“Cosmetics are substances or preparations intended for external use on the human body (epidermis, hair, nails, lips and external genital organs) or teeth and oral mucosa, primarily to cleanse, perfume, enhance the appearance and/or alter body odor or protect or keep the body in good condition.”.
Pursuant to the Minister of Health Regulation Number 1176/MENKES/PER/VIII/2010 regarding Cosmetic Notification that every cosmetic may only be distributed after obtaining Distribution License in the form of the Cosmetic Notification. This obligation is excluded for cosmetics intended for research, and a sample of cosmetic for exhibition use in limited quantities and is not for sale.
WHO CAN IMPORT COSMETICS TO INDONESIA?
The parties entitled to import cosmetics to Indonesia are importers, distributors, cosmetics and/or pharmaceutical industries which have the Cosmetic Import License in accordance with laws and regulations, authorized by the Manufacturer in the country of origin as stipulated in the Head of National Agency of Drug & Food Control Indonesia Regulation Number HK.00.05.42.2995 regarding Supervision of Cosmetic Import dated 10th June 2008.
In order to obtain Cosmetics Import License, both cosmetic producer from the country of origin and its distributors in Indonesia must shall , at least, prepare the required documents, both for the Manufacturer (country of origin) as well as the document of product information, and the legality of the distributor. The following are the requirements to obtain Cosmetic Import License:
- Documents to be prepared by the Manufacturer (country of origin) includes: Certificate of Free Sale (CFS), Certificate of Good Manufacturing Practice (GMS), and Letter of Appointment (LoA);
- Product Information (provided by the Manufacturer):
- Formula/ ingredients in percentage with its usage, CAS number, reference and usage of material
- COA of Raw Material and MSDS (Material Safety Data Sheet) with the origin of material
- Specification of Packaging Material and COA of Packaging Material
- Process of Making
- Result of Finished Product analysis which includes specification, method and result (from the factory origin)
- Stability of the Finished Product and the Conclusion of Expired Date
- Batch Number and its definition
- Function and Usage of Products
- 3 pieces of sample
- Colored Package/Lab
- Legality of the Importer Company, including the Company’s license and General Import License (Izin Angka Pengenal Impor / API-U) and Customs Master Number (Nomor Induk Kepabeanan / NIK).
The Cosmetic Notification is valid for 3 (three) years. After the expiration period, the applicant must extend the Cosmetic Notification. The procedure for extending the Cosmetic Notification is the same as submitting the new Notification.
Besides having Cosmetic Notification, according to the Law, both importer and manufacturer must have a recommendation from the Indonesia National Agency of Drug and Food Control (BPOM) in the form of Certificate of Import (Surat Keterangan Impor / SKI) in order to be able to take goods from customs.
To obtain SKI, the company must apply to Inspection and Certification Director of Traditional Medicines, Food Supplement & Cosmetic Evaluation and attach the following documents:
- Invoice, packing list, Bill of Lading (B/L) or Air Ways Bill (AWB);
- Certificate of Analysis (CoA);
- Cosmetic Import Notification;
- Letter of conformity of the name listed on the invoice and the name listed in the cosmetic import license.
In the letter of conformity, the company also states that, if necessary, is willing that the goods will be secured and sealed, and took as samples by BPOM Officer, and the company shall bear all costs incurred for the test.
Other statements are that the company shall not be distributing or selling the goods prior to the inspection by BPOM, be liable to sanctions in accordance with the applicable law if the company fail to comply with the aforesaid statement.
HOW CAN SMART CONSULTING HELP YOU?
SMART Consulting is an Indonesian Corporate Legal Services experienced in assisting Clients with the legal aspects when our Clients invest in Indonesia. It includes ensuring the business licenses of these companies are in accordance with Indonesian regulations. In addition, SMART Legal Consulting has the knowledge, experiences, and connection in filing Cosmetic Notification processing of the BPOM Certificate of Import (SKI) as referred above.
Please contact SMART Help Desk to arrange your meeting with us:
H: + 62821-1234-1235