM benchmark and a time-dependent factor that shrinks each year. The second is a deduction for any carbon price effectively paid in the country of production, net of rebates or compensation. If the result is negative, the obligation is zero.

In 2026 the certificate price is the quarterly average of EU ETS auction clearing prices, calculated under Implementing Regulation (EU) 2025/2548. The Commission published the first two quarterly prices at 75.36 euros per certificate for Q1 2026 and 75.28 euros for Q2 2026, each certificate corresponding to one tonne of CO2 emitted. From 2027 onward prices are published weekly. These figures are the reference EU buyers use when they price the CBAM cost into a purchase from a US supplier.

The embedded emissions figure is the main input a US exporter controls. The benchmark, the phase-in factor and the certificate price are set in Brussels. A buyer comparing two suppliers of the same hot-rolled coil or the same urea will see the difference almost entirely in the emissions data each one provides.

Published CBAM certificate prices, 2026 (Commission, price of CBAM certificates page)
Quarter of application Publication date Price per certificate
Q1 2026 April 7, 2026 75.36 euros
Q2 2026 July 6, 2026 75.28 euros
Q3 2026 Scheduled October 5, 2026 Not yet published
Q4 2026 Scheduled January 4, 2027 Not yet published

Data US Exporters Must Supply to EU Buyers

The Commission’s Guidance No. 2, a quick guide for non-EU operators, is direct about the flow: wherever CBAM goods end up imported into the EU, the importer will at some point contact the producer to gather embedded emissions data, and the producer must be prepared to provide it. That applies when a US plant sells to a trader who resells into the EU, and when the US product is a precursor that another producer turns into a CBAM good bound for the EU.

The operator's emissions report

Where embedded emissions are calculated from actual data, the producer prepares an annual operator’s emissions report and a summary of it, which under Article 10 of Implementing Regulation (EU) 2025/2547 must contain at least the information listed in the templates in Annex IV to that regulation. For electricity, a declarant-specific addendum is added. The report covers the installation’s direct emissions, the indirect emissions from electricity consumed where the good is in scope for them, and the specific embedded free allocation needed for the adjustment.

  • Installation identity and the production processes and routes used for each CBAM good.
  • Direct emissions attributed to each good, and indirect emissions from electricity where Annex II of the CBAM Regulation does not exclude them.
  • For each purchased precursor: its CN code, specific direct and indirect embedded emissions, the producer’s reporting period, the installation where it was made, its specific embedded free allocation, and any carbon price paid.
  • Quantities of each precursor used during the reporting period.
  • Any carbon price effectively paid in the country of production, expressed per tonne of good, supported by a carbon price report certified by an independent person.

Sharing through the CBAM Registry or bilaterally

Guidance No. 2 describes two routes. The recommended, currently voluntary route is to register the installation in the operators’ module of the CBAM Registry, upload the verified data once, and share it with every EU declarant that imports the goods. Declarants then see a summary rather than the full report, which protects process data a US producer may consider confidential. The alternative is to send the same report to each buyer separately. Under that route, declarants are obliged to request the complete verification and emissions reports, so the full data leaves the producer’s control. From 2027 the Registry is due to let producers share data with downstream operators that use their goods as precursors.

Aerial view of a loaded container ship crossing open ocean
The EU importer files the CBAM declaration, but the emissions data behind each tonne has to come from the producing installation.

Verification, Default Values and Why They Matter

In the definitive period, actual emissions used in a CBAM declaration must be verified by a verifier accredited by an EU national accreditation body. Verification is done per installation and includes a site visit, and the verifier issues one verification report per installation that the producer can share with its buyers. Verification companies established outside the EU may apply for accreditation to any national accreditation body offering the service. National accreditation bodies began CBAM accreditation in April 2026, accredited verifiers can register in the CBAM Registry from September 2026, and verification reports can be issued from January 2027. Check the accreditation certificate of any verifier you contract.

The alternative to verified actual data is the default values the Commission sets in Implementing Regulation (EU) 2025/2621, as corrected by Implementing Regulation (EU) 2026/1740 in July 2026. Default values are not specific to any installation, so a US producer running a lower-emission route gets no credit for it unless it supplies verified actual data. For an EU buyer the default value is the fallback when a supplier sends nothing usable, and that fallback determines the certificate cost the buyer attaches to the supplier’s material.

The practical point for a US exporter is timing. Verified 2026 data must exist before the EU buyer files its first annual declaration in 2027. A producer that has not built a monitoring plan and engaged a verifier by early 2027 will have little room to replace default values in its buyers’ first declarations.

CBAM Timeline and Certificate Purchases

The dates below come from the Commission’s CBAM pages and Guidance No. 1. They apply to the EU declarant, but each one sets a deadline for the data a US supplier has to deliver upstream.

The downstream extension proposal

The Commission has also tabled proposal COM(2025) 989, which would extend CBAM to about 180 downstream steel and aluminum products from 2028 and add anti-circumvention measures. The Council’s general approach of June 12, 2026 would add about 200 further goods, and the European Parliament’s environment committee report would take the list to 457 products, with the plenary vote due in September 2026, so the final scope may be wider. It is still a proposal, not law. US exporters of fabricated steel and aluminum products that sit outside Annex I today should track it, because adoption would pull their goods into the same data requests their upstream suppliers face now.

CBAM definitive period milestones relevant to US suppliers
Date Milestone
January 1, 2026 Definitive regime applies. Importers apply for authorised declarant status. Non-EU operators start monitoring embedded emissions.
April 2026 National accreditation bodies begin CBAM accreditation of verifiers.
September 2026 Accredited verifiers can register in the CBAM Registry and start first verifications.
January 2027 Verifiers can issue first verification reports. Operators can share them with declarants.
February 2027 Declarants can purchase CBAM certificates on the common central platform.
September 30, 2027 First annual CBAM declaration due, covering goods imported in 2026.
2026 to 2033 CBAM phased in as EU ETS free allocation is phased out.
2034 Embedded emissions of CBAM goods fully covered by certificates.

What US Exporters Should Do Now

Start with scope. Map every product shipped to EU customers to its CN code and check it against Annex I, including goods sold through traders and goods that become precursors in an EU-bound product. Then confirm with each EU buyer who the declarant is and whether the buyer expects data through the CBAM Registry or bilaterally.

Next, build the monitoring plan for each installation and line up an accredited verifier. The Commission’s sector guidance for iron and steel, aluminum, fertilizers, cement and hydrogen, published August 14, 2026, sets out the production routes and system boundaries a verifier will test against. Collect precursor data from your own suppliers now, since their emissions roll into yours.

Finally, put the CBAM data in the commercial file alongside origin and export classification. The shipment documents that support import and export freight to the EU should carry the same CN code the emissions report uses, so the buyer can tie each tonne to a verified figure. A consistent trade compliance management record also keeps the CBAM file aligned with US-side obligations such as the Section 232 steel and aluminum regime that governs the same metals on import. For EU buyers building a landed cost calculation, the certificate cost now sits next to freight, duty and VAT, and exporters that supply verified data give them a lower and more predictable number to work with. For the US tariff position on goods moving the other way, see our overview of US tariffs on EU imports.

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Frequently Asked Questions

Do US exporters have to register for CBAM?

The legal obligation sits with the EU importer acting as authorised CBAM declarant. US producers are not required to register, but the Commission recommends that non-EU installation operators register in the CBAM Registry to upload verified emissions data once and share it with all their EU declarants.

When is the first CBAM declaration due?

The first annual CBAM declaration is due by September 30, 2027 and covers goods imported into the EU during 2026. Declarations are then due by September 30 each year for the previous calendar year, under Article 6(1) of the CBAM Regulation as amended by Regulation (EU) 2025/2083.

What is the CBAM 50-tonne threshold?

Importers are exempt if the net mass of CBAM goods they import in a calendar year does not exceed 50 tonnes in total, across all CN codes. Crossing the threshold makes the importer liable for all goods imported that year, including those imported earlier. The exemption does not cover electricity or hydrogen.

What happens if a US supplier does not provide emissions data?

The EU declarant can use the Commission’s default values set in Implementing Regulation (EU) 2025/2621, as corrected in 2026. Default values are not installation-specific, so a supplier with lower actual emissions gets no benefit unless it provides verified actual data.

How much does a CBAM certificate cost?

In 2026 the price is the quarterly average of EU ETS auction prices. The Commission published 75.36 euros for Q1 2026 and 75.28 euros for Q2 2026. Weekly prices apply from 2027, and certificates are purchased on the common central platform from February 2027.

Can a US carbon price reduce the CBAM cost?

The declarant can deduct a carbon price effectively paid in the country of production, net of rebates or compensation, provided it is documented in a carbon price report certified by an independent person. The deduction is attributed per tonne of good.

Which products does CBAM cover?

Goods listed by CN code in Annex I to Regulation (EU) 2023/956 from the iron and steel, aluminum, cement, fertilizer, electricity and hydrogen sectors, including some precursors and downstream products. Proposal COM(2025) 989 would add about 180 downstream products from 2028 if adopted, and the Council and Parliament positions would widen that list.

Kitchen cabinet tariffs under Section 232 are 25% today, not 50%. Proclamation 10976 (90 FR 48127) put wood cabinets, vanities and their parts under a Section 232 duty from October 14, 2025, with increases scheduled for January 1, 2026. Proclamation 11000 (91 FR 1039) then delayed those increases to January 1, 2027. Some budgets still carry the 50% rate for 2026, and those budgets overstate duty by 25 points on every covered entry.

The date that matters now is January 1, 2027. On that date the rate on cabinets, vanities and parts doubles to 50%, and the rate on upholstered wood seating moves from 25% to 30%. For kitchen and bath distributors, cabinet importers, builders’ procurement teams and furniture retailers running multi-container monthly programs, the next three months decide how much inventory enters at the lower rate. This guide covers the current and scheduled rates, where the classification line falls between cabinets, vanities, parts and seating, the country caps, and two overlays the same buyers face: TSCA composite-wood certification and the Section 201 safeguard on quartz countertops. Status as of September 23, 2026.

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Current Rates and the January 1, 2027 Step-Up

The timber program sits in Chapter 99 subheading 9903.76. CBP implemented it through CSMS #66492057. The table shows each heading, today’s rate and the scheduled change under Proclamation 11000.

Two points in the table drive most planning errors. First, the 50% cabinet and vanity rate is a 2027 number, not a 2026 one. Second, the country rates for the UK, Japan, the EU, South Korea and Taiwan hold at 10% and 15%: the UK’s 10% is added to the Column 1 rate, while the 15% for the other four is inclusive of Column 1, so goods from those origins face a different calculation than the headline rate. A sourcing mix that includes EU, Japanese, Korean or Taiwanese product should be modeled line by line rather than at a blended rate.

Section 232 timber headings for cabinets, vanities and seating, as of September 23, 2026
Heading Scope Rate today From January 1, 2027
9903.76.01 Softwood lumber 10% No increase announced
9903.76.02 Upholstered wood seating 25% 30%
9903.76.03 Kitchen cabinets, vanities and parts 25% 50%
9903.76.04 Goods in covered lines that are not cabinets or vanities 0% No change announced
9903.76.20 United Kingdom 10%, added to Column 1 No change announced
9903.76.21 Japan 15% cap, inclusive of Column 1 No change announced
9903.76.22 European Union 15% cap, inclusive of Column 1 No change announced
9903.76.23 South Korea 15% cap, inclusive of Column 1 No change announced
9903.76.24 Taiwan 15% cap, inclusive of Column 1 No change announced
Wood kitchen cabinets being installed in an unfinished kitchen
Wood cabinets, vanities and their parts pay 25% under Section 232 through December 31, 2026.

Where the Classification Line Falls: Cabinets, Vanities, Parts and Seating

The duty attaches to specific ten-digit statistical lines, not to everything a buyer would call a cabinet. For cabinets and vanities the covered lines are 9403.40.9060, 9403.60.8093 and 9403.91.0080. For upholstered wood seating they are 9401.61.4011, 9401.61.4031, 9401.61.6011 and 9401.61.6031. A product outside those lines is outside the timber action, and a product inside them that is not actually a cabinet or vanity can claim 9903.76.04 at 0%.

Parts and RTA Kits Are Covered

Parts classified under 9403.91.0080 fall under the 25% rate, and ready-to-assemble cabinet kits are covered as well. Importers who shifted to shipping doors, boxes and panels separately in the hope of avoiding the cabinet line should check where those parts actually classify. The cabinet rate follows the parts line.

Vanities With Integrated Tops or Sinks

A vanity shipped with an integrated sink or countertop is a composite good, and its classification turns on General Rules of Interpretation 3(b) and the component that gives the article its essential character. Whether the set lands in a covered 9403 line or elsewhere can change the duty by up to 25 points today and up to 50 points from January 1, 2027. That analysis should be documented per SKU before the step-up, and where the answer is contestable, a binding ruling is worth considering.

Metal-Frame Seating Sits Outside the Timber Action

Seating with metal frames, classified under 9401.71 or 9401.79, is not upholstered wood seating and falls outside the timber action. It is not automatically duty-free under Section 232, however. It may be a steel or aluminum derivative, and derivatives now pay on the full customs value. Our guide to steel and aluminum tariffs covers that separate program.

The 9903.76.04 Proof File

Heading 9903.76.04 lets goods in a covered statistical line enter at 0% when they are not cabinets or vanities. The claim needs a proof file: product specifications, drawings or photos, and a written reason the article is not a cabinet or vanity. Without it, the claim is hard to defend in a post-entry review.

No USMCA Carve-Out, No Forced Labor Stack

The timber action has no USMCA carve-out: cabinets and vanities from Mexico pay the same 25% as product from Vietnam, China or Malaysia, and 50% from January 1, 2027. Canadian vanities classified in 9403.60.8093 also carry the 50% Section 338 duty since September 15, 2026, because 9403.60.80 is on the Section 338 motor vehicle list.

On the other side, goods under the timber action are exempt from the Section 301 forced labor tariff. Importers should confirm that the exemption is actually applied on the entry rather than assume it. Our guide to Section 301 forced labor tariffs explains where that duty does apply. For softwood lumber itself, including the separate antidumping and countervailing duties on Canadian product, see our guide to lumber tariffs.

TSCA Title VI Certification for Composite-Wood Cabinetry

Many imported cabinets and vanities contain particleboard, MDF or hardwood plywood, which brings in a separate requirement at entry. Under 19 CFR 12.121, importers of chemical substances and articles make a TSCA certification before release. For articles containing regulated composite wood, 40 CFR 770.30(d) has required a positive certification since March 22, 2019. The composite wood must be labeled under 40 CFR 770.45, and supplier records must be kept for three years.

