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Trusted Cosmetics Regulatory Services in Singapore
Integrated regulatory solution for cosmetics from Bench to Beauty in Singapore market
Cosmetic market of Singapore experiencing demand for skincare products and annual growth of 2.20% CAGR. Health Science Authority (HSA) responsible for regulating the cosmetic products in Singapore. At Artixio, our team provides esteemed regulatory support from product development to post market services, and navigates cosmetics regulations brings successful approvals and reducing time for market launch.
Cosmetic regulations in Singapore
In Singapore, cosmetics mainly regulated as per Health Product Act and its Regulation, 2007. As Singapore is Member of ASEAN (Association of South-East Asian Nation) cosmetic products must be in compliance with ASEAN Cosmetic Directive (ACD).
ACD is agreement among the ASEAN member countries, aimed to harmonize cosmetic regulation and reduce technical barrier to facilitate product approval with the Asian region.
ACD provides guidelines for regulating cosmetic products
- Definition and examples of cosmetic products
- Prohibited, restricted and permitted ingredients
- Labelling requirements
- Good manufacturing practices
- Safety assessment
- Adverse event reporting
- Documentation
- Limits of contaminants
Cosmetic Product Notification in Singapore
For marketing the cosmetic product in Singapore requires prior notification. Detailed process of Cosmetic Notification (CN) illustrated below
Artixio’s services for cosmetic products in cosmetics
- End-to-end guidance on cosmetic regulation in Singapore
- Appointing local authorizes agent
- Support for account generation on online portal
- Classifying cosmetic product as per ACD regulations
- Co-ordination in submission of application to HSA
- Strategic regulatory support throughout product lifecycle
- Labelling and artwork services
Why Artixio
Esteemed regional team in navigating registration of cosmetic in Singapore
Globally recognized professional with history of successful product launches & life cycle compliance
In accordance with evolving regulatory requirements, supported by gap assessment
Expert Regional Regulatory Teams in 120+ Countries
Customer centric and flexible services
KPI based, continual process excellence
FAQs
What is meant by cosmetic as per Singapore?
- Any substance or preparation that is intended to be used externally on human body parts for the purpose of- Cleaning, changing their appearance, perfuming, and protecting of body parts.
- The following products are examples that are not considered as cosmetics injections and eye-drops.
- Products that are consumed orally, such as tablets, capsules or beverages.
- Products that are intended for treatment, such as acne treatment creams.
In which circumstances is it not required to submit notification to HSA?
In following conditions prior notification need not to be submitted
- Cosmetic products are supplied solely for testing or trial use in research and development of that product.
- Cosmetic products are supplied solely for advertising, sponsorship or promotional activity.
- Cosmetic products are manufactured in accordance with the specifications of a medical practitioner and supplied solely to the medical practitioner for the use of patients under his care.
What are the fees required to be paid for Cosmetic product notification and re-notification?
| Products applied around the eyes or on the lips, oral or dental care products, or hair dyes containing diamine compounds | ||
|---|---|---|
| Sr. No. | Purpose | Fees |
| 1 | Single product or each of the first 3 variants of a product | $28 |
| 2 | Each of the fourth and subsequent variants of a product | $8 |
| Other cosmetic products that are not mentioned above | ||
| Sr. No. | Purpose | Fees |
| 1 | Single product or each of the first 3 variants of a product | $13 |
| 2 | Each of the fourth and subsequent variants of a product | $8 |
What documents and information are needed to submit with notification of cosmetic product through PRISM portal?
Key documents that are required to submit with notification are listed below-
- Particulars of local company responsible for placing the cosmetic product in the market.
- Particulars of manufacturer.
- Full ingredient list.
- Labeling information.
- Fee payment details.
- Detailed information on documents required to be submitted is provided by: STEP-BY-STEP GUIDE ON COSMETIC PRODUCT NOTIFICATION
What are the responsibilities of the sponsor for launching cosmetics product in Singapore?
- Sponsor is responsible for the safety and quality of your products.
- Sponsor should submit additional safety and quality information requested by HSA.
- Sponsor must maintain records of supply of the cosmetic products for two years.
- Sponsor must monitor and report adverse events related to cosmetic products to HSA.
- Sponsor is responsible for recalling the product if it is found to have any safety concerns.
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