Expensive to get wrongJapan

Japan’s Act names seven things on the container

Article 61 of Japan’s Pharmaceuticals and Medical Devices Act requires a cosmetic’s immediate container to carry seven categories of information, and ingredient naming appears only as the names of ingredients the Minister designates, with anything further delegated to Ordinance of the Ministry of Health, Labour and Welfare.

The statute does not itself impose the full ingredient list that the European Union, Korea and Australia each require by primary instrument, so a team reading Acts across markets to size a labelling project will under-read Japan unless it also reads the ordinance the Act defers to.

Limits how to read Japan sorts the shelf into two legal classes

Exceptions and limits

MechanismArticle 66 is current, checked against the original
The prohibition on false or exaggerated advertising in Article 66 remains in the revision e-Gov reports as currently enforced from 21 May 2026, in the same terms the index’s existing Japanese claims describe, including the deeming provision for statements that could be misunderstood as a doctor’s guarantee.
Why the claim above is true. It does not limit it. Confidence 90 of 100.
Wrong if e-Gov reports a later enforced revision of Act No. 145 of 1960 in which Article 66 is amended or repealed, or in which the doctor-guarantee paragraph no longer deems such statements to fall within paragraph 1.
（誇大広告等）第六十六条　何人も、医薬品、医薬部外品、化粧品、医療機器又は再生医療等製品の名称、製造方法、効能、効果又は性能に関して、明示的であると暗示的であるとを問わず、虚偽又は誇大な記事を広告し、記述し、又は流布してはならない。２　医薬品、医薬部外品、化粧品、医療機器又は再生医療等製品の効能、効果又は性能について、医師その他の者がこれを保証したものと誤解されるおそれがある記事を広告し、記述し、又は流布することは、前項に該当するものとする。
Cite as omr:jp:the-statute-names-seven-things-on-a-cosmetic-container#article-66-is-current-checked-against-the-original

88 of a possible 97Tier A, primary document or measured outcome. Nothing at this tier is allowed past 97, however good it looks.

Verified August 6, 2026Rechecked every 365 days, next by August 6, 2027.

Constraint

Held since November 25, 2014A rule, law or policy that limits what you may do or say. The earliest date we are willing to say this held. It may well have been true before that; we do not backdate a record past the evidence we have read. Supported, version 1.

This entry is wrong if

Article 61 is amended to enumerate a full ingredient list, or the ministerial ordinance made under item 7 is shown to be the operative full-ingredient requirement, in which case this claim should be replaced by one about the ordinance.

Written before the record was published, not after. If you can show this, send it to hello@tryorbt.com and the correction goes on the record with the entry.

Evidence

Tier Aregulation
Digital Agency, Government of Japan (e-Gov Law Search): 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 (Act No. 145 of 1960), current enforced revision 335AC0000000145_20260521_505AC0000000063
（直接の容器等の記載事項）第六十一条　化粧品は、その直接の容器又は直接の被包に、次に掲げる事項が記載されていなければならない。ただし、厚生労働省令で別段の定めをしたときは、この限りでない。一　製造販売業者の氏名又は名称及び住所　二　名称　三　製造番号又は製造記号　四　厚生労働大臣の指定する成分を含有する化粧品にあつては、その成分の名称　五　厚生労働大臣の指定する化粧品にあつては、その使用の期限　六　第四十二条第二項の規定によりその基準が定められた化粧品にあつては、その基準において直接の容器又は直接の被包に記載するように定められた事項　七　前各号に掲げるもののほか、厚生労働省令で定める事項
The whole article. Item 4 is the only ingredient item and it is limited to ingredients the Minister designates; item 7 is the open delegation to ordinance. Rendering: name and address of the marketing authorisation holder; product name; manufacturing number or code; for cosmetics containing ingredients designated by the Minister, the names of those ingredients; for cosmetics designated by the Minister, the expiry date; for cosmetics with standards set under Article 42(2), the matters those standards require on the container; and anything else prescribed by ordinance.
Read 2026-08-06 · Open government · page hash 9ff97bbd3847
Tier Aregulation
Digital Agency, Government of Japan (e-Gov Law Search): 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 (Act No. 145 of 1960), current enforced revision 335AC0000000145_20260521_505AC0000000063
（直接の容器等の記載事項）第五十九条　医薬部外品は、その直接の容器又は直接の被包に、次に掲げる事項が記載されていなければならない。……二　「医薬部外品」の文字
Article 59, quoted alongside to show the contrast the two-class system produces: a quasi-pharmaceutical must carry the words “医薬部外品” on the container, and a cosmetic under Article 61 has no equivalent status marking. Ellipsis omits items 1 and 3 to 12.
Read 2026-08-06 · Open government · page hash 9ff97bbd3847

History

v1createdAugust 5, 2026
Entered from the authoritative Japanese text on e-Gov, read 2026-08-06 via the documented v2 JSON API, at the revision the register flags CurrentEnforced. Quotes are Japanese because that is what is authoritative; English renderings in the evidence notes are ours, and the confidence is set below the claims in this index that quote official English.
v1createdon a caveatAugust 5, 2026
Entered from the authoritative Japanese text on e-Gov, read 2026-08-06 via the documented v2 JSON API, at the revision the register flags CurrentEnforced. Quotes are Japanese because that is what is authoritative; English renderings in the evidence notes are ours, and the confidence is set below the claims in this index that quote official English.

Append-only. Nothing in this list is edited or removed once written, including the entries that record our own mistakes. Every change to every record is on the corrections page, and the same log is in entries.json under revisions.

jp
japan
labelling
ingredients
packaging
compliance

Cite this entry

“Japan’s Act names seven things on the container”, The Orbt Market Index 0.1.0, entry omr:jp:the-statute-names-seven-things-on-a-cosmetic-container, retrieved September 9, 2026, https://tryorbt.com/markets/entry/jp--the-statute-names-seven-things-on-a-cosmetic-container. Dataset: https://doi.org/10.5281/zenodo.22679129

Orbt, "Japan’s Act names seven things on the container," Orbt Market Index, entry omr:jp:the-statute-names-seven-things-on-a-cosmetic-container, verified August 6, 2026, https://tryorbt.com/markets/entry/jp--the-statute-names-seven-things-on-a-cosmetic-container.

@misc{orbt-jp-the-statute-names-seven-things-on-a-cosmetic-container,
  title        = {Japan’s Act names seven things on the container},
  author       = {{Orbt}},
  year         = {2026},
  doi          = {10.5281/zenodo.22679129},
  note         = {The Orbt Market Index 0.1.0 (dataset DOI 10.5281/zenodo.22679129), entry omr:jp:the-statute-names-seven-things-on-a-cosmetic-container. Verified 2026-08-06},
  howpublished = {\url{https://tryorbt.com/markets/entry/jp--the-statute-names-seven-things-on-a-cosmetic-container}},
  license      = {Orbt Index Public Licence. Free to quote and cite; not to redistribute}
}

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