日本語版：ペプチド原料の輸入準備（日本向け）
Japan · Destination-specific import and receiving qualification
Preparing peptide raw-material imports for Japan destination review
Japan separates its controls by use: finished cosmetics sit under the Pharmaceutical and Medical Devices Act (PMD Act) with a licensed Japanese marketing authorization holder, while industrial chemicals are governed by the Chemical Substances Control Law (CSCL) with an existing-substances inventory, MITI-numbered customs declarations and pre-import notification duties for new substances. This preparation framework identifies the record set and open questions for the Japanese destination; it does not determine legality, classification or admissibility for any particular material or shipment.
Who should own each import-preparation workstream?
| Workstream | Responsible parties | Inputs to reconcile | Required evidence and limit |
|---|---|---|---|
| Destination and substance/use scope | Buyer with supplier technical input | The exact destination (Japan), material identity, specification, intended B2B application and destination-use context; the same substance can fall under different Japanese frameworks depending on use (cosmetic ingredient vs industrial chemical vs research reagent). | A documented substance/use review against Japan's current official sources; no use-based classification is assumed here. |
| Ingredient inventory and chemical-status screening | Importer's technical/compliance reviewer | Screening of the substance against Japan's existing-chemicals inventory (ENCS, substances carry MITI numbers used at customs clearance) and the parallel ISHL list; identifying whether the substance is existing, new, monitored or designated under the Chemical Substances Control Law (CSCL). | A current inventory search with dated results; a new substance requires notification to METI, MHLW and MOE at least three months before manufacture or import. |
| Cosmetic-route interface (if the use is cosmetic) | Japanese MAH licensee and its regulatory reviewer | Whether the Japanese marketing authorization holder (cosmetics manufacturing-and-marketing licence issued by the prefecture) has filed the PMDA foreign-manufacturer notification and the prefectural product notification; whether any ingredient is designated by MHLW and therefore needs item-by-item approval under Article 14 of the PMD Act. | Confirmed MAH-side filing status and a formula screen against the Cosmetics Standards (Ministry of Health and Welfare Notification No. 331 of 2000: prohibited ingredients plus positive lists for preservatives, UV absorbers and tar colours). |
| Batch and receiving documents | Supplier quality contact and buyer receiving/quality team | Specification revision, COA and analytical records, packing details, document recipients and receiving acceptance criteria; MITI-number linkage between substance identity and customs declaration data. | Current batch-linked records and an agreed handoff, with discrepancies handled before acceptance. |
| Labelling, SDS and language review | Importer, formulator/brand and a competent Japanese reviewer | Japanese-language documentation expectations: all-ingredient Japanese labelling for finished cosmetics, GHS labelling and Japanese SDS for industrial chemicals under the Industrial Safety and Health Act; the importer's product-liability exposure as a party treated as manufacturer under the Product Liability Act. | A current, official-source-based Japanese documentation review; machine translation is not a compliance basis. |
| Route, clearance and exception handling | Buyer, supplier, Japanese importer and appointed logistics parties | Agreed trade term, actual route and gateway, customs declaration data alignment (gazette reference numbers or METI permissions where the substance category requires them), handling constraints and exception contacts. | Approved order-specific terms and route evidence; no transit time, clearance or delivery outcome is guaranteed. |
How should the buyer and importer sequence the review?
- 1
Fix the destination and the intended use first
Name Japan as the destination and document the intended use before anything else; the applicable framework (PMD Act cosmetics route, CSCL industrial-chemical route, or both) follows from the substance and its use, not from the seller's product name.
- 2
Name the responsible parties
Record the Japanese importer/MAH-side contacts, the technical/compliance reviewer, supplier quality contacts, the forwarder and the receiving reviewers before discussing document handoff.
- 3
Complete Japan official-source review
Have qualified parties screen the substance identity against the ENCS/ISHL inventories, confirm CSCL status and any notification duty, and — for cosmetic use — confirm MAH filing status and the formula screen against the Cosmetics Standards; retain sources, dates and open questions.
- 4
Reconcile documents and order terms
Match product, batch, invoice, packing and customs declaration data to the agreed scope, confirm Japanese label and SDS expectations, then resolve discrepancies before dispatch or receiving.
Which document handoffs need separate review?
Product and destination review
Material identity, specification, composition and intended-use brief, plus dated official-source and qualified-party conclusions applicable to Japan.
Batch and receiving review
Use the quality and documentation guide to frame COA and analytical questions, then agree the actual batch and receiving package.
Trade and exception review
Reconcile the shipping-term template and sample/returns framework with approved order-specific responsibilities.
What must remain unresolved until evidence is approved?
No destination classification, registration, clearance or delivery commitment is made on this page. Current official sources for Japan, substance/use conclusions, inventory screening results, MAH-side filing status, labeling and SDS review, actual route terms and named technical/compliance reviewers are still required before indexing.
- Do not describe any material on this site as "Japan compliant" or "PMDA approved"; notification or approval status belongs to the Japanese licensee's filings, not to the supplier's documents.
- Do not make or repeat cosmetic efficacy claims (whitening, anti-wrinkle, therapeutic effects); the PMD Act prohibits misleading claims, and any efficacy wording is the MAH's regulatory decision.
- Do not treat machine translation of foreign documents as a compliance basis for Japanese labeling or SDS; a competent Japanese review is required.
- Do not state MITI numbers, HS codes, duty rates or clearance timelines for any substance or shipment; these are determined in the importer's screening and customs declaration.
- Do not treat raw-material documents (COA, invoice, packing list) as proof of notification, approval, admissibility or receiving acceptance.
- Do not copy this matrix to another destination without a separate official-source review.