3 facts to know when importing cosmetics into Singapore
Cosmetics are required to be notified before they can be sold in the market unless in the few circumstances below:
- Supplied solely as a sample in connection with any advertising, sponsorship or promotional activity
- Supplied solely for testing or trial use in connection with any research or development of that product
- 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 cosmetic in Singapore, we need to perform the following steps:
- We need to determine whether the cosmetic product meets the definition of Cosmetic in the local context . As shared in my previous article: https://theregconsultants.com/regulatory-classification-of-medical-products/ ,
A “cosmetic product” is defined as any substance or preparation that is intended to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to:
- Changing appearance
- Correcting body odours
- Keeping in good condition
Example of products that are not cosmetics: oral supplements for beauty purposes, injections/injectable products, massage and essential oil, aesthetic/beauty devices, lubricants, insect repellents, sanitary pads, hand sanitizers, cream for treatment of acne/eczema/psoriasis, toothbrush, dental floss, detergent, temporary tattoo fake eye lashes, nail stickers and LED light used in dental kit (whitening gel is a cosmetic).
- In terms of product safety, we need to consider the main components such as the composition, labelling , claims , whether the product manufactured meets the specifications set and whether appropriate testing has been performed to ensure that the product is safe and function as it is claimed.
- We need to ensure that the cosmetic products does not contain ingredients that are in the negative list based on ANNEXES OF THE ASEAN COSMETIC DIRECTIVE.
- Labelling of cosmetics should contains the key information below:
- Name of the cosmetic product
- Function of the cosmetic product
- Instructions for use
- Full ingredients listing
- Country of manufacture
- Contents (weight/volume)
- Batch number
- Manufacturing/ expiry date (expiry date is only required for products with less than 30 months durability)
- Name and address in Singapore of company responsible for placing the product in the market
- Special precautions, if any (especially those listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)
- Cosmetic claims should be appropriate assigned based on the key ingredient function, target site of application and physiological effects of cosmetics. Some examples of claims that can be accepted accordance to ASEAN Cosmetic Claims Guide are presented below:
|Hair care product||Eliminates dandruff permanently Restores hair cells
Hair loss can be arrested or reversed Stimulates hair growth
|Skin products||Prevents, reduces or reverses the physiological changes and degeneration conditions brought about by aging
Prevents, heals, treats or stops acne Treatment of cellulite
Reduces/controls swelling/oedema Removes/burns fat
|Oral or dental hygiene products||Treatment or prevention of dental abscess, gumboils, inflammation, mouth ulcers, periodontitis, pyorrhoea, periodontal disease, stomatitis, thrush or any oral diseases or infections
Whitens tetracycline-induced stains
- Quality of the product- In order to ensure that the product manufacturer meets with international requirements, it would be appropriate to ensure that the manufacturing facilities have relevant certification that complies with GMP or ISO standard 22716:2007 ,perform local testing if required to check for heavy metals and microbiological content, as well as for common adulterants.
Examples of appropriate testing on products are provided below:
|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 in skincare cosmetic products. The inappropriate use of hydroquinone could result in changes in skin colour and hypersensitivity reactions such as rashes, redness, tingling and burning of skin. Tretinoin could lead to redness and peeling of the skin and should only be used under medical supervision.|
- Cosmetic notification should be performed by appointed companies that are intending to import or sell the cosmetic products in the market. As cosmetic products are not evaluated by the authority, it is important for importers to be responsible for the safety and quality of the product. There are 3 main things that should be maintained on site for the importer namely:
- Product Information File which contains all the quality and safety records of the cosmetics to comply to the relevant standards. It should be kept to update in accordance to what is happening over at the manufacturing end that could have an impact on your product.
- Records of cosmetic supply to the market- It should be maintained for 2 years in accordance to the Guidelines on the Control of Cosmetics. The record should contain the name and notification number of the product, name and address of company supplied, and the batch number, date and quantity of 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 7 days for adverse events that result in death or life threatening and 15 days for adverse events that results in hospitalisation or any persistent or significant disability or incapacity.
To end off the article, we are sharing some useful links for you to kick start the process:
- Guidelines on the Control of Cosmetic Products
- ASEAN Cosmetic Directive
- Overview on how the local authority regulates cosmetic
- HEALTH PRODUCTS (COSMETIC PRODUCTS — ASEAN COSMETIC DIRECTIVE) REGULATIONS 2007
If you need any support to confirm that your cosmetic product is meeting the local requirements, feel free to be in touch or share it with your peers who might need them.