Definition of cosmetic products
According to the Guidelines for Control of Cosmetic Products in Malaysia, cosmetic products are defined as “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.”
Some examples of cosmetic products include body soap, facial cleansers and creams, sunscreens, toothpaste and mouth rinse, hair shampoos and conditioners, hair dyes, perfumes and deodorants, and colour cosmetics including lipsticks, eye shadow, compact powder and nail polish.
Acts and Regulations relating to cosmetics
Cosmetic products are regulated by law under the Control of Drugs and Cosmetics Regulations 1984. These Regulations relate to the control of safety, quality and claimed benefit of cosmetics with the ultimate aim of protecting and promoting public health.
Background of the Notification Procedure
From 2002 to the end of 2007, cosmetic products were controlled via a pre-market registration system. A company who is responsible for placing a product in the local market must submit the required documents and information for review and registration by the National Pharmaceutical Control Bureau (NPCB), an agency under the Ministry of Health (MOH), before the product can be manufactured, imported or sold in Malaysia.
In conformance with the harmonisation of cosmetic regulations in the ASEAN region, the registration system was replaced by the notification procedure beginning 1 January 2008. Through the ASEAN Cosmetic Harmonisation Scheme, all ASEAN member states agreed to adopt and implement the ASEAN Cosmetic Directive (ACD).
Cosmetic product notification
All cosmetic products marketed in Malaysia must first be notified to the NPCB and only notified products may legally be imported or manufactured for sale in the country. Cosmetic product notification is submitted online via the Quest 3 system.
All notified cosmetic products must comply with the requirements stipulated in the Guidelines for Control of Cosmetic Products in Malaysia. The company who notifies the product or also known as notification holder must declare that they are responsible for all matters pertaining to the product marketed in Malaysia and the product complies with all the stipulated requirements. The notification holder is accountable for ensuring the safety, quality and the claimed benefits of the products where the claims made to the products must be well substantiated or proven with sufficient and reliable documentation.
The Guideline for Control of Cosmetic Products in Malaysia is available on the NPCB website www.bpfk.gov.my
Ensuring product safety and quality
The notification holder must ensure that the product is safe for use and of good quality. Cosmetic products must not contain any ingredients listed as banned substances or substances used beyond its allowable conditions such as restricted concentrations and uses. Information on banned ingredients and ingredients with specific condition of uses and concentrations are available on the Guidelines for Control of Cosmetic Products in Malaysia. All notified products marketed in Malaysia must be manufactured in a manufacturing premise that conforms to the requirements of Good Manufacturing Practices (GMP) in Malaysia.
Post-Market Surveillance of Cosmetic Products
The NPCB actively monitors notified cosmetic products in the market via post-market surveillance (PMS) activities to ensure the compliance of the cosmetics to the guidelines and regulations and the products are of good quality and safe.
The main surveillance activities include screening of product information submitted during product notification, audit of the Product Information File, product sampling for laboratory testing and labelling compliance, GMP audit on the manufacturing premises and monitoring of product advertisements. The NPCB also monitors adverse event reports and investigates product complaints.
Following the PMS activities, the NPCB has found that there are several categories of products that have been wrongly notified as cosmetics. These include products with medicinal claims such as massage oils for treatment of body aches, headache and joint pain; slimming products used externally or orally with claim to burn fat and reduce body weight; gels, oils or creams intended to be used as lubricants or for improving sexual performance; products used in mesotherapy and injected into the skin or beauty products for oral consumption sold in the form of drinks, powders or pills. All these categories of products and intended uses are not classified as cosmetic products.
Action Taken on Non-Compliant Products
If a product is found to be non-compliant to the stipulated guidelines and regulations, the NPCB will take necessary actions such as cancellation of the product’s notification and/or recall of the product from the market.
Consumers and cosmetics
Although the notification holders are responsible to ensure the safe use and good quality of the marketed products, the consumers are equally responsible when choosing and buying their personal care and beauty products. Consumers are advised to buy cosmetics from reliable source and the products are notified with NPCB. The notification status of a cosmetic product can be checked on the NPCB website www.bpfk.gov.my
NPCB encourages consumers to submit any enquiry or report product’s complaint should there is any doubts regarding a cosmetic product. The public is also advised to report any adverse events experienced while using a cosmetic product.
|Last Reviewed||:||29 March 2015|
|Writer/Translator||:||Erina Camillia bt. Mohd Chazali|