The same skincare claim meets two different tests in each market

Quality gets the product out. Culture gets the brand in. So in every new market a brand has to be incubated again — to that culture — not translated. Terra Vista is a Japan-registered cross-border advisory group, and this page covers the third of four decisions in a skincare brand’s move abroad: the claim it leads with. A sentence that sells the product at home can be unusable in Japan, permitted in Thailand though only confirmed in advance where the company chooses to ask the Cosmetic Committee, and permitted in both markets while persuading buyers in neither. Two separate tests produce that outcome, and two different parties answer them.

Every regulatory fact below is quoted from the primary document that carries it and linked to that document, so a reader can check each statement rather than take it on trust. Where our records do not settle a question, the text says so and stops there, because a plausible reading of a statute is not the same thing as the statute.

Two tests decide a skincare claim, and different parties answer each one

A skincare claim entering a new market faces two separate tests: the market’s rules decide whether a brand may carry the claim at all, and the local reader decides what the claim means in the local language. Rules are published, so the first test can be researched from a desk. Reading is not published, so the second test has to be checked with people who buy in that market.

Answering both at once falls between three suppliers a brand usually already has. A contract manufacturer states what the formulation is able to do. An advertising agency writes the sentence well. A local operator knows how media runs in one country. Each answers accurately inside its own remit, and the span from what may be said to what gets understood runs across all three, so ownership of that span tends to be settled last.

Japan bounds the claim with a list, Thailand bounds it with a prohibition

For a cosmetic handled by notification rather than by item-by-item approval, Japan bounds the efficacy claims that may be displayed and advertised to the 56 items listed in Annex Table 1 of the Director-General notification of 21 July 2011, while Thailand instead prohibits seven types of statement in section 41 of the Thai Cosmetic Act of 2015 (Buddhist Era 2558) and publishes no list of permitted wording.

A positive list can be read end to end before a single line of copy is written, and a prohibition list cannot be read that way, because the space it leaves open is defined only by what it excludes. Japan’s structure adds a second layer to that: the notification carrying the 56 items states no conditions for using them, and the conditions sit in a separate notification issued the same day by two division directors.

Reading only the list also overstates how tight the Japanese boundary is. The same-day division-director notification adds that makeup effects and the feel of using the product may still be displayed and advertised outside the 56 items, so long as the wording is not contrary to fact, which puts finish, texture and sensory description on a different axis from efficacy.

Five questions separate the two markets in practice, and the table below places each market’s answer beside the document it comes from. Four of the five rows are settled in both markets by reading the documents named beside them, which is why a brand can work through those rows from a desk. One row differs in kind: certainty before publication, which Thailand routes through an optional opinion from the Cosmetic Committee, and which our records leave open on the Japanese side.

Reading across those rows, the largest operational difference is where certainty comes from, and in Japan it has two layers. Whether the efficacy may be claimed is settled by the Director-General notification and the division-director notification of 21 July 2011, with the fine-lines item alone adding a test the marketing authorization holder runs and keeps rather than files. How that claim may then be phrased is bounded by a separate advertising standard of 29 September 2017, which bars guarantees of efficacy or safety and bars maximum-level expressions.

Thailand puts that certainty somewhere else, because the Cosmetic Committee itself gives an opinion before publication when a notifier or an advertiser asks for one, and silence within sixty days counts as consent. Asking is optional rather than required, and a company that does not ask has no published list of permitted wording to read against instead.

In Japan the claim question and the category question are one question

Japan defines a cosmetic by the purpose for which the product is used and by whether the product’s action on the human body is mild, rather than by the ingredient list the product carries. A cosmetic outside the approval provision of Japan’s pharmaceuticals and medical devices Act is handled by a notification for each item, while a product inside that provision requires an approval for each item.

A claim is the plainest published statement of the purpose a product is used for, which is why we treat the claim question and the category question as one question rather than two. Naming that link as our reasoning rather than as a rule matters here, because the statute states the test and says nothing about how a marketing sentence maps onto it.

