A manufacturer that buys a Japanese raw material in bulk rarely has a problem with the powder itself. The problems sit around it: a quotation that names an ingredient but no content or standard, a certificate of analysis for a different lot from the one that arrived, an allergen statement written for Japan’s list rather than for the country where the product will be sold, or a drum that reaches the plant with less shelf life left than the production plan needed.
This guide is for supplement, food and cosmetic manufacturers, OEM factories and brands that buy raw materials from Japan for their own production. It covers what to put in the specification, which documents come with each lot, how to handle samples, shelf life and transport, and which steps belong to the importer. Ingredient-specific notes for coenzyme Q10, NMN and phosphatidylserine are in separate guides.
Health supplements are foods, not medicines, and are not a substitute for medical treatment. This article is about raw materials and their paperwork; it makes no claim about what any ingredient does in the body.
💬 Buying a raw material from Japan for your own production? We source it by name and specification, collect the specification, CoA and SDS, and arrange a sample first. See ingredients and packaging supply.
Write the specification before you ask for a price
A raw material is defined by its name, form, content and the standard it is tested against, so fix those fields first; two quotations for “the same ingredient” with different content or a different test standard cannot be compared.
Japanese suppliers quote against a written product specification. When the request says only “CoQ10 powder” or “NMN”, each supplier answers with its own standard product, and the buyer ends up comparing a pure crystalline material with a diluted powder, or a material tested by one method with one tested by another. The fix is to send your own target specification and ask each supplier to answer line by line.
| Field in your request | Why it matters | Example of a usable line |
|---|---|---|
| Common name and chemical form | Several forms can share one market name | ”Coenzyme Q10, oxidised form (ubidecarenone)“ |
| Physical form | Crystalline powder, granule, oil suspension or water-dispersible powder run differently on a line | ”Crystalline powder for capsule filling” |
| Content (assay) and basis | A figure means little without its basis, for example on the anhydrous or the as-is material | ”Not less than X% on the anhydrous basis” |
| Standard or method referenced | A pharmacopoeia monograph, a food additive standard or the supplier’s own method give different limits | ”Tested to the Japanese Pharmacopoeia monograph, current edition” |
| Carriers and excipients | Diluted or dispersible grades contain other substances that must appear on your label and allergen file | ”Carrier and its source stated on the specification” |
| Impurity and microbiological limits | Your incoming inspection needs the same limits the supplier tests to | ”Heavy metals, residual solvents and microbiology limits stated with the method” |
| Packing | Drum size, inner bag and atmosphere affect storage and partial use | ”Inner aluminium bag, sealed, in a fibre drum” |
The Japanese Pharmacopoeia is a useful reference because it is published by the Ministry of Health, Labour and Welfare and is free to read. Its 19th edition has a monograph for ubidecarenone (coenzyme Q10 in its oxidised form) that sets the content, the identification tests, the related-substance limit by liquid chromatography and the storage condition. Many supplement raw materials have no monograph at all, which is why the specification must state which method each figure comes from. Our specification sheet guide covers how a Japanese specification is laid out.
The documents that come with each lot
Expect a specification, a certificate of analysis for the lot shipped, a safety data sheet, and allergen and origin information; agree the list before the order, not when the goods are at the port.
| Document | What to check on it | Common gap |
|---|---|---|
| Product specification | Every field in your request, with the method and the edition of any standard | An older version, or a “typical values” sheet presented as a specification |
| Certificate of analysis (CoA) | Lot number matches the drum label and the packing list; results against each specification limit; date of manufacture and expiry or retest date | A CoA for the sample lot sent with the production lot |
| Safety data sheet (SDS) | Product name and composition match the specification; storage and handling sections | An SDS for a related grade with a different carrier |
| Allergen statement | Covers carriers and processing aids as well as the active substance | Written only against Japan’s list |
| Origin statement or certificate of origin | Country where the material was produced, and where it was last substantially processed | Origin of the trading company stated instead of the producer’s country |
| Other certificates where your market or customer asks for them | Halal, kosher or non-GMO statements name the product and are valid on the shipment date | A certificate for the factory but not for this product |
The certificate of analysis is where most incoming-inspection disputes start. Ask in advance whether it is issued by the producer’s own quality department or by an outside laboratory, and which results are tested on each lot and which are guaranteed by periodic testing. Our certificate of analysis guide explains how to read one line by line.
Allergen statements need your list, not only Japan’s
Japan’s allergen labelling list is not the same as the list in the country where your product is sold, so ask for a statement that answers each item on your own list.
Japan’s Consumer Affairs Agency sets two tiers. Nine “specified raw materials” must be labelled in Japan; cashew nut moved into that mandatory group on 1 April 2026. A further 20 items, including soybean and gelatin, are recommended for labelling rather than required. A Japanese supplier’s standard allergen statement is often written against exactly these 29 items.
Your own market may use a different list or a different threshold. Send the supplier your list and ask for a yes or no against each item, including:
- the active substance itself;
- any carrier or dispersing agent, which is where soybean or milk derivatives most often appear;
- processing aids and fermentation media where the producer is willing to disclose them;
- whether the production line also handles any listed allergen.
Samples, lots and remaining shelf life
Test a sample against the agreed specification before the first order, and agree in writing how much shelf life must remain when the goods arrive.
A sample is only useful if it represents what you will buy. Ask for the CoA of the lot the sample came from, and use the sample for the tests you will repeat on every incoming lot: identification, content and the impurity limits that matter to your regulator. If you run a stability study on your finished product, plan it around the raw material grade you will actually order, not a laboratory pack. Our samples and quotation guide describes how Japanese suppliers handle sample requests.
