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How does Japan regulate cosmetic ingredients?

Japan legally classifies beauty products into cosmetics and quasi drugs, which have different ingredient standards. Both cosmetics and quasi drugs shall comply with the "Ordinance on Tar Color Used in Pharmaceuticals, etc."

Besides, cosmetics shall also meet the requirements of the "Standards for Cosmetics" as well as the negative and positive ingredient lists attaching to it, including:

1) List of Permitted UV Absorbers for Cosmetics (positive list)

2) List of Permitted Preservatives for Cosmetics (positive list)

3) List of Restricted Ingredients for Cosmetics (positive list)

4) List of Prohibited Ingredients for Cosmetics (negative list)

How does Japan regulate quasi-drug ingredients?

Quasi drugs are a product category unique to Japan, which falls in between pharmaceuticals and cosmetics. They contain active ingredients approved by the Ministry of Health, Labour and Welfare (MHLW) and have stronger efficacy. Common examples include deodorants, depilatories, hair dyes, hair perms, products promoting hair growth, and medicated cosmetics (whitening, anti-acne, anti-aging products, etc.).

Japan mainly adopts the following 10 lists to regulate the application scope and use limitations of quasi-drug ingredients:

1) List of Additives for Quasi-drugs

2) List of Additives for Hair Dyes

3) List of Additives for Permanent Wave Products

4) Standards for Marketing Approval of Hair Coloring Agents

5) Standards for Marketing Approval of Permanent Wave Agents

6) Standards for Marketing Approval of Medicated Oral-care Products

7) Standards for Marketing Approval of Bath Additives

8) List of Active Ingredients for Medicated Cosmetics

9) Instructions for Application of Marketing Approval for Medicated Soaps

10) Instructions for Application of Marketing Approval for Medicated Shampoo and Hair Conditioner

In the Cosmetic Ingredient Search Tool, the data in the first three lists above has been integrated into the “List of Permitted Additives for Quasi Drugs”, and the data in the last seven lists has been integrated into the “List of Permitted Active Ingredients for Quasi Drugs.”

What is the difference between quasi-drugs and cosmetics?

The most significant difference between quasi-drugs and cosmetics is whether they contain “active ingredients” that claim specific efficacies. If the products do not contain an active ingredient, it will be considered cosmetics. In terms of effectiveness, it will be relatively mild than quasi-drugs. 

Only products containing active ingredients approved by MHLW can be marketed as quasi-drugs in Japan. For such products, their efficacy claims shall be consistent with the efficacy of the active ingredients used. For example, a product can claim whitening efficacy if it contains a whitening active ingredient. A product can claim anti-acne efficacy if it contains an anti-acne active ingredient.

How to distinguish between active ingredients and additives in quasi-drugs?

Quasi-drug active ingredients are defined as “ingredients that have specific efficacies and are approved under the Pharmaceuticals and Medical Devices Act”. The concentration, quality and safety, approval systems of active ingredients are subject to strict regulations and reviews.

The additives refer to ingredients other than the active ingredients in quasi-drugs, such as excipients, stabilizers, emulsifiers, buffer agents, adhesives, colorants, fragrances, corrective agents, etc.

Can enterprises use an active ingredient not in the positive list of quasi-drug active ingredients in quasi-drug formulation?

Yes, but they need to apply to MHLW for new ingredient registration and get approval. It is noteworthy that MHLW implements a strict approval system for new ingredients. For details about New Quasi-drug Ingredient Application, please refer to Cosmepedia: Japan Quasi-drug Regulation.

What should enterprises do if the active ingredient used in quasi-drug products is beyond the approved use scope or limits?

MHLW implements a strict approval system for new ingredients. The approved matter includes not only the ingredient itself, but also its use scope, dosage, and specifications, etc. If the listed ingredient’s use amount exceeds the given limit or its specification differs from the requirements in the permitted active ingredient lists, it will be recognized as an off-list ingredient and needs re-application as a new ingredient for MHLW’s approval.

What is the “Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021)?”

"Japanese Standards of Quasi-drug Ingredients 2021" (JSQI 2021) is the overarching technical standards for quasi-drugs, which specifies the most basic specification requirements and testing methods for quasi-drugs ingredients. JSQI 2021 is composed of general rules, general test methods, standard product specifications and ingredient specifications. The regulatory requirements for most ingredients in the lists of permitted active ingredients and the lists of permitted additives are related to the provisions in JSQI 2021.

What should we pay attention to when searching the cosmetic and quasi-drugs ingredients?

1. There are four ingredients prohibited for use in cosmetics but allowed to be used in quasi-drugs:

◆ Pyrogallol: permitted active and additive ingredient for quasi-drug

◆ Hexachlorophen: permitted additive ingredient for quasi-drug

◆ Sodium Perborate: permitted active ingredient for quasi-drug

◆ Hydrogen Peroxide: permitted active ingredient for quasi-drug

2. Some quasi-drug ingredients' application scope varies depending on the reference of their specifications. Take the ingredient Glycerin as an example, if its specification complies with JSQI 2021, it can be used in hair removal, hair growth, medicated cosmetics, medicated lip, medicated toothpaste, bath, permanent wave, and hair coloring products. If its specification complies with the "Japan’s Specifications and Standards for Food Additives" or the "Japanese Pharmacopoeia", the ingredient can only be used in permanent wave and hair coloring products.

Are heavy metal and microorganism restrictions included in this regulatory database of Japan’s cosmetic ingredients?

Heavy metals and microorganisms are not included in the regulatory database of Japan’s cosmetic ingredients. But in the production of cosmetics, there are restrictions on these substances. Please refer to Cosme-list for more details about these limit requirements.

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