to Indonesian
a. that public is necessary to be protected from distribution of cosmetics are not fulfilled safety, function, and quality conditions;
b. that cosmetics that will enter the territory of the Republic of Indonesia to be circulated should be equipped with Distribution permit in the form of notification;
b. that regulation on the control on the entry of cosmetics as stipulated in Regulation of the Head of the Head of Drugs an Foods Control Agency No. HK.00.05.42.2995 of 2008 concerning Control on the entry of Cosmetics is not match with recent situations and conditions and shall be changed;
d. that based on consideration as intended in paragraph a, paragraph b, and paragraph c, it is necessary to stipulate Regulation of the Head of National Agency of Drug and Food Control concerning Control on the entry of Cosmetics;
1. Law No. 8/1999 concerning Consumer Protection (Statute Book of the Republic of Indonesia No. 42/1999, Supplement to Statute Book of the Republic of Indonesia No. 3821);
2. Law No. 36/2009 concerning Health (Statute Book of the Republic of Indonesia No. 144/2009, Supplement to Statute Book of the Republic of Indonesia No. 5063);
3. Government Regulation No. 72/1998 concerning the Secure of Pharmaceutical Preparations and Health Instruments (Statute Book of the Republic of Indonesia No. 138/1998, Supplement to Statute Book of the Republic of Indonesia No. 3781);
4. Government Regulation No. 48/2010 concerning Kinds and Tariff on the Kind of Non Tax State Revenue in National Agency of Drug and Food Control (Statute Book of the Republic of Indonesia No. 67/2010, Supplement to Statute Book of the Republic of Indonesia No. 5131);
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. Regulation of the Minister of Health No. 1176/Menkes/Per/VIII/2010 concerning Cosmetics Notification;
8. Decree of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM/2001 concerning Organization and Work Mechanism in the National Agency of Drug and Food Control as amended by Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.21.4231 of 2004;
9. Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.23.4415 of 2008 concerning the Implementation of Electronic System in the Framework of Indonesia National Single Window in National Agency of Drug and Food Control Area;
10. Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.23.4416 of 2008 concerning Stipulation of Service Level Arrangement in National Agency of Drug and Food Control in the Framework of Indonesia National Single Window;
11. Regulation of the Head of National Agency of Drug and Food Control No. HK.03.1.23.12.10.11983 of 2010 concerning Criteria and Procedures to Apply Cosmetics Notification;
REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL CONCERNING CONTROL ON THE ENTRY OF COSMETICS
In this regulation:
1. Distribution permit is an approval on the cosmetics registration in the form of notification that is issued by Head of Agency to be distributed in Indonesian territory.
2. Entry of cosmetics is importation of cosmetic by land, sea and/or air into Indonesian territory.
3. Head of Agency is Head of Agency that has duty and responsibility in the control of drugs and foods.
(1) Every entry of cosmetic shall meet the laws and regulations.
(2) In addition to fulfilling the provisions as intended in paragraph (1), entry of cosmetic shall secure approval to entry form Head of Agency.
(3) Approval as intended in paragraph (2) in the form of Import Statement (SKI).
(1) Cosmetics that can be entered into Indonesian territory to be circulated are cosmetics that already obtain Distribution permit in the form of notification.
(2) Cosmetics as intended in paragraph (1) only can entered into Indonesian territory by cosmetics importers that have Importer's Identity Number (API) according to the regulation in force.
(3) Exemption from provision as intended in paragraph (1) are cosmetics that used for research and sample cosmetics for exhibition in limited quantity and not for sale.
(1) Home products that are further processed to become domestic cosmetic products can obtain SKI.
(2) Domestic cosmetics products as intended in paragraph (1) should have notification..
(1) SKI as intended in Article 2 paragraph (3) is given based on application.
(2) Application shall be filed in writing to the Head of Agency by Cosmetics Notification Holder or his/her proxy by attaching following documents:
(3) The names of cosmetic listed in invoice as intended in paragraph (2) c should be the same with the names of cosmetic listed in Cosmetics Notification or Distribution Permit.
(4) Beside the attached documents as intended in paragraph (2), SKI application for cosmetics that are used for research and sample cosmetics for exhibition as intended in Article 3 paragraph (3), shall also attach the proposal and/or supporting data.
All data of cosmetic import shall be documented by the Cosmetics Notification Holder for the easiness and smoothness of checking and retracing at any time by the officers of National Agency of Drug and Food Control.
SKI as intended in Article 2 paragraph (3) is valid only for one shipment.
Procedure of application as intended in Article 5 is filed electronically through website of National Agency of Drug and Food Control (http://e-bpom.pom.go.id) according to:
1. Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.23.4415 of 2008 concerning the Implementation of Electronic System in Respect of Indonesia National Single Window in National Agency of Drug and Food Control Area; and
2. Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.23.4416 of 2008 concerning Stipulation of Service Level Arrangement in the National Agency of Drug and Food Control in Respect to Indonesia National Single Window.
(1) Every cosmetic industry, cosmetic importer, individual business/business entity that conduct contract on the production with cosmetic industry that has production permit, that enter cosmetics into Indonesia territory without import permit as intended in Article 3 paragraph (2) subject to administrative sanctions.
(2) Administrative sanctions as intended in paragraph (1) are:
By this Regulation come into force:
This Regulation shall come into force on the date of promulgation.
For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on April 20, 2011
HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
signed,
KUSTANTINAH