Background sI copy V.jpg

Indonesia

Classification

Regulation Number 27 (2013)of the Head of the Agency of Drug and Food Control (in brief: BPOM (Indonesian)).[1][N1]  Within the ambit of the mentioned act the following definition applies.

Health Supplement is a product that is meant to complement the nutritional need, maintain, increase and improve health function, containing one or more ingredients in the form of vitamin, mineral, amino acid or other ingredient (originating from plant or non-plant) that have nutritional value and/or physiological effect, not intended as food.

Decision of the Head of National Agency of Food And Drug ControlNo. HK.00.05.23.3644/2004 on Basic Provisions of Food Supplement Control[2] applies a similar definition for the purpose of that act.

In addition, article 4 of HK.00.05.23.3644/2004, prescribes that food supplements are to be presented in the form of pill, tablet, capsule, powder, granule, semi-solid and liquid preparations that are purposed not for food.

Registration

-   Type of registration

The responsible authority is the Indonesian National Agency for Drug & Food Control (BPOM).[3]In order for food and drugs to be imported and commercialized a circulation permit [import license]and compliance with the rules on import is required. Only the holder of a circulation permit may import drugs or food.

The subsequent registration of foods, including food supplements, consists of an approval from the Head of the Agency (article 42 Regulation No. 28-2004 on security, quality and nutrition of food)[4]. Theapprovalis called a SKI, being an import notification letter.

The requirements regarding registration of food supplements are further implemented by Regulation HK.00.05.41.1381on procedure of food supplement registration.[5]

-   Applicant

A distinction is made between applicants of domestic and imported food supplements. For imported food supplements, the registration must be completed by a local agent. The registration of imported food supplements requires an appointment letter awarded in the country of origin to the pharmaceutical, traditional medicine of food business entity responsible for marketing in Indonesia.

The local entity needs to possess an importer license in the pharmaceutical preparation sector.

The foreign manufacturer needs to possess GMP-certification issued by the authorities of the country of origin or an accredited institution. Additional in-situ examination may be conducted by the Indonesian BPOM.

-   Procedure

Registrations can be completed in bahasa Indonesia and or English, the documentation may be provided in either language.

Different categories of registration apply depending on the composition of the food supplement or changes that are made to an existing registration (variation registration; category 4-6)   .

Category 1 – new

registration of food supplement that contains one or more materials in the form of vitamin, mineral, amino acid, carbohydrate, protein, fat or other materials in the form of isolate

Category 2 – new

registration of food supplement that contains one or more materials in the form of vitamin, mineral, amino acid, carbohydrate, protein, fat, other isolates, and other materials in the form of natural materials

Category 3 – new

registration of food supplements of categories 1 and 2 with a claim of new usage, new preparation form, posology and new dosage

Category 4 - variation

registration of food supplement that has obtained circulation license with:

4.1. change of product name without change of composition;

4.2. change or increase of package size;

4.3. change of claim in the marking that does not change the benefits;

4.4. change of package design;

4.5. change of factory name or licenser name without change of ownership status;

4.6. change of importer name, without change of ownership status.

Category 5 - variation

registration of food supplement hat has obtained circulation license with:

5.1. change of specification and or analysis method of raw materials;

5.2. change of specification and or analysis method of finished product;

5.3. change of stability;

5.4. change of production technology;

5.5. change of production site;

5.6. change or increase of package type

Category 6

registration of food supplement that has obtained circulation license with:

6.1. change of formula or composition whose main ingredients are categorized in one group;

6.2. change of additive that does not change the benefits

The registration needs to be presented with the head of the National Agency of Drug and Food Control and consists of two phases;

(i)     pre-assessment

This step comprises evaluation of the submitted documentation. It comprises an evaluation whether the forwarded documents are complete and valid and the determination of category for registration (1-6). For a variation registration a time frame of 10 working days applies from the date of receipt of the registration dossier. For new registrations, the time frame is 20 days.

(ii)     assessment.

