New Procedure of Control Cosmetics Products In Malaysia

Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations 1984.

In conformance with the harmonization of cosmetic regulations in the ASEAN country. New system will be implemented starting from 1 January 2008.

Instead of registration, now the company required to notify their product which is compliance to the ASEAN Cosmetic Directive to the local Authority - National Pharmaceutical Control Bureau, also well known as NPCB.

The product only can be manufactured, imported or sold in the country after the notification is done.

Post Market Surveillance will be conducted by NPCB to ensure the compliance, action will be taken against the product which is not compliant with the Directive.

The following definition are based on the ASEAN Cosmetic Directive:

Cosmetic Product

A cosmetic product mean "any substance or preparation intended to be placed 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 odours and/or protecting them or keeping them in good condition.

Manufacturer

A manufacturer is a company which is engaged in any process carried out in the course of making the cosmetic product. The manufacturing process includes all the operations of purchase starting materials, bulk intermediates and products formulation and production (grinding, mixing, encapsulation and/or packing), quality control, release, storage and distribution of cosmetic products and the related controls.

Primary Assembler

A primary assembler is a company who is engaged in the process of enclosing the product in a primary/intermediate container which is labeled or to be labeled before the product is sold or supplied in it.

Secondary Assembler

Secondary assembler is a company who is engaged only in a process of labeling the product container where the product is already enclosed in its primary container and/or packing the product which is already enclosed in its labeled primary container into a carton which is labeled or to be labeled, before the product is sold or supplied.

Product Variant

Product variant mean, items in a range of cosmetic products, which are produced by the same manufacturer, similar in composition and are intended for the same use but available in different colours, fragrances or flavours.