The common assumption that articles never need a TSCA certification is wrong for this category. A cabinet program should hold a Title VI supplier-statement file for every factory and confirm that the positive certification is transmitted on every composite-wood line. EPA also proposed updates to the composite wood standards at 91 FR 6161 on February 11, 2026; that rule is not final.

Quartz Countertops: The Section 201 Safeguard Overlay

The same buyers who import cabinets usually import countertops, and quartz surface products now carry their own remedy. Proclamation 11051 (91 FR 50645), effective August 15, 2026, imposed a four-year tariff-rate quota under Section 201 on HTS 6810.99.0020, 6810.99.0040 and 7020.00.6000. Australia, Canada, Mexico, the CAFTA-DR and CBERA countries, Colombia, Korea, Israel, Panama, Peru, Singapore and the developing countries listed in note 41(c) are excluded.

In the current HTSUS, heading 9903.45.30 carries 25% on entries within the quota and 9903.45.31 carries 50% above it. The quota quantities and rates for each of the four years are set in the Annex to Proclamation 11051. Because a quota fills over the year, the effective rate on a given shipment can depend on when it is entered. Our guide to Section 201 safeguard measures explains how tariff-rate quotas fill and how excluded origins are documented.

Planning Around January 1, 2027

The step-up turns entry timing into a cost decision. Three options are open. The first is to pull forward: bring in and enter covered cabinets and vanities before December 31, 2026 at 25%, which requires cash and warehouse capacity and a rebuilt landed cost model for the 2027 rate. The second is to use a customs bonded warehouse or a foreign-trade zone for inventory control, understanding that timber goods admitted to a zone require privileged foreign status, so a zone does not avoid the Section 232 duty. How zone and warehouse inventory is treated around the January 1 step-up should be confirmed against CBP guidance before relying on it. The third is to shift origin to a capped jurisdiction where the product and supply chain allow it, with a documented country of origin determination.

Each option carries risk. Pulling forward depends on vessel and port timing in the last weeks of December. Origin shifts require substantive manufacturing, not relabeling. Our Section 232 consulting team builds the per-SKU model and the shipping plan together so the decision rests on the actual lines being imported.

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Frequently Asked Questions

What is the current tariff on imported kitchen cabinets?

Wood kitchen cabinets, vanities and their parts under heading 9903.76.03 pay 25% under Section 232 through December 31, 2026. The rate rises to 50% on January 1, 2027 under Proclamation 11000, which delayed the increase originally scheduled for January 1, 2026.

Did the cabinet and vanity tariff go up to 50% in January 2026?

No. Proclamation 11000 delayed the scheduled increase to January 1, 2027. The rate in 2026 is 25%.

What is the tariff on upholstered wood furniture?

Upholstered wood seating under 9903.76.02 pays 25% today and 30% from January 1, 2027. Metal-frame seating under 9401.71 or 9401.79 falls outside the timber action but may be a steel or aluminum derivative.

Are RTA cabinets and cabinet parts covered?

Yes. Ready-to-assemble kits are covered, and parts classified under 9403.91.0080 fall under the cabinet and vanity rate.

Do cabinets from Mexico or Canada qualify for a USMCA exemption?

No. The timber action has no USMCA carve-out. The partner rates are 10% for the UK and 15%, inclusive of the Column 1 rate, for Japan, the EU, South Korea and Taiwan. Canadian vanities in 9403.60.8093 also pay the 50% Section 338 duty.

Do imported cabinets need a TSCA certification?

Cabinets and vanities containing regulated composite wood such as particleboard, MDF or hardwood plywood require a positive TSCA certification under 40 CFR 770.30(d), with labeling under 40 CFR 770.45 and supplier records kept for three years.

Does the Section 301 forced labor tariff apply to cabinets?

No. Goods under the Section 232 timber action are exempt from the Section 301 forced labor tariff.

For years the working rule in electronics importing was simple: if the model has an FCC ID, it can come in. That rule no longer holds. Between December 2025 and August 2026 the Federal Communications Commission expanded the FCC Covered List to drones, consumer routers, advanced robotic devices and power inverters, and in July 2026 it went further, banning the continued import and marketing of previously authorized equipment added to the Covered List in 2024 or earlier: fully for Huawei and ZTE, and for specified security uses for Hytera, Hikvision and Dahua.

The result is a split that catches security distributors, network-equipment importers, solar and storage suppliers and robotics resellers. Some products with valid FCC IDs are now barred. Other products in newly covered categories can still be imported, because their authorization predates the listing, but no new foreign-produced model in those categories can be authorized unless it holds a Department of War or DHS Conditional Approval or falls within a published exemption. This guide sets out what the Covered List bans at the border, the 2025 and 2026 expansions, where previously authorized equipment stands, and what the import record should show.

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What the Covered List Blocks at the Border

The Covered List is the FCC’s list of communications equipment and services it has determined pose a national security risk. Its main lever is equipment authorization. Radio-frequency devices have to be authorized by the FCC before they can be imported or marketed in the United States, and the FCC does not grant new authorizations for equipment on the Covered List. For most listed categories, that is the whole mechanism: new models are blocked, while models authorized before the listing are not automatically affected.

The import side is governed by 47 CFR 2.1204, which sets the conditions under which radio-frequency devices may be imported. An importer that brings in a device with no valid authorization, or one whose authorization cannot be granted because the product is on the Covered List, is importing a device that does not meet those conditions. The FCC does not run the border itself, but CBP enforces admissibility on the FCC’s behalf, which is how a regulatory listing turns into a detention.

The listing is also not limited to finished devices. The December 2025 drone action, for example, covers foreign-produced unmanned aircraft systems and their critical components. Distributors who import modules, cameras or radios for assembly in the United States need to check components as carefully as finished goods. From October 13, 2026, FCC 26-50 also bars new authorizations for devices that incorporate a logic-bearing hardware component produced by a Covered List entity (a rule that does not reach the production-location listings such as drones and routers), and requires online marketplaces to show each device’s FCC ID at the point of sale, with compliance on that display duty phased in from March 1, 2027.

The 2025 and 2026 Expansions: Drones, Routers, Robots, Inverters

The Covered List grew in four steps over nine months. Each step added a category of equipment rather than a list of named companies, which is why the practical exposure is much wider than earlier listings aimed at specific manufacturers.

Drones came first. In DA 25-1086 on December 22, 2025, the FCC added foreign-produced unmanned aircraft systems and UAS critical components, together with the communications and video surveillance equipment listed in section 1709 of the FY2025 NDAA, which means no new equipment authorizations for them. A temporary exemption for Blue UAS and Buy American qualifying products runs until January 1, 2027 under DA 26-22. Consumer routers followed on March 23, 2026. Foreign-produced advanced robotic devices and power inverters were added on July 28, 2026. On August 20, 2026 the FCC narrowed the inverter listing to utility-interactive inverters (UL 1741) with remote communication capability and removed inverters eligible for the section 45X credit, so the version of the inverter listing an importer relies on has to be the current one.

Each addition reaches models that were in development or awaiting authorization when the listing took effect. Importers who planned a product refresh in any of these categories should assume a new foreign-produced model cannot be authorized unless it holds a Department of War or DHS Conditional Approval, falls within a published exemption or clearly falls outside the listing, and should confirm the precise scope against the FCC’s published list rather than a summary.

FCC Covered List additions affecting importers, December 2025 to August 2026
Date Category or action Import effect
December 22, 2025 (DA 25-1086) Foreign-produced UAS and UAS critical components; section 1709 communications and video surveillance equipment No new equipment authorizations; Blue UAS and Buy American exemption to January 1, 2027 (DA 26-22)
March 23, 2026 Consumer routers No new authorizations for covered models
July 16, 2026 (DA 26-635, published July 6) Previously authorized equipment listed in 2024 or earlier: Huawei and ZTE for all uses; Hytera, Hikvision and Dahua for covered security uses Continued import and marketing banned for covered uses; critical-infrastructure surveillance suspended until the FCC 26-50 definition takes effect on October 13, 2026
July 28, 2026 Foreign-produced advanced robotic devices and power inverters No new authorizations for covered models
August 20, 2026 Inverter scope narrowed Scope narrowed to utility-interactive inverters (UL 1741); 45X-eligible inverters excluded. Recheck inverter models

Previously Authorized Equipment: Two Different Answers

The question importers ask most often is whether a model that already has an FCC ID can still be brought in. Since July 2026 the answer depends on who made it and, for some manufacturers, on the end use.

For equipment caught by DA 26-635, published in the Federal Register on July 6, 2026, the answer is generally no. The order bars the continued import and marketing of previously authorized equipment added to the Covered List in 2024 or earlier. For Huawei and ZTE that bar applies to all uses. Hytera, Hikvision and Dahua equipment is on the Covered List only for public safety, security of government facilities, physical security surveillance of critical infrastructure and other national security purposes, and the order does not apply to importation and marketing for other uses. The prohibition took effect on July 16, 2026, as stated in the Federal Register notice. The prohibition for critical-infrastructure surveillance was suspended until the FCC defined critical infrastructure; FCC 26-50 adopts that definition effective October 13, 2026, so that use is expected to be barred from that date. The order sets no transition period for distributors holding inventory.

For the categories added from December 2025 onward, drones, consumer routers, advanced robotic devices and power inverters, the answer is different. The listing blocks new authorizations, so a model authorized before its category was listed can generally still be imported and sold. That is the same logic that applies to drones: the Section 232 tariff reaches drones whatever their authorization date, but the FCC block reaches only new models. For drones this may change: in PS Docket 26-184 (DA 26-742 and DA 26-832) the FCC has proposed barring the continued import and marketing of specified previously authorized foreign-produced drones and section 1709 devices, and in PS Docket 26-189 (DA 26-758) of military-grade covered drones, so importers should not assume existing drone authorizations will keep working.

The confusion comes from treating these two situations as one. A distributor holding a valid FCC ID for a Huawei or ZTE device is in the first group and cannot import it for any use. Previously authorized Hikvision, Dahua and Hytera equipment is barred only when imported or marketed for public safety, government facilities, other national security purposes and (once the suspension ends) critical-infrastructure surveillance; imports for other uses are outside DA 26-635. A router importer holding a valid FCC ID for a model authorized before March 23, 2026 is in the second group and generally can. Both have FCC IDs; only one can clear.

Logistics compliance officer checking shipment data on a tablet beside containers
Covered List status has to be checked per model and per manufacturer, not per product category.

Surveillance Cameras and the Use-Based Hikvision and Dahua Ban

Security and surveillance is where DA 26-635 has the sharpest effect, because Hikvision and Dahua equipment has long been sold under other brand names. The ban follows the equipment, not the label on the box, so a private-label camera built by one of the named manufacturers raises the same question as a branded one.

Distributors should trace each camera, recorder and related device back to the manufacturer behind the FCC ID and the grantee on the authorization. Where the grantee or the manufacturer is Huawei or ZTE, the model comes off the import plan. For Hikvision, Dahua and Hytera, the ban is use-based: the distributor has to control and document the end use. Sales into public safety, government facilities or other national security uses are barred, and critical-infrastructure surveillance joins that list once FCC 26-50 takes effect on October 13, 2026. General commercial and residential sales are outside the order, but the importer should be able to show that end-use screening, because the order sets no end-use certification of its own.

Inventory already in the United States is a separate question from new imports, because the ban reaches marketing as well as import. That is an FCC compliance question for the seller, and it should be answered by counsel rather than by the logistics team.

Inverters, Robots and Routers: Screening New Product Lines

For the categories added in 2026, the practical risk is not inventory already authorized. It is the next model. Solar and storage suppliers that planned to launch connected inverters, robotics distributors with new platforms, and network-equipment importers refreshing router lines all need to confirm whether the new model can be authorized before committing to production and freight.

Inverters need particular care because the FCC narrowed the scope 23 days after listing it. A model assessed against the July 28 listing should be reassessed against the August 20 narrowing, which may bring it back outside scope. Importers active in energy equipment are already dealing with other trade controls on the same goods, covered in our overview of solar tariffs, and the FCC question sits alongside them rather than replacing them.

Pending rulemaking adds another layer. The FCC’s test-lab integrity rules in FCC 26-28 took effect on June 15, 2026 (some provisions delayed), and the same item proposes to stop recognizing test labs and certification bodies outside mutual recognition or trade agreement territories. That proposal is still pending. If adopted, it would affect where the testing behind an authorization can be done, which matters for any importer whose suppliers test in the same country they manufacture in.

Entry Declarations and the Import Record

The paper side of FCC imports is lighter than many importers expect. FCC Form 740, the old import declaration for radio-frequency devices, has not been required since 2017. That removed a filing step, but it did not remove the import conditions in 47 CFR 2.1204. The importer still needs to know which condition a device meets and be able to show it.

In practice the import record should tie each SKU to its FCC ID, the grantee, the manufacturer, the authorization date, and the Covered List status of its category and manufacturer on the date of import. That record is what the importer produces when CBP or the FCC asks why a device was admissible. It is also what protects the importer when a supplier changes a component or a factory without saying so, because a changed product may no longer match its authorization.

Holding that data per SKU is ordinary trade compliance management work, and it fits in the same item master as classification and origin. Because the drone, router, robot and inverter listings are framed around where equipment is produced, country of origin determination for each model has to be settled on facts, not on the invoice alone.

  • FCC ID, grantee and manufacturer for every radio-frequency SKU.
  • Authorization date compared with the listing date for its category.
  • Manufacturer screened against Huawei, ZTE, Hytera, Hikvision and Dahua, including private-label supply.
  • Country of production for drones, routers, robots and inverters.
  • Test lab location, pending the outcome of the FCC 26-28 proposal on labs outside mutual recognition territories.

When a Shipment Is Detained

A detention on FCC grounds usually starts with CBP questioning whether a device is authorized or whether its authorization can still be relied on. The fastest resolution comes from producing the SKU-level record described above, with the FCC ID and the dates that show the model falls outside the Covered List restrictions. Where the model is caught by DA 26-635 or is an unauthorized new model in a covered category, the options narrow to export or abandonment, and the question becomes cost control rather than release.

A licensed customs brokerage team handling electronics entries should see the Covered List status before the goods ship, not after the detention notice. The same pre-shipment gate that importers already use for other restricted imports applies here: if the model is not clearly admissible, it does not get booked.

Supplier screening belongs in the same process. Distributors that already run restricted party screening on counterparties can extend it to the five named manufacturers and their affiliates, so that a new supplier offering familiar camera hardware under an unfamiliar brand is caught at onboarding.

