[bogo]

Cosmetics are indispensable in our lives.
Its "Scope of Indication" has changed with the PMD Act (Yakki-hou) (previously named PAL(Yakuji-hou)) that regulates it in Japan.
Let's check out the changes it this time.

1.Enactment of the PAL [1][2]

• in 1873: "Isei","Yakuzai-torishirabe-no-houhou" were promulgated
• in 1943: "PAL(Act No. 48 of March 12, 1943)"was scattered under the WWII
• in 1948: "PAL(Act No. 197 of July 29, 1948)"was scattered. This PAL was fully revised under GHQ
• in 1960: "PAL(Act No. 145 of 1960)" was scattered. This PAL was fully revised again.

It is said that the PAL of 1960 was inherited by the current PMD Act.
So, let's take a look at the changes in the "Scope of Indications" for cosmetics from here.

2."Scope of Indications" for cosmetics of the PAL of 1960

The "Scope of Indications" of cosmetics at this time is shown in Appendix 1 of Notification [3].
I pasted the capture image, but I'm sorry, it's only in Japanese.

At that time, the "Scope of Indications" was determined for each category.
It is similar to the table of the "Scope of Indications" of current quasi-drugs.
(In order from the leftmost column, it is the category, item, and range of efficacy.)

3."Scope of Indications" for cosmetics of the PAL of 2000

2000 was a turbulent year for the Japanese cosmetics industry.
Due to the large-scale deregulation (change of the approval system* to cosmetic standards + notification system), it has become extremely easy for new entrants and new product launches. At this time, it can be said that the Japanese cosmetics industry entered the Warring States period. The responsibility required of companies has clearly increased [4][5].

*From 1986 to 2000, the permission system underwent the following changes.
Individual permission system (manufacturing permission for individual items) → Classification permission system (if it meets the cosmetic type permission criteria, notification is sufficient) → Classification approval system (Ingredients outside the classification permission standard can be submitted if they are within the approval range)

The "Scope of Indications" as revised in 2000 is indicated in the Annex to the Notice [6].
I've also attached the capture image though I could only find the Japanese version.

With this revision, the setting of the scope for each category was abolished, and the mechanism was changed to stipulate the "cosmetic efficacy"[6]. It can be seen that this is almost the same as the current one.

4."Scope of Indications" for cosmetics of the PAL of 2011

The "Scope of Indications" for cosmetics efficacy for 2011 is shown in the Annex to the Notice [7].
However, this is just the 2000 edition with the addition of "(56) Makes fine wrinkles due to dryness less noticeable."
Since it is information that comes out immediately if you search, I will omit the captcha.

Summery / Oggo.jp

As I have written so far, the scope of Indications for cosmetics has undergone a transformation.

In the cosmetics business, it is important to note that this is the "range of efficacy" and not the "range in which your product can be advertised."
If you misunderstand this point when developing your products, it may lead to long-term damage, such as violating the Act against Unjustifiable Premiums and Misleading Representations and giving consumers misunderstandings and negative images of the raw materials and techniques used.

I would like to talk about the actual regulation of cosmetics advertising in Japan in another topic.

Oggo.jp actively supports the cosmetics business.
We are proud to offer a wide range of support, so please feel free to contact us if you have any concerns.
The first consultation is free of charge.

Reference

1. 宮本法子「薬事衛生の歴史的変遷と薬学教育6年制改革の開始」日本医史学雑誌第54巻第3号. 305-306. 305. http://jsmh.umin.jp/journal/54-3/305.pdf. （参照2022−08−04）
2. 城下賢一「薬事法改正と行政・団体関係1956-1960 : 自民党政権初期の政策決定過程の事例分析」. 立命館大学人文科学研究所紀要 124号. 169-203. 169,170. https://ritsumei.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_detail&item_id=14219&item_no=1&page_id=13&block_id=21. . （参照2022−08−04）
3. 昭和36年2月8日付け薬発第44号薬務局長通知「薬事法の施行について」https://www.mhlw.go.jp/web/t_doc?dataId=00ta6817&dataType=1&pageNo=1. （参照2022−08−04）
4. 岩倉 良平「薬事法と規制緩和」色材協会誌74 巻 (2001) 5 号. 247-257. https://www.jstage.jst.go.jp/article/shikizai1937/74/5/74_247/_pdf/-char/ja（参照2022−08−04）
5. 平成12年9月29日付け医薬発第990号厚生省医薬安全局長通知「化粧品規制緩和に係る薬事法施行規則の一部改正等について」https://www.mhlw.go.jp/web/t_doc?dataId=00ta6887&dataType=1&pageNo=1. （参照2022−08−04）
6. 平成12年12月28日付け医薬発第1339号医薬安全局長通知「化粧品の効能の範囲の改正について」https://www.city.hirakata.osaka.jp/cmsfiles/contents/0000002/2816/66845.pdf. （参照2022−08−04）
7. 平成23年7月21日付け薬食発0721第1号厚生労働省医薬食品局長通知「化粧品の効能の範囲の改正について」https://www.mhlw.go.jp/web/t_doc?dataId=00tb7518&dataType=1&pageNo=1. （参照2022−08−04）

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