New Cosmetic Startup in Singapore
Are you looking to enter the cosmetics market in Singapore? Look no further, CTFAS is your ideal partner to support you to make this entry a smooth and easy process.
1. Is my product classified as a Cosmetic Product in Singapore?
In Singapore, the Singapore Health Sciences Authority (HSA) regulates cosmetic products under the Health Products Act (HPA) and its Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (“the Regulations”). The Regulations are in line with the ASEAN Cosmetic Directive (ACD), which adopts similar regulatory principles and requirements as the European Union (EU) regulations on cosmetic products.
Under the current law, companies dealing with cosmetic products are directly responsible for the safety and quality of their products. They are to ensure that the products they are supplying comply with the requirements under the law.
Companies must notify the Health Sciences Authority (HSA) by submitting a Cosmetic Product Notification prior to supplying a cosmetic product locally. This is to facilitate regulatory follow-up if safety concerns arise. As cosmetic products are not evaluated by HSA, the product notification should not be misconstrued as product certification or registration by HSA.
>>> Kindly refer to “Classification guide” to check whether your product can be classified as a cosmetic product in Singapore. Refer to the link below:
https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Cosmetic_Products/Overview.html
2. What must I do before I submit a Cosmetic Product Notification with HSA?
>>> Check that the ingredients in your cosmetic product comply with the requirements stated in the “Annexes of ASEAN Cosmetic Directive (ACD)”. Refer to the link below:
https://ctfas.org/regulatory-cat/industry-updates/
Alternatively, you may also engage external Safety Assessors for a fee to generate a Safety Assessment Report on the formulation of your cosmetic product. This Safety Assessment Report is a required document in your Product Information File (PIF) if you decide to go ahead to submit a Cosmetic Product Notification with HSA. Kindly write in to CTFAS Secretariat if you need assistance to engage one.
>>> Check that your cosmetic product comply with the labelling requirements – “Appendix II (ASEAN Cosmetic Labeling Requirements”. Refer to the link below:
>>> Prepare the Product Information File (PIF) for your cosmetic product.
In view of the ACD requirements, companies placing products in the market need to organize the PIF in such a way that it meets the requirements and be easily consulted by the Authorities. It is recommended that the PIF be organised into 4 parts as follows:
Part I: Administrative Documents and Product Summary
Part II: Quality Data of Raw Material
Part III: Quality Data of Finished Product
Part IV: Safety and Efficacy Data
A Table of Contents should be provided for each of the 4 parts.
Refer to the link below for the “Guidelines for Product Information File”:
Alternatively, you may also engage external consultants for a fee to organize the PIF. Kindly write in to CTFAS Secretariat if you need assistance to engage one.
3. How to submit a Cosmetic Product Notification with HSA?
>>> Apply for Client Registration and Identification Service (CRIS) Account.
CRIS account allows companies to authorise their employees or third party service providers to access HSA’s E-services (e.g. PRISM) to perform electronic transactions on behalf of the companies. You will need a Unique Entity Number (UEN) from ACRA to register as a CorpPass Admin, before you can apply for the CRIS account.
- To start a new business entity to get the UEN, please visit ACRA website:
https://www.acra.gov.sg/
- To register as a CorpPass Admin, please visit the CorpPass website:
https://www.corppass.gov.sg
To apply for CRIS account, visit the link below:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/CRIS.html
>>> Submit a new Cosmetic Product Notification in Pharmaceutical Regulatory Information System (PRISM).
prism@hsa gives users the convenience of carrying out transactions with the HSA and searching for related information online.
Visit the prism@hsa link below:
Refer to the “Step-by-step Guide on Notification Procedures” on how to submit product notification via the link below:
https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Cosmetic_Products/Overview.html
If you face any technical issues, please contact HSA helpdesk at [email protected] or call +6567760168.
An acknowledgement of notification email will be auto-generated and sent to the applicant’s email address if notification has been submitted successfully. You may start selling your cosmetic product upon receipt of the acknowledgement of notification.
4. After the submission of Cosmetic Product Notification with HSA, do I need to do anything?
>>> Below are the responsibilities of the company after the submission of Cosmetic Product Notification with HSA:
- Sellers of cosmetic products are responsible for the safety and quality of their products. Cosmetic products should not contain adulterants or prohibited substances and they should not breach the limits for specified substances.
- Maintain records of supply of the cosmetic products for 2 years.
- Submit safety and technical information when requested by HSA.
- Monitor and report adverse events and recalls to HSA.
On how to “Report adverse events (Cosmetic Products)”, please visit the link below:
https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Cosmetic_Products/Overview.html
>>> Re-Notification is required every year.
The Notification is valid for only 1 year. To renew, visit the prism@hsa link below:
>>> Cancel Notification.
If you no longer sell the product, visit the prism@hsa link to cancel the notification:
5. Where can I find out more information about Cosmetic Product Registration in Singapore?
Below are some websites where you can find more information:
Information above is correct as of 15 Oct 2018