Drone Models Already Authorized Before the Listing

Drone importers face the Covered List and a tariff at the same time, and the two work differently. Proclamation 11055 imposed Section 232 duties on drones and listed critical components from September 3, 2026 (other listed components from February 9, 2027). From September 3 the rate is 100% on drones over 25 kg, drones with thermal imagers, docking stations and the critical components in Annex I, and 25% on drones of 25 kg or less; Annex III components pay 25% from February 9, 2027. The duty applies regardless of FCC authorization date, subject to the proclamation’s partner-country caps (15% for the EU, Japan, Korea, Taiwan, Switzerland and Liechtenstein, 10% for the UK, where substantially all critical components and technology are certified as US or partner content), a 180-day delay for companies on the Blue UAS Cleared List, the Blue UAS Framework or the FCC Conditional Approval List, and onshoring relief. The FCC action applies only to new authorizations, so a previously authorized model can still be imported, but it will pay the duty.

The tariff side is covered in our guide to Section 232 tariffs. For the FCC side, the checks are the same as for any other covered category: confirm the authorization predates the listing, confirm the country of production, and confirm whether the Blue UAS or Buy American exemption under DA 26-22 applies before it expires on January 1, 2027.

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Frequently Asked Questions

What is the FCC Covered List?

It is the FCC’s list of communications equipment and services determined to pose a national security risk. The FCC does not grant new equipment authorizations for covered equipment, which blocks new models from being imported or marketed in the United States.

Can I import a camera that already has an FCC ID?

It depends on the manufacturer and the end use. DA 26-635, effective July 16, 2026, bars the continued import and marketing of previously authorized Huawei and ZTE equipment for all uses. Hikvision, Dahua and Hytera equipment is barred only for public safety, government facility and national security uses, and for critical-infrastructure surveillance once the FCC 26-50 definition takes effect on October 13, 2026. Cameras from other manufacturers with a valid authorization are not affected by that order.

Are foreign routers banned from import?

Consumer routers were added to the Covered List on March 23, 2026. That blocks new authorizations for covered models. Models authorized before that date can generally still be imported, but the scope of the listing should be checked per model.

Are inverters on the FCC Covered List?

Foreign-produced power inverters were added on July 28, 2026. On August 20, 2026 the FCC narrowed the listing to utility-interactive inverters (UL 1741) with remote communication capability and removed inverters eligible for the section 45X credit. Models should be assessed against the narrowed scope, not the original listing.

Do I still need to file FCC Form 740?

No. Form 740 has not been required since 2017. The import conditions in 47 CFR 2.1204 still apply, so the importer should keep a record showing which condition each device meets.

How do the drone tariffs and the FCC drone listing interact?

They are separate. The Section 232 drone duty under Proclamation 11055 applies from September 3, 2026 regardless of FCC authorization date, at 100% or 25% depending on the product, subject to partner-country caps and other relief. The FCC listing of December 22, 2025 blocks only new authorizations, so an already-authorized model can still be imported but pays the duty, although pending FCC proposals in PS Docket 26-184 would bar some previously authorized drones.

“Articles never need TSCA” is one of the most durable assumptions in import compliance, and one of the most expensive to hold in 2026. A container of dining chairs, kitchen cabinets or MDF shelving needs a TSCA import certification on every line containing regulated composite wood, and has since 22 March 2019. A shipment of PVC-containing goods with phenol, isopropylated phosphate (PIP (3:1)) faces a distribution ban after 31 October 2026, unless the part falls under one of the rule’s exclusions (such as wire harnesses and circuit boards) or a later phase-in date (such as 2034 for parts in new electronic equipment). And the PFAS reporting obligation that was supposed to open in April 2026 has moved, with the exemption most article importers are counting on still only proposed.

Under 19 CFR 12.121, an importer of a chemical substance, mixture or article subject to a TSCA rule must certify before release either that the shipment complies with TSCA (a positive certification) or that it is not subject to TSCA (a negative certification). Getting the direction wrong is not a technicality: a negative certification on goods that are subject to a rule is a false statement on the entry. This guide covers which certification applies, how composite wood and PIP (3:1) change the answer for furniture and electronics importers, and where PFAS reporting stands. Rules checked against the eCFR and Federal Register as of September 2026.

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Positive vs Negative Certification

The two statements answer different questions. A positive certification says the shipment is subject to TSCA and complies with all applicable rules and orders in effect. A negative certification says the shipment is not subject to TSCA at all, for example a food, drug, cosmetic, pesticide or other product regulated under a different statute and excluded from the TSCA definition of a chemical substance. Under 19 CFR 12.121(a)(2) it is required when an excluded chemical is not clearly identified as such; when it is clearly identified, such as a pesticide entered with an EPA Notice of Arrival, a disclaim may apply instead.

In ACE the certification is transmitted as part of the entry. CBP implementation guidance for the TSCA message set uses program code TS1, with EP4 for a positive certification and EP5 for a negative one. The certification is made by the importer, or by its broker when the importer has authorized the broker to certify on its behalf through the customs power of attorney and supporting instructions. Either way the legal responsibility stays with the importer of record.

The practical rule is simple to state and harder to apply: if any TSCA rule reaches the product, the answer is positive, and the importer must be able to show compliance with that rule. Negative certifications belong to products that TSCA does not reach, not to products the importer believes are low risk.

Which TSCA import certification applies
Shipment Certification ACE code
Industrial chemical, resin, coating or solvent Positive EP4
Furniture, cabinets or millwork containing hardwood plywood, MDF or particleboard Positive (required since 22 March 2019) EP4
Food, drug, cosmetic or registered pesticide excluded from TSCA Negative (EP5) when not clearly identified as excluded; a disclaim may apply when it is, such as a pesticide filed with an NOA EP5, or a disclaim code
Article with no TSCA rule applicable to it Certification generally not required Disclaim code A if the HTS line is flagged for TSCA
Article containing PIP (3:1), distributed after 31 October 2026 Distribution prohibited unless a carve-out applies Check 40 CFR 751.407

Articles vs Chemical Substances

TSCA import certification was built around chemical substances and mixtures: drums of solvent, bags of pigment, totes of resin. For those, the question is always which certification to make, and the answer turns on whether each substance is on the TSCA Inventory or otherwise covered, and whether any rule or order applies to it. Importers of these products, including many cosmetics and chemical logistics accounts, usually have the process in place.

Articles are different. An article is a manufactured item formed to a specific shape or design, whose end use depends on that shape or design and whose chemical composition does not change during use (19 CFR 12.120). For most articles no certification is required at all. The exception is written into specific rules: when EPA issues a rule that reaches articles, the importer of those articles must certify compliance. Composite wood is the largest such rule by import volume, and the persistent, bioaccumulative and toxic chemical rules, including PIP (3:1), are the reason electronics and cable importers now need to look at articles too.

That is why the “articles never need TSCA” assumption breaks. It was mostly true for years and became false one rule at a time. A compliance file that still treats all finished goods as outside TSCA has not caught up with the rules issued since 2016.

Composite Wood (Title VI) Certification for Furniture and Cabinets

TSCA Title VI, implemented at 40 CFR 770, sets formaldehyde emission standards for hardwood plywood, medium-density fiberboard and particleboard, and for finished goods that contain them. Under 40 CFR 770.30(d), importers of articles containing regulated composite wood must make a positive TSCA import certification, a requirement that has applied since 22 March 2019. It covers dining tables, cabinets, bathroom vanities, bookcases, flooring with composite cores and a long list of hotel and office furniture.

Three documents make the certification defensible. The panels or finished goods must be labeled as TSCA Title VI compliant under 40 CFR 770.45. The importer must hold records showing that the composite wood came from certified sources, including supplier statements that trace back to the panel producer. And those records must be kept for three years. An EP4 on the entry without that file is a certification the importer cannot support if EPA or CBP asks.

The weak point is the supply chain behind the furniture factory. A factory that buys panels from several mills, or switches mills mid-season to manage cost, can break the documentation trail without changing anything visible on the product. Importers of furniture and cabinetry, many of whom are also managing lumber tariffs on the same goods, should collect panel-level supplier statements per purchase order, not once per supplier relationship.

EPA proposed updating the standards incorporated into the Title VI rule at 91 FR 6161 on 11 February 2026. That is a proposal, not a change in the current obligation, and the existing certification and labeling requirements continue to apply.

Specialist reviewing wood and composite flooring samples with a client
Flooring, cabinets and furniture with hardwood plywood, MDF or particleboard need a positive TSCA certification.

PIP (3:1) Distribution Ban After October 31, 2026

PIP (3:1) is a flame retardant and plasticizer used widely in PVC, which puts it in wire and cable insulation, electronics, appliance components and some industrial equipment. EPA’s rule at 40 CFR 751.407 prohibits the distribution in commerce of articles containing PIP (3:1) after 31 October 2026. Specific parts and uses have later dates, from 2029 to 2054 or the end of equipment service life, and some uses, such as wire harnesses and circuit boards, are excluded outright. The carve-out that applies depends on the exact part and end use listed in the rule.

For importers the risk sits in inventory rather than at the border. Goods already landed and sitting in a distribution center are still subject to the prohibition once the date passes, so the question is not only what ships next month but what is on the shelf on 1 November. Importers of electrical and electronic goods should request written supplier declarations on PIP (3:1) content now, identify which SKUs rely on a part-specific extension, and align the TSCA import certification on each entry with what the declarations show.

Supplier declarations are only as good as the bill of materials behind them. Cable harnesses and PVC components are commonly sourced from sub-suppliers two or three tiers below the assembler, so the request needs to reach the component level to be meaningful.

PFAS Section 8(a)(7) Reporting: Where It Stands

The TSCA section 8(a)(7) rule requires one-time reporting on PFAS manufactured, including imported, in past years. The start date of 13 April 2026 no longer applies. Under the rule published at 91 FR 18786 on 13 April 2026, the submission period now opens on 31 January 2027, or 60 days after EPA’s forthcoming final rule on the reporting scope, whichever is earlier.

The change importers of articles care most about is still pending. EPA has proposed an exemption for PFAS imported as part of an article (90 FR 50923, 13 November 2025), but it is a proposal only. Until a final rule is published, article importers cannot treat the exemption as settled, and the safe planning assumption is that article imports may be in scope when the window opens.

The preparation work is the same either way: build an inventory of imported products that may contain PFAS, by SKU and by year, and identify which suppliers can document PFAS content. If the article exemption is finalized, the inventory narrows to chemical imports. If it is not, the inventory becomes the reporting base. Doing the work now avoids compressing it into the weeks before the window opens.

Running TSCA Certification as a Line-Level Control

TSCA certification problems are rarely caused by not knowing the rule. They come from the certification being set once per importer or once per product family and never revisited as the product mix changes. A furniture importer adds a line with an MDF back panel; an electronics importer changes cable suppliers; a chemical distributor starts carrying a product that falls outside TSCA. Each change can flip the correct answer on specific lines.

The control that works is line-level: each product record carries its TSCA status, the basis for it and the supporting document, and the broker transmits the certification from that record rather than from a default. HTS classification helps flag candidates, since composite wood furniture and PVC-insulated cable cluster in predictable chapters, but the HTS code alone does not decide TSCA status. The product content does.

The same control belongs inside the wider trade compliance management program alongside other agency requirements, from US import licenses to partner government agency data. A licensed customs brokerage can transmit the right code on every line only if the importer’s product data carries the answer, and a customs compliance platform that stores those attributes per SKU turns an annual scramble into a routine field check.

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Frequently Asked Questions

What is the difference between a positive and a negative TSCA certification?

A positive certification states that the shipment is subject to TSCA and complies with all applicable rules and orders. A negative certification states that the shipment is not subject to TSCA, for example because it is a food, drug, cosmetic or pesticide regulated under another statute. Both are made under 19 CFR 12.121 before release.

Do imported articles need a TSCA import certification?

Most articles do not. The exception is any article covered by a TSCA rule that reaches articles, and the largest by volume is composite wood: furniture, cabinets and other goods containing hardwood plywood, MDF or particleboard need a positive certification under 40 CFR 770.30(d).

Which ACE codes are used for TSCA certification?

CBP guidance for the TSCA message set uses program code TS1, with EP4 for a positive certification and EP5 for a negative certification.

What records support a composite wood TSCA certification?

Title VI compliant labeling under 40 CFR 770.45 and records showing the composite wood came from certified sources, including supplier statements, kept for three years.

What happens to PIP (3:1) articles after October 31, 2026?

Under 40 CFR 751.407 their distribution in commerce is prohibited after that date, except for specific parts and uses with later dates, from 2029 to 2054 or the end of equipment service life, and uses such as wire harnesses and circuit boards that are excluded outright. Inventory already in the US is covered, not only new imports.

When does TSCA PFAS 8(a)(7) reporting start?

The submission period opens on 31 January 2027, or 60 days after EPA’s forthcoming final rule, whichever is earlier (91 FR 18786). The April 2026 start date no longer applies, and the proposed exemption for PFAS in imported articles has not been finalized.

FDA Form 2877 is the importer’s declaration for electronic products that emit radiation and are subject to a federal performance standard. Two opposite mistakes cause most of the trouble at entry. Some importers file a 2877 declaration for every electronic product with a light or a power supply, which invites questions FDA did not need to ask. Others assume a CE mark or a foreign test report replaces the US requirement, and ship lasers or microwave ovens without the accession number FDA expects to see.

The rule is narrower and stricter than either assumption. A 2877 declaration applies only to products covered by a performance standard in 21 CFR 1020 to 1040, and for those products the entry has to carry the right declaration code and, in the common case, a valid accession number tied to the right manufacturer. This guide covers which products trigger the form, how the declaration codes work in ACE, what to collect from the foreign manufacturer, and how holds on radiation-emitting products play out.

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When Form 2877 Applies and When It Does Not

FDA regulates radiation-emitting electronic products under Chapter V, Subchapter C of the Federal Food, Drug, and Cosmetic Act. The general requirements sit in 21 CFR 1000 to 1005 and apply broadly, including the duty to deal with defects. Performance standards are a smaller set of product-specific rules in 21 CFR 1020 to 1040, and Form FDA 2877 is required only for products that one of those standards covers.

That distinction settles most questions. A laser level, a microwave oven or a cabinet X-ray unit is under a standard, so the importer declares compliance. An LED bulb, most LED face masks and most UV-C germicidal lamps are not covered by any 2877 standard, so no declaration is filed for them, although the general radiation-safety and defect obligations still apply. The list of standards has also shrunk: a January 20, 2023 final rule (88 FR 3638) repealed or amended several standards, and Part 1050 on ultrasonic therapy products no longer appears in the eCFR.