The actual assessment consists of the evaluation of the provided documentation and supporting data. All data used in the registration is kept confidential.

The required documentation comprises;

Product documents

-   Import license of local agent (importer)

-   Letter of authorization (from foreign manufacturer to local agent)

-   Certificate of free sale from country of origin

Documents of quality and technology

-   GMPof manufacturer (HACCP validation)

-   Composition: ingredients and actives

-   Directions of use; direction, dosage, warning, precaution,

contraindication / recommendation, and duration ofadministration

-   Certificate of analysis – with % of each ingredient

-   Certificate of analysis of raw materials

-   Safety test certificate from authorized laboratory in Indonesia

-   Toxicity test

Documents that support claim effectiveness

-   Documents of quality and technology

-   Documents that support effectiveness claim in accordance with the type and level of proofing.

Package design

-   Etiquette, box, wrapping, strip, blister, catch cover, and other packages in accordance with the prevailing provisions on wrapping and marking, that constitutes package design of food supplement that will be circulated and must be completed with color design

-   Brochures that mention information on the food supplement

-   Time limit

The time limit for the actual assessment depends on the route that needs to be followed.

registration channel 1

7 working days

registration channel 2

15 working days

registration channel 3

30 working days

registration channel 4

60 working days

It is estimated that 60 days should be counted for the registration of food supplements.

-   Payment

Fee applies determined according to statutory documents.

-   Outcome[6]

Either compliance or (provisional) incompliance regarding quality, safety and efficacy shall be awarded. In case of compliance a decision letter by the Agency Head will be issued. Different sizes of one product are covered under a single registration. The same accounts for different flavors of one product.

In case of provisional incompliance, additional data will be requested. The data needs to be forwarded within three months from the date of the notice. If the time-limit is exceeded the dossier is returned by email. In that case a new registration will have to be initiated.

The registration remains valid for a period of 5 years. Authorization belongs to the local agent and cannot be awarded to other distributors, apart from when a different registration is completed.Extension of the circulation permit can be obtained through re-registration.

Refusal means that the products need to be re-registered and the fees need to be paid again.

-   Overview (flow chart)

LOCAL

Composition

Regarding the composition of health supplements, the Indonesian authorities refer to the Decision of the Head of National Agency of Food And Drug ControlNo. HK.00.05.23.3644/2004 on Basic Provisions of Food Supplement Control.[7]

They indicated this information is not available in English; the available English translation does not include the tables of maximum values and authorized substances. However the tables in the Indonesian version can easily be read as well.

Attachment 1 concerns the limitations for vitamins, minerals and amino acids. Attachment 2 regulates the use of sweeteners. Other additives are those which are allowed in food in general.

Attachment 3 contains the prohibited substances.

Several other acts arelisted here (also not available in English) may be of relevance:

Decree of The Head of National Agency of Drug and Food Control The Republic of Indonesia no.HK.00.05.52.6291 of 2007, on Nutrition Reference Values

HK.00.05.42.6575 Year 2007 on Prohibition from using Benzyl Piperazine in Food Supplements

HK.00.1.23.05.12.3428 Year 2012 on Prohibition from Producing and Circulating Traditional Medicine and Food Supplement Containing Pausinystalia Yohimbe Plants

Labelling

-          General labelling

The labelling of food supplements is regulated by article 15 of the Decision of the Head of National Agency of Food And Drug ControlNo. HK.00.05.23.3644/2004. But general food labelling may be of relevance as well:Regulation No. 69/1999 onFood Labels and Advertisements.[8]

As a general requirement the information shall not be misleading.

See also Regulation Number HK.03.1.23.06.10.5166[9]: Inclusion of Information of Certain Materials of Origin, Content of Alcohol, and Expiration Date on the Label of Drug, Food Supplement, and Food.

A label is understood as ´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

i.    Food supplement indication

Food Supplement (in Indonesian is “SuplemenMakanan”).

ii.   Name of the product

May be the trade name or a generic name.

