EXPOSITION TO THE REGULATION OF THE GOVERNMENT THE REPUBLIC OF INDONESIA
NUMBER 28 OF 2004

CONCERNING
FOOD SAFETY, QUALITY AND NUTRITION

GENERAL

Food is human's most basic need as it is influential in his existence and survival in terms of both its quantity and quality. As it is highly important, food is basically one of the human basic needs and is fully the right of every Indonesian citizen.

Availability of adequate, safe, quality and nutritious food is the main precondition that should be met in the effort to realize a dignified person and quality human resources.

Human resources are the most important element and equally the main objective of national development as quality human resources are the determining factor of the developmental success that will in the end be capable of improving the people's welfare and living standard and could reduce or even eliminate poverty.

The quality of human resources, among others, is highly determined by the quality of food people consume, and all the resources and efforts should be mobilized to the optimum, so as to make safe, quality and nutritious food adequately available and affordable to the people in terms of their purchasing power.

To make safe food adequately available, there is a need to undertake the realization of a food system that is capable of protecting the people who consume it, so that the food in distribution and/or trade is not detrimental but is safe for human mental health. In other words, such food should meet the food safety requirements.

Advancement of science and technology in the field of food and the ever-advanced and open trade world both domestically and internationally will bring about impacts on the ever-diversified types of food distributed in the community, either produced domestically or imported.

Food consumed by the people basically goes through a chain of process that includes production, storage, transportation and distribution before it reaches the consumers.

In order for the chain to meet the food safety, quality and nutrition requirements, there needs to realize an effective system of arrangement, supervision and control in the field of food safety, quality and nutrition in the form of a Government Regulation on Food safety, Quality and Nutrition, which constitutes the implementation directives of Law Number 7 of 1996 concerning Food.

Article By Article

Article 1

Point 1

Food shall include chewing gum and the like, excluding cosmetics, tobacco, tobacco processing products or materials designated for medicine.

Other materials shall mean the materials used in the process of preparation, processing and/or making of food or drinks other than food additives and processing aid.

Examples of other materials would be catalytic materials, such as digestion enzyme. Raw materials shall mean the basic materials used to produce food. Raw materials may be in the form of fresh food or half-processed food.

Point 2

Fresh food shall, in this provision, include food that could be consumed directly by humans without experiencing any processing, such as fruits and some vegetables and those that could be used as raw materials for food processing, such as soy beans, corns, meat, fish, milk, eggs and so on.

Point 3

Processed food shall, in this provision, include processed food that is ready for consumption directly and processed food that should be cooked first, and then used as raw materials for food, such as tapioca, flour and soy protein isolate.

Point 4

Certain processed food shall mean processed food for consumption of certain groups, such as formula milk for babies, food designated for pregnant women or lactating mothers, special food for sufferers of certain diseases, and any similar food that has great impacts on the quality development of human health.

Point 5

Self-explanatory

Point 6

Business venues shall, in this provision, include catering, hotels, restaurants, eating places, cafeteria, side walk food vendor, and food vendors.

Point 7

Self-explanatory

Point 8

Self-explanatory

Point 9

Self-explanatory

Point 10

Self-explanatory

Point 11

Self-explanatory

Point 12

Self-explanatory

Point 13

Offer to sell food shall mean the activity customarily performed prior to food trading transaction, for instance giving for free food product samples in the framework of promotion.

Point 14

Self-explanatory

Point 15

Self-explanatory

Point 16

Self-explanatory

Point 17

Food additives are not usually consumed as food nor are they food ingredients, has or has no nutrition value that is deliberately added into food for technological purposes for making, processing, preparing, treating, packing, packaging, storing and/or transporting food to produce or expected to produce any component or to impact the characteristics of the food directly or indirectly. Food additives are not include contamination or any materials added into food in order to maintain or increase the nutrition value. For instance, vitamin C shall be regarded as a food additive if the purpose of adding it is not to improve the nutrition value but as an antioxidant, for instance for maintaining the red color in corned beef.

