Request a DemoAs a member of ASEAN, Brunei Darussalam regulates cosmetic products under the Medicines (Cosmetic Products) Regulations, 2007, which are aligned with the ASEAN Cosmetic Directive.
In Brunei, cosmetic products can only be marketed after they have been notified to the Ministry of Health (MoH) through an upfront declaration of compliance by the importer or manufacturer before being placed on the market. The responsible person must also ensure that the product meets all safety, quality, and labeling requirements, including the maintenance of a Product Information File (PIF).
Part 1 Regulatory Framework and Competent Authority
1.1 Main Cosmetic Regulations in Brunei
Regulations | Introduction | Status |
|---|---|---|
It serves as the primary legal framework governing the manufacture, importation, notification, and marketing of cosmetic products in Brunei. | In force | |
It is a harmonized regulatory framework adopted by ASEAN Member States to ensure the safety, quality, and claimed benefits of cosmetic products marketed within the region. | In force | |
Checklist for Companies Submission of Cosmetic Product Notification Form | It is designed to guide companies in preparing and submitting the notification to the MoH. | In force |
It is a mandatory document that must be submitted to the MoH prior to marketing any cosmetic product. | In force | |
It is used to record details of all cosmetic product notifications submitted. | In force |
1.2 Competent Authority
The Ministry of Health (MoH) oversees the implementation and enforcement of the Medicines (Cosmetic Products) Regulations, 2007, ensuring that all cosmetic products marketed in Brunei meet established safety, quality, and labeling standards. Its responsibilities include evaluating and processing cosmetic product notifications, maintaining the list of notified products, conducting post-market surveillance, and taking regulatory action against non-compliant or unsafe products.
Part 2 Cosmetic Products
2.1 Definition
According to Medicines (Cosmetic Products) Regulations, "cosmetic product" means any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and correcting body odours, protecting them or keeping them in good condition or all or any of those purposes.
2.2 Classification
The Cosmetic Product Notification Form specifies the types of products, as listed below:
Types | Details |
|---|---|
Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc.) | |
Face masks (with the exception of chemical peeling products) | |
Tinted bases (liquids, pastes, powders) | |
Make-up powders, after-bath powder, hygienic powders, etc. | |
Toilet soaps, deodorant soaps, etc. | |
Perfumes, EDT and eau de Cologne | |
Bath or shower preparations (salts, foams, oils, gels, etc.) | |
Depilatories | |
Deodorants and anti-perspirants | |
Shaving product (creams, foams, lotions, etc.) | |
Products for making-up and removing make-up from the face and the eyes | |
Products intended for application to the lips | |
Products for care of the teeth and the mouth | |
Products for nail care and make-up | |
Hair care products |
|
Products for external intimate hygiene | |
Sunbathing products | |
Products for tanning without sun | |
Skin whitening products | |
Anti-wrinkle products |
2.3 Notification
Before a cosmetic product can be marketed in Brunei, the importer or manufacturer must submit a notification to the MoH and obtain an Acknowledgment Letter. Notifications can be submitted offline by providing the required documents to the Cosmetic Unit, Drug Administration Section, Department of Pharmaceutical Services, 2nd Floor, Spg 433, Kampong Madaras, Lebuhraya Rimba, Mukim Gadong 'A', Brunei Darussalam. The following information must be included when submitting a notification:
Information Type | Details |
|---|---|
Original copy(ies) of the Cosmetic Product Notification Form |
|
Original copy of the Log for the Notification of Cosmetic Products |
|
CD which contains: Cosmetic Product Notification Form & Log for the Notification of Cosmetic Products | |
A copy of the company's certificate of incorporation | Business nature includes cosmetics |
A copy of importer's and representative's (if applicable) Brunei Darussalam Smart Identity Card | |
Letter of authorization for the appointed representative (if applicant is not the company owner) |
For the MoH, it takes 8 days to conduct research and verification on cosmetic product notification forms, from the date of receipt until the Acknowledgment Letter is issued.
A notification is generally valid for one year, but the applicant may request an extended validity of two or three years.
2.4 Product Information File (PIF)
The person responsible for placing the cosmetic product on the market shall keep the following information or documents readily available for possible inspection by the MoH, and such information shall be provided in English, Malay, or both.
No. | Information |
|---|---|
1 | The qualitative and quantitative composition of the product; in case of perfume compositions, the name and code number of the composition and the identity of the supplier |
2 | Specifications of the raw materials and finished product |
3 | The method of manufacture complying with the good manufacturing practice specified in the Medicines (Cosmetic Products) Regulations |
4 | Assessment of the safety for human health of the finished product, based on its ingredients, its chemical structure and its level of exposure |
5 | Existing data on undesirable effects on human health resulting from the use of the cosmetic product |
6 | Supporting data for claimed benefits of cosmetic products should be made available to justify the nature of its effect |
7 | The available methods used by the manufacturer to check the ingredients of cosmetic products corresponding with the certificate of analysis |
8 | The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products, methods for checking compliance with those criteria or both |
2.5 Labeling
Following the Medicines (Cosmetic Products) Regulations, Brunei requires that cosmetic products display the following specific items on their outer packaging. If a product does not have outer packaging, these items must appear on the immediate packaging.
The name of the cosmetic product and its function
Instructions on the use of the cosmetic product
Full ingredient listing
Country of manufacture
The name and address of the company or person responsible for placing the product on the local market
The contents given by weight or volume, in either metric or both metric and imperial system
The manufacturer's batch number
The manufacturing or the expiry date of the product in clear terms (e.g. month/year)
Special precautions to be observed in use, especially those listed in the column Conditions of use and warnings which must be printed on the label in the Schedule 1 of Medicines (Cosmetic Products) Regulations
All information on the label of a cosmetic product shall be provided in English, Malay, or both. When symbols or codes (whether in the form of color or otherwise) are used to convey information on the label, their meaning must be clearly explained.
Furthermore, companies shall not supply a cosmetic product with a label containing any statement, trademark, picture, or other sign that, directly or indirectly, implies that the product is promoted or endorsed by the Authority, or that could create a misleading impression regarding the product's formulation, composition, quality, or safety.
2.6 Advertisement
Companies shall not advertise any cosmetic product or cause any cosmetic product to be advertised with claims, whether expressly or by implication, that the product has a therapeutic benefit or can be used for a therapeutic purpose. In addition, a company shall not make any claims that are likely to create a misleading impression regarding the formulation, composition, quality, or safety of the cosmetic product.
Part 3 Cosmetic Ingredients
The Medicines (Cosmetic Products) Regulations include five ingredient lists, covering ingredients that are prohibited or restricted for use, as well as positive lists of colorants, preservatives, and UV filters permitted in cosmetic products marketed in Brunei. Companies shall refer to these lists during product formulation to ensure compliance with the regulations.
Schedule 1 Part 1: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
Schedule 1 Part 2: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down & List of Substances Provisionally Allowed
Schedule 1 Part 3: List of Colouring Agents Allowed for Use in Cosmetic Products
Schedule 1 Part 4: List of Preservatives Allowed
Schedule 1 Part 5: List of Permitted UV Filters Which Cosmetic Products May Contain
