MFDS Notice No. 2026-66 changes the health functional food and GMP symbols to distinguish them from the HACCP mark used for ordinary food. From 1 January 2028, a health functional food manufactured, processed or imported—including one shipped for import—must show on its principal display panel either the new health functional food symbol at least 15 × 15 mm or the Korean words “건강기능식품”. The symbol colour may change when needed for legibility; on packaging of 150 cm² or less, its size may be adjusted while remaining identifiable. Earlier goods may be sold, displayed, transported or used in business until their use-by date.
Practical sourcing action
For a finished Ginkgo product placed in Korea’s health functional food channel, have the importer confirm the classification and import declaration, then control artwork and SKU transition by manufacture or shipment date. Verify the principal-panel symbol or Korean wording, the symbol size and colour, and any GMP mark; retain evidence for old stock. The ingredient index lists Ginkgo leaf extract as a functional ingredient, but this labelling notice neither authorises a formula or claim nor creates a Ginkgo import ban.
In-force item 2357 lists GINKGO BILOBA for active, excipient and homoeopathic purposes. Ginkgo leaf extract used in a medicine must meet Identification Test B of USP32–NF27 Powdered Ginkgo Extract. That condition excludes powdered or dried leaf. This ingredient listing is not finished-product approval or food authorisation.
Practical sourcing action
Have the Australian sponsor confirm the ARTG pathway and ingredient-purpose code. For extract lots, obtain traceable USP32–NF27 Identification Test B results and audit GMP, dose, permitted indications and label together.
The FY2026 plan has MHLW quarantine stations review commercial food imports through Article 27 notifications and conduct risk-based monitoring or ordered inspections. The reviewed plan does not list a Ginkgo-specific ban. Each leaf or extract product still needs classification, specification, additive and residue review.
Practical sourcing action
Before shipment, have the importer consult the destination quarantine station with composition, species and part, extraction process, specifications, additives, residue and contaminant tests, label and import history. File the Article 27 notification for the consignment and sample or test as directed.
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Imported Foods Monitoring and Guidance Plan for FY 2026
From 2026, China-licensed drug manufacturers exporting products regulated as pharmaceuticals in the destination must use GMP-compliant facilities and maintain export-product dossiers; export certificates are available. Ginkgo shipped as food follows the separate Customs export-food inspection route.
Practical sourcing action
Obtain the destination’s written classification first. For the drug route, audit licence scope, line, GMP, dossier and provincial certificate filing. For the food route, prepare Customs registration, contract, invoice, packing list, factory release and raw-material supply documents.
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Announcement of the National Medical Products Administration on Issuing the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers ([2025] No. 113)
FDA’s final rule took effect on 27 October 2025. From 1 October 2026, prior notice for food arriving by international mail must include the mail service and tracking number. Ginkgo supplements and ingredients can be food imports, but transport mode and exemptions matter.
Practical sourcing action
Add transport mode, FDA product category, prior-notice owner, mail service and tracking fields to purchase and shipping instructions before the October 2026 compliance date.
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Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
US Food and Drug Administration, Department of Health and Human Services
ChP 2025 took effect on 1 October 2025. Applicable national drug standards govern drug R&D, manufacture including imports, distribution and supervision. The public notice does not verify numerical requirements in the Ginkgo leaf or extract monographs.
Practical sourcing action
Confirm the drug classification and approved standard. Obtain the licensed ChP 2025 Ginkgo leaf, extract and relevant finished-product monographs, then compare the supplier CoA, methods and change-validation package item by item.
From 1 July 2025, the Czech food-supplement decree lists daily maxima of 60 mg for standardized 24/6 ginkgo-leaf extract and 4,000 mg for dried leaf. The limits are national and do not settle claims, novel-food status or medicine classification.
Practical sourcing action
For Czech supply, obtain the exact extract specification and proposed daily dose, then review formula, label and claims against current Czech rules.
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Decree of 4 December 2024 amending Decree No 58/2018 on food supplements and on the composition of foodstuffs
Ministry of Agriculture of the Czech Republic; notified through the European Commission Technical Regulation Information System
RCEP provides a preferential-tariff pathway for qualifying originating goods, not one universal Ginkgo rate. Eligibility depends on the correct HS code, importing-party schedule, product-specific origin rule, direct consignment and valid proof. China-grown leaves and China-processed extracts may have different origin analyses.
Practical sourcing action
Have the broker confirm the full tariff code and 2026 importing-country schedule and Annex 3A rule. Test origin with cultivation, BOM, process and transport records; compare RCEP with other available FTAs, then secure a compliant certificate or declaration of origin.
