A brand has a formula that sells well in its home market and wants the same product made in Japan. The factory runs it against Japan’s rules and comes back with three lines marked in red: one preservative, one UV filter and one colourant. Nothing in the formula was unsafe or unusual where it came from. It simply did not match Japan’s lists, which are built differently from many other markets’ lists.
This article explains how that check works, what the factory needs from you to run it, and what typically has to change. If you send the right information first, the check is a single round instead of three.
💬 Sunsho Trade manages own-brand cosmetics made at a GMP-certified partner factory in Japan for brands outside Japan. Send us your formula and we will arrange the check against Japan’s Standards before any sample, or see the Japan cosmetics OEM guide.
What the Standards for Cosmetics are, in one paragraph
Japan’s Standards for Cosmetics (化粧品基準) are a single ministerial notification that bans some substances outright, caps others, and allows only listed substances as preservatives and UV filters — and every cosmetic made in Japan must meet it, whether it is sold in Japan or exported.
The Standards are Ministry of Health and Welfare Notification No. 331 of 29 September 2000, applied from 1 April 2001. They replaced the older system of approvals by product type, so formulas are now built inside the limits the Standards set. A factory in Japan works inside those limits for every product it makes. An export-only product is still manufactured in Japan, so the Standards apply to the formula on the production line. Whether your destination market has extra rules is a separate question for your importer.
The five layers your formula is checked against
The check runs through five layers in order: general safety of raw materials, the prohibited list, restricted ingredients with limits, the positive lists for preservatives and UV filters, and tar colours — plus one specific rule on glycerin.
| Layer | Where it sits in the Standards | What the check asks |
|---|---|---|
| Raw material safety | Paragraph 1 | Could any raw material risk public health, including through impurities or infection risk? |
| Prohibited substances | Paragraph 2 and Appendix 1 | Does the formula contain anything on the prohibited list, a pharmaceutical ingredient outside the permitted exceptions, a material not meeting the Standards for Biological Raw Materials, or certain specified chemical substances? |
| Restricted ingredients | Paragraph 3 and Appendix 2 | Is each restricted ingredient at or below the maximum amount per 100 g for this product type? |
| Preservatives and UV filters | Paragraph 4, Appendices 3 and 4 | Is every preservative on Appendix 3 and every UV filter on Appendix 4, within the limit for this product type? |
| Tar colours | Paragraph 4, Ordinance No. 30 of 1966 | Is each tar colour usable under the ministerial ordinance, and in a permitted product type? |
| Glycerin | Paragraph 5 | Does the glycerin used contain no more than 0.1 g diethylene glycol per 100 g? |
Checked against the published texts of the Ministry of Health, Labour and Welfare on 17 October 2026.
A few details matter more than the rest.
The prohibited list (Appendix 1) includes substances such as mercury and its compounds, hexachlorophene, formalin, methyl alcohol, hydrogen peroxide, boric acid and chloroform. Paragraph 2 also bars pharmaceutical ingredients, except those used only as additives and those listed in Appendices 2 to 4.
The restricted list (Appendix 2) sets maximum amounts per 100 g. Some limits apply to all cosmetics. Others depend on the product type. Rinse-off products such as soap and shampoo can have different limits from leave-on products. Products used on mucous membranes have their own limits. Zirconium is not permitted in aerosols. The same ingredient at the same percentage can therefore pass in a shampoo and fail in a cream.
The positive lists (Appendices 3 and 4) work the opposite way to a ban. A preservative must be on Appendix 3, and a UV filter — a substance that specifically absorbs UV to protect skin or hair — must be on Appendix 4. If a substance is not on the list, it cannot be used in that role. The limits again differ by product type.
Tar colours follow the Ministerial Ordinance on tar colours usable in pharmaceuticals and similar products (Ordinance No. 30 of 1966). Some carry use restrictions; for example, Red No. 219 and Yellow No. 204 may be used only in products used solely on hair and nails.
Why a formula from another market fails
Most failures come from the positive lists and the product-type limits: an ingredient allowed abroad is not on Japan’s list, or is on it at a lower limit for the type of product you are making.
Different markets organise their ingredient rules differently. Two systems can both protect consumers and still disagree about which preservatives or UV filters are listed, and at what level. That is why a formula that complies at home is not evidence that it complies in Japan. The check has to be done ingredient by ingredient against the current Standards, not by comparing one market’s list with another’s.
These are the points where a formula most often needs work:
- Preservative system. A preservative not on Appendix 3, or above the Appendix 3 limit for this product type. Preservatives are often used in blends, so one blend can carry several substances to check.
- UV filters. A UV filter not on Appendix 4, or above its limit. This matters for sunscreens and for any day product with UV protection. See our article on Japanese sunscreen OEM for testing and labelling.
- Colourants. A colourant that is a tar colour outside the ordinance, or one restricted to hair and nail products used in a face product.
- Leave-on versus rinse-off. A level that was set for a wash-off product but is now proposed in a leave-on product.
- Hidden components. Raw materials supplied as premixes, or extracts with a preservative already in them. The check covers every substance, not only those on your top-level formula sheet.
