WORLD TRADE  
ORGANIZATION  G/TBT/N/IDN/48 
19 January 2011  
 (11-0315) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  INDONESIA
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  The National Agency for Drug and Food Control (NADFC) Republic 
of Indonesia 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :  
1. Bureau of Law and Public Relation 
National Agency for Drug and Food Control (NADFC) Jl. Percetakan Negara No. 23 Jakarta 10560 – Indonesia 
Tel.:  +(62-21) 4209221, 4263333;  
Fax:  +(62-21) 4209221, 4263333; E-mail:  mailto:humas_bpom@yahoo.com
  
Website:  http://www.pom.go.id  
 2. Bureau of International Cooperation 
National Agency for Drug and Food Control (NADFC) 
Jl. Percetakan Negara No. 23 Jakarta 10560 – Indonesia Telephone:   +(62-21) 42875379 Facsimile:   +(62-21) 42875379 
E-mail:  mailto:kerjasamaln_bpom@yahoo.co.id
  
3. Notified under Article 2.9.2 [X], 2.10. 1 [ ], 5.6.2 [X], 5.7.1 [ ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Drug, Traditional 
Medicines, Health Supplement and Food 
5. Title, number of pages and language(s) of the notified document:  Regulation of The 
Head of National Agency for Drug and F ood Control Republic of Indonesia No. 
HK.03.1.23.06.10.5166 Year 2010 concerning inclus ion of the Information on Particular 
Substances, Alcohol Content an d Expired Date on The Label of Drug/Medicine, Traditional 
Medicines, Complementary Medicines, and Food (7 pages, in Indonesian). G/TBT/N/IDN/48 
Page 2  
 
  6. Description of content:   
This regulation states that be sides having to comply with the relevant existing laws, the 
labelling of drug/medicines, traditional medici nes, complementary medicines, and processed 
food shall bear the information related to the following items : 
a. Animal-origin materials; 
b. Alcohol content; and  
c. Expiry date. 
This regulation states that th e product above that contain anim al-origin materials/substances 
shall include the information on its labelling. Sp ecific rules applied for such products using 
materials derived from porcine (pork-origin) or during manufactured process coming into 
contact with materials derived from porcine (pork-origin).  The animal-origin materials are 
gelatine, glycerine, enzyme, fat, collagen, colostrums, embryo extract, blood extract, hydrolized haemoglobin, keratin, hair extract,  placenta, protein, thymus extract, thymus 
hydrolisate, stomach extract, oil, shortening, thickener, emulsifier, stabilizer, I-systein, 
monoglyceride, diglycerid e, or triglyceride.  
This regulation states that the following label information are applied : 
1. Particular substance conten t or drug, traditional medicines,  health supplement and food 
which contains certain substance has received certification from the competent institution, the certification information should be declar ed in the labelling as Halal label. 
2. For drug/medicines, traditional medicine s, and complementary medicines containing 
particular substance derived fro m porcine (pork-origin) shall bear specific marking on its 
label by putting information of "Porcine Origin" (Mengandung Babi). 
3. For drug/medicines in which its manufacturi ng process contact with particular substance 
derived from porcine (pork-origin) shall bear specific marking on its label by putting information of "This product was in contact with materials derived from porcine during its 
manufacturing process" (Pad a proses pembuatannya bersi nggungan dengan bahan bersumber 
babi). 
4. For processed food products in which its ma nufacturing process contact with particular 
substance derived from porcine (pork-origin), it  shall bear specific marking on its label by 
putting information  of  "Containing Pork" (me ngandung babi), by written text and picture of 
pig. 
5. For product containing alcohol, it shall bear its Content of alcohol which is stated in 
percentage.  The afore-mentioned label information of the pr oducts shall also bear the expired date which 
consist of the following information: month and year of expiry. For processed food with shelf 
life less than 3 months, the label shall bear th e expired date which consist of the following 
information: date, month, and ye ar of expiry. The provision re lating to expire d date do not 
apply for the following products: 
a. Wine; 
b. Alcoholic beverage with al cohol contain more than 10%; 
c. Vinegar; 
d. Sugar; and 
e. Bread and pastry with shelf life less than or equal to 24 (twenty four) hours. 
 This regulation also states that  requirements on size of such markings on the label shall be 
proportional, with the minimum size of  letters are not less than 1.5 mm. 
  G/TBT/N/IDN/48 
 Page 3 
 
 
  This regulation also states that several leve l of administration sanctions will be applied 
according to the type of violation of the provision of this regulation. 
 Drug/Medicine, Traditional Me dicines, Complementary Medicines and Processed Food 
which already in the market before the date of en try into force of this regulation have to adjust 
their marking/labelling to comply with the provision in this regulation within one year after 
the date of entry into force of the regulation (30 June 2010).  This regulation replaced Regulation of Head of the National Agency for Drug and Food 
Control, the Republic of Indonesia No. HK .03.1.23.06.10.3156 Year 2010 concerning 
Drug/Medicine, Traditional Medicines, Cosm etics, Food Supplements and Food Products 
which are Sourced and Containing from Particular  Materials/Substances  and/or Containing 
Alcohol. 
7. Objective and rationale, including the nature of urgent problems where applicable:   
1. To protect public health from the risk of marketed drug/medicines, traditional medicine, 
complementary medicines which do not meet qual ity, safety and efficacy requirements as 
well as food which are not safe and not appropriate to  be consumed.  
2. To establish fair trade competition.  
3. Right of Consumers to get clear information 
8. Relevant documents:    
1. Act No. 7 Year 1996 on Food 
2. Act No. 8 Year 1999 on Consumer Protection 3. Act No. 36 Year 2009 on Health 4. Government Regulation No. 72 year 1 998 on Pharmaceutical Product and Medical 
Devices Safety 
5. Government Regulation No. 69 Year 1999 on Food Advertisement and Labelling. 
6. Government Regulation No. 28 year 2004 on Food Safety, Quality and Nutrition 
9. Proposed date of adoption:   
Proposed date of entry into force:   }30 June 2011   
10. Final date for comments:  60 days after notification 
11. Text available from: National  enquiry point [ ], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:   
Center for Cooperation on Standardization 
National Standardization Agency, Indonesia (BSN) Manggala Wanabakti Bld, Block IV, 4th floor 
Jl. Jend. Gatot Subroto, Senayan 
Jakarta 10270 – Indonesia Tel.:  +(62-21) 5747043 ext 215 Fax:  +(62-21) 5747045 E-mail:  mailto:tbt.indonesia@gmail.com; tbt.indonesia@bsn.go.id
  
 
And can also be downloaded here:  
http://members.wto.org/crna ttachments/2011/tbt/IDN/11_0124_00_x.pdf