A CE mark does not substitute for any of this. European conformity marking has no standing at a US port, and a laser product that meets IEC 60825-1 still needs to be reported to FDA and declared at entry. FDA’s Laser Notice 56 sets the conditions under which conformance with IEC 60825-1 is accepted in place of parts of the US laser standard, and FDA has not published any final rule amending the laser standard in 21 CFR 1040 since then.

Laser, LED, UV and Microwave Products Under the Performance Standards

The table maps the standards to the product categories importers see most often. Where a product combines functions, such as a projector with a laser light source or a beauty device built around a laser, the standard follows the radiation source, not the retail category.

Products that are also medical devices

Diagnostic X-ray equipment and lasers intended for medical use are both radiation-emitting products and medical devices. FDA’s ACE guidance requires them to meet both sets of data requirements: the device registration, listing and premarket data, and the radiation declaration. Importers that already handle device entries as an FDA initial importer still need the 2877 layer on these lines.

Performance standards that trigger a Form FDA 2877 declaration (21 CFR)
Standard Product type Typical imports
1020.10 Television receivers with cathode ray tubes CRT televisions only (not LCD, LED or OLED sets)
1020.20 Cold-cathode gas discharge tubes Educational and demonstration discharge tubes
1020.30 to 1020.33 Diagnostic X-ray systems Medical and dental X-ray equipment
1020.40 Cabinet X-ray systems Baggage and parcel security scanners
1030.10 Microwave ovens Countertop and built-in microwave ovens
1040.10 and 1040.11 Laser products Laser levels, LiDAR modules, laser projectors, laser pointers and toys
1040.20 Sunlamp products Tanning lamps and beds
1040.30 High-intensity mercury vapor discharge lamps Mercury vapor lamps
None Not under a 2877 standard Most LED bulbs, LED masks and UV-C germicidal lamps

Declaration Codes RA, RB, RC and RD in ACE

At entry, Form FDA 2877 declarations are transmitted electronically as Affirmation of Compliance codes in the FDA message set, under the radiation program (RAD) with processing code REP for non-medical products, or under the device program with processing code RED for radiation-emitting medical devices. FDA’s ACE Affirmation of Compliance list dated March 10, 2026 is the current reference, and only one radiation declaration is allowed per entry line.

The declaration families work as follows. The RB group is used for products declared in compliance with their standard, and RB1 is the code that carries the accession number. The RA group covers the recognized exceptions, such as products made before the standard took effect, components, small quantities of household goods and test units. The RC and RD groups cover noncompliant products. RC codes are for products that will not be brought into compliance: RC1 for research, investigations or training, which requires an approved Form FDA 766 and a temporary importation bond, and RC2 for trade shows, which requires a temporary importation bond but no Form 766. RD codes are for products being brought into compliance while held intact in a bonded warehouse under a temporary importation bond: RD1 when Form FDA 766 is already approved, RD2 when it is submitted with the entry, and RD3 when it will be submitted within 60 days.

Where RB1 entries fail

A frequent rejection is an RB1 line sent without an accession number, or with one that belongs to a different manufacturer. RB1 has to travel with the ACC code (product report accession number) or the ANC code (annual report accession number), and the manufacturer declared on the line has to match the manufacturer on the report FDA holds. Trading companies that sell factory output under their own name can create this mismatch without noticing it. A licensed customs broker catches it before transmission only if the accession data is collected with the purchase order.

Form 2877 declaration families as transmitted in ACE
Code family What it declares What must accompany it
RA1 to RA7 Exception to the standard: pre-standard, component, household goods, test unit Facts supporting the exception
RB1 to RB2 Product complies with its performance standard RB1: accession number (ACC or ANC), manufacturer name matching the report
RC1 to RC2 Noncompliant product imported temporarily for research, training or trade shows RC1: approved Form FDA 766 and TIB; RC2: TIB and trade show dates
RD1 to RD3 Noncompliant product reconditioned under bond RD1: approved Form FDA 766, corrective action plan, accepted product report, TIB and bonded warehouse; RD2 and RD3: Form 766 pending or due within 60 days

Accession Numbers: What the Foreign Manufacturer Must Supply

Under 21 CFR 1002.10, the manufacturer of a product subject to a standard submits a product report to FDA before the product is introduced into commerce. FDA assigns an accession number to the report, and that number is what the RB1 declaration points to. The importer cannot generate one; it has to come from the manufacturer that filed the report.

Foreign manufacturers of electronic products carry a second obligation. Under 21 CFR 1005.25, each must designate a permanent US resident as its agent for service of process before offering products for import. The agent is separate from any device-side US Agent and from the importer of record, though one company can hold more than one role.

For each radiation-emitting SKU, the document pack collected before booking should contain:

  • The applicable standard (for example 1040.10 for a laser product) and the product’s classification under it.
  • The accession number of the product report or annual report, and the exact manufacturer name on that report.
  • Model numbers covered by the report, matched to the commercial invoice.
  • Confirmation that the 1005.25 agent designation is in place.
  • For medical lasers or X-ray equipment, the device registration, listing and premarket data as well.
Logistics supervisor checking shipment data on a handheld device beside a container truck
Accession numbers and manufacturer names are checked against the invoice before the entry is transmitted.

Holds and Refusals for Radiation-Emitting Products

FDA screens radiation-emitting products through the same entry review as other regulated goods. A line with a valid declaration and a matching accession number can be released as May Proceed; a line with missing or inconsistent data is routed to review, and a product that appears not to comply can be detained.

Import alerts shape the risk by product type. Import Alert 95-04 covers laser pointers, laser levels, laser gunsights, laser light show projectors and similar laser products from firms on its Red List, and allows detention without physical examination. Import Alert 95-01 covers sunlamps, and Import Alert 95-05 covers noncertified electronic products.

A detained product that can be fixed goes through Form FDA 766, the application to bring it into compliance, backed by a bond with a redelivery condition. The importer pays for FDA supervision of the work, charged at 267% of the GS-11/4 hourly rate with a one-hour minimum. Where the goods need to stay under customs control, entry into a customs bonded warehouse is part of the RD route. A product that cannot be brought into compliance is refused and must be exported or destroyed under supervision within 90 days of the refusal notice.

The bond exposure is real. CBP can demand redelivery of noncompliant goods (19 CFR 141.113(c) for radiation-emitting medical devices, 141.113(d) for other electronic products), and failure to redeliver triggers liquidated damages of up to three times the value of restricted merchandise under 19 CFR 141.113(i). The right customs bond structure matters for any importer with regular radiation-emitting lines.

Building a 2877 Check Into the Purchase Order

Most 2877 problems are created months before arrival, when a buyer approves a factory sample without asking whether the product sits under a standard. Moving the check upstream costs little and removes the most frequent causes of hold.

How CargoTrans supports radiation-emitting imports

CargoTrans classifies products against the standards, collects accession data from foreign manufacturers, transmits the declarations and manages Form 766 and bond requirements when a product needs reconditioning. The work sits within our trade compliance management service. For products that face outright restrictions rather than a declaration, see our guide to prohibited and restricted imports.

  • At sourcing: classify each new electronic SKU against the performance standards and flag every laser, microwave, X-ray, sunlamp or mercury vapor lamp product.
  • At PO: require the accession number, report holder name and 1005.25 agent from the factory as a contract deliverable.
  • Before booking: match models, manufacturer name and accession number to the commercial invoice, and screen the supplier against Import Alerts 95-01, 95-04 and 95-05.
  • At entry: transmit a single radiation declaration per line, RB1 with ACC or ANC for compliant goods, the correct RA code for an exception.
  • After entry: retain the signed 2877 declaration with the entry records for five years.
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Frequently Asked Questions

Does every electronic product need FDA Form 2877?

No. Form FDA 2877 applies only to electronic products covered by a performance standard in 21 CFR 1020 to 1040, such as lasers, microwave ovens, cabinet and diagnostic X-ray systems, sunlamps and mercury vapor lamps. Most LED bulbs, LED masks and UV-C germicidal lamps are not under a 2877 standard, although general radiation-safety and defect obligations still apply.

What is an FDA accession number?

It is the number FDA assigns to a manufacturer’s product report or annual report for a radiation-emitting product subject to a standard. The report is filed before the product enters commerce under 21 CFR 1002.10. At entry it is transmitted with the RB1 declaration as ACC (product report) or ANC (annual report).

Why was my RB1 declaration rejected?

The usual causes are a missing accession number or a manufacturer name on the entry line that does not match the manufacturer on the FDA report. Private-label brands and trading companies that ship under a different name from the report holder are the typical source of the mismatch.

Does a CE mark replace FDA laser requirements?

No. A CE mark has no standing at a US port. A laser product still needs an FDA product report and accession number and a Form 2877 declaration. FDA’s Laser Notice 56 governs when conformance with IEC 60825-1 is accepted in place of parts of the US laser standard.

Can a noncompliant laser or microwave be fixed after arrival?

Sometimes. The importer applies on Form FDA 766 to bring the product into compliance, under bond, and pays for FDA supervision. The reconditioning route is declared with the RD codes: the goods stay intact in a bonded warehouse under a temporary importation bond, and the work cannot start until FDA approves the Form FDA 766 and the corrective action plan. If FDA refuses the goods, they must be exported or destroyed within 90 days of the refusal notice.

What is Import Alert 95-04?

It is FDA’s import alert for laser pointers, laser levels, laser gunsights, laser light show projectors and similar laser products from firms on its Red List. It allows detention without physical examination of products from listed firms, so shipments are held unless the importer overcomes the appearance of a violation.

Who must be the US agent for a foreign electronics manufacturer?

Under 21 CFR 1005.25, each foreign manufacturer of electronic products must designate a permanent US resident as its agent for service of process before offering products for import.

A children’s product certificate is the document a U.S. importer issues to state that a product designed or intended primarily for children 12 or younger meets every children’s product safety rule that applies to it. Since July 8, 2026, its data also has to reach ACE at entry through the CPSC PGA Message Set. That change turned a document that used to sit in a supplier folder into a set of fields CPSC can screen line by line before release.

The CPC differs from a general-use certificate in three ways that drive cost and risk: the testing has to come from a CPSC-accepted third-party laboratory, testing has to be repeated on a defined cycle, and the product and packaging need permanent tracking marks. This piece covers those mechanics and the eFiling data specific to a CPC. The broader CPSC framework is covered in our CPSC compliance guide.

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CPC vs GCC: Which Certificate the Product Needs

The certificate type follows the product’s intended user, not the rule being certified. A General Certificate of Conformity (GCC) under CPSA section 14(a)(1) covers general-use products subject to a CPSC rule. A Children’s Product Certificate under section 14(a)(2) and 16 CFR part 1107 covers a children’s product, defined at 15 U.S.C. 2052(a)(2) as one designed or intended primarily for children 12 years of age or younger, that is subject to a children’s product safety rule.

Several rules appear on both CPSC lists: ATVs, bicycles, bicycle helmets, clothing storage units, magnets, Reese’s Law, lead in paint under 16 CFR 1303, flammability rules 1610, 1611, 1630/1631 and 1632/1633, and toy firearms. A dresser for adults is certified on a GCC to 16 CFR 1261; the same design marketed for a child’s room goes on a CPC. A youth ATV or a sidewalk bicycle is a children’s product even though the adult versions are certified on GCCs.

Some rules only exist for children’s products. Total lead content in substrate under 15 U.S.C. 1278a (100 ppm) applies to children’s products only. Phthalate limits in 16 CFR 1307 apply to children’s toys and child care articles, meaning products that facilitate sleep, feeding or teething for children 3 and under. Children’s sleepwear falls under 16 CFR 1615 (sizes 0 to 6X) and 1616 (7 to 14).

GCC and CPC compared (CPSA section 14; 16 CFR 1107, 1110; CATAIR v2.5)
GCC CPC
Products General-use products subject to a CPSC rule Products designed or intended primarily for children 12 or younger
Testing basis Test of each product or a reasonable testing program; first-party testing allowed Third-party testing by a CPSC-accepted laboratory before import
Periodic testing Not prescribed Annually, every 2 years with production testing, or every 3 years with an ISO/IEC 17025 lab program
eFiling lab role PG19 LAB with name and contact PG19 ITL with mandatory 4-digit CPSC Lab ID
Tracking labels Not required Permanent marks on product and packaging, to the extent practicable

Third-Party CPSC-Accepted Labs and the Lab ID

Under 15 U.S.C. 2063(a)(2), samples of a children’s product must be tested by a CPSC-accepted third-party conformity assessment body before the product is imported. A report from a lab that is not on CPSC’s accepted list does not support a CPC, however competent the lab. For a GCC, by contrast, any qualified lab and even first-party testing is acceptable.

A procurement team that approves a supplier’s lab therefore needs to confirm, in CPSC’s lab locator, that the lab is CPSC-accepted before the report is relied on for any rule the certificate will cite, including lead, phthalates and any product-specific standard.

The eFiling data makes the lab’s status visible. In the Full message set under CATAIR v2.5, the testing party on a CPC is entered in PG19 with entity role ITL, and for that role the 4-digit CPSC Lab ID is mandatory. A missing Lab ID and a CPC citing a non-accepted lab are both on the list of predictable failure points that follow from the rule and the implementation guide.

Labs, manufacturers and other trade parties may enter certificate data into CPSC’s Product Registry on the importer’s behalf as invited users. Labs never file into ACE, and under 16 CFR 1110.15 the finished product certifier remains legally responsible for what they enter.

Periodic Testing and Tracking Labels

A CPC is not a one-time document. Under 16 CFR 1107.21, a manufacturer of a children’s product must conduct periodic third-party testing at least once a year. The interval can extend to every 2 years where a production testing plan is in place, or to every 3 years where testing is done by an ISO/IEC 17025 accredited lab program. Records must be kept as set out in 1107.26.

For importers, the periodic cycle creates a data problem at the border. The certificate transmitted at entry must show the most recent date and place of testing for each lab relied on. A certificate that quotes a test date from a cycle that has lapsed, or from a factory that no longer makes the product, is exactly the kind of stale data that makes an entry harder to clear.

Tracking labels are a separate statutory duty. 15 U.S.C. 2063(a)(5) requires permanent distinguishing marks on a children’s product and its packaging, to the extent practicable, that let the manufacturer and the consumer identify the location and date of production and the batch or run. Failure to provide tracking labels is a prohibited act under 15 U.S.C. 2068(a)(6). The marks also make it possible to match the physical goods to the manufacture date and place on the certificate.

