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a. that in the framework to protect public health, medicine, traditional medicine, supplement food, and food shall fulfill requirements of safety, function, and quality;
b. that requirement for safety, function, and quality shall have objective, complete and not make misunderstanding of information at label of medicine, traditional medicine, supplement food and food;
c. that except information as intended in paragraph b, public shall be given information of certain substances, alcohol contain, and expired time in label of medicine, traditional medicine, supplement food and food;
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 Drug and Food Control Agency concerning Inclusion of the Information on Certain Substances, Alcohol Contain, and Expired Time on the Label of Medicine, Traditional Medicine, Supplement Food, and Food;
1. Law No. 7/1996 concerning Food (Statute Book of the Republic of Indonesia No. 99/1996, Supplement to Statute Book No. 3656);
2. Law No. 8/1999 concerning Consumers Protection (Statute Book of the Republic of Indonesia No. 42/1999, Supplement to Statute Book No. 3821 );
3. Law No. 36/2009 concerning Health (Statute Book No. 144/2009, Supplement of Statute Book No. 5063);
4. Government Regulation No. 72/1998 concerning Securing the Supply of Pharmacy and Health instruments (Statute Book No. 138/1998, Supplement to Statute Book No. 3781);
5. Government Regulation No. 69/1999 concerning Food Label and Advertisement (Statute Book No. 131/1999, Supplement to Statute Book No. 3867);
6. Government Regulation No. 28/2004 concerning Food Safety, Quality and Nutrient (Statute Book No. 107/2004, Supplement to Statute Book No. 4424);
7. Presidential Decree No. 103/2001 concerning Position, Mission, Functions, Authority, Organization Structure, and Work Mechanism of Non-Department Government Agencies having been amended several times, lastly by Presidential Regulation No. 64/2005;
8. Presidential Decree No. 110/2001 concerning Organization Unit And Task of First Echelon of Non Ministerial Government Agency as amended several times, the latest by Presidential Regulation No. 52/2005;
9. Decree of the Head of Drug and Food Control Agency No. 02001/SK/KBPOM/2001 concerning Organization and Working Procedure of Drug and Food Control Agency as amended by Decree of the Head of Drug and Food Control Agency No. HK.00.05.21.4231/2004;
REGULATION OF THE HEAD OF DRUG AND FOOD CONTROL AGENCY CONCERNING INCLUSION OF THE INFORMATION ON CERTAIN SUBSTANCES, ALCOHOL CONTAIN AND EXPIRED TIME ON THE LABEL OF MEDICINE, TRADITIONAL MEDICINE, SUPPLEMENT FOOD, AND FOOD.
In this Regulation:
1. Certain Substances are substances containing or originating from animals or other living beings solely by itself or a mixture or processed product or its derivative.
2. Alcohol is ethyl alcohol with chemical formula C2H5OH.
3. Expired time is explanation about expired time of medicine, traditional medicine, supplement food, and food that still can be consumed in the form of date, month, and year, or month and year.
4. Label is every explanation about product in the form of picture, text, combination of both of them, or other form that is accompanied with, entered in, stick at, or part of the packing of the products.
Certain substances as intended in Article 1 paragraph 1 may be in the form of gelatin, glycerin, enzyme, fat, collagen, colostrums, embryo extract, blood extract, hydrolyzed hemoglobin, keratin, hair extract, placenta, protein, thymus extract, thymus hydrolyzed, stomach extract, oil, shortening, thickener, emulsifier, stabilizer, I-systein, monoglyceride, diglyceride, or triglyceride.
(1) Besides having to comply relevant existing laws, labeling of medicine, traditional medicine, supplement food and food shall bear the information of origin material, alcohol content, and expiry date, as be governed in this Regulation.
(2) In case originating or certain substance as intended in paragraph (1) and/or product containing certain substances already get certificate from authority agency, explanation of certificate should be put in the label.
(3) In case explanation of certificate as intended in paragraph (2) is allowable by Islamic law, it shall be put according to explanation in the certificate.
(1) Particular substance content or medicines, traditional medicines, supplement food and food shall be informed in the label.
(2) Beside information as intended in paragraph (1) for medicine, traditional medicine, supplement food that contain certain substances originating from pig shall be stated sign in black text of "PIG CONTAIN" in the black box with white background like following sample:
PIG CONTAIN
(3) Special sign as intended in paragraph (2) for drug in production process got in contact with substances originating certain substance from pig shall be stated in "During production process, got in contract with substances originating from pig" text.
(4) Text as intended in paragraph (3) in the for black text in the black box with white background like following sample:
During production process, got in contract with substances originating from pig.
(5) Information as intended in paragraph (2) for food should put special sign int the form red text of "pig contain + (picture of pig)" in the red box with white background, like following sample:
PIG CONTAIN
(6) Text as intended in paragraph (5) shall have minimum 1.5 mm, clear readable, and has proportional with size of label.
(1) Medicine, traditional medicine, supplement food, and food with alcohol contain should put alcohol contain at the label
(2) Alcohol contain as intended in paragraph (1) is put in percentage form.
(1) Medicines, traditional medicines, supplement food and food shall put expired time at the label.
(2) Expired time as intended in paragraph (1) shall put clearly so it is easy to be seen and read.
(1) Medicines, traditional medicines, supplement food and food expired time is written by put month and year of expired time.
(2) Expired time of food, that has storage period less than 3 (three) months is written by put date, month and year of expired time.
(1) Excepted from provision as intended in Article 6 is for traditional medicine that is not required to be registered.
(2) Excepted from provision as intended in Article 6 for foods in the form:
Any violation on provisions of this Regulation may be imposed to administrative sanctions in the form of:
Medicines, traditional Medicines, complementary food and processed food which already in the market before the date of this regulation comes into force have to adjust their marking/labeling to comply with the provision in this regulation within 1 (one) year after the date of this Regulation comes into force.
When this Regulation comes into force, Regulation of the Head of Drug and Food Control Agency No. HK.00.05.1.23.3516 concerning Distribution Permit of Medicine, Traditional Medicines, Cosmetics, Food Supplements and Food Products which are Sourced and Containing from Particular Substances and/or Containing Alcohol is revoked and declared null and void.
This Regulation comes into force on the date of promulgated.
For public cognizance, this regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on June 30, 2010
HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA
signed,
DRA. KUSTANTINAH, APT, M.APP.SC