The name of the food, the net weight and name and address of the party producing or importing food into Indonesia shall be placed on the side of packages of food which allow the public to easily see, observe and/or read.

iii.  Name and address of producer or importer

iv.  Size, content, net weight

v.   Composition

Both qualitative and quantitative.

Article 19 of : Regulation No. 69/1999states that ´the information on ingredients used in the activities or processes of production of food shall be mentioned on labels as a list of ingredients in the order starting from the ingredient which has the largest proportion, except vitamins, minerals and other nutritional supplements

vi.  Alcohol content

Onlyifapplicable.

vii.  Benefits, method of use and dosage of use

viii. Contraindication, side effects and warnings

If any.

ix.  Circulation license number

x.   Batch number/production code

xi.  Date of expiration

xii.  Other information relating to safety or quality or origin of certain materials in accordance with the prevailing provisions

-          Language requirements

 

Article 15 (2) of Regulation No. 69/1999[10] requires the information to be provided in Indonesian, using Arabic numbers and Latin letters. Only in the case there is no equivalent, other signs may be used.

Domestic food supplements must use bahasa Indonesia in the marking, while imported food supplements must use bahasa Indonesia beside the original language (art. 16 Regulation HK.00.05.41.1381on procedure of food supplement registration[11]).

On the basis of Law No 8 of 1999 about Consumer Protection, article 8, paragraph (1) grain j, it is prohibited to not provide information and/or the directions of use in Indonesian.

-          Nutrition labelling

Nutrition labelling is mandatory for fortified foods and foods with claims under article 32 of Regulation No. 69/1999[12]. It shall be accompanied by the statements that the food contains vitamins, minerals and or other kinds of nutrition supplemented.

See also Regulation HK.00.06.51.0475 on Guidelines on Nutrition Information Uses on Food Label[13].

The nutrients shall be displayed in the following order:

a.   total volume of energy, with specification based on amounts of energy which are derived from fat, protein and carbohydrate

b.   total volumes of fat, saturated fat, cholesterol, carbohydrate, fibber, sugar, protein, vitamins and mineral

In case of nutrition labelling on food packaging the following particulars also need to be included on the label:

-   dose of use

-   volume of doses per package;

-   content of energy per dose of use;

-   content of protein per dose (in gram);

-   content of carbohydrate per dose (in gram);

-   content of fat per dose (in gram);

-   percentage and figures of nutrition adequacy number recommended [recommended daily intakes].

Nutrition statements are allowed as long as the amounts correspond to at least 10% of the daily recommended nutrition adequacy volume in a dose of the food. The statement that a food contains more of a certain nutrient than another food (comparative claim) is not allowed.

-          Halal labelling

Halal indication is not necessary for imported products. But substances from pork origin must be labelled that they contain pork as ´MENGANDUNG BABI´ in a box with a black font and white letters. This may be of importance for the following substances: gelatine, glycerine, enzyme, fat, collagen, colostrums, embryo extract, blood extract, hydrolized hemoglobin, keratin, hair extract, placenta, protein, thymus extract, thymus hydrolized, stomach extract, oil, shortening, thickener, emulsifier, stabilizer, l-systein, monoglyceride, diglyceride, or triglyceride.

-          Other

The use of stickers is not allowed. 

Packaging

According to the Decision of the Head of National Agency of Food And Drug ControlNo. HK.00.05.23.3644/2004 on Basic Provisions of Food Supplement Control[14], the container must protect the food supplement from external influences; secure quality, integrity and originality of its content. The same applies to the lid. 

 Claims

On the basis of article 6 of Regulation No. 69/1999 on Food Labels and Advertisement, statements on the benefits of a food may only be included if they are supported by scientific evidence.