The expensive version of this story is when the check is done after samples are approved, or after packaging has been printed. Reformulating at that stage means a new sample round, new stability work and often new artwork. Run the check first.
💬 Have a formula from another market and want to know which lines Japan will question? Send the full formula with percentages and we will arrange the check before samples are made.
What the factory needs from you to run the check
Send the complete formula with percentages, the function of each ingredient, the raw-material specifications including any components inside premixes and extracts, the product type, and the markets you plan to sell in.
A factory cannot check what it cannot see. The most common cause of a second and third check round is missing information, not a failed ingredient. Use this list:
- The full formula with percentages. Every ingredient, adding up to 100. A list of “key ingredients” cannot be checked.
- The function of each ingredient. Preservative, UV filter, colourant, emulsifier, humectant, fragrance and so on. The function decides which list applies.
- Raw-material specifications. For each raw material, its composition. For premixes, each component and its share. For extracts, the extracted substance and the solvents used. For fragrance, a statement from the fragrance supplier about compliance.
- The product type and how it is used. Leave-on or rinse-off, face or body, near the eyes or lips, hair and nails only. Limits change with use.
- The format. An aerosol, for example, has its own restrictions.
- The destination markets. Japan’s Standards are applied in Japan. If you also share your destination markets, the factory can flag where a change for Japan might also affect your export label.
If your formula belongs to a contract manufacturer elsewhere and you do not have the full composition, say so early. Sometimes the right answer is to start from one of the Japanese factory’s existing base formulas instead. That choice is covered in stock or custom formula.
The check, step by step
The factory screens the formula against each layer, marks every ingredient as clear, needing a change, or needing more information, and proposes replacements before any sample is made.
A workable sequence looks like this:
- Category first. Confirm the product is a cosmetic and not a quasi-drug. That decision is covered in cosmetic or quasi-drug. The Standards discussed here are the cosmetics standards.
- Screen the prohibited list. Any match ends the discussion for that ingredient. It is removed, not reduced.
- Screen the restricted list. Compare each restricted ingredient with the Appendix 2 limit for this product type.
- Screen the positive lists. Every preservative against Appendix 3, every UV filter against Appendix 4, each with the product-type limit.
- Screen the colourants. Check every tar colour against the ordinance and its use restrictions.
- Check specific rules. For example, the diethylene glycol limit for glycerin.
- Return a marked-up formula. Each line marked clear, change, or information needed, with a proposed replacement where a change is required.
- Agree the changes, then sample. Only after the formula is agreed does it go to the lab bench.
The result of step 7 is the document you want to keep. It records why the formula looks the way it does, which helps later when your importer asks questions or when you reorder.
What typically has to change, and what it costs you
A changed preservative or UV filter is not a paperwork edit: it can change texture, stability and the ingredient list on your label, so plan for a new sample round and an updated label after any change.
| Change | What it affects downstream |
|---|---|
| Preservative replaced | Stability and preservative-efficacy testing, the ingredient list on the label |
| UV filter replaced or reduced | SPF and PA testing, texture, the ingredient list, possibly the UV claim |
| Colourant replaced | Shade matching, the ingredient list |
| Restricted ingredient reduced | Possibly feel or performance, the order of the ingredient list |
| Premix or extract re-specified | The ingredient list, because premixes and extracts are listed component by component |
Two consequences are worth planning for. First, any change in a preservative or UV filter means the stability programme and, where relevant, preservative-efficacy testing should be run on the final formula, not the original. That work is covered in stability and compatibility testing. Second, the ingredient list changes. Japan’s ingredient-labelling rules and how they relate to INCI names are explained in full ingredient labelling and INCI. Do not finalise label artwork until the formula is frozen.
💬 Want the formula check, samples, packaging and export documents handled by one team in English? See our own-brand OEM service, or send your formula and product brief.
Frequently asked questions
1. If my formula is legal in my home market, will it pass in Japan?
Not necessarily. Japan uses positive lists for preservatives and UV filters, and limits that differ by product type. A substance allowed elsewhere may not be on Japan’s list, or may be listed at a lower limit. The check has to be done ingredient by ingredient against the current Standards.
2. Do the Standards apply if the product is only for export?
The product is manufactured in Japan under a Japanese licence, so the factory works inside the Standards. Your destination market may add its own requirements; your importer should confirm those.
3. Which ingredients are on a positive list?
Preservatives (Appendix 3) and UV filters (Appendix 4). Tar colours follow a separate ministerial ordinance. Other ingredients are governed by the prohibited list, the restricted list and the general safety rule for raw materials.
4. Why does the factory ask for the composition of premixes and extracts?
Because every substance in the product is checked, including those inside a premix or an extract, such as a preservative added by the raw-material supplier. The same detail is needed later for the ingredient list.
5. Can a failed ingredient simply be reduced instead of replaced?
Sometimes. If an ingredient is restricted and only over the limit for the product type, reducing it can work. If it is prohibited, or not on a positive list for its role, it has to be removed or replaced.