Navigating the Regulatory Landscape of Processed Food for Special Nutritional Purposes (PKGK) in Indonesia

Processed food for special nutritional purposes, abbreviated as PKGK, is a special food category in Indonesia, playing a critical role in supporting public health, particularly for individuals with specific dietary needs. PKGK encompasses food products designed for various groups such as infants, pregnant women, athletes, the elderly, and individuals with certain medical conditions.

In Indonesia, the Food and Drug Authority (BPOM) is responsible for the regulatory oversight of PKGK. Given the importance of these products in public health, BPOM enforces a robust regulatory framework that governs their safety, efficacy, and quality. This article explores the key regulations, approval processes, and compliance obligations for PKGK products in Indonesia, providing a comprehensive view of the regulatory landscape.

Regulatory Framework of PKGK in Indonesia  

1. Key Regulations Governing PKGK 

First of all, as a special category of food products, PKGK are regulated by several overarching food regulations, such as Indonesia Food Law No. 18 2012 and Government Regulation No. 86 of 2019 on Food Safety, which outlines the principles of food safety and quality standards in Indonesia, including sanitation and packaging requirements. Besides, all processed foods including PKGK, must be registered with BPOM before market circulation, as per BPOM Regulation No. 23 of 2023 on Processed Food Registration. For imported foods, importers must apply for an import permit as required by BPOM Regulation No. 27 of 2022 on Control of the Importation of Drugs and Food into Indonesian Territory.

Apart from that, Indonesia has set up a series of detailed and specific regulatory requirements for PKGK products in BPOM Regulation No. 1 of 2018 on Control of Processed Food for Special Nutritional Purposes and its amendments, covering multiple aspects of product compliance, such as production, packaging, labeling and advertising, as well as market circulation.

2. Legal Definition & Classification 

Under BPOM Regulation No. 1 of 2018 on Control of Processed Food for Special Nutritional Purposes, PKGK is defined as processed food that is processed or formulated specifically to meet certain nutritional needs of consumers due to certain physical/physiological conditions and diseases/disorders.

PKGK products can be further classified into two types:

a. Processed food for special diets (abbreviated as PDK), is a kind of processed food that is processed or specially formulated to meet certain nutritional needs of consumers due to certain physical or physiological conditions. Examples of PDK products include infant/toddler/child formula, complementary food for breast milk, snacks for children, special drinks for pregnant/breastfeeding women, sports nutrition and weight control products.

b. Processed food for special medical purposes (abbreviated as PKMK), is a kind of processed food that is processed or formulated specifically for diet management for people with certain diseases/disorders. Examples of PKMK products include human milk fortifier, PKMK for premature babies, and PKMK for diabetes sufferers.

Categories of PKGK Products in BPOM Regulation No. 24 of 2020 on the Second Amendment to Control of Processed Food for Special Nutritional Purposes

3. Pre-Market Registration  

According to BPOM Regulation No. 23 of 2023 on Processed Food Registration, all processed food products in retail sales, including PKGK products, must finish product registration with BPOM to obtain Business Licensing to Support Business Activities (PB-UMKU). The registration process ensures that the product complies with national food safety standards and is suitable for consumption by the target population. Processed food registration is implemented based on the risk level of the matter. For different risk categories, PB-UMKU functions differently. In terms of the registration of PKGK products, risks are classified as the following:

• High risk category (PB-UMKU as Marketing Authorization): new registration and major variation registration of PKGK products;

• Low medium risk category (PB-UMKU as Commitment Fulfillment Certificate): minor variation registration of PKGK products.

