to Indonesian
a. that cosmetic that will enter the territory of Indonesia to be circulated should be equipped with circulation permit;
b. that to prevent the circulation of imported cosmetic that are not equipped with circulation permit, it is necessary to supervise them since they enter to territory of Indonesia;
c. that based on consideration as intended in paragraph a and paragraph b, it is necessary to stipulate Regulation of the Head of Drugs and Foods Control Agency concerning Control on the Entry of Cosmetic;
1. Law No. 23/1992 concerning Health (Statute Book No. 100/1992, Supplement to Statute Book No. 3495);
2. Law No. 8/1999 concerning Consumer Protection (Statute Book No. 42/1999, Supplement to Statute Book No. 3821);
3. Government Regulation No. 72/1998 concerning the Secure of Pharmaceutical Preparations and Health Instruments (Statute Book No. 138/1998, Supplement to Statute Book No. 3781);
4. Government Regulation No. 17/2001 concerning the Upper Tariff of Non Tax State Revenue Applicable to the Drug and Food Control Agency (Statute Book No. 35/2001, Supplement to Statute Book No. 4087);
5. Presidential Decree No. 103/2001 concerning Position, Mission, Functions, Authority, Organization Structure and Work Mechanism of Non Ministerial Government Agencies as amended several times, the latest by Presidential Regulation No. 64/2005;
6. Presidential Decree No. 110/2001 concerning Organization Units and Mission of First Echelon Non Ministry Government Agencies as amended several times, the latest by Presidential Regulation No. 52/2005;
7. Decree of the Head of Drugs and Foods Control Agency No. HK.00.05.4.1745/2003 concerning Cosmetic.
REGULATION OF THE HEAD OF DRUGS AND FOODS CONTROL AGENCY CONCERNING CONTROL ON THE ENTRY OF COSMETIC
In this Regulation:
1. Circulation permit is an approval of the cosmetic registration, issued by Head of Agency to be distributed in Indonesian territory.
2. Imported cosmetic are cosmetic made by foreign industry, that are imported and distributed in the Indonesian territory.
3. Importation of cosmetic is importation of cosmetic by land, sea and or air into Indonesian territory.
4. Head of Agency is Head of Drugs and Foods Control Agency of the Republic of Indonesia.
(1) Only importer, distributor, industry of cosmetic and or pharmaceutical industry which has import permit in accordance with laws and regulations and are given power of attorney by producers in the origin country can import cosmetic into Indonesian territory,
(2) Cosmetic that can be taken into the Indonesian territory for circulation shall be cosmetic equipped with circulation permit.
(3) Excepted from provisions as intended in paragraph (2) are cosmetic used for laboratory tests, customer response test, researches or exhibitions not to be traded.
(4) The procedures to import cosmetic as intended in paragraph (3) is to be laid down in a separate regulation.
(1) Every importation of cosmetic shall meet the laws and regulations.
(2) In addition to fulfilling the provisions as intended in paragraph (1), importation of cosmetic shall secure approval to entry form Head of Agency.
(3) Applications for importation of cosmetic as intended in paragraph (2) shall be filled to the Head of Agency.
Applications for importation of cosmetic shall be subject to fees on each item of product in accordance with laws and regulations.
Approval of the import as intended in Article 3 paragraph (2) shall be valid for only one shipment.
The procedures to secure approval to import cosmetic as intended in Article 3 paragraph (2) is to be laid down in separate regulation.
Within the framework of control of importer, distributor, cosmetic industry and or pharmaceutical industry that import cosmetic shall has documentation of cosmetic distribution.
(1) Violators of provisions in this regulation can be subject to administrative sanctions or criminal sanction in accordance with the laws and regulations.
(2) Administrative sanction as intended in paragraph (1) are:
By the issuance of this Regulation, all the existing regulations related to the importation of cosmetic shall remain valid, provided they do not contradict this regulation and/or have not been replaced under this regulation.
This Regulation shall come into force as from the date of stipulation.
For public cognizance, this regulation shall be announced by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
On June 10, 2008
Head of Drugs and Foods Control Agency of the Republic of Indonesia
signed,
Dr. Husniah Rubiana Thamrin Akib, MS, Mkes, SpFK