Further, claims are regulated by Regulation No.HK_.03.1.23.11.11.09909 Control of Claim on Processed Food Labeling and Advertisement.[15]

The Act contains a list of claims with conditions of use[16]. Other claims may be submitted to the Head of the Agency on the condition that they are:

-          in line with national policy for health and nutrition

-          not associated with the treatment and prevention of disease in individuals

-          not encourage the wrong dietary pattern

-          based on the total diet, especially for health claims, and

-          truthful and not misleading

The claims as the following are prohibited:

-          A statement that any food given will provide an adequate source of essential nutrients;

-          Exploit fear in the consumers;

-          Cause consumer eating a particular type of Processed Food incorrectly and/or

-          Illustrated that a nutrient or component can prevent, treat or cure disease.

Three types of claims are distinguished; nutrition claims, health claims, and glycemic index claims.

For claims which have not been approved before; they will be subjected to scientific evaluation.

Claims used in advertising should be in line with those on the approved label.


[1]Regulation Number 27 (2013), http://extwprlegs1.fao.org/docs/pdf/ins133260.pdf [English].

[2]Decision No. HK.00.05.23.3644/2004 , http://asrot.pom.go.id/img/Peraturan/Keputusan%20Kepala%20BPOM%20No.%20HK.00.05.23.3644%20tentang%20Ketentuan%20Pokok%20Pengawasan%20SM.pdf [Indonesian],

http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/473.%20BPOM_HK.00.05.23.3644.2004_final.html [English].

[3]Homepage National Agency of Drug and Food Control, http://www.pom.go.id/index.php/home/en

[4]Regulation No. 2812004, http://extwprlegs1.fao.org/docs/pdf/ins52865.pdf [English].

[5] Regulation HK.00.05.41.1381 on procedure of food supplement registration,http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/477.HK%2000%2005%2041%201381.html[English].

[6] Articles 19-23 of Regulation HK.00.05.41.1381on procedure of food supplement registration.

[7] Decision No. HK.00.05.23.3644/2004, http://asrot.pom.go.id/img/Peraturan/Keputusan%20Kepala%20BPOM%20No.%20HK.00.05.23.3644%20tentang%20Ketentuan%20Pokok%20Pengawasan%20SM.pdf [Indonesian], English: http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/473.%20BPOM_HK.00.05.23.3644.2004_final.html [English].

[8]Regulation NO. 69/1999http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/30.PP_NUMBER%2069%20OF%201999.eng.html [English].

[9]Regulation HK.03.1.23.06.10.5166, http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/4012_HK.03.1.23.06.10.5166_e.html [English].

[10] Regulation NO. 69/1999 http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/30.PP_NUMBER%2069%20OF%201999.eng.html [English].

[11]RegulationHK.00.05.41.1381, http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/477.HK%2000%2005%2041%201381.html [English].

[12]RegulationNO.69/1999http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/30.PP_NUMBER%2069%20OF%201999.eng.html [English].[13]Regulation HK.00.06.51.0475, http://standarpangan.pom.go.id/dokumen/peraturan/2005/2005-HK.00.06.51.0475-Informasi_Nilai_Gizi__Batang_Tubuh_.pdf[Indonesian].[14]DecisionHK.00.05.23.3644/2004: http://asrot.pom.go.id/img/Peraturan/Keputusan%20Kepala%20BPOM%20No.%20HK.00.05.23.3644%20tentang%20Ketentuan%20Pokok%20Pengawasan%20SM.pdf [Indonesian], http://www.flevin.com/id/lgso/translations/JICA%20Mirror/english/473.%20BPOM_HK.00.05.23.3644.2004_final.html [English].[15]Regulation No.HK_.03.1.23.11.11.09909, https://extranet.who.int/nutrition/gina/en/node/22946 [English - overview only]https://extranet.who.int/nutrition/gina/sites/default/files/IDN%202011%20Regulation%20No.HK_.03.1.23.11.11.09909%20Control%20of%20Claim%20on%20Processed%20Food%20Labeling%20and%20Advertisement%20(official).pdf[Indonesian]. See presentation BPOM: https://www.slideshare.net/Adrienna/indonesia-nutrition-labelling-claims2015.

[16] See WHO summary on https://extranet.who.int/nutrition/gina/en/node/22946 [N1]New website being set-up:http://www.pom.go.id/new/