Mastering Cosmetic Notification Procedures for Singaporean Market Entry

Singapore is a signatory of the ASEAN Cosmetic Directive (ACD), which harmonizes the cosmetic product requirements among the ASEAN countries. Cosmetic product manufacturers and importers must comply with the regulations under the ACD before supplying any cosmetic products in Singapore. One of the critical steps is to notify the Health Sciences Authority (HSA), as notification is a way of ensuring that cosmetic products are safe and effective.

1. Competent Authority

The HSA is the competent authority for cosmetic notifications in Singapore, playing a critical role in safeguarding public health and safety by regulating cosmetics in Singapore. It implements the ACD through the Health Products Act and other relevant regulations. Within HSA, the Cosmetic Control Unit (CCU) was established to oversee the regulatory control of cosmetic products.

2. Legal Framework

The following are the critical legal documents and guidelines that form the basis for cosmetic notification regulations in Singapore.

Document Name	Implementation date/released date	Status	Introduction
ASEAN Cosmetic Directive (ACD)	1 January 2008	In force	This document is the foundation for all legal regulations concerning cosmetics in Singapore. Legal regulations within Singapore must be in line with the provisions laid out in this document.
Health Products Act	31 December 2008	In force	This is the primary legislation that regulates health products, including cosmetic products, in Singapore.
Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007	1 January 2008	In force	The Regulations is the subsidiary legislation that specifies the definitions, scope, notification procedures, labeling requirements, and ingredient restrictions for cosmetic products in Singapore.
Guidelines on the Control of Cosmetic Products	1 April 2019	In force	The Guidelines provides detailed information and guidance on many topics, such as product classification, notification submission, safety assessment, post-market surveillance, adverse event reporting, and enforcement actions.
Cosmetic Product Classification Guide	7 January 2020	In force	The Guide provides information on checking if the products to be manufactured or imported are cosmetic products.

3. Who Should Submit Cosmetic Notification

Under the Singapore regulations, the person responsible for placing cosmetics on the market ("the Responsible Person") must inform the HSA by submitting a product notification before the cosmetic product's supply and/or sale.

The Responsible Person is defined in the Regulations as a locally registered company that is instrumental in causing the cosmetic product available for sale in Singapore, which may be the importer, manufacturer, distributor, or retailer.

A cosmetic product notification is required:

Even if the product has already been notified by another company in Singapore and is currently being imported to Singapore from the same manufacturer.
For every different variant of the same cosmetic product, such as different shades of lipstick and different scents of shampoo.

A cosmetic product notification is not required for the following products. However, businesses still need to comply with other requirements, such as labeling, ingredients, and adverse event reporting:

Sample products connected with advertising, sponsorship, or promotional activities.
Products used for testing or trial in connection with any research or development of that product.
Products 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 or her care.
Different pack sizes of the same product.

4. Responsibilities of the Responsible Person

Since cosmetic products are not subject to evaluation by the HSA, it is essential to clarify that the acknowledgment of product notification should not be misconstrued as an endorsement or certification of the product's safety and quality by the authority. Consequently, the principal responsibilities of the Responsible Person in Singapore include:

Ensuring the sellers of cosmetic products being responsible for the safety and quality of their products. Cosmetic products should not contain contaminants or prohibited substances, or they should not breach the limits for specified substances.
Maintaining records of the supply of cosmetic products for two years.
Submitting safety and technical information when requested by HSA.
Monitoring and report adverse events and recalls to HSA.
Recalling the product if the product is found to have any safety concerns.

5. Documents and Information Required

The following information is required for cosmetic notification:

1	Particulars of the local company responsible for placing the cosmetic product in the market: Company name & address (with postal code) Billing address Tel & Fax number
2	Particulars of a person authorized to represent the local company: Name (as in NRIC/FIN) National Registration Identity Card/Foreign Identification Number (NRIC/FIN) Designation in the company Preferred mode of communication (email/fax/SMS)
3	Particulars of manufacturer(s): Name and address (with postal code) Notes: A manufacturer is a company that is engaged in any process carried out in the course of making the cosmetic product. The manufacturing process includes the purchases of starting materials, bulk intermediates and products, formulation and production (such as grinding, mixing, encapsulation and/or packaging), quality control, release, storage and distribution of cosmetic products and the related controls.
4	Particulars of product: Brand name Product name Product type and brief function (skincare, anti-wrinkle, makeup…) Product presentation and variants, if any (single product, single palette, combination products in a single kit…)

6. Procedure and Timeline

- The product notification shall be submitted via the HSA online system Pharmaceutical Regulatory Information System (PRISM). To access PRISM, the company notifying the product must apply for a Client Registration and Identification Service (CRIS) Company Account via the following website: https://www.hsa.gov.sg/e-services/cris

- In Singapore, cosmetic notifications are not subject to review. Once a cosmetic notification has been successfully submitted, an acknowledgment will be automatically generated to confirm the receipt. Company may start selling cosmetic product upon receipt of the acknowledgement.

7. Re-notification and Update of Notification

1) Re-notification:

In Singapore, each cosmetic notification is valid for one year. If enterprises wish to continue marketing their product in Singapore, further notification (re-notification) is required annually.

2) Update of notification:

Enterprises may update the following details after the notification is submitted:

Changes in the name or address of the company (no change in Unique Entity Number (UEN)) and without change of distribution rights.
Change in applicant's details (e.g., email address).
Manufacturer's details.

Amendments to notification are not allowed for the following changes:

Brand name
Product name
Product type
Company change of distribution rights

Instead, enterprises will need to cancel the notification and submit a new one for these changes. No refund will be provided for any cancellation of notification. Enterprises can also cancel the notification if they no longer intend to sell the product.