Cosmetic
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1. Why us?
Navigating the regulatory landscape for cosmetic products in Singapore can be complex, but with our deep understanding of the local regulatory requirements, we make the process seamless for you. We provide expert consultation and guide you through every step of the registration process, ensuring that your products meet all the necessary compliance standards for the Singapore market.
2.What is a Cosmetic Product
A cosmetic product refers to any substance or preparation that is intended for use within on external parts of the human body, such as the skin, hair, nails, lips or mouth (including gums, teeth and tongue), for the purpose of cleansing, perfuming, altering appearance, correcting body odours, protecting, or maintaining them in good condition.
Cosmetic products in Singapore are regulated under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations, which is aligned with the ASEAN Cosmetic Directive (ACD). The ACD is a regional agreement among ASEAN member countries to harmonise regulatory standards. It adopts principles similar to the European Union (EU) for cosmetic products such as ingredient restrictions and safety and labelling requirements.
Cosmetic product suppliers must ensure their products meet the ACD requirements and ensure that:
Products are free from prohibited substances and conform to ingredient limits
Proper record-keeping of product supply is maintained for at least 2 years
Labels, ingredients, and safety are demonstrably compliant with regulatory standards, and shall be available when requested.
Prompt reporting of adverse events or product defects to HSA as soon as possible
An appropriate recall shall be initiated if safety concerns arise
Examples of Cosmetic Products in Singapore
The following are commonly classified as cosmetic products (non-exhaustive list):
Skin lotions, gels, masks, and emulsions
Make-up, tinted bases, and powders
Personal hygiene items such as toothpaste, mouthwash, soaps and deodorants
Hair care products such as shampoos, conditioners, hair dyes, and styling lotions
Manicure and pedicure products
Sun protection, intimate hygiene products, and baby or facial wipes
What is Not Considered a Cosmetic Product?
Products such as sanitary pads, insect repellents, household detergents, dental floss, eye drops, or products intended for use during treatment or ingestions such as medical devices, supplements or medicated creams are generally not classified as cosmetic products.
Not Sure if Your Product Qualifies?
Contact us for a free consultation, and we'll help you clarify whether your product is considered a cosmetic under Singapore's regulations. Our regulatory experts will guide you through product classification, notification requirements, and compliance documentation, helping you get to market faster—with confidence.
3. Cosmetic Notification
Before supplying cosmetic products in Singapore, a cosmetic product notification is required to be submitted to the Health Sciences Authority (HSA). This is a mandatory step for each cosmetic product, including variations of the same product (e.g., different colours, or formulations), even if similar products have already been notified by other entities or manufacturers.
However, a notification is not required in the following situations:
Product samples intended for advertisement, sponsorship or marketing purposes
Product supplied solely for research and development
Custom-made products in accordance with the specifications and instruction of a medical practitioner, and supplied solely by that medical practitioner for the use of patients under his care.
Different pack sizes of the same cosmetic product
4. Cosmetic Product Information File (PIF)
Although documents are not required for submission, the PIF should be readily available to the regulatory body for inspection. The PIF includes:
Part I: Administrative Documents and Product Summary: Description of the product, formulation, packaging, and labels
Part II: Quality Data of Raw Materials: Specifications, test methods, and safety data
Part III: Quality Data of Finished Product: Specifications, test methods, stability reports, and safety data
Part IV: Safety and Efficacy Data: Safety assessments, evidence of product claims, GMP certification, and any reports on confirmed adverse events
5.Fees
Notifications are valid for one year. To continue marketing in Singapore, re-notification must be submitted annually.
As of Aug 2024, the fees are as follows-:
| Notification and Re-Notification Fees for Cosmetic Products | |
|---|---|
| For products used around eyes, lips, oral/dental care, or hair dyes with diamines | |
| Single product or for the first 3 variants of a product | S$28 |
| Each of the fourth and its subsequent variant of a product | S$8 |
| Other cosmetic products not mentioned above | |
| Single product or for the first 3 variants of a product | S$13 |
| Each of the fourth and its subsequent variant of a product | S$8 |
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