Cosmetic Licensing and Regulations in Taiwan: Key Questions Answered

Cosmetic license or registration number?

I apologize, but I would like to ask the following questions: 1.
Is there a statement that "this product is exempt from application according to the announcement by the Department of Health in May 1998"? 2.
Are all current cosmetic outer packaging required to have a suggested retail price, batch number, recommended usage, Department of Health registration number, and customer service hotline? (I heard that non-medicated products do not require a Department of Health registration number, is that correct?) 3.
If the outer packaging lists active ingredients such as peony, bodhi, chrysanthemum, European mallow, peony root, saxifrage, yellow coptis root, trehalose, complex high-concentration amino acids, ethyl tyrosine, cysteine, and arbutin, does this classify as a general cosmetic (non-medicated)?

vanna, 20~29 year old female. Ask Date: 2012/12/21

Dr. Zeng Biru reply Pharmacology

1.
"For citation purposes, our institution does not sell or dispense cosmetic products.
According to the document from the Department of Health, Drug No.
87031871 issued in May 1998, the importation or manufacturing of general cosmetics that do not contain medical or toxic substances is exempt from application for record-keeping; however, their labels, inserts, and packaging must not imply any therapeutic effects.

2.
Currently, general cosmetics must comply with Article 6 of the Cosmetics Hygiene Management Regulations, which requires labeling to include the 'manufacturer's name, product name, address, ingredients, intended use, directions for use, weight or volume, batch number or production date.' Importers must also indicate the name and address of the importing manufacturer, and no therapeutic claims are allowed.
According to the aforementioned regulations, general cosmetics must indicate the batch number and recommended usage, but there is no requirement to state the suggested retail price or customer service hotline.
Non-medicated general cosmetics do not have a Department of Health registration number.
3.
The classification as medicated cosmetics is related to the concentration of their ingredients; for instance, arbutin is limited to a maximum concentration of 7%, and exceeding this threshold classifies the product as a medicated cosmetic."

Reply Date: 2012/12/21

More Info

In Taiwan, the cosmetic industry is regulated by the Ministry of Health and Welfare (MOHW), which oversees the safety and efficacy of cosmetic products. Understanding the licensing and regulations surrounding cosmetics can be quite complex, but I will address your questions to provide clarity.

1. Exemption from Application: The phrase "本產品依衛生署87年5月公告免申請" refers to specific products that are exempt from the need for formal application or registration with the MOHW. This exemption typically applies to certain categories of cosmetics that are deemed low-risk. However, it is essential to verify the specific criteria and categories that qualify for this exemption, as they may change over time. It is advisable to consult the latest regulations or contact the MOHW directly for the most accurate information.

2. Packaging Requirements: Currently, cosmetic products sold in Taiwan must adhere to specific labeling requirements. These include:
- Suggested Retail Price: While it is not mandatory for all products, many brands choose to include this information for consumer transparency.

- Batch Number: This is crucial for traceability and is required for all cosmetic products.

- Suggested Usage: This is often included to guide consumers on how to use the product effectively.

- Health Department Registration Number: Non-medicated cosmetics do not require a registration number, but they must comply with safety regulations.

- Customer Service Hotline: Including a contact number for customer inquiries is a good practice and is often encouraged for consumer support.

3. Classification of Ingredients: The ingredients you listed, such as peony, lotus, chrysanthemum, and various amino acids, are typically found in general cosmetics and do not classify the product as a medicated cosmetic. In Taiwan, a product is considered a general cosmetic if it does not contain any pharmaceutical ingredients or claims to treat or prevent diseases. Therefore, if your product does not make any medical claims and contains only cosmetic ingredients, it would fall under the category of general cosmetics.

In summary, understanding the regulations surrounding cosmetics in Taiwan involves recognizing the exemptions, labeling requirements, and the classification of ingredients. It is crucial for manufacturers and consumers alike to stay informed about these regulations to ensure compliance and safety. If you have further questions or need specific guidance, consulting with a regulatory expert or the MOHW would be beneficial.

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