Regulation of the Head of the Food and Drug Supervisory Board No. 03.1.23.06.10.5166 on the inclusion of information on the origin of certain materials, alcoholic content and expiry date on the labels of drugs, traditional drugs, food supplements and foods

GOVERNMENT REGULATlONS THE INCLUSION OF INFORMATION ON THE ORIGIN OF CERTAIN MATERIALS, ALCOHOLIC CONTENT AND EXPIRY DATE ON THE LABELS OF DRUGS,TRADITIONAL DRUGS, FOOD SUPLEMENTS AND FOODS (Regulation of the Head of the Food and Drug Supervisory Board No. HK.03.1.23.06.1 0.5166 dated June 30, 2010) BU5JneS5 News 8153/ ';f-Y-1Jl! BY THE GRACE OF ALMIGHTY GOD THE HEAD OF THE FOOD AND DRUG SUPERVISO RY BOARD OF THE REPUBLIC OF INDONESIA, Considering; a. that to protect public health. drugs. traditional drugs. food supplements and foods must meet snnuritv, re stora tive [Jower/hf'nf'fit, and qualir v rf' quirements; b. that information on security, restorative powerl benefit and quality requirements put on the labels of drugs, traditional drugs. food supplements and foods must be objective and complete and must not be misleading; b. that in addition to the information as referred to in letter b, the public are also entitled to receive info rrnarior, on r hn orioin of r.r>rt::Jin mrlteri::Jls. al coholic content and expiry date put on the labels 45 GUVERNMENT REGULATIONS of drugs, traditional drugs, food supplements, and foods; d. that based on the considerations as referred to in letter <:I, letter b and letter c, it is necessary to stip ulate Regulation of the Head of the Food and Drug Supervisory Board on the Inclusion of Information on the Origin of Certain Materials, Alcoholic Con tent, and Expiry Date on the Labels of Drugs, Tra ditional LJrugs, food Supplements and foods; In view of : 1. Law No.7/1996 on Food (Statute Book of 1996 No. 99, Supplement to Statute Book No. 3656); 2. Law No. 8/1999 on Consumer Protection (Stat ute Book of 1999 No. 42, Supplement to Statute Book No. 3821); 3. Law No. 36/2009 on Health (Statute Book of 2009 No. 14, Supplement to Statute Book No. 5063); 4. Government Regulation No. 72/1988 on the SClfeguarding of Pharmaceutical Preparetious arul Health Instruments (Statute Book of 1998 No. 138, Supplement to Statute Book No. 3781); 5. Government Regulation No. 69/1999 on Food La bel and Advertisement (Statute Book of 1999 No. 1J 1, Supplement to Statute Book No.3867); 6. Government Regulation No. 28/2004 on Food Security, Quality and Nutrition (Statute Rook of 2004 No. 107, Supplement to Statute Book No. 4424); 7. Presidential Decree No. 103/2001 on the Position, Task, Function, Authority, Organizational Struc ture and Working Mechanism of Non Ministcriol Government Institutes as already several times amended the latest by Presidential Decree No. 64/2005; 8. Presidential Decree No. 110/2001 on the Orga nizational Unit and TaSks of Echelon I Officials of Non-Ministry Government Institute as already several times amended the latest by Presidential' Regulation No.52/2005; 9. Decision of the Head of the Food and Drug Super visory Board No. 02001 /SK/KBPOM/200 1 on the Organization and Work Mechanism of the Food and Drug Supervisory Board as already amended by Decision of the Head of the Food and Drug Su pervisory Board No. HK.00.05.21.4231/2004; DECIDES To stipulate: REGULATION OF THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD ON THE INCLUSION OF INFORMATION ON THE ORIGIN OF CERTAIN MA TERIALS, ALCOHOLIC CONTENT AND EXPIRY DATE ON THE LABELS OF DRUGS, TRADITIONAL DRUGS, FOOD SUPPLEMENTS AND FOODS. CHAPTER I GENERAL PROVISIONS Article 1 Referred to in this Regulation as : 1. eel ta in mater ial is i:I material orlqinatlnq or con taining or originating from animals. either in a sin gular or mixture form or processed product or its derivatives. 2. Alcohol is ethyl alcohol with a chemical formula of C2H50H. 3. Expiry date is a piece of information on the ex riry rlrlte of d rujjs, traditio nal drUGS, food sup plements, and foods fit for consumption in the form of date, month, and year or month and year. 4. Label is any information on product in the form of picture, written statement or a cornbinetion of picture and written statement or other form at tached to, incorporated with, stuck on, or part of product package. Article 2 The certa in materials as referred to in Arti~le point 1 can come in the form of gelatin, gliserin, 46 Bus;n"ss News 8151/9-9-201 i GOVERNMENT REGULATIONS enzyme. fat. collagen.. colostrum, embryo extract. blood extract, hydrolyzed haemoglobin, keratin, hair extract, placenta, protein. thymus extract, thymus hydrolisate, stomach extract, oil, reroti fat (short eni ng), condenser, ernulslfier. stabilizer, l-sistein, monogliseride, digliseride, or trigliseride. Article 3 (1l In addition to fulfilling the law