Warehouse staff checking cartons against a clipboard
Tracking marks on product and packaging tie each carton to the batch and factory on the certificate.

What a Children's Product Certificate Must List

16 CFR 1110.11 sets seven data elements for every finished product certificate: product identification, every applicable rule listed separately, the certifier, the records custodian, the date and place of manufacture, the most recent date and place of testing with each lab relied on, and the attestation. On a CPC, three of those carry most of the risk.

Rules cited section by section

For toys, the CPC must list each applicable section of ASTM F963, as incorporated in 16 CFR 1250, not just the standard number. CPSC’s citation guidance uses the section number as the citation code, for example 4.6. Some F963 sections, such as 4.1 (material quality) and the labeling sections, do not require third-party testing, and a few, such as 4.2 flammability, are not mandatory; CPSC’s F963 guidance lists which sections go on the certificate and which need a CPSC-accepted lab. Toy guns certify to F963 and to 16 CFR 1272. Water beads (1250.4, effective March 12, 2026) and neck floats (1250.5, effective June 15, 2026) are now part of 16 CFR 1250.

Material determinations as exclusion codes

CPSC determinations cover certain materials, such as untreated wood (16 CFR 1251), engineered wood (1252), textiles and fibers (1253), certain plastics (1308) and natural materials under 1500.91. Relying on a determination does not remove the rule from the certificate. The rule is still cited, and the determination is entered as a testing exclusion code in place of test data. A children’s garment of a fabric exempt under 16 CFR 1610.1(d) follows the same pattern: 1610 is cited on the CPC with the exemption as an exclusion code. Buttons, snaps, zippers and prints on that garment still need third-party lead and paint testing.

Component testing

16 CFR part 1109 allows a CPC to rest on component tests, such as lead and phthalate results on individual materials, provided due care and traceability are maintained. Component part certificates are voluntary and are never eFiled, but every test the CPC relies on, including component tests, must be recorded on the finished product certificate.

eFiling Data for a CPC: Full vs Reference Message Set

Two filing paths exist. The Full PGA Message Set carries all certificate data at entry: product identifiers, citations in PG60, the certifier and records custodian, the manufacturer in PG19 role MF, the accepted lab in PG19 role ITL with its Lab ID, the lab test date in PG30 and the attestation in PG22. The Reference PGA Message Set transmits only three identifiers (Certifier ID, Product ID and Version ID) pointing to a certificate already certified in CPSC’s Product Registry.

For a toy or apparel importer with a large, repeating catalog, the Reference set is the practical route. CPSC’s paperwork burden estimate puts a Reference filing at 15.3 seconds against 4.75 minutes for a Full filing (90 FR 1800). Our CPSC eFiling services cover Product Registry onboarding and the Reference set at entry. The trade-off is governance: a certified record can only be edited within 48 hours, after which a change needs a new Version ID, and Version IDs must be unique per Primary Product ID across the whole Business Account.

The one-product-per-certificate rule (16 CFR 1110.13(a)) shapes both paths. A change in design, manufacturing process or location, or component, paint or material source makes a product materially different and requires a separate certificate. For apparel, CPSC’s Product Registry FAQ treats garments from the same material in multiple styles, sizes and colors as one product when they are manufactured and tested together. Certificates must be in English for eFiling and kept for five years from creation (16 CFR 1110.17).

Who certifies matters when the entry is filed. The certifier for imports is the importer of record. If a broker acts as IOR, it may name the owner, purchaser or consignee in PG19 role CE; if it files without doing so, CPSC treats the IOR as the certifier and has said it can hold such a broker responsible. That makes the customs power of attorney and the IOR arrangement part of CPC planning, particularly for a non-resident importer shipping directly to U.S. customers.

2026 Standard Updates That Can Invalidate an Existing CPC

2026 is a heavy version-update year for durable infant products. The CFR part number stays the same, but the incorporated ASTM edition changes, and a certificate citing testing to the old edition for goods made after the new effective date is the classic silent failure. The paperwork looks complete; the test basis is wrong.

Updates effective in 2026 include bassinets (February 21, 90 FR 57691), crib mattresses under 16 CFR 1241 updated to ASTM F2933-25 (May 3, 91 FR 6510), hook-on chairs (July 19, 91 FR 15536), gates and enclosures (July 19, 91 FR 16162), infant swings (July 25, 91 FR 20875), full-size cribs (August 1, 91 FR 23908) and toddler beds (August 29, 91 FR 27199). A direct final rule removing obsolete part 1500 provisions on infant bouncer seats and stationary activity centers (91 FR 45992) was withdrawn on September 17, 2026 (91 FR 58817); the mandatory standards at 16 CFR 1229 and 1238 were never affected and still apply.

Some infant products have no certificate path at all. Inclined sleepers for infants and padded crib bumpers are banned by statute (15 U.S.C. 2057d and 2057e) and are refused at entry.

The control is a date check at SKU level: for each infant or toy SKU, compare the manufacture date on the certificate with the effective date of the current edition of every cited rule, and flag any certificate whose test report predates a change that took effect before production. A trade compliance management routine run before each production season catches these before the goods ship.

Where CPC Filings Break at Entry

The following risks follow directly from the rule and CATAIR v2.5. They are phrased as risks, not statistics; CPSC has published no hold or rejection data since eFiling began on July 8, 2026.

  • PG19 role ITL declared without the 4-digit CPSC Lab ID.
  • A CPC that relies on a lab not accepted by CPSC for the cited rule.
  • ASTM F963 cited as a whole instead of by section.
  • A testing exclusion claimed without the underlying rule citation.
  • One certificate covering several materially different products, for example the same toy from two factories.
  • Manufacture date or place on the certificate not matching the factory on the commercial invoice.
  • A Reference set pointing to an archived or uncertified Version ID.
  • Children’s apparel filed under the adult apparel enforcement discretion instead of on a CPC.

What happens if the CPC is missing or wrong

ACE does not reject entries for missing CPSC data (CSMS #69382435, July 29, 2026), and CPSC has said it does not currently intend to ask CBP to deny entry solely for failure to eFile. Enforcement continues through other channels. Missing or false data raises the shipment’s risk score. Goods not accompanied by a certificate, or accompanied by a false one, can be refused admission under 15 U.S.C. 2066(a)(2) and must be destroyed unless export is approved and completed within 90 days, at the owner’s or consignee’s cost. Civil penalty maxima stand at $120,000 per violation and $17,150,000 for a related series (86 FR 68244).

A licensed customs brokerage team can check CPC data against the invoice before transmission, but the certificate content remains the importer’s responsibility. For importers who want that check built into release, our customs compliance platform keeps certificate identifiers alongside entry data.

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Frequently Asked Questions

What is a children's product certificate?

It is the certificate an importer or domestic manufacturer issues under CPSA section 14(a)(2) and 16 CFR parts 1107 and 1110 stating that a product designed or intended primarily for children 12 or younger complies with every applicable children’s product safety rule, based on testing by a CPSC-accepted third-party laboratory.

Can we use our supplier's lab report if the lab is not CPSC-accepted?

Not for a CPC. Children’s products must be tested by a CPSC-accepted third-party conformity assessment body (15 U.S.C. 2063(a)(2)), and the Full message set requires that lab’s 4-digit Lab ID. For general-use products on a GCC, any qualified lab or first-party testing is acceptable.

How often does a children's product need retesting?

At least once a year under 16 CFR 1107.21, extendable to every 2 years with a production testing plan or every 3 years with an ISO/IEC 17025 accredited lab program. A material change to design, process, factory or component source requires a new certificate regardless of the cycle.

Do we need one CPC per color and size?

Not necessarily. The rule is one product per certificate, and CPSC’s Product Registry FAQ treats apparel from the same material in several styles, sizes and colors as one product when manufactured and tested together. A different factory or material source makes it a separate product.

Is a CPC eFiled for goods made in the United States?

No. Domestic manufacturers still need certificates, but eFiling applies only to imported finished products (16 CFR 1110.9(b), 1110.13(a)(2)).

Who is liable for the CPC if our broker is importer of record?

The IOR is the certifier. A broker acting as IOR may name the owner, purchaser or consignee as the certifying entity (PG19 role CE). If it does not, CPSC treats the IOR as the certifier and has stated it can hold that broker legally responsible.

Are component test reports eFiled with the CPC?

Component part certificates are never eFiled, but every test the CPC relies on, including component tests under 16 CFR part 1109, must be recorded on the finished product certificate.

Section 338 tariffs are the least familiar trade remedy most US importers of Canadian goods now pay. Since 12:01 a.m. Eastern on August 22, 2026, three lists of Canadian products carry an additional 50% duty under 19 U.S.C. 1338, Section 338 of the Tariff Act of 1930. The lists were published in Proclamations 11046, 11047 and 11048, signed on July 20, 2026 and published on July 23 (91 FR 46639, 46653 and 46663), and CBP implemented them through CSMS #69606660.

Two later changes turned a single duty into a moving target. From September 15, 2026, Proclamations 11064 and 11065 added 122 HTS codes to the alcohol and motor vehicle lists, removed 10, and made those two lists apply on top of Section 232. From 12:01 a.m. ET on September 29, 2026, a short list of Canadian products is banned from importation. Those bans are narrower than much of the coverage suggests: they do not ban Canadian cars or all Canadian dairy. This guide sets out the legal basis, the three lists, the September 15 changes, the exact scope of the bans and how the duty stacks. For the full picture of duties on Canadian goods beyond Section 338, see our Canada tariff guide. Status as of September 23, 2026.

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The Legal Basis: 19 U.S.C. 1338 and the Three Proclamations

Section 338 is a US measure aimed at Canada. It is not a Canadian law, and it is not an extension of the IEEPA tariffs that the Supreme Court struck down in Learning Resources v. Trump on February 20, 2026. It rests on a separate statutory authority, which is one reason many trade teams did not have it in their tariff models.

The authority was exercised through three proclamations signed the same day. Proclamation 11046 covers an alcohol list, Proclamation 11047 a dairy list and Proclamation 11048 a list that the text calls a motor vehicle list. Each list maps to its own Chapter 99 heading, a fourth heading handles goods already subject to Section 232, and a fifth exempts Canadian civil aircraft. The rate on all three lists is 50% on top of the ordinary duty.

Section 338 headings for Canadian goods, as of September 23, 2026
Heading Scope Rate
9903.03.12 Alcohol list 50%
9903.03.13 Dairy list 50%
9903.03.14 Motor vehicle list, goods drawn from Chapters 4 to 97 50%
9903.03.15 Goods already under Section 232, dairy list only since September 15 0%
9903.03.16 Canadian civil aircraft, engines and parts (not unmanned aircraft) 0%

The Motor Vehicle List Is Mostly Not Vehicles

The name of heading 9903.03.14 causes more misclassification than any other part of the program. The motor vehicle list draws goods from Chapters 4 through 97 of the HTSUS. It covers Canadian furniture, cosmetics and apparel, among many other products. An importer of Canadian furniture or cosmetics who reads the heading title and moves on can underpay by 50 points.

The only reliable approach is a line-by-line screen of every Canadian-origin HTS number the company imports against all three lists. The screen has to be run on the eight-digit subheading, not a six-digit family, because the lists are drawn at the tariff line. Our HTS classification team runs these screens against the current list text rather than summaries.

What Changed on September 15: 122 Codes Added, 10 Removed, a Narrower Offset

Proclamations 11064 and 11065, signed on September 8 and effective September 15, 2026, added 122 HTS codes to the alcohol and motor vehicle lists, removed 10, and made those two lists apply on top of Section 232. CBP implemented the changes in CSMS #69851916. Any screen completed before that date is out of date, and entries filed after September 15 against an older screen can carry the wrong heading in either direction.

The more expensive change concerns the Section 232 offset. At launch, heading 9903.03.15 set the Section 338 duty at 0% for goods already under Section 232, across all three lists. Since September 15 that offset applies only to dairy-list goods. Alcohol-list and motor-vehicle-list goods that are also Section 232 articles now pay both duties. As an illustration, a vehicle-list good carrying a 25% Section 232 duty now adds 50% under Section 338 on the same entry, before the ordinary rate.

That change reaches well beyond alcohol. Any motor-vehicle-list product that is also subject to Section 232 tariffs now pays both duties. Importers who relied on the offset in August should recheck every entry filed since September 15 and confirm that both Chapter 99 headings are reported where they apply.

The September 29 Import Bans: Exactly Which Products

Proclamations 11061, 11062 and 11063, published in the Federal Register on September 14, 2026 (FR docs 2026-18835, 2026-18836 and 2026-18837), bar a short list of Canadian products imported on or after 12:01 a.m. ET on September 29, 2026. The list is specific, and precision matters because the bans are often described far more broadly than the text supports.

The Five Banned Categories

The following Canadian products imported on or after 12:01 a.m. ET on September 29, 2026 are excluded from importation:

  • Packaged beer, wine, cider and spirits
  • Whey classified under 0404.10
  • Certain molasses
  • Non-alcoholic beer under 2202.91.00
  • Motorcycles with engines over 800 cc under 8711.50.00

What the Bans Do Not Cover

The bans do not cover Canadian passenger cars or trucks, and they do not cover all Canadian dairy. Dairy-list products other than whey remain enterable at the 50% duty. Bulk alcohol is not banned and continues to enter at 50%. Motorcycles at or below the 800 cc line are outside the ban. Goods that were imported before September 29 but not yet entered pay the 50% duty rather than being refused.

What Is Not Yet Confirmed

As of September 23, 2026, we had not located the CBP CSMS message that implements the September 29 bans in ACE. Until it is published, the operational details, such as how CBP will treat goods in transit, in a bonded warehouse or in a foreign-trade zone on that date, should be treated as unconfirmed. Importers with product on the water should plan entry timing now and confirm treatment as soon as CBP issues guidance. Our overview of restricted imports explains how refused and prohibited goods are handled at the border generally.

Row of wine bottles on a retail shelf
Packaged wine, beer, cider and spirits from Canada cannot be imported from September 29, 2026. Bulk alcohol stays enterable at 50%.

Why USMCA Origin Does Not Exempt Canadian Goods From Section 338

The most common assumption we hear from Canada-integrated manufacturers is that USMCA-qualifying goods are exempt. They are not. The Section 338 proclamations contain no USMCA exemption, and a valid preference claim does not remove the 50% duty. Compare the Section 232 treatment of certain aluminum and steel articles under Proclamation 11032, where USMCA-qualifying goods pay 25% only on non-U.S. content, with a 15% floor. Section 338 has no equivalent carve-out.