For imported products, the registration should be undertaken by local importers appointed by foreign manufacturers through the online portal. BPOM may conduct on-site inspections of overseas manufacturers if necessary. In principle, the PB-UMKU shall be valid for five years, and can be prolonged via registration extension. The following documents are required for PKGK registration:

• General information: food category name, trade name, packaging type, net weight/net content, applicant names that may be similar to the name on the Free Sale Certificate, and importer/distributor name

• Management documents: agency sales agreement from the original country/origin manufacturer (Letter of appointment, LOA)

• Technical documents: ingredient list, process flow, certificate of analysis, product shelf-life information, production code, and label design

• Other support documents: trade mark certificate, GMO product certification, food irradiation information, and scientific evidence to support the claims in the label

4. Major Product Compliance Requirements  

1) Production

Ÿ PKGK manufacturers are required to implement Good Processed Food Production Methods (CPPOB) as well as Hazard Analysis and Critical Control Point (HACCP) system. For imported PKGK products, the implementation of CPPOB shall be proven by a certificate or similar document, issued by an authorized institution in the country of origin that has a mutual recognition agreement with an authorized institution in Indonesia. In the event that there is no mutual recognition agreement with an authorized institution in Indonesia, the fulfillment of the CPPOB shall be proven by a local inspection by BPOM.

Ÿ PKGK produced in a commercially sterile manner must meet the requirements for commercially sterile food in accordance with the provisions of laws and regulations, such as BPOM Regulation No. 19 of 2019 on Guidelines for Good Production Methods for Commercially Sterile Foods that are Processed and Packaged Aseptically.

Ÿ PKGK intended for babies, children, pregnant and breastfeeding women must neither receive irradiation treatment, nor contain irradiated ingredients.

2) Labeling

The labeling of PKGK products shall be in line with general labeling requirements for processed food stated in relevant legislations, such as Government Regulation 69/1999 Foods Labels and Advertisements, BPOM Regulation 20/2021 on Processed Food Labels, BPOM Regulation No. 26 of 2021 Information on Nutritional Values on Processed Food Labels, BPOM Regulation No.1 of 2022 on Claims on Processed Food Labels and Advertisements, and Decree of the Head of BPJPH No. 40 of 2022 on the Determination of the Halal Label.

Apart from that, BPOM Regulation No. 1 of 2018 on Control of Processed Food for Special Nutritional Purposes stipulates that all PKGK products must contain the following information on their labels:

Ÿ Product type name

Ÿ Intended use

Ÿ Preparation method

Ÿ Serving method

Ÿ Storage method

Ÿ Warnings

Ÿ Nutritional value information

In addition, for all PDK products, the caption "CONSULT WITH A HEALTH PERSONNEL" must be stated in bold on the labels. While for all PKMK products, the followings must be included on the labels:

Ÿ "MUST HAVE A DOCTOR'S PRESCRIPTION"

Ÿ“The Product is not for Parenteral Use"

Ÿ Osmolality values of products administered enterally through a feeding tube (nasogastric tube)

Importantly, for each type of PKGK products, it must also comply with additional specific labeling requirements stated in Appendix 1 of BPOM Regulation No. 24 of 2020. For instance, infant formula products must clearly indicate the source of protein used in the products, and carry special statements as "Infant formula products are not sterile products, therefore please pay attention to the preparation instructions" and "Breast milk is the best food for your baby."

3) Safety, nutrition and quality

For each type of PKGK products, it must meet corresponding requirements for its safety, nutrition and quality in Appendix 1 of BPOM BPOM Regulation No. 24 of 2020.

Take infant formula for example, A.1.1 of Appendix 1 establishes detailed requirements and indicators for its safety, nutrition and quality, covering descriptions and definitions, ingredients, nutritional components, food additives, etc.

Protein content of infant formula

 5. Advertising  

Regulated by BPOM Regulation No. 6 of 2021 on the Supervision of Processed Food Advertising, PKGK products are allowed to be advertised. However, infant formula and follow-up formula are prohibited from being advertised in any mass media except in print media specifically about health.

6. Post-Market Supervision 

Once a PKGK product is on the market, it is subject to continuous post-market surveillance. This ensures that the products maintain their quality and safety over time. BPOM conducts regular inspections, monitors adverse event reports, and may initiate product recalls if safety issues arise.

The surveillance process is a collaborative effort between BPOM, manufacturers, and consumers. Consumers are encouraged to report any adverse events or violations of labeling and safety standards, which will be then investigated by BPOM.