Is Expiry Labelling Mandatory in Japan?
- Jun 5
- 7 min read
Background
In Japan, cosmetics are primarily governed by the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices（Act No. 145 of 1960) (also known as the Pharmaceuticals and Medical Devices Act (PMDA), formerly known as the Pharmaceutical Affairs Act (PAA) or the 薬事法 (Yakujihō).
In accordance with the Article 61 of PMDA, cosmetics must have the following information labelled on their immediate container or immediate packaging. However, this shall not apply if otherwise provided for by Ministry of Health, Labour and Welfare (MHLW) Ordinance.
Mandatory Cosmetics Labelling Requirements in Japan
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_________Q
Does this mean that All cosmetics sold in Japan bear an expiry date?
A_________
Not all cosmetics in Japan are required to display an expiration date
Why is "expiry date labeLling" attracting attention now?
▶Increasing consumer safety awareness and quality assurance needs
In recent years, consumer interest in cosmetics has expanded beyond functionality to include product safety and quality retention. This trend has become particularly significant with the growing popularity of natural formulations and preservative-free products.
As a result, consumers are increasingly asking questions such as:
“What is the expiry date?”
“How long can I safely use this product?”
To mitigate consumer complaints, product returns, and reputational risks, companies should correctly understand Japan’s regulatory requirements relating to expiry date labelling.
▶Why is there a difference in whether or not an expiry date is Labelled?
Consumers may notice that some cosmetic products sold in Japan display an expiry date, while others do not.
This difference is not simply left to the discretion of manufacturers or distributors. Rather, it is based on regulatory requirements established under MHLW notifications issued in 1980.
Under these rules, cosmetics meeting certain conditions may be exempted from expiry date labelling requirements, whereas products that do not satisfy these conditions must display an expiry date.
What are the conditions under which expiration date labelling is mandatory?
The underlying regulations that regulates whether or not an expiry date must be dislpayed are
Pharmaceuticals, Medical Devices, etc. that must have an Expiration Date Indicated pursuant to the Provisions of Article 50, Item 16, etc. of the PMDA (MHLW Notification No. 166 of 1980)
Importantly, these regulations do not require all cosmetics to display an expiry date. Instead, expiry date labelling is mandatory only for products that meet certain criteria, including:
Cosmetics containing ascorbic acid, its esters or salts thereof, or enzymes; and
Cosmetics that may change in properties and quality within three years under appropriate storage conditions after manufacture or import.
This determination should not focus solely on the stability of individual ingredients. Rather, the assessment should consider whether the overall properties and quality of the cosmetic product may deteriorate within the relevant period.
For example, natural and organic cosmetics that do not contain preservatives or antioxidants, as well as creams and liquid formulations prone to deterioration after opening, may require expiry date labelling if their quality could change within three years.
Similarly, products intended for long-term storage rather than single-use applications should also be evaluated carefully to determine whether deterioration risks exist within the three-year period.
Decision-making process based on product design and quality data
Whether an expiry date must be displayed should be determined based on product-specific stability and shelf-life data.
Key factors to evaluate include:
Whether the product contains ascorbic acid, its esters or salts thereof, or enzymes;
The type and concentration of preservatives used;
The characteristics of the formulation (e.g., cream, liquid, gel);
The airtightness of the container; and
Resistance to light, humidity, and other environmental conditions.
From the product development stage, companies should verify whether the product can maintain its quality for more than three years under unopened and appropriate storage conditions.
Maintaining supporting stability data is important, as this serves as the basis for determining whether expiry date labelling may be omitted. Accordingly, regulatory affairs, product development, and quality assurance departments should collaborate early in the product lifecycle to establish an appropriate compliance strategy.
When is expiryDate LAbelling Exempted?
Cosmetic products that have been confirmed to remain stable for at least three years under appropriate storage conditions are generally exempted from expiry date labelling requirements.
For example, general lotions and emulsions containing sufficient preservatives and packaged in airtight and light-resistant containers may not require expiry date labelling if stability has been adequately demonstrated for three years or more.
In such cases, manufacturers and distributors may choose to omit expiry date labelling after sufficiently confirming product stability.
NOTE!"no labelling required" does not mean "no expiry date."
It's important to note that, "no labelling required" does not mean "no expiration date."
The absence of an expiry date label does not mean that the product can be used indefinitely. The regulations merely exempt certain products from displaying the expiry date. Even where labelling is not required, manufacturers and distributors are still expected to establish an internal shelf life based on stability testing and scientific evidence.