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RCEP text
Australian Government Department of Foreign Affairs and Trade
A March 2026 FDA letter names Ginkgo Biloba Tincture among products promoted with disease claims and therefore treated as drugs. It is firm- and claim-specific, not a new ginkgo ban. Supplement status still depends on ingredient history, manufacture, label and promotion.
Practical sourcing action
Audit labels, websites, social posts and testimonials before purchase; document dietary-ingredient and extraction history, and remove disease claims or follow the drug-approval route.
FSA guidance for England and Wales says third-country food herbs must meet GB safety rules and normally need no health certificate, while other controls may apply. Ginkgo is not named, and the August 2026 update only repaired links, so shipment classification remains essential.
Practical sourcing action
Confirm intended use and commodity treatment with the importer, then screen origin, pesticide, contaminant, labelling, organic and higher-risk requirements before dispatch.
MHRA’s May 2026 refresh says supplements and herbal products can be medicines depending on claims, presentation, composition, function and intended purpose. It is general guidance, not a ginkgo ruling. Disease-oriented promotion can redirect a proposed ginkgo supplement into the medicines route.
Practical sourcing action
Freeze the formula and all label, website, social and testimonial claims; seek MHRA advice before launch if the classification remains borderline.
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Borderline products: how to tell if your product is a medicine
UK Medicines and Healthcare products Regulatory Agency
The October 2025 MHRA list includes Bio-Biloba THR 20243/0002, a tablet with defined ginkgo-leaf dry extract and named traditional indications. This is a product-specific registration record; the update does not show that the ginkgo entry changed in 2025 or remains marketed.
Practical sourcing action
Use the entry only as a formulation and route benchmark; obtain your own UK registration and verify the holder, status and market availability directly.
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Herbal medicines granted a traditional herbal registration (THR)
UK Medicines and Healthcare products Regulatory Agency
BICON’s current dried-herbs case covers thoroughly dried, non-propagable leaves for human consumption or therapeutics. Plant-origin dietary supplements and natural medicines use a separate case. Exact conditions depend on species, plant part, processing, origin, end use and shipment date.
Practical sourcing action
Rerun BICON using Ginkgo biloba, exact part or extract, process, origin, end use and packaging; save the dated full conditions and alerts. Put permit, declaration, treatment, clean-packaging and inspection responsibilities in the contract, then complete food or TGA review.
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BICON — Dried herbs for human consumption
Australian Government Department of Agriculture, Fisheries and Forestry
MHLW’s 2026 consolidated non-medicinal example list includes Ginkgo biloba seed and leaf: they are not judged medicines only when medicinal efficacy is not claimed. The entry does not expressly clear concentrated or standardised Ginkgo leaf extracts.
Practical sourcing action
Keep medicinal efficacy claims out of a food route. For standardised or concentrated extract, submit species, part, solvent, DER or ratio, specification, daily intake, dosage form, label and advertising to MHLW using the official inquiry form and obtain a written classification view.
EMA’s published monograph covers powdered dried leaf and a defined acetone dry extract for herbal-medicine assessment. It is a scientific baseline, not an EU product licence; national authorities decide applications. No final Revision 1 was visible on the EMA page at the review date.
Practical sourcing action
Match plant part, DER, solvent and dosage form to the monograph, then confirm the target Member State’s authorization route before contracting supply.
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European Union herbal monograph on Ginkgo biloba L., folium
European Medicines Agency, Committee on Herbal Medicinal Products
FDA’s ginkgo memorandum found no basis to treat the reviewed conventional-food use as GRAS and no applicable food-additive regulation or prior sanction. The current inventory still lists it. This finding concerns conventional food; it is not itself a ban on dietary supplements.
Practical sourcing action
Do not place ginkgo extract in a US conventional food without a defensible legal basis; document the intended category before purchase and review supplements separately.
The 2002 notice lists Ginkgo leaf as usable in health foods. Current rules require registration for products using ingredients outside the current directory and for most first-imported health foods. This old list is neither ordinary-food authorisation nor proof of current filing-directory status.
Practical sourcing action
Check the current health-food ingredient directory and ordinary-food basis against the final dosage form and claims. If registration applies, have the eligible foreign manufacturer and China agent prepare ingredient, process, quality, safety, function and label dossiers.
Official pages are monitored for changes. A page change is a review signal; published policy analysis changes only after verification. Check dates describe source access, not a new law or a product approval.
Checking monitoring status…
Classification depends on formulation, intended use, claims and destination. Confirm permits, current tariff codes and preferential-origin evidence for each shipment. No universal market clearance or automatic tax benefit is implied.
Editorial analysis; official source titles are retained in their original language.