USMCA still matters for the ordinary duty. A qualifying good can still claim the preferential rate on the base tariff line, so the claim is worth keeping where it is supportable. The origin analysis itself follows USMCA rules of origin, and nothing in Section 338 changes it. What changes is the total: a USMCA-qualifying good on one of the three lists pays the 50% Section 338 duty on top of whatever preferential base rate applies.

Stacking, Entry Filing and Timing

A correct Section 338 entry reports the primary HTS number, the applicable 9903.03 heading and, for goods that are also Section 232 articles, the relevant Section 232 heading. Since September 15, dairy-list goods under Section 232 use 9903.03.15 at 0%; alcohol-list and motor-vehicle-list goods report both duties. The duty is assessed on the entered value, so valuation errors compound at a 50% rate.

Timing decisions have moved from logistics to compliance. For banned products, the date that matters is importation: goods imported on or after September 29 are refused, while goods imported before that date but not yet entered can still be entered at the 50% rate. For goods that remain enterable, the decision is whether to enter now, hold in a customs bonded warehouse or re-source. Our Tariff Response Unit models those options per product line.

Canada's Counter-Surtax and US Exporters

The measure runs in both directions. Canada has applied a counter-surtax of 15%, 25% or 50% on listed US goods since September 8, 2026, under CBSA Customs Notice 26-23. US exporters selling into Canada should confirm whether their products appear on the Canadian lists and whether their Canadian customers are absorbing the surtax or passing it back through price renegotiation. Where Canadian remission is available for a product, exporters should coordinate the request with their Canadian buyers early.

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Frequently Asked Questions

What are Section 338 tariffs?

Section 338 tariffs are additional duties imposed under 19 U.S.C. 1338. On Canadian goods, Proclamations 11046, 11047 and 11048 set a 50% duty on an alcohol list, a dairy list and a so-called motor vehicle list, effective 12:01 a.m. Eastern on August 22, 2026.

Does USMCA qualification exempt Canadian goods from Section 338?

No. The proclamations contain no USMCA exemption. A qualifying good can still claim the preferential rate on the base tariff line, but it pays the 50% Section 338 duty on top.

Is Canada banned from exporting cars and dairy to the US from September 29?

No. The bans, which apply to goods imported on or after September 29, 2026, cover packaged beer, wine, cider and spirits, whey under 0404.10, certain molasses, non-alcoholic beer under 2202.91.00 and motorcycles over 800 cc under 8711.50.00. Canadian cars are not banned, and other dairy products remain enterable at the 50% duty.

What does the motor vehicle list cover?

Heading 9903.03.14 covers goods drawn from Chapters 4 through 97 of the HTSUS, including furniture, cosmetics and apparel. Screen each eight-digit HTS subheading against the list rather than relying on the heading title.

Do Section 338 duties stack with Section 232?

Since September 15, 2026, the Section 232 offset under 9903.03.15 applies only to dairy-list goods. Alcohol-list and motor-vehicle-list goods that are also Section 232 articles pay both duties.

What happens to banned goods that arrived before September 29 but were not entered?

Goods imported before September 29, 2026 but not yet entered pay the 50% duty instead of being refused. The CBP message implementing the bans had not been located as of September 23, 2026, so confirm handling of goods in transit, bonded warehouses and zones once CBP publishes guidance.

Since July 8, 2026, every finished consumer product that needs a certificate under 16 CFR part 1110 has to carry that certificate’s data into ACE at entry. The harder operational question for large importers sits on the other side of the ledger: what to transmit for the thousands of lines that share a CPSC-flagged HTS code but need no certificate at all. The answer is the CPSC disclaim, a short PGA record that tells CPSC staff why nothing else is attached.

A disclaim is optional under the final rule. CPSC chose not to require it, but it encourages filers to use one because a disclaim informs its staff why a certificate does not accompany the shipment, which reduces the possibility of a hold. This piece covers only the disclaim mechanism: the two codes, the intended use codes that must travel with them, how a disclaim differs from a testing exclusion, and where a disclaim is the wrong filing. For the full regulatory picture, start with our CPSC compliance guide.

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What a Disclaim Line Contains in the CPSC PGA Message Set

CPSC accepts three ways to report a flagged line: the Full PGA Message Set with every certificate data element, the Reference PGA Message Set pointing to a certificate held in the Product Registry, and the Disclaim message. The disclaim is by far the lightest. Per the CBP implementation guide (CATAIR v2.5, June 22, 2026), it consists of an OI record plus a PG01 record with the disclaimer code in position 80 and a mandatory intended use code. There is no certifier, no lab, no manufacture date and no citation block.

Methods can be mixed within one entry, so a single invoice with coin-cell remotes, adult knit hats and adult polyester jackets can carry a Reference set on one line and disclaims on the others. The constraint that matters for data mapping is that CATAIR allows only one OI record per HTS code, so the broker’s software has to resolve the method line by line, not entry by entry.

The disclaim is also the CPSC filing a licensed customs brokerage team is best placed to prepare with the importer. Full and Reference filings depend on data the certifier owns. A disclaim depends on a correct reading of whether any certificate rule applies, which is a classification and scope judgment. Our CPSC eFiling service builds that disclaim logic line by line alongside Full and Reference filings.

Disclaim A vs Disclaim B

The two codes are not interchangeable, and the choice fixes which intended use codes are valid. Disclaim A states that the product is not regulated by this agency. Disclaim B states that data is not required per agency guidance, which in practice means CPSC has announced enforcement discretion for that product.

Disclaim A covers four situations. First, the product is within CPSC jurisdiction but no rule requiring a certificate applies: CPSC’s own examples include hats and gloves, collectible toys intended for adults, and sport helmets other than bicycle helmets. Second, the product is outside CPSC jurisdiction, such as medical products that resemble general-use products or non-consumer industrial equipment. Third, component parts imported for further manufacturing in the United States. Fourth, upholstered furniture where 16 CFR 1640 is the only applicable rule, because 1640 requires a label, not a certificate. Personal-use products returned after repair and consumer-to-consumer gifts also fall under Disclaim A.

Disclaim B is narrow. It applies to adult wearing apparel made only of fabrics exempt under 16 CFR 1610.1(d)(1) or (d)(2), and to household refrigerators that bear an appropriate safety certification mark under 16 CFR 1750. The apparel discretion dates to 81 FR 12587 (March 10, 2016); the refrigerator discretion to 84 FR 37767.

Disclaim A and Disclaim B compared (CATAIR v2.5; CPSC Citation, Testing Exclusion and Disclaim Guidance v3, Feb. 27, 2026)
Disclaim A Disclaim B
Meaning Product is not regulated by this agency Data is not required per agency guidance
Legal basis No certificate rule applies, or product outside CPSC jurisdiction CPSC enforcement discretion
Typical lines Adult hats and gloves, adult collectible toys, non-bicycle sport helmets, component parts, 1640-only upholstered furniture, gifts Adult apparel of 1610.1(d) exempt fabrics; certified-mark refrigerators
Intended use code Guidance list: 081.XXX, 090.XXX, 100.XXX, 130.XXX except 130.001-005, 155.XXX, 940.XXX, 970.XXX, 980.000 with description; other codes may be used 130.006 only
Children's products Only if no children's rule applies Never

Intended Use Codes That Must Travel With Each Disclaim

A disclaim without an intended use code is incomplete. For Disclaim A, CATAIR v2.5 lists as guidance codes in the 081, 090, 100, 130 (except 130.001 through 130.005), 155, 940 and 970 families, plus 980.000 with a free-text description; other intended use codes may be used. The code tells CPSC what the goods are for, and that context is what lets a targeter accept a claim that no certificate applies.

For Disclaim B the rule is absolute: intended use code 130.006 is mandatory and no other code is allowed. A Disclaim B filed with any other code is on the list of rejection and hold risks derived from the rule and CATAIR, and it is an easy error to automate away because the pairing never varies.

Operationally, intended use codes belong in the product master, not in the broker’s head. For an importer with a large catalog, the cleanest setup is one field per SKU holding the CPSC method (Full, Reference, Disclaim A, Disclaim B) and, for disclaims, the intended use code. The broker’s software then reads the field at entry. A trade compliance management program that already keeps HTS and origin at SKU level can carry these two extra attributes without a new system.

Testing Exclusion vs Disclaim: Two Different Filings

The most expensive confusion in this area is treating a testing exclusion as if it were a disclaim. They answer different questions. A disclaim says no certificate is required for this line. A testing exclusion says a certificate is required, and for one specific rule on that certificate the product relies on a statutory or regulatory exemption or determination instead of test results.

Testing exclusions are mandatory when relied on. They are filed inside a Full message set with PG19 entity role NOL (no lab testing) and a PG60 exclusion code, and the underlying rule still has to be cited. Examples from CPSC’s code workbook: a children’s garment made of a fabric exempt under 1610.1(d)(1) is certified on a Children’s Product Certificate that lists 1610 with the exemption as an exclusion code; unfinished and untreated wood relies on the determination at 16 CFR 1251.2; textiles rely on the lead determination at 1500.91(d)(7); one-of-a-kind rugs rely on 1630.2(b) or 1631.2(b).

The rug case shows the trap clearly. An antique or hide rug sounds like something exempt from the flammability standard, so the instinct is to disclaim it. It is not exempt from certification: the one-of-a-kind status is a testing exclusion, and a certificate is still required. The same logic applies to children’s apparel made of exempt fabric, where the 2016 discretion does not extend to children’s products at all.

A related error runs in reverse: citing an exclusion code without the rule it excludes. A testing exclusion claimed without the underlying rule citation is one of the predictable failure points that follow from the rule and CATAIR. The certificate has to list the rule, then attach the exclusion to it.

When Not to Disclaim

A disclaim is a statement to a federal agency, and the attestation behind CPSC filings makes clear that knowingly false statements are a federal crime. Disclaiming a line that needs a certificate does not remove the certificate requirement. Goods not accompanied by a required certificate can be refused admission under 15 U.S.C. 2066(a)(2), and failure to furnish a certificate is a prohibited act under 15 U.S.C. 2068(a)(6), with civil penalty maxima currently at $120,000 per violation and $17,150,000 for a related series (86 FR 68244).

These are the lines that most often get disclaimed when they should not be:

  • Children’s apparel of any fabric. Disclaim B covers adult apparel only; children’s garments always need a CPC, with the 1610.1(d) exemption entered as a testing exclusion code.
  • Adult apparel containing any non-exempt fabric, such as lightweight silk under 2.6 oz per square yard, raised-surface cotton or rayon, or blends with fibers outside the 1610.1(d)(2) list. These need a General Certificate of Conformity citing 1610.
  • Upholstered furniture with painted parts or intended for children. 1640 alone supports Disclaim A; lead paint under 16 CFR 1303 or a children’s furniture rule brings back a certificate.
  • Consumer electronics that contain button or coin cells. These need a certificate to 16 CFR 1263 under Reese’s Law. Units under the same HTS code that contain no such cells are the ones eligible for Disclaim A.
  • Candles with metal-cored wicks, which must meet the 0.06 percent lead limit in 16 CFR 1500.17(a)(13) and need a GCC citing it, while most other candles and home decor need no certificate.
  • Toys marketed as adult collectibles where the age grading is doubtful. Disclaim A is available for collectibles intended for adults, but the age determination is the importer’s burden.

How a Disclaim Interacts With 1USG Review and Risk Scoring

CPSC runs its import screening through CBP’s 1USG messaging. Lines under CPSC-interest HTS codes return an Under Review status while CPSC evaluates them. The CPSC clock is 4 business hours for air and truck (8 with added risk factors) and 8 business hours for ocean (16 with added risk factors), counted 8am to 4pm port time on federal workdays. If CPSC takes no action, a May Proceed issues automatically. A May Proceed can still be followed by a CPSC exam at the importer’s premises.

ACE does not reject entries for missing CPSC data. CSMS #69382435 (July 29, 2026), which superseded the July 8 message, instructs software developers to let filers submit even when CPSC flagging requirements are not met, and states that CBP will not reject such entries. CPSC may still respond with an SO message reviewing or potentially rejecting the submitted data, and it may take enforcement action on any entry that lacks required eFiling data.

That is where the disclaim earns its place. CPSC’s rulemaking says missing or false data raises the risk score and the likelihood of an exam hold, while consistent filers will benefit from lowered risk scores. A flagged line that goes in with no CPSC record at all gives the targeter nothing to work with. The same line with a correct Disclaim A and intended use code explains itself. Hair dryers, holiday lights and power or extension cords illustrate the point: they are substantial product hazard items under 16 CFR 1120.3 with no certifiable rule, yet they appear on the June 2026 1USG list, so a disclaim reduces friction on goods that will otherwise draw review.

Status of any held entry can be checked in the CPSC Import Shipment Tracking Tool using the entry number with filer code, but those statuses are not official releases; the ABI message remains the record.

Building a Disclaim Rule Set for Mixed HTS Lines

CPSC’s September 2026 guidance lists about 600 HTS codes and states explicitly that the list does not cover every code where a certificate may be required. Many of those codes mix regulated and unregulated goods. Adult clothing chapters 61 and 62 are the obvious example; electronics headings that include both coin-cell and cell-free products are another. The decision cannot be made at HTS level alone.

A workable rule set has three layers. The first is scope: for each SKU, which CPSC rules apply, if any, based on product type and intended user. The second is method: certificate required (Full or Reference), Disclaim A with a specified intended use code, Disclaim B with 130.006, or no filing where the line is not flagged. The third is evidence: for every disclaimed SKU, a short record of why no certificate applies, such as the fiber content that places an adult garment inside 1610.1(d), or the product specification that confirms no button or coin cell.

Classification drives the first layer, so disclaim logic breaks whenever the tariff number moves. When a SKU is reclassified under the Harmonized Tariff Schedule, its CPSC method should be re-reviewed at the same time. Fiber content matters twice for apparel: once for the duty rate discussed in our note on apparel and footwear duties, and again for whether Disclaim B is available.

One area is not settled. How CPSC expects children’s drawstring garments, a 15(j) item with no citation code in the December 2025 code list, to be filed has not been confirmed, and it should be confirmed with eFilingSupport@cpsc.gov before a workflow is built around it. Scarves are a Disclaim A example in CPSC’s disclaim guidance, yet adult clothing including scarves is on the 1USG review list, so those lines will still show Under Review.

