Key Regulatory Considerations for Importing Cosmetics into Singapore

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Cosmetic products are substances or mixtures intended for application to the external parts of the body, such as the skin, hair, nails, lips and teeth, for purposes including cleansing, perfuming, protecting or enhancing appearance.

In Singapore, cosmetic products are regulated by the Health Sciences Authority and are subject to a mandatory cosmetic product notification prior to supply in the market.

Cosmetics are required to be notified through the cosmetic product notification process before they can be sold in the market unless they fall under the circumstances below:

1. Supplied solely as a sample in connection with any advertising, sponsorship or promotional activity
2. Supplied solely for testing or trial use in connection with any research or development of that product
3. Manufactured by or in accordance with the specifications of a medical practitioner and supplied solely by that medical practitioner for the use of patients under his care

Companies intending to place cosmetic products on the Singapore market are required to complete the notification process prior to supply. You may refer to our cosmetic product notification support services for further details.

Before supplying cosmetics in Singapore, we need to perform the following steps:

1. Classification 

The first step is to determine whether the product falls within the definition of a cosmetic in the local context. As shared in the previous article: https://theregconsultants.com/regulatory-classification-of-medical-products/, a “cosmetic product” is defined as any substance or preparation designed for application to the external parts of the body, including teeth and oral mucous membranes. These products must undergo a cosmetic product notification process before they can be legally marketed in Singapore.

• Cleaning
• Perfuming
• Changing appearance
• Correcting body odours
• Protecting
• Keeping in good condition

 

Examples of products that are not cosmetics are:

• Oral supplements for beauty purposes
• Injections/injectable products
• Massage and essential oils
• Aesthetic/beauty devices
• Lubricants
• Insect repellents
• Sanitary pads
• Hand sanitisers
• Creams for treating acne, eczema, and psoriasis
• Toothbrushes
• Dental floss
• Detergents
• Temporary tattoos
• Fake eyelashes
• Nail stickers
• LED lights used in dental kits (note that whitening gel is considered a cosmetic product)

 

2. Safety and Testing 

In terms of product safety, companies need to consider the main components, such as the composition, labelling, claims, and whether the product manufactured meets the specifications set. 

Companies should ensure that cosmetic products do not contain ingredients listed in the prohibited or restricted annexes under the ASEAN Cosmetic Directive.

Labelling of cosmetics should contain the key information below:

1. Name of the cosmetic product
2. Function of the cosmetic product
3. Instructions for use
4. Full ingredients listing
5. Country of manufacture
6. Contents (weight/volume)
7. Batch number
8. Manufacturing/expiry date (expiry date is only required for products with less than 30 months durability)
9. Name and address in Singapore of the company responsible for placing the product in the market
10. Special precautions, if any (especially those listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)

Cosmetic claims should be appropriately assigned based on the key ingredient function, target site of application, and physiological effects of cosmetics. Some examples of claims that are unacceptable in accordance with the ASEAN Cosmetic Claims Guide can be found here:

To ensure product meets safety and quality consistency,  manufacture should follows Good Manufacturing Practices (GMP) or ISO standard 22716:2007, conducts local testing for potential contaminants, and ensures the product is free from common adulterants.

Examples of appropriate testing on products are provided below:

Product Type	Claims
Teeth whitening products	To test the concentration of hydrogen peroxide. Hydrogen peroxide, when in high concentrations, is corrosive and may cause irritation to the eyes, mucous membranes, and skin. Only products with hydrogen peroxide of concentration up to 0.1% can be allowed for supply to consumers directly.
Skin Whitening creams	To test for the presence of adulterants e.g., Hydroquinone, tretinoin, and mercury. Hydroquinone and tretinoin are potent ingredients that are not suitable for use in skincare cosmetic products. The inappropriate use of hydroquinone could result in changes in skin color and hypersensitivity reactions such as rashes, redness, tingling, and burning of the skin. Tretinoin could lead to redness and peeling of the skin and should only be used under medical supervision.

In practice, a structured regulatory review is often required to assess ingredient acceptability, claims and supporting documentation prior to notification.

3. On-site requirements 

Cosmetic product notification should be performed by a locally registered company acting as the Responsible Person for placing the product in the Singapore market. This may be the importer, distributor, retailer, or an appointed local representative.

As cosmetic products are not evaluated by the authorities prior to supply, the Responsible Person remains accountable for ensuring the safety and quality of the product.

The following key documentation that should be maintained and kept on site as as follow and must be ready for inspection:

• Product information file: This file contains all the quality and safety records of the cosmetics to comply with the relevant standards. It should be kept updated in accordance with what is happening at the manufacturing end that could impact your product.
• Records of cosmetic supply to the market: Records should be maintained for two years in accordance with the Guidelines on the Control of Cosmetics. The record should contain the product’s name and notification number, the company’s name and address, and the batch number, date, and quantity of the product supplied.
• Monitor and report any product defect/adverse events to the authority and perform a prompt recall for the product: The reporting timeline is seven days for adverse events that are life-threatening or result in death and 15 days for adverse events that result in hospitalisation or any persistent or significant disability or incapacity.

TRC supports clients on an end-to-end basis, from classification and regulatory assessment through to cosmetic product notification and post-market compliance.

You may refer to our cosmetic regulatory support services or contact us to discuss your specific requirements.

Frequently Asked Questions

1. What is cosmetic product notification?

Cosmetic product notification is a mandatory requirement in Singapore. Companies must notify their products to the authority before supplying them in the market.

2. Which cosmetic regulation does Singapore follow?

Singapore follows the ASEAN Cosmetic Directive, which establishes guidelines for cosmetic product safety, labelling, and claims. Products must undergo cosmetic product notification before entering the market.

3. Do I need a cosmetic product safety report for notification?

Yes, during the cosmetic product notification process, safety assessments, including toxicological evaluations, must be conducted to ensure the product is safe for use.

4. What is HSA cosmetic product notification?

HSA cosmetic product notification is a mandatory process that ensures cosmetic products meet Singapore’s regulatory and safety standards before being sold.

5. What is the process for notifying cosmetic products in Singapore?

The process is carried out through the Product Registration and Information System (PRISM). Manufacturers and importers must submit the required information and documentation to the Health Sciences Authority (HSA) via this online platform.

6. Do I need a local company to notify cosmetic products in Singapore?

Yes. Cosmetic product notification must be performed by a company registered in Singapore, acting as the Responsible Person for placing the product in the market.

The Responsible Person is accountable for ensuring that the product complies with all applicable regulatory requirements, including safety, labelling and post-market obligations.

7. What are common issues encountered during cosmetic product notification?

Common issues include incorrect product classification, use of restricted or prohibited ingredients, non-compliant labelling, and unsupported product claims.

In practice, these issues are often identified only at a later stage, resulting in delays or the need for product reformulation prior to market entry.

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