LETTER OF THE FOOD AND DRUG SUPERVISORY BOARD
No.KH.00.01.3352

COSMETICS CONTAINING PROHIBITED SUBSTANCES AND DYE

1. Supervision executed by the Food and Drug Supervisory Board (BPOM) in 2005 and 2006 found 27 (seventy seven) brands of cosmetics containing substances which may not be used on cosmetics, namely Mercury (Hg), Hydroquinone > 2%, dyeing agent Rhodamine B and Red K.3 (list enclosed). The use of the substances in cosmetics preparation can endanger health and is prohibited as contained in Regulation of the Minister of Health No. 455/MENKES/PER/V/1998 on Substances, Dying Agent, Substratum, Preservatives and Solar Shield in Cosmetics and Decision of the Head of the Food and Drug Supervisory Board No. HK.00.05.4.1745 on Cosmetics.

2. Mercury (Hg) is categorized as dangerous heavy metal, which in small quantity even can be toxic. The use of Mercury (Hg) in Whitening cream can result in effects, starting from the change in skin color, which eventually can cause black sports in the skin, allergy, skin irritation as well as the use in high dosage can cause permanent damage to brain, kidney and embryo growth failure even short-term exposure in high dosage also can cause vomit, diarrhea and lung failure as well as constitutes carcinogenic substance (potential to cause cancer) to the human.

3. Hydroquinone is categorized hard medicine only usable on the basis of doctor prescription. The danger of the use of the medicine without supervision from the doctor can cause skin irritation, redden sin and sense of burnt also can cause failure in kidney (nepropathy), leukemia and hepatocellular adenoma).

4. Red Dye K.10 (Rhodamine) and Red Dye K.3 (CI Pigment Red 53: D & c red No. 8; 15585) constitutes synthetic dye generally used as paper, textile or ink dye. The dye can cause irritation to respiratory channel and constitutes carcinogenic (potential to cause cancer) as well as Rhonamine in the high concentration can cause damage to the heart.

5. In order to protect communities/consumers from the above mentioned risks, the Food and Drug Supervisory Board instructed producers/distributors to withdraw the products from circulation and destroy them. As a result of follow up, some 1.002 items of products were withdrawn and destroyed.

6. Production, import and/or distribution of products failing to meet the standards are violation of Law No.23/1992 on Health, which can be sentenced to five-year imprisonment at the maximum or a fine of Rp 100.000.000 (one hundred million rupiahs) at the maximum.

7. In relation thereto, BPOM asks to public at large to not purchase or use the cosmetics as contained in the list of attachment to this public warning. Communities/consumers affected by risks arising from the use of the cosmetics should report to BPOM RI in Jakarta or Grand POM Centers/Centers throughout Indonesia, Customer Service Unit (ULPK) Tel. No. 021-4263333.

The warning is informed for protecting the safety of communities and all parties are expected to pay serious attention.

THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD
(signed)
DR. HUSNIAH RUBIAN THAMRIN AKIB, MS.M.Kes. SpFK

 


Attachment

PUBLIC WARNING NO. KH.00.01.3352
On September 7, 2006
Concerning
Cosmetics that contained banned material and pigment