👋 - Kishan Babuji
Today’s edition is a bit of a long one, but it’s well worth the read. We’re focusing entirely on Japan. First, Karen shares a quick summary of the changes Japan has implemented so far this year. Then, you’ll find a special guest piece from Jiwon Koh, a visiting attorney from Japan, who provides an essential in-depth breakdown of Japan’s consequential 2025 reforms to cosmetic claims governance and ingredient highlighting.
Please email us for access to the 56 Cosmetic Efficacy Claims in Japan.
Regulatory Bytes From Karen
Japan: Sharpened Labeling and Evidence Expectations
Japan spent 2025 fine‑tuning how information is presented to consumers and how evidence underpins higher‑value claims.
Legacy “special labeling” rules have been modernized. Japan’s Ministry of Health, Labour and Welfare (MHLW) updated the long‑standing regime for special labeling of specific ingredients, requiring clearer identification and function disclosure of risk‑linked substances and tightening consistency between label, advertising, and dossier.
Full, intelligible ingredient labeling is under a brighter spotlight. Guidance emphasized complete ingredient lists in Japanese alongside INCI‑like nomenclature, with special care around sensitizers and borderline ingredients that might push a product into quasi‑drug territory.
Functional claims must be properly substantiated. Authorities and 2025 guidance reiterated that whitening, anti‑dandruff, and similar “effect” claims require robust data and are routed through the quasi‑drug framework under a responsible marketing authorization holder.
What it means for you: For Japan, 2025 was less about new bans and more about closing daylight between label, claims, and evidence. Expect more questions on dossiers for border‑line cosmetics and quasi‑drugs, and make sure your Japanese ingredient lists and claims narratives are airtight.
Guest Article by Jiwon Koh, Attorney (Japan Cosmetics Regulatory Practice)
Japan’s 2025 Ingredient Highlighting Reforms: What Changed, How It Interacts with the 56 Cosmetic Claims, and What Global Brands Must Now Do
1. Why Japan’s 2025 Notification Matters
In 2025, Japan quietly implemented one of the most consequential updates to cosmetic claims governance in decades. On March 10, 2025, the Ministry of Health, Labour and Welfare (MHLW) issued Notification Iyaku-Kanma-Hatsu 0310 No. 3, “Special Highlighting of Certain Ingredients in Cosmetics”, the“2025 Tokki-hyoji Notification”.
The 2025 Tokki-hyoji Notification:
Formally repeals the old “Yakukankei No. 53 (1985)” notice; and
Reorganizes in concrete detail—with an attached Q&A—what Japan calls tokki hyōji: the special highlighting of specific ingredients in cosmetics.
The preface to the notification states that the expressions are being revised:
“in light of changes in the environment surrounding cosmetics advertising, and to make them easier to understand.”
In other words, Japan is not changing the basic definitions of cosmetics and quasi-drugs, nor the licensing structure for Marketing Authorization Holders (MAHs) and manufacturers. Instead, the 2025 rule is best understood as a claims-governance reform: it rewrites how ingredient-centric stories may be told on packaging, e-commerce pages, and advertisements in an era of EC, SNS, and influencer marketing.
For U.S. and EU brands, this is very different in focus from MoCRA. While MoCRA in the United States primarily builds a safety infrastructure (facility registration, product listing, serious adverse event reporting, GMP, etc.), Japan’s 2025 reform tightens the rules of engagement for ingredient‐led claims in a system that already limits cosmetic efficacy to 56 permitted indications.
2. What Actually Changed on March 10, 2025?
2.1 No change to basic definitions—but a major change in claims architecture
As of 2025, there have been no major statutory reforms that alter:
the definitions of cosmetics and quasi-drugs under Articles 2(3) and 2(2) of the PMD Act;
the basic licensing framework for MAHs and manufacturers; or
the overall structure of the GQP (Good Quality Practice) and GVP (Good Vigilance Practice) Ordinances.