Carrying an efficacy claim outside the 56 items does not by itself place a product in the third limb of Japan’s quasi-drug definition, and the reverse reading is easy to reach from the list alone. The limb reaches only items designated by the Minister of Health, Labour and Welfare, so designation rather than the wording of a claim is what moves a product across that line.

An anti-ageing claim splits in Japan, and one half survives

The advertising guideline of the Japanese cosmetics industry federation, bound into the division-director notification of 21 July 2011 as reference material, separates a wrinkle claim into wording that is permitted and wording that is not, and places three common formulations on the prohibited side.

Permitted under item E18 of that guideline is an expression that moisture makes fine lines caused by dryness less noticeable. Not permitted are expressions that eliminate fine lines, expressions that prevent fine lines, and expressions of skin rejuvenation or anti-ageing effect. The guideline adds that the claim must not create the impression that the product works on all wrinkles including those caused by ageing, and that emphasising only the words for fine lines steps outside the permitted range.

So the half of an anti-ageing line that falls outside the permitted range is the promise of reversal, and the half that survives is narrower than the original: fine lines, caused by dryness, made less noticeable, by moisture. A brand deserves to hear that plainly rather than be told the claim was approved, because the surviving sentence keeps the texture benefit and drops the age benefit, and the guideline places skin rejuvenation and anti-ageing wording on the prohibited side, so the age benefit is not recoverable by rewording inside this category as the guideline is written.

Two openings sit outside the permitted efficacy range, and the same guideline names both: one leaves the cosmetic category, the other stays inside it. Wrinkle wording individually approved for a quasi-drug or a comparable category may be used within the range of that approval. Wording for a makeup effect that makes wrinkles look less noticeable stays permitted as before, so long as it neither guarantees the effect nor states something contrary to fact.

Carrying even the surviving version has a condition attached, and the condition is absent from the notification listing the 56 items. The same-day division-director notification requires the marketing authorization holder to run a test based on the anti-wrinkle product evaluation guideline named in it, or an equivalent or better test, and to confirm the effect.

Testing may be outsourced to another testing institution, but the records of the results and of the evaluation must be retained by the marketing authorization holder, and the judgement that the test is reliable and that the effect matches the claim rests with that same holder. Nothing is submitted to the authority and no prior approval is issued, which means the party who has to produce the support is the holder of the cosmetics marketing authorization, not the factory and not the agency.

The status of that guideline matters as much as its content. E18 is an industry self-regulatory standard rather than a statute, the notification asks only that adequate consideration be given to it, and the guideline carries no penalty of its own, so a brand should treat it as the clearest available statement of expected wording and not as the instrument that imposes the sanction.

Thailand bounds the claim by prohibition and offers an optional opinion, not a permitted list

Section 41 of the Thai Cosmetic Act prohibits advertising that uses statements unfair to consumers or statements liable to harm society as a whole, and lists seven such types, among them statements that are false or exaggerated, statements causing misunderstanding in a material respect, and statements showing efficacy in treating disease or efficacy that is not a cosmetic purpose.

Two further items in the same list are cultural rather than clinical: a statement that directly or indirectly encourages unlawful or immoral acts or leads to degradation of the national culture, and a statement that creates division or damages unity among the people. A brand whose campaign idea depends on provocation should read those two items before the creative brief is written, not after.

Reading section 41 alone cannot answer whether one specific sentence is permitted, because the section gives no positive list of acceptable wording, and the carve-out written into its final paragraph for statements an ordinary person would immediately see could not possibly be true is not defined any further. Section 46 of the same Act exists for exactly that gap.

Under section 46 a notifier or an advertiser in doubt may ask the Cosmetic Committee for an opinion before advertising, and the Committee must give that opinion and inform the applicant within sixty days of the Food and Drug Administration (FDA) office receiving the request. Failure to inform within the period counts as the Committee having consented, and an act done in accordance with the opinion, or with that deemed consent, is not a criminal offence.

