3 facts to know when importing cosmetics into Singapore

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Cosmetic products are substances or mixtures designed for use on the external parts of the body, such as the skin, hair, nails, lips, and teeth, for the purpose of cleansing, perfuming, protecting, or enhancing appearance. In Singapore, all cosmetic products must comply with safety regulations and require a cosmetic product notification before they can be distributed or sold. This ensures the products meet health and safety standards established by the Health Sciences Authority (HSA).

The cosmetic product notification process in Singapore is a regulatory requirement administered by the Health Sciences Authority (HSA). Before any cosmetic product can be sold or distributed in Singapore, it must be notified to the HSA through the Cosmetic Products Notification Portal (CPNP). This procedure ensures that products meet ASEAN Cosmetic Directive standards, are free of prohibited substances, and comply with safety guidelines regarding labelling, claims, and ingredients.

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

 

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

1. Determine If The Product Meets The Definition Of Cosmetics

We need to determine whether the cosmetic product meets the definition of 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. Consider If The Manufactured Product Meets Specifications And Testing Criteria

In terms of product safety, we need to consider the main components, such as the composition, labelling, claims, and whether the product manufactured meets the specifications set. Additionally, the product must go through a cosmetic product notification process, including safety evaluations, to ensure compliance with local regulations.

We must ensure that cosmetic products do not contain ingredients on the negative list based on the ANNEXES OF 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 regulatory compliance, the product must undergo cosmetic product notification. This includes verifying that the manufacturer 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.

 

3. Essential Items That Need To Be Kept On-Site

Cosmetic product notification should be performed by appointed companies that intend to import or sell cosmetic products in the market.  As cosmetic products are not evaluated by the authorities, it is important for importers to be responsible for the safety and quality of the product.  There are three main things that should be maintained on-site for the importer, namely:

• 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.

 

To cap off the article, here are some useful links for you to kick-start the process:

1. Guidelines on the Control of Cosmetic Products
2. ASEAN Cosmetic Directive
3. Overview of how the local authority regulates cosmetic  
4. HEALTH PRODUCTS (COSMETIC PRODUCTS — ASEAN COSMETIC DIRECTIVE) REGULATIONS 2007

Frequently Asked Questions

1. What is cosmetic product notification?

Cosmetic product notification is a regulatory requirement by the Health Sciences Authority (HSA) in Singapore. All cosmetic products must be notified before they can be sold to ensure compliance with safety standards.

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.

Ensuring that your cosmetic product meets Singapore’s stringent regulatory requirements is key to a successful launch in this dynamic market. If you need support with the cosmetic product notification process or have questions about compliance, don’t hesitate to reach out to us.

Our team is ready to assist you in navigating the complexities and ensuring your products align with all local regulations. Share our services with peers who may benefit, and let us simplify your compliance journey together.

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