These internally established expiry periods become extremely important when responding to consumer complaints, product quality investigations, or regulatory inquiries. Given that the absence of an expiry date may create misunderstandings among consumers, companies are encouraged to provide supplementary storage instructions and usage guidance through packaging, FAQs, or official websites.
How to display the expiry date?
In accordance with MHLW Notification No. 166 of 1980, the expiry date should be stated "to the month." There is no obligation to include the day.
It is acceptable to simplify the indication, for example, "December 2026" to "08.12." However, it is required to include words such as "Expiry Date" to make the meaning of the year and month clear.
Examples of labels used in practice (e.g., "Expiry Date: Year/Month")
While there is no legally mandated format for displaying this information, the following are common practical examples.
"Expiry date: June 2027"
"EXP: 2027/06" (A common format for export and import products)
"Manufacturing date: June 2024 / Use within 6 months of opening"
Such formats improve consumer understanding and help minimize confusion. For products intended for export, companies should also consider consistency with overseas labelling requirements, including those applicable in the EU and the US.
Risk of Violations Under the Premiums and Representations Act and the PMDA
Failure to display a mandatory expiry date, or the use of ambiguous expressions relating to product stability, may potentially raise concerns under Japan’s Act against Unjustifiable Premiums and Misleading Representations (Premiums and Representations Act).
For example, claims implying that a product maintains quality indefinitely, despite actual deterioration risks, may be considered misleading representations if adequate supporting evidence is unavailable.
In addition, cosmetics that are legally required to display an expiry date but fail to do so may violate Article 61, Item 5 of the PMDA.
Under the Premiums and Representations Act, regulatory assessments focus not only on explicit statements, but also on how consumers are likely to perceive the overall representation. Accordingly, combinations of claims such as “high quality” or “long-lasting” together with the omission of expiry date information may potentially be viewed as "misleading".
Failure to comply with expiry date labelling requirements under the PMDA may result in administrative actions by the authorities, including orders for corrective measures, product recalls, suspension of sales, or other regulatory enforcement actions. In addition, representations that are considered misleading under the Premiums and Representations Act may trigger investigations by the Consumer Affairs Agency (CAA), resulting in corrective orders, public disclosure of violations, reputational damage, and, in serious cases, administrative surcharges. Beyond legal penalties, non-compliance may also increase the risk of consumer complaints, product liability disputes, and loss of consumer trust.
Alignment with Overseas Labelling Requirements
While Japan exempts certain cosmetics from expiry date labelling requirements, stricter requirements may apply in overseas jurisdictions. For example, in the European Union, the Period After Opening (PAO) symbol is widely used and may be mandatory under certain circumstances.
For companies involved in exports or cross-border e-commerce, inconsistencies between Japanese and overseas labelling practices may create compliance risks or commercial issues in foreign markets.
Accordingly, adopting globally harmonized labelling strategies is becoming increasingly important.
Development of Internal Standards and Labelling Manuals
Manufacturers and distributors are encouraged to establish and document internal labelling standards and decision-making procedures.
Examples may include:
Defining product categories requiring mandatory expiry date labelling;
Establishing minimum shelf-life thresholds triggering labelling obligations; and
Documenting scientific justifications for omitting expiry date displays.
Maintaining such records can significantly reduce compliance risks and improve preparedness for regulatory inspections, audits, or administrative inquiries.
Final Takeaway
While the answer to the question, “Must I label the expiry date on cosmetics?” may appear relatively straightforward and ultimately depends on the regulatory requirements of each jurisdiction, the broader reality is far more complex in today’s global marketplace.
Expiry date and shelf-life labelling requirements vary significantly across regions, with differences not only in whether labelling is mandatory, but also in how information must be presented, substantiated, and communicated to consumers. As cosmetic supply chains and distribution channels become increasingly globalized, companies can no longer afford to assess compliance solely from the perspective of a single target market.
Instead, cosmetic manufacturers, brand owners, and regulatory teams should adopt a holistic, portfolio-wide regulatory strategy from the product development stage. Taking a bird’s-eye view of global market requirements allows companies to better harmonize formulations, packaging, stability testing strategies, and labelling approaches across multiple jurisdictions.
Such an approach can help:• maximize economies of scale;• reduce unnecessary packaging variations;• improve operational efficiency;• minimize regulatory rework and relabelling costs; and• accelerate time-to-market across different regions.
Ultimately, expiry date labelling is no longer just a local compliance issue — it has become part of broader global product stewardship, supply chain optimization, and international market access strategy.
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