Three limits apply to that opinion route. Asking is optional rather than mandatory, so the widely repeated claim that cosmetic advertising must be approved by the Thai authority before it runs does not match the Act. The opinion is not final, because the Committee may reach a different view later where there is good reason. Criminal protection is all the section gives, civil exposure is untouched, and labels run through a separate procedure in section 24 of the same Act.

The fee schedule attached to the Act sets a ceiling of 10,000 baht per matter for a section 46 opinion, and section 5 of the same Act requires the actual fee to be prescribed by ministerial regulation at a rate not exceeding that schedule. Our records do not contain that ministerial regulation, so the schedule figure is a statutory ceiling and not a price anyone should budget from.

The evidence behind a claim sits with a different party in each market

Japan places the evidence for the fine-lines efficacy inside the marketing authorization holder’s own files with nothing filed to the authority, while the ASEAN Cosmetic Directive that Thailand applies requires the company responsible for placing the product on the market to keep supporting data for claimed benefits readily accessible to the regulatory authority.

Article 8 of that Directive lists what has to be kept accessible at the address specified on the label, and the list runs from the qualitative and quantitative composition of the product through raw material and finished product specifications, method of manufacture, safety assessment for human health, existing data on undesirable effects, and supporting data for claimed benefits to justify the nature of the effect.

Neither Article 8 nor the Product Information File (PIF) guidelines prescribe how many files a company must keep, so the widely circulated rule that ten stock keeping units require ten dossiers has no source in either document. Article 8 contains none of the words file, dossier, per product or each product, and the guidelines state on their own face that they are not a legal document and that compliance with them is not a mandatory requirement.

Establishing that absence took two copies rather than one. Two versions of the Directive circulate with a different cross-reference inside the same sentence of Article 8, and the copy hosted at one of the two addresses is an optical character recognition scan carrying visible recognition errors in its body text, so the word search was run against the second copy as well before the result was relied on.

Language forms a separate line inside the same Article. Article 8 does not require the data to be held in English, and its second paragraph requires the official language of the member state concerned or a language readily understood by that state’s regulatory authority. A company keeping its safety and supporting-data files only in its home language has therefore not necessarily complied, and has not necessarily failed either.

The sentence that gets tested is the local-language one

Thailand requires the label of a cosmetic sold there to use Thai text of a size that can be read clearly, and requires that text to be true, to avoid causing misunderstanding in a material respect about the cosmetic, and to avoid being contrary to Thai morality or Thai good culture.

Foreign language may be added alongside the Thai text under the same provision. Japan arrives at a comparable position from a different direction, across two documents: the Act sets out what Article 61 requires on the container of a cosmetic, and the ministerial ordinance requires those entries to be made in Japanese, in its Article 218, which Article 221-3 applies to cosmetics. What that fixes is the language of the mandatory container items, not the language of marketing copy.

What those requirements settle is the label and the container, not every sentence a brand writes. The Thai text on the label of a cosmetic sold in Thailand is the version that has to be true and free of misunderstanding in a material respect, and in Japan the ministerial ordinance requires the entries Article 61 puts on the container to be made in Japanese. Under those requirements the text that is measured exists only in the local language, so it is the translated version that has to hold up rather than the wording approved at head office.

Thailand at least has a clear addressee for the question of whether the same requirement reaches the marketing sentence away from the label: a notification holder there can say whether anything obliges selling copy to be in Thai. Which party to ask is the part we can settle here; the answer itself is theirs to give.

One question stays open here, and naming it is more useful than a confident answer. The Japanese industry advertising guideline says nothing about claims made in languages other than Japanese, so how it applies to English or Chinese copy aimed at buyers inside Japan is not a question our records settle, and we would take it to a party who files in that market rather than infer an answer.

