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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 circulated in accordance with Article 10.6


1.

Member to Agreement notifying: Indonesia

If applicable, name of local government 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 Food Control Republic of Indonesia No. HK.03.1.23.06.10.5166 Year 2010 concerning inclusion of the Information on Particular Substances, Alcohol Content and Expired Date on The Label of Drug/Medicine, Traditional Medicines, Complementary Medicines, and Food (7 pages, in Indonesian).

6.

Description of content:

This regulation states that besides having to comply with the relevant existing laws, the labelling of drug/medicines, traditional medicines, 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 the product above that contain animal-origin materials/substances shall include the information on its labelling. Specific 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, diglyceride, or triglyceride.

This regulation states that the following label information are applied :

1. Particular substance content or drug, traditional medicines, health supplement and food which contains certain substance has received certification from the competent institution, the certification information should be declared in the labelling as Halal label.

2. For drug/medicines, traditional medicines, and complementary medicines containing particular substance derived from 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 manufacturing 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" (Pada proses pembuatannya bersinggungan dengan bahan bersumber babi).

4. For processed food products in which its manufacturing process contact with particular substance derived from porcine (pork-origin), it shall bear specific marking on its label by putting information of "Containing Pork" (mengandung 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 products 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 the expired date which consist of the following information: date, month, and year of expiry. The provision relating to expired date do not apply for the following products:

a. Wine;


b. Alcoholic beverage with alcohol 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.
This regulation also states that several level of administration sanctions will be applied according to the type of violation of the provision of this regulation.
Drug/Medicine, Traditional Medicines, Complementary Medicines and Processed Food which already in the market before the date of entry 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, Cosmetics, 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 quality, 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 1998 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/crnattachments/2011/tbt/IDN/11_0124_00_x.pdf





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