and requlation, the labels of drugs, traditional drugs, food supple ments and foods shall also carry information on tile urigin of certain materials, alcoholic content and expiry date as stipulated in this RegUlation. (2) If the origin of certain materials as referred to in paragraph (1) and/or products containing the ori gin of certain materials have received a certi ficate from the authorized agency, intorrnatron on the relevant ce rtificate shall be put on the label. (3) If information on the certificate as referred to in paragraph (2) comes in the form of halal label, it shall be put in the label according to that con tained in the relevant certificate. CHAPTER II CERTAIN MATERIALS Article 4 (1) The labels of drugs, traditional drugs. food sup plements ,:If1d touds corualnluq cer tain matertals shall carry information on the content of the cer tain materials on the labels. (2) In addition to the information as referred to in paragraph (1 L the labels of drugs, traditional drugs, and food supplements containinq certain materials originating from pork shall carry spe r.irll mark in thp. form of words "C:ont!3inina Pnrk" written in black inside a black box on white base like the following example: [ CONTAINING PORK I (3) The special mark as referred to in paragraph (2) for drugs whose production process touches on certain materials originating from pork shall carry a written statement "In its production process it touches on material originating from pork". (4) The statement as referred to in paragraph (3) shall be written in hlar.k inside a black box on white base like the following example: In its production process it touches on materials originating from pork. (5) The information as referred to in paragraph (2) for foods shall contain special mark in the form of written statement "containing pork + (picture of pig)" in red inside a red box on white base like the following example: CONTAINING PORK (6) The written statement as referred to in paragraph (5) shall measure at least 1.5 mm, shall be read clearly, and shall be in proportion to the size of label. CHAPTER III ALCOHOLIC CONTENT Article 5 (1) The labels of drugs, traditional drugs, food sup plements and foods containing alcohol shall carry information on alcoholic content. (2) The alcoholic content as referred to in paragraph (1) shall he expressed in percentage. CHAPTER IV EXPIRY DATE Article 6 (1) The lebels of druqs, traditional drugs, food sup plements and foods shall carry the expiry date. Bu.>;n-eS$ N{;Iw~ 8153J9-9-2011 47 (2) The expiry date as referred to in paragraph (1) ::;11011 b e stuck.. on the lab el l;leariy so tlrat it l;an easily be seen and read. Article 7 (1) The expiry date of drugs, traditional drugs, food supplements and foods shall be written by men tioning month and year. (2) The expiry date of foods with a storage period of less than 3 (three) months shall be written by mentioning date, month and year. Article 8 (1) EXl;epteu LU pr ovistons in Ar ticle 6 ::;11011 lie u aui tional drugs that must not be registered. (2) Excepted to provisions in Article 6 for foods in the form of : a. alcoholic drink made of wine; b. drinks containing alcohol of more than 10 (ten) percent; c. vineGar; d. sugar (sucrose); and e. bread and cake with a storage period of less than or equal to 24 (twenty-four) hours. CHAPTER V ADMINISTRATIVE SANCTIONS Article 9 Violators of this regulation can be lia ble to ad ministrative sanctions in the form of : a. Written warning; b. Order to withdraw and/or destroy products; c. The freezing of circulation permitlregistration ap proval; Or d. Other administrative sanctions according to the law and regulation. CHAPTER VI TRANSITiONAL PROVISIONS Article 10 The labels of drugs, traditional drugs, food supplements, and foods that have secured a circula tion permit/registration approval before this regulation is put into force shall adjust to this regulation no later than 1 (one) year after this regulation has been stipu lated. CHAPTER VII CONCLUSION Article 11 When this Regulation begins to take effect, Regulation of the Head of the Food and Drug Supervi sory Board No. HK.00.05.1.23.3516 on the Circula tion Permits of Drugs, Traditional Drugs, Cosmetics, Food Supplements and Foods Originating and Con taining Certain Materials and/or Containing Alcohol shall be declared null and void. Article 12 This Regulation shall come into force as from 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 .Junn 30. 7010 THE HEAD OF THE FOOD AND DRUG SUPERVISO RY BOARD OF THE REPUBLIC OF INDONESIA, sgd. DRA. KUSTANTINAH. APT., M.APP.SC Promulgated in Jakarta On July 5, 2010 THE LAW AND HUMAN RIGHTS MINISTER sud. PATRIALIS AKBAR, SH, MH ::>TATE GAZETTE OF THE REPUBLIC OF INDONESIA OF 2010 NO.328 (S) 48 BUSIIleS5 News 815319·9·2011