Both statutes reach the impression, not only the wording

Japan’s advertising prohibition applies to false or exaggerated articles about a cosmetic’s name, manufacturing method, efficacy, effect or performance whether the article is expressed explicitly or by implication, and Thailand’s advertising provision separately prohibits statements that would cause misunderstanding in a material respect about the cosmetic.

Two shapes are named in those rules directly. Japan’s provision treats an article liable to be understood as a guarantee given by a physician or another person as falling inside the prohibition, and Japan’s advertising standard of 29 September 2017 separately bars expressions guaranteeing efficacy or safety and bars maximum-level expressions or expressions of that kind.

Both shapes survive translation intact, which is what makes them expensive to discover late. A superlative and an expert endorsement can be rendered word for word into another language without a single translation error, and still sit inside the wording those rules address by name, so the failure is not a language failure, and a translation check is not the check that finds it.

Japan’s advertising standard also states the media it covers, and the coverage is broad: newspapers, magazines, television, radio, websites and social networking services, described there as all media. A brand that rewrites the sentence on its pack and leaves the same sentence running on its social accounts has fixed one surface, and websites and social networking services are named in that list.

What the two markets attach to a claim that is not permitted

Japan addresses the advertising prohibition to any person rather than only to the marketing authorization holder, and Thailand addresses its advertising offence to any person rather than only to the notifier, so a distributor, an advertising agency or a creator can fall inside the wording of either statute. Neither statute then draws the further line about which party is actually pursued.

The figures below are not all of one kind, and reading them as a single row of ceilings gets the largest one backwards. The two criminal fines and the Thai daily fine are ceilings, each written as a fine of not more than a stated amount: 2,000,000 yen in Japan, 100,000 baht in Thailand, and a further 10,000 baht for each day a violation continues.

The Japanese surcharge runs the other way. Article 75-5-2 sets 4.5 per cent of the total amount of consideration as the rate an order carries rather than a rate an order may go up to, and the three-year figure in the same provision caps the period the rate applies to rather than the sum. The 2,250,000 yen figure in that provision is a floor below which no order may be made rather than a ceiling anything reaches, so the smallest surcharge it permits to be ordered already sits above the 2,000,000 yen ceiling on the criminal fine.

Neither of those two Japanese figures is an amount anyone is known to have paid. Our records carry nothing on amounts actually imposed in either market, so no expected cost is given here, and none should be inferred from the figures listed below.

• Japan, criminal: advertising that is false or exaggerated is punishable by imprisonment for not more than two years or a fine of not more than 2,000,000 yen, or both, under Article 85 of the Act.
• Japan, surcharge: a separate order requires payment of 4.5 per cent of the total amount of consideration for the products transacted during the surcharge period, that period being capped at three years counted back from its last day, with no order where the calculated amount comes to less than 2,250,000 yen, under Article 75-5-2.
• Japan, what the rate applies to: the provision applies the rate to the total amount of consideration, so cost and margin are not deducted before the calculation is made.
• Thailand, criminal: advertising not in accordance with section 41, or failure to comply with section 42, is punishable by imprisonment for not more than one year or a fine of not more than 100,000 baht, or both, under section 84.
• Thailand, continuing violation: section 88 adds a further fine of not more than 10,000 baht per day throughout the period during which the violation continues or is not corrected, and section 84 should never be quoted without it.

Adding those figures into an exposure estimate is where our records stop. Section 88 sets no test for when a violation counts as continuing and no date from which the daily fine starts, so any arithmetic of the form one year unremoved equals a given total would be our inference delivered in the voice of the statute. Whether that daily fine is today a criminal fine or a non-criminal administrative penalty is also unsettled in our records, and stating it either way would be a guess.

Japan’s advertising standard carries no penalty of its own, and sanctions run instead through the statutory prohibition on false or exaggerated advertising, the criminal provision attached to it, and the surcharge provision. Treating the standard as the enforceable instrument misreads the structure, because the standard sets the expression while the Act sets the consequence.