Timing also varies by entry type. Goods entered for consumption or warehousing from a foreign-trade zone become subject to eFiling on January 8, 2027, so importers running zone inventory should build the SKU method field now and apply it to zone withdrawals from that date. Our customs compliance platform holds SKU-level attributes alongside entry data, which is where this kind of rule set belongs.

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Disclaim decisions belong in the SKU master so the broker's software can apply them line by line.
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Frequently Asked Questions

Is a CPSC disclaim mandatory?

No. The final rule at 90 FR 1800 does not require disclaims. CPSC encourages them because they explain why a certificate does not accompany the shipment and can reduce the possibility of a hold. Lines that need a certificate cannot be disclaimed.

What is the difference between Disclaim A and Disclaim B?

Disclaim A means the product is not regulated by CPSC for certificate purposes: no certificate rule applies, the product is outside CPSC jurisdiction, it is a component part for further U.S. manufacturing, or it is upholstered furniture where 16 CFR 1640 is the only rule. Disclaim B means data is not required per agency guidance, covering adult apparel of fabrics exempt under 16 CFR 1610.1(d) and refrigerators bearing a safety certification mark.

Which intended use code goes with Disclaim B?

Only 130.006. CATAIR v2.5 makes it mandatory and allows no other code. Disclaim A takes an intended use code; CATAIR’s guidance list covers the 081, 090, 100, 130 (except 130.001-005), 155, 940 and 970 families and 980.000 with a description, and other codes may be used.

Can we use Disclaim B for children's clothing made of polyester?

No. CPSC’s 2016 enforcement discretion covers adult apparel only. Children’s garments need a Children’s Product Certificate listing 16 CFR 1610, with the 1610.1(d) exemption entered as a testing exclusion code.

Is a testing exclusion the same as a disclaim?

No. A testing exclusion sits inside a certificate that is required, and replaces test data for one specific rule. It is filed with PG19 role NOL and a PG60 exclusion code, and the underlying rule must still be cited. A disclaim states that no certificate is needed for the line.

Will ACE reject our entry if we neither file a certificate nor disclaim?

No. CSMS #69382435 confirms CBP will not reject such entries. CPSC may still respond with an SO message, place a hold, request an exam, or pursue refusal of admission and penalties where a certificate was required.

Can one entry mix disclaims and certificate filings?

Yes. Full, Reference and Disclaim methods can be mixed within one entry. CATAIR allows only one OI record per HTS code, so the method has to be resolved line by line.

A 510(k) exemption is the most misread status in device importing. It removes one requirement, the premarket notification under 21 CFR 807 subpart E, and leaves every other control in place. The foreign plant still has to be registered, the device still has to be listed, the carton still has to meet part 801 labeling, and the entry still has to carry three mandatory FDA Affirmation of Compliance codes. Importers who treat a 510k exempt product as a line with no FDA paperwork find out at the port, when the entry fails automated screening and goes to manual review.

This guide covers what the exemption removes and what it keeps, the limitations that quietly cancel it, how exempt status is transmitted in ACE, the rule behind each common hold on exempt lines, and the changes of the past year that affect them. Facts are taken from the eCFR, FDA’s March 2026 ACE Quick Reference Guide and FDA’s classification database as of September 2026.

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What 510(k) Exemption Removes and What It Keeps

Exemption is decided device type by device type, in the classification regulation for that generic type. The elastic bandage regulation at 21 CFR 880.5075 is typical: Class I, general controls, exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 880.9. That sentence is the whole exemption. It says nothing about registration, listing, labeling or adverse event reporting, and none of those are waived.

Class is not a shortcut. FDA states that approximately 572, or 74%, of Class I device types are exempt from 510(k), which leaves roughly a quarter that are not. The non-powdered surgeon’s glove at 21 CFR 878.4460 is Class I and carries no exemption language, so it needs a cleared 510(k). The reverse also happens. Surgical N95 respirators under 878.4040(b)(1) are Class II and exempt only if they are NIOSH-approved, biocompatibility is shown, and flammability and fluid resistance are characterized. They lose the exemption if they claim antimicrobial, antiviral or smoke filtration performance.

For the importer of record, the operative rule is 21 CFR 807.40(c): no device may be imported or offered for import unless it is listed and manufactured at a registered foreign establishment. The US side carries its own duties. An initial importer registers its own establishment and meets its listing obligation by identifying the foreign manufacturers under 21 CFR 807.20(a)(5), rather than listing devices, unless it also relabels or repacks. Those role duties are covered on our FDA initial importer page; the table below covers what attaches to the exempt device itself.

Controls that still apply to a 510(k)-exempt device
Requirement Still applies? Rule
Foreign establishment registration (manufacturer and exporter) Yes 21 CFR 807.40(c)
Device listing Yes, reviewed every year from 1 October to 31 December 21 CFR 807.40(c), 807.22(b)(3)
US Agent for the foreign establishment Yes, one agent, changes reported within 10 business days 21 CFR 807.40(b)
Labeling and misbranding rules Yes 21 CFR 801
UDI Usually, except Class I devices exempted by regulation from part 820 GMP 21 CFR 801.30(a)(2)
Quality system (QMSR) Yes, unless the classification regulation exempts it; 820.35 records often remain 21 CFR 820
MDR and corrections and removals Yes, no 510(k)-based exemption 21 CFR 803, 806

Limitations of Exemption Under 21 CFR 8xx.9

Every classification part from 862 to 892 contains a .9 section, and every exemption in that part is conditional on it. 21 CFR 880.9 is representative. The exemption holds only for a device that has the existing or reasonably foreseeable characteristics of commercially distributed devices within its generic type. Step outside that and a 510(k) is required, even though the product code still reads exempt in FDA’s database. The limitations of exemption fall into three groups:

The test runs against the carton, not the catalog

What decides the limitation is the product description, the labeling and the claims printed on the goods that actually ship. 21 CFR 880.5240 covers medical adhesive tape and adhesive bandages without a disinfectant. An adhesive bandage whose pad carries an antimicrobial sits outside that generic type and outside the exemption, and it may be regulated as a drug-device combination product. The same pattern catches private-label programs where the US brand adds a claim the original product never made.

Private label has one narrow relief. Under 21 CFR 807.85(b), a distributor or repackager that only adds its own name and changes nothing else is exempt from premarket notification when another person has already filed a 510(k) for the device. That relief applies where another firm filed the 510(k) or the device was marketed before 28 May 1976, and it does not touch the registration and listing checks at entry. A brand owner that writes the specifications for a contract-made device is a specification developer, which registers, lists and falls under the quality system rules in its own right.

  • Different intended use, 8xx.9(a): a new medical purpose, or a change from professional use to lay use, such as a clinic product repackaged and marketed to consumers.
  • Different fundamental scientific technology, 8xx.9(b): for example, a device that cuts with a laser where the generic type uses a blade.
  • High-risk in vitro diagnostic uses, 8xx.9(c): IVDs intended for cancer, genetic disorders, surrogate markers for HIV, hepatitis, tuberculosis or myocardial infarction, cardiovascular risk, diabetes management, direct identification of microorganisms, certain antibody assays, noninvasive testing or point-of-care use.
Warehouse worker wearing mask and gloves unloading cartons of medical supplies from a van
The exemption limits are tested against the labeling and claims on the cartons that actually ship.

How Exempt Status Is Declared at Entry

FDA data for a device line travel with the customs entry through ACE as the FDA PGA message set, and exempt status is expressed by what the filer transmits and what it leaves out. FDA’s Industry Quick Reference Guide to the ACE Supplemental Guide, dated 10 March 2026, sets the codes for a foreign-manufactured finished device under Intended Use Code 081.001, and for a foreign-made device imported to be refurbished in the United States under 081.002 (an already refurbished device stays under 081.001).

What the missing PM# tells FDA

FDA’s wording on PM# is that if the product requires premarket clearance, such as a 510(k), the premarket number must be provided. For an exempt device no PM# is sent, and that absence is how the entry says exempt. DEV, DFE and LST stay mandatory. Kits of foreign-made finished devices go under Intended Use Code 081.004, where DEV, DFE, KIT and LST are all mandatory. FDA also states that declaring a code not on its list results in an entry rejection.

The FDA product code on the line has to match the product code on the listing. Device product codes sit in industry codes 73 to 92, and a mismatch between the entry and the listing is one of the fastest ways to lose an automated release. The HTSUS number and the FDA product code are chosen under different rules, and both need to be right, so an HTS classification review on device lines should check the two side by side.

Numbers the broker needs before the goods ship

Section 801(o) of the FD&C Act gives the requirement its edge: if the device registration information is not submitted at entry, the article may be refused admission and held at the port. The foreign manufacturer already has to identify each known importer and each person who imports or offers devices for import, brokers included, under 21 CFR 807.41. A customs brokerage setup for devices therefore starts with the supplier’s registration and listing data rather than the commercial invoice.

Three FDA databases settle the question before filing. The Product Classification Database shows class, regulation number, and 510(k) and GMP exempt status for each product code. FDA’s list of Class I and Class II exemptions gives the same answer by device type, and FDA itself tells users to confirm exempt status and limitations against 21 CFR parts 862 to 892. The Registration and Listing database confirms that the foreign establishment and the listing are active.

Affirmation of Compliance codes for a finished device, IUC 081.001 (FDA Quick Reference Guide, March 2026)
Code Meaning Status
DEV Foreign manufacturer registration number Mandatory
DFE Foreign exporter registration number Mandatory
LST Device listing number Mandatory
PM# Premarket number (510(k), PMA, De Novo and others) Conditional, not sent for exempt devices
IRC Impact-resistant lens certification Conditional
LWC Electrode lead wire and patient cable compliance Conditional
DI Device Identifier from the UDI Optional

Why Exempt Devices Still Get Held

Exempt status removes a document; it does not lower the screening. FDA says entries transmitted with complete, accurate and valid data may receive a lower risk score and a May Proceed release. Anything else goes to manual review, which since 4 August 2025 has been handled centrally by the FDA ImportShield Program rather than port by port. The holds seen on exempt lines trace back to a short list of rules:

Preventable from the desk

Almost every one of these holds can be caught with data the importer can check before booking: registration status, listing product code, the three mandatory codes, the sterile flag and the carton claims. What happens once a Notice of FDA Action issues is a separate process. Device admissibility sits alongside the other agency controls covered in our guide to prohibited and restricted imports, and the same rule holds across all of them: the problem is cheaper to fix in the supplier file than at the terminal.

  • Inactive registration: the foreign establishment missed the annual 1 October to 31 December update or did not pay the establishment fee, and shows as failed to register under 807.22(c).
  • Missing or mismatched listing: the device is not listed, or is listed under a product code that differs from the entry line (807.40(c)).
  • Missing or wrong codes: DEV, DFE or LST was not transmitted, or the numbers do not match FDA records.
  • Outside the generic type: a new claim, lay use, a different technology or a .9(c) IVD use means the exemption never applied.
  • Sterile versions: the tongue depressor (880.6230) and absorbent tipped applicator (880.6025) are GMP exempt only when not labeled or otherwise represented as sterile. A sterile version booked as exempt breaks that condition.
  • Labeling under part 801: no English labeling, no name and place of business, or no adequate directions for use.
  • Import Alerts: a firm or product on an Import Alert is subject to detention without physical examination whatever its exempt status. Import Alert 89-08 covers devices without a required 510(k) or PMA, and 99-34 covers firms without valid registration or listing.
  • UDI gaps: a device that requires a UDI and lacks one, or lacks a matching GUDID record, falls under Import Alert 99-49.
Gloved inspector checking cartons of medical devices against shipping documents on a clipboard
Most holds on exempt devices come from registration, listing or code data that can be verified before booking.

What Changed in 2026 for Exempt Device Imports

The most material change for exempt lines sits inside the classification regulations rather than in the exemption itself. A technical amendments rule published on 4 December 2025 (90 FR 55978, FR Doc. 2025-21955), effective 2 February 2026, rewrote the GMP exemption wording across the classification parts to cite the Quality Management System Regulation. Devices that keep a recordkeeping duty now point to records and complaint files under 820.35.

The Quality Management System Regulation took effect on 2 February 2026. It rebuilt part 820 around ISO 13485:2016 and retired the old section numbers, including 820.198 for complaint files. The GMP exemptions did not become broader in the process. The elastic bandage remains GMP exempt except for 820.35, the adhesive bandage under 880.5240 has no GMP exemption, and the sterile condition on the tongue depressor and swab still applies, so a supplier quality file remains part of an exempt device program.

UDI enforcement reached the border. Import Alert 99-49, published 22 June 2026, provides for detention without physical examination of devices without a UDI or a matching GUDID record. Under 801.30(a)(2) the main relief is for Class I devices that FDA has exempted by regulation from part 820 GMP, so 510(k) exemption alone does not excuse a missing UDI. ACE carries the device identifier as the DI code, which is optional for Intended Use Code 081.001.

FDA’s entry review also changed platforms. The March 2026 Quick Reference Guide is now the current source for which codes are mandatory by commodity, and SERIO+, which brings PREDICT screening and FDA’s internal review tools into one system, was planned by FDA for full implementation in March 2026.

Registration renewal costs more. The annual device establishment registration fee for FY2027, covering payments from 1 October 2026 to 30 September 2027, is $13,785 under the notice published on 30 July 2026. The renewal window opens with that fee, and a foreign supplier that lets registration lapse drops to failed-to-register status, which stops its exempt devices at entry as surely as it stops cleared ones.

A Pre-Shipment Check for Exempt Device Lines

Run these checks per product code and per supplier, before the purchase order ships:

Exemption is not a duty status

Premarket exemption has no bearing on what the goods pay at entry. A 510(k)-exempt device from China or the EU still pays whatever chapter 99 duties apply, including the Section 301 forced labor tariffs, which carry no blanket device exemption.

The checks above only hold up if they are written down and repeated every renewal cycle. Folding them into a documented trade compliance management program keeps exempt device imports from depending on one person remembering the October window or the sterile flag on a single SKU.

  • Confirm exemption by product code in the Product Classification Database, then read the .9 section of that CFR part against the actual labeling and claims.
  • Check whether the device is sterile and whether its GMP exemption survives sterility.
  • Verify that the foreign manufacturer’s and exporter’s registrations are active for the current fiscal year, and that the listing uses the same product code as the entry line.
  • Collect DEV, DFE and LST numbers before departure, and decide whether the line is a kit under 081.004.
  • Confirm UDI and GUDID status unless the device is a Class I type exempted from part 820.
  • Screen the firm and the product against current device Import Alerts.
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Frequently Asked Questions

Does a 510k exempt device need FDA registration to import?

