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.

Cosmetic product notification

Beginning 1 January 2008 all ASEAN member states agreed to adopt the cosmetic notification procedure as control system for all cosmetic products in the ASEAN region in conformance with the ASEAN cosmetic harmonisation scheme and the ASEAN Cosmetic Directive (ACD).

All cosmetic products marketed in Malaysia must first be notified to the National Pharmaceutical Regulatory Agency (NPRA) 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. Notified cosmetics does not mean it is being approved by MOH. Product notification is a process that requires companies to be responsible for the product information submitted to NPRA on their products marketed in Malaysia.

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. 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 NPRA website www.npra.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 is available in 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 NPRA 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, labelling compliance, GMP audit on the manufacturing premises and monitoring of product advertisements. The NPRA also monitors adverse event reports and investigates product complaints.

Following the PMS activities, the NPRA has found that there are several categories of products that have been misunderstood as cosmetics by consumers. 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 producsts are 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 NPRA 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.The notification status of a cosmetic product can be checked on NPRA official website at www.npra.gov.my to verify the notification status of cosmetic products or download NPRA Product Status Application from Google Play Store before purchasing such products. A list of cosmetic products tested and found to contain prohibited substances such as hydroquinone is published on the NPRA’s website.

Consumers are encouraged to report to the NPRA, if they experience any allergic reactions or adverse effects from the use of cosmetic products or encounter any suspicious cosmetics using Notified Cosmetic Complaint Form, available through the link:https://npra.gov.my/images/public/BORANG_ADUAN_KOSMETIK.pdf and e-mail to kosmetik@npra.gov.my for further action.