Food additives shall include, among others, colouring, preservatives, sweeteners, flavoring, flavor enhancers, anti coagulants, bleachers and thickeners.

Point 18

Self-explanatory

Point 19

Ionizing radiation used may originate from radioactive substances that can slow down sprouting, for instance in potatoes, onions, to decelerate decay, for instance in frog thighs, frozen shrimps, prevent decay in other food, for instance in spices and various kinds of seeds.

Point 20

Self-explanatory

Point 21

Self-explanatory

Point 22

Technical specifications or requirements shall, in this provision, include among others the food type, color or composition formulated on the basis of certain criteria according to the development of science and technology as well as other relevant aspects. Food quality standard shall, in this provision, include processed and unprocessed food. In a broader sense, the standard that applies to food shall include various requirements of food safety, nutrition and quality as well as other requirements in the framework of creating a fair food trade, for instance labeling and advertising requirements.

The various standards shall neither conflict with each other nor stand individually; in fact, they constitute a unity, the further outline of which shall be regulated by the Government.

Point 23

Self-explanatory

Point 24

Self-explanatory

Point 25

Food quality certificates may, among others, be in the form of health and analysis certificates. Analysis certificates shall be issued by accredited laboratories. Health certificates shall be issued by authorized agencies. Other quality certificates may be issued by authorized agencies or accredited certifying institutions.

Point 26

Self-explanatory

Point 27

Self-explanatory

Article 2

Paragraph (1)

Any person who is responsible shall, in this provision, mean any person who performs, has any interest in, or benefits from the activity or process of food production, storage, transportation and/or distribution, such as food producers, storage providers, transporters and/or distributors; they either own or rent the facilities and infrastructure required.

In this provision, included among others in food distribution shall be food serving.

Paragraph (2)

Facilities and/or infrastructure shall, in this provision, include building design and construction, layout, equipment and installation, waste disposal facilities and other facilities that are used directly or indirectly in the activity or process of food production, storage, transportation and/or distribution.

Article 3

Self-explanatory

Article 4

Paragraph (1)

Self-explanatory

Paragraph (2)

Good Agricultural Practices Guidelines shall, in this provision, include Food Crops Practices Guidelines, Good Animal Husbandry Practices Guidelines and Good Fishery Practices Guidelines.

Article 5

Paragraph (1)

Self-explanatory

Paragraph (2)

Good Fresh Food Practices Guidelines shall, in this provision, include Good Agricultural Produce Fresh Food Practices Guidelines, Good Animal Husbandry Product Fresh Food Practices Guidelines and Good Fishery Product Fresh Food practices Guidelines.

Article 6

Paragraph (1)

Self-explanatory

Paragraph (2)

Establishment of Good manufacturing Practices of Processed Food Guidelines by the Ministers who are responsible for the fields of industry or fisheries shall be in accordance with their respective duties as contemplated in Government Regulation Number 17of 1986 concerning Authority exercised over Industrial Arrangement, Supervision and Development.

Paragraph (3)

Certain processed food shall be processed food designated for certain groups, such as babies, pregnant or lactating mothers, sufferers of certain diseases and similar food that has great impacts on the quality development of human health.

As consumers of certain processed food include highly risky community groups, and in compliance with the purpose of consuming that food, in its production process, certain, more specific undertaking methods shall be required.

Article 7

Self-explanatory

Article 8

Self-explanatory

Article 9

Self-explanatory

Article 10

Good practices guidelines shall be directed towards business agents, so that in performing their activities they will always comply with food safety. Good practices guidelines shall be applied voluntarily; however, if an activity is deemed critical, such guidelines may be set forth compulsorily.

Any activity deemed critical shall be an activity in the food chain that needs extra-careful handling, making it impossible to be implemented appropriately if it is performed voluntarily by the agent who carries out such an activity.

For instance, Good Fresh Milk Handling Practices Guidelines may be made compulsory, due to the high risk of biological contamination, so that it needs extra-careful handling.