For production lots, three points belong in the purchase order:
- Expiry or retest date. Some materials carry an expiry date, others a retest date after which the material can be re-tested and released. Know which one your quality system accepts.
- Minimum remaining shelf life on arrival. State it as a fraction of total shelf life or as a date. The right figure depends on your production schedule, so it is yours to set.
- Single lot or mixed lots. If a shipment may contain more than one lot, each lot needs its own CoA and its own line on the packing list.
💬 Need a sample and its CoA before you commit to a lot? Tell us the ingredient, the specification and the country of use. Ask about a raw material.
Storage and transport conditions
Take the storage condition from the specification or monograph and carry it through the whole route, including the time a drum spends at a port or in a bonded warehouse.
Many supplement raw materials are sensitive to light, oxygen, moisture or heat. The Japanese Pharmacopoeia monograph for ubidecarenone, for example, states that the substance slowly decomposes in light and must be stored protected from light in a tight container. Other materials take up moisture easily or must be kept cool. The supplier’s specification and SDS state the condition for each product.
| Condition on the specification | What it means for shipping | What to ask |
|---|---|---|
| Room temperature, protected from light | Standard dry container is often enough; keep drums sealed | Is the inner bag light-blocking? |
| Cool or refrigerated | Reefer container or temperature-controlled air freight | What temperature range, and how long may the material be outside it? |
| Keep tightly closed, avoid moisture | Desiccant or moisture-barrier bags; plan partial use | Is the material resealed under nitrogen or with desiccant after opening? |
| Inert gas packing | Opening the bag starts exposure | Pack size that matches your batch size |
Customs, import steps and the country of use
The importer in your country classifies the goods, clears them and confirms that the ingredient may be used there; the supplier side provides the documents those steps rely on.
Tariff classification is decided by the customs authority of the importing country. Japan’s own customs advance rulings show how the form matters: a chemically single β-nicotinamide mononucleotide powder for use as a food and cosmetic raw material was classified by Tokyo Customs in February 2026 under heading 29.34, as a heterocyclic compound. A mixed or formulated material may fall elsewhere. Give your customs broker the specification and the SDS, and ask it to confirm the code in your own tariff before the first shipment.
Whether an ingredient may be used in a food or supplement is also a country-by-country question. In Japan, the Ministry of Health, Labour and Welfare keeps a list of substances that are not judged to be medicines as long as no medicinal effect is claimed; the version updated on 5 August 2026 names coenzyme Q10, β-nicotinamide mononucleotide and phosphatidylserine. That status applies in Japan. For any other market, the manufacturer confirms the current rule in the country of use. Import clearance and any import notification are made by the importer, normally your company or an importer you appoint. For the export side from Japan, see our Japan export documents guide.
What decides the price and the timing
Price and lead time follow the specification, the quantity, the packing and the documents you need, so a quotation is only meaningful once those are fixed.
| Factor | Why it moves the quotation |
|---|---|
| Content and form | A high-purity crystalline grade and a diluted or dispersible grade are different products |
| Standard tested to | Testing to a pharmacopoeia monograph or to extra limits adds work |
| Quantity and packing | Full production packs, split packs and sample packs are priced differently |
| Stock or made to order | Some materials are held in stock, others are produced against orders |
| Documents and certificates | Halal, kosher or extra test reports may need time to obtain |
| Shipping condition | Temperature control and air freight change both cost and timing |
We do not quote a price or a lead time before the specification is agreed. Consumables for the same run can be sourced alongside; see our guides to HPMC and other empty capsules and bottles, pouches and labels.
💬 Ready to send a specification? Tell us the ingredient, the form and content, the quantity and the country of use, and we will come back with suppliers’ specifications and documents. Send your request.
Frequently asked questions
1. Will you tell me the name of the Japanese manufacturer?
We specify raw materials by name, grade and content rather than by brand, and supply the documents your quality team needs to approve the material: specification, certificate of analysis, safety data sheet, and allergen and origin information. If your regulator or customer requires specific producer information for a registration, tell us at the start so we can ask the supplier what it can provide.
2. Can I buy a small quantity for a trial before a full order?
Yes. We arrange samples first, with the certificate of analysis of the lot they came from, so you can run identification, content and stability checks before the first production order. Sample size and price depend on the material and the supplier.
3. Is a Japanese Pharmacopoeia grade required for a supplement?
Not as a rule. Which standard you need depends on how your finished product is regulated in the country where it is sold, and on what your customer asks for. Many supplement raw materials have no pharmacopoeia monograph, so the specification must state the method behind each figure instead.
4. Who handles import clearance in my country?
The importer does, normally your company or an importer you appoint. We supply the documents clearance usually relies on, such as the specification, the CoA, the SDS, origin information and the export shipping documents.
5. Can raw materials and packaging travel in one shipment?
Yes, when the storage conditions are compatible. Raw materials and consumables such as empty capsules, bottles and labels can be combined, which keeps one set of shipping documents and one arrival date for the production run.
Checked on 25 October 2026. Sources: Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 19th edition, official monographs, “Ubidecarenone” (mhlw.go.jp/content/11120000/001689418.pdf); Ministry of Health, Labour and Welfare, list of substances not judged to be medicines unless medicinal effects are claimed, attachment 2, updated 5 August 2026 (mhlw.go.jp/content/001734639.pdf); Consumer Affairs Agency, allergen labelling page and “What is allergen labelling”, April 2026 (caa.go.jp/policies/policy/food_labeling/food_sanitation/allergy/); Japan Customs, advance ruling on tariff classification, registration 126000367, 27 February 2026 (customs.go.jp/tetsuzuki_search/bunrui/J1/26/J12600131.htm). Rules on using an ingredient in foods differ by country; the manufacturer confirms the current rule in the country of use.