A handful of botanical ingredients carry an extra label warning in Japan that most supplement ingredients do not. Brands sourcing a Japan-made product sometimes discover this only when a factory asks whether their formula contains one of them — by which point it can be too late to redesign the label cheaply.
This guide explains Japan’s “designated ingredients, etc.” (指定成分等, shitei seibun tou) system: which ingredients it currently covers, the label warning it requires, the manufacturing and quality controls it imposes, and the health-damage reporting duty that comes with it.
Health supplements are foods, not medicines, and are not a substitute for medical treatment.
💬 Formula includes a botanical extract and you are not sure of its status in Japan? We check it against the designated ingredients list before you commit. See Japan-made supplement OEM.
What the designated ingredients system is
Since 1 June 2020, Japan’s Food Sanitation Act has let the Ministry of Health, Labour and Welfare (MHLW) designate specific ingredients that need special attention for food-sanitation reasons, and impose extra label, manufacturing and reporting duties on foods containing them.
The system followed a wave of reported health damage — mainly irregular vaginal bleeding and menstrual disorders — linked to health foods containing Pueraria mirifica between 2012 and 2017. Rather than banning the ingredient outright, MHLW created a middle category: foods containing it (and others MHLW later designates) stay legal to sell, but only under tighter conditions than an ordinary food ingredient.
| Feature | Ordinary food ingredient | Designated ingredient |
|---|---|---|
| Sale in Japan | Permitted under general food law | Still permitted, under extra conditions |
| Label | Standard food labelling | Standard labelling plus a mandatory designated-ingredient warning |
| Manufacturing | General food hygiene rules | Manufacturing and quality control to a standard MHLW sets |
| Adverse-event handling | No product-specific reporting duty | Business must report suspected health damage to the authorities |
The four ingredients currently designated
As of this guide, MHLW has designated four ingredients: Coleus forskohlii, greater celandine, Pueraria mirifica and black cohosh.
| Designated ingredient | Also known as | Why it was flagged |
|---|---|---|
| Coleus forskohlii | Coleus, source of forskolin | Associated with reported adverse events in health foods |
| Greater celandine | Chelidonium majus, クサノオウ | Associated with reported adverse events in health foods |
| Pueraria mirifica | White Kwao Krua | Widespread reports of irregular vaginal bleeding and menstrual disorders, 2012–2017 |
| Black cohosh | — | Associated with reported adverse events in health foods |
MHLW can add to this list. A brand should not assume a botanical is safe from the system just because it is absent today; check the current designation at the time you specify a formula. See our forskolin and kudzu flower guides for two ingredients from the same botanical family as designated ones, and how their status differs.
💬 Working with a botanical extract and want to know before you commit whether it is designated, restricted or simply unfamiliar to a Japanese factory? Tell us the ingredient.
The mandatory label warning
A food containing a designated ingredient must carry a specific warning on its label, not just the ingredient’s name.
The Food Labelling Standards, revised to take effect 1 June 2020, require a food containing a designated ingredient to state on its container or package:
| Required label element | What it communicates |
|---|---|
| ”Food containing designated ingredients (指定成分等含有食品)” plus the ingredient’s name | The product falls under this system, and which ingredient triggered it |
| A statement that the ingredient requires special attention from a food-sanitation standpoint | Signals the reason for the extra label, without alleging the specific product is unsafe |
| An instruction to stop consumption and consult a physician if the consumer notices a change in their physical condition | Gives the consumer a clear action if something feels wrong |
| The food business operator’s contact details, in a minimum type size | Lets a consumer or authority reach the business directly |
This is separate from, and additional to, ordinary food labelling — allergen declarations, nutrition information and the rest still apply as normal.
Manufacturing controls and health-damage reporting
A business making or processing a designated-ingredient food must follow a manufacturing and quality-control method MHLW sets, and must report suspected health damage to the authorities.
Two obligations run alongside the label requirement:
- Manufacturing and quality control. The Food Sanitation Act requires a designated-ingredient food to be manufactured or processed by a method that conforms to standards the Minister of Health, Labour and Welfare sets — a GMP-like requirement aimed at reducing batch-to-batch variation and contamination risk in a category MHLW already treats as higher-risk.
- Health-damage reporting. A food business handling a designated-ingredient product must report to the relevant prefectural or local health authority when it becomes aware of information suggesting the food may have caused, or risks causing, human health damage — a duty specific to this category, separate from the broader Foods with Function Claims reporting duty that applies to a different, overlapping set of products. See our Foods with Function Claims guide for that separate system.
A product can sit in both systems at once — for example, an FFC-notified product that also contains a designated ingredient — in which case both sets of obligations apply together.
Before you ask for a quotation
Check every botanical against the current designated ingredients list before the formula is fixed.
- Every botanical or extract in the formula, by its scientific name, not only a trade or common name
- Whether any ingredient matches, or is derived from a plant closely related to, a currently designated ingredient
- Whether you want the product notified as a Food with Function Claims in Japan, which brings a separate reporting duty
- Who at your business (or your Japanese partner) will monitor and act on the health-damage reporting duty, if applicable
- Your label’s capacity to carry the extra warning text and business contact details
💬 Send us your formula and we will flag anything that falls under the designated ingredients system before you commit to a specification. Start the conversation.
Frequently asked questions
1. Does a designated ingredient mean the ingredient is banned in Japan?
No. It stays legal to sell as a food, under extra conditions: a mandatory warning label, a manufacturing and quality-control standard, and a health-damage reporting duty for the business.
2. How many ingredients are currently designated?
Four: Coleus forskohlii, greater celandine, Pueraria mirifica and black cohosh. MHLW can add ingredients, so check the current list at the time you specify a formula rather than relying on this guide alone.
3. Why was Pueraria mirifica the trigger for this system?
Reports of irregular vaginal bleeding and menstrual disorders linked to health foods containing it, gathered between 2012 and 2017, prompted the 2020 revision of the Food Sanitation Act that created the designated ingredients category.
4. Does the designated-ingredient warning replace normal food labelling?
No, it is additional. Allergen declarations, nutrition labelling and other standard requirements still apply on top of the designated-ingredient warning.
5. If my formula contains none of the four ingredients, am I free of this system entirely?
For now, yes, with respect to this specific system — but confirm the current list before finalising your formula, since MHLW can designate further ingredients, and check separately whether any ingredient is restricted under other Japanese food rules.
Sources: Ministry of Health, Labour and Welfare, list of designated ingredients under Food Sanitation Act Ministerial Notification No. 119 effective 1 June 2020 (mhlw.go.jp/content/12401000/000701977.pdf); Tokyo Metropolitan Government, Bureau of Public Health, “Foods Containing Designated Ingredients, etc.” (hokeniryo1.metro.tokyo.lg.jp/shokuhin/eng/kaisei/shiteiseibun.html and Japanese-language equivalent at tmiph.metro.tokyo.lg.jp/kj_shoku/kenkounavi/mshiteiseibun/); MHLW, “指定成分等含有食品（健康被害情報）” (mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/syokuchu/04_00003.html); ChemLinked, “Labeling of Food Containing Designated Ingredients etc. Enforced by Japan on June 1, 2020”; PubMed 35264518, “Recognition and Prevalence of ‘Designated Ingredient, etc.’ in Health Foods” (background on the Pueraria mirifica health-damage reports). Checked on 25 September 2026.