Article 11

Communities should be protected from food that uses or contains any materials declared prohibited as food additives. Such materials may risk human health and lives.

Article 12

Food that uses or contains food additives that are not in accordance with the regulations has negative impacts on human health.

Therefore, the use of food additives in the food production activity or process shall be regulated strictly in the framework of realizing food safety, so that the people will be prevented from consuming food that may disturb, impair and risk human health and lives.

Article 13

Self-explanatory

Article 14

Self-explanatory

Article 15

Paragraph (1)

The use of irradiation techniques and methods in the food production activity or process has developed and expanded remarkably, particularly in food preservation.

The use of such techniques or methods that has reached the commercial level shall remain safe for the people. Therefore, to prevent the uncontrollable use of irradiation techniques and methods such irradiation shall be strictly regulated and supervised. In order for the activity not to cause any risk that may impact negatively human health and safety, requirements shall be set forth to be met by irradiation service providing facilities.

Paragraph (2)

The provision on irradiated food shall include the permitted types of commodities and doses of commodities, the general requirements in connection with radiation sources, absorbed doses, irradiating facilities and irradiation process control, irradiated food hygiene, technological requirements and re-irradiation.

Article 16

Self-explanatory

Article 17

Self-explanatory

Article 18

Self-explanatory

Article 19

Paragraph (1)

Packaging is a part of a good food production practices. Food shall be packaged appropriately, so that packaged food will not be easily rotten and/or contaminated, and its quality will not decrease.

Paragraph (2)

Correct food packaging procedures shall be particularly designated for certain food with certain qualities/characteristics and, thus, needs special treatment during packaging, for instance food with high-level fat content or food with high temperature that shall not be packaged in plastics that will possibly release carcinogenic monomer into the food.

Article 20

Paragraph (1)

This provision is set forth in the framework of preventing food product contamination by any materials that may impair or risk human health.

Food final packaging shall mean the final packaging of food product customarily done in the final stage of the production process or activity of food traded for human consumption.

Paragraph (2)

Food procured in large quantities customarily not packaged in final shall be food in large packaging intended for trade (retail) further in smaller packages, such as rice, flour and sugar.

Such a practice shall be adjusted with what is customarily practiced in relevant food commodities or what is practiced by the local community.

Paragraph (3)

Self-explanatory

Article 21

Paragraph (1)

The quality assurance system shall be a prevention effort that shall be complied with and/or implemented in the framework of producing quality food that is safe for human health; this is usually done from the beginning of the food production activity until it is ready for trade, and it is a system of quality control and supervision that develops in line with science and technology.

The quality assurance system shall be administered by applying, among others, Good Agricultural Practices, Good Fresh Food Practices, Good Processed Food Practices, Good Food Distribution Practices, Good Retail Practices or Good Ready-to-Serve Food Practices.

Paragraph (2)

Self-explanatory

Paragraph (3)

Self-explanatory

Paragraph (4)

Self-explanatory

Article 22

Paragraph (1)

Self-explanatory

Paragraph (2)

Self-explanatory

Paragraph (3)

In respect of imported products, laboratory acknowledgement of exporting countries shall be based on mutual agreements bilaterally or multilaterally.

Paragraph (4)

Establishment of testing laboratory requirements shall be set forth by government agencies in accordance with their respective duties and authority; they shall be set forth gradually, taking into account the types of food produced and the technical specifications and/or parameters required.

Article 23

Letter a

Poisoning or hazardous substances that risk human health and lives shall include, among others, metals, metalloids, any poisonous chemical substances, hazardous microorganisms, mycotoxin, pesticide residues, hormones and animal medicines that are greater than the maximum limit set forth.

Letter b

Self-explanatory

Letter c

Prohibited substances shall include, among others, borax, formalin, rhodamin B or methanyl yellow.

Letter d

Self-explanatory

Letter e

Expired food shall mean food that has passed the time period in which its quality is guaranteed, so long as its storage complies with the instructions provided by the producer.