The 2025 Tokki-hyoji Notification instead targets a specific but highly practical question:
When a cosmetic product specially highlights a particular ingredient, under what conditions is that legally acceptable?
To answer this, the notification:
Defines what counts as “special highlighting of certain ingredients”;
Clarifies that the concept applies not only to packages and containers, but also to EC sites, pamphlets, and advertising; and
Establishes a dual-requirement whenever an ingredient is highlighted:
display of the ingredient name, and
clear indication of its formulation purpose, which must be objectively substantiated.
2.2 Different impacts on cosmetics and quasi-drugs
Cosmetics.
The main target is cosmetics. For these products, the notification:
makes it explicit that tokki hyōji includes textual, visual, and even English-language emphasis on ingredients; and
requires that any highlighted ingredient be accompanied by:
its name (in principle, the Japanese cosmetic ingredient name), and
its purpose in the formulation, framed within cosmetic-level efficacy or formulation technology.
In practical terms, this means that at the formulation design and copywriting stages, companies can no longer treat ingredient highlights as “soft” marketing. They must be prepared to show:
why a given ingredient is being highlighted in the first place; and
how its stated purpose can be objectively explained based on data.
Quasi-drugs.
For quasi-drugs:
where a company wishes to highlight a component other than an approved quasi-drug active, it may be treated analogously to cosmetics.
In other words, the 2025 notification does not change the approval-based system for quasi-drug actives or quasi-drug efficacy claims. Those continue to rely on:
inclusion of individually approved active ingredients at specified levels, and
product approval as a quasi-drug.
However, where a quasi-drug wishes to highlight non-active ingredients, the new cosmetics-oriented tokki hyōji rules effectively become the practical standard.
3. The 56 Cosmetic Efficacy Claims and Ingredient Highlighting
3.1 The 56-claim framework as the starting point
Since the “Yakushoku-hatsu 0721 No. 1 (2011)” MHLW notice, Japan has limited cosmetic efficacy claims to 56 permitted indications. These cover familiar concepts such as:
moisturizing, keeping the skin healthy, conditioning the skin;
smoothing the skin, preventing dryness, protecting the skin;
preventing sunburn and sun spots (within cosmetic scope);
keeping hair and scalp healthy, etc.
The 2025 Tokki-hyoji Notification does not add to or subtract from this list. Instead, it builds on it, making clear that when an ingredient is specially highlighted:
Its formulation purpose must fall within the permitted cosmetic efficacy range and/or
expressions based on formulation technology (for example, texture, feel, product stability); andThat purpose must be “objectively substantiated.”
The Q&A to the notification gives concrete examples of acceptable formulation purposes, including:
“moisturizing,” “conditioning,” “skin protection,” “UV protection,” “tightening,” “emollient/oil supplement,” “making the scalp or hair moist and smooth,” and
formulation-technology-based purposes such as “coating agent,” “thickener,” or “antioxidant for the product.”
These are not exhaustive, but they illustrate the type of purposes that can be used when grounded in the 56-claim system or formulation science and supported by objective evidence.
3.2 What “objectively substantiated” means in practice
The notification and its Q&A explain, in substance, that:
“Objectively substantiated” means the expression can be objectively explained as an efficacy or formulation-technology-based statement; and
The supporting materials may consist of internal data, provided that they have sufficient objectivity.
Reasonably interpreted, this means that Japan is not demanding GCP-level, pharmaceutical clinical trials for cosmetic tokki hyōji. However, regulators do expect companies to be able to rationally explain, for example:
Why does this concentration and formulation of Ingredient X justify stating that it is a “moisturizing ingredient” or “skin-protecting ingredient”?
The documentation may combine:
raw material supplier data;
in vitro assays;
basic human use tests;
published literature; and/or
internal formulation evaluations.
The bar is therefore best understood as a “reasonable basis” standard for cosmetic-level claims, rather than a drug-level evidentiary requirement—but it is a real burden of proof, especially where ingredients are visually or textually highlighted.
