MHLW Import Notification:
A Step-by-Step Guide for Foreign Brands

Japan's CBD import notification process is governed primarily by the Food Sanitation Act (食品衛生法) and the Cannabis Control Act (大麻取締法), with MHLW as the central regulatory authority. The process has no online equivalent and requires paper-based or in-person submission at a designated port of entry inspection station. For international brands without an established Japanese entity or representative, navigating this process independently is effectively impossible.

Legal Framework

CBD products for oral consumption are classified as food products under the Food Sanitation Act. Import notification (輸入届出) must be filed with the quarantine station (検疫所) at the port of import before or at the time of shipment arrival. MHLW may also require additional review for products with cannabinoid content under pharmaceutical affairs regulations.

Since December 2024, the Cannabis Control Act's component-based framework means CBD import also requires demonstration of THC residue compliance — directly linking Food Sanitation Act import notification to Cannabis Control Act standards for the first time in statutory text.

Required Documents

The following documents are required for a standard CBD oil import notification:

1. Import notification form (輸入届出書): Japanese-language form specifying product name, manufacturer, country of origin, ingredient list, intended use, and expected import volume. Must be completed by the Japanese importer of record.
2. Product specification sheet: Full ingredient list with Japanese names, concentration ranges, and sourcing information. Must be in Japanese.
3. Certificate of Analysis (Japan-accredited laboratory): Confirming THC residue compliance for the applicable product category, CBD content, CBN content, and other cannabinoids. Must be from a PMDA-recognized testing facility.
4. Manufacturing process documentation: Description of how the product is manufactured, including extraction method, purification steps, and quality controls. Japanese translation required.
5. Labeling documentation: All labeling for the product as it will be sold in Japan. Must comply with Japanese food labeling standards (food labeling law, 食品表示法).
6. Cannabinoid source documentation: Evidence that the hemp used as CBD source complies with Japanese requirements for legally cultivated hemp (THC content of source plant, cultivation documentation).
7. Import flow diagram: Illustration of the import pathway from manufacturer through to Japanese consumer, identifying each entity in the chain.

The Notification Process

Step 1: Prepare documentation

All documents except the Japan-accredited CoA can be prepared before testing is completed. Begin documentation preparation in parallel with laboratory testing coordination. Allow 4–6 weeks for Japanese translation of technical documents.

Step 2: Submit to quarantine station

Import notification must be submitted to the quarantine station responsible for the port of entry designated for your shipment. Submission can be made electronically via Japan's FAINS system (Food Import Notification System) or in paper form. FAINS requires registration as a Japanese legal entity or through an authorized representative.

Step 3: Quarantine station review

Standard review period: 5–15 business days for products that have been notified previously. For novel products or first-time notifications, expect 3–6 weeks. The quarantine station may request additional information or documentation during review.

Step 4: MHLW referral (if applicable)

Complex cases may be referred to MHLW central for additional review. This adds 2–4 weeks to the process. Products with novel cannabinoid profiles, new product categories, or documentation gaps are most likely to be referred.

Step 5: Clearance or rejection

On clearance, the notification receives an acceptance stamp and reference number. This document travels with the shipment through customs. On rejection, a reason for rejection is issued. The most common rejection reasons are addressed below.

Common Rejection Reasons

• THC residue non-compliance: CoA shows THC above applicable limit. Most common for aqueous products where the 0.1 ppm limit applies.
• Non-qualifying laboratory: CoA issued by laboratory not certified under PMDA standards. Common for brands using US or EU laboratories assuming international accreditation is equivalent.
• Incomplete ingredient documentation: Excipients, carriers, flavoring agents not fully declared with Japanese names and concentration data.
• CBN presence: Detectable CBN at current laboratory detection limits. Growing cause of rejection since late 2025.
• Labeling non-compliance: Therapeutic or drug claims in product labeling. CBD products must be marketed as food supplements, not pharmaceuticals.
• Missing manufacturing documentation: Extraction method or purification process not adequately documented.

Import Notification vs. Import Verdict™

Import notification is the formal regulatory process required before each import. Import Verdict™ is a pre-notification assessment that confirms your product is importable before you commit to the notification process. The sequence for a new product entering Japan should be: (1) Import Verdict™ assessment, (2) Japan-accredited laboratory testing, (3) Import notification filing, (4) First shipment.