Article 24

Paragraph (1)

Letter a

Self-explanatory

Letter b

The provisions on contamination thresholds shall include:

1) biological contamination maximum threshold requirements;

2) chemical contamination maximum threshold requirements; and

3) maximum threshold requirements of other objects that may disturb, impair or risk human health.

Letter c

Self-explanatory

Letter d

Self-explanatory

Paragraph (2)

Self-explanatory

Paragraph (3)

Self-explanatory

Article 25

Paragraph (1)

Healthcare units shall include, among others, community healthcare centers, policlinics, government / private hospitals at the provincial or regency/town.

Paragraph (2)

Self-explanatory

Paragraph (3)

Food borne diseases outbreak shall be any incidents in which two or more people suffer from any health problems with the same or nearly the same symptoms after consuming any food, and based on epidemiological analysis such food is proven to have been the source of contagion.

Paragraph (4)

Self-explanatory

Paragraph (5)

Self-explanatory

Paragraph (6)

Self-explanatory

Article 26

Paragraph (1)

Self-explanatory

Paragraph (2)

Central Government shall, in this provision, mean the ministry responsible for the field of health and/or the Agency.

Article 27

Self-explanatory

Article 28

Self-explanatory

Article 29

Self-explanatory

Article 30

The Indonesian National Standard may be imposed compulsorily on some or all of the technical specifications and/or parameters in the Indonesian National Standard.

The agencies authorized to impose the Indonesian National Standard compulsorily shall be as follows:

a. For fresh food from agricultural produce, by the Minister who is responsible for the field of agriculture;

b. For fresh food from fisheries, by the Minister who is responsible for the field of fisheries;

c. For processed food, by the Ministers who are responsible for the fields of industry, agriculture or fisheries in accordance with the prevailing legislation;

d. For Food Additives and certain processed food, by the Head of the Agency.

Article 31

Self-explanatory

Article 32

Self-explanatory

Article 33

Paragraph (1)

Nutrition status standard shall include two matters. The first shall be the individual nutrition status standard classified according to malnutrition that occurs. Such a classification shall be based on the results of examination and physical measurement (anthropometrically and medically clinically) and biochemical examination of body fluids, such as blood and urine (biochemical). The classification may be stated qualitatively, namely over nutrition, under nutrition and severe nutrition.

The second shall be the community nutrition status standard, which means prevalence or percentage of community groups according to the level of malnutrition that occurs.

Paragraph (2)

Malnutrition shall mean health disturbance caused by insufficient and/or imbalanced nutrients that are needed for growth, intelligence and activity/ productivity.

Paragraph (3)

Self-explanatory

Article 34

Periodical changes shall be made on the basis of results of surveys on the communities nutrition status. Requirement Dietary Intake (RDI) shall be the adequate daily average nutrients for every person according to age, sex, body size and body activity to reach an optimum health level.

Article 35

Paragraph (1)

Food nutrition enrichment shall mean adding more nutrients because such nutrients decrease naturally or disappear due to processing and/or storage.

Food nutrition fortification shall mean adding more essential nutrients to certain food that originally does not contain such nutrients.

Enrichment and/or fortification shall, in this provision, mean a national program in the framework of preventing malnutrition, maintenance and improvement of the community nutrition status.

Paragraph (2)

Self-explanatory

Paragraph (3)

Enrichment procedures shall mean the techniques for adding certain nutrients to food that is produced for the purpose of increasing its nutrient content.

Fortification procedures shall mean the techniques for adding certain nutrients to food that originally does not contain such nutrients for the purpose of putting more types of nutrients into it. For instance: adding iodine to salt.

Paragraph (4)

Self-explanatory

Paragraph (5)

Self-explanatory

Article 36

In this provision, food imported into Indonesian territories shall include donated food.

Other prevailing legislation in effect shall include the legislation in the fields of labeling, custom, and in the fields of animal, fish and plant quarantine.