Yes. The foreign manufacturer must be registered and the device listed under 21 CFR 807.40(c), and DEV, DFE and LST are mandatory Affirmation of Compliance codes at entry for a finished device under Intended Use Code 081.001. The exemption removes only the premarket notification.

Is a PM# transmitted for a 510(k)-exempt device?

No. PM# is conditional and is required only when the device needs premarket clearance or approval, such as a 510(k) or PMA. For an exempt device the filer sends DEV, DFE and LST and omits PM#.

Is every Class I device 510(k) exempt?

No. FDA states that approximately 74% of Class I device types are exempt. The non-powdered surgeon’s glove under 21 CFR 878.4460 is Class I and needs a 510(k). Confirm by product code in the Product Classification Database, then check the .9 limitations for that CFR part.

What cancels a 510(k) exemption?

The limitations in the .9 section of each classification part: a different intended use, including a move from professional to lay use, a different fundamental scientific technology, or, for IVDs, one of the listed high-risk uses. A new claim on the label, such as an antimicrobial pad on an adhesive bandage, can take the product outside its generic type.

Does a 510(k)-exempt device need a UDI?

Usually. Under 21 CFR 801.30(a)(2) the main exception is for Class I devices FDA has exempted by regulation from part 820 GMP. Devices without a required UDI or a matching GUDID record fall under Import Alert 99-49, published 22 June 2026.

Do MDR and recall reporting rules apply to exempt devices?

Yes. Parts 803 and 806 have no exemption tied to 510(k) status. An importer reports deaths and serious injuries within 30 calendar days of becoming aware, and reports corrections and removals initiated to reduce a risk to health within 10 working days.

Does FDA prior notice apply to medical devices?

No. Prior notice under 21 CFR part 1 subpart I covers food for humans and animals only. Device entries are screened through the registration, listing and Affirmation of Compliance data transmitted in ACE.

A container of room air conditioners can clear every tariff and classification check and still be refused admission, because nobody on the U.S. side certified the models to the Department of Energy before they were distributed. The DOE energy efficiency import rule sits in 19 CFR 12.50: CBP will refuse admission to any covered product or equipment found noncompliant with a DOE energy conservation standard or an FTC energy labeling standard. The part most importers get wrong is who owes the certification. Under the Energy Policy and Conservation Act, to manufacture includes to import, so the U.S. importer carries the manufacturer’s obligations, not the factory in Guangdong or Monterrey.

This guide is written for appliance, HVAC, motor, lighting and transformer importers. It covers what 19 CFR 12.50 authorizes at the border, how the certification duty lands on the importer, what a CCMS report must contain, how conditional release and redelivery work under the bond, and the errors that most often turn a routine entry into a refusal.

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What 19 CFR 12.50 Authorizes CBP to Do

19 CFR 12.50 defines a covered import as a consumer product or industrial equipment that DOE classifies as covered by an energy conservation standard, or that the FTC classifies as covered by an energy labeling standard, under the Energy Policy and Conservation Act (42 U.S.C. 6291 to 6317), and for which an entry for consumption has been filed. The definition expressly includes goods withdrawn from a bonded warehouse for consumption and foreign merchandise entered for consumption from a foreign trade zone, so warehousing a shipment does not move it outside the rule.

The operative sentence is short: CBP will refuse admission into the customs territory of the United States to any covered import found noncompliant with applicable energy conservation or energy labeling standards. Refusal can follow a written or electronic notice from DOE or the FTC that identifies the importer and describes the merchandise. It can also start at CBP. The regulation states that CBP may make a noncompliance finding without having received a prior notice from DOE or the FTC, and will then confer with the relevant agency on disposition.

DOE’s own rule mirrors this from the other side. 10 CFR 429.5 states that any person importing a covered product or covered equipment must comply with parts 429, 430 and 431 and is subject to their remedies, and that covered goods offered for importation in violation of those parts shall be refused admission under CBP rules. Energy efficiency is therefore an admissibility requirement in the same family as the other restricted imports that partner government agencies police at entry, not a post-sale marketing question.

Why the Importer Is the Manufacturer Under DOE Rules

The definitions in 10 CFR 430.2 (consumer products) and 10 CFR 431.2 (commercial and industrial equipment) both say that manufacture means to manufacture, produce, assemble, or import. A manufacturer is any person who manufactures a covered product. The chain is direct: the company that imports is, for EPCA purposes, the manufacturer of what it imports.

DOE’s General Counsel states it in plain terms in its importer Q&As: under EPCA, an importer is a manufacturer, and the importer is responsible for ensuring the products are certified before importing them into the United States. That responsibility does not transfer because the overseas factory has a relationship with DOE. According to the same guidance, if the original equipment manufacturer submitted a certification report, the importer may still face penalties unless it authorized that submitter to file on its behalf and the submitter identified the importer on the report.

Private labelers add a second layer. 10 CFR 430.2 defines a private labeler as the owner of a brand or trademark on a product made by someone else, where the brand owner authorized the labeling and the manufacturer’s own brand does not appear. The certification report must list the private labeler’s name and address alongside the manufacturer’s. A retailer importing house-brand dehumidifiers is typically both importer and private labeler, and both roles show up in the filing.

The analysis is the same for a foreign seller acting as non-resident importer of record: it owns the certification, the test data and the penalty exposure.

Covered Products and the Annual Certification Calendar

10 CFR 429.12(a) requires each manufacturer, before distributing in commerce any basic model of a covered product or covered equipment subject to a standard, to submit a certification report showing the basic model meets the standard, and to recertify annually by a fixed date per product category. A basic model groups units of one type, made by one manufacturer, with the same primary energy source and essentially identical characteristics that affect energy or water use.

The annual dates matter for import planning because missing a category’s annual filing is itself a failure to certify under 10 CFR 429.102(a)(1), even for a model certified the year before. The calendar below is taken from Table 1 to paragraph (d) of 10 CFR 429.12 and shows the categories most often imported.

New models, re-rated models and discontinued models

Annual filing does not cover a new basic model. Under 10 CFR 429.12(e), any new basic model must be certified before distribution in commerce. A modification that increases energy or water consumption, or lowers efficiency enough to require a re-rating, must be certified as a new basic model. When a model is discontinued, the manufacturer reports that status in the next annual report, and 10 CFR 429.71 requires the records to be kept for two years after DOE is notified of the discontinuance.

Annual DOE certification deadlines, 10 CFR 429.12(d), selected categories
Deadline Product and equipment categories
February 1 Portable air conditioners
March 1 Fluorescent lamp ballasts, compact fluorescent lamps, general service fluorescent and incandescent lamps, incandescent reflector lamps, ceiling fans and light kits, showerheads, faucets, water closets, urinals
May 1 Water heaters, consumer furnaces, pool heaters, commercial water heating equipment and packaged boilers, commercial warm air furnaces, furnace fans
June 1 Dishwashers, commercial pre-rinse spray valves, exit signs, traffic signal modules, distribution transformers
July 1 Room air conditioners, central air conditioners and heat pumps, commercial HVAC equipment
August 1 Refrigerators, refrigerator-freezers and freezers, commercial refrigeration, automatic commercial ice makers, walk-in coolers and freezers
September 1 Dehumidifiers, metal halide lamp ballasts and fixtures, external power supplies, pumps, battery chargers
October 1 Residential clothes washers and dryers, direct heating equipment, cooking products, commercial clothes washers

What a CCMS Certification Report Must Contain

Reports go to DOE electronically through the Compliance Certification Management System (CCMS) using DOE’s product-specific templates, and 10 CFR 429.12(h) requires a registration form signed by a company officer before a manufacturer or third party submitter can access the system. The content is fixed by 10 CFR 429.12(b). For each basic model the report lists the product type and class, the manufacturer’s name and address, any private labeler, the brand, the basic model number and every individual model number under it, the filing type (new, discontinued, correction or carryover), the test sample size or the alternative method used, and any waiver or exception relief.

One line ties the filing directly to customs data. Paragraph (b)(9) requires the certifying party’s CBP importer identification number assigned under 19 CFR 24.5, where applicable. The importer number on the certification and the importer of record on the entry should match. When they do not, the file shows a certifier that is not the party bringing the goods in, which is the exact gap DOE’s importer guidance warns about.

The compliance statement is signed by a company official and certifies that the basic model meets the standard, that testing followed the DOE test procedures in parts 429, 430 and 431, that the report is true and complete, and that the manufacturer is aware of the penalties under the Act and 18 U.S.C. 1001 for false statements. That signature puts the importer’s name behind test data the importer usually did not generate, so the importer needs the underlying test reports on file before anyone signs.

Using the factory or a lab as third party submitter

10 CFR 429.12(g) allows a manufacturer to use a third party submitter, such as a trade association, an independent test lab or a private labeler, but the manufacturer remains responsible for the submission. Each manufacturer using a third party submitter must have an authorization form on file with DOE naming that submitter. For an importer relying on its supplier’s filing, that authorization form is the document that converts the factory’s report into the importer’s certification.

Conditional Release, the Bond and Redelivery

Refusal is not the only outcome. Under 19 CFR 12.50(d), CBP may, on a written or electronic recommendation from DOE or the FTC, release a noncompliant covered import to the importer of record for reconditioning, re-labeling or other modification instead of refusing it outright. The release is conditional, the goods fall under DOE or FTC jurisdiction while they are brought into compliance, and the release is subject to the basic importation bond conditions in 19 CFR 113.62.

The conditional release period ends at the earliest of three events: CBP issues a notice of refusal of admission, DOE or the FTC notifies CBP that the goods are compliant and may proceed, or 30 days pass from release. The importer may ask DOE or the FTC for an extension within the initial 30 days or within any authorized extension, and CBP may grant it on the agency’s recommendation.

If DOE or the FTC reports that the goods were not brought into compliance in time, CBP issues a refusal of admission and demands redelivery of the merchandise to CBP custody. Failure to redeliver results in liquidated damages equal to three times the value of the covered product, with value determined under 19 U.S.C. 1401a, the same basis used for customs value on the entry. On a container of commercial HVAC equipment, a missed redelivery can cost more than the goods.

This is why the bond matters on energy-regulated freight. Whether the importer runs a single or continuous bond, the 113.62 redelivery condition is what backs a conditional release, and a surety will look hard at an importer with repeated refusals.

Two warehouse managers in hard hats reviewing paperwork between racks of imported goods
Conditionally released goods stay under DOE or FTC jurisdiction until the agency confirms compliance or CBP demands redelivery.

Penalties Beyond the Border

Admissibility is one exposure. DOE enforcement is the other. 10 CFR 429.102 lists prohibited acts, including failure to certify under 10 CFR 429.12, failure to test under DOE procedures, distributing a noncompliant product, distributing a basic model after a notice of noncompliance, and knowingly certifying a rating not supported by test data. DOE may respond with a notice of noncompliance determination, additional certification testing, injunctive relief or civil penalties for knowing violations.

10 CFR 429.120 sets the maximum civil penalty for knowing violations at $575 per violation in the current eCFR text. The unit of count is what makes it expensive. For failure to certify, each unit distributed in violation is a separate violation. For failures to keep or produce records, each day of noncompliance counts separately for each basic model. An importer that knowingly brought in 10,000 uncertified units faces the per-unit arithmetic, not a single fine.

Common Errors That Stop Covered Imports

  • Relying on the factory’s CCMS listing without an authorization form on file with DOE naming the factory as third party submitter, and without the importer identified on the report.
  • Certifying the basic model but omitting individual model numbers that appear on the commercial invoice or the nameplate, so the shipped model cannot be matched to a certified one.
  • Importing a new or re-rated model on the strength of last year’s certification, when 10 CFR 429.12(e) requires certification before distribution.
  • Missing the annual recertification date for the product category, then shipping in the gap.
  • Holding no copy of the test data. 10 CFR 429.71 places the recordkeeping duty on the manufacturer, which for imports means the importer.
  • Leaving the CBP importer number off the report or filing under an entity that is not the importer of record on the entry.
  • Treating FTC EnergyGuide labeling as optional because the DOE certification is in place, when 19 CFR 12.50 applies to noncompliance with either standard.

Building DOE Checks Into the Entry Workflow

The practical fix is to treat DOE certification like any other partner agency requirement and verify it before the goods sail, not after a hold. For each new SKU in a covered category, the importer’s compliance file should hold the basic model and individual model numbers, the CCMS confirmation, the authorization form if a third party filed, the test report or AEDM basis, and the category’s annual deadline. The same discipline applies to the agency permits and licenses that other product lines need.

Classification is the natural trigger. When a new HTS number in chapters 84 or 85 is assigned to an appliance, motor, lamp, pump or transformer, the broker should ask whether the item is a DOE covered product before the first entry. A customs brokerage team that sees the commercial invoice before arrival can catch a model number that does not match the certification while the goods are still on the water.

Large importers with hundreds of covered models usually need this inside a broader trade compliance management program, where DOE status sits alongside tariff, origin and other agency data for each SKU. The review cost is small next to a refusal, a 30-day conditional release clock, or per-unit penalty exposure under 10 CFR 429.120.

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Frequently Asked Questions

Does my foreign factory's DOE certification cover my imports?

Only if you authorized it. DOE’s importer guidance says that if the OEM filed a certification report, the importer may still be penalized unless it submitted an authorization for the OEM or another third party to file on its behalf and the submitter identified the importer on the report. Under EPCA the importer is the manufacturer and is responsible for certification before import.

What does 19 CFR 12.50 require?

It directs CBP to refuse admission to any covered consumer product or industrial equipment that does not comply with applicable DOE energy conservation standards or FTC energy labeling standards. CBP can act on a DOE or FTC notice, or on its own finding after conferring with the agency. It also allows conditional release for reconditioning or re-labeling under bond.

How long does a conditional release last?

The period ends at the earliest of a CBP refusal notice, a DOE or FTC notice that the goods comply, or 30 days after release. The importer can request an extension from DOE or the FTC within the initial 30 days or any authorized extension.

What happens if I do not redeliver goods CBP demands back?

Under 19 CFR 12.50(d)(4), failure to redeliver results in liquidated damages equal to three times the value of the covered product, with value determined under 19 U.S.C. 1401a.

What is the DOE civil penalty for failing to certify?

The current eCFR text of 10 CFR 429.120 sets a maximum of $575 per violation for knowing violations. For failure to certify, each unit distributed in violation counts as a separate violation, so exposure scales with volume.

Do I need to recertify every year?

Yes. 10 CFR 429.12 requires annual certification by a category-specific date, for example July 1 for room and central air conditioners and commercial HVAC equipment, and certification of any new basic model before distribution in commerce.