Cosmetics in Brunei are regulated by the country’s “Medicines (Cosmetic Products) Regulations 2007,” which are in line with the ASEAN Cosmetic Directive (ACD) and require all importers/ manufacturers to notify the Ministry of Health (MoH) before launching any cosmetic product in the local market.
Importers/manufacturers must be registered under the Business Names Act (Chapter 92) and have adequate knowledge of how to comply with all regulations. Individuals must hold a Brunei Darussalam Identity Card but an importer may appoint a representative that holds this card and possesses the necessary regulatory knowledge. A company must also be incorporated under the Companies Act (Chapter 39).
An importer/manufacturer is to keep the product’s technical and safety information in a Product Information File (PIF) that is available to the MoH—with all records of importations, distributions and sales ready for auditing purposes. Procedures for sending complaints, defects and adverse events to the MoH also must be in place.
Importers/manufacturers must ensure that every consignment complies with safety, quality and other requirements and will not jeopardize human health under normal or reasonably Cosmetic Notification in Brunei foreseeable conditions of use.
A completed notification form for each product’s first submission must include: a copy of the company’s certificate of incorporation, a copy of the importer’s and representative’s (if applicable) Brunei Darussalam Identity Card, and a letter of authorization for the appointed representative(s) (if applicable). All notifications must contain:
• product brand and name;
• a list of variants or shades (if applicable); • product type; • intended use;
• product presentation;
• name and address of manufacturer and assembler (if applicable);
• name and address of company responsible for placing the product in the local market; • name and address of person representing the local company;
• details of the importer (if different from above);
• product ingredient list; • declaration by the company;
• company stamp; and
• name and signature of the representative at the local company.
For product presentations in “a single product” (i.e., a range of variants similar in composition for the same use but different in colors, flavors, and so on and “palette[s] in a range of one product type”), a single notification form may be submitted with a full ingredient listing of the colorants used. For example, an eyeshadow may list mica, dimethicone and talc as ingredients with a “may contain” statement on the colorants CI 77491, CI 77510, CI 47005 and CI 42090. As another example, a blush may list talc, mica and dimethicone as ingredients but then also list CI 15850, CI 455410 and CI 75120 as “may contain” colorants.
Payment of fees for notification and renewal should be made at the beginning of the process. Amendments to a cosmetic product notification and any subsequent amendments in the details of the notified cosmetic product must be sent to the MoH. Certain types of changes to the details of notified products and the subsequent requirements are listed on the MoH’s website (www.moh.gov.kh), where an electronic copy of the Notification Form is also available. The printed form is obtainable from the Cosmetic Unit.