Article 37

Self-explanatory

Article 38

Self-explanatory

Article 39

Self-explanatory

Article 40

Further provisions to be set forth shall, among others, be the requirements for documents and/or certificates needed the results of testing laboratory, the setting of expiry dates, and the approval on food importation.

Article 41

Paragraph (1)

This provision is the minimum requirement that shall be met. In addition to such a requirement, food to be exported from Indonesian territories shall meet the requirements that are effective in destination countries.

Paragraph (2)

Self-explanatory

Paragraph (3)

Self-explanatory

Paragraph (4)

Self-explanatory

Article 42

Paragraph (1)

Processed food shall, in this provision, also include certain processed food, food additives, genetically modified food products or irradiated food.

Processed food imported into Indonesian territories as donation shall comply with the provision as contemplated in this Article.

Retail packaging shall, in this provision, mean food final packaging that shall not be opened for repackaging in smaller packages for trading purposes.

Paragraph (2)

Self-explanatory

Paragraph (3)

The registration approval letter issued shall have the registration number. Such a registration number shall be put on the label of the relevant food and putting such a number shall be in accordance with the provisions that are effective on food labeling and advertisements.

Paragraph (4)

Self-explanatory

Paragraph (5)

Self-explanatory

Paragraph (6)

Self-explanatory

Article 43

Paragraph (1)

Self-explanatory

Paragraph (2)

The obligation to possess production certificates for home industries shall be imposed in phases, due to limited facilities and knowledge of home industry managers in food safety, quality and nutrition.

Such phasing shall provide home industries with the opportunity to improve their capability to produce products that meet food safety, quality and nutrition requirements.

Paragraph (3)

Production certificates shall be provided for processed food produced by home industries that have met the requirements in accordance with the prevailing legislation.

Issuance of such production certificates for home industries by the Regents/Mayors shall be based on the fulfillment of the requirements for good production practices for home industries that shall include, among others, sanitation requirements, use of food additives and labeling.

Good Food Production Practices for Home Industries shall be set forth by the Head of the Agency.

Paragraph (4)

Due to limitations of home industries in respect of buildings, sanitation facilities, equipment and employees, the types of food allowed for production by home industries shall be restricted. Home industries shall only be allowed to produce food that is not highly risky for health.

Article 44

Letter a

Self-explanatory

Letter b

In this provision, small quantities shall mean adequate quantities needed only for relevant purposes.

Article 45

Self-explanatory

Article 46

Paragraph (1)

In this provision, allegations may be the testing results, based on people's reports or the results of tracing the occurrences of poisoning cases.

Paragraph (2)

Self-explanatory

Paragraph (3)

Self-explanatory

Paragraph (4)

Self-explanatory

Paragraph (5)

Self-explanatory

Paragraph (6)

Self-explanatory

Article 47

Self-explanatory

Article 48

Paragraph (1)

Self-explanatory

Paragraph (2)

Self-explanatory

Paragraph (3)

Self-explanatory

Paragraph (4)

Self-explanatory

Paragraph (5)

Withdrawal and destruction guidelines shall, in this provision, include among others the withdrawal methods, the withdrawal time period and the destruction methods.

Article 49

Self-explanatory

Article 50

In the framework of preventing the people from disturbances as the consequence of consuming food products that risk and/or disturb health, the results of food product examinations shall be informed to the people.

Article 51

Paragraph (1)

Self-explanatory

Paragraph (2)

Self-explanatory

Paragraph (3)

Self-explanatory

Paragraph (4)

The supervision efforts as contemplated in this provision shall be carried out by means of various approaches in the framework of improving the capacity of ready-to-serve food producers and home industries.

Paragraph (5)

Supervision on the activities of regional government agencies shall, among others, be in the form of training for food inspectors, provision of guidelines in connection with drug and food control in regions.

Article 52

Self-explanatory

Article 53

Self-explanatory

Article 54

Self-explanatory

SUPPLEMENT TO STATUTE BOOK OF THE REPUBLIC OF INDONESIA NUMBER 4424.