3.3 “Aging care” vs quasi-drug “anti-wrinkle”
This has important implications for anti-aging positioning.
For quasi-drug-level claims such as “wrinkle improvement” or “whitening (suppression of melanin production),” the long-standing framework remains:
include an individually approved quasi-drug active ingredient at the specified level, and
obtain product approval as a quasi-drug.
For cosmetic-level expressions such as “aging care” (in Japan, typically defined as “moisturizing care appropriate to one’s age,” not a medical claim), the question becomes:
does the expression remain within the 56 cosmetic efficacy items (for example, moisturizing, keeping the skin healthy, conditioning the skin)? and
if an ingredient is highlighted as delivering that effect, can its formulation purpose and effect be objectively substantiated under the new tokki hyōji framework?
For global brands, this means that anti-aging strategy in Japan must cleanly separate:
quasi-drug pathways (with approved actives and formal approval); and
cosmetic-level “aging care” positioning within the 56-claim + tokki hyōji structure.
4. Labeling Practice, INCI Names, and “Scientific Evidence”
4.1 No new 2025 obligation for full ingredient lists
One point of confusion has been whether 2025 introduced new rules on ingredient lists themselves. It did not.
Japan has, for many years, required full ingredient lists in Japanese cosmetic ingredient names on cosmetic labels. The 2025 notification does not revise this basic rule.
Instead, it clarifies:
Under what conditions may a subset of ingredients—the specially highlighted ones—be singled out in advertising and on packaging?
In other words, the full ingredient list remains governed by existing rules; the 2025 notification speaks to the “extra” emphasis a brand places on particular ingredients.
The notification also does not provide a fixed statutory sell-through period or grandfathering rules for existing stock. In practice, timing and corrective measures—for example, relabeling or implementing label corrections at the next print run—are typically handled through administrative guidance on a case-by-case basis, often in dialogue with local prefectural authorities, rather than through a rigid one-size-fits-all deadline.
4.2 INCI names: still widely used in practice
Legally, the full ingredient list must use Japanese cosmetic ingredient names, but for internationally marketed products it remains common practice to:
add INCI names in English in parentheses, or
provide parallel English labeling for other markets.
The 2025 Tokki-hyoji Notification does not prohibit the use of INCI names. Instead, it focuses on ensuring that:
formulation purposes are clearly stated and fall within the permitted cosmetic scope or formulation technology; and
those purposes are objectively substantiated, regardless of whether the ingredient is identified by a Japanese name, INCI, or both.
From a practical standpoint, U.S./EU brands can continue to use INCI in global packaging, but must ensure that Japanese overlabels and marketing materials:
use the appropriate Japanese ingredient names; and
correctly express the formulation purposes in line with the 56-claim system and the 2025 notification.
5. Overlabeling, MAHs, and the “Responsible Person” Question
The U.S. concept of the “Responsible Person” under MoCRA does not have a one-to-one counterpart in Japanese law. However, the combined operation of MAHs, manufacturers, and pharmacists serves a somewhat analogous function.
The Marketing Authorization Holder (MAH-like role):
places the product on the Japanese market in its own name; and
bears ultimate responsibility for quality and safety, with pharmacists or similarly qualified personnel in key positions.
The manufacturer (factory / packaging entity):
performs the actual manufacturing, packaging, and labeling; and
also has qualified staff in place.
For imported products, the usual pattern is:
The overseas brand does not register directly as a Responsible Person.
Instead, a Japanese import/distribution company becomes the MAH.
The MAH’s in-house pharmacist or regulatory staff:
reviews the formula and labeling for compliance, and
prepares the Japanese overlabels (stick-on labels) required for sale in Japan.
The 2025 Tokki-hyoji Notification does not change who the MAH is, nor does it create a new formal “Responsible Person” category. However, because:
ingredient highlighting now triggers specific obligations to state formulation purposes and assemble objective substantiation,
the practical workload and responsibility of MAHs, pharmacists, and regulatory staff will increase—especially for importers who adapt global packaging for Japan.
For global brands, this means that early coordination with the Japanese MAH and its pharmacists on:
which ingredients to highlight;
how to state formulation purposes; and
what substantiation is available,
will be key to avoiding last-minute relabeling or claim revisions.
6. Enforcement, Stealth Marketing, and the Broader Risk Landscape
Japan’s 2025 Tokki-hyoji Notification is not being applied in isolation. It sits atop an existing body of advertising and enforcement practice, anchored by the Guidelines for Proper Advertising of Pharmaceuticals, etc. and, more recently, stealth marketing regulation under the Act against Unjustifiable Premiums and Misleading Representations.
Typical problematic patterns in recent years have included:
cosmetic products claiming pharmaceutical-level effects (for example, anti-inflammatory, hair growth promotion, improvement of atopic dermatitis);
influencer posts promising results such as “clears acne overnight” or “pharmaceutical-level effect”; and
before/after images of cells, blood vessels, or skin structure suggesting improvement in human structure or function.
Such cases have been treated as violations of rules on false or exaggerated advertising under the PMD Act and related consumer protection law.
The 2025 tokki hyōji notification is structured to work together with these frameworks by adding a new layer of discipline to ingredient-focused stories:
how ingredient names are presented;
how formulation purposes are worded; and
how visual and English-language messaging about ingredients is treated as part of the claim.
At the same time, Japan’s 2023 stealth marketing guidance emphasizes that paid or sponsored communications—including influencer content—that are not clearly labeled as such may constitute misleading representations. For cross-border brands that rely heavily on influencers, this means:
ingredient highlight claims in influencer content;
disclosures of sponsorship; and
alignment between influencer scripts and the 56-claim / tokki hyōji framework
all need to be managed as part of a unified compliance strategy.
7. Practical Takeaways for U.S. and EU Brands
For non-Japanese companies, the key message is that Japan’s 2025 reforms are not just another labeling tweak. They reshape how ingredient-led branding must be structured in a market where:
cosmetic efficacy is limited to 56 claims, and
ingredient highlighting now carries its own substantiation and wording obligations.
Some concrete steps for U.S./EU brands:
Map your claims to Japan’s 56 efficacy items.
Before entering Japan—or even at the concept stage—cross-walk existing global claims to the 56 permitted indications. Identify which claims:can be retained with minor wording adjustments;
must be reframed as purely cosmetic (for example, “aging care” rather than “anti-wrinkle”); or
require a quasi-drug pathway.
Create a tokki hyōji substantiation file for each highlighted ingredient.
For every ingredient you intend to highlight on packaging, EC pages, or influencer scripts, prepare a file that:states the formulation purpose in Japanese and English;
links that purpose to the 56-claim framework and/or formulation technology; and
compiles the supporting data (supplier data, in vitro, human use test, literature, internal evaluations).
Align global packaging and Japanese overlabels early.
Work with your Japanese MAH and pharmacists to:determine which global ingredient stories can be localized;
ensure that Japanese labels include both the ingredient name and formulation purpose where ingredients are highlighted; and
anticipate any required claim downgrades for Japan.
Integrate EC, SNS, and influencer content into the same compliance review.
Assume that EC product pages, brand websites, SNS posts, and influencer content are all in scope for tokki hyōji. Treat:ingredient highlights in these channels, and
stealth marketing disclosure requirements,
as a single regulatory problem rather than separate silos.
Keep MoCRA and Japan’s system in parallel, not blended.
From a governance perspective:MoCRA is constructing a safety reporting and infrastructure regime in the U.S.;
Japan’s 2025 notification is tightening a claims-governance regime anchored in the 56-claim framework and advertising rules.
For global brands, success now requires mastering both: robust safety systems for the U.S., and finely tuned ingredient-claim architectures for Japan.