What Terra Vista does at the claim step

Terra Vista takes the claim a brand uses today and runs the claim market by market against two questions: whether the claim sits inside what the market’s rules permit, and what the sentence will be understood to mean once written in the local language and read by a local buyer.

Where a claim falls outside what a market permits, we name the half that puts it outside rather than rejecting the whole sentence, offer wording that stays inside, state plainly how much of the original meaning the replacement can carry, and name what that replacement needs as support and which party has to produce it. Where a claim cannot survive in a market at all, we say so and show what the category can carry instead.

We do not act as a legal authority. Our work is to read each market’s own documents against one specific product and one specific claim, say which of a brand’s current answers does not hold, and set out the route we consider most workable, with the document behind each line so the reasoning can be checked and, where a point rests on practice rather than text, taken to the party who does that work.

The claims that survive become the plan for what runs where: one proposition, forked by market, with the reason each version differs from the others written down beside it. A brand entering two markets at once needs that fork on paper before media is booked, because the fork determines what can be shared across markets and what has to be built twice.

Questions worth settling at this step

Five questions have to be settled at the claim step, and each is answered below in short form, with the supporting documents linked in the sections above. Answers here stay general on purpose, because the specific answer depends on the product, the category and the market.

Can I still use the claim I have always led with?

Sometimes yes, and often only in part. The usual outcome is not approval or rejection of the whole sentence but a split, where one clause stays and another falls outside what the market permits. The first move is to identify which clause is doing the selling, because that clause decides both whether the claim is permitted and whether the product is still worth buying once the clause is gone.

If I cannot use it, what do I change it to, and does the original meaning survive?

A replacement usually exists, and the replacement is narrower than the original. Honest practice is to say how much of the original meaning the narrower version carries and what has been dropped, rather than presenting the replacement as equivalent. Where nothing in the category can carry the original benefit, saying so early costs far less than discovering it after packaging has been printed.

I want several markets at once. One set of messaging, or one per market?

One proposition, forked by market. A single global sentence forces the strictest market to set the ceiling for every other market, and a separate proposition per market destroys the thing that makes a brand recognisable across borders. The workable answer keeps the proposition shared and forks the wording, with the reason for each fork written down beside it.

The translation is accurate, so why do local buyers read the claim differently than expected?

Accuracy of translation and accuracy of impression are different things, and the rules in both markets described above reach the impression rather than the words alone. A sentence can be rendered correctly word for word and still create an understanding the market does not permit, or an understanding local buyers simply do not find credible.

Once the claim is settled, who builds the campaign and what does it include?

The party that runs media in the target market builds and runs the campaign, and that party is normally local. What comes out of this step is the input that party needs: which version of the claim runs in which market, what supports each version, which party holds that support, and which wording has already been ruled out and why.

Why the claim step sits where it does

A claim compresses the whole cross-border problem into a single sentence, which is why the claim step sits third of four rather than first. The break in cross-border business is not logistics — it is culture. Goods ship, money transfers, and regulations can be checked line by line. What does not ship is business context, decision logic, and the way trust is built, and a claim is where all three surface at once.

So the way Terra Vista works is: Culture as the bridge, understanding as the path. Applied to this step that means Culture Isn’t Cargo — understand culture, don’t just ship it. Working that way means not translating the sentence that already worked at home and sending it across, but first working out what the market permits and how people there judge, and only then deciding what gets said.

Terra Vista is a Japan-registered cross-border advisory group, and the claim is the third of four decisions in the way we work. Choose the market, then work out that market’s rules, then write the claim, and choose the factory last. A contract manufacturer, an agency and a regulatory adviser each own one segment of that sequence, and what we own is the brand not changing shape as it moves between them. The market decision and the compliance route that come before this step, and the factory conversation that comes after it, are set out on